-CITE-
    21 USC TITLE 21 - FOOD AND DRUGS                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    
-HEAD-    
                         TITLE 21 - FOOD AND DRUGS                     


-MISC1-
                                                                
    Chap.                                                            Sec.
    1.      Adulterated or Misbranded Foods or Drugs                   1
    2.      Teas [Repealed]                                           41
    3.      Filled Milk                                               61
    4.      Animals, Meats, and Meat and Dairy Products               71
    5.      Viruses, Serums, Toxins, Antitoxins, and Analogous
             Products                                                151
    5A.     Bureau of Narcotics [Omitted]                            161
    6.      Narcotic Drugs [Repealed or Transferred]                 171
    7.      Practice of Pharmacy and Sale of Poisons in Consular
             Districts in China                                      201
    8.      Narcotic Farms [Repealed]                                221
    9.      Federal Food, Drug, and Cosmetic Act                     301
    10.     Poultry and Poultry Products Inspection                  451
    11.     Manufacture of Narcotic Drugs [Repealed]                 501
    12.     Meat Inspection                                          601
    13.     Drug Abuse Prevention and Control                        801
    14.     Alcohol and Drug Abuse Educational Programs and
             Activities [Repealed]                                  1001
    15.     Egg Products Inspection                                 1031
    16.     Drug Abuse Prevention, Treatment, and Rehabilitation    1101
    17.     National Drug Enforcement Policy [Repealed]             1201
    18.     President's Media Commission on Alcohol and Drug
             Abuse Prevention [Omitted]                             1301
    19.     Pesticide Monitoring Improvements                       1401
    20.     National Drug Control Program                           1501
    21.     Biomaterials Access Assurance                           1601
    22.     National Drug Control Policy                            1701
    23.     National Youth Anti-Drug Media Campaign [Repealed]      1801
    24.     International Narcotics Trafficking                     1901
    25.     Miscellaneous Anti-Drug Abuse Provisions                2001

-End-


-CITE-
    21 USC CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR
           DRUGS                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS

-HEAD-
           CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS       


-MISC1-
             SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906         
    Sec.                                                     
    1 to 15.    Repealed or Transferred.                              

                 SUBCHAPTER II - MISCELLANEOUS PROVISIONS             
    16.         Introduction into, or sale in, State or Territory or
                 District of Columbia of dairy or food products
                 falsely labeled or branded.                          
    17.         Penalty for sale or introduction of falsely labeled
                 dairy or food products; venue.                       
    18.         Suspension of importation of adulterated articles.    
    19.         Repealed.                                             
    20.         Apples in interstate commerce; standard grades.       
    21.         Branding grades on barrels of apples.                 
    22.         Barrels misbranded.                                   
    23.         Penalties.                                            
    24.         Omitted.                                              
    25.         Oleomargarine, butterine, or imitation butter or
                 cheese transported into a State subject to its police
                 powers.                                              
    26.         Omitted.                                              

-End-


-CITE-
    21 USC SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906

-HEAD-
             SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906         

-End-



-CITE-
    21 USC Secs. 1 to 5                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906

-HEAD-
    Secs. 1 to 5. Repealed.

-MISC1-
    Secs. 1 to 5. Repealed. June 25, 1938, ch. 675, Sec. 902(a), 52
      Stat. 1059.
      Section 1, act June 30, 1906, ch. 3915, Sec. 1, 34 Stat. 768,
    made it unlawful to manufacture adulterated or misbranded foods or
    drugs in Territories or District of Columbia and provided penalty
    for violations. See sections 331 and 333 of this title.
      Section 2, act June 30, 1906, ch. 3915, Sec. 2, 34 Stat. 768,
    prohibited introduction, shipment, delivery or sale of adulterated
    or misbranded foods or drugs in interstate or foreign commerce,
    provided penalty for violations and exempted exports conforming to
    specifications of foreign purchaser and not in conflict with laws
    of foreign country importing the same. See sections 331, 333 and
    381 of this title.
      Section 3, acts June 30, 1906, ch. 3915, Sec. 3, 34 Stat. 768;
    Mar. 4, 1913, ch. 141, Sec. 1, 37 Stat. 736, authorized Secretaries
    of the Treasury, Agriculture, and Commerce to make uniform rules
    and regulations for enforcement of food and drug laws, including
    collection and examination of specimens. See section 371 of this
    title.
      Section 4, act June 30, 1906, ch. 3915, Sec. 12, 34 Stat. 772,
    provided that act or omission of officer, agent, and so forth, of
    corporation, shall be deemed act or omission of corporation.
      Section 5, act June 30, 1906, ch. 3915, Sec. 12, 34 Stat. 772,
    defined "territory" and "person". See section 321 of this title and
    section 1 of Title 1, General Provisions.

                         EFFECTIVE DATE OF REPEAL                     
      Section 902(a) of act June 25, 1938, ch. 675, 52 Stat. 1059,
    which repealed sections 1 to 5, 7 to 14, and 15 of this title,
    provided that the repeal of those sections should take effect upon
    the effective date of act June 25, 1938, which was to take effect
    twelve months after the date of its enactment. Act June 23, 1939,
    ch. 242, Sec. 2(b), 53 Stat. 854, provided that: "The provisions of
    such act of June 30, 1906, as amended, to the extent that they
    impose, or authorize the imposition of, any requirement imposed by
    section 403(k) of the Federal Food, Drug, and Cosmetic Act [section
    343(k) of this title], shall remain in force until January 1,
    1940."

-End-



-CITE-
    21 USC Sec. 6                                               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906

-HEAD-
    Sec. 6. Transferred

-COD-
                               CODIFICATION                           
      Section, act Mar. 4, 1923, ch. 268, 42 Stat. 1500, was
    transferred to section 321a of this title.

-End-



-CITE-
    21 USC Secs. 7 to 14                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906

-HEAD-
    Secs. 7 to 14. Repealed.

-MISC1-
    Secs. 7 to 14. Repealed. June 25, 1938, ch. 675, Sec. 902(a), 52
      Stat. 1059.
      Section 7, act June 30, 1906, ch. 3915, Sec. 6, 34 Stat. 769,
    defined "drug" and "food". See section 321 of this title.
      Section 8, act June 30, 1906, ch. 3915, Sec. 7, 34 Stat. 769,
    deemed drugs to be adulterated when sold having a difference from
    recognized standards, except where there is an explanatory
    statement on or in container, and when sold below professed
    standard; confectioneries, when containing mineral substances,
    poisonous color or flavors, other deleterious ingredients, liquors
    or narcotics; food, when concerned with injurious mixtures, use of
    substitutes, abstraction of valuable constituents, concealment of
    damage or inferiority, deleterious ingredients, preservatives in
    shipment conditionally excepted, animal or vegetable substances
    unfit for food and products of animals diseased or having died
    otherwise than by slaughter. See sections 342 and 351 of this
    title.
      Section 9, act June 30, 1906, ch. 3915, Sec. 8, 34 Stat. 771,
    defined "misbranded" and provided for its application to drugs and
    food. See sections 343 and 352 of this title.
      Section 10, acts June 30, 1906, ch. 3915, Sec. 8, 34 Stat. 771;
    Aug. 23, 1912, ch. 352, 37 Stat. 416; Mar. 3, 1913, ch. 117, 37
    Stat. 732; July 24, 1919, ch. 26, 41 Stat. 271; July 8, 1930, ch.
    874, 46 Stat. 1019, deemed drugs to be misbranded when there is an
    imitation or use of name of other article, when there is removal
    and substitution of contents of package or failure to state on
    label quantity or proportion of narcotics therein, and when there
    is a false statement of curative or therapeutic effect; and food,
    when there is an imitation or use of name of other article, when
    there is a false label or brand removal and substitution of
    contents of package, or failure to state or label quantity or
    proportion of narcotics therein, when the packages are not marked
    with weight, with certain variations and exemptions permitted, when
    there are false or misleading statements on package or label as to
    ingredients or substances; and food, when mixtures or compounds
    under distinctive names, the articles are labeled, branded as
    compounds, imitations, or blends; construed the term "blend" and
    related to disclosure of trade formulas of proprietary foods, and
    canned food. See sections 321b, 341, 343 and 352 of this title.
      Section 11, acts June 30, 1906, ch. 3915, Sec. 4, 34 Stat. 769;
    Jan. 18, 1927, ch. 39, 44 Stat. 1003, provided for examination of
    specimens, notice of adulteration or misbranding, hearing,
    certification of violations to United States district attorney and
    notice of judgment.
      Section 12, act June 30, 1906, ch. 3915, Sec. 5, 34 Stat. 769,
    provided for prosecution by district attorneys for enforcement of
    penalties.
      Section 13, act June 30, 1906, ch. 3915, Sec. 9, 34 Stat. 771,
    provided for a seller's guaranty as protection to dealer. See
    section 333 of this title.
      Section 14, act June 30, 1906, ch. 3915, Sec. 10, 34 Stat. 771,
    provided for seizure of articles by libel for condemnation, at suit
    of and in name of United States, in United States district court
    where found, conforming to proceedings in admiralty, with right to
    trial by jury, destruction or sale of adulterated or misbranded
    articles, bond and payment of proceeds into Treasury of United
    States. See sections 332, 334 and 337 of this title.

                         EFFECTIVE DATE OF REPEAL                     
      For effective date of repeal, see section 902(a) of act June 25,
    1938, set out as a note under sections 1 to 5 of this title.

-End-



-CITE-
    21 USC Sec. 14a                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906

-HEAD-
    Sec. 14a. Transferred

-COD-
                               CODIFICATION                           
      Section, act June 30, 1906, ch. 3915, Sec. 10A, as added June 22,
    1934, ch. 712, 48 Stat. 1204, and amended, which related to
    examination of sea food on request of packer, marking of food with
    results, fees, and penalties, was successively renumbered section
    702A and then 706 of the Federal Food, Drug, and Cosmetic Act by
    act July 12, 1943, ch. 221, title II, Sec. 201, 57 Stat. 500, and
    by Pub. L. 102-571, title I, Sec. 106(3), Oct. 29, 1992, 106 Stat.
    4498, and was successively classified to section 372a and then 376
    of this title.

-End-



-CITE-
    21 USC Sec. 15                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906

-HEAD-
    Sec. 15. Repealed.

-MISC1-
    Sec. 15. Repealed. June 25, 1938, ch. 675, Sec. 902(a), 52 Stat.
      1059.
      Section, act June 30, 1906, ch. 3915, Sec. 11, 34 Stat. 772,
    provided for examination of samples of imports, refusal of
    admission and delivery to consignee, delivery to consignee pending
    examination and decision on bond and charges for storage and lien
    therefor. See section 381 of this title.

                         EFFECTIVE DATE OF REPEAL                     
      For effective date of repeal, see section 902(a) of act June 25,
    1938, set out as a note under sections 1 to 5 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER II - MISCELLANEOUS PROVISIONS             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
                 SUBCHAPTER II - MISCELLANEOUS PROVISIONS             

-End-



-CITE-
    21 USC Sec. 16                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 16. Introduction into, or sale in, State or Territory or
      District of Columbia of dairy or food products falsely labeled or
      branded

-STATUTE-
      No person or persons, company or corporation, shall introduce
    into any State or Territory of the United States or the District of
    Columbia from any other State or Territory of the United States or
    the District of Columbia, or sell in the District of Columbia or in
    any Territory any dairy or food products which shall be falsely
    labeled or branded as to the State or Territory in which they are
    made, produced, or grown, or cause or procure the same to be done
    by others.

-SOURCE-
    (July 1, 1902, ch. 1357, Sec. 1, 32 Stat. 632.)

-End-



-CITE-
    21 USC Sec. 17                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 17. Penalty for sale or introduction of falsely labeled dairy
      or food products; venue

-STATUTE-
      If any person or persons violate the provisions of section 16 of
    this title, either in person or through another, he shall be guilty
    of a misdemeanor and shall be punished by a fine of not less than
    $500 nor more than $2,000. The jurisdiction for the prosecution of
    said misdemeanor shall be within the district of the United States
    court in which it is committed.

-SOURCE-
    (July 1, 1902, ch. 1357, Sec. 2, 32 Stat. 632.)

-End-



-CITE-
    21 USC Sec. 18                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 18. Suspension of importation of adulterated articles

-STATUTE-
      Whenever the President is satisfied that there is good reason to
    believe that any importation is being made, or is about to be made,
    into the United States, from any foreign country, of any article
    used for human food or drink that is adulterated to an extent
    dangerous to the health or welfare of the people of the United
    States, or any of them, he may issue his proclamation suspending
    the importation of such articles from such country for such period
    of time as he may think necessary to prevent such importation; and
    during such period it shall be unlawful to import into the United
    States from the countries designated in the proclamation of the
    President any of the articles the importation of which is so
    suspended.

-SOURCE-
    (Aug. 30, 1890, ch. 839, Sec. 4, 26 Stat. 415.)

-End-



-CITE-
    21 USC Sec. 19                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 19. Repealed.

-MISC1-
    Sec. 19. Repealed. May 29, 1928, ch. 901, Sec. 1(100), 45 Stat. 993.
      Section, act May 23, 1908, ch. 192, 35 Stat. 261, related to
    report to Congress of expenditures in enforcing food and drug laws.

-End-



-CITE-
    21 USC Sec. 20                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 20. Apples in interstate commerce; standard grades

-STATUTE-
      The standard grades for apples when packed in barrels which shall
    be shipped or delivered for shipment in interstate or foreign
    commerce, or which shall be sold or offered for sale within the
    District of Columbia or the Territories of the United States shall
    be as follows: Apples of one variety, which are well-grown
    specimens, hand picked, of good color for the variety, normal
    shape, practically free from insect and fungous injury, bruises,
    and other defects, except such as are necessarily caused in the
    operation of packing, or apples of one variety which are not more
    than 10 per centum below the foregoing specifications shall be
    "Standard grade minimum size two and one-half inches", if the
    minimum size of the apples is two and one-half inches in transverse
    diameter; "Standard grade minimum size two and one-fourth inches",
    if the minimum size of the apples is two and one-fourth inches in
    transverse diameter; or "Standard grade minimum size two inches",
    if the minimum size of the apples is two inches in transverse
    diameter.

-SOURCE-
    (Aug. 3, 1912, ch. 273, Sec. 2, 37 Stat. 250.)

-End-



-CITE-
    21 USC Sec. 21                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 21. Branding grades on barrels of apples

-STATUTE-
      The barrels in which apples are packed in accordance with the
    provisions of sections 20 to 23 of this title may be branded in
    accordance with the provisions of section 20 of this title.

-SOURCE-
    (Aug. 3, 1912, ch. 273, Sec. 3, 37 Stat. 251.)

-End-



-CITE-
    21 USC Sec. 22                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 22. Barrels misbranded

-STATUTE-
      Barrels packed with apples shall be deemed to be misbranded
    within the meaning of sections 20 to 23 of this title - 
      First. If the barrel bears any statement, design, or device
    indicating that the apples contained therein are "Standard" grade
    and the apples when packed do not conform to the requirements
    prescribed by section 20 of this title.
      Second. If the barrel bears any statement, design, or device
    indicating that the apples contained therein are "Standard" grade
    and the barrel fails to bear also a statement of the name of the
    variety, the name of the locality where grown, and the name of the
    packer or the person by whose authority the apples were packed and
    the barrel marked.

-SOURCE-
    (Aug. 3, 1912, ch. 273, Sec. 5, 37 Stat. 251.)

-End-



-CITE-
    21 USC Sec. 23                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 23. Penalties

-STATUTE-
      Any person, firm or corporation, or association who shall
    knowingly pack or cause to be packed apples in barrels or who shall
    knowingly sell or offer for sale such barrels in violation of the
    provisions of sections 20 to 23 of this title shall be liable to a
    penalty of $1 and costs for each such barrel so sold or offered for
    sale, to be recovered at the suit of the United States in any court
    of the United States having jurisdiction.

-SOURCE-
    (Aug. 3, 1912, ch. 273, Sec. 6, 37 Stat. 251.)

-COD-
                               CODIFICATION                           
      Section is also set out as section 233 of Title 15, Commerce and
    Trade.

-End-



-CITE-
    21 USC Sec. 24                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 24. Omitted

-COD-
                               CODIFICATION                           
      Section, act Mar. 4, 1915, ch. 144, 38 Stat. 1102, related to
    payment of the cost of inspection under a provision authorizing the
    investigation of the character of chemical and physical tests
    applied to American food products in foreign countries and the
    inspection of such products before shipment to such countries at
    the request of the shippers or owners. That provision was repeated
    in subsequent appropriation acts but was omitted from the
    appropriation act of July 12, 1943, ch. 221, 57 Stat. 494, and from
    all subsequent appropriation acts.

-End-



-CITE-
    21 USC Sec. 25                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 25. Oleomargarine, butterine, or imitation butter or cheese
      transported into a State subject to its police powers

-STATUTE-
      All articles known as oleomargarine, butterine, imitation,
    process, renovated, or adulterated butter, or imitation cheese, or
    any substance in the semblance of butter or cheese not the usual
    product of the dairy and not made exclusively of pure and
    unadulterated milk or cream, transported into any State or
    Territory or the District of Columbia, and remaining therein for
    use, consumption, sale, or storage therein, shall, upon the arrival
    within the limits of such State or Territory or the District of
    Columbia, be subject to the operation and effect of the laws of
    such State or Territory or the District of Columbia, enacted in the
    exercise of its police powers to the same extent and in the same
    manner as though such articles or substances had been produced in
    such State or Territory or the District of Columbia, and shall not
    be exempt therefrom by reason of being introduced therein in
    original packages or otherwise.

-SOURCE-
    (May 9, 1902, ch. 784, Sec. 1, 32 Stat. 193.)

-End-



-CITE-
    21 USC Sec. 26                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
    SUBCHAPTER II - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 26. Omitted

-COD-
                               CODIFICATION                           
      Section, which was from the appropriation acts of Jan. 18, 1927,
    ch. 39, 44 Stat. 984; May 16, 1928, ch. 572, 45 Stat. 548; Feb. 16,
    1929, ch. 227, 45 Stat. 1198; May 27, 1930, ch. 341, 46 Stat. 424,
    and subsequent Department of Agriculture Appropriation Acts to and
    including act June 28, 1944, ch. 296, Sec. 4, 58 Stat. 461, and
    related to inspection of food and other products, is covered by
    section 2256 of Title 7, Agriculture.

-End-


-CITE-
    21 USC CHAPTER 2 - TEAS                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 2 - TEAS

-HEAD-
                             CHAPTER 2 - TEAS                         

-End-



-CITE-
    21 USC Secs. 41 to 50                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 2 - TEAS

-HEAD-
    Secs. 41 to 50. Repealed.

-MISC1-
    Secs. 41 to 50. Repealed. Pub. L. 104-128, Sec. 2, Apr. 9, 1996,
      110 Stat. 1198.
      Section 41, acts Mar. 2, 1897, ch. 358, Sec. 1, 29 Stat. 604; May
    16, 1908, ch. 170, 35 Stat. 163; May 31, 1920, ch. 217, 41 Stat.
    712; 1940 Reorg. Plan No. IV, Sec. 12, eff. June 30, 1940, 5 F.R.
    2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11,
    1953, 18 F.R. 2053, 67 Stat. 631; May 24, 1962, Pub. L. 87-456,
    title III, Sec. 303(a), 76 Stat. 77; Aug. 23, 1988, Pub. L. 100-
    418, title I, Sec. 1214(l), 102 Stat. 1158, prohibited unlawful
    importation of substandard tea.
      Section 42, acts Mar. 2, 1897, ch. 358, Sec. 2, 29 Stat. 605; May
    31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec. 12,
    eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; July 12, 1943, ch.
    221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, Sec. 5, eff.
    Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L.
    96-88, title V, Sec. 509(b), 93 Stat. 695, related to establishment
    and composition of board of experts in teas.
      Section 43, acts Mar. 2, 1897, ch. 358, Sec. 3, 29 Stat. 605; May
    31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec. 12,
    eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
    No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct.
    17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
    authorized establishment of purity standards.
      Section 44, acts Mar. 2, 1897, ch. 358, Sec. 4, 29 Stat. 605; May
    31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec. 12,
    eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
    No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct.
    17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
    related to bonds of importers, examination of imported teas, and
    importation at ports without examiners.
      Section 45, act Mar. 2, 1897, ch. 358, Sec. 5, 29 Stat. 605,
    related to delivery permits and reexamination and retention of
    substandard teas.
      Section 46, acts Mar. 2, 1897, ch. 358, Sec. 7, 29 Stat. 606; May
    31, 1920, ch. 217, 41 Stat. 712, 713, related to examiners and
    examination according to usages of trade.
      Section 46a, acts Mar. 2, 1897, ch. 358, Sec. 13, formerly act
    July 1, 1941, ch. 269, title II, 55 Stat. 478; renumbered Sec. 13
    of act Mar. 2, 1897, and amended Aug. 10, 1993, Pub. L. 103-66,
    title IV, Sec. 4401, 107 Stat. 378, related to deposit of fee prior
    to examination.
      Section 47, acts Mar. 2, 1897, ch. 358, Sec. 6, 29 Stat. 606; May
    31, 1920, ch. 217, 41 Stat. 712, 713; 1940 Reorg. Plan No. IV, Sec.
    12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg.
    Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631;
    Oct. 17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
    required referral of disputes to United States Board of Tea Appeals
    and authorized board to permit delivery or order destruction or
    exportation of substandard teas.
      Section 48, acts Mar. 2, 1897, ch. 358, Sec. 8, 29 Stat. 606; May
    31, 1920, ch. 217, 41 Stat. 712, related to reexaminations,
    including findings by examiner and assistance of experts.
      Section 49, acts Mar. 2, 1897, ch. 358, Sec. 9, 29 Stat. 606; May
    31, 1920, ch. 217, 41 Stat. 712, related to reimporting rejected
    teas and forfeitures for violation of provisions.
      Section 50, acts Mar. 2, 1897, ch. 358, Sec. 10, 29 Stat. 607;
    May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec.
    12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg.
    Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631;
    Oct. 17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
    authorized issuance of regulations.

                         EFFECTIVE DATE OF REPEAL                     
      Section 3 of Pub. L. 104-128 provided that: "This Act [repealing
    this chapter] shall take effect on the date of enactment of this
    Act [Apr. 9, 1996]."

                           SHORT TITLE OF REPEAL                       
      Section 1 of Pub. L. 104-128 provided that: "This Act [repealing
    this chapter] may be cited as the 'Federal Tea Tasters Repeal Act
    of 1996'."

                                SHORT TITLE                            
      Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
    part that act Mar. 2, 1897, which was classified generally to this
    chapter, could be cited as the Tea Importation Act.

-End-


-CITE-
    21 USC CHAPTER 3 - FILLED MILK                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 3 - FILLED MILK

-HEAD-
                          CHAPTER 3 - FILLED MILK                      

-MISC1-
    Sec.                                                     
    61.         Definitions.                                          
    62.         Manufacture, shipment, or delivery for shipment in
                 interstate or foreign commerce prohibited.           
    63.         Penalties; acts of agents deemed acts of principals.  
    64.         Regulations for enforcement.                          

                   FEDERAL FOOD, DRUG, AND COSMETIC ACT               
      By virtue of act June 25, 1938, ch. 675, Sec. 902(c), 52 Stat.
    1059 [section 392(b) of this title], nothing contained in section
    301 et seq. of this title shall be construed as in any way
    affecting, modifying, repealing, or superseding the provisions of
    sections 61 to 64 of this title.

                         BUREAU OF DAIRY INDUSTRY                     
      General provisions, see sections 401 to 404 of Title 7,
    Agriculture.

-End-



-CITE-
    21 USC Sec. 61                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 3 - FILLED MILK

-HEAD-
    Sec. 61. Definitions

-STATUTE-
      Whenever used in this chapter - 
      (a) The term "person" includes an individual, partnership,
    corporation, or association;
      (b) The term "interstate or foreign commerce" means commerce (1)
    between any State, Territory, or possession, or the District of
    Columbia, and any place outside thereof; (2) between points within
    the same State, Territory, or possession, or within the District of
    Columbia, but through any place outside thereof; or (3) within any
    Territory or possession, or within the District of Columbia; and
      (c) The term "filled milk" means any milk, cream, or skimmed
    milk, whether or not condensed, evaporated, concentrated, powdered,
    dried, or desiccated, to which has been added, or which has been
    blended or compounded with, any fat or oil other than milk fat, so
    that the resulting product is in imitation or semblance of milk,
    cream, or skimmed milk, whether or not condensed, evaporated,
    concentrated, powdered, dried, or desiccated. This definition shall
    not include any distinctive proprietary food compound not readily
    mistaken in taste for milk or cream or for evaporated, condensed,
    or powdered milk, or cream where such compound (1) is prepared and
    designed for feeding infants and young children and customarily
    used on the order of a physician; (2) is packed in individual cans
    containing not more than sixteen and one-half ounces and bearing a
    label in bold type that the content is to be used only for said
    purpose; (3) is shipped in interstate or foreign commerce
    exclusively to physicians, wholesale and retail druggists, orphan
    asylums, child-welfare associations, hospitals, and similar
    institutions and generally disposed of by them.

-SOURCE-
    (Mar. 4, 1923, ch. 262, Sec. 1, 42 Stat. 1486.)


-MISC1-
                                SHORT TITLE                            
      Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
    part that act Mar. 4, 1923, which enacted this chapter, may be
    cited as the "Filled Milk Act".

-End-



-CITE-
    21 USC Sec. 62                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 3 - FILLED MILK

-HEAD-
    Sec. 62. Manufacture, shipment, or delivery for shipment in
      interstate or foreign commerce prohibited

-STATUTE-
      It is declared that filled milk, as defined in section 61 of this
    title, is an adulterated article of food, injurious to the public
    health, and its sale constitutes a fraud upon the public. It shall
    be unlawful for any person to manufacture within any Territory or
    possession, or within the District of Columbia, or to ship or
    deliver for shipment in interstate or foreign commerce, any filled
    milk.

-SOURCE-
    (Mar. 4, 1923, ch. 262, Sec. 2, 42 Stat. 1487.)

-End-



-CITE-
    21 USC Sec. 63                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 3 - FILLED MILK

-HEAD-
    Sec. 63. Penalties; acts of agents deemed acts of principals

-STATUTE-
      Any person violating any provision of this chapter shall upon
    conviction thereof be subject to a fine of not more than $1,000 or
    imprisonment of not more than one year, or both. When construing
    and enforcing the provisions of this chapter, the act, omission, or
    failure of any person acting for or employed by any individual,
    partnership, corporation, or association, within the scope of his
    employment or office, shall in every case be deemed the act,
    omission, or failure, of such individual, partnership, corporation,
    or association, as well as of such person.

-SOURCE-
    (Mar. 4, 1923, ch. 262, Sec. 3, 42 Stat. 1487.)

-COD-
                               CODIFICATION                           
      The original text of this section contained a further provision
    that no penalty should be enforced for any violation occurring
    within 30 days after act Mar. 4, 1923 became law and was omitted as
    temporary and obsolete.

-End-



-CITE-
    21 USC Sec. 64                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 3 - FILLED MILK

-HEAD-
    Sec. 64. Regulations for enforcement

-STATUTE-
      The Secretary of Health and Human Services is authorized and
    directed to make and enforce such regulations as may in his
    judgment be necessary to carry out the purposes of this chapter.

-SOURCE-
    (Mar. 4, 1923, ch. 262, Sec. 4, as added Aug. 27, 1935, ch. 743, 49
    Stat. 885; 1940 Reorg. Plan No. IV, Sec. 12, eff. June 30, 1940, 5
    F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, Sec. 5, eff. Apr.
    11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96-88, title V, Sec.
    509(b), Oct. 17, 1979, 93 Stat. 695.)

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted in text for
    "Secretary of Health, Education, and Welfare" pursuant to section
    509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
    Title 20, Education.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration to Federal Security
    Agency, see notes set out under section 321 of this title.

-End-


-CITE-
    21 USC CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY
           PRODUCTS                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

-HEAD-
          CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS      


-MISC1-
     SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                                 PRODUCTS
    Sec.                                                     
    71 to 99.   Transferred, Repealed, or Omitted.                    

           SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE       
    101.        Suspension of importation of all animals.             
    102 to 107. Repealed or Omitted.                                  

    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
    111 to 113. Repealed or Omitted.                                  
    113a.       Establishment of research laboratories for
                 foot-and-mouth disease and other animal diseases;
                 research contracts; employment of technicians and
                 scientists; appropriations.                          
    114 to 114h. Repealed.                                            
    114i.       Pseudorabies eradication.                             
    115 to 135b. Repealed, Omitted, or Transferred.                   
    136.        Additional inspection services.                       
    136a.       Collection of fees for inspection services.           

               SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM           
    141.        Prohibition of importation without permit.            
    142.        Milk or cream when unfit for importation.             
    143.        Inspection; certified statement in lieu thereof;
                 waiver of requirements of section 142; regulations;
                 suspension and revocation of permits.                
    144.        Unlawful receiving of imported milk or cream.         
    145.        Penalties.                                            
    146.        Authorization of appropriations.                      
    147.        Repeal of inconsistent laws.                          
    148.        Powers of State with respect to milk or cream lawfully
                 imported.                                            
    149.        Definitions.                                          

-End-


-CITE-
    21 USC SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND
           MEAT AND DAIRY PRODUCTS                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
     SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                                 PRODUCTS

-End-



-CITE-
    21 USC Secs. 71 to 92                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Secs. 71 to 92. Transferred

-COD-
                               CODIFICATION                           
      Section 71, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which
    related to inspection of meat and meat food products, examination
    of cattle before slaughtering, separate slaughtering of diseased
    animals and examination of carcasses, was transferred to section
    603 of this title.
      Section 72, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which
    related to post mortem examination of carcasses, marking and
    labeling, destruction of condemned carcasses, and reinspection, was
    transferred to section 604 of this title.
      Section 73, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which
    related to examination of carcasses brought into slaughtering or
    packing establishments and of meat food products issued from and
    returned thereto, was transferred to section 605 of this title.
      Section 74, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which
    related to examination and inspection of meat food products, marks
    of inspection, destruction of condemned products, and products for
    export, was transferred to section 606 of this title.
      Section 75, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
    related to labeling of receptacles and coverings of meat and meat
    food products inspected and passed, supervision by inspectors,
    prohibition of sales under false names, was transferred to section
    607 of this title.
      Section 76, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
    related to sanitary inspection and regulation of slaughtering and
    packing establishments, and rejection of meat or meat food products
    unfit for food, was transferred to section 608 of this title.
      Section 77, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
    related to examination of cattle and food products thereof
    slaughtered and prepared during night time, was transferred to
    section 609 of this title.
      Section 78, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
    related to prohibition of transportation of carcasses, meat, or
    meat food products not properly inspected and marked, was
    transferred to section 610 of this title.
      Section 79, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to forgery, alteration, and unauthorized use of marks,
    labels, and certificates, was transferred to section 611 of this
    title.
      Section 80, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to inspection of animals for export, was transferred to
    section 612 of this title and was subsequently repealed by Pub. L.
    107-171, title X, Sec. 10418(a)(19), May 13, 2002, 116 Stat. 508.
      Section 81, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to certificates of condition of animals for export, was
    transferred to section 613 of this title and was subsequently
    repealed by Pub. L. 107-171, title X, Sec. 10418(a)(19), May 13,
    2002, 116 Stat. 508.
      Section 82, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to clearance to vessels carrying cattle for export with
    proper certificate of inspection, was transferred to section 614 of
    this title and was subsequently repealed by Pub. L. 107-171, title
    X, Sec. 10418(a)(19), May 13, 2002, 116 Stat. 508.
      Section 83, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to inspection of carcasses, the meat of which is intended
    for export, was transferred to section 615 of this title.
      Section 84, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to certificates of condition of carcasses, the meat of
    which is intended for export, was transferred to section 616 of
    this title.
      Section 85, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to clearance to vessels carrying meat for export with
    proper certificate of inspection, was transferred to section 617 of
    this title.
      Section 86, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
    related to official certificates of inspection and delivery of
    copies thereof to different parties, was transferred to section 618
    of this title.
      Section 87, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
    related to prohibition of transportation or sale of meat or meat
    food products without complying with provisions of inspection law,
    was transferred to section 619 of this title.
      Section 88, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
    related to offenses and penalties, was transferred to section 620
    of this title.
      Section 89, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
    related to appointment of inspectors, their duties, and rule making
    authority of the Secretary of Agriculture, was transferred to
    section 621 of this title.
      Section 90, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
    related to penalties for bribery, was transferred to section 622 of
    this title.
      Section 91, acts Mar. 4, 1907, ch. 2907, 34 Stat. 1265; June 29,
    1938, ch. 810, 52 Stat. 1235, which related to definitions,
    exceptions to inspection requirements in case of farmers and
    retailers, and penalties for sale of meat and meat food products
    unfit for food, was transferred to section 623 of this title.
      Section 92, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, which was
    a proviso following the first sentence of section 91 of this title,
    was restored to that section and has been transferred to section
    623 of this title.

-End-



-CITE-
    21 USC Sec. 93                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Sec. 93. Repealed.

-MISC1-
    Sec. 93. Repealed. May 29, 1928, ch. 901, Sec. 1(92), 45 Stat. 993.
      Section, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, related to
    statement in annual estimates as to persons employed, their
    compensation and expenses.

-End-



-CITE-
    21 USC Secs. 94 to 95                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Secs. 94 to 95. Transferred

-COD-
                               CODIFICATION                           
      Section 94, act June 30, 1914, ch. 131, 38 Stat. 420, which
    related to inspection of reindeer, was transferred to section 692
    of this title.
      Section 94a, act May 23, 1908, ch. 192, 35 Stat. 254, which
    related to inspection of dairy products for export, was transferred
    to section 693 of this title.
      Section 95, acts June 30, 1906, ch. 3913, 34 Stat. 679; June 26,
    1934, ch. 756, Sec. 2, 48 Stat. 1225, which related to
    authorization of appropriations for expenses of inspection, was
    transferred to section 694 of this title.

-End-



-CITE-
    21 USC Sec. 96                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Sec. 96. Repealed.

-MISC1-
    Sec. 96. Repealed. Pub. L. 90-201, Sec. 18, Dec. 15, 1967, 81 Stat.
      600.
      Section, act July 24, 1919, ch. 26, 41 Stat. 241, provided for
    marking horse meat transported in interstate commerce. See section
    619 of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Dec. 15, 1967, see section 20 of Pub. L. 90-201,
    set out as an Effective Date note under section 601 of this title.

-End-



-CITE-
    21 USC Secs. 97 to 97d                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Secs. 97 to 97d. Omitted

-COD-
                               CODIFICATION                           
      Sections 97 to 97d, act July 30, 1947, ch. 356, title I, Sec. 1,
    61 Stat. 531, 532, set up a meat inspection fund and provided for
    payment for meat inspection service by the persons or organizations
    who were furnished such inspection on and after July 1, 1947. These
    provisions ceased to be effective on July 1, 1948, under section 98
    of this title which requires the cost of such inspection to be
    borne by the United States. The unobligated balance in the meat
    inspection fund was carried to the general fund of the Treasury by
    act June 19, 1948, ch. 543, Sec. 1, 62 Stat. 515.

-End-



-CITE-
    21 USC Sec. 98                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Sec. 98. Transferred

-COD-
                               CODIFICATION                           
      Section, act June 5, 1948, ch. 423, 62 Stat. 344, which related
    to payment of cost of meat inspection, was transferred to section
    695 of this title.

-End-



-CITE-
    21 USC Sec. 99                                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
                    PRODUCTS                    

-HEAD-
    Sec. 99. Repealed.

-MISC1-
    Sec. 99. Repealed. July 28, 1953, ch. 251, title I, Sec. 101, 67
      Stat. 208.
      Section, act Aug. 31, 1951, ch. 374, title I, Sec. 101, 65 Stat.
    229, related to reimbursement for excess expenses of meat
    inspection.

-End-


-CITE-
    21 USC SUBCHAPTER II - IMPORTATION OF CATTLE AND
           QUARANTINE                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE

-HEAD-
           SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE       

-End-



-CITE-
    21 USC Sec. 101                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE

-HEAD-
    Sec. 101. Suspension of importation of all animals

-STATUTE-
      Whenever, in the opinion of the President, it shall be necessary
    for the protection of animals in the United States against
    infectious or contagious diseases, he may, by proclamation, suspend
    the importation of all or any class of animals for a limited time,
    and may change, modify, revoke, or renew such proclamation, as the
    public good may require; and during the time of such suspension the
    importation of any such animals shall be unlawful.

-SOURCE-
    (Aug. 30, 1890, ch. 839, Sec. 9, 26 Stat. 416.)

-End-



-CITE-
    21 USC Secs. 102 to 105                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE

-HEAD-
    Secs. 102 to 105. Repealed.

-MISC1-
    Secs. 102 to 105. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(6), May 13, 2002, 116 Stat. 507.
      Section 102, act Aug. 30, 1890, ch. 839, Sec. 7, 26 Stat. 416,
    related to quarantine of imported animals.
      Section 103, act Aug. 30, 1890, ch. 839, Sec. 8, 26 Stat. 416,
    related to prohibition of importation of animals except at
    quarantine ports, slaughter of infected animals, appraisal, and
    payment.
      Section 104, act Aug. 30, 1890, ch. 839, Sec. 6, 26 Stat. 416;
    June 28, 1926, ch. 700, Sec. 2, 44 Stat. 775; Feb. 28, 1931, ch.
    348, 46 Stat. 1460; July 22, 1954, ch. 558, Sec. 32, 68 Stat. 510;
    Jan. 28, 1956, ch. 12, Sec. 1, 70 Stat. 5; Pub. L. 97-461, Sec. 4,
    Jan. 12, 1983, 96 Stat. 2524; Pub. L. 103-182, title III, Sec.
    361(b), Dec. 8, 1993, 107 Stat. 2122; Pub. L. 103-465, title IV,
    Sec. 431(h), Dec. 8, 1994, 108 Stat. 4969, related to importation
    of animals.
      Section 105, act Aug. 30, 1890, ch. 839, Sec. 10, 26 Stat. 417;
    Pub. L. 103-182, title III, Sec. 361(c), Dec. 8, 1993, 107 Stat.
    2122; Pub. L. 103-465, title IV, Sec. 431(i), Dec. 8, 1994, 108
    Stat. 4969, related to inspection of animals.

-End-



-CITE-
    21 USC Secs. 106, 107                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE

-HEAD-
    Secs. 106, 107. Omitted

-COD-
                               CODIFICATION                           
      Sections, acts Aug. 10, 1917, ch. 52, Sec. 9, 40 Stat. 275; Nov.
    21, 1918, ch. 212, Sec. 3, 40 Stat. 1048, related to slaughter of
    tick-infested cattle. Section 12 of act Aug. 10, 1917, provided
    that the act should cease to be in effect when the national
    emergency resulting from World War I had passed.

-End-


-CITE-
    21 USC SUBCHAPTER III - PREVENTION OF INTRODUCTION AND
           SPREAD OF CONTAGION                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-End-



-CITE-
    21 USC Secs. 111, 112                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 111, 112. Repealed.

-MISC1-
    Secs. 111, 112. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508.
      Section 111, act Feb. 2, 1903, ch. 349, Sec. 2, 32 Stat. 792;
    July 22, 1954, ch. 558, Sec. 33, 68 Stat. 510; Jan. 28, 1956, ch.
    12, Sec. 2, 70 Stat. 5, related to regulations to prevent
    contagious diseases.
      Section 112, act May 29, 1884, ch. 60, Sec. 4, 23 Stat. 32; Feb.
    2, 1903, ch. 349, Sec. 1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45
    Stat. 59, related to investigations as to pleuropneumonia and other
    diseases and regulations.

                                SHORT TITLE                            
      Act Feb. 2, 1903, ch. 349, 32 Stat. 791, classified to former
    sections 112 and 120 to 122 of this title, is popularly known as
    the Cattle Contagious Diseases Act of 1903.
      Act May 29, 1884, ch. 60, 23 Stat. 31, classified to former
    sections 112, 113 to 114a-1, 115, 116, 117 to 120, and 130 of this
    title and section 391 of Title 7, Agriculture, is popularly known
    as the Animal Industry Act.

-End-



-CITE-
    21 USC Sec. 112a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 112a. Omitted

-COD-
                               CODIFICATION                           
      Section, act Feb. 7, 1928, ch. 30, 45 Stat. 59, amended acts May
    29, 1884, ch. 60, 23 Stat. 31; Feb. 2, 1903, ch. 349, 32 Stat. 791;
    and Mar. 3, 1905, ch. 1496, 33 Stat. 1264, to include live poultry
    in their provisions, added "and/or live poultry" following "live
    stock" wherever the term "live stock" appeared, and extended the
    penalties, terms, and provisions of said acts to live poultry. For
    complete classification of such acts to the Code, see Short Title
    note set out under section 112 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 113                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 113. Repealed.

-MISC1-
    Sec. 113. Repealed. Pub. L. 107-171, title X, Sec. 10418(a)(7),
      (8), May 13, 2002, 116 Stat. 507, 508.
      Section, act May 29, 1884, ch. 60, Sec. 5, 23 Stat. 32; Feb. 2,
    1903, ch. 349, Sec. 1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat.
    59, related to measures to prevent exportation of diseased
    livestock and live poultry.

-End-



-CITE-
    21 USC Sec. 113a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 113a. Establishment of research laboratories for foot-and-
      mouth disease and other animal diseases; research contracts;
      employment of technicians and scientists; appropriations

-STATUTE-
      The Secretary of Agriculture is authorized to establish research
    laboratories, including the acquisition of necessary land,
    buildings, or facilities, and also the making of research contracts
    under the authority contained in section 427i(a) of title 7, for
    research and study, in the United States or elsewhere, of foot-and-
    mouth disease and other animal diseases which in the opinion of
    the Secretary constitute a threat to the livestock industry of the
    United States: Provided, That no live virus of foot-and-mouth
    disease may be introduced for any purpose into any part of the
    mainland of the United States (except coastal islands separated
    therefrom by water navigable for deep-water navigation and which
    shall not be connected with the mainland by any tunnel) unless the
    Secretary determines that it is necessary and in the public
    interest for the conduct of research and study in the United States
    (except at Brookhaven National Laboratory in Upton, New York) and
    issues a permit under such rules as the Secretary shall promulgate
    to protect animal health, except that the Secretary of Agriculture
    may transport said virus in the original package across the
    mainland under adequate safeguards, and except further, that in the
    event of outbreak of foot-and-mouth disease in this country, the
    Secretary of Agriculture may, at his discretion, permit said virus
    to be brought into the United States under adequate safeguards. To
    carry out the provisions of this section, the Secretary is
    authorized to employ technical experts or scientists: Provided,
    That the number so employed shall not exceed five and that the
    maximum compensation for each shall not exceed the highest rate of
    grade 18 of the General Schedule. There is authorized to be
    appropriated such sums as Congress may deem necessary; in addition,
    the Secretary is authorized to utilize in carrying out this
    section, funds otherwise available for the control or eradication
    of such diseases.

-SOURCE-
    (May 29, 1884, ch. 60, Sec. 12, as added Apr. 24, 1948, ch. 229, 62
    Stat. 198; amended July 31, 1956, ch. 804, title I, Sec. 119, 70
    Stat. 742; Pub. L. 85-573, July 31, 1958, 72 Stat. 454; Pub. L. 87-
    793, Sec. 1001(e), Oct. 11, 1962, 76 Stat. 864; Pub. L. 88-426,
    title III, Sec. 305(1), Aug. 14, 1964, 78 Stat. 422; Pub. L. 101-
    624, title XVI, Sec. 1618(b), Nov. 28, 1990, 104 Stat. 3733.)

-COD-
                               CODIFICATION                           
      Provisions that authorized the Secretary to employ technical
    experts and scientists "without regard to the Classification Act",
    meaning the Classification Act of 1923, were omitted as obsolete.
    Sections 1202 and 1204 of the Classification Act of 1949, 63 Stat.
    972, 973, repealed the 1923 Act and all laws or parts of laws
    inconsistent with the 1949 Act. While section 1106(a) of the 1949
    Act provided that references in other laws to the 1923 Act should
    be held and considered to mean the 1949 Act, it did not have the
    effect of continuing the exception contained in this section
    because of section 1106(b) which provided that the application of
    the 1949 Act to any position, officer, or employee shall not be
    affected by section 1106(a). The Classification Act of 1949 was
    repealed by Pub. L. 89-554, Sept. 6, 1966, Sec. 8(a), 80 Stat. 632
    (the first section of which revised and enacted Title 5, Government
    Organization and Employees, into law). Section 5102 of Title 5
    contains the applicability provisions of the 1949 Act, and section
    5103 of Title 5 authorizes the Office of Personnel Management to
    determine the applicability to specific positions and employees.


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-624 substituted "United States (except" for
    "United States except" and "tunnel) unless the Secretary determines
    that it is necessary and in the public interest for the conduct of
    research and study in the United States (except at Brookhaven
    National Laboratory in Upton, New York) and issues a permit under
    such rules as the Secretary shall promulgate to protect animal
    health," for "tunnel, and".
      1962 - Pub. L. 87-793 substituted "shall not exceed the highest
    rate of grade 18 of the General Schedule" for "shall not exceed
    $19,000 per annum".
      1958 - Pub. L. 85-573 inserted in proviso clause of first
    sentence the exception clause respecting transportation of virus in
    original package across mainland under adequate safeguards.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-793 effective on first day of first pay
    period which begins on or after Oct. 11, 1962.

                                  REPEALS                              
      Act July 31, 1956, ch. 804, title I, Sec. 119, 70 Stat. 742,
    which increased the maximum compensation of technical experts or
    scientists, was repealed by Pub. L. 88-426, title III, Sec. 305(1),
    Aug. 14, 1964, 78 Stat. 422.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Secs. 114 to 114d-1                                  01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 114 to 114d-1. Repealed.

-MISC1-
    Secs. 114 to 114d-1. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(8), (9), May 13, 2002, 116 Stat. 508.
      Section 114, act May 29, 1884, ch. 60, Sec. 3, 23 Stat. 32,
    related to regulations for suppression of diseases and cooperation
    of States and Territories.
      Section 114a, act May 29, 1884, ch. 60, Sec. 11, as added Sept.
    21, 1944, ch. 412, title I, Sec. 101(a), 58 Stat. 734; amended Oct.
    30, 1951, ch. 637, Sec. 1, 65 Stat. 693; Aug. 8, 1953, ch. 381, 67
    Stat. 493; Aug. 3, 1956, ch. 950, Sec. 2, 70 Stat. 1032; Pub. L. 87-
    518, Sec. 7, July 2, 1962, 76 Stat. 131; Pub. L. 101-624, title
    XXV, Sec. 2509(c)(2), Nov. 28, 1990, 104 Stat. 4071, related to
    control and eradication of diseases, cooperation of States and
    farmers' associations, purchase and destruction of diseased
    animals, and defined "State" for statutory purposes.
      A prior section 11 of act May 29, 1884, required annual reports
    to Congress concerning the suppression of contagious diseases among
    domestic animals, and was classified to section 560 of former Title
    5, prior to repeal by act May 29, 1928, ch. 901, Sec. 1, 45 Stat.
    993.
      Section 114a-1, act May 29, 1884, ch. 60, Sec. 13, as added Oct.
    30, 1951, ch. 637, Sec. 2, 65 Stat. 693, related to interstate
    movement of domestic animals reacting to tests for brucellosis,
    immediate slaughter, and rules and regulations.
      Section 114b, act Feb. 28, 1947, ch. 8, Sec. 1, 61 Stat. 7; Pub.
    L. 89-521, Sec. 1, July 27, 1966, 80 Stat. 330; Pub. L. 92-152,
    Sec. 1, Nov. 5, 1971, 85 Stat. 418; Pub. L. 94-231, Sec. 3, Mar.
    15, 1976, 90 Stat. 216; Pub. L. 101-255, Sec. 1(1), Mar. 15, 1990,
    104 Stat. 114; Pub. L. 101-624, title XXV, Sec. 2505, Nov. 28,
    1990, 104 Stat. 4068, related to cooperation in animal disease
    control.
      Section 114c, act Feb. 28, 1947, ch. 8, Sec. 2, 61 Stat. 7; Aug.
    3, 1956, ch. 950, Sec. 3, 70 Stat. 1033; Pub. L. 92-152, Sec. 2,
    Nov. 5, 1971, 85 Stat. 419; Pub. L. 101-255, Sec. 1(2), Mar. 15,
    1990, 104 Stat. 114, related to use of funds.
      Section 114d, act Feb. 28, 1947, ch. 8, Sec. 3, as added Pub. L.
    101-255, Sec. 1(3), Mar. 15, 1990, 104 Stat. 114, related to sale
    of sterile screwworms.
      A prior section 114d, act Feb. 28, 1947, ch. 8, Sec. 3, 61 Stat.
    8, related to reports by Secretary of Agriculture to Congress with
    respect to activities carried on under sections 114b and 114c of
    this title, prior to repeal by Pub. L. 86-533, Sec. 1(20), June 29,
    1960, 74 Stat. 249.
      Section 114d-1, act Feb. 28, 1947, ch. 8, Sec. 5, as added Pub.
    L. 89-521, Sec. 2, July 27, 1966, 80 Stat. 330; amended Pub. L. 101-
    255, Sec. 1(5), Mar. 15, 1990, 104 Stat. 114, related to
    cooperation with public and private entities.

                                SHORT TITLE                            
      Section 6 of act Feb. 28, 1947, ch. 8, as added by Pub. L. 101-
    255, Sec. 1(6), Mar. 15, 1990, 104 Stat. 114, provided that the
    act Feb. 28, 1947, ch. 8, which enacted sections 114b to 114d-1 of
    this title and provisions set out as a note under former section
    114b of this title, could be referred to as the "Animal Disease
    Control Cooperation Act of 1947".

-End-



-CITE-
    21 USC Secs. 114d-2 to 114d-6                               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 114d-2 to 114d-6. Repealed.

-MISC1-
    Secs. 114d-2 to 114d-6. Repealed. Pub. L. 92-152, Sec. 3, Nov. 5,
      1971, 85 Stat. 419.
      Section 114d-2, Pub. L. 90-388, Sec. 1, July 6, 1968, 82 Stat.
    294, provided for cooperation with Central America in control and
    eradication of foot-and-mouth disease or rinderpest.
      Section 114d-3, Pub. L. 90-388, Sec. 2, July 6, 1968, 82 Stat.
    294, provided for uses of funds.
      Section 114d-4, Pub. L. 90-388, Sec. 3, July 6, 1968, 82 Stat.
    294, defined governments of Central America.
      Section 114d-5, Pub. L. 90-388, Sec. 4, July 6, 1968, 82 Stat.
    294, provided for cooperation with public and private organizations
    and individuals.
      Section 114d-6, Pub. L. 90-388, Sec. 5, July 6, 1968, 82 Stat.
    294, provided for authorization of appropriations.

-End-



-CITE-
    21 USC Secs. 114e to 114h                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 114e to 114h. Repealed.

-MISC1-
    Secs. 114e to 114h. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(10), (11), May 13, 2002, 116 Stat. 508.
      Section 114e, act June 16, 1948, ch. 477, Sec. 1, 62 Stat. 458,
    related to research and investigations into the control and
    eradication of cattle grubs.
      Section 114f, act June 16, 1948, ch. 477, Sec. 2, 62 Stat. 458,
    defined the term "State" and authorized appropriations.
      Section 114g, Pub. L. 87-209, Sec. 1, Sept. 6, 1961, 75 Stat.
    481, related to hog cholera eradication program.
      Section 114h, Pub. L. 87-209, Sec. 2, Sept. 6, 1961, 75 Stat.
    481, related to advisory committee.

-End-



-CITE-
    21 USC Sec. 114i                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 114i. Pseudorabies eradication

-STATUTE-
    (a) Findings
      Congress finds that efforts to eradicate pseudorabies in United
    States swine populations by the Department of Agriculture in
    cooperation with State agencies and the pork industry have a high
    priority and should be continued until pseudorabies is completely
    eradicated in the United States.
    (b) Establishment of program
      The Secretary of Agriculture shall establish and carry out a
    program for the eradication of pseudorabies in United States swine
    populations.
    (c) Use of funds for testing and control of pseudorabies
      The Secretary shall ensure that not less than 65 percent of the
    funds appropriated for the program established under subsection (b)
    of this section shall be used for testing and screening of animals
    and for other purposes directly related to the eradication or
    control of pseudorabies. This requirement on the use of
    appropriated funds for this program shall not be implemented in a
    manner that would adversely affect any other animal or plant
    disease or pest eradication or control program.
    (d) Authorization of appropriations
      There are authorized to be appropriated for each of the fiscal
    years 1991 through 2007 such sums as may be necessary for the
    purpose of carrying out the program established under subsection
    (b) of this section.

-SOURCE-
    (Pub. L. 101-624, title XXV, Sec. 2506, Nov. 28, 1990, 104 Stat.
    4068; Pub. L. 104-127, title IX, Sec. 916, Apr. 4, 1996, 110 Stat.
    1187; Pub. L. 107-171, title X, Sec. 10505, May 13, 2002, 116 Stat.
    511.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (d). Pub. L. 107-171 substituted "2007" for
    "2002".
      1996 - Subsec. (d). Pub. L. 104-127 substituted "2002" for
    "1995".

-End-



-CITE-
    21 USC Secs. 115 to 128                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 115 to 128. Repealed.

-MISC1-
    Secs. 115 to 128. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(7), (8), (12)-(14), May 13, 2002, 116 Stat. 507, 508.
      Section 115, act May 29, 1884, ch. 60, Sec. 6, 23 Stat. 32; June
    28, 1926, ch. 700, Sec. 1, 44 Stat. 774; Feb. 7, 1928, ch. 30, 45
    Stat. 59; Pub. L. 87-763, Oct. 9, 1962, 76 Stat. 762, prohibited
    transportation of diseased livestock and live poultry.
      Section 116, act May 29, 1884, ch. 60, 23 Stat. 31; May 31, 1920,
    ch. 217, 41 Stat. 699, related to excepted shipment of certain
    cattle.
      Section 117, act May 29, 1884, ch. 60, Sec. 7, 23 Stat. 32; Feb.
    7, 1928, ch. 30, 45 Stat. 59; Pub. L. 95-439, Sec. 1, Oct. 10,
    1978, 92 Stat. 1061; Pub. L. 97-461, Sec. 5, Jan. 12, 1983, 96
    Stat. 2524, related to penalties for transportation of diseased
    livestock or live poultry.
      Section 118, act May 29, 1884, ch. 60, Sec. 9, 23 Stat. 33; June
    25, 1948, ch. 646, Sec. 1, 62 Stat. 909, related to duty of United
    States attorneys.
      Section 119, act May 29, 1884, ch. 60, Sec. 2, 23 Stat. 31; Feb.
    9, 1889, ch. 122, Sec. 1, 25 Stat. 659; July 14, 1890, ch. 707, 26
    Stat. 288; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to
    appointment of agents to examine and report on methods of treatment
    of animals, and means for suppression of diseases.
      Section 120, act May 29, 1884, ch. 60, Secs. 4, 5, 23 Stat. 32;
    Feb. 2, 1903, ch. 349, Sec. 1, 32 Stat. 791; Feb. 7, 1928, ch. 30,
    45 Stat. 59, related to regulation of exportation and
    transportation of infected livestock and live poultry.
      Section 121, act Feb. 2, 1903, ch. 349, Sec. 1, 32 Stat. 791;
    Feb. 7, 1928, ch. 30, 45 Stat. 59, related to shipments from areas
    suspected to be infected and to control of animals and live
    poultry.
      Section 122, act Feb. 2, 1903, ch. 349, Sec. 3, 32 Stat. 792;
    Pub. L. 97-461, Sec. 6, Jan. 12, 1983, 96 Stat. 2525, related to
    offenses and penalties.
      Section 123, act Mar. 3, 1905, ch. 1496, Sec. 1, 33 Stat. 1264;
    Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(a), July
    2, 1962, 76 Stat. 131; Pub. L. 95-439, Sec. 2, Oct. 10, 1978, 92
    Stat. 1061, related to quarantine.
      Section 124, act Mar. 3, 1905, ch. 1496, Sec. 2, 33 Stat. 1264;
    Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(b), July
    2, 1962, 76 Stat. 131, prohibited transportation or delivery
    therefor from quarantined State or Territory or portion thereof, of
    quarantined animals and live poultry.
      Section 125, act Mar. 3, 1905, ch. 1496, Sec. 3, 33 Stat. 1265;
    Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(b), July
    2, 1962, 76 Stat. 131; Pub. L. 95-439, Sec. 3, Oct. 10, 1978, 92
    Stat. 1061, related to regulations for inspection, disinfection,
    and certification, and delivery and shipment of quarantined animals
    and live poultry from State or Territory.
      Section 126, act Mar. 3, 1905, ch. 1496, Sec. 4, 33 Stat. 1265;
    Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(b), July
    2, 1962, 76 Stat. 131, related to moving quarantined animals and
    live poultry from State or Territory, under regulations.
      Section 127, act Mar. 3, 1905, ch. 1496, Sec. 6, 33 Stat. 1265;
    Pub. L. 97-461, Sec. 7, Jan. 12, 1983, 96 Stat. 2525, related to
    penalties for transportation from quarantined State, Territory,
    etc.
      Section 128, act June 30, 1914, ch. 131, 38 Stat. 419; Pub. L. 87-
    518, Sec. 9, July 2, 1962, 76 Stat. 131, related to extension of
    quarantine law to carriers in interstate commerce.

                                SHORT TITLE                            
      Act Mar. 3, 1905, ch. 1496, 33 Stat. 1264, which enacted sections
    123 to 127 of this title, was popularly known as the "Cattle
    Contagious Diseases Act of 1905".

-End-



-CITE-
    21 USC Sec. 129                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 129. Omitted

-COD-
                               CODIFICATION                           
      Section, Pub. L. 107-76, title I, Nov. 28, 2001, 115 Stat. 712,
    related to transfer of funds for emergency arrest of animal,
    poultry, or plant diseases or pests, and was from the Agriculture,
    Rural Development, Food and Drug Administration, and Related
    Agencies Appropriations Act, 2002. Similar provisions which are
    permanent are classified to sections 7772 and 8316 of Title 7,
    Agriculture.


-MISC1-
                             PRIOR PROVISIONS                         
      Provisions similar to those in this section were contained in the
    following prior appropriation acts:
      Pub. L. 106-387, Sec. 1(a) [title I], Oct. 28, 2000, 114 Stat.
    1549, 1549A-9, repealed by Pub. L. 107-171, title X, Sec.
    10418(a)(15), May 13, 2002, 116 Stat. 508.
      Pub. L. 106-78, title I, Oct. 22, 1999, 113 Stat. 1143.
      Pub. L. 105-277, div. A, Sec. 101(a) [title I], Oct. 21, 1998,
    112 Stat. 2681, 2681-8.
      Pub. L. 105-86, title I, Nov. 18, 1997, 111 Stat. 2086.
      Pub. L. 104-180, title I, Aug. 6, 1996, 110 Stat. 1576.
      Pub. L. 104-37, title I, Oct. 21, 1995, 109 Stat. 307.
      Pub. L. 103-330, title I, Sept. 30, 1994, 108 Stat. 2443.
      Pub. L. 103-111, title I, Oct. 21, 1993, 107 Stat. 1054.
      Pub. L. 102-341, title I, Aug. 14, 1992, 106 Stat. 882.
      Pub. L. 102-142, title I, Oct. 28, 1991, 105 Stat. 886.
      Pub. L. 101-506, title I, Nov. 5, 1990, 104 Stat. 1323.
      Pub. L. 101-161, title I, Nov. 21, 1989, 103 Stat. 959.
      Pub. L. 100-460, title I, Oct. 1, 1988, 102 Stat. 2237.
      Pub. L. 100-202, Sec. 101(k) [title I], Dec. 22, 1987, 101 Stat.
    1329-322, 1329-331.
      Pub. L. 99-500, Sec. 101(a) [title I], Oct. 18, 1986, 100 Stat.
    1783, 1783-8, and Pub. L. 99-591, Sec. 101(a) [title I], Oct. 30,
    1986, 100 Stat. 3341, 3341-8.
      Pub. L. 99-190, Sec. 101(a) [H.R. 3037, title I], Dec. 19, 1985,
    99 Stat. 1185; Pub. L. 100-202, Sec. 106, Dec. 22, 1987, 101 Stat.
    1329-433.
      Pub. L. 97-370, title I, Dec. 18, 1982, 96 Stat. 1792.
      Pub. L. 97-103, title I, Dec. 23, 1981, 95 Stat. 1472.
      Pub. L. 96-528, title I, Dec. 15, 1980, 94 Stat. 3099.
      Pub. L. 96-108, title I, Nov. 9, 1979, 93 Stat. 826.
      Pub. L. 95-448, title I, Oct. 11, 1978, 92 Stat. 1076.
      Pub. L. 95-97, title I, Aug. 12, 1977, 91 Stat. 813.
      Pub. L. 94-351, title I, July 12, 1976, 90 Stat. 854.
      Pub. L. 94-122, title I, Oct. 21, 1975, 89 Stat. 645.
      Pub. L. 93-563, title I, Dec. 31, 1974, 88 Stat. 1824.
      Pub. L. 93-135, title I, Oct. 24, 1973, 87 Stat. 472.
      Pub. L. 92-399, title I, Aug. 22, 1972, 86 Stat. 594.
      Pub. L. 92-73, title I, Aug. 10, 1971, 85 Stat. 185.
      Pub. L. 91-566, title I, Dec. 22, 1970, 84 Stat. 1482.
      Pub. L. 91-127, title I, Nov. 26, 1969, 83 Stat. 246.
      Pub. L. 90-463, title I, Aug. 8, 1968, 82 Stat. 640.
      Pub. L. 90-113, title I, Oct. 24, 1967, 81 Stat. 321.
      Pub. L. 89-556, title I, Sept. 7, 1966, 80 Stat. 690.
      Pub. L. 89-316, title I, Nov. 2, 1965, 79 Stat. 1166.
      Pub. L. 88-573, title I, Sept. 2, 1964, 78 Stat. 863.
      Pub. L. 88-250, title I, Dec. 30, 1963, 77 Stat. 821.
      Pub. L. 87-879, title I, Oct. 24, 1962, 76 Stat. 1204.
      Pub. L. 87-112, title I, July 26, 1961, 75 Stat. 228.
      Pub. L. 86-532, title I, June 29, 1960, 74 Stat. 233.
      Pub. L. 86-80, title I, July 8, 1959, 73 Stat. 168.
      Pub. L. 85-459, title I, June 13, 1958, 72 Stat. 189.
      Pub. L. 85-118, title I, Aug. 2, 1957, 71 Stat. 330.
      June 4, 1956, ch. 355, title I, 70 Stat. 230.
      May 23, 1955, ch. 43, title I, 69 Stat. 52.
      June 29, 1954, ch. 409, title I, 68 Stat. 305.
      July 28, 1953, ch. 251, title III, 67 Stat. 223.
      July 5, 1952, ch. 574, title III, 66 Stat. 354.
      Aug. 31, 1951, ch. 374, title II, 65 Stat. 243.
      Sept. 6, 1950, ch. 896, Ch. VI, title I, 64 Stat. 661.
      June 29, 1949, ch. 280, title I, 63 Stat. 332.
      June 19, 1948, ch. 543, 62 Stat. 515.
      July 30, 1947, ch. 356, title I, 61 Stat. 532.
      June 22, 1946, ch. 445, 60 Stat. 278.
      May 5, 1945, ch. 109, 59 Stat. 144.
      June 28, 1944, ch. 296, 58 Stat. 434.
      July 12, 1943, ch. 215, 57 Stat. 403.
      July 22, 1942, ch. 516, 56 Stat. 676.
      July 1, 1941, ch. 267, 55 Stat. 418.
      June 25, 1940, ch. 421, 54 Stat. 542.
      June 30, 1939, ch. 253, title I, 53 Stat. 951.
      June 16, 1938, ch. 464, title I, 52 Stat. 722.
      June 29, 1937, ch. 404, 50 Stat. 406.
      June 4, 1936, ch. 489, 49 Stat. 1432.
      May 17, 1935, ch. 131, title I, 49 Stat. 257.
      Mar. 26, 1934, ch. 89, 48 Stat. 477.
      Mar. 3, 1933, ch. 203, 47 Stat. 1442.
      July 7, 1932, ch. 443, 47 Stat. 620.
      Feb. 23, 1931, ch. 278, 46 Stat. 1252.
      May 27, 1930, ch. 341, 46 Stat. 403.
      Feb. 16, 1929, ch. 227, 45 Stat. 1198.
      May 16, 1928, ch. 572, 45 Stat. 548.
      Jan. 18, 1927, ch. 39, 44 Stat. 1005.
      May 11, 1926, ch. 286, 44 Stat. 529.
      Feb. 10, 1925, ch. 200, 43 Stat. 851.
      Dec. 5, 1924, ch. 4, 43 Stat. 683.
      June 5, 1924, ch. 266, 43 Stat. 458.
      Apr. 2, 1924, ch. 81, 43 Stat. 40.
      Feb. 26, 1923, ch. 119, 42 Stat. 1318.
      May 11, 1922, ch. 185, 42 Stat. 536.
      Mar. 4, 1917, ch. 179, 39 Stat. 1167.

-End-



-CITE-
    21 USC Secs. 129a to 131                                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 129a to 131. Repealed.

-MISC1-
    Secs. 129a to 131. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(1), (8), (16), May 13, 2002, 116 Stat. 507, 508.
      Section 129a, Pub. L. 97-46, Sec. 1, Sept. 25, 1981, 95 Stat.
    953; Pub. L. 106-224, title IV, Sec. 438(b), June 20, 2000, 114
    Stat. 454, related to transfer of funds for emergency arrest of
    animal or poultry diseases. Section was formerly classified to
    section 147b of Title 7, Agriculture.
      Section 130, act May 29, 1884, ch. 60, Sec. 8, 23 Stat. 33; 1967
    Reorg. Plan No. 3, Sec. 402(430), eff. Aug. 11, 1967, 32 F.R.
    11669, 81 Stat. 948; Pub. L. 93-198, title IV, Sec. 401, Dec. 24,
    1973, 87 Stat. 793, related to pleuropneumonia in District of
    Columbia and duties of Council of the District of Columbia.
      Section 131, act May 26, 1910, ch. 256, 36 Stat. 440, related to
    fences along international boundary lines to keep out diseased
    animals.

                              EFFECTIVE DATE                          
      Pub. L. 97-46, Sec. 2, Sept. 25, 1981, 95 Stat. 953, provided
    that section 129a of this title was to become effective Sept. 25,
    1981, prior to repeal by Pub. L. 107-171, title X, Sec.
    10418(a)(1), May 13, 2002, 116 Stat. 507.

-End-



-CITE-
    21 USC Sec. 132                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 132. Transferred

-COD-
                               CODIFICATION                           
      Section, act May 23, 1908, ch. 192, 35 Stat. 254, which related
    to inspection of dairy products for export, was transferred to
    section 693 of this title.

-End-



-CITE-
    21 USC Sec. 133                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 133. Repealed.

-MISC1-
    Sec. 133. Repealed. July 13, 1949, ch. 307, 63 Stat. 410.
      Section, act July 24, 1946, ch. 592, 60 Stat. 633, related to
    establishment of a quarantine station on Swan Island.

-End-



-CITE-
    21 USC Secs. 134 to 135b                                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Secs. 134 to 135b. Repealed.

-MISC1-
    Secs. 134 to 135b. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(17), (18), May 13, 2002, 116 Stat. 508.
      Section 134, Pub. L. 87-518, Sec. 1, July 2, 1962, 76 Stat. 129,
    related to definitions for Pub. L. 87-518.
      Section 134a, Pub. L. 87-518, Sec. 2, July 2, 1962, 76 Stat. 129,
    related to seizure, quarantine, and disposal of livestock or
    poultry to guard against introduction or dissemination of
    communicable disease.
      Section 134b, Pub. L. 87-518, Sec. 3, July 2, 1962, 76 Stat. 130,
    related to regulations for clean and sanitary movement of animals.
      Section 134c, Pub. L. 87-518, Sec. 4, July 2, 1962, 76 Stat. 130,
    related to regulations for movement of animals affected or exposed
    to communicable disease.
      Section 134d, Pub. L. 87-518, Sec. 5, July 2, 1962, 76 Stat. 130,
    related to inspections, seizures, and issuance of warrants.
      Section 134e, Pub. L. 87-518, Sec. 6, July 2, 1962, 76 Stat. 131;
    Pub. L. 97-461, Sec. 8, Jan. 12, 1983, 96 Stat. 2525, related to
    enforcement provisions.
      Section 134f, Pub. L. 87-518, Sec. 11, July 2, 1962, 76 Stat.
    132, related to promulgation of regulations.
      Section 134g, Pub. L. 87-518, Sec. 12, July 2, 1962, 76 Stat.
    132, related to authority in addition to other laws and repeal of
    inconsistent provisions.
      Section 134h, Pub. L. 87-518, Sec. 13, July 2, 1962, 76 Stat.
    132, related to separability.
      Section 135, Pub. L. 91-239, Sec. 1, May 6, 1970, 84 Stat. 202;
    Pub. L. 103-465, title IV, Sec. 431(j), Dec. 8, 1994, 108 Stat.
    4969, related to the establishment of international animal
    quarantine station, acceptance of gifts, cooperation with breeders'
    organizations, and collection of fees.
      Section 135a, Pub. L. 91-239, Sec. 2, May 6, 1970, 84 Stat. 202;
    Pub. L. 97-461, Sec. 9, Jan. 12, 1983, 96 Stat. 2525, related to
    smuggling penalties.
      Section 135b, Pub. L. 91-239, Sec. 3, May 6, 1970, 84 Stat. 202,
    related to authorization of appropriations.

-End-



-CITE-
    21 USC Sec. 136                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 136. Additional inspection services

-STATUTE-
      The Secretary of Agriculture, in carrying out regulations
    prohibiting or restricting the entry of materials that may harbor
    pests, or diseases, is authorized to enter into agreements with
    operators or owners of vessels or aircraft for the purpose of
    providing inspection services at points of entry in the United
    States in addition to the regular or on-call basis currently
    available in connection with such vessels or aircraft. Any such
    agreement shall provide for the payment by the operator or owner of
    an amount determined by the Secretary to be necessary to defray the
    costs of providing additional service pursuant to such agreement.

-SOURCE-
    (Pub. L. 101-624, title XXV, Sec. 2508, Nov. 28, 1990, 104 Stat.
    4069.)

-End-



-CITE-
    21 USC Sec. 136a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

-HEAD-
    Sec. 136a. Collection of fees for inspection services

-STATUTE-
    (a) Quarantine and inspection fees
      (1) Fees authorized
        The Secretary of Agriculture may prescribe and collect fees
      sufficient - 
          (A) to cover the cost of providing agricultural quarantine
        and inspection services in connection with the arrival at a
        port in the customs territory of the United States, or the
        preclearance or preinspection at a site outside the customs
        territory of the United States, of an international passenger,
        commercial vessel, commercial aircraft, commercial truck, or
        railroad car;
          (B) to cover the cost of administering this subsection; and
          (C) through fiscal year 2002, to maintain a reasonable
        balance in the Agricultural Quarantine Inspection User Fee
        Account established under paragraph (5).
      (2) Limitation
        In setting the fees under paragraph (1), the Secretary shall
      ensure that the amount of the fees is commensurate with the costs
      of agricultural quarantine and inspection services with respect
      to the class of persons or entities paying the fees. The costs of
      the services with respect to passengers as a class includes the
      costs of related inspections of the aircraft or other vehicle.
      (3) Status of fees
        Fees collected under this subsection by any person on behalf of
      the Secretary are held in trust for the United States and shall
      be remitted to the Secretary in such manner and at such times as
      the Secretary may prescribe.
      (4) Late payment penalties
        If a person subject to a fee under this subsection fails to pay
      the fee when due, the Secretary shall assess a late payment
      penalty, and the overdue fees shall accrue interest, as required
      by section 3717 of title 31.
      (5) Agricultural quarantine inspection user fee account
        (A) Establishment
          There is established in the Treasury of the United States a
        fund, to be known as the "Agricultural Quarantine Inspection
        User Fee Account", which shall contain all of the fees
        collected under this subsection and late payment penalties and
        interest charges collected under paragraph (4) through fiscal
        year 2002.
        (B) Use of account
          For each of fiscal years 1996 through 2002, funds in the
        Agricultural Quarantine Inspection User Fee Account shall be
        available, in such amounts as are provided in advance in
        appropriations Acts, to cover the costs associated with the
        provision of agricultural quarantine and inspection services
        and the administration of this subsection. Amounts made
        available under this subparagraph shall be available until
        expended.
        (C) Excess fees
          Fees and other amounts collected under this subsection in any
        of fiscal years 1996 through 2002 in excess of $100,000,000
        shall be available for the purposes specified in subparagraph
        (B) until expended, without further appropriation.
      (6) Use of amounts collected after fiscal year 2002
        After September 30, 2002, the unobligated balance in the
      Agricultural Quarantine Inspection User Fee Account and fees and
      other amounts collected under this subsection shall be credited
      to the Department of Agriculture accounts that incur the costs
      associated with the provision of agricultural quarantine and
      inspection services and the administration of this subsection.
      The fees and other amounts shall remain available to the
      Secretary until expended without fiscal year limitation.
      (7) Staff years
        The number of full-time equivalent positions in the Department
      of Agriculture attributable to the provision of agricultural
      quarantine and inspection services and the administration of this
      subsection shall not be counted toward the limitation on the
      total number of full-time equivalent positions in all agencies
      specified in section 5(b) of the Federal Workforce Restructuring
      Act of 1994 (Public Law 103-226; 5 U.S.C. 3101 note) or other
      limitation on the total number of full-time equivalent positions.
    (b) Omitted
    (c) Animal inspection and veterinary diagnostics
      (1) Animal inspection
        The Secretary may prescribe and collect fees to reimburse the
      Secretary for the cost of carrying out the provisions of the
      Federal Animal Quarantine Laws that relate to the importation,
      entry, and exportation of animals, articles, or means of
      conveyance.
      (2) Veterinary diagnostics
        The Secretary may prescribe and collect fees to recover the
      costs of carrying out the provisions of the Animal Health
      Protection Act [7 U.S.C. 8301 et seq.] that relate to veterinary
      diagnostics.
      (3) Fees
        All fees collected pursuant to this subsection and any late
      payment penalties or accrued interest collected pursuant to this
      subsection shall be credited to the accounts that incur the cost
      and shall remain available until expended without fiscal year
      limitation.
      (4) Liability
        Any person for whom an activity related to the importation,
      entry, or exportation of an animal, article, or means of
      conveyance or relating to veterinary diagnostics, is performed
      pursuant to the section, shall be liable for payment of fees
      assessed. Upon failure to pay such fees when due, the Secretary
      shall assess a late payment penalty, and such overdue fees shall
      accrue interest, as required by section 3717 of title 31. All
      fees, late payment penalties, and accrued interest collected
      shall be credited to such accounts that incur the costs and shall
      remain available until expended without fiscal year limitation.
      (5) Leins (!1)

        (A) In general
          The Secretary shall have a lien against the animal, article,
        means of conveyance, or facility for which services have been
        provided under this section for the fees, any late payment
        penalty, and any accrued interest assessed under this
        subsection.
        (B) Other animals, etc.
          In the case of any person who fails to make payment when due
        under this subsection, the Secretary shall have a lien against
        any animal, article, or means of conveyance thereafter
        imported, moved in interstate commerce, or attempted to be
        exported by the person after the date of such failure until the
        date on which such owner or operator make (!2) full payment to
        the Secretary under this subsection.

        (C) Sales of animals, etc.
          (i) Authority
            The Secretary may, if a person does not pay fees, late
          payment penalties, or accrued interest on such, after
          providing reasonable notice of default to such person, sell
          at public sale after reasonable public notice, or otherwise
          dispose of, any such animal, article, means of conveyance or
          facility on which the Secretary has a lien under this
          paragraph.
          (ii) Excess proceeds
            If the sale proceeds under clause (i) exceed the fees due,
          any late payment penalty assessed, any accrued interest on
          such, and the expenses associated with the sale, such excess
          shall be paid to the owner of the animal, article, means of
          conveyance, or facility if such owner submits an application
          for such excess together with proof of ownership not later
          than 6 months after the date of such sale. If no such
          application is made, such excess shall be credited to
          accounts that incur the costs associated with the fees
          collected and shall remain available until expended, without
          fiscal year limitation. The Secretary shall suspend
          performance of services to persons who have failed to pay
          fees, late payment penalty, or accrued interest under this
          section.
    (d) Regulations
      The Secretary may prescribe such regulations as the Secretary
    determines necessary to carry out the provisions of this section.
    (e) Recovery of amounts owed
      An action may be brought for the recovery of fees, late payment
    penalties, and accrued interest which have not been paid in
    accordance with this section against any person obligated for
    payment of such assessments under this section in any United States
    district court or other United States court for any territory or
    possession in any jurisdiction in which such person is found or
    resides or transacts business, and such court shall have
    jurisdiction to hear and decide such action.
    (f) Definitions
      (1) Animal quarantine laws
        For purposes of this section, the term "animal quarantine laws"
      means - 
          (A) section 306 of the Tariff Act of 1930 (!3) (19 U.S.C.
        1306);

          (B) section 9 of the Act of August 30, 1890 (21 U.S.C. 101);
          (C) the Animal Health Protection Act [7 U.S.C. 8301 et seq.];
        or
          (D) any other Act administered by the Secretary relating to
        plant or animal diseases or pests.
      (2) Customs territory
        For the purposes of subsection (a) of this section, the term
      "customs territory of the United States" means the 50 States, the
      District of Columbia, and Puerto Rico.
      (3) Person
        For the purposes of this section, the term "person" means an
      individual, corporation, partnership, trust, association, or any
      other public or private entity, or any officer, employee, or
      agent thereof.
      (4) United States
        For the purposes of subsection (b) of this section, the term
      "United States" means the several States of the United States,
      the District of Columbia, Guam, the Commonwealth of the Northern
      Mariana Islands, the Commonwealth of Puerto Rico, the Virgin
      Islands of the United States, and all other territories and
      possessions of the United States.
      (5) Vessel
        For the purposes of subsection (a) of this section, the term
      "vessel" does not include any ferry.

-SOURCE-
    (Pub. L. 101-624, title XXV, Sec. 2509, Nov. 28, 1990, 104 Stat.
    4069; Pub. L. 101-508, title I, Sec. 1203, Nov. 5, 1990, 104 Stat.
    1388-11; Pub. L. 102-237, title X, Sec. 1015, Dec. 13, 1991, 105
    Stat. 1902; Pub. L. 104-127, title IX, Sec. 917, Apr. 4, 1996, 110
    Stat. 1187; Pub. L. 107-171, title X, Sec. 10418(b)(5), May 13,
    2002, 116 Stat. 509.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Animal Health Protection Act, referred to in subsecs. (c)(2),
    (f)(1)(C), is subtitle E (Secs. 10401-10418) of title X of Pub. L.
    107-171, May 13, 2002, 116 Stat. 494, which is classified
    principally to chapter 109 (Sec. 8301 et seq.) of Title 7,
    Agriculture. For complete classification of this Act to the Code,
    see Short Title note set out under section 8301 of Title 7 and
    Tables.
      Section 306 of the Tariff Act of 1930 (19 U.S.C. 1306), referred
    to in subsec. (f)(1)(A), was repealed by Pub. L. 107-171, title X,
    Sec. 10418(a)(5), May 13, 2002, 116 Stat. 507.

-COD-
                               CODIFICATION                           
      Section is comprised of section 2509 of Pub. L. 101-624. Subsec.
    (b) and another subsec. (c)(2) of section 2509 of Pub. L. 101-624
    amended section 7759(f) of Title 7, Agriculture, and section 114a
    of this title, respectively.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (c)(2). Pub. L. 107-171, Sec. 10418(b)(5)(A),
    added par. (2) relating to veterinary diagnostics.
      Subsec. (f)(1)(B) to (O). Pub. L. 107-171, Sec. 10418(b)(5)(B),
    added subpars. (B) to (D) and struck out former subpars. (B) to
    (O), which read as follows:
      "(B) sections 6 through 10 of the Act of August 30, 1890 (26
    Stat. 416, chapter 839; 21 U.S.C. 101-105);
      "(C) section 2 of the Act of February 2, 1903 (32 Stat. 792,
    chapter 349; 21 U.S.C. 111);
      "(D) the Act of May 29, 1884 (23 Stat. 32, chapter 60; 21 U.S.C.
    112 to 114a-1, 115, 117-119, and 130) (commonly known as the
    'Animal Industry Act');
      "(E) the Act of February 28, 1947 (61 Stat. 7, chapter 8; 21
    U.S.C. 114b, 114c, and 114d-1);
      "(F) the Act of June 16, 1948 (62 Stat. 458, chapter 477; 21
    U.S.C. 114e and 114f);
      "(G) Public Law 87-209 (21 U.S.C. 114g and 114h);
      "(H) the Act of May 31, 1920 (41 Stat. 699, chapter 217; 21
    U.S.C. 116);
      "(I) the Act of February 2, 1903 (32 Stat. 791, chapter 349; 21
    U.S.C. 112 and 120-122) (commonly known as the 'Cattle Contagious
    Diseases Act of 1903');
      "(J) the Act of March 3, 1905 (33 Stat. 1264, chapter 1496; 21
    U.S.C. 123-127) (commonly known as the 'Cattle Contagious Diseases
    Act of 1905');
      "(K) the matter under the heading 'Bureau of Animal Industry' of
    the Act of June 30, 1914 (38 Stat. 419, chapter 131; 21 U.S.C.
    128);
      "(L) section 101 of Public Law 92-73 (21 U.S.C. 129);
      "(M) the matter under the heading 'Miscellaneous' of the Act of
    May 26, 1910 (36 Stat. 440, chapter 256; 21 U.S.C. 131);
      "(N) sections 1 through 6 and 11 through 13 of Public Law 87-518
    (21 U.S.C. 134-134h); or
      "(O) any other Act administered by the Secretary relating to
    plant or animal diseases or pests, other than the first section of
    Public Law 91-239 (21 U.S.C. 135)."
      1996 - Subsec. (a). Pub. L. 104-127 added subsec. (a) and struck
    out heading and text of former subsec. (a) which consisted of pars.
    (1) to (4) relating to quarantine, inspection, and transportation
    fees.
      1991 - Subsec. (a)(1). Pub. L. 102-237, Sec. 1015(1), designated
    existing provisions as subpar. (A), realigned margin, added
    heading, and added subpars. (B) to (D).
      Subsec. (a)(3)(B)(ii). Pub. L. 102-237, Sec. 1015(2), added cl.
    (ii) and struck out former cl. (ii) which read as follows: "The
    Secretary of Treasury shall use the Account to provide
    reimbursements to any appropriations accounts that incur the costs
    associated with the services authorized in paragraph (1). Any such
    reimbursement shall be subject to appropriations under clause (v)."
      Subsec. (a)(4). Pub. L. 102-237, Sec. 1015(3), substituted
    "Subject to the limits set forth in paragraph (1), the" for "The".
      1990 - Subsec. (a)(1). Pub. L. 101-508, Sec. 1203(1), substituted
    "an international passenger, commercial vessel, commercial
    aircraft, commercial truck, or railroad car." for "a commercial
    vessel, commercial aircraft, commercial truck, or railroad car,".
      Subsec. (a)(3)(B)(ii). Pub. L. 101-508, Sec. 1203(2)(A), inserted
    at end "Any such reimbursement shall be subject to appropriations
    under clause (v)."
      Subsec. (a)(3)(B)(v). Pub. L. 101-508, Sec. 1203(2)(B), added cl.
    (v).

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-508 effective Nov. 29, 1990, see section
    1301 of Pub. L. 101-508, set out as an Effective Date note under
    section 940d of Title 7, Agriculture.

             REPORT ON AGRICULTURAL QUARANTINE INSPECTION FUND         
      Pub. L. 104-66, title I, Sec. 1012(c), Dec. 21, 1995, 109 Stat.
    712, provided that: "The Secretary of Agriculture shall not be
    required to submit a report to the appropriate committees of
    Congress on the status of the Agricultural Quarantine Inspection
    fund more frequently than annually."

-FOOTNOTE-               

    (!1) So in original. Probably should be "Liens".

    (!2) So in original. Probably should be "makes".

    (!3) See References in Text note below.


-End-


-CITE-
    21 USC SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
               SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM           


-MISC1-
                   FEDERAL FOOD, DRUG, AND COSMETIC ACT               
      By virtue of act June 25, 1938, ch. 675, Sec. 902(c), 52 Stat.
    1059 [section 392(b) of this title], nothing contained in section
    301 et seq. of this title shall be construed as in any way
    affecting, modifying, repealing, or superseding the provisions of
    this subchapter.

-End-



-CITE-
    21 USC Sec. 141                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 141. Prohibition of importation without permit

-STATUTE-
      On and after May 16, 1927, the importation into the United States
    of milk and cream is prohibited unless the person by whom such milk
    or cream is shipped or transported into the United States holds a
    valid permit from the Secretary of Health and Human Services.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 1, 44 Stat. 1101; 1940 Reorg. Plan
    No. IV, Sec. 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237;
    1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053,
    67 Stat. 631; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979,
    93 Stat. 695.)

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted in text for
    "Secretary of Health, Education, and Welfare" pursuant to section
    509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
    Title 20, Education.


-MISC1-
                                SHORT TITLE                            
      Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
    part that act Feb. 15, 1927, which is classified to this
    subchapter, may be cited as "Import Milk Act".


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration to Federal Security
    Agency, see notes set out under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 142                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 142. Milk or cream when unfit for importation

-STATUTE-
      Milk or cream shall be considered unfit for importation (1) when
    all cows producing such milk or cream are not healthy and a
    physical examination of all such cows has not been made within one
    year previous to such milk being offered for importation; (2) when
    such milk or cream, if raw, is not produced from cows which have
    passed a tuberculin test applied by a duly authorized official
    veterinarian of the United States, or of the country in which such
    milk or cream is produced, within one year previous to the time of
    the importation, showing that such cows are free from tuberculosis;
    (3) when the sanitary conditions of the dairy farm or plant in
    which such milk or cream is produced or handled do not score at
    least fifty points out of one hundred points according to the
    methods for scoring as provided by the score cards used by the
    Bureau of Dairy Industry of the United States Department of
    Agriculture at the time such dairy farms or plants are scored; (4)
    in the case of raw milk if the number of bacteria per cubic
    centimeter exceeds three hundred thousand and in the case of raw
    cream seven hundred and fifty thousand, in the case of pasteurized
    milk if the number of bacteria per cubic centimeter exceeds one
    hundred thousand, and in the case of pasteurized cream five hundred
    thousand; (5) when the temperature of milk or cream at the time of
    importation exceeds fifty degrees Fahrenheit.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 2, 44 Stat. 1101.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Agricultural Research Service became the successor to functions
    of Bureau of Dairy Industry under Secretary of Agriculture's
    Memorandum 1320, Supplement 4, Nov. 2, 1953.

-End-



-CITE-
    21 USC Sec. 143                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 143. Inspection; certified statement in lieu thereof; waiver
      of requirements of section 142; regulations; suspension and
      revocation of permits

-STATUTE-
      The Secretary of Health and Human Services shall cause such
    inspections to be made as are necessary to insure that milk and
    cream are so produced and handled as to comply with the provisions
    of section 142 of this title, and in all cases when he finds that
    such milk and/or cream is produced and handled so as not to be
    unfit for importation under clauses 1, 2, and 3 of section 142 of
    this title, he shall issue to persons making application therefor
    permits to ship milk and/or cream into the United States: Provided,
    That in lieu of the inspections to be made by or under the
    direction of the Secretary he may, in his discretion, accept a duly
    certified statement signed by a duly accredited official of an
    authorized department of any foreign government and/or of any State
    of the United States or any municipality thereof that the
    provisions in clauses 1, 2, and 3 of section 142 of this title have
    been complied with. Such certificate of the accredited official of
    an authorized department of any foreign government shall be in the
    form prescribed by the Secretary, who is authorized and directed to
    prescribe such form as well as rules and regulations regulating the
    issuance of permits to import milk or cream into the United States.
      The Secretary is authorized, in his discretion, to waive the
    requirement of clause 4 of section 142 of this title when issuing
    permits to operators of condenseries in which milk and/or cream is
    used when sterilization of the milk and/or cream is a necessary
    process: Provided, however, That no milk and/or cream shall be
    imported whose bacterial count per cubic centimeter in any event
    exceeds one million two hundred thousand: Provided, further, That
    such requirements shall not be waived unless the farm producing
    such milk to be imported is within a radius of fifteen miles of the
    condensery in which it is to be processed: Provided further, That
    if milk and/or cream imported when the requirements of clause 4 of
    section 142 of this title, have been so waived, is sold, used, or
    disposed of in its raw state or otherwise than as condensed milk by
    any person, the permit shall be revoked and the importer shall be
    subject to fine, imprisonment, or other penalty prescribed by this
    subchapter.
      The Secretary is directed to waive the requirements of clauses 2
    and 5 of section 142 of this title insofar as the same relate to
    milk when issuing permits to operators of, or to producers for
    delivery to, creameries and condensing plants in the United States
    within twenty miles of the point of production of the milk, and who
    import no raw milk except for pasteurization or condensing:
    Provided, That if milk imported when the requirements of clauses 2
    and 5 of section 142 of this title have been so waived is sold,
    used, or disposed of in its raw state, or otherwise than as
    pasteurized, condensed, or evaporated milk by any person, the
    permit shall be revoked and the importer shall be subjected to
    fine, imprisonment, or other penalty prescribed by this subchapter.
      The Secretary is authorized and directed to make and enforce such
    regulations as may in his judgment be necessary to carry out the
    purpose of this subchapter for the handling of milk and cream, for
    the inspection of milk, cream, cows, barns, and other facilities
    used in the production and handling of milk and/or cream and the
    handling, keeping, transporting, and importing of milk and/or
    cream: Provided, however, That unless and until the Secretary shall
    provide for inspections to ascertain that clauses 1, 2, and 3 of
    section 142 of this title have been complied with, the Secretary
    shall issue temporary permits to any applicants therefor to ship or
    transport milk and/or cream into the United States.
      The Secretary is authorized to suspend or revoke any permit for
    the shipment of milk or cream into the United States when he shall
    find that the holder thereof has failed to comply with the
    provisions of or has violated this subchapter or any of the
    regulations made hereunder, or that the milk and/or cream brought
    or shipped by the holder of such permit into the United States is
    not produced and handled in conformity with, or that the quality
    thereof does not conform to, all of the provisions of section 142
    of this title.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 3, 44 Stat. 1102; 1940 Reorg. Plan
    No. IV, Sec. 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237;
    1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053,
    67 Stat. 631; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979,
    93 Stat. 695.)

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted in text for
    "Secretary of Health, Education, and Welfare" pursuant to section
    509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
    Title 20, Education.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration to Federal Security
    Agency, see notes set out under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 144                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 144. Unlawful receiving of imported milk or cream

-STATUTE-
      It shall be unlawful for any person in the United States to
    receive milk or cream imported into the United States unless the
    importation is in accordance with the provisions of this
    subchapter.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 4, 44 Stat. 1103.)

-End-



-CITE-
    21 USC Sec. 145                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 145. Penalties

-STATUTE-
      Any person who knowingly violates any provision of this
    subchapter shall, in addition to all other penalties prescribed by
    law, be punished by a fine of not less than $50 nor more than
    $2,000, or by imprisonment for not more than one year, or by both
    such fine and imprisonment.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 5, 44 Stat. 1103.)

-End-



-CITE-
    21 USC Sec. 146                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 146. Authorization of appropriations

-STATUTE-
      There is authorized to be appropriated, out of any moneys in the
    Treasury not otherwise appropriated, the sum of $50,000 per annum,
    to enable the Secretary of Health and Human Services to carry out
    the provisions of this subchapter.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 6, 44 Stat. 1103; 1940 Reorg. Plan
    No. IV, Sec. 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237;
    1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053,
    67 Stat. 631; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979,
    93 Stat. 695.)

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted in text for
    "Secretary of Health, Education, and Welfare" pursuant to section
    509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
    Title 20, Education.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration to Federal Security
    Agency, see Transfer of Functions notes set out under section 321
    of this title.

-End-



-CITE-
    21 USC Sec. 147                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 147. Repeal of inconsistent laws

-STATUTE-
      Any laws or parts of laws inconsistent with this subchapter are
    repealed.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 7, 44 Stat. 1103.)

-End-



-CITE-
    21 USC Sec. 148                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 148. Powers of State with respect to milk or cream lawfully
      imported

-STATUTE-
      Nothing in this subchapter is intended nor shall be construed to
    affect the powers of any State, or any political subdivision
    thereof, to regulate the shipment of milk or cream into, or the
    handling, sale, or other disposition of milk or cream in, such
    State or political subdivision after the milk and/or cream shall
    have been lawfully imported under the provisions of this
    subchapter.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 8, 44 Stat. 1103.)

-End-



-CITE-
    21 USC Sec. 149                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
    SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM

-HEAD-
    Sec. 149. Definitions

-STATUTE-
      When used in this subchapter - 
      (a) The term "person" means an individual, partnership,
    association, or corporation.
      (b) The term "United States" means the fifty States and the
    District of Columbia.

-SOURCE-
    (Feb. 15, 1927, ch. 155, Sec. 9, 44 Stat. 1103; Pub. L. 86-70, Sec.
    19, June 25, 1959, 73 Stat. 145; Pub. L. 86-624, Sec. 15, July 12,
    1960, 74 Stat. 415.)


-MISC1-
                                AMENDMENTS                            
      1960 - Subsec. (b). Pub. L. 86-624 substituted "means the fifty
    States and the District of Columbia" for "means continental United
    States, including Alaska".
      1959 - Subsec. (b). Pub. L. 86-70 inserted ", including Alaska"
    after "continental United States".

-End-


-CITE-
    21 USC CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS,
           AND ANALOGOUS PRODUCTS                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
      CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                                 PRODUCTS

-MISC1-
    Sec.                                                     
    151.        Preparation and sale of worthless or harmful products
                 for domestic animals prohibited; preparation to be in
                 compliance with rules at licensed establishments.    
    152.        Importation regulated and prohibited.                 
    153.        Inspection of imports; denial of entry and
                 destruction.                                         
    154.        Regulations for preparation and sale; licenses.       
    154a.       Special licenses for special circumstances; expedited
                 procedure; conditions; exemptions; criteria.         
    155.        Permits for importation.                              
    156.        Licenses conditioned on permitting inspection;
                 suspension of licenses.                              
    157.        Inspection.                                           
    158.        Offenses; punishment.                                 
    159.        Enforcement; penalties applicable; Congressional
                 findings.                                            

                   FEDERAL FOOD, DRUG, AND COSMETIC ACT               
      By virtue of act June 25, 1938, ch. 675, Sec. 902(c), 52 Stat.
    1059 [section 392(b) of this title], nothing contained in section
    301 et seq. of this title shall be construed as in any way
    affecting, modifying, repealing, or superseding the provisions of
    this chapter.

-End-



-CITE-
    21 USC Sec. 151                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 151. Preparation and sale of worthless or harmful products for
      domestic animals prohibited; preparation to be in compliance with
      rules at licensed establishments

-STATUTE-
      It shall be unlawful for any person, firm, or corporation to
    prepare, sell, barter, or exchange in the District of Columbia, or
    in the Territories, or in any place under the jurisdiction of the
    United States, or to ship or deliver for shipment in or from the
    United States, the District of Columbia, any territory of the
    United States, or any place under the jurisdiction of the United
    States, any worthless, contaminated, dangerous, or harmful virus,
    serum, toxin, or analogous product intended for use in the
    treatment of domestic animals, and no person, firm, or corporation
    shall prepare, sell, barter, exchange, or ship as aforesaid any
    virus, serum, toxin, or analogous product manufactured within the
    United States and intended for use in the treatment of domestic
    animals, unless and until the said virus, serum, toxin, or
    analogous product shall have been prepared, under and in compliance
    with regulations prescribed by the Secretary of Agriculture, at an
    establishment holding an unsuspended and unrevoked license issued
    by the Secretary of Agriculture as hereinafter authorized.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 832; Pub. L. 99-
    198, title XVII, Sec. 1768(a), Dec. 23, 1985, 99 Stat. 1654.)

-COD-
                               CODIFICATION                           
      The sections of this chapter are comprised of the sentences of
    the eighth paragraph under the heading "Bureau of Animal Industry,"
    in the Department of Agriculture Appropriation Act, 1914, as
    amended.
      Another section 1768 of Pub. L. 99-198, cited as a credit to this
    section, amended section 136y of Title 7, Agriculture.


-MISC1-
                                AMENDMENTS                            
      1985 - Pub. L. 99-198 substituted "in or from the United States,
    the District of Columbia, any territory of the United States, or
    any place under the jurisdiction of the United States" for "from
    one State or Territory or the District of Columbia to any other
    State or Territory or the District of Columbia".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Section 1768(f) of Pub. L. 99-198 provided that:
      "(1) Except as provided in paragraph (2), the amendments made by
    this section [enacting sections 154a and 159 of this title and
    amending this section and sections 154 and 157 of this title] shall
    become effective on the date of enactment of this Act [Dec. 23,
    1985].
      "(2)(A) Subject to subparagraphs (B) through (D), in the case of
    a person, firm, or corporation preparing, selling, bartering,
    exchanging, or shipping a virus, serum, toxin, or analogous product
    during the 12-month period ending on the date of enactment of this
    Act [Dec. 23, 1985] solely for intrastate commerce or for
    exportation, such product shall not after such date of enactment,
    as a result of its not having been licensed or produced in a
    licensed establishment, be considered in violation of the eighth
    paragraph of the matter under the heading 'BUREAU OF ANIMAL
    INDUSTRY' of the Act entitled 'An Act making appropriations for the
    Department of Agriculture for the fiscal year ending June
    thirtieth, nineteen hundred and fourteen', approved March 14, 1913
    (as amended by this section) [this chapter], until the first day of
    the 49th month following the date of enactment of this Act.
      "(B) The exemption granted by subparagraph (A) may be extended by
    the Secretary of Agriculture for a period up to 12 months in an
    individual case on a showing by a person, firm, or corporation of
    good cause and a good faith effort to comply with such eighth
    paragraph with due diligence.
      "(C) The exemption granted by subparagraph (A) must be claimed by
    the person, firm, or corporation preparing such product by the
    first day of the 13th month following the date of enactment of this
    Act [Dec. 23, 1985], in the form and manner prescribed by the
    Secretary, unless the Secretary grants an extension of the time to
    claim such exemption in an individual case for good cause shown.
      "(D) On the issuance by the Secretary of a license to such
    person, firm, or corporation for such product prior to the first
    day of the 49th month following the date of enactment of this Act
    [Dec. 23, 1985], or the end of an extension of the exemption
    granted by the Secretary, the exemption granted by subparagraph (A)
    shall terminate with respect to such product."

                                SHORT TITLE                            
      Act Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 832, which is
    classified to this chapter, is popularly known as the "Virus-Serum-
    Toxin Act".


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.


-MISC2-
                              APPROPRIATIONS                          
      An appropriation of $25,000 was made by act Mar. 4, 1913, for the
    purpose of carrying into effect these provisions. The appropriation
    for the fiscal year 1926 was by act Feb. 10, 1925, ch. 200, 43
    Stat. 827.

-End-



-CITE-
    21 USC Sec. 152                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 152. Importation regulated and prohibited

-STATUTE-
      The importation into the United States of any virus, serum,
    toxin, or analogous product for use in the treatment of domestic
    animals, and the importation of any worthless, contaminated,
    dangerous, or harmful virus, serum, toxin, or analogous product for
    use in the treatment of domestic animals, is prohibited without (1)
    a permit from the Secretary of Agriculture, or (2) in the case of
    an article originating in Canada, such permit or, in lieu of such
    permit, such certification by Canada as may be prescribed by the
    Secretary of Agriculture.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 832; Pub. L. 100-
    449, title III, Sec. 301(d), Sept. 28, 1988, 102 Stat. 1868.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.


-MISC1-
                                AMENDMENTS                            
      1988 - Pub. L. 100-449 amended section generally. Prior to
    amendment, section read as follows: "The importation into the
    United States, without a permit from the Secretary of Agriculture,
    of any virus, serum, toxin, or analogous product for use in the
    treatment of domestic animals, and the importation of any
    worthless, contaminated, dangerous, or harmful virus, serum, toxin,
    or analogous product for use in the treatment of domestic animals,
    are prohibited."

             EFFECTIVE AND TERMINATION DATES OF 1988 AMENDMENT         
      Amendment by Pub. L. 100-449 effective on the date the United
    States-Canada Free-Trade Agreement enters into force (Jan. 1,
    1989), and to cease to have effect on the date the Agreement ceases
    to be in force, see section 501(a), (c) of Pub. L. 100-449, set out
    in a note under section 2112 of Title 19, Customs Duties.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 153                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 153. Inspection of imports; denial of entry and destruction

-STATUTE-
      The Secretary of Agriculture is authorized to cause the Bureau of
    Animal Industry to examine and inspect all viruses, serums, toxins,
    and analogous products, for use in the treatment of domestic
    animals, which are being imported or offered for importation into
    the United States, to determine whether such viruses, serums,
    toxins, and analogous products are worthless, contaminated,
    dangerous, or harmful, and if it shall appear that any such virus,
    serum, toxin, or analogous product, for use in the treatment of
    domestic animals, is worthless, contaminated, dangerous, or
    harmful, the same shall be denied entry and shall be destroyed or
    returned at the expense of the owner or importer.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 832.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 154                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 154. Regulations for preparation and sale; licenses

-STATUTE-
      The Secretary of Agriculture is authorized to make and promulgate
    from time to time such rules and regulations as may be necessary to
    prevent the preparation, sale, barter, exchange, or shipment as
    aforesaid of any worthless, contaminated, dangerous, or harmful
    virus, serum, toxin, or analogous product for use in the treatment
    of domestic animals, or otherwise to carry out this chapter, and to
    issue, suspend, and revoke licenses for the maintenance of
    establishments for the preparation of viruses, serums, toxins, and
    analogous products, for use in the treatment of domestic animals,
    intended for sale, barter, exchange, or shipment as aforesaid.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 832; Pub. L. 99-
    198, title XVII, Sec. 1768(b), Dec. 23, 1985, 99 Stat. 1654.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.
      Another section 1768 of Pub. L. 99-198, cited as a credit to this
    section, amended section 136y of Title 7, Agriculture.


-MISC1-
                                AMENDMENTS                            
      1985 - Pub. L. 99-198 inserted "or otherwise to carry out this
    chapter," after "domestic animals,".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as
    otherwise provided, see section 1768(f) of Pub. L. 99-198, set out
    as a note under section 151 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 154a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 154a. Special licenses for special circumstances; expedited
      procedure; conditions; exemptions; criteria

-STATUTE-
      In order to meet an emergency condition, limited market or local
    situation, or other special circumstance (including production
    solely for intrastate use under a State-operated program), the
    Secretary may issue a special license under an expedited procedure
    on such conditions as are necessary to assure purity, safety, and a
    reasonable expectation of efficacy. The Secretary shall exempt by
    regulation from the requirement of preparation pursuant to an
    unsuspended and unrevoked license any virus, serum, toxin, or
    analogous product prepared by any person, firm, or corporation - 
        (1) solely for administration to animals of such person, firm,
      or corporation;
        (2) solely for administration to animals under a veterinarian-
      client-patient relationship in the course of the State licensed
      professional practice of veterinary medicine by such person,
      firm, or corporation; or
        (3) solely for distribution within the State of production
      pursuant to a license granted by such State under a program
      determined by the Secretary to meet criteria under which the
      State - 
          (A) may license virus, serum, toxin, and analogous products
        and establishments that produce such products;
          (B) may review the purity, safety, potency, and efficacy of
        such products prior to licensure;
          (C) may review product test results to assure compliance with
        applicable standards for purity, safety, and potency, prior to
        release to the market;
          (D) may deal effectively with violations of State law
        regulating virus, serum, toxin, and analogous products; and
          (E) exercises the authority referred to in subclauses (A)
        through (D) consistent with the intent of this chapter of
        prohibiting the preparation, sale, barter, exchange, or
        shipment of worthless, contaminated, dangerous, or harmful
        virus, serum, toxin, or analogous products.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], as added Pub. L. 99-198,
    title XVII, Sec. 1768(c), Dec. 23, 1985, 99 Stat. 1654.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.
      Another section 1768 of Pub. L. 99-198, cited as a credit to this
    section, amended section 136y of Title 7, Agriculture.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective Dec. 23, 1985, except as otherwise provided,
    see section 1768(f) of Pub. L. 99-198, set out as an Effective Date
    of 1985 Amendment note under section 151 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 155                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 155. Permits for importation

-STATUTE-
      The Secretary of Agriculture is authorized to issue permits for
    the importation into the United States of viruses, serums, toxins,
    and analogous products, for use in the treatment of domestic
    animals, which are not worthless, contaminated, dangerous, or
    harmful.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 833.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 156                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 156. Licenses conditioned on permitting inspection; suspension
      of licenses

-STATUTE-
      All licenses issued under authority of this chapter to
    establishments where such viruses, serums, toxins, or analogous
    products are prepared for sale, barter, exchange, or shipment as
    aforesaid, shall be issued on condition that the licensee shall
    permit the inspection of such establishments and of such products
    and their preparation; and the Secretary of Agriculture may suspend
    or revoke any permit or license issued under authority of said
    chapter, after opportunity for hearing has been granted the
    licensee or importer, when the Secretary of Agriculture is
    satisfied that such license or permit is being used to facilitate
    or effect the preparation, sale, barter, exchange, or shipment as
    aforesaid, or the importation into the United States of any
    worthless, contaminated, dangerous, or harmful virus, serum, toxin,
    or analogous product for use in the treatment of domestic animals.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 833.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    Act", meaning act Mar. 4, 1913, ch. 145, 37 Stat. 828, which
    enacted this chapter, sections 155 and 393 of Title 7, Agriculture,
    section 316 of Title 15, Commerce and Trade, sections 501, 502,
    512, 558, and 560 of Title 16, Conservation, and section 630 of
    former Title 31, Money and Finance, and amended section 83 of
    former Title 5, Executive Departments and Government Officers and
    Employees, and sections 518 and 673 of Title 16.
      Section 316 of Title 15 was omitted from the Code as superseded
    by section 5701 et seq. of Title 5, Government Organization and
    Employees. Section 630 of former Title 31 was repealed by act Sept.
    12, 1950, ch. 946, title III, Sec. 301(64), 64 Stat. 842. Section
    83 of former Title 5 was repealed and reenacted as section 5946 of
    Title 5 by Pub. L. 89-554, Sept. 6, 1966, 80 Stat. 514. For
    complete classification of act Mar. 4, 1913, to the Code, see
    Tables.

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 157                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 157. Inspection

-STATUTE-
      Any officer, agent, or employee of the Department of Agriculture
    duly authorized by the Secretary of Agriculture for the purpose
    may, at any hour during the daytime or nighttime, enter and inspect
    any establishment where any virus, serum, toxin, or analogous
    product for use in the treatment of domestic animals is prepared
    for sale, barter, exchange, or shipment as aforesaid.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 833; Pub. L. 99-
    198, title XVII, Sec. 1768(d), Dec. 23, 1985, 99 Stat. 1655.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.
      Another section 1768 of Pub. L. 99-198, cited as a credit to this
    section, amended section 136y of Title 7, Agriculture.


-MISC1-
                                AMENDMENTS                            
      1985 - Pub. L. 99-198 struck out "licensed under this chapter"
    after "enter and inspect any establishment".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as
    otherwise provided, see section 1768(f) of Pub. L. 99-198, set out
    as a note under section 151 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of the Secretary of Agriculture
    relating to agricultural import and entry inspection activities
    under this chapter to the Secretary of Homeland Security, and for
    treatment of related references, see sections 231, 551(d), 552(d),
    and 557 of Title 6, Domestic Security, and the Department of
    Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.

-End-



-CITE-
    21 USC Sec. 158                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 158. Offenses; punishment

-STATUTE-
      Any person, firm, or corporation who shall violate any of the
    provisions of this chapter shall be deemed guilty of a misdemeanor,
    and shall, upon conviction, be punished by a fine of not exceeding
    $1,000 or by imprisonment not exceeding one year, or by both such
    fine and imprisonment, in the discretion of the court.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 833.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      For explanation of "this chapter", referred to in text, see
    References in Text note set out under section 156 of this title.

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.

-End-



-CITE-
    21 USC Sec. 159                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
                 PRODUCTS                          

-HEAD-
    Sec. 159. Enforcement; penalties applicable; Congressional findings

-STATUTE-
      The procedures of sections 672, 673, and 674 of this title
    (relating to detentions, seizures and condemnations, and
    injunctions, respectively) shall apply to the enforcement of this
    chapter with respect to any product prepared, sold, bartered,
    exchanged, or shipped in violation of this chapter or a regulation
    promulgated under this chapter. The provisions (including
    penalties) of section 675 of this title shall apply to the
    performance of official duties under this chapter. Congress finds
    that (i) the products and activities that are regulated under this
    chapter are either in interstate or foreign commerce or
    substantially affect such commerce or the free flow thereof, and
    (ii) regulation of the products and activities as provided in this
    chapter is necessary to prevent and eliminate burdens on such
    commerce and to effectively regulate such commerce.

-SOURCE-
    (Mar. 4, 1913, ch. 145, Sec. 1 [part], as added Pub. L. 99-198,
    title XVII, Sec. 1768(e), Dec. 23, 1985, 99 Stat. 1655.)

-COD-
                               CODIFICATION                           
      See note set out under section 151 of this title.
      Another section 1768 of Pub. L. 99-198, cited as a credit to this
    section, amended section 136y of Title 7, Agriculture.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective Dec. 23, 1985, except as otherwise provided,
    see section 1768(f) of Pub. L. 99-198, set out as an Effective Date
    of 1985 Amendment note under section 151 of this title.

-End-


-CITE-
    21 USC CHAPTER 5A - BUREAU OF NARCOTICS                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5A - BUREAU OF NARCOTICS

-HEAD-
                     CHAPTER 5A - BUREAU OF NARCOTICS                 

-End-



-CITE-
    21 USC Secs. 161 to 165                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 5A - BUREAU OF NARCOTICS

-HEAD-
    Secs. 161 to 165. Omitted

-COD-
                               CODIFICATION                           
      Section 161, acts June 14, 1930, ch. 488, Sec. 1, 46 Stat. 585;
    Oct. 15, 1949, ch. 695, Sec. 6(a), 63 Stat. 881, established a
    Bureau of Narcotics in the Department of the Treasury and provided
    for appointment of a Commissioner of Narcotics for the Bureau with
    duty of making an annual report to Congress.
      Section 162, acts June 14, 1930, ch. 488, Sec. 2, 46 Stat. 585;
    June 26, 1930, ch. 623, Sec. 1, 46 Stat. 819; Oct. 27, 1970, Pub.
    L. 91-513, title III, Sec. 1101(a)(4), 84 Stat. 1291, provided for
    appointment and compensation of a deputy commissioner and other
    personnel for the Bureau of Narcotics, required the deputy to be an
    acting Commissioner during absence or disability of the
    Commissioner or a vacancy in the office, and authorized designation
    of a member of the Treasury Department as an acting Commissioner in
    event there is no Commissioner or deputy commissioner.
      Section 163, act Mar. 3, 1927, ch. 348, Sec. 4(a), 44 Stat. 1382,
    provided for transfer of control of narcotic drugs to the Secretary
    of the Treasury from the Commissioner of Internal Revenue and his
    assistants, agents, and inspectors.
      Section 164, acts June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586;
    June 26, 1930, ch. 623, Sec. 2, 46 Stat. 819; Ex. Ord. No. 6639,
    Mar. 10, 1934, abolished the Federal Narcotics Control Board and
    transferred powers of such Board to the Commissioner of Narcotics,
    authorized the Secretary of the Treasury to confer or impose his
    duties under section 163 of this title upon the Commissioner or
    other personnel of the Bureau of Narcotics, continued in effect
    orders, rules, and regulations in existence on July 1, 1930, until
    modified, superseded, or repealed by the Commissioner, with
    approval of the Secretary of the Treasury, and provided for
    determination before such Bureau of Narcotics of proceedings,
    investigations, and other matters pending on July 1, 1930 before
    Bureau of Prohibition or Federal Narcotics Control Board respecting
    narcotic drug law administration or enforcement. Bureau of
    Prohibition personnel, records, property, and unexpended balances
    of appropriations were previously transferred to Bureau of
    Narcotics as were powers of the Attorney General respecting the
    Bureau of Prohibition to the Commissioner of Internal Revenue.
      Section 165, act June 14, 1930, ch. 488, Sec. 5, 46 Stat. 587,
    provided for review of decisions of Commissioner of Narcotics by
    the Secretary of the Treasury.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Functions of the Secretary of the Treasury administered through
    or respecting the Bureau of Narcotics and all functions of the
    Bureau, the Commissioner of Narcotics, and the officers, employees
    and agencies of the Bureau were transferred to the Attorney General
    and the Bureau and the office of Commissioner of Narcotics were
    abolished by Reorg. Plan No. 1 of 1968, eff. Apr. 8, 1968, 33 F.R.
    5611, 82 Stat. 1367, set out in the Appendix to Title 5, Government
    Organization and Employees. All positions, personnel, property,
    records, and unexpended balances of appropriations, allocations,
    and other funds of the Bureau and the Treasury Department, in
    connection with functions transferred under this reorganization
    plan, were transferred to the Justice Department.
      The Bureau of Narcotics and Dangerous Drugs, including the office
    of Director thereof, in the Department of Justice was abolished by
    Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87
    Stat. 1091, set out in the Appendix to Title 5, Government
    Organization and Employees. Reorg. Plan No. 2 of 1973 also created
    in the Department of Justice a single, comprehensive agency for the
    enforcement of drug laws to be known as the Drug Enforcement
    Administration, empowered the Attorney General to authorize the
    performance by officers, employees, and agencies of the Department
    of functions transferred to him, and directed the Attorney General
    to coordinate all drug law enforcement functions to assure maximum
    cooperation between the Drug Enforcement Administration, the
    Federal Bureau of Investigation, and the other units of the
    Department of Justice involved in drug law enforcement.

-End-


-CITE-
    21 USC CHAPTER 6 - NARCOTIC DRUGS                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS

-HEAD-
                        CHAPTER 6 - NARCOTIC DRUGS                    


-EXEC-
                         EXECUTIVE ORDER NO. 10302                     
      Ex. Ord. No. 10302, Nov. 5, 1951, 16 F.R. 11257, formerly set out
    as a note preceding section 171, which established the
    Interdepartmental Committee on Narcotics, was revoked by Ex. Ord.
    No. 11529, Apr. 24, 1970, 35 F.R. 6697.

-End-


-CITE-
    21 USC IMPORTATION OR EXPORTATION                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    IMPORTATION OR EXPORTATION

-HEAD-
                        IMPORTATION OR EXPORTATION                    

-End-



-CITE-
    21 USC Secs. 171 to 174                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    IMPORTATION OR EXPORTATION

-HEAD-
    Secs. 171 to 174. Repealed.

-MISC1-
    Secs. 171 to 174. Repealed. Pub. L. 91-513, title III, Sec.
      1101(a)(2), (4), Oct. 27, 1970, 84 Stat. 1291.
      Section 171, acts Feb. 9, 1909, ch. 100, Sec. 1, 35 Stat. 614;
    Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, Sec. 1,
    42 Stat. 596; June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586; July 1,
    1944, ch. 377, Sec. 8, 58 Stat. 721; Mar. 8, 1946, ch. 81, Sec. 7,
    60 Stat. 39; Aug. 8, 1953, ch. 394, Sec. 8, 67 Stat. 506, defined
    "narcotic drug", "United States", and "person". See section 801 et
    seq. of this title.
      Section 172, acts Feb. 9, 1909, ch. 100, Sec. 2(a), 35 Stat. 614;
    Jan. 17, 1914, ch. 9, 38 Stat. 275; June 7, 1924, ch. 352, 43 Stat.
    657, established a Federal Narcotics Control Board. Act May 26,
    1922, ch. 202, Sec. 1, 42 Stat. 596, also classified to this
    section, was repealed by Pub. L. 89-554, Sec. 8(a), Sept. 6, 1966,
    80 Stat. 645.
      Section 173, acts Feb. 9, 1909, ch. 100, Sec. 2(b), (d), 35 Stat.
    614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202,
    Sec. 1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; June 14,
    1930, ch. 488, Sec. 3, 46 Stat. 586, prohibited importation of
    narcotic drugs. See section 801 et seq. of this title.
      Section 173a, act June 14, 1930, ch. 488, Sec. 6, 46 Stat. 587,
    provided for importation of additional amounts of coca leaves.
      Section 174, acts Feb. 9, 1909, ch. 100, Sec. 2(c), (f), 35 Stat.
    614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202,
    Sec. 1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; Nov. 2,
    1951, ch. 666, Secs. 1, 5(1), 65 Stat. 767; July 18, 1956, ch. 629,
    title I, Sec. 105, 70 Stat. 570, set penalties for bringing
    narcotic drugs into the United States contrary to law. See chapter
    13 of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 27, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as an Effective Date note under section 951 of this title.

                             SAVINGS PROVISION                         
      Section 1103 of Pub. L. 91-513 provided that:
      "(a) Prosecutions for any violation of law occurring prior to the
    effective date of section 1101 [the first day of the seventh
    calendar month that begins after Oct. 26, 1970] shall not be
    affected by the repeals or amendments made by such section or
    section 1102 [repealing sections 171 to 174, 176 to 185, 188 to
    188n, 191 to 193, 197, 198, 199, 501 to 517 of this title, sections
    1401 to 1407, and 3616 of Title 18, Crimes and Criminal Procedure,
    sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736,
    4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238,
    and 7491 of Title 26, Internal Revenue Code, sections 529a and 529g
    of former Title 31, Money and Finance, and section 1421m of Title
    48, Territories and Insular Possessions, and amending sections 162
    and 967 of this title, section 4251 of Title 18, section 1584 of
    Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103,
    7236, 7607, 7609, 7641, 7651, and 7655 of Title 26, section 2901 of
    Title 28, Judiciary and Judicial Procedure, sections 529d, 529e,
    and 529f of former Title 31, section 304m of former Title 40,
    Public Buildings, Property, and Works, section 3411 of Title 42,
    The Public Health and Welfare, section 239a of Title 46, Shipping,
    and section 787 of former Title 49, Transportation], or abated by
    reason thereof.
      "(b) Civil seizures or forfeitures and injunctive proceedings
    commenced prior to the effective date of section 1101 [the first
    day of the seventh calendar month that begins after Oct. 26, 1970]
    shall not be affected by the repeals or amendments made by such
    section or section 1102, or abated by reason thereof."

-End-



-CITE-
    21 USC Sec. 175                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    IMPORTATION OR EXPORTATION

-HEAD-
    Sec. 175. Repealed.

-MISC1-
    Sec. 175. Repealed. June 27, 1952, ch. 477, title IV, Sec.
      403(a)(10), 66 Stat. 279.
      Section, acts Feb. 9, 1909, ch. 100, Sec. 2(e), 35 Stat. 614;
    Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, Sec. 1,
    42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, related to
    deportation of convicted aliens. See section 1251 et seq. of Title
    8, Aliens and Nationality.

-End-



-CITE-
    21 USC Secs. 176 to 185                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    IMPORTATION OR EXPORTATION

-HEAD-
    Secs. 176 to 185. Repealed.

-MISC1-
    Secs. 176 to 185. Repealed. Pub. L. 91-513, title III, Sec.
      1101(a)(2), (9), Oct. 27, 1970, 84 Stat. 1291, 1292.
      Section 176, acts Feb. 9, 1909, ch. 100, Sec. 2(g), 35 Stat. 614;
    Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202 Sec. 1,
    42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, covered
    liability of masters of vessels and persons in charge of railroad
    cars and other vehicles used to carry narcotic drugs.
      Section 176a, act Feb. 9, 1909, ch. 100, Sec. 2(h), as added July
    18, 1956, ch. 629, title I, Sec. 106, 70 Stat. 570, covered illegal
    importation of marihuana and set penalties for such illegal
    importation. See section 801 et seq. of this title.
      Section 176b, act Feb. 9, 1909, ch. 100, Sec. 2(i), as added July
    18, 1956, ch. 629, title I, Sec. 107, 70 Stat. 571, prohibited sale
    of heroin to juveniles and set penalties for such illegal sale. See
    section 801 et seq. of this title.
      Section 177, acts Feb. 9, 1909, ch. 100, Sec. 2(a), 35 Stat. 614;
    Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, Sec. 1,
    42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, vested
    administration of Narcotic Drugs Import and Export Act in
    Department of the Treasury.
      Section 178, act Feb. 9, 1909, ch. 100, Sec. 4, as added Jan. 17,
    1914, ch. 9, 38 Stat. 275, prohibited possession of smoking opium.
    See section 801 et seq. of this title.
      Section 179, act Feb. 9, 1909, ch. 100, Sec. 4, as added Jan. 17,
    1914, ch. 9, 38 Stat. 275, covered liability of masters of vessels
    and persons in charge of railroad cars or other vehicles for
    possession of smoking heroin. See section 801 et seq. of this
    title.
      Section 180, act Feb. 9, 1909, ch. 100, Sec. 5, as added Jan. 17,
    1914, ch. 9, 38 Stat. 275; amended May 26, 1922, ch. 202, Sec. 2,
    42 Stat. 597; June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586,
    prohibited admission of smoking opium even for transportation to
    another country or for transferal from one vessel to another.
      Section 181, act Feb. 9, 1909, ch. 100, Sec. 3, as added Jan. 17,
    1914, ch. 9, 38 Stat. 275, created a presumption of illegal
    importation based upon presence of smoking opium in United States.
      Section 182, act Feb. 9, 1909, ch. 100, Sec. 6, as added Jan. 17,
    1914, ch. 9, 348 Stat. 275; amended May 26, 1922, ch. 202, Sec. 2,
    42 Stat. 597; June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586; Apr.
    22, 1960, Pub. L. 86-429, Sec. 15, 74 Stat. 66, forbade exportation
    of narcotic drugs. See section 801 et seq. of this title.
      Section 183, act Feb. 9, 1909, ch. 100, Sec. 7, as added Jan. 17,
    1914, ch. 9, 38 Stat. 277, set out penalties for illegal
    exportation of narcotic drugs.
      Section 184, act Feb. 9, 1909, ch. 100, Sec. 8, as added Jan. 17,
    1914, ch. 9, 38 Stat. 277; amended May 26, 1922, ch. 202, Sec. 3,
    42 Stat. 598, provided for seizure and forfeiture of narcotic drugs
    found on vessels and not shown on manifest or landed from vessels
    without a permit.
      Section 184a, acts July 11, 1941, ch. 289, Sec. 1, 55 Stat. 584;
    July 18, 1956, ch. 629, title I, Sec. 108, 70 Stat. 571, made
    illegal bringing on board a vessel of United States any narcotic
    drugs not constituting a part of the cargo.
      Section 185, act Feb. 9, 1909, ch. 100, Sec. 9, as added May 26,
    1922, ch. 202, Sec. 4, 42 Stat. 598, authorized the citation of act
    Feb. 9, 1909, ch. 100, as the "Narcotic Drugs Import and Export
    Act".

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as an Effective Date note under section 951 of this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of repeal of these sections by section 1101
    of Pub. L. 91-513 not to be affected or abated by reason thereof,
    see section 1103 of Pub. L. 91-513, set out as a note under
    sections 171 to 174 of this title.

-End-


-CITE-
    21 USC MARIHUANA AND HEALTH REPORTING                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MARIHUANA AND HEALTH REPORTING

-HEAD-
                      MARIHUANA AND HEALTH REPORTING                  

-End-



-CITE-
    21 USC Secs. 186, 187                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MARIHUANA AND HEALTH REPORTING

-HEAD-
    Secs. 186, 187. Transferred

-COD-
                               CODIFICATION                           
      Section 186, Pub. L. 91-296, title V, Sec. 501, June 30, 1970, 84
    Stat. 352, which related to congressional findings as to marihuana
    use, the need for a better understanding of the health
    consequences, and the lack of information thereto, was transferred
    and set out as a note under section 242 of Title 42, The Public
    Health and Welfare.
      Section 187, Pub. L. 91-296, title V, Sec. 502, June 30, 1970, 84
    Stat. 352, which directed the Secretary of Health, Education and
    Welfare to report to Congress on the current information on the
    health consequence of marihuana use, with recommendations for
    legislative and administrative action and to submit a preliminary
    report no later than 90 days after June 30, 1970, was transferred
    and set out as a note under section 242 of Title 42.

-End-


-CITE-
    21 USC DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF
      THE OPIUM POPPY                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY

-HEAD-
    DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY

-End-



-CITE-
    21 USC Secs. 188 to 188n                                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY

-HEAD-
    Secs. 188 to 188n. Repealed.

-MISC1-
    Secs. 188 to 188n. Repealed. Pub. L. 91-513, title III, Sec.
      1101(a)(7), Oct. 27, 1970, 84 Stat. 1292.
      Sections, acts Dec. 11, 1942, ch. 720, 56 Stat. 1045; June 25,
    1959, Pub. 86-70, Sec. 20, 73 Stat. 145; July 12, 1960, Pub. L. 86-
    624, Sec. 16, 74 Stat. 415, known as the "Opium Poppy Control Act
    of 1942", provided for the domestic control of production and
    distribution of the opium poppy. Sections 1 to 17 of said Act of
    Dec. 11, 1942, were classified, respectively, to sections 188, 188
    notes, and 188a to 188n of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as an Effective Date note under section 951 of this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of repeal of these sections by section 1101
    of Pub. L. 91-513 not to be affected or abated by reason thereof,
    see section 1103 of Pub. L. 91-513, set out as a note under section
    171 of this title.

-End-


-CITE-
    21 USC IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN,
      IN CHINA, BY UNITED STATES CITIZENS                  01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
      UNITED STATES CITIZENS                                  

-HEAD-
      IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
                          UNITED STATES CITIZENS

-End-



-CITE-
    21 USC Secs. 191 to 193                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
      UNITED STATES CITIZENS                                  

-HEAD-
    Secs. 191 to 193. Repealed.

-MISC1-
    Secs. 191 to 193. Repealed. Pub. L. 91-513, title III, Sec.
      1101(a)(1), Oct. 27, 1970, 84 Stat. 1291.
      Sections, acts Feb. 23, 1887, ch. 210, 24 Stat. 409; June 25,
    1948, ch. 646, Secs. 5, 39, 62 Stat. 986, 992, prohibited
    importation of opium by Chinese subjects and the trafficking in, in
    China, of opium by United States citizens. Sections 1 to 3 of said
    Act of Feb. 23, 1887, were classified to sections 191 to 193,
    respectively, of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as an Effective Date note under section 951 of this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of repeal of these sections by section 1101
    of Pub. L. 91-513 not to be affected or abated by reason thereof,
    see section 1103 of Pub. L. 91-513, set out as a Savings Provision
    note under section 171 of this title.

-End-


-CITE-
    21 USC MISCELLANEOUS                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MISCELLANEOUS

-HEAD-
                               MISCELLANEOUS                           

-End-



-CITE-
    21 USC Sec. 196                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MISCELLANEOUS

-HEAD-
    Sec. 196. Repealed.

-MISC1-
    Sec. 196. Repealed. July 1, 1944, ch. 373, title XIII, Sec. 1313,
      58 Stat. 714.
      Section, act June 14, 1930, ch. 488, Sec. 4(b), (c), 46 Stat.
    587; 1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4
    F.R. 2728, 53 Stat. 1424, related to studies and investigations by
    Surgeon General of the Public Health Service. See section 242 of
    Title 42, The Public Health and Welfare.

                       RENUMBERING OF REPEALING ACT                   
      Section 611 of act July 1, 1944, which repealed this section, was
    renumbered 711 by act Aug. 13, 1946, ch. 958, Sec. 5, 60 Stat.
    1049, 713 by act Feb. 28, 1948, ch. 83, Sec. 9(b), 62 Stat. 47, 813
    by act July 30, 1956, ch. 779, Sec. 3(b), 70 Stat. 720, 913 by Pub.
    L. 88-581, Sec. 4(b), Sept. 4, 1964, 78 Stat. 919, 1013 by Pub. L.
    89-239, Sec. 3(b), Oct. 6, 1965, 79 Stat. 931, 1113 by Pub. L. 91-
    572, Sec. 6(b), Dec. 24, 1970, 84 Stat. 1506, 1213 by Pub. L. 92-
    294, Sec. 3(b), May 16, 1972, 86 Stat. 137, 1313 by Pub. L. 93-
    154, Sec. 2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed
    by Pub. L. 93-222, Sec. 7(b), Dec. 29, 1973, 87 Stat. 936.

-End-



-CITE-
    21 USC Secs. 197, 198                                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MISCELLANEOUS

-HEAD-
    Secs. 197, 198. Repealed.

-MISC1-
    Secs. 197, 198. Repealed. Pub. L. 91-513, title III, Sec.
      1101(a)(4), Oct. 27, 1970, 84 Stat. 1291.
      Section 197, act June 14, 1930, ch. 488, Sec. 7, 46 Stat. 587,
    directed Secretary of the Treasury to cooperate with Secretary of
    State in discharge of international obligations of United States
    concerning traffic in narcotic drugs.
      Section 198, acts June 14, 1930, ch. 488, Sec. 8, 46 Stat. 587;
    July 18, 1956, ch. 629, title III, Sec. 302, 70 Stat. 575, directed
    Secretary of the Treasury to cooperate with the several States in
    suppression of abuse of narcotic drugs in their respective
    jurisdictions.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as an Effective Date note under section 951 of this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of repeal of these sections by section 1101
    of Pub. L. 91-513 not to be affected or abated by reason thereof,
    see section 1103 of Pub. L. 91-513, set out as a note under
    sections 171 to 174 of this title.

-End-



-CITE-
    21 USC Secs. 198a to 198c                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MISCELLANEOUS

-HEAD-
    Secs. 198a to 198c. Transferred

-COD-
                               CODIFICATION                           
      Section 198a, act Aug. 11, 1955, ch. 800, Sec. 1, 69 Stat. 684,
    as amended, which related to the authority of Secretary of the
    Treasury to issue subpenas, administer oaths and compel attendance
    of witnesses for purpose of any investigation, was transferred to
    section 967 of this title.
      Section 198b, act Aug. 11, 1955, ch. 800, Sec. 2, 69 Stat. 685,
    which related to service of subpenas and proof of service, was
    transferred to section 968 of this title.
      Section 198c, act Aug. 11, 1955, ch. 800, Sec. 3, 69 Stat. 685,
    which related to contempt proceedings, was transferred to section
    969 of this title.

-End-



-CITE-
    21 USC Sec. 199                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MISCELLANEOUS

-HEAD-
    Sec. 199. Repealed.

-MISC1-
    Sec. 199. Repealed. Pub. L. 91-513, title III, Sec. 1101(a)(5),
      Oct. 27, 1970, 84 Stat. 1292.
      Section, act July 3, 1930, ch. 829, 46 Stat. 850, authorized
    payment to persons giving information concerning violations of
    narcotics laws. See section 886(a) of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as an Effective Date note under section 951 of this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of repeal of this section by section 1101 of
    Pub. L. 91-513 not to be affected or abated by reason thereof, see
    section 1103 of Pub. L. 91-513, set out as a note under section 171
    of this title.

-End-



-CITE-
    21 USC Secs. 200 to 200b                                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 6 - NARCOTIC DRUGS
    MISCELLANEOUS

-HEAD-
    Secs. 200 to 200b. Repealed.

-MISC1-
    Secs. 200 to 200b. Repealed. Nov. 2, 1951, ch. 666, Sec. 5(2), 65
      Stat. 769.
      Sections, acts Aug. 12, 1937, ch. 598, Secs. 1-3, 50 Stat. 627;
    July 1, 1944, ch. 377, Sec. 9, 58 Stat. 721; Mar. 8, 1946, ch. 81,
    Sec. 8, 60 Stat. 39, related to punishment for offenses after first
    offense. See section 801 et seq. of this title.

                             SAVINGS PROVISION                         
      Section 6 of act Nov. 2, 1951, provided that any rights or
    liabilities now existing under former sections 200 to 200b of this
    title should not be affected by their repeal.

-End-


-CITE-
    21 USC CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF
           POISONS IN CONSULAR DISTRICTS IN CHINA          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
     CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                            DISTRICTS IN CHINA

-MISC1-
    Sec.                                                     
    201.        Doing business without a license unlawful; employment
                 of Chinese subjects.                                 
    202.        Certain classes of persons and corporations excepted;
                 insecticides.                                        
    203.        Application for license; requirements; qualifications
                 for license.                                         
    204.        Issuance of license.                                  
    205.        Display of license in pharmacy.                       
    206.        Revocation of license.                                
    207.        Restrictions on sales; written orders or
                 prescriptions.                                       
    208.        Certain preparations and sales excepted.              
    209.        Poisons; book entry of sale; labels.                  
    210.        Pharmacist; unauthorized use of title.                
    211.        Preservation of originals of prescriptions compounded
                 and copies thereof; inspection of prescriptions by
                 consular officers; marking containers of drugs.      
    212.        Offenses; punishment; duty to enforce provisions.     
    213.        Fraudulent representations to evade or defeat
                 restrictions.                                        
    214.        Previous laws unaffected.                             
    215.        "Consul" defined.                                     

-End-



-CITE-
    21 USC Sec. 201                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 201. Doing business without a license unlawful; employment of
      Chinese subjects

-STATUTE-
      It shall be unlawful in the consular districts of the United
    States in China for any person whose permanent allegiance is due to
    the United States not licensed as a pharmacist within the meaning
    of this chapter to conduct or manage any pharmacy, drug or chemical
    store, apothecary shop, or other place of business for the
    retailing, compounding, or dispensing of any drugs, chemicals, or
    poisons, or for the compounding of physicians' prescriptions, or to
    keep exposed for sale at retail, any drugs, chemicals, or poisons,
    except as hereinafter provided, or, except as hereinafter provided,
    for any person whose permanent allegiance is due to the United
    States not licensed as a pharmacist within the meaning of this
    chapter to compound, dispense, or sell, at retail, any drug,
    chemical, poison, or pharmaceutical preparation upon the
    prescription of a physician, or otherwise, or to compound
    physicians' prescriptions, except as an aid to and under the proper
    supervision of a pharmacist licensed under this chapter. And it
    shall be unlawful for any person, firm, or corporation owing
    permanent allegiance to the United States owning partly or wholly
    or managing a pharmacy, drug store, or other place of business to
    cause or permit any person other than a licensed pharmacist to
    compound, dispense, or sell at retail any drug, medicine, or
    poison, except as an aid to and under the proper supervision of a
    licensed pharmacist. Where it is necessary for a person, firm, or
    corporation whose permanent allegiance is due to the United States
    and owning partly or wholly or managing a pharmacy, drug store, or
    other place of business to employ Chinese subjects to compound,
    dispense, or sell at retail any drug, medicine, or poison, such
    person, firm, or corporation, owner, part owner, or manager of a
    pharmacy, drug store, or other place of business may employ such
    Chinese subjects when their character, ability, and age of twenty-
    one years or over have been certified to by at least two
    recognized and reputable practitioners of medicine, or two
    pharmacists licensed under this chapter whose permanent allegiance
    is due to the United States.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 1, 38 Stat. 817.)

-COD-
                               CODIFICATION                           
      Section is comprised of part of section 1 of act Mar. 3, 1915.
    Remainder of such section 1 is classified to section 202 of this
    title.

-End-



-CITE-
    21 USC Sec. 202                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 202. Certain classes of persons and corporations excepted;
      insecticides

-STATUTE-
      Nothing in section 201 of this title shall be construed to
    interfere with any recognized and reputable practitioner of
    medicine, dentistry, or veterinary surgery in the compounding of
    his own prescriptions, or to prevent him from supplying to his
    patients such medicines as he may deem proper, except as
    hereinafter provided; nor with the exclusively wholesale business
    of any person, firm, or corporation whose permanent allegiance is
    due to the United States dealing and licensed as pharmacists, or
    having in their employ at least one person who is so licensed,
    except as hereinafter provided; nor with the sale by persons,
    firms, or corporations whose permanent allegiance is due to the
    United States other than pharmacists of poisonous substances sold
    exclusively for use in the arts, or as insecticides, when such
    substances are sold in unbroken packages bearing labels having
    plainly printed upon them the name of the contents, the word
    "Poison", when practicable the name of at least one suitable
    antidote, and the name and address of the vender.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 1, 38 Stat. 818.)

-COD-
                               CODIFICATION                           
      Section is comprised of part of section 1 of act Mar. 3, 1915.
    Remainder of such section 1 is classified to section 201 of this
    title.

-End-



-CITE-
    21 USC Sec. 203                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 203. Application for license; requirements; qualifications for
      license

-STATUTE-
      Every person whose permanent allegiance is due to the United
    States desiring to practice as a pharmacist in the consular
    districts in China shall file with the consul an application, duly
    verified under oath, setting forth the name and age of the
    applicant, the place or places at which he pursued and the time
    spent in the study of pharmacy, the experience which the applicant
    has had in compounding physicians' prescriptions under the
    direction of a licensed pharmacist, and the name and location of
    the school or college of pharmacy, if any, of which he is a
    graduate, and shall submit evidence sufficient to show to the
    satisfaction of said consul that he is of good moral character and
    not addicted to the use of alcoholic liquors or narcotic drugs so
    as to render him unfit to practice pharmacy. Applicants shall be
    not less than twenty-one years of age and shall have had at least
    four years' experience in the practice of pharmacy or shall have
    served three years under the instruction of a regularly licensed
    pharmacist, and any applicant who has been graduated from a school
    or college of pharmacy recognized by the proper board of his State,
    Territory, District of Columbia, or other possession of the United
    States as in good standing shall be entitled to practice upon
    presentation of his diploma.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 2, 38 Stat. 818.)

-COD-
                               CODIFICATION                           
      The words "now practicing as a pharmacist or," which preceded
    "desiring to practice" in the original text of this section, were
    omitted as obsolete.

-End-



-CITE-
    21 USC Sec. 204                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 204. Issuance of license

-STATUTE-
      If the applicant for license as a pharmacist has complied with
    the requirements of section 203 of this title, the consul shall
    issue to him a license which shall entitle him to practice pharmacy
    in the consular districts of the United States in China, subject to
    the provisions of this chapter.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 3, 38 Stat. 819.)

-End-



-CITE-
    21 USC Sec. 205                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 205. Display of license in pharmacy

-STATUTE-
      Every license to practice pharmacy shall be conspicuously
    displayed by the person to whom the same has been issued in the
    pharmacy, drug store, or place of business, if any, of which the
    said person is the owner or part owner or manager.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 5, 38 Stat. 819.)

-End-



-CITE-
    21 USC Sec. 206                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 206. Revocation of license

-STATUTE-
      The license of any person whose permanent allegiance is due to
    the United States to practice pharmacy in the consular districts of
    the United States in China may be revoked by the consul if such
    person be found to have obtained such license by fraud, or be
    addicted to the use of any narcotic or stimulant, or to be
    suffering from physical or mental disease, in such manner and to
    such extent as to render it expedient that in the interests of the
    public his license be canceled; or to be of an immoral character;
    or if such person be convicted in any court of competent
    jurisdiction of any offense involving moral turpitude. It shall be
    the duty of the consul to investigate any case in which it is
    discovered by him or made to appear to his satisfaction that any
    license issued under the provisions of this chapter is revocable
    and shall, after full hearing, if in his judgment the facts warrant
    it, revoke such license.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 4, 38 Stat. 819.)

-End-



-CITE-
    21 USC Sec. 207                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 207. Restrictions on sales; written orders or prescriptions

-STATUTE-
      It shall be unlawful for any person, firm, or corporation whose
    permanent allegiance is due to the United States, either personally
    or by servant or agent or as the servant or agent of any other
    person or of any firm or corporation, to sell, furnish, or give
    away any cocaine, salts of cocaine, or preparation containing
    cocaine or salts of cocaine, or morphine or preparation containing
    morphine or salts of morphine, or any opium or preparation
    containing opium, or any chloral hydrate or preparation containing
    chloral hydrate, except upon the original written order or
    prescription of a recognized and reputable practitioner of
    medicine, dentistry, or veterinary medicine, which order or
    prescription shall be dated and shall contain the name of the
    person for whom prescribed, or, if ordered by a practitioner of
    veterinary medicine, shall state the kind of animal for which
    ordered and shall be signed by the person giving the order or
    prescription. Such order or prescription shall be, for a period of
    three years, retained on file by the person, firm, or corporation
    who compounds or dispenses the article ordered or prescribed, and
    it shall not be compounded or dispensed after the first time except
    upon the written order of the original prescriber.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 6, 38 Stat. 819.)

-COD-
                               CODIFICATION                           
      Section is comprised of part of section 6 of act Mar. 3, 1915.
    Remainder of such section 6 is classified to section 208 of this
    title.

-End-



-CITE-
    21 USC Sec. 208                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 208. Certain preparations and sales excepted

-STATUTE-
      The provisions of section 207 of this title shall not apply to
    preparations containing not more than two grains of opium or not
    more than one-quarter grain of morphine, or not more than one-
    quarter grain of cocaine, or not more than two grains of chloral
    hydrate in the fluid ounce, or, of a solid preparation, in one
    avoirdupois ounce, nor shall they apply to preparations sold in
    good faith for diarrhea and cholera, each bottle or package of
    which is accompanied by specific directions for use and caution
    against habitual use, nor to liniments or ointments sold in good
    faith as such when plainly labeled "for external use only", nor to
    powder of ipecac and opium, commonly known as Dover's powder, when
    sold in quantities not exceeding twenty grains. The provisions of
    this section or section 207 of this title shall not be construed to
    permit the selling, furnishing, giving away, or prescribing for the
    use of any habitual users of the same any cocaine, salts of
    cocaine, or preparation containing cocaine or salts of cocaine, or
    morphine or salts of morphine, or preparations containing morphine
    or salts of morphine, or any opium or preparation containing opium,
    or any chloral hydrate or preparation containing chloral hydrate.
    But the preceding sentence shall not be construed to prevent any
    recognized or reputable practitioner of medicine whose permanent
    allegiance is due to the United States from furnishing in good
    faith for the use of any habitual user of narcotic drugs who is
    under his professional care such substances as he may deem
    necessary for their treatment, when such prescriptions are not
    given or substances furnished for the purpose of evading the
    provisions of this section. But the provisions of this section or
    section 207 of this title shall not apply to sales at wholesale
    between jobbers, manufacturers, and retail druggists, hospitals,
    and scientific or public institutions.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 6, 38 Stat. 819.)

-COD-
                               CODIFICATION                           
      Section is comprised of section 6 of act Mar. 3, 1915. Remainder
    of such section 6 is classified to section 207 of this title.

-End-



-CITE-
    21 USC Sec. 209                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 209. Poisons; book entry of sale; labels

-STATUTE-
      It shall be unlawful for any person, firm, or corporation whose
    permanent allegiance is due to the United States to sell or deliver
    to any other person any of the following-described substances, or
    any poisonous compound, combination, or preparation thereof, to
    wit: The compounds of and salts of antimony, arsenic, barium,
    chromium, copper, gold, lead, mercury, silver, and zinc, the
    caustic hydrates of sodium and potassium, solution or water of
    ammonia, methyl alcohol, paregoric, the concentrated mineral acids,
    oxalic and hydrocyanic acids and their salts, yellow phosphorus,
    Paris green, carbolic acid, the essential oils of almonds,
    pennyroyal, tansy, rue, and savin; croton oil, creosote,
    chloroform, cantharides, or aconite, belladonna, bitter almonds,
    colchicum, cotton root, cocculus indicus, conium, cannabis indica,
    digitalis, ergot, hyoscyamus, ignatia, lobelia, nux vomica,
    physostigma, phytolacca, strophanthus, stramonium, veratrum viride,
    or any of the poisonous alkaloids or alkaloidal salts derived from
    the foregoing, or any other poisonous alkaloids or their salts, or
    any other virulent poison, except in the manner following, and,
    moreover, if the applicant be less than eighteen years of age,
    except upon the written order of a person known or believed to be
    an adult.
      It shall first be learned, by due inquiry, that the person to
    whom delivery is about to be made is aware of the poisonous
    character of the substance and that it is desired for a lawful
    purpose, and the box, bottle, or other package shall be plainly
    labeled with the name of the substance, the word "Poison", the name
    of at least one suitable antidote, when practicable, and the name
    and address of the person, firm, or corporation dispensing the
    substance. And before delivery be made of any of the foregoing
    substances, excepting solution or water of ammonia and sulphate of
    copper, there shall be recorded in a book kept for that purpose the
    name of the article, the quantity delivered, the purpose for which
    it is to be used, the date of delivery, the name and address of the
    person for whom it is procured, and the name of the individual
    personally dispensing the same; and said book shall be preserved by
    the owner thereof for at least three years after the date of the
    last entry therein. The foregoing provisions shall not apply to
    articles dispensed upon the order of persons believed by the
    dispenser to be recognized and reputable practitioners of medicine,
    dentistry, or veterinary surgery. When a physician writes upon his
    prescription a request that it be marked or labeled "Poison" the
    pharmacist shall, in the case of liquids, place the same in a
    colored glass, roughened bottle, of the kind commonly known in
    trade as a "poison bottle", and, in the case of dry substances, he
    shall place a poison label upon the container. The record of sale
    and delivery above mentioned shall not be required of manufacturers
    and wholesalers who shall sell any of the foregoing substances at
    wholesale to licensed pharmacists, but the box, bottle, or other
    package containing such substance, when sold at wholesale, shall be
    properly labeled with the name of the substance, the word "poison",
    and the name and address of the manufacturer or wholesaler. It
    shall not be necessary, in sales either at wholesale or at retail,
    to place a poison label upon, nor to record the delivery of, the
    sulphide of antimony, or the oxide or carbonate of zinc, or of
    colors ground in oil and intended for use as paints, or calomel;
    nor in the case of preparations containing any of the substances
    named in this section, when a single box, bottle, or other package,
    or when the bulk of one-half fluid ounce or the weight of one-half
    avoirdupois ounce does not contain more than an adult medicinal
    dose of such substance; nor in the case of liniments or ointments
    sold in good faith as such, when plainly labeled "For external use
    only"; nor, in the case of preparations put up and sold in the form
    of pills, tablets, or lozenges, containing any of the substances
    enumerated in this section and intended for internal use, when the
    dose recommended does not contain more than one-fourth of an adult
    medicinal dose of such substance.
      For the purpose of this and of every other section of this
    chapter no box, bottle, or other package shall be regarded as
    having been labeled "Poison" unless the word "Poison" appears
    conspicuously thereon, printed in plain, uncondensed gothic letters
    in red ink.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 7, 38 Stat. 820.)

-End-



-CITE-
    21 USC Sec. 210                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 210. Pharmacist; unauthorized use of title

-STATUTE-
      It shall be unlawful for any person whose permanent allegiance is
    due to the United States, not legally licensed as a pharmacist, to
    take, use, or exhibit the title of pharmacist, or licensed or
    registered pharmacist, or the title of druggist or apothecary, or
    any other title or description of like import.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 10, 38 Stat. 821.)

-End-



-CITE-
    21 USC Sec. 211                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 211. Preservation of originals of prescriptions compounded and
      copies thereof; inspection of prescriptions by consular officers;
      marking containers of drugs

-STATUTE-
      Every person, firm, or corporation whose permanent allegiance is
    due to the United States owning, partly owning, or managing a drug
    store or pharmacy shall keep in his place of business a suitable
    book or file, in which shall be preserved for a period of not less
    than three years the original of every prescription compounded or
    dispensed at such store or pharmacy, or a copy of such
    prescription, except when the preservation of the original is
    required by section 207 or 208 of this title. Upon request the
    owner, part owner, or manager of such store shall furnish to the
    prescribing physician, or to the person for whom such prescription
    was compounded or dispensed, a true and correct copy thereof. Any
    prescription required by section 207 or 208 of this title, and any
    prescription for, or register of sales of, substances mentioned in
    such sections shall at all times be open to inspection by duly
    authorized consular officers in the consular districts of the
    United States in China. No person, firm, or corporation whose
    permanent allegiance is due to the United States shall, in a
    consular district, compound or dispense any drug or drugs or
    deliver the same to any other person without marking on the
    container thereof the name of the drug or drugs contained therein
    and directions for using the same.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 9, 38 Stat. 821.)

-End-



-CITE-
    21 USC Sec. 212                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 212. Offenses; punishment; duty to enforce provisions

-STATUTE-
      Any person, firm, or corporation, whose permanent allegiance is
    due to the United States, violating any of the provisions of this
    chapter shall be deemed guilty of a misdemeanor and, upon
    conviction thereof, shall be punished by a fine of not less than
    $50 and not more than $100 or by imprisonment for not less than one
    month and not more than sixty days, or by both such fine and
    imprisonment, in the discretion of the court, and if the offense be
    continuing in its character, each week or part of a week during
    which it continues shall constitute a separate and distinct
    offense. And it shall be the duty of the consular and judicial
    officers of the United States in China to enforce the provisions of
    this chapter.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 11, 38 Stat. 821.)

-End-



-CITE-
    21 USC Sec. 213                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 213. Fraudulent representations to evade or defeat
      restrictions

-STATUTE-
      No person, firm, or corporation whose permanent allegiance is due
    to the United States seeking to procure in the consular districts
    of the United States in China any substance the sale of which is
    regulated by the provisions of this chapter shall make any
    fraudulent representations so as to evade or defeat the
    restrictions herein imposed.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 8, 38 Stat. 821.)

-End-



-CITE-
    21 USC Sec. 214                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 214. Previous laws unaffected

-STATUTE-
      Nothing in this chapter shall be construed as modifying or
    revoking any of the provisions of sections 191 to 193 (!1) of this
    title.


-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 13, 38 Stat. 822.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Sections 191 to 193 of this title, referred to in text, were
    repealed by Pub. L. 91-513, title III, Sec. 1101(a)(1), Oct. 27,
    1970, 84 Stat. 1291. See section 801 et seq. of this title.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 215                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
                 DISTRICTS IN CHINA                

-HEAD-
    Sec. 215. "Consul" defined

-STATUTE-
      The word "consul" as used in this chapter shall mean the consular
    officer in charge of the district concerned.

-SOURCE-
    (Mar. 3, 1915, ch. 74, Sec. 12, 38 Stat. 822.)

-End-


-CITE-
    21 USC CHAPTER 8 - NARCOTIC FARMS                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 8 - NARCOTIC FARMS

-HEAD-
                        CHAPTER 8 - NARCOTIC FARMS                    

-End-



-CITE-
    21 USC Secs. 221 to 237                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 8 - NARCOTIC FARMS

-HEAD-
    Secs. 221 to 237. Repealed.

-MISC1-
    Secs. 221 to 237. Repealed. July 1, 1944, ch. 373, title XIII, Sec.
      1313, 58 Stat. 714.
      Section 221, act Jan. 19, 1929, ch. 82, Sec. 1, 45 Stat. 1085,
    defined "habit-forming narcotic drug", "narcotic", and "addict".
    See section 201 of Title 42, The Public Health and Welfare.
      Section 222, act Jan. 19, 1929, ch. 82, Sec. 2, 45 Stat. 1085,
    provided for narcotic farms.
      Section 222a, act June 23, 1935, ch. 725, Sec. 1, 49 Stat. 1840,
    provided name for narcotic farm at Lexington, Ky.
      Section 222b, act Mar. 28, 1938, ch. 55, Sec. 1, 52 Stat. 134,
    provided name for narcotic farm at Fort Worth, Texas.
      Section 223, act Jan. 19, 1929, ch. 82, Sec. 3, 45 Stat. 1085;
    1939 Reorg. Plan No. I, Sec. 205(b), eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1425, provided for an annual estimate of expenses of
    maintenance of narcotic farms.
      Section 224, act Jan. 19, 1929, ch. 82, Sec. 4, 45 Stat. 1086,
    provided for construction of buildings for two of the narcotic
    farms.
      Section 225, acts Jan. 19, 1929, ch. 82, Sec. 5, 45 Stat. 1086;
    June 14, 1930, ch. 488, Sec. 4(a), 46 Stat. 586; 1939 Reorg. Plan
    No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
    1424, provided for control and management of narcotic farms.
      Section 226, act Jan. 19, 1929, ch. 82, Sec. 6, 45 Stat. 1086;
    1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1424, 1425, provided for care and treatment of
    addicts.
      Section 227, act Jan. 19, 1929, ch. 82, Sec. 7, 45 Stat. 1086,
    provided for transfer to and from farms of addicts who are
    prisoners.
      Section 228, act Jan. 19, 1929, ch. 82, Sec. 8, 45 Stat. 1087,
    provided that it was the duty of prosecuting officers to report
    convicted persons believed to be addicts.
      Section 229, act Jan. 19, 1929, ch. 82, Sec. 9, 45 Stat. 1087;
    1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1424, 1425, provided for employment of addicts.
      Section 230, act Jan. 19, 1929, ch. 82, Sec. 10, 45 Stat. 1087,
    provided for parole of inmates.
      Section 231, act Jan. 19, 1929, ch. 82, Sec. 11, 45 Stat. 1087;
    1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1424, 1425, provided for discharge of addicts.
      Section 232, act Jan. 19, 1929, ch. 82, Sec. 12, 45 Stat. 1088;
    1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1424, 1425, provided for admission of voluntary
    patients.
      Section 233, act Jan. 19, 1929, ch. 82, Sec. 13, 45 Stat. 1088;
    1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1424, 1425, provided for furnishing of gratuities
    and transportation to discharged convicts.
      Section 234, act. Jan. 19, 1929, ch. 82, Sec. 14, 45 Stat. 1089;
    1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
    2728, 53 Stat. 1424, 1425, provided penalties for introduction of
    narcotic drugs into a narcotic farm.
      Section 235, act Jan. 19, 1929, ch. 82, Sec. 15, 45 Stat. 1089,
    provided penalties for escape of inmates.
      Section 236, act Jan. 19, 1929, ch. 82, Sec. 16, 45 Stat. 1089,
    provided penalties for procuring of escape by inmates.
      Section 237, act Jan. 19, 1929, ch. 82, Sec. 17, 45 Stat. 1089,
    provided for deportation of alien inmates who are entitled to a
    discharge from narcotic farms.

                       RENUMBERING OF REPEALING ACT                   
      Section 611 of act July 1, 1944, which repealed this section, was
    renumbered Sec. 711 by act Aug. 13, 1946, ch. 958, Sec. 5, 60 Stat.
    1049, Sec. 713 by act Feb. 28, 1948, ch. 83, Sec. 9(b), 62 Stat.
    47, Sec. 813 by act July 30, 1956, ch. 779, Sec. 3(b), 70 Stat.
    720, Sec. 913 by Pub. L. 88-581, Sec. 4(b), Sept. 4, 1964, 78 Stat.
    919, Sec. 1013 by Pub. L. 89-239, Sec. 3(b), Oct. 6, 1965, 79 Stat.
    931, Sec. 1113 by Pub. L. 91-572, Sec. 6(b), Dec. 24, 1970, 84
    Stat. 1506, Sec. 1213 by Pub. L. 92-294, Sec. 3(b), May 16, 1972,
    86 Stat. 137, Sec. 1313 by Pub. L. 93-154, Sec. 2(b)(2), Nov. 16,
    1973, 87 Stat. 604, and was repealed by Pub. L. 93-222, Sec. 7(b),
    Dec. 29, 1973, 87 Stat. 936.

-End-




-CITE-
    21 USC CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

-HEAD-
             CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT         

-MISC1-
                        SUBCHAPTER I - SHORT TITLE                    
    Sec.                                                     
    301.        Short title.                                          

                        SUBCHAPTER II - DEFINITIONS                    
    321.        Definitions; generally.                               
    321a.       "Butter" defined.                                     
    321b.       "Package" defined.                                    
    321c.       Nonfat dry milk; "milk" defined.                      
    321d.       Market names for catfish and ginseng.                 

              SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES          
    331.        Prohibited acts.                                      
    332.        Injunction proceedings.                               
    333.        Penalties.                                            
    333a.       Repealed.                                             
    334.        Seizure.                                              
    335.        Hearing before report of criminal violation.          
    335a.       Debarment, temporary denial of approval, and
                 suspension.                                          
    335b.       Civil penalties.                                      
    335c.       Authority to withdraw approval of abbreviated drug
                 applications.                                        
    336.        Report of minor violations.                           
    337.        Proceedings in name of United States; provision as to
                 subpoenas.                                           

                           SUBCHAPTER IV - FOOD                       
    341.        Definitions and standards for food.                   
    342.        Adulterated food.                                     
    343.        Misbranded food.                                      
    343-1.      National uniform nutrition labeling.                  
    343-2.      Dietary supplement labeling exemptions.               
    343-3.      Disclosure.                                           
    343a.       Repealed.                                             
    344.        Emergency permit control.                             
    345.        Regulations making exemptions.                        
    346.        Tolerances for poisonous or deleterious substances in
                 food; regulations.                                   
    346a.       Tolerances and exemptions for pesticide chemical
                 residues.                                            
    346b.       Authorization of appropriations.                      
    347.        Intrastate sales of colored oleomargarine.            
    347a.       Congressional declaration of policy regarding
                 oleomargarine sales.                                 
    347b.       Contravention of State laws.                          
    348.        Food additives.                                       
    349.        Bottled drinking water standards; publication in
                 Federal Register.                                    
    350.        Vitamins and minerals.                                
    350a.       Infant formulas.                                      
    350b.       New dietary ingredients.                              
    350c.       Maintenance and inspection of records.                
    350d.       Registration of food facilities.                      
    350e.       Sanitary transportation practices.                    

                     SUBCHAPTER V - DRUGS AND DEVICES                 

                        PART A - DRUGS AND DEVICES                    
    351.        Adulterated drugs and devices.                        
    352.        Misbranded drugs and devices.                         
    353.        Exemptions and consideration for certain drugs,
                 devices, and biological products.                    
    353a.       Pharmacy compounding.                                 
    354.        Veterinary feed directive drugs.                      
    355.        New drugs.                                            
    355a.       Pediatric studies of drugs.                           
    355b.       Adverse-event reporting.                              
    355c.       Research into pediatric uses for drugs and biological
                 products.                                            
    356.        Fast track products.                                  
    356-1.      Accelerated approval of priority countermeasures.     
    356a.       Manufacturing changes.                                
    356b.       Reports of postmarketing studies.                     
    356c.       Discontinuance of life saving product.                
    357.        Repealed.                                             
    358.        Authority to designate official names.                
    359.        Nonapplicability of subchapter to cosmetics.          
    360.        Registration of producers of drugs or devices.        
    360a.       Repealed.                                             
    360b.       New animal drugs.                                     
    360c.       Classification of devices intended for human use.     
    360d.       Performance standards.                                
    360e.       Premarket approval.                                   
    360f.       Banned devices.                                       
    360g.       Judicial review.                                      
    360h.       Notification and other remedies.                      
    360i.       Records and reports on devices.                       
    360j.       General provisions respecting control of devices
                 intended for human use.                              
    360k.       State and local requirements respecting devices.      
    360l.       Postmarket surveillance.                              
    360m.       Accredited persons.                                   

              PART B - DRUGS FOR RARE DISEASES OR CONDITIONS          
    360aa.      Recommendations for investigations of drugs for rare
                 diseases or conditions.                              
    360bb.      Designation of drugs for rare diseases or conditions. 
    360cc.      Protection for drugs for rare diseases or conditions. 
    360dd.      Open protocols for investigations of drugs for rare
                 diseases or conditions.                              
    360ee.      Grants and contracts for development of drugs for rare
                 diseases and conditions.                             

               PART C - ELECTRONIC PRODUCT RADIATION CONTROL           
    360hh.      Definitions.                                          
    360ii.      Program of control.                                   
    360jj.      Studies by Secretary.                                 
    360kk.      Performance standards for electronic products.        
    360ll.      Notification of defects in and repair or replacement
                 of electronic products.                              
    360mm.      Imports.                                              
    360nn.      Inspection, records, and reports.                     
    360oo.      Prohibited acts.                                      
    360pp.      Enforcement.                                          
    360qq.      Repealed.                                             
    360rr.      Federal-State cooperation.                            
    360ss.      State standards.                                      

              PART D - DISSEMINATION OF TREATMENT INFORMATION          
    360aaa.     Requirements for dissemination of treatment
                 information on drugs or devices.                     
    360aaa-1.   Information authorized to be disseminated.            
    360aaa-2.   Establishment of list of articles and publications
                 disseminated and list of providers that received
                 articles and reference publications.                 
    360aaa-3.   Requirement regarding submission of supplemental
                 application for new use; exemption from requirement. 
    360aaa-4.   Corrective actions; cessation of dissemination.       
    360aaa-5.   Definitions.                                          
    360aaa-6.   Rules of construction.                                

         PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES     
    360bbb.     Expanded access to unapproved therapies and
                 diagnostics.                                         
    360bbb-1.   Dispute resolution.                                   
    360bbb-2.   Classification of products.                           
    360bbb-3.   Authorization for medical products for use in
                 emergencies.                                         
    360bbb-4.   Technical assistance.                                 

         PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES     
    360ccc.     Conditional approval of new animal drugs for minor use
                 and minor species.                                   
    360ccc-1.   Index of legally marketed unapproved new animal drugs
                 for minor species.                                   
    360ccc-2.   Designated new animal drugs for minor use or minor
                 species.                                             

                         SUBCHAPTER VI - COSMETICS                     
    361.        Adulterated cosmetics.                                
    362.        Misbranded cosmetics.                                 
    363.        Regulations making exemptions.                        
    364.        Repealed.                                             

                    SUBCHAPTER VII - GENERAL AUTHORITY                

                PART A - GENERAL ADMINISTRATIVE PROVISIONS            
    371.        Regulations and hearings.                             
    372.        Examinations and investigations.                      
    372a.       Transferred.                                          
    373.        Records.                                              
    374.        Inspection.                                           
    374a.       Inspections relating to food allergens.               
    375.        Publicity.                                            
    376.        Examination of sea food on request of packer; marking
                 food with results; fees; penalties.                  
    377.        Revision of United States Pharmacopoeia; development
                 of analysis and mechanical and physical tests.       
    378.        Advertising of foods.                                 
    379.        Confidential information.                             
    379a.       Presumption of existence of jurisdiction.             
    379b.       Consolidated administrative and laboratory facility.  
    379c.       Transferred.                                          
    379d.       Automation of Food and Drug Administration.           

                              PART B - COLORS                          
    379e.       Listing and certification of color additives for
                 foods, drugs, devices, and cosmetics.                

                               PART C - FEES                           

                  SUBPART 1 - FREEDOM OF INFORMATION FEES              
    379f.       Recovery and retention of fees for freedom of
                 information requests.                                

                    SUBPART 2 - FEES RELATING TO DRUGS                
    379g.       Definitions.                                          
    379h.       Authority to assess and use drug fees.                

                   SUBPART 3 - FEES RELATING TO DEVICES               
    379i.       Definitions.                                          
    379j.       Authority to assess and use device fees.              

                 SUBPART 4 - FEES RELATING TO ANIMAL DRUGS             
    379j-11.    Definitions.                                          
    379j-12.    Authority to assess and use animal drug fees.         

                    PART D - INFORMATION AND EDUCATION                
    379k.       Information system.                                   
    379l.       Education.                                            

                   PART E - ENVIRONMENTAL IMPACT REVIEW               
    379o.       Environmental impact.                                 

        PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
             PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
    379r.       National uniformity for nonprescription drugs.        
    379s.       Preemption for labeling or packaging of cosmetics.    

                          PART G - SAFETY REPORTS                      
    379v.       Safety report disclaimers.                            

                  PART H - SERIOUS ADVERSE EVENT REPORTS              
    379aa.      Serious adverse event reporting for nonprescription
                 drugs.                                               
    379aa-1.    Serious adverse event reporting for dietary
                 supplements.                                         

                   SUBCHAPTER VIII - IMPORTS AND EXPORTS               
    381.        Imports and exports.                                  
    382.        Exports of certain unapproved products.               
    383.        Office of International Relations.                    
    384.        Importation of prescription drugs.                    

                       SUBCHAPTER IX - MISCELLANEOUS                   
    391.        Separability clause.                                  
    392.        Exemption of meats and meat food products.            
    393.        Food and Drug Administration.                         
    393a.       Office of Pediatric Therapeutics.                     
    394.        Scientific review groups.                             
    395.        Loan repayment program.                               
    396.        Practice of medicine.                                 
    397.        Contracts for expert review.                          
    398.        Notices to States regarding imported food.            
    399.        Grants to States for inspections.                     

-End-


-CITE-
    21 USC SUBCHAPTER I - SHORT TITLE                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER I - SHORT TITLE

-HEAD-
                        SUBCHAPTER I - SHORT TITLE                    

-End-



-CITE-
    21 USC Sec. 301                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER I - SHORT TITLE

-HEAD-
    Sec. 301. Short title

-STATUTE-
      This chapter may be cited as the Federal Food, Drug, and Cosmetic
    Act.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 1, 52 Stat. 1040.)


-MISC1-
               EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES           
      Act June 23, 1939, ch. 242, Secs. 1, 2, 53 Stat. 853, 854,
    provided that:
      "[Sec. 1] (a) The effective date of the following provisions of
    the Federal Food, Drug, and Cosmetic Act is hereby postponed until
    January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1)
    [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
    to (k) of this title]; 501(a), (4) [351(a)(4) of this title];
    502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this
    title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this
    title].
      "(b) The Secretary of Agriculture shall promulgate regulations
    further postponing to July 1, 1940 the effective date of the
    provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g),
    (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g),
    and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of
    this title] of such Act with respect to lithographed labeling which
    was manufactured prior to February 1, 1939, and to containers
    bearing labeling which, prior to February 1, 1939, was
    lithographed, etched, stamped, pressed, printed, fused or blown on
    or in such containers, where compliance with such provisions would
    be unduly burdensome by reason of causing the loss of valuable
    stocks of such labeling or containers, and where such postponement
    would not prevent the public interest being adequately served:
    Provided, That in no case shall such regulations apply to labeling
    which would not have complied with the requirements of the Food and
    Drugs Act of June 30, 1906, as amended.
      "Sec. 2. (a) The provisions of section 8 [section 10 of this
    title], paragraph fifth, under the heading 'In the case of food:',
    of the Food and Drugs Act of June 30, 1906, as amended, and
    regulations promulgated thereunder, and all other provisions of
    such Act to the extent that they may relate to the enforcement of
    such section 8 [section 10 of this title] and of such regulations,
    shall remain in force until January 1, 1940.
      "(b) The provisions of such Act of June 30, 1906, as amended,
    [sections 1 to 5, 7 to 15, and 372a of this title] to the extent
    that they impose, or authorize the imposition of, any requirement
    imposed by section 403(k) of the Federal Food, Drug, and Cosmetic
    Act [section 343(k) of this title], shall remain in force until
    January 1, 1940.
      "(c) Notwithstanding the provisions of section 1 of this Act,
    such section shall not apply - 
        "(1) to the provisions of section 502(d) and (e) of the Federal
      Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar
      as such provisions relate to any substance named in section 8
      [section 10 of this title], paragraph second, under the heading
      'In the case of drugs:', of the Food and Drugs Act of June 30,
      1906, as amended, or a derivative of any such substance; or
        "(2) to the provisions of section 502(b), (d), (e), (f), (g),
      and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d)
      to (h) of this title], insofar as such provisions relate to drugs
      to which section 505 [355 of this title] of such Act applies."

                              EFFECTIVE DATE                          
      Section 902(a) of act June 25, 1938, provided that: "This Act
    [enacting this chapter and repealing sections 1 to 5 and 7 to 15 of
    this title], shall take effect twelve months after the date of its
    enactment [June 25, 1938]. The Federal Food and Drugs Act of June
    30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15),
    shall remain in force until such effective date, and, except as
    otherwise provided in this subsection, is hereby repealed effective
    upon such date: Provided, That the provisions of section 701
    [section 371 of this title] shall become effective on the enactment
    of this Act, and thereafter the Secretary is authorized hereby to
    (1) conduct hearings and to promulgate regulations which shall
    become effective on or after the effective date of this Act as the
    Secretary shall direct, and (2) designate prior to the effective
    date of this Act food having common or usual names and exempt such
    food from the requirements of clause (2) of section 403(i) [section
    343(i) of this title] for a reasonable time to permit the
    formulation, promulgation, and effective application of definitions
    and standards of identity therefor as provided by section 401
    [section 341 of this title]: Provided further, That sections
    502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively
    of this title], and all other provisions of this Act to the extent
    that they may relate to the enforcement of such sections, shall
    take effect on the date of the enactment of this Act, except that
    in the case of a cosmetic to which the proviso of section 601(a)
    [section 361(a) of this title], relates, such cosmetic shall not,
    prior to the ninetieth day after such date of enactment, be deemed
    adulterated by reason of the failure of its label to bear the
    legend prescribed in such proviso: Provided further, That the Act
    of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section 321a
    of this title]; 42 Stat. 1500, ch. 268), defining butter and
    providing a standard therefor; the Act of July 24, 1919 (U.S.C.,
    1934 ed., title 21, sec. 10 [section 321b of this title]; 41 Stat.
    271, ch. 26], defining wrapped meats as in package form; and the
    amendment to the Food and Drugs Act, section 10A, approved August
    27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [section
    372a of this title]) shall remain in force and effect and be
    applicable to the provisions of this Act."

                       SHORT TITLE OF 2006 AMENDMENT                   
      Pub. L. 109-462, Sec. 1, Dec. 22, 2006, 120 Stat. 3469, provided
    that: "This Act [enacting sections 379aa and 379aa-1 of this title,
    amending sections 331, 343, 352, and 381 of this title, and
    enacting provisions set out as notes under sections 331, 343, 352,
    379aa, and 381 of this title] may be cited as the 'Dietary
    Supplement and Nonprescription Drug Consumer Protection Act'."

                      SHORT TITLE OF 2005 AMENDMENTS                  
      Pub. L. 109-59, title VII, Sec. 7201, Aug. 10, 2005, 119 Stat.
    1911, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
    of title VII of Pub. L. 109-59, enacting section 350e of this
    title, amending sections 331, 342, and 373 of this title and
    section 5701 of Title 49, Transportation, omitting sections 5702 to
    5714 of Title 49, and enacting provisions set out as a note under
    section 331 of this title] may be cited as the 'Sanitary Food
    Transportation Act of 2005'."
      Pub. L. 109-43, Sec. 1, Aug. 1, 2005, 119 Stat. 439, provided
    that: "This Act [amending sections 352 and 379j of this title,
    enacting provisions set out as a note under section 352 of this
    title, and amending provisions set out as notes under sections 352
    and 379i of this title] may be cited as the 'Medical Device User
    Fee Stabilization Act of 2005'."

                      SHORT TITLE OF 2004 AMENDMENTS                  
      Pub. L. 108-282, title I, Sec. 101, Aug. 2, 2004, 118 Stat. 891,
    provided that: "This title [enacting sections 360ccc to 360ccc-2 of
    this title, amending sections 321, 331, 352, 353, 354, and 360b of
    this title, enacting provisions set out as notes under sections
    360ccc and 393 of this title, and amending provisions set out as a
    note under section 360b of this title] may be cited as the 'Minor
    Use and Minor Species Animal Health Act of 2004'."
      Pub. L. 108-282, title II, Sec. 201, Aug. 2, 2004, 118 Stat. 905,
    provided that: "This title [enacting section 374a of this title and
    section 242r of Title 42, The Public Health and Welfare, amending
    sections 321, 343, and 343-1 of this title, and enacting provisions
    set out as notes under sections 321 and 343 of this title and
    sections 243 and 300d-2 of Title 42] may be cited as the 'Food
    Allergen Labeling and Consumer Protection Act of 2004'."
      Pub. L. 108-214, Sec. 1, Apr. 1, 2004, 118 Stat. 572, provided
    that: "This Act [amending sections 331, 352, 360, 360e, 374, 379i,
    and 379j of this title and provisions set out as notes under
    sections 352, 360l, and 379j of this title] may be cited as the
    'Medical Devices Technical Corrections Act'."

                      SHORT TITLE OF 2003 AMENDMENTS                  
      Pub. L. 108-155, Sec. 1, Dec. 3, 2003, 117 Stat. 1936, provided
    that: "This Act [enacting section 355c of this title, amending
    sections 355, 355a, and 355b of this title and sections 262 and
    284m of Title 42, The Public Health and Welfare, enacting
    provisions set out as a note under section 355c of this title, and
    amending provisions set out as notes under section 355a of this
    title and section 284m of Title 42] may be cited as the 'Pediatric
    Research Equity Act of 2003'."
      Pub. L. 108-130, Sec. 1, Nov. 18, 2003, 117 Stat. 1361, provided
    that: "This Act [enacting sections 379j-11 and 379j-12 of this
    title and provisions set out as notes under section 379j-11 of this
    title] may be cited as the 'Animal Drug User Fee Act of 2003'."

                      SHORT TITLE OF 2002 AMENDMENTS                  
      Pub. L. 107-281, Sec. 1, Nov. 6, 2002, 116 Stat. 1992, provided
    that: "This Act [amending sections 360cc and 360ee of this title
    and enacting provisions set out as a note under section 360ee of
    this title] may be cited as the 'Rare Diseases Orphan Product
    Development Act of 2002'."
      Pub. L. 107-250, Sec. 1(a), Oct. 26, 2002, 116 Stat. 1588,
    provided that: "This Act [enacting sections 379i and 379j of this
    title and section 289g-3 of Title 42, The Public Health and
    Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360,
    360c, 360e, 360m, and 374 of this title, and enacting provisions
    set out as notes under sections 352, 360e, 360j, 360l, 379i, and
    379j of this title and section 289g-3 of Title 42] may be cited as
    the 'Medical Device User Fee and Modernization Act of 2002'."
      Pub. L. 107-188, title V, Sec. 501, June 12, 2002, 116 Stat. 687,
    provided that: "This subtitle [subtitle A (Secs. 501-509) of title
    V of Pub. L. 107-188, amending sections 356b, 379g, and 379h of
    this title and enacting provisions set out as notes under sections
    356b and 379g of this title] may be cited as the 'Prescription Drug
    User Fee Amendments of 2002'."
      Pub. L. 107-109, Sec. 1, Jan. 4, 2002, 115 Stat. 1408, provided
    that: "This Act [enacting sections 355b and 393a of this title and
    section 284m of Title 42, The Public Health and Welfare, amending
    sections 321, 355, 355a, and 379h of this title and sections 282,
    284k, 284l, 285a-2, and 290b of Title 42, and enacting provisions
    set out as notes under sections 355 and 355a of this title and
    sections 284m and 289 of Title 42] may be cited as the 'Best
    Pharmaceuticals for Children Act'."

                       SHORT TITLE OF 2000 AMENDMENT                   
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(a)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-35, provided that: "This section
    [enacting section 384 of this title, amending sections 331, 333,
    and 381 of this title, and enacting provisions set out as a note
    under section 384 of this title] may be cited as the 'Medicine
    Equity and Drug Safety Act of 2000'."
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(a)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-40, provided that: "This section
    [amending section 381 of this title and enacting provisions set out
    as a note under section 381 of this title] may be cited as the
    'Prescription Drug Import Fairness Act of 2000'."

                       SHORT TITLE OF 1998 AMENDMENT                   
      Pub. L. 105-324, Sec. 1, Oct. 30, 1998, 112 Stat. 3035, provided
    that: "This Act [amending sections 321 and 346a of this title] may
    be cited as the 'Antimicrobial Regulation Technical Corrections Act
    of 1998'."

                       SHORT TITLE OF 1997 AMENDMENT                   
      Pub. L. 105-115, Sec. 1(a), Nov. 21, 1997, 111 Stat. 2296,
    provided that: "This Act [enacting sections 343-3, 353a, 355a, 356
    to 356c, 360m, 360aaa to 360aaa-6, 360bbb to 360bbb-2, 379k, 379l,
    379o, 379r, 379s, 379v, 396, and 397 of this title and sections
    247b-8 and 299a-3 of Title 42, The Public Health and Welfare,
    amending sections 321, 331, 334, 335a, 343, 348, 351 to 353, 355,
    360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee,
    371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title,
    section 45C of Title 26, Internal Revenue Code, section 156 of
    Title 35, Patents, section 8126 of Title 38, Veterans' Benefits,
    and sections 262, 263a, and 282 of Title 42, repealing sections 356
    and 357 of this title, and enacting provisions set out as notes
    under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l,
    360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and
    sections 247b-8 and 282 of Title 42] may be cited as the 'Food and
    Drug Administration Modernization Act of 1997'."

                      SHORT TITLE OF 1996 AMENDMENTS                  
      Pub. L. 104-250, Sec. 1(a), Oct. 9, 1996, 110 Stat. 3151,
    provided that: "This Act [enacting section 354 of this title,
    amending sections 331, 353, and 360b of this title, and enacting
    provisions set out as notes under section 360b of this title] may
    be cited as the 'Animal Drug Availability Act of 1996'."
      Pub. L. 104-170, title IV, Sec. 401(a), Aug. 3, 1996, 110 Stat.
    1513, provided that: "This title [amending sections 321, 331, 333,
    342, and 346a of this title] may be cited as the 'Food Quality
    Protection Act of 1996'."
      [Another "Food Quality Protection Act of 1996", was enacted by
    Pub. L. 104-170, Sec. 1, 110 Stat. 1489, which is set out as a note
    under section 136 of Title 7, Agriculture.]
      Pub. L. 104-134, title II, Sec. 2101(a), Apr. 26, 1996, 110 Stat.
    1321-313, provided that: "This chapter [chapter 1A (Secs. 2101-
    2105) of title II of Pub. L. 104-134, enacting section 382 of this
    title and amending sections 331 and 381 of this title and section
    262 of Title 42, The Public Health and Welfare] may be cited as the
    'FDA Export Reform and Enhancement Act of 1996'."

                      SHORT TITLE OF 1994 AMENDMENTS                  
      Pub. L. 103-417, Sec. 1(a), Oct. 25, 1994, 108 Stat. 4325,
    provided that: "This Act [enacting sections 343-2 and 350b of this
    title and section 287c-11 of Title 42, The Public Health and
    Welfare, amending sections 321, 331, 342, 343, and 350 of this
    title and section 281 of Title 42, and enacting provisions set out
    as notes under sections 321 and 343 of this title] may be cited as
    the 'Dietary Supplement Health and Education Act of 1994'."
      Pub. L. 103-396, Sec. 1, Oct. 22, 1994, 108 Stat. 4153, provided
    that: "This Act [amending sections 331, 343-1, 360b, and 371 of
    this title and enacting provisions set out as notes under section
    360b of this title] may be cited as the 'Animal Medicinal Drug Use
    Clarification Act of 1994'."

                       SHORT TITLE OF 1993 AMENDMENT                   
      Pub. L. 103-80, Sec. 1, Aug. 13, 1993, 107 Stat. 773, provided
    that: "This Act [amending sections 321, 331 to 333, 334, 335b, 341
    to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc,
    360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this
    title and section 263b of Title 42, The Public Health and Welfare,
    and enacting provisions set out as a note under section 343 of this
    title] may be cited as the 'Nutrition Labeling and Education Act
    Amendments of 1993'."

                      SHORT TITLE OF 1992 AMENDMENTS                  
      Pub. L. 102-571, title I, Sec. 101(a), Oct. 29, 1992, 106 Stat.
    4491, provided that: "This title [enacting sections 379g and 379h
    of this title, transferring sections 372a, 376, and 379c of this
    title to sections 376, 379e and 379f, respectively, of this title,
    amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361,
    362, 453, 601, and 1033 of this title, enacting provisions set out
    as notes under section 379g of this title, and amending provisions
    set out as notes under sections 343 and 343-1 of this title] may be
    cited as the 'Prescription Drug User Fee Act of 1992'."
      Pub. L. 102-571, title II, Sec. 201, Oct. 29, 1992, 106 Stat.
    4500, provided that: "This title [enacting provisions set out as
    notes under sections 343 and 393 of this title and amending
    provisions set out as notes under sections 343 and 343-1 of this
    title] may be cited as the 'Dietary Supplement Act of 1992'."
      Pub. L. 102-353, Sec. 1(a), Aug. 26, 1992, 106 Stat. 941,
    provided that: "This Act [amending sections 333, 353, and 381 of
    this title and enacting provisions set out as a note under section
    353 of this title] may be cited as the 'Prescription Drug
    Amendments of 1992'."
      Pub. L. 102-300, Sec. 1(a), June 16, 1992, 106 Stat. 238,
    provided that: "This Act [amending sections 321, 331, 334, 346a,
    352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to
    372a, 376, and 381 of this title and section 262 of Title 42, The
    Public Health and Welfare and enacting and amending provisions set
    out as notes under section 360i of this title] may be cited as the
    'Medical Device Amendments of 1992'."
      Pub. L. 102-282, Sec. 1(a), May 13, 1992, 106 Stat. 149, provided
    that: "This Act [enacting sections 335a to 335c of this title,
    amending sections 321, 336, 337, and 355 of this title, and
    enacting provisions set out as notes under section 335a of this
    title] may be cited as the 'Generic Drug Enforcement Act of 1992'."

                      SHORT TITLE OF 1990 AMENDMENTS                  
      Pub. L. 101-635, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4583,
    provided that: "This Act [enacting sections 379b to 379d and 394 of
    this title] may be cited as the 'Food and Drug Administration
    Revitalization Act'."
      Pub. L. 101-629, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4511,
    provided that: "This Act [enacting sections 360l and 383 of this
    title, amending sections 321, 333, 351, 353, and 360c to 360j of
    this title and sections 263b to 263n of Title 42, The Public Health
    and Welfare, redesignating sections 263b to 263n of Title 42 as
    sections 360gg to 360ss of this title, repealing section 263b of
    Title 42, and enacting provisions set out as notes under sections
    333, 360c, 360i, 360j, 360hh and 383 of this title] may be cited as
    the 'Safe Medical Devices Act of 1990'."
      Pub. L. 101-535, Sec. 1(a), Nov. 8, 1990, 104 Stat. 2353,
    provided that: "This Act [enacting section 343-1 of this title,
    amending sections 321, 337, 343, 345, and 371 of this title, and
    enacting provisions set out as notes under sections 343 and 343-1
    of this title] may be cited as the 'Nutrition Labeling and
    Education Act of 1990'."

                      SHORT TITLE OF 1988 AMENDMENTS                  
      Pub. L. 100-670, Sec. 1(a), Nov. 16, 1988, 102 Stat. 3971,
    provided that: "This Act [amending sections 321, 353, and 360b of
    this title, section 2201 of Title 28, Judiciary and Judicial
    Procedure, and sections 156 and 271 of Title 35, Patents, and
    enacting provisions set out as notes under section 360b of this
    title] may be cited as the 'Generic Animal Drug and Patent Term
    Restoration Act'."
      Pub. L. 100-607, title V, Sec. 501, Nov. 4, 1988, 102 Stat. 3120,
    provided that: "This title [enacting section 393 of this title,
    amending sections 5315 and 5316 of Title 5, Government Organization
    and Employees, and enacting provisions set out as notes under
    section 393 of this title] may be cited as the 'Food and Drug
    Administration Act of 1988'."
      Pub. L. 100-293, Sec. 1(a), Apr. 22, 1988, 102 Stat. 95, provided
    that: "This Act [amending sections 331, 333, 353, and 381 of this
    title and enacting provisions set out as notes under section 353 of
    this title] may be cited as the 'Prescription Drug Marketing Act of
    1987'."
      Pub. L. 100-290, Sec. 1, Apr. 18, 1988, 102 Stat. 90, provided
    that: "This Act [amending sections 360bb and 360ee of this title,
    enacting provisions set out as a note under section 360aa of this
    title, and amending provisions set out as a note under section 236
    of Title 42, The Public Health and Welfare] may be cited as the
    'Orphan Drug Amendments of 1988'."

                       SHORT TITLE OF 1986 AMENDMENT                   
      Pub. L. 99-660, title I, Sec. 101(a), Nov. 14, 1986, 100 Stat.
    3743, provided that: "This title [enacting section 382 of this
    title, amending sections 241 and 262 of Title 42, The Public Health
    and Welfare, and enacting provisions set out as notes under section
    333 of this title and section 262 of Title 42] may be cited as the
    'Drug Export Amendments Act of 1986'."

                       SHORT TITLE OF 1985 AMENDMENT                   
      Pub. L. 99-91, Sec. 1, Aug. 15, 1985, 99 Stat. 387, provided
    that: "This Act [amending sections 360aa to 360cc, and 360ee of
    this title, and sections 295g-1 and 6022 of Title 42, The Public
    Health and Welfare, and enacting provisions set out as notes under
    section 360aa of this title and section 236 of Title 42] may be
    cited as the 'Orphan Drug Amendments of 1985'."

                       SHORT TITLE OF 1984 AMENDMENT                   
      Pub. L. 98-417, Sec. 1, Sept. 24, 1984, 98 Stat. 1585, provided:
    "That this Act [enacting section 156 of Title 35, Patents, amending
    sections 355 and 360cc of this title, sections 68b, 68c, and 70b of
    Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary
    and Judicial Procedure, and sections 271 and 282 of Title 35, and
    enacting provisions set out as notes under section 355 of this
    title and section 68b of Title 15] may be cited as the 'Drug Price
    Competition and Patent Term Restoration Act of 1984'."

                      SHORT TITLE OF 1983 AMENDMENTS                  
      Pub. L. 98-22, Sec. 1, Apr. 22, 1983, 97 Stat. 173, provided:
    "That this Act [amending provisions set out as a note under section
    348 of this title] may be cited as the 'Saccharin Study and
    Labeling Act Amendment of 1983'."
      Pub. L. 97-414, Sec. 1(a), Jan. 4, 1983, 96 Stat. 2049, provided
    that: "This Act [enacting part B of subchapter V of chapter 9 of
    this title, section 44H of Title 26, Internal Revenue Code, section
    155 of Title 35, Patents, and sections 236, 255, and 298b-4 of
    Title 42, The Public Health and Welfare, amending sections 1274,
    1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and
    Trade, section 904 of this title, sections 280C and 6096 of Title
    26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254o,
    254p, 256, 294j, 295g-1, 295g-4, 295h, 295h-1a, 297-1, 300, 300a-1,
    300a-3, 300b, 300e-1, 300m, 300n-5, 300q-2, 300u-5, 300w-3, 300x-1,
    300x-4, 300y-11, 4577, and 4588 of Title 42, enacting provisions
    set out as notes under section 360aa of this title, section 44H of
    Title 26, and sections 241, 255, 287i, and 300x-1 of Title 42, and
    repealing provisions set out as a note under section 300t-11 of
    Title 42] may be cited as the 'Orphan Drug Act'."

                       SHORT TITLE OF 1981 AMENDMENT                   
      Pub. L. 97-42, Sec. 1, Aug. 14, 1981, 95 Stat. 946, provided:
    "That this Act [amending provisions set out as a note under section
    348 of this title] may be cited as the 'Saccharin Study and
    Labeling Act Amendment of 1981'."

                       SHORT TITLE OF 1980 AMENDMENT                   
      Pub. L. 96-359, Sec. 1, Sept. 26, 1980, 94 Stat. 1190, provided:
    "That this Act [enacting section 350a of this title, amending
    sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and
    enacting a provision set out as a note under section 350a of this
    title] may be cited as the 'Infant Formula Act of 1980'."

                       SHORT TITLE OF 1977 AMENDMENT                   
      Pub. L. 95-203, Sec. 1, Nov. 23, 1977, 91 Stat. 1451, provided
    that: "This Act [enacting section 343a of this title, amending
    sections 321 and 343 of this title, enacting provisions set out as
    notes under sections 343 and 348 of this title, and amending
    provisions set out as notes under sections 218 and 289l-1 of Title
    42, The Public Health and Welfare] may be cited as the 'Saccharin
    Study and Labeling Act'."

                       SHORT TITLE OF 1976 AMENDMENT                   
      Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
    that: "This Act [enacting sections 360c to 360k, 379, and 379a of
    this title and section 3512 of Title 42, The Public Health and
    Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,
    374, 379e, and 381 of this title and section 55 of Title 15,
    Commerce and Trade] may be cited as the 'Medical Device Amendments
    of 1976'."

                       SHORT TITLE OF 1972 AMENDMENT                   
      Pub. L. 92-387, Sec. 1, Aug. 16, 1972, 86 Stat. 559, provided
    that: "This Act [amending sections 331, 335, and 360 of this title
    and enacting provisions set out as notes under section 360 of this
    title] may be cited as the 'Drug Listing Act of 1972'."

                      SHORT TITLE OF 1968 AMENDMENTS                  
      Pub. L. 90-602, Sec. 1, Oct. 18, 1968, 82 Stat. 1173, provided
    that: "This Act [enacting provisions now comprising part C (Secs.
    360hh-360ss) of subchapter III of this chapter and provisions set
    out as notes under section 360hh of this title] may be cited as the
    'Radiation Control for Health and Safety Act of 1968'."
      Pub. L. 90-399, Sec. 1, July 13, 1968, 82 Stat. 342, provided:
    "That this Act [enacting section 360b of this title, amending
    sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title,
    and enacting provisions set out as a note under section 360b of
    this title] may be cited as the 'Animal Drug Amendments of 1968'."

                       SHORT TITLE OF 1965 AMENDMENT                   
      Pub. L. 89-74, Sec. 1, July 15, 1965, 79 Stat. 226, provided:
    "That this Act [amending sections 321, 331, 333, 334, 360, and 372
    of this title and section 1114 of Title 18, Crimes and Criminal
    Procedure, and enacting provisions set out as notes under sections
    321 and 352 of this title] may be cited as the 'Drug Abuse Control
    Amendments of 1965'."

                       SHORT TITLE OF 1962 AMENDMENT                   
      Pub. L. 87-781, Sec. 1, Oct. 10, 1962, 76 Stat. 780, provided in
    part that such Act [enacting sections 358 to 360 of this title,
    amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
    374, 379e, and 381 of this title, and enacting provisions set out
    as notes under sections 321, 331, 332, 352, 355, 358, 360, and 374
    of this title] may be cited as the 'Drug Amendments of 1962'."

                       SHORT TITLE OF 1960 AMENDMENT                   
      Pub. L. 86-618, Sec. 1, July 12, 1960, 74 Stat. 397, provided:
    "That this Act [amending sections 321, 331, 333, 342, 346, 351,
    352, 361, 362, 371, and 379e of this title, repealing sections 354
    and 364 of this title, and enacting notes set out under this
    section] may be cited as the 'Color Additive Amendments of 1960'."

                       SHORT TITLE OF 1958 AMENDMENT                   
      Pub. L. 85-929, Sec. 1, Sept. 6, 1958, 72 Stat. 1784, provided:
    "That this Act [amending sections 321, 331, 342, 346, 348 of this
    title and section 210 of Title 42, The Public Health and Welfare,
    and enacting provisions set out as notes under sections 321, 342,
    and 451 of this title] may be cited as the 'Food Additives
    Amendment of 1958'."

                           HAZARDOUS SUBSTANCES                       
      Federal Hazardous Substances Act as not modifying this chapter,
    see Pub. L. 86-613, Sec. 18, July 12, 1960, 74 Stat. 380, set out
    as an Effect Upon Federal and State Laws note under section 1261 of
    Title 15, Commerce and Trade.

-End-


-CITE-
    21 USC SUBCHAPTER II - DEFINITIONS                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
                        SUBCHAPTER II - DEFINITIONS                    

-End-



-CITE-
    21 USC Sec. 321                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321. Definitions; generally

-STATUTE-
      For the purposes of this chapter - 
      (a)(1) The term "State", except as used in the last sentence of
    section 372(a) of this title, means any State or Territory of the
    United States, the District of Columbia, and the Commonwealth of
    Puerto Rico.
      (2) The term "Territory" means any Territory or possession of the
    United States, including the District of Columbia, and excluding
    the Commonwealth of Puerto Rico and the Canal Zone.
      (b) The term "interstate commerce" means (1) commerce between any
    State or Territory and any place outside thereof, and (2) commerce
    within the District of Columbia or within any other Territory not
    organized with a legislative body.
      (c) The term "Department" means Department of Health and Human
    Services.
      (d) The term "Secretary" means the Secretary of Health and Human
    Services.
      (e) The term "person" includes individual, partnership,
    corporation, and association.
      (f) The term "food" means (1) articles used for food or drink for
    man or other animals, (2) chewing gum, and (3) articles used for
    components of any such article.
      (g)(1) The term "drug" means (A) articles recognized in the
    official United States Pharmacopoeia, official Homoeopathic
    Pharmacopoeia of the United States, or official National Formulary,
    or any supplement to any of them; and (B) articles intended for use
    in the diagnosis, cure, mitigation, treatment, or prevention of
    disease in man or other animals; and (C) articles (other than food)
    intended to affect the structure or any function of the body of man
    or other animals; and (D) articles intended for use as a component
    of any article specified in clause (A), (B), or (C). A food or
    dietary supplement for which a claim, subject to sections
    343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
    and 343(r)(5)(D) of this title, is made in accordance with the
    requirements of section 343(r) of this title is not a drug solely
    because the label or the labeling contains such a claim. A food,
    dietary ingredient, or dietary supplement for which a truthful and
    not misleading statement is made in accordance with section
    343(r)(6) of this title is not a drug under clause (C) solely
    because the label or the labeling contains such a statement.
      (2) The term "counterfeit drug" means a drug which, or the
    container or labeling of which, without authorization, bears the
    trademark, trade name, or other identifying mark, imprint, or
    device, or any likeness thereof, of a drug manufacturer, processor,
    packer, or distributor other than the person or persons who in fact
    manufactured, processed, packed, or distributed such drug and which
    thereby falsely purports or is represented to be the product of, or
    to have been packed or distributed by, such other drug
    manufacturer, processor, packer, or distributor.
      (h) The term "device" (except when used in paragraph (n) of this
    section and in sections 331(i), 343(f), 352(c), and 362(c) of this
    title) means an instrument, apparatus, implement, machine,
    contrivance, implant, in vitro reagent, or other similar or related
    article, including any component, part, or accessory, which is - 
        (1) recognized in the official National Formulary, or the
      United States Pharmacopeia, or any supplement to them,
        (2) intended for use in the diagnosis of disease or other
      conditions, or in the cure, mitigation, treatment, or prevention
      of disease, in man or other animals, or
        (3) intended to affect the structure or any function of the
      body of man or other animals, and

    which does not achieve its primary intended purposes through
    chemical action within or on the body of man or other animals and
    which is not dependent upon being metabolized for the achievement
    of its primary intended purposes.
      (i) The term "cosmetic" means (1) articles intended to be rubbed,
    poured, sprinkled, or sprayed on, introduced into, or otherwise
    applied to the human body or any part thereof for cleansing,
    beautifying, promoting attractiveness, or altering the appearance,
    and (2) articles intended for use as a component of any such
    articles; except that such term shall not include soap.
      (j) The term "official compendium" means the official United
    States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
    United States, official National Formulary, or any supplement to
    any of them.
      (k) The term "label" means a display of written, printed, or
    graphic matter upon the immediate container of any article; and a
    requirement made by or under authority of this chapter that any
    word, statement, or other information appear on the label shall not
    be considered to be complied with unless such word, statement, or
    other information also appears on the outside container or wrapper,
    if any there be, of the retail package of such article, or is
    easily legible through the outside container or wrapper.
      (l) The term "immediate container" does not include package
    liners.
      (m) The term "labeling" means all labels and other written,
    printed, or graphic matter (1) upon any article or any of its
    containers or wrappers, or (2) accompanying such article.
      (n) If an article is alleged to be misbranded because the
    labeling or advertising is misleading, then in determining whether
    the labeling or advertising is misleading there shall be taken into
    account (among other things) not only representations made or
    suggested by statement, word, design, device, or any combination
    thereof, but also the extent to which the labeling or advertising
    fails to reveal facts material in the light of such representations
    or material with respect to consequences which may result from the
    use of the article to which the labeling or advertising relates
    under the conditions of use prescribed in the labeling or
    advertising thereof or under such conditions of use as are
    customary or usual.
      (o) The representation of a drug, in its labeling, as an
    antiseptic shall be considered to be a representation that it is a
    germicide, except in the case of a drug purporting to be, or
    represented as, an antiseptic for inhibitory use as a wet dressing,
    ointment, dusting powder, or such other use as involves prolonged
    contact with the body.
      (p) The term "new drug" means - 
        (1) Any drug (except a new animal drug or an animal feed
      bearing or containing a new animal drug) the composition of which
      is such that such drug is not generally recognized, among experts
      qualified by scientific training and experience to evaluate the
      safety and effectiveness of drugs, as safe and effective for use
      under the conditions prescribed, recommended, or suggested in the
      labeling thereof, except that such a drug not so recognized shall
      not be deemed to be a "new drug" if at any time prior to June 25,
      1938, it was subject to the Food and Drugs Act of June 30, 1906,
      as amended, and if at such time its labeling contained the same
      representations concerning the conditions of its use; or
        (2) Any drug (except a new animal drug or an animal feed
      bearing or containing a new animal drug) the composition of which
      is such that such drug, as a result of investigations to
      determine its safety and effectiveness for use under such
      conditions, has become so recognized, but which has not,
      otherwise than in such investigations, been used to a material
      extent or for a material time under such conditions.

      (q)(1)(A) Except as provided in clause (B), the term "pesticide
    chemical" means any substance that is a pesticide within the
    meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
    [7 U.S.C. 136 et seq.], including all active and inert ingredients
    of such pesticide. Notwithstanding any other provision of law, the
    term "pesticide" within such meaning includes ethylene oxide and
    propylene oxide when such substances are applied on food.
      (B) In the case of the use, with respect to food, of a substance
    described in clause (A) to prevent, destroy, repel, or mitigate
    microorganisms (including bacteria, viruses, fungi, protozoa,
    algae, and slime), the following applies for purposes of clause
    (A):
        (i) The definition in such clause for the term "pesticide
      chemical" does not include the substance if the substance is
      applied for such use on food, or the substance is included for
      such use in water that comes into contact with the food, in the
      preparing, packing, or holding of the food for commercial
      purposes. The substance is not excluded under this subclause from
      such definition if the substance is ethylene oxide or propylene
      oxide, and is applied for such use on food. The substance is not
      so excluded if the substance is applied for such use on a raw
      agricultural commodity, or the substance is included for such use
      in water that comes into contact with the commodity, as follows:
          (I) The substance is applied in the field.
          (II) The substance is applied at a treatment facility where
        raw agricultural commodities are the only food treated, and the
        treatment is in a manner that does not change the status of the
        food as a raw agricultural commodity (including treatment
        through washing, waxing, fumigating, and packing such
        commodities in such manner).
          (III) The substance is applied during the transportation of
        such commodity between the field and such a treatment facility.

        (ii) The definition in such clause for the term "pesticide
      chemical" does not include the substance if the substance is a
      food contact substance as defined in section 348(h)(6) of this
      title, and any of the following circumstances exist: The
      substance is included for such use in an object that has a food
      contact surface but is not intended to have an ongoing effect on
      any portion of the object; the substance is included for such use
      in an object that has a food contact surface and is intended to
      have an ongoing effect on a portion of the object but not on the
      food contact surface; or the substance is included for such use
      in or is applied for such use on food packaging (without regard
      to whether the substance is intended to have an ongoing effect on
      any portion of the packaging). The food contact substance is not
      excluded under this subclause from such definition if any of the
      following circumstances exist: The substance is applied for such
      use on a semipermanent or permanent food contact surface (other
      than being applied on food packaging); or the substance is
      included for such use in an object that has a semipermanent or
      permanent food contact surface (other than being included in food
      packaging) and the substance is intended to have an ongoing
      effect on the food contact surface.

    With respect to the definition of the term "pesticide" that is
    applicable to the Federal Insecticide, Fungicide, and Rodenticide
    Act [7 U.S.C. 136 et seq.], this clause does not exclude any
    substance from such definition.
      (2) The term "pesticide chemical residue" means a residue in or
    on raw agricultural commodity or processed food of - 
        (A) a pesticide chemical; or
        (B) any other added substance that is present on or in the
      commodity or food primarily as a result of the metabolism or
      other degradation of a pesticide chemical.

      (3) Notwithstanding subparagraphs (1) and (2), the Administrator
    may by regulation except a substance from the definition of
    "pesticide chemical" or "pesticide chemical residue" if - 
        (A) its occurrence as a residue on or in a raw agricultural
      commodity or processed food is attributable primarily to natural
      causes or to human activities not involving the use of any
      substances for a pesticidal purpose in the production, storage,
      processing, or transportation of any raw agricultural commodity
      or processed food; and
        (B) the Administrator, after consultation with the Secretary,
      determines that the substance more appropriately should be
      regulated under one or more provisions of this chapter other than
      sections 342(a)(2)(B) and 346a of this title.

      (r) The term "raw agricultural commodity" means any food in its
    raw or natural state, including all fruits that are washed,
    colored, or otherwise treated in their unpeeled natural form prior
    to marketing.
      (s) The term "food additive" means any substance the intended use
    of which results or may reasonably be expected to result, directly
    or indirectly, in its becoming a component or otherwise affecting
    the characteristics of any food (including any substance intended
    for use in producing, manufacturing, packing, processing,
    preparing, treating, packaging, transporting, or holding food; and
    including any source of radiation intended for any such use), if
    such substance is not generally recognized, among experts qualified
    by scientific training and experience to evaluate its safety, as
    having been adequately shown through scientific procedures (or, in
    the case of a substance used in food prior to January 1, 1958,
    through either scientific procedures or experience based on common
    use in food) to be safe under the conditions of its intended use;
    except that such term does not include - 
        (1) a pesticide chemical residue in or on a raw agricultural
      commodity or processed food; or
        (2) a pesticide chemical; or
        (3) a color additive; or
        (4) any substance used in accordance with a sanction or
      approval granted prior to September 6, 1958, pursuant to this
      chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et
      seq.] or the Meat Inspection Act of March 4, 1907, as amended and
      extended [21 U.S.C. 601 et seq.];
        (5) a new animal drug; or
        (6) an ingredient described in paragraph (ff) in, or intended
      for use in, a dietary supplement.

      (t)(1) The term "color additive" means a material which - 
        (A) is a dye, pigment, or other substance made by a process of
      synthesis or similar artifice, or extracted, isolated, or
      otherwise derived, with or without intermediate or final change
      of identity, from a vegetable, animal, mineral, or other source,
      and
        (B) when added or applied to a food, drug, or cosmetic, or to
      the human body or any part thereof, is capable (alone or through
      reaction with other substance) of imparting color thereto;

    except that such term does not include any material which the
    Secretary, by regulation, determines is used (or intended to be
    used) solely for a purpose or purposes other than coloring.
      (2) The term "color" includes black, white, and intermediate
    grays.
      (3) Nothing in subparagraph (1) of this paragraph shall be
    construed to apply to any pesticide chemical, soil or plant
    nutrient, or other agricultural chemical solely because of its
    effect in aiding, retarding, or otherwise affecting, directly or
    indirectly, the growth or other natural physiological processes of
    produce of the soil and thereby affecting its color, whether before
    or after harvest.
      (u) The term "safe" as used in paragraph (s) of this section and
    in sections 348, 360b, 360ccc, and 379e of this title, has
    reference to the health of man or animal.
      (v) The term "new animal drug" means any drug intended for use
    for animals other than man, including any drug intended for use in
    animal feed but not including such animal feed, - 
        (1) the composition of which is such that such drug is not
      generally recognized, among experts qualified by scientific
      training and experience to evaluate the safety and effectiveness
      of animal drugs, as safe and effective for use under the
      conditions prescribed, recommended, or suggested in the labeling
      thereof; except that such a drug not so recognized shall not be
      deemed to be a "new animal drug" if at any time prior to June 25,
      1938, it was subject to the Food and Drug Act of June 30, 1906,
      as amended, and if at such time its labeling contained the same
      representations concerning the conditions of its use; or
        (2) the composition of which is such that such drug, as a
      result of investigations to determine its safety and
      effectiveness for use under such conditions, has become so
      recognized but which has not, otherwise than in such
      investigations, been used to a material extent or for a material
      time under such conditions.

    Provided that any drug intended for minor use or use in a minor
    species that is not the subject of a final regulation published by
    the Secretary through notice and comment rulemaking finding that
    the criteria of paragraphs (1) and (2) have not been met (or that
    the exception to the criterion in paragraph (1) has been met) is a
    new animal drug.
      (w) The term "animal feed", as used in paragraph (w) (!1) of this
    section, in section 360b of this title, and in provisions of this
    chapter referring to such paragraph or section, means an article
    which is intended for use for food for animals other than man and
    which is intended for use as a substantial source of nutrients in
    the diet of the animal, and is not limited to a mixture intended to
    be the sole ration of the animal.

      (x) The term "informal hearing" means a hearing which is not
    subject to section 554, 556, or 557 of title 5 and which provides
    for the following:
        (1) The presiding officer in the hearing shall be designated by
      the Secretary from officers and employees of the Department who
      have not participated in any action of the Secretary which is the
      subject of the hearing and who are not directly responsible to an
      officer or employee of the Department who has participated in any
      such action.
        (2) Each party to the hearing shall have the right at all times
      to be advised and accompanied by an attorney.
        (3) Before the hearing, each party to the hearing shall be
      given reasonable notice of the matters to be considered at the
      hearing, including a comprehensive statement of the basis for the
      action taken or proposed by the Secretary which is the subject of
      the hearing and a general summary of the information which will
      be presented by the Secretary at the hearing in support of such
      action.
        (4) At the hearing the parties to the hearing shall have the
      right to hear a full and complete statement of the action of the
      Secretary which is the subject of the hearing together with the
      information and reasons supporting such action, to conduct
      reasonable questioning, and to present any oral or written
      information relevant to such action.
        (5) The presiding officer in such hearing shall prepare a
      written report of the hearing to which shall be attached all
      written material presented at the hearing. The participants in
      the hearing shall be given the opportunity to review and correct
      or supplement the presiding officer's report of the hearing.
        (6) The Secretary may require the hearing to be transcribed. A
      party to the hearing shall have the right to have the hearing
      transcribed at his expense. Any transcription of a hearing shall
      be included in the presiding officer's report of the hearing.

      (y) The term "saccharin" includes calcium saccharin, sodium
    saccharin, and ammonium saccharin.
      (z) The term "infant formula" means a food which purports to be
    or is represented for special dietary use solely as a food for
    infants by reason of its simulation of human milk or its
    suitability as a complete or partial substitute for human milk.
      (aa) The term "abbreviated drug application" means an application
    submitted under section 355(j) of this title for the approval of a
    drug that relies on the approved application of another drug with
    the same active ingredient to establish safety and efficacy, and - 
        (1) in the case of section 335a of this title, includes a
      supplement to such an application for a different or additional
      use of the drug but does not include a supplement to such an
      application for other than a different or additional use of the
      drug, and
        (2) in the case of sections 335b and 335c of this title,
      includes any supplement to such an application.

      (bb) The term "knowingly" or "knew" means that a person, with
    respect to information - 
        (1) has actual knowledge of the information, or
        (2) acts in deliberate ignorance or reckless disregard of the
      truth or falsity of the information.

      (cc) For purposes of section 335a of this title, the term "high
    managerial agent" - 
        (1) means - 
          (A) an officer or director of a corporation or an
        association,
          (B) a partner of a partnership, or
          (C) any employee or other agent of a corporation,
        association, or partnership,

      having duties such that the conduct of such officer, director,
      partner, employee, or agent may fairly be assumed to represent
      the policy of the corporation, association, or partnership, and
        (2) includes persons having management responsibility for - 
          (A) submissions to the Food and Drug Administration regarding
        the development or approval of any drug product,
          (B) production, quality assurance, or quality control of any
        drug product, or
          (C) research and development of any drug product.

      (dd) For purposes of sections 335a and 335b of this title, the
    term "drug product" means a drug subject to regulation under
    section 355, 360b, or 382 of this title or under section 262 of
    title 42.
      (ee) The term "Commissioner" means the Commissioner of Food and
    Drugs.
      (ff) The term "dietary supplement" - 
        (1) means a product (other than tobacco) intended to supplement
      the diet that bears or contains one or more of the following
      dietary ingredients:
          (A) a vitamin;
          (B) a mineral;
          (C) an herb or other botanical;
          (D) an amino acid;
          (E) a dietary substance for use by man to supplement the diet
        by increasing the total dietary intake; or
          (F) a concentrate, metabolite, constituent, extract, or
        combination of any ingredient described in clause (A), (B),
        (C), (D), or (E);

        (2) means a product that - 
          (A)(i) is intended for ingestion in a form described in
        section 350(c)(1)(B)(i) of this title; or
          (ii) complies with section 350(c)(1)(B)(ii) of this title;
          (B) is not represented for use as a conventional food or as a
        sole item of a meal or the diet; and
          (C) is labeled as a dietary supplement; and

        (3) does - 
          (A) include an article that is approved as a new drug under
        section 355 of this title or licensed as a biologic under
        section 262 of title 42 and was, prior to such approval,
        certification, or license, marketed as a dietary supplement or
        as a food unless the Secretary has issued a regulation, after
        notice and comment, finding that the article, when used as or
        in a dietary supplement under the conditions of use and dosages
        set forth in the labeling for such dietary supplement, is
        unlawful under section 342(f) of this title; and
          (B) not include - 
            (i) an article that is approved as a new drug under section
          355 of this title, certified as an antibiotic under section
          357 of this title, or licensed as a biologic under section
          262 of title 42, or
            (ii) an article authorized for investigation as a new drug,
          antibiotic, or biological for which substantial clinical
          investigations have been instituted and for which the
          existence of such investigations has been made public,

      which was not before such approval, certification, licensing, or
      authorization marketed as a dietary supplement or as a food
      unless the Secretary, in the Secretary's discretion, has issued a
      regulation, after notice and comment, finding that the article
      would be lawful under this chapter.

    Except for purposes of paragraph (g), a dietary supplement shall be
    deemed to be a food within the meaning of this chapter.
      (gg) The term "processed food" means any food other than a raw
    agricultural commodity and includes any raw agricultural commodity
    that has been subject to processing, such as canning, cooking,
    freezing, dehydration, or milling.
      (hh) The term "Administrator" means the Administrator of the
    United States Environmental Protection Agency.
      (ii) The term "compounded positron emission tomography drug" - 
        (1) means a drug that - 
          (A) exhibits spontaneous disintegration of unstable nuclei by
        the emission of positrons and is used for the purpose of
        providing dual photon positron emission tomographic diagnostic
        images; and
          (B) has been compounded by or on the order of a practitioner
        who is licensed by a State to compound or order compounding for
        a drug described in subparagraph (A), and is compounded in
        accordance with that State's law, for a patient or for
        research, teaching, or quality control; and

        (2) includes any nonradioactive reagent, reagent kit,
      ingredient, nuclide generator, accelerator, target material,
      electronic synthesizer, or other apparatus or computer program to
      be used in the preparation of such a drug.

      (jj) The term "antibiotic drug" means any drug (except drugs for
    use in animals other than humans) composed wholly or partly of any
    kind of penicillin, streptomycin, chlortetracycline,
    chloramphenicol, bacitracin, or any other drug intended for human
    use containing any quantity of any chemical substance which is
    produced by a micro-organism and which has the capacity to inhibit
    or destroy micro-organisms in dilute solution (including a
    chemically synthesized equivalent of any such substance) or any
    derivative thereof.
      (kk) Priority supplement. - The term "priority supplement" means
    a drug application referred to in section 101(4) of the Food and
    Drug Administration Modernization Act of 1997 (111 Stat. 2298).
      (ll)(1) The term "single-use device" means a device that is
    intended for one use, or on a single patient during a single
    procedure.
      (2)(A) The term "reprocessed", with respect to a single-use
    device, means an original device that has previously been used on a
    patient and has been subjected to additional processing and
    manufacturing for the purpose of an additional single use on a
    patient. The subsequent processing and manufacture of a reprocessed
    single-use device shall result in a device that is reprocessed
    within the meaning of this definition.
      (B) A single-use device that meets the definition under clause
    (A) shall be considered a reprocessed device without regard to any
    description of the device used by the manufacturer of the device or
    other persons, including a description that uses the term
    "recycled" rather than the term "reprocessed".
      (3) The term "original device" means a new, unused single-use
    device.
      (mm)(1) The term "critical reprocessed single-use device" means a
    reprocessed single-use device that is intended to contact normally
    sterile tissue or body spaces during use.
      (2) The term "semi-critical reprocessed single-use device" means
    a reprocessed single-use device that is intended to contact intact
    mucous membranes and not penetrate normally sterile areas of the
    body.
      (nn) The term "major species" means cattle, horses, swine,
    chickens, turkeys, dogs, and cats, except that the Secretary may
    add species to this definition by regulation.
      (oo) The term "minor species" means animals other than humans
    that are not major species.
      (pp) The term "minor use" means the intended use of a drug in a
    major species for an indication that occurs infrequently and in
    only a small number of animals or in limited geographical areas and
    in only a small number of animals annually.
      (qq) The term "major food allergen" means any of the following:
        (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean
      shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g.,
      almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
        (2) A food ingredient that contains protein derived from a food
      specified in paragraph (1), except the following:
          (A) Any highly refined oil derived from a food specified in
        paragraph (1) and any ingredient derived from such highly
        refined oil.
          (B) A food ingredient that is exempt under paragraph (6) or
        (7) of section 343(w) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,
    ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,
    1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,
    1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title
    III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,
    Secs. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,
    Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Secs. 1,
    4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,
    Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-
    516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278, title
    V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295,
    Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95-203,
    Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359, Sec. 3,
    Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I, Sec.
    107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535, Sec.
    5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec. 16(b),
    Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May 13,
    1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,
    1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.
    29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 3(b), (dd)(1),
    4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Secs.
    3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-
    170, title IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-
    115, title I, Secs. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111
    Stat. 2320, 2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct. 30,
    1998, 112 Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan. 4,
    2002, 115 Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d), Oct.
    26, 2002, 116 Stat. 1619; Pub. L. 108-282, title I, Sec. 102(b)(1),
    (5)(A), (B), title II, Sec. 203(c)(1), Aug. 2, 2004, 118 Stat. 891,
    902, 908.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Food and Drugs Act of June 30, 1906, as amended, referred to
    in par. (p)(1), and the Food and Drug Act of June 30, 1906, as
    amended, referred to in par. (v)(1), is act June 30, 1906, ch.
    3915, 34 Stat. 768, as amended, which was classified to subchapter
    I (Sec. 1 et seq.) of chapter 1 of this title, was repealed (except
    for section 14a which was transferred to section 372a of this
    title) by act June 25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059,
    and is covered by this chapter.
      The Federal Insecticide, Fungicide, and Rodenticide Act, referred
    to in par. (q)(1), is act June 25, 1947, ch. 125, as amended
    generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
    classified generally to subchapter II (Sec. 136 et seq.) of chapter
    6 of Title 7, Agriculture. For complete classification of this Act
    to the Code, see Short Title note set out under section 136 of
    Title 7 and Tables.
      The Poultry Products Inspection Act, referred to in par. (s)(4),
    is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
    is classified generally to chapter 10 (Sec. 451 et seq.) of this
    title. For complete classification of this Act to the Code, see
    Short Title note set out under section 451 of this title and
    Tables.
      The Meat Inspection Act of March 4, 1907, as amended and
    extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch.
    2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81
    Stat. 584, which are classified generally to subchapters I to IV
    (Sec. 601 et seq.) of chapter 12 of this title. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 601 of this title and Tables.
      Section 101(4) of the Food and Drug Administration Modernization
    Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.
    105-115, which is set out as a note under section 379g of this
    title.


-MISC1-
                                AMENDMENTS                            
      2004-Par. (u). Pub. L. 108-282, Sec. 102(b)(5)(A), substituted
    "360b, 360ccc" for "360b".
      Par. (v). Pub. L. 108-282, Sec. 102(b)(5)(B), inserted concluding
    provisions.
      Pars. (nn) to (pp). Pub. L. 108-282, Sec. 102(b)(1), added pars.
    (nn) to (pp).
      Par. (qq). Pub. L. 108-282, Sec. 203(c)(1), added par. (qq).
      2002 - Par. (kk). Pub. L. 107-109 added par. (kk).
      Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).
      1998 - Par. (q)(1). Pub. L. 105-324, Sec. 2(a), added subpar. (1)
    and struck out former subpar. (1) which read as follows: "The term
    'pesticide chemical' means any substance that is a pesticide within
    the meaning of the Federal Insecticide, Fungicide, and Rodenticide
    Act, including all active and inert ingredients of such pesticide."
      Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted
    "subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in
    introductory provisions.
      1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
    "or 357" after "section 355(j)".
      Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out "357,"
    after "section 355,".
      Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
    ", certified as an antibiotic under section 357 of this title,"
    before "or licensed as a biologic".
      Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).
      Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).
      1996 - Par. (q). Pub. L. 104-170, Sec. 402(a), amended par. (q)
    generally. Prior to amendment, par. (q) read as follows: "The term
    'pesticide chemical' means any substance which, alone, in chemical
    combination or in formulation with one or more other substances, is
    'a pesticide' within the meaning of the Federal Insecticide,
    Fungicide, and Rodenticide Act as now in force or as hereafter
    amended, and which is used in the production, storage, or
    transportation of raw agricultural commodities."
      Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.
    (1) and (2) generally. Prior to amendment, subpars. (1) and (2)
    read as follows:
      "(1) a pesticide chemical in or on a raw agricultural commodity;
    or
      "(2) a pesticide chemical to the extent that it is intended for
    use or is used in the production, storage, or transportation of any
    raw agricultural commodity; or".
      Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)
    and (hh).
      1994 - Par. (g)(1). Pub. L. 103-417, Sec. 10(a), amended last
    sentence generally. Prior to amendment, last sentence read as
    follows: "A food for which a claim, subject to sections
    343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
    and 343(r)(5)(D) of this title, is made in accordance with the
    requirements of section 343(r) of this title is not a drug under
    clause (B) solely because the label or labeling contains such a
    claim."
      Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).
      Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).
      1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted
    "Health and Human Services" for "Agriculture".
      Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language
    of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.
      Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.
    (w) to (ff) as (v) to (ee), respectively.
      1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 6(b)(1), which
    directed the substitution of "Health and Human Services" for
    "Health, Education, and Welfare", could not be executed because
    such words did not appear in the original statutory text. See 1993
    Amendment note above and Transfer of Functions notes below.
      Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.
    103-80, Sec. 4(b), substituted "its primary" for "any of its
    principal" in two places in concluding provisions.
      Par. (u). Pub. L. 102-571 substituted "379e" for "376".
      Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out "of
    Health, Education, and Welfare" after "employees of the
    Department".
      Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).
      Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).
      1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out ";
    but does not include devices or their components, parts, or
    accessories" after "clause (A), (B), or (C)".
      Pub. L. 101-535 inserted at end "A food for which a claim,
    subject to sections 343(r)(1)(B) and 343(r)(3) of this title or
    sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in
    accordance with the requirements of section 343(r) of this title is
    not a drug under clause (B) solely because the label or labeling
    contains such a claim."
      Par. (h)(3). Pub. L. 101-629, Sec. 16(b)(2), which directed the
    amendment of subpar. (3) by substituting "its primary" for "any of
    its principal", could not be executed because "any of its
    principal" did not appear in subpar. (3).
      1988 - Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which
    read as follows: "which drug is composed wholly or partly of any
    kind of penicillin, streptomycin, chlortetracycline,
    chloramphenicol, or bacitracin, or any derivative thereof, except
    when there is in effect a published order of the Secretary
    declaring such drug not to be a new animal drug on the grounds that
    (A) the requirement of certification of batches of such drug, as
    provided for in section 360b(n) of this title, is not necessary to
    insure that the objectives specified in paragraph (3) thereof are
    achieved and (B) that neither subparagraph (1) nor (2) of this
    paragraph (w) applies to such drug."
      1980 - Par. (aa). Pub. L. 96-359 added par. (aa).
      1977 - Par. (z). Pub. L. 95-203 added par. (z).
      1976 - Par. (h). Pub. L. 94-295, Sec. 3(a)(1)(A), expanded
    definition of "device" to include implements, machines, implants,
    in vitro reagents, and other similar or related articles, added
    recognition in the National Formulary or the United States
    Pharmacopeia, or any supplement to the Formulary or Pharmacopeia,
    to the enumeration of conditions under which a device may qualify
    for inclusion under this chapter, and inserted requirements that a
    device be one which does not achieve any of its principal intended
    purposes through chemical action within or on the body of man or
    other animals and which is not dependent upon being metabolized for
    the achievement of any of its principal intended purposes.
      Par. (n). Pub. L. 94-278 inserted "or advertising" after
    "labeling" wherever appearing.
      Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).
      1972 - Par. (q). Pub. L. 92-516 substituted reference to
    pesticide for reference to economic poison.
      1970 - Par. (a)(2). Pub. L. 91-513, Sec. 701(g), struck out
    reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334,
    337, 360, 360a, 372, 373, 374, and 375 of this title as they apply
    to depressant or stimulant drugs.
      Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which
    defined "depressant or stimulant drug".
      1968 - Par. (a)(2). Pub. L. 90-639, Sec. 4(a), extended
    provisions to cover depressant and stimulant drugs, the containers
    thereof, and equipment used in manufacturing, compounding, or
    processing such drugs, to the Canal Zone.
      Par. (p). Pub. L. 90-399, Sec. 102(a), (b), inserted "(except a
    new animal drug or an animal feed bearing or containing a new
    animal drug)" after "Any drug" in subpars. (1) and (2),
    respectively.
      Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).
      Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to
    section 360b of this title.
      Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to
    lysergic acid diethylamide.
      Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and
    (x).
      1965 - Par. (g). Pub. L. 89-74, Sec. 9(b), designated existing
    provisions as subpar. (1), redesignated cls. (1) to (4) thereof as
    (A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)"
    and added subpar. (2).
      Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).
      1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing
    provisions as subpar. (2), inserted "Commonwealth of Puerto Rico
    and the", and added subpar. (1).
      Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted "and
    effectiveness" after "to evaluate the safety", and "and effective"
    after "as safe".
      Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted "and
    effectiveness" after "safety".
      1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color
    additives from definition of "food additive".
      Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former
    par. (t) redesignated (u).
      Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as
    (u) and inserted reference to section 376 of this title.
      1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).
      1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and
    (r).

                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Pub. L. 108-282, title II, Sec. 203(d), Aug. 2, 2004, 118 Stat.
    908, provided that: "The amendments made by this section [amending
    this section and sections 343 and 343-1 of this title] shall apply
    to any food that is labeled on or after January 1, 2006."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 501 of Pub. L. 105-115 provided that: "Except as
    otherwise provided in this Act [see Short Title of 1997 Amendment
    note set out under section 301 of this title], this Act and the
    amendments made by this Act, other than the provisions of and the
    amendments made by sections 111, 121, 125, and 307 [enacting
    section 355a of this title, amending this section and sections 331,
    335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381,
    and 382 of this title, section 45C of Title 26, Internal Revenue
    Code, section 156 of Title 35, Patents, and section 8126 of Title
    38, Veterans' Benefits, repealing sections 356 and 357 of this
    title, and enacting provisions set out as notes under sections 351
    and 355 of this title], shall take effect 90 days after the date of
    enactment of this Act [Nov. 21, 1997]."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-535 effective six months after the date
    of the promulgation of final regulations to implement section
    343(r) of this title, or if such regulations are not promulgated,
    the date proposed regulations are to be considered as such final
    regulations (Nov. 8, 1992), with exception for persons marketing
    food the brand name of which contains a term defined by the
    Secretary under section 343(r)(2)(A)(i) of this title, see section
    10(a) of Pub. L. 101-535, set out as a note under section 343 of
    this title.

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
    1976, see section 502(c) of Pub. L. 94-278, set out as a note under
    section 334 of this title.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-516 effective at the close of Oct. 21,
    1972, except if regulations are necessary for the implementation of
    any provision that becomes effective on Oct. 21, 1972, and
    continuation in effect of subchapter I of chapter 6 of Title 7, and
    regulations thereunder, relating to the control of economic
    poisons, as in existence prior to Oct. 21, 1972, until superseded
    by provisions of Pub. L. 92-516, and regulations thereunder, see
    section 4 of Pub. L. 92-516, set out as an Effective Date note
    under section 136 of Title 7, Agriculture.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

        EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS    
      Section 6 of Pub. L. 90-639 provided that: "The amendments made
    by this Act [amending this section, sections 331, 333, 334, and
    360a of this title, and provisions set out as a note under section
    289a of Title 42, The Public Health and Welfare] shall apply only
    with respect to violations of the Federal Food, Drug, and Cosmetic
    Act [this chapter] committed after the date of the enactment of
    this Act [Oct. 24, 1968]."
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, except that in the case of a
    drug (other than one subject to section 360b(n) of this title)
    intended for use in animals other than man which, on Oct. 9, 1962,
    was commercially used or sold in the United States, was not a new
    drug as defined in par. (p) of this section then in force, and was
    not covered by an effective application under section 355 of this
    title, the words "effectiveness" and "effective" contained in par.
    (v) of this section not applicable to such drug when intended
    solely for use under conditions prescribed, recommended, or
    suggested in labeling with respect to such drug on that day, see
    section 108(a), (b)(3) of Pub. L. 90-399, as amended, set out as an
    Effective Date and Transitional Provisions note under section 360b
    of this title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Section 11 of Pub. L. 89-74 provided that: "The foregoing
    provisions of this Act [see Short Title of 1965 Amendment note set
    out under section 301 of this title] shall take effect on the first
    day of the seventh calendar month [Feb. 1, 1966] following the
    month in which this Act is enacted [July 15, 1965]; except that (1)
    the Secretary shall permit persons, owning or operating any
    establishment engaged in manufacturing, preparing, propagating,
    compounding, processing, wholesaling, jobbing, or distributing any
    depressant or stimulant drug, as referred to in the amendments made
    by section 4 of this Act to section 510 of the Federal Food, Drug,
    and Cosmetic Act [section 360 of this title], to register their
    name, places of business, and establishments, and other information
    prescribed by such amendments, with the Secretary prior to such
    effective date, and (2) sections 201(v) and 511(g) of the Federal
    Food, Drug, and Cosmetic Act, as added by this act [par. (v) of
    this section and par. (g) of section 360a of this title], and the
    provisions of sections 8 [amending section 372 of this title and
    section 1114 of Title 18, Crimes and Criminal Procedure] and 10
    [set out as a note under this section] shall take effect upon the
    date of enactment of this Act [July 15, 1965]."

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Section 107 of Pub. L. 87-781 provided that:
      "(a) Except as otherwise provided in this section, the amendments
    made by the foregoing sections of this part A [amending this
    section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of
    this title, and enacting provisions set out as a note under section
    355 of this title] shall take effect on the date of enactment of
    this Act [Oct. 10, 1962].
      "(b) The amendments made by sections 101, 103, 105, and 106 of
    this part A [amending sections 331, 332, 351, 352, 355, and 357 of
    this title] shall, with respect to any drug, take effect on the
    first day of the seventh calendar month following the month in
    which this Act is enacted [Oct. 1962].
      "(c)(1) As used in this subsection, the term 'enactment date'
    means the date of enactment of this Act; and the term 'basic Act'
    means the Federal Food, Drug, and Cosmetic Act [this chapter].
      "(2) An application filed pursuant to section 505(b) of the basic
    Act [section 355(b) of this title] which was 'effective' within the
    meaning of that Act on the day immediately preceding the enactment
    date shall be deemed as of the enactment date, to be an application
    'approved' by the Secretary within the meaning of the basic Act as
    amended by this Act.
      "(3) In the case of any drug with respect to which an application
    filed under section 505(b) of the basic Act is deemed to be an
    approved application on the enactment date by virtue of paragraph
    (2) of this subsection - 
        "(A) the amendments made by this Act to section 201(p), and to
      subsections (b) and (d) of section 505, of the basic Act [par.
      (p) of this section, and subsecs. (b) and (d) of section 355 of
      this title], insofar as such amendments relate to the
      effectiveness of drugs, shall not, so long as approval of such
      application is not withdrawn or suspended pursuant to section
      505(e) of that Act [section 355(e) of this title], apply to such
      drug when intended solely for use under conditions prescribed,
      recommended, or suggested in labeling covered by such approved
      application, but shall apply to any changed use, or conditions of
      use, prescribed, recommended, or suggested in its labeling,
      including such conditions of use as are the subject of an
      amendment or supplement to such application pending on, or filed
      after, the enactment date; and
        "(B) clause (3) of the first sentence of section 505(e) of the
      basic Act, as amended by this Act [section 355(e) of this title],
      shall not apply to such drug when intended solely for use under
      conditions prescribed, recommended, or suggested in labeling
      covered by such approved application (except with respect to such
      use, or conditions of use, as are the subject of an amendment or
      supplement to such approved application, which amendment or
      supplement has been approved after the enactment date under
      section 505 of the basic Act as amended by this Act [section 355
      of this title]) until whichever of the following first occurs:
      (i) the expiration of the two-year period beginning with the
      enactment date; (ii) the effective date of an order under section
      505(e) of the basic Act [section 355(e) of this title], other
      than clause (3) of the first sentence of such section 505(e)
      [section 355(e) of this title], withdrawing or suspending the
      approval of such application.
      "(4) In the case of any drug which, on the day immediately
    preceding the enactment date, (A) was commercially used or sold in
    the United States, (B) was not a new drug as defined by section
    201(p) of the basic Act as then in force [par. (p) of this
    section], and (C) was not covered by an effective application under
    section 505 of that Act [section 355 of this title], the amendments
    to section 201(p) [par. (p) of this section] made by this Act shall
    not apply to such drug when intended solely for use under
    conditions prescribed, recommended, or suggested in labeling with
    respect to such drug on that day."

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
    6(a) of Pub. L. 85-929, set out as a note under section 342 of this
    title.

                     EFFECTIVE DATE OF 1954 AMENDMENT                 
      For effective date of amendment by act July 22, 1954, see section
    5 of that act, set out as a note under section 342 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282           
      Amendment by Pub. L. 102-282 not to preclude any other civil,
    criminal, or administrative remedy provided under Federal or State
    law, including any private right of action against any person for
    the same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter
    authority of Secretary of Health and Human Services and Secretary
    of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
    et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
    seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
    seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

                             SAVINGS PROVISION                         
      Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, Sec.
    2, Oct. 26, 1974, 88 Stat. 1455, provided that:
      "(a) Prosecutions for any violation of law occurring prior to the
    effective date [see Effective Date of 1970 Amendment note above] of
    section 701 [repealing section 360a of this title, and amending
    sections 321, 331, 333, 334, 360, 372, and 381 of this title,
    sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure,
    and section 242 of Title 42, The Public Health and Welfare] shall
    not be affected by the repeals or amendments made by such section,
    or abated by reason thereof.
      "(b) Civil seizures or forfeitures and injunctive proceedings
    commenced prior to the effective date of section 701 shall not be
    affected by the repeals or amendments made by such section, or
    abated by reason thereof.
      "(c) All administrative proceedings pending before the Bureau of
    Narcotics and Dangerous Drugs [now the Drug Enforcement
    Administration] on the date of enactment of this Act [Oct. 27,
    1970] shall be continued and brought to final determination in
    accord with laws and regulations in effect prior to such date of
    enactment. Where a drug is finally determined under such
    proceedings to be a depressant or stimulant drug, as defined in
    section 201(v) of the Federal Food, Drug, and Cosmetic Act [par.
    (v) of this section], such drug shall automatically be controlled
    under this title [subchapter I of chapter 13 of this title] by the
    Attorney General without further proceedings and listed in the
    appropriate schedule after he has obtained the recommendation of
    the Secretary. Any drug with respect to which such a final
    determination has been made prior to the date of enactment of this
    Act which is not listed in section 202 [section 812 of this title]
    within schedules I through V shall automatically be controlled
    under this title [subchapter I of chapter 13 of this title] by the
    Attorney General without further proceedings, and be listed in the
    appropriate schedule, after he has obtained the recommendations of
    the Secretary.
      "(d) Notwithstanding subsection (a) of this section or section
    1103 [of Pub. L. 91-513, set out as a note under sections 171 to
    174 of this title], section 4202 of title 18, United States Code,
    shall apply to any individual convicted under any of the laws
    repealed by this title or title III [subchapter I or subchapter II
    of chapter 13 of this title] without regard to the terms of any
    sentence imposed on such individual under such law."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      Functions of Secretary of Health, Education, and Welfare [now
    Health and Human Services] under Federal Food, Drug, and Cosmetic
    Act, to the extent such functions related to administration and
    enforcement of the Poison Prevention Packaging Act of 1970 (15
    U.S.C. 1471 et seq.), transferred to Consumer Product Safety
    Commission by section 2079 of Title 15, Commerce and Trade.
      Functions of Secretary of Health, Education, and Welfare [now
    Health and Human Services] under Drug Abuse Control Amendments of
    1965 [see Short Title of 1965 Amendment note set out under section
    301 of this title] transferred to Attorney General except function
    of regulating counterfeiting of those drugs which are not
    "depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1
    of 1968, set out in the Appendix to Title 5, Government
    Organization and Employees.
      Functions of Federal Security Administrator transferred to
    Secretary of Health, Education, and Welfare and all agencies of
    Federal Security Agency transferred to Department of Health,
    Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,
    set out in the Appendix to Title 5, Government Organization and
    Employees. Federal Security Agency and office of Administrator
    abolished by section 8 of Reorg. Plan No. 1 of 1953.
      Food and Drug Administration in Department of Agriculture and its
    functions, except those functions relating to administration of
    Insecticide Act of 1910 and Naval Stores Act, transferred to
    Federal Security Agency, to be administered under direction and
    supervision of Federal Security Administrator, by Reorg. Plan No.
    IV of 1940, set out in the Appendix to Title 5.


-MISC2-
                           REGULATION OF TOBACCO                       
      Section 422 of Pub. L. 105-115 provided that: "Nothing in this
    Act [see Short Title of 1997 Amendment note set out under section
    301 of this title] or the amendments made by this Act shall be
    construed to affect the question of whether the Secretary of Health
    and Human Services has any authority to regulate any tobacco
    product, tobacco ingredient, or tobacco additive. Such authority,
    if any, shall be exercised under the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before
    the date of the enactment of this Act [Nov. 21, 1997]."

            CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103-417        
      Section 2 of Pub. L. 103-417 provided that: "Congress finds that -
     
        "(1) improving the health status of United States citizens
      ranks at the top of the national priorities of the Federal
      Government;
        "(2) the importance of nutrition and the benefits of dietary
      supplements to health promotion and disease prevention have been
      documented increasingly in scientific studies;
        "(3)(A) there is a link between the ingestion of certain
      nutrients or dietary supplements and the prevention of chronic
      diseases such as cancer, heart disease, and osteoporosis; and
        "(B) clinical research has shown that several chronic diseases
      can be prevented simply with a healthful diet, such as a diet
      that is low in fat, saturated fat, cholesterol, and sodium, with
      a high proportion of plant-based foods;
        "(4) healthful diets may mitigate the need for expensive
      medical procedures, such as coronary bypass surgery or
      angioplasty;
        "(5) preventive health measures, including education, good
      nutrition, and appropriate use of safe nutritional supplements
      will limit the incidence of chronic diseases, and reduce long-
      term health care expenditures;
        "(6)(A) promotion of good health and healthy lifestyles
      improves and extends lives while reducing health care
      expenditures; and
        "(B) reduction in health care expenditures is of paramount
      importance to the future of the country and the economic well-
      being of the country;
        "(7) there is a growing need for emphasis on the dissemination
      of information linking nutrition and long-term good health;
        "(8) consumers should be empowered to make choices about
      preventive health care programs based on data from scientific
      studies of health benefits related to particular dietary
      supplements;
        "(9) national surveys have revealed that almost 50 percent of
      the 260,000,000 Americans regularly consume dietary supplements
      of vitamins, minerals, or herbs as a means of improving their
      nutrition;
        "(10) studies indicate that consumers are placing increased
      reliance on the use of nontraditional health care providers to
      avoid the excessive costs of traditional medical services and to
      obtain more holistic consideration of their needs;
        "(11) the United States will spend over $1,000,000,000,000 on
      health care in 1994, which is about 12 percent of the Gross
      National Product of the United States, and this amount and
      percentage will continue to increase unless significant efforts
      are undertaken to reverse the increase;
        "(12)(A) the nutritional supplement industry is an integral
      part of the economy of the United States;
        "(B) the industry consistently projects a positive trade
      balance; and
        "(C) the estimated 600 dietary supplement manufacturers in the
      United States produce approximately 4,000 products, with total
      annual sales of such products alone reaching at least
      $4,000,000,000;
        "(13) although the Federal Government should take swift action
      against products that are unsafe or adulterated, the Federal
      Government should not take any actions to impose unreasonable
      regulatory barriers limiting or slowing the flow of safe products
      and accurate information to consumers;
        "(14) dietary supplements are safe within a broad range of
      intake, and safety problems with the supplements are relatively
      rare; and
        "(15)(A) legislative action that protects the right of access
      of consumers to safe dietary supplements is necessary in order to
      promote wellness; and
        "(B) a rational Federal framework must be established to
      supersede the current ad hoc, patchwork regulatory policy on
      dietary supplements."

     DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE 
      Section 5 of Pub. L. 90-639 provided that: "It is the sense of
    the Congress that, because of the inadequate knowledge on the part
    of the people of the United States of the substantial adverse
    effects of misuse of depressant and stimulant drugs, and of other
    drugs liable to abuse, on the individual, his family, and the
    community, the highest priority should be given to Federal programs
    to disseminate information which may be used to educate the public,
    particularly young persons, regarding the dangers of drug abuse."

             CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY         
      Section 2 of Pub. L. 89-74 provided that: "The Congress hereby
    finds and declares that there is a widespread illicit traffic in
    depressant and stimulant drugs moving in or otherwise affecting
    interstate commerce; that the use of such drugs, when not under the
    supervision of a licensed practitioner, often endangers safety on
    the highways (without distinction of interstate and intrastate
    traffic thereon) and otherwise has become a threat to the public
    health and safety, making additional regulation of such drugs
    necessary regardless of the intrastate or interstate origin of such
    drugs; that in order to make regulation and protection of
    interstate commerce in such drugs effective, regulation of
    intrastate commerce is also necessary because, among other things,
    such drugs, when held for illicit sale, often do not bear labeling
    showing their place of origin and because in the form in which they
    are so held or in which they are consumed a determination of their
    place of origin is often extremely difficult or impossible; and
    that regulation of interstate commerce without the regulation of
    intrastate commerce in such drugs, as provided in this Act [see
    Short Title of 1965 Amendment note set out under section 301 of
    this title], would discriminate against and adversely affect
    interstate commerce in such drugs."

       EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS   
      Section 10 of Pub. L. 89-74 provided that:
      "(a) Nothing in this Act [enacting section 360a of this title,
    amending sections 321, 331, 333, 334, 360, and 372 of this title
    and section 1114 of Title 18, Crimes and Criminal Procedure, and
    enacting provisions set out as notes under sections 321, 352, and
    360a of this title] shall be construed as authorizing the
    manufacture, compounding, processing, possession, sale, delivery,
    or other disposal of any drug in any State in contravention of the
    laws of such State.
      "(b) No provision of this Act nor any amendment made by it shall
    be construed as indicating an intent on the part of the Congress to
    occupy the field in which such provision or amendment operates to
    the exclusion of any State law on the same subject matter, unless
    there is a direct and positive conflict between such provision or
    amendment and such State law so that the two cannot be reconciled
    or consistently stand together.
      "(c) No amendment made by this Act shall be construed to prevent
    the enforcement in the courts of any State of any statute of such
    State prescribing any criminal penalty for any act made criminal by
    any such amendment."

              EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS          
      Section 202 of Pub. L. 87-781 provided that: "Nothing in the
    amendments made by this Act [enacting sections 358 to 360, amending
    sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
    and 381 of this title, and enacting provisions set out as notes
    under sections 321, 331, 332, 352, 355, 360, and 374 of this title]
    to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be
    construed as invalidating any provision of State law which would be
    valid in the absence of such amendments unless there is a direct
    and positive conflict between such amendments and such provision of
    State law."

-CROSS-
                                DEFINITIONS                            
      Section 2 of Pub. L. 105-115 provided that: "In this Act [see
    Short Title of 1997 Amendment note set out under section 301 of
    this title], the terms 'drug', 'device', 'food', and 'dietary
    supplement' have the meaning given such terms in section 201 of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."

-FOOTNOTE-
    (!1) So in original. Probably should be paragraph "(v)".


-End-



-CITE-
    21 USC Sec. 321a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321a. "Butter" defined

-STATUTE-
      For the purposes of the Food and Drug Act of June 30, 1906
    (Thirty-fourth Statutes at Large, page 768) "butter" shall be
    understood to mean the food product usually known as butter, and
    which is made exclusively from milk or cream, or both, with or
    without common salt, and with or without additional coloring
    matter, and containing not less than 80 per centum by weight of
    milk fat, all tolerances having been allowed for.

-SOURCE-
    (Mar. 4, 1923, ch. 268, 42 Stat. 1500.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Food and Drug Act of June 30, 1906, referred to in text, is
    act June 30, 1906, ch. 3915, 34 Stat. 768, as amended, which was
    classified to subchapter I (Sec. 1 et seq.) of chapter 1 of this
    title, was repealed (except for section 14a which was transferred
    to section 376 of this title) by act June 25, 1938, ch. 675, Sec.
    902(a), 52 Stat. 1059, and is covered by this chapter.

-COD-
                               CODIFICATION                           
      Section, which was not enacted as part of the Federal Food, Drug,
    and Cosmetic Act which comprises this chapter, was formerly
    classified to section 6 of this title. Section 902(a) of act June
    25, 1938, set out as an Effective Date note under section 301 of
    this title, provided that this section should remain in force and
    effect and be applicable to the provisions of this chapter.

-End-



-CITE-
    21 USC Sec. 321b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321b. "Package" defined

-STATUTE-
      The word "package" where it occurs the second and last time in
    the act entitled "An act to amend section 8 of an act entitled, 'An
    act for preventing the manufacture, sale, or transportation of
    adulterated or misbranded or poisonous deleterious foods, drugs,
    medicines, and liquors, and for regulating traffic therein, and for
    other purposes,' " approved March 3, 1913, shall include and shall
    be construed to include wrapped meats inclosed in papers or other
    materials as prepared by the manufacturers thereof for sale.

-SOURCE-
    (July 24, 1919, ch. 26, 41 Stat. 271.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      An act approved March 3, 1913, referred to in text, is act Mar.
    3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this
    title. For complete classification of this Act to the Code, see
    Tables.
      "An act for preventing the manufacture, sale, or transportation
    of adulterated or misbranded or poisonous deleterious foods, drugs,
    medicines, and liquors, and for regulating traffic therein, and for
    other purposes,", referred to in text, is act June 30, 1906, ch.
    3915, 34 Stat. 768, which was classified to subchapter I (Sec. 1 et
    seq.) of chapter 1 of this title, was repealed (except for section
    14a which was transferred to section 376 of this title) by act June
    25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059, and is covered by
    this chapter.

-COD-
                               CODIFICATION                           
      Section, which was not enacted as part of the Federal Food, Drug,
    and Cosmetic Act which comprises this chapter, was formerly
    classified to the last sentence of paragraph third of section 10 of
    this title. Section 902(a) of act June 25, 1938, set out as an
    Effective Date note under section 301 of this title, provided that
    this section should remain in force and effect and be applicable to
    the provisions of this chapter.

-End-



-CITE-
    21 USC Sec. 321c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321c. Nonfat dry milk; "milk" defined

-STATUTE-
      For the purposes of the Federal Food, Drug, and Cosmetic Act of
    June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et
    seq.] nonfat dry milk is the product resulting from the removal of
    fat and water from milk, and contains the lactose, milk proteins,
    and milk minerals in the same relative proportions as in the fresh
    milk from which made. It contains not over 5 per centum by weight
    of moisture. The fat content is not over 1 1/2  per centum by
    weight unless otherwise indicated.
      The term "milk", when used herein, means sweet milk of cows.

-SOURCE-
    (Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70
    Stat. 486.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch.
    675, sec. 1, 52 Stat. 1040), referred to in text, probably means
    act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
    classified generally to this chapter (Sec. 301 et seq.). For
    complete classification of this Act to the Code, see section 301 of
    this title and Tables.

-COD-
                               CODIFICATION                           
      Section was not enacted as a part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter, but was made applicable
    thereto.


-MISC1-
                                AMENDMENTS                            
      1956 - Act July 2, 1956, substituted "nonfat dry milk" for
    "nonfat dry milk solids or defatted milk solids".

-End-



-CITE-
    21 USC Sec. 321d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321d. Market names for catfish and ginseng

-STATUTE-
    (a) Catfish labeling
      (1) In general
        Notwithstanding any other provision of law, for purposes of the
      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) - 
          (A) the term "catfish" may only be considered to be a common
        or usual name (or part thereof) for fish classified within the
        family Ictaluridae; and
          (B) only labeling or advertising for fish classified within
        that family may include the term "catfish".
      (2) Omitted
    (b) Ginseng labeling
      (1) In general
        Notwithstanding any other provision of law, for purposes of the
      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) - 
          (A) the term "ginseng" may only be considered to be a common
        or usual name (or part thereof) for any herb or herbal
        ingredient derived from a plant classified within the genus
        Panax; and
          (B) only labeling or advertising for herbs or herbal
        ingredients classified within that genus may include the term
        "ginseng".
      (2) Omitted

-SOURCE-
    (Pub. L. 107-171, title X, Sec. 10806, May 13, 2002, 116 Stat.
    526.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (a)(1), (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to this chapter. For
    complete classification of this Act to the Code, see section 301 of
    this title and Tables.

-COD-
                               CODIFICATION                           
      Section is comprised of section 10806 of Pub. L. 107-171.
    Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107-171
    amended section 343 of this title.
      Section was enacted as part of the Farm Security and Rural
    Investment Act of 2002, and not as part of Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.

-End-


-CITE-
    21 USC SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
              SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES          

-End-



-CITE-
    21 USC Sec. 331                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 331. Prohibited acts

-STATUTE-
      The following acts and the causing thereof are prohibited:
      (a) The introduction or delivery for introduction into interstate
    commerce of any food, drug, device, or cosmetic that is adulterated
    or misbranded.
      (b) The adulteration or misbranding of any food, drug, device, or
    cosmetic in interstate commerce.
      (c) The receipt in interstate commerce of any food, drug, device,
    or cosmetic that is adulterated or misbranded, and the delivery or
    proffered delivery thereof for pay or otherwise.
      (d) The introduction or delivery for introduction into interstate
    commerce of any article in violation of section 344, 355, or 360bbb-
    3 of this title.
      (e) The refusal to permit access to or copying of any record as
    required by section 350a, 350c, 350e, 354, 360bbb-3, 373, 374(a),
    379aa, or 379aa-1 of this title; or the failure to establish or
    maintain any record, or make any report, required under section
    350a, 350c(b), 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j),
    (l) or (m), 360ccc-1(i).,(!1) 360e(f), 360i, 360bbb-3, 379aa, or
    379aa-1 of this title, or the refusal to permit access to or
    verification or copying of any such required record.

      (f) The refusal to permit entry or inspection as authorized by
    section 374 of this title.
      (g) The manufacture within any Territory of any food, drug,
    device, or cosmetic that is adulterated or misbranded.
      (h) The giving of a guaranty or undertaking referred to in
    section 333(c)(2) of this title, which guaranty or undertaking is
    false, except by a person who relied upon a guaranty or undertaking
    to the same effect signed by, and containing the name and address
    of, the person residing in the United States from whom he received
    in good faith the food, drug, device, or cosmetic; or the giving of
    a guaranty or undertaking referred to in section 333(c)(3) of this
    title, which guaranty or undertaking is false.
      (i)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark, stamp,
    tag, label, or other identification device authorized or required
    by regulations promulgated under the provisions of section 344 or
    379e of this title.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate, stone, or
    other thing designed to print, imprint, or reproduce the trademark,
    trade name, or other identifying mark, imprint, or device of
    another or any likeness of any of the foregoing upon any drug or
    container or labeling thereof so as to render such drug a
    counterfeit drug.
      (3) The doing of any act which causes a drug to be a counterfeit
    drug, or the sale or dispensing, or the holding for sale or
    dispensing, of a counterfeit drug.
      (j) The using by any person to his own advantage, or revealing,
    other than to the Secretary or officers or employees of the
    Department, or to the courts when relevant in any judicial
    proceeding under this chapter, any information acquired under
    authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,
    360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1, 360ccc-
    2.,(!1) 374, 379, or 379e of this title concerning any method or
    process which as a trade secret is entitled to protection; or the
    violating of section 346a(i)(2) of this title or any regulation
    issued under that section..(!1) This paragraph does not authorize
    the withholding of information from either House of Congress or
    from, to the extent of matter within its jurisdiction, any
    committee or subcommittee of such committee or any joint committee
    of Congress or any subcommittee of such joint committee.
      (k) The alteration, mutilation, destruction, obliteration, or
    removal of the whole or any part of the labeling of, or the doing
    of any other act with respect to, a food, drug, device, or
    cosmetic, if such act is done while such article is held for sale
    (whether or not the first sale) after shipment in interstate
    commerce and results in such article being adulterated or
    misbranded.
      (l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,
    111 Stat. 2380.
      (m) The sale or offering for sale of colored oleomargarine or
    colored margarine, or the possession or serving of colored
    oleomargarine or colored margarine in violation of subsections (b)
    or (c) of section 347 of this title.
      (n) The using, in labeling, advertising or other sales promotion
    of any reference to any report or analysis furnished in compliance
    with section 374 of this title.
      (o) In the case of a prescription drug distributed or offered for
    sale in interstate commerce, the failure of the manufacturer,
    packer, or distributor thereof to maintain for transmittal, or to
    transmit, to any practitioner licensed by applicable State law to
    administer such drug who makes written request for information as
    to such drug, true and correct copies of all printed matter which
    is required to be included in any package in which that drug is
    distributed or sold, or such other printed matter as is approved by
    the Secretary. Nothing in this paragraph shall be construed to
    exempt any person from any labeling requirement imposed by or under
    other provisions of this chapter.
      (p) The failure to register in accordance with section 360 of
    this title, the failure to provide any information required by
    section 360(j) or 360(k) of this title, or the failure to provide a
    notice required by section 360(j)(2) of this title.
      (q)(1) The failure or refusal to (A) comply with any requirement
    prescribed under section 360h or 360j(g) of this title, (B) furnish
    any notification or other material or information required by or
    under section 360i or 360j(g) of this title, or (C) comply with a
    requirement under section 360l of this title.
      (2) With respect to any device, the submission of any report that
    is required by or under this chapter that is false or misleading in
    any material respect.
      (r) The movement of a device in violation of an order under
    section 334(g) of this title or the removal or alteration of any
    mark or label required by the order to identify the device as
    detained.
      (s) The failure to provide the notice required by section 350a(c)
    or 350a(e) of this title, the failure to make the reports required
    by section 350a(f)(1)(B) of this title, the failure to retain the
    records required by section 350a(b)(4) of this title, or the
    failure to meet the requirements prescribed under section
    350a(f)(3) of this title.
      (t) The importation of a drug in violation of section 381(d)(1)
    of this title, the sale, purchase, or trade of a drug or drug
    sample or the offer to sell, purchase, or trade a drug or drug
    sample in violation of section 353(c) of this title, the sale,
    purchase, or trade of a coupon, the offer to sell, purchase, or
    trade such a coupon, or the counterfeiting of such a coupon in
    violation of section 353(c)(2) of this title, the distribution of a
    drug sample in violation of section 353(d) of this title or the
    failure to otherwise comply with the requirements of section 353(d)
    of this title, or the distribution of drugs in violation of section
    353(e) of this title or the failure to otherwise comply with the
    requirements of section 353(e) of this title.
      (u) The failure to comply with any requirements of the provisions
    of, or any regulations or orders of the Secretary, under section
    360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
      (v) The introduction or delivery for introduction into interstate
    commerce of a dietary supplement that is unsafe under section 350b
    of this title.
      (w) The making of a knowingly false statement in any statement,
    certificate of analysis, record, or report required or requested
    under section 381(d)(3) of this title; the failure to submit a
    certificate of analysis as required under such section; the failure
    to maintain records or to submit records or reports as required by
    such section; the release into interstate commerce of any article
    or portion thereof imported into the United States under such
    section or any finished product made from such article or portion,
    except for export in accordance with section 381(e) or 382 of this
    title, or with section 262(h) of title 42; or the failure to so
    export or to destroy such an article or portions thereof, or such a
    finished product.
      (x) The falsification of a declaration of conformity submitted
    under section 360d(c) of this title or the failure or refusal to
    provide data or information requested by the Secretary under
    paragraph (3) of such section.
      (y) In the case of a drug, device, or food - 
        (1) the submission of a report or recommendation by a person
      accredited under section 360m of this title that is false or
      misleading in any material respect;
        (2) the disclosure by a person accredited under section 360m of
      this title of confidential commercial information or any trade
      secret without the express written consent of the person who
      submitted such information or secret to such person; or
        (3) the receipt by a person accredited under section 360m of
      this title of a bribe in any form or the doing of any corrupt act
      by such person associated with a responsibility delegated to such
      person under this chapter.

      (z) The dissemination of information in violation of section
    360aaa of this title.
      (aa) The importation of a prescription drug in violation of
    section 384 of this title, the falsification of any record required
    to be maintained or provided to the Secretary under such section,
    or any other violation of regulations under such section.
      (bb) The transfer of an article of food in violation of an order
    under section 334(h) of this title, or the removal or alteration of
    any mark or label required by the order to identify the article as
    detained.
      (cc) The importing or offering for import into the United States
    of an article of food by, with the assistance of, or at the
    direction of, a person debarred under section 335a(b)(3) of this
    title.
      (dd) The failure to register in accordance with section 350d of
    this title.
      (ee) The importing or offering for import into the United States
    of an article of food in violation of the requirements under
    section 381(m) of this title.
      (ff) The importing or offering for import into the United States
    of a drug or device with respect to which there is a failure to
    comply with a request of the Secretary to submit to the Secretary a
    statement under section 381(o) of this title.
      (gg) The knowing failure to comply with paragraph (7)(E) of
    section 374(g) of this title; the knowing inclusion by a person
    accredited under paragraph (2) of such section of false information
    in an inspection report under paragraph (7)(A) of such section; or
    the knowing failure of such a person to include material facts in
    such a report.
      (hh) The failure by a shipper, carrier by motor vehicle or rail
    vehicle, receiver, or any other person engaged in the
    transportation of food to comply with the sanitary transportation
    practices prescribed by the Secretary under section 350e of this
    title.
      (ii) The falsification of a report of a serious adverse event
    submitted to a responsible person (as defined under section 379aa
    or 379aa-1 of this title) or the falsification of a serious adverse
    event report (as defined under section 379aa or 379aa-1 of this
    title) submitted to the Secretary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941,
    ch. 613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59
    Stat. 463; Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24,
    1948, ch. 613, Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec.
    3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477;
    Pub. L. 85-929, Sec. 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86-
    618, title I, Secs. 104, 105(a), July 12, 1960, 74 Stat. 403; Pub.
    L. 87-781, title I, Secs. 103(c), 104(e)(1), 106(c), 114(a), title
    III, Sec. 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795;
    Pub. L. 89-74, Secs. 5, 9(c), July 15, 1965, 79 Stat. 232, 235;
    Pub. L. 90-399, Sec. 103, July 13, 1968, 82 Stat. 352; Pub. L. 90-
    639, Sec. 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91-513,
    title II, Sec. 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92-
    387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94-295, Secs.
    3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L.
    96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99-570,
    title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207-120; Pub.
    L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101-
    502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101-508,
    title IV, Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388-210; Pub.
    L. 102-300, Sec. 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102-
    571, title I, Sec. 107(2), (3), Oct. 29, 1992, 106 Stat. 4499;
    Pub. L. 103-80, Sec. 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L.
    103-396, Sec. 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103-
    417, Sec. 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104-134,
    title II, Sec. 2103, Apr. 26, 1996, 110 Stat. 1321-319; Pub. L. 104-
    170, title IV, Sec. 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104-
    250, Sec. 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105-115,
    title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), title II, Secs. 204(b),
    210(c), title IV, Secs. 401(b), 421, Nov. 21, 1997, 111 Stat. 2325,
    2336, 2345, 2364, 2380; Pub. L. 106-387, Sec. 1(a) [title VII, Sec.
    745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A-39; Pub. L. 107-
    188, title III, Secs. 303(b), 304(d), 305(b), 306(c), 307(b),
    321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670,
    672, 676, 677; Pub. L. 107-250, title II, Sec. 201(d), Oct. 26,
    2002, 116 Stat. 1609; Pub. L. 108-136, div. A, title XVI, Sec.
    1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108-173, title XI,
    Sec. 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108-214,
    Sec. 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282,
    title I, Sec. 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub.
    L. 109-59, title VII, Sec. 7202(d), (e), Aug. 10, 2005, 119 Stat.
    1913; Pub. L. 109-462, Secs. 2(c), 3(b), 4(a), Dec. 22, 2006, 120
    Stat. 3472, 3475.)


-STATAMEND-
                           AMENDMENT OF SECTION                       
      For termination of amendment by section 401(e) of Pub. L. 105-
    115, see Effective and Termination Dates of 1997 Amendment note
    below.


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (e). Pub. L. 109-462, Sec. 3(b), substituted "374(a),
    379aa, or 379aa-1" for "374(a), or 379aa" and "360bbb-3, 379aa, or
    379aa-1" for "360bbb-3, or 379aa".
      Pub. L. 109-462, Sec. 2(c), substituted ", 374(a), or 379aa" for
    ", or 374(a)" and ", 360bbb-3, or 379aa" for ", or 360bbb-3".
      Par. (ii). Pub. L. 109-462, Sec. 4(a), added par. (ii).
      2005 - Par. (e). Pub. L. 109-59, Sec. 7202(d), inserted "350e,"
    before "354," in two places.
      Par. (hh). Pub. L. 109-59, Sec. 7202(e), added par. (hh).
      2004 - Par. (e). Pub. L. 108-282, Sec. 102(b)(5)(C), which
    directed the substitution of "360b(a)(4)(C), 360b (j), (l) or (m),
    360ccc-1(i)." for "360b(a)(4)(C), 360b(j), (l) or (m)" was executed
    by making the substitution for "360b(a)(4)(C), 360b(j), (l), or
    (m)", to reflect the probable intent of Congress.
      Par. (j). Pub. L. 108-282, Sec. 102(b)(5)(D), substituted "360j,
    360ccc, 360ccc-1, 360ccc-2." for "360j".
      Par. (gg). Pub. L. 108-214 amended par. (gg) generally. Prior to
    amendment, text read as follows: "The knowing failure of a person
    accredited under paragraph (2) of section 374(g) of this title to
    comply with paragraph (7)(E) of such section; the knowing inclusion
    by such a person of false information in an inspection report under
    paragraph (7)(A) of such section; or the knowing failure of such a
    person to include material facts in such a report."
      2003 - Par. (d). Pub. L. 108-136 substituted "section 344, 355,
    or 360bbb-3" for "section 344 or 355".
      Par. (e). Pub. L. 108-136 inserted "360bbb-3," after "350c, 354,"
    and substituted "360i, or 360bbb-3" for "or 360i".
      Par. (aa). Pub. L. 108-173 substituted "prescription drug in
    violation of section 384" for "covered product in violation of
    section 384".
      2002 - Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted "by
    section 350a, 350c, 354, 373, or 374(a) of this title" for "by
    section 350a, 354, or 373 of this title" and "under section 350a,
    350c(b)" for "under section 350a".
      Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted "350c," after
    "350a,".
      Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w)
    generally. Prior to amendment, par. (w) read as follows: "The
    making of a knowingly false statement in any record or report
    required or requested under subparagraph (A) or (B) of section
    381(d)(3) of this title, the failure to submit or maintain records
    as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this
    title, the release into interstate commerce of any article imported
    into the United States under section 381(d)(3) of this title or any
    finished product made from such article (except for export in
    accordance with section 381(e) or 382 of this title or section
    262(h) of title 42), or the failure to export or destroy any
    component, part or accessory not incorporated into a drug,
    biological product or device that will be exported in accordance
    with section 381(e) or 382 of this title or section 262(h) of title
    42."
      Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).
      Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).
      Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).
      Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).
      Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).
      Par. (gg). Pub. L. 107-250 added par. (gg).
      2000 - Par. (aa). Pub. L. 106-387 added par. (aa).
      1997 - Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out
    "357(d) or (g)," after "355(i) or (k),".
      Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out ",
    356, 357," before "or 379e of this title".
      Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out "356,
    357," before "360,".
      Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which
    read as follows: "The using, on the labeling of any drug or device
    or in any advertising relating to such drug or device, of any
    representation or suggestion that approval of an application with
    respect to such drug or device is in effect under section 355,
    360e, or 360j(g) of this title, as the case may be, or that such
    drug or device complies with the provisions of such section."
      Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).
      Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).
      Par. (z). Pub. L. 105-115, Sec. 401(b), (e), temporarily added
    par. (z). See Effective and Termination Dates of 1997 Amendment
    note below.
      1996 - Par. (e). Pub. L. 104-250 inserted ", 354," before "or 373
    of this title" and "354," before "355(i) or (k)".
      Par. (j). Pub. L. 104-170 inserted before period at end of first
    sentence "; or the violating of section 346a(i)(2) of this title or
    any regulation issued under that section."
      Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating
    to introduction into interstate commerce of unsafe dietary
    supplement as (v) and added par. (w).
      1994 - Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted
    "357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),".
      Par. (u). Pub. L. 103-417 added par. (u) relating to introduction
    into interstate commerce of unsafe dietary supplement.
      Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to
    failure to comply with regulations or orders of Secretary.
      1993 - Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted "379,
    or 379e" for "379e, or 379".
      Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted "350a(e)" for
    "350a(d)".
      1992 - Pars. (i)(1), (j). Pub. L. 102-571 substituted "379e" for
    "376".
      Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).
      1990 - Par. (e). Pub. L. 101-502 substituted "or (k)" for "or
    (j)".
      Par. (j). Pub. L. 101-508 inserted at end "This paragraph does
    not authorize the withholding of information from either House of
    Congress or from, to the extent of matter within its jurisdiction,
    any committee or subcommittee of such committee or any joint
    committee of Congress or any subcommittee of such joint committee."
      1988 - Par. (t). Pub. L. 100-293 added par. (t).
      1986 - Par. (s). Pub. L. 99-570 amended par. (s) generally. Prior
    to amendment, par. (s) read as follows: "The failure to provide the
    notice required by section 350a(b) or 350a(c), the failure to make
    the reports required by section 350a(d)(1)(B), or the failure to
    meet the requirements prescribed under section 350a(d)(2)."
      1980 - Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to
    section 350a of this title in two places.
      Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to
    section 350a of this title.
      Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).
      1976 - Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted
    references to sections 360e(f) and 360i of this title.
      Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to
    sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of
    this title.
      Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted "drug or
    device" for "drug" wherever appearing, and inserted references to
    sections 360e and 360j(g) of this title.
      Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted "section
    360(j) or 360(k) of this title," for "section 360(j) of this
    title,".
      Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).
      Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).
      1972 - Par. (p). Pub. L. 92-387 added failure to provide
    information required by section 360(j) of this title, and failure
    to provide notice required by section 360(j)(2) of this title as
    prohibited acts.
      1970 - Par. (q). Pub. L. 91-513 struck out par. (q) which set out
    penalties for illegal manufacture, sale, disposition, possession
    and other traffic in stimulant and depressant drugs. See section
    801 et seq. of this title.
      1968 - Par. (e). Pub. L. 90-399, Sec. 103(1), inserted reference
    to section 360b(j), (l), and (m) of this title.
      Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to
    section 360b of this title.
      Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply
    to possession in violation of section 360a(c) of this title, into
    subcls. (A) and (B) which refer, respectively, to possession in
    violation of section 360a(c)(1) of this title and possession in
    violation of section 360a(c)(2) of this title.
      1965 - Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing
    provisions as subpar. (1) and added subpars. (2) and (3).
      Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).
      1962 - Par. (e). Pub. L. 87-781, Secs. 103(c), 106(c), prohibited
    the failure to establish or maintain any record, or make any
    report, required under sections 355(i) or (j) and 507(d) or (g) of
    this title, or the refusal to permit access to, or verification or
    copying of, any such required record.
      Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted "approval of"
    before "an application", and substituted "in effect" for
    "effective".
      Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).
      Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).
      1960 - Par. (i). Pub. L. 86-618, Sec. 105(a), struck out
    references to sections 346(b), 354, and 364 of this title and
    inserted reference to section 376 of this title.
      Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section
    376 of this title.
      1958 - Par. (j). Pub. L. 85-929, inserted reference to section
    348 of this title.
      1953 - Par. (n). Act Aug. 7, 1953, added par. (n).
      1950 - Par. (m). Act Mar. 16, 1950, added par. (m).
      1948 - Par. (k). Act June 24, 1948, inserted "(whether or not the
    first sale)" so as to make it clear that this subsection is not
    limited to the case where the act occurs while the article is held
    for the first sale after interstate shipment, and extended coverage
    of subsection to acts which result in adulteration.
      1947 - Par. (j). Act Mar. 10, 1947, inserted reference to
    sections 356 and 357 of this title.
      1945 - Par. (i). Act July 6, 1945, inserted reference to section
    357 of this title.
      1941 - Par. (i). Act Dec. 22, 1941, inserted reference to section
    356 of this title.

                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Amendment by section 2(c) of Pub. L. 109-462 effective 1 year
    after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462, set
    out as a note under section 352 of this title.
      Amendment by section 3(b) of Pub. L. 109-462 effective 1 year
    after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109-462, set
    out as a note under section 343 of this title.
      Pub. L. 109-462, Sec. 4(b), Dec. 22, 2006, 120 Stat. 3475,
    provided that: "The amendment made by this section [amending this
    section] shall take effect 1 year after the date of enactment of
    this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Pub. L. 109-59, title VII, Sec. 7204, Aug. 10, 2005, 119 Stat.
    1914, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
    of title VII of Pub. L. 109-59, enacting section 350e of this
    title, amending this section, sections 342 and 373 of this title,
    and section 5701 of Title 49, Transportation, omitting sections
    5702 to 5714 of Title 49, and enacting provisions set out as a note
    under section 301 of this title] takes effect on October 1, 2005."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat.
    676, provided that: "The amendments made by this section [amending
    this section and sections 360 and 381 of this title] take effect
    upon the expiration of the 180-day period beginning on the date of
    the enactment of this Act [June 12, 2002]."
      Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat.
    678, provided that: "The amendments made by this section [amending
    this section and section 381 of this title] take effect upon the
    expiration of the 90-day period beginning on the date of the
    enactment of this Act [June 12, 2002]."

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Amendment by sections 204, 210, and 421 of Pub. L. 105-115
    effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.
      Amendment by section 401(b) of Pub. L. 105-115 effective 1 year
    after Nov. 21, 1997, or upon Secretary's issuance of final
    regulations pursuant to section 401(c) of Pub. L. 105-115,
    whichever is sooner, and ceases to be effective Sept. 30, 2006, or
    7 years after date Secretary promulgates regulations under section
    401(c) of Pub. L. 105-115, whichever is later, see section 401(d),
    (e) of Pub. L. 105-115, set out as an Effective and Termination
    Dates note under section 360aaa of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by Pub. L. 103-396 effective upon adoption of final
    regulations under section 2(c) of Pub. L. 103-396, set out as a
    Regulations note under section 360b of this title, see section 2(d)
    of Pub. L. 103-396, set out as a note under section 360b of this
    title.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment
    made by that section is effective as if included in subtitle D of
    title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L.
    101-239, title VI, Secs. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285,
    see 42 U.S.C. 300aa-1 note, 300aa-10 note.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-293 effective upon expiration of 90 days
    after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
    as a note under section 353 of this title.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-387 effective on first day of sixth month
    beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
    out as a note under section 360 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENTS                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.
      Amendment by Pub. L. 90-639 applicable only with respect to
    violations of this chapter committed after Oct. 24, 1968, see
    section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
    Amendments; Transitional Provisions note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
    of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by sections 103(c) and 106(c) of Pub. L. 87-781
    effective on first day of seventh calendar month following Oct.
    1962, and amendment by section 104(e)(1) of Pub. L. 87-781
    effective Oct. 10, 1962, see section 107 of Pub. L. 87-781, set out
    as a note under section 321 of this title.
      Section 114(b) of Pub. L. 87-781 provided that: "This section
    [amending this section] shall take effect on the first day of the
    seventh calendar month following the month in which this Act is
    enacted [October 1962]."

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
    6(a) of Pub. L. 85-929, set out as a note under section 342 of this
    title.

                     EFFECTIVE DATE OF 1950 AMENDMENT                 
      Amendment by act Mar. 16, 1950, effective July 1, 1950, see
    section 7 of that act, set out as an Effective Date note under
    section 347 of this title.

                                REGULATIONS                            
      Secretary of Health and Human Services to promulgate regulations
    to implement amendments made by section 401 of Pub. L. 105-115 not
    later than 1 year after Nov. 21, 1997, see section 401(c) of Pub.
    L. 105-115, set out as a note under section 360aaa of this title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188           
      Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat.
    675, provided that: "Nothing in this title [enacting sections 350c,
    350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319,
    and 8320 of Title 7, Agriculture, and section 247b-20 of Title 42,
    The Public Health and Welfare, amending this section, sections 334,
    335a, 342, 343, 360, 372, 374, and 381 of this title, and section
    43 of Title 18, Crimes and Criminal Procedure, and enacting
    provisions set out as notes under this section and sections 341,
    350c, 350d, and 381 of this title], or an amendment made by this
    title, shall be construed to alter the jurisdiction between the
    Secretaries of Agriculture and of Health and Human Services, under
    applicable statutes and regulations."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-FOOTNOTE-
    (!1) So in original.


-End-



-CITE-
    21 USC Sec. 332                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 332. Injunction proceedings

-STATUTE-
    (a) Jurisdiction of courts
      The district courts of the United States and the United States
    courts of the Territories shall have jurisdiction, for cause shown
    (!1) to restrain violations of section 331 of this title, except
    paragraphs (h), (i), and (j).

    (b) Violation of injunction
      In case of violation of an injunction or restraining order issued
    under this section, which also constitutes a violation of this
    chapter, trial shall be by the court, or, upon demand of the
    accused, by a jury.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 302, 52 Stat. 1043; Pub. L. 87-781,
    title I, Sec. 103(d), title II, Sec. 201(c), Oct. 10, 1962, 76
    Stat. 784, 793; Pub. L. 103-80, Sec. 3(d), Aug. 13, 1993, 107 Stat.
    775.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(d)(1), struck out ",
    and subject to the provisions of section 17 (relating to notice to
    opposite party) of the Act entitled 'An Act to supplement existing
    laws against unlawful restraints and monopolies, and for other
    purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed.,
    title 28, sec. 381)," after "for cause shown".
      Subsec. (b). Pub. L. 103-80, Sec. 3(d)(2), struck out at end
    "Such trial shall be conducted in accordance with the practice and
    procedure applicable in the case of proceedings subject to the
    provisions of section 22 of such Act of October 15, 1914, as
    amended (U.S.C., 1934 ed., title 28, sec. 387)."
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 103(d), struck out
    "(e)," after "paragraphs".
      Pub. L. 87-781, Sec. 201(c), struck out "(f)," after
    "paragraphs".

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by section 103(c) of Pub. L. 87-781 effective on first
    day of seventh calendar month following October 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.
      Section 203 of title II of Pub. L. 87-781 provided that: "The
    amendments made by this title [amending this section and section
    374 of this title and enacting provisions set out as notes under
    sections 321 and 374 of this title] shall take effect on the date
    of enactment of this Act [Oct. 10, 1962]."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 333                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 333. Penalties

-STATUTE-
    (a) Violation of section 331 of this title; second violation;
      intent to defraud or mislead
      (1) Any person who violates a provision of section 331 of this
    title shall be imprisoned for not more than one year or fined not
    more than $1,000, or both.
      (2) Notwithstanding the provisions of paragraph (1) of this
    section,(!1) if any person commits such a violation after a
    conviction of him under this section has become final, or commits
    such a violation with the intent to defraud or mislead, such person
    shall be imprisoned for not more than three years or fined not more
    than $10,000, or both.

    (b) Prescription drug marketing violations
      (1) Notwithstanding subsection (a) of this section, any person
    who violates section 331(t) of this title by - 
        (A) knowingly importing a drug in violation of section
      381(d)(1) of this title,
        (B) knowingly selling, purchasing, or trading a drug or drug
      sample or knowingly offering to sell, purchase, or trade a drug
      or drug sample, in violation of section 353(c)(1) of this title,
        (C) knowingly selling, purchasing, or trading a coupon,
      knowingly offering to sell, purchase, or trade such a coupon, or
      knowingly counterfeiting such a coupon, in violation of section
      353(c)(2) of this title, or
        (D) knowingly distributing drugs in violation of section
      353(e)(2)(A) of this title,

    shall be imprisoned for not more than 10 years or fined not more
    than $250,000, or both.
      (2) Any manufacturer or distributor who distributes drug samples
    by means other than the mail or common carrier whose
    representative, during the course of the representative's
    employment or association with that manufacturer or distributor,
    violated section 331(t) of this title because of a violation of
    section 353(c)(1) of this title or violated any State law
    prohibiting the sale, purchase, or trade of a drug sample subject
    to section 353(b) of this title or the offer to sell, purchase, or
    trade such a drug sample shall, upon conviction of the
    representative for such violation, be subject to the following
    civil penalties:
        (A) A civil penalty of not more than $50,000 for each of the
      first two such violations resulting in a conviction of any
      representative of the manufacturer or distributor in any 10-year
      period.
        (B) A civil penalty of not more than $1,000,000 for each
      violation resulting in a conviction of any representative after
      the second conviction in any 10-year period.

    For the purposes of this paragraph, multiple convictions of one or
    more persons arising out of the same event or transaction, or a
    related series of events or transactions, shall be considered as
    one violation.
      (3) Any manufacturer or distributor who violates section 331(t)
    of this title because of a failure to make a report required by
    section 353(d)(3)(E) of this title shall be subject to a civil
    penalty of not more than $100,000.
      (4)(A) If a manufacturer or distributor or any representative of
    such manufacturer or distributor provides information leading to
    the institution of a criminal proceeding against, and conviction
    of, any representative of that manufacturer or distributor for a
    violation of section 331(t) of this title because of a sale,
    purchase, or trade or offer to purchase, sell, or trade a drug
    sample in violation of section 353(c)(1) of this title or for a
    violation of State law prohibiting the sale, purchase, or trade or
    offer to sell, purchase, or trade a drug sample, the conviction of
    such representative shall not be considered as a violation for
    purposes of paragraph (2).
      (B) If, in an action brought under paragraph (2) against a
    manufacturer or distributor relating to the conviction of a
    representative of such manufacturer or distributor for the sale,
    purchase, or trade of a drug or the offer to sell, purchase, or
    trade a drug, it is shown, by clear and convincing evidence - 
        (i) that the manufacturer or distributor conducted, before the
      institution of a criminal proceeding against such representative
      for the violation which resulted in such conviction, an
      investigation of events or transactions which would have led to
      the reporting of information leading to the institution of a
      criminal proceeding against, and conviction of, such
      representative for such purchase, sale, or trade or offer to
      purchase, sell, or trade, or
        (ii) that, except in the case of the conviction of a
      representative employed in a supervisory function, despite
      diligent implementation by the manufacturer or distributor of an
      independent audit and security system designed to detect such a
      violation, the manufacturer or distributor could not reasonably
      have been expected to have detected such violation,

    the conviction of such representative shall not be considered as a
    conviction for purposes of paragraph (2).
      (5) If a person provides information leading to the institution
    of a criminal proceeding against, and conviction of, a person for a
    violation of section 331(t) of this title because of the sale,
    purchase, or trade of a drug sample or the offer to sell, purchase,
    or trade a drug sample in violation of section 353(c)(1) of this
    title, such person shall be entitled to one-half of the criminal
    fine imposed and collected for such violation but not more than
    $125,000.
      (6) Notwithstanding subsection (a) of this section, any person
    who is a manufacturer or importer of a prescription drug under
    section 384(b) of this title and knowingly fails to comply with a
    requirement of section 384(e) of this title that is applicable to
    such manufacturer or importer, respectively, shall be imprisoned
    for not more than 10 years or fined not more than $250,000, or
    both.
    (c) Exceptions in certain cases of good faith, etc.
      No person shall be subject to the penalties of subsection (a)(1)
    of this section, (1) for having received in interstate commerce any
    article and delivered it or proffered delivery of it, if such
    delivery or proffer was made in good faith, unless he refuses to
    furnish on request of an officer or employee duly designated by the
    Secretary the name and address of the person from whom he purchased
    or received such article and copies of all documents, if any there
    be, pertaining to the delivery of the article to him; or (2) for
    having violated section 331(a) or (d) of this title, if he
    establishes a guaranty or undertaking signed by, and containing the
    name and address of, the person residing in the United States from
    whom he received in good faith the article, to the effect, in case
    of an alleged violation of section 331(a) of this title, that such
    article is not adulterated or misbranded, within the meaning of
    this chapter designating this chapter or to the effect, in case of
    an alleged violation of section 331(d) of this title, that such
    article is not an article which may not, under the provisions of
    section 344 or 355 of this title, be introduced into interstate
    commerce; or (3) for having violated section 331(a) of this title,
    where the violation exists because the article is adulterated by
    reason of containing a color additive not from a batch certified in
    accordance with regulations promulgated by the Secretary under this
    chapter, if such person establishes a guaranty or undertaking
    signed by, and containing the name and address of, the manufacturer
    of the color additive, to the effect that such color additive was
    from a batch certified in accordance with the applicable
    regulations promulgated by the Secretary under this chapter; or (4)
    for having violated section 331(b), (c) or (k) of this title by
    failure to comply with section 352(f) of this title in respect to
    an article received in interstate commerce to which neither section
    353(a) nor 353(b)(1) of this title is applicable, if the delivery
    or proffered delivery was made in good faith and the labeling at
    the time thereof contained the same directions for use and warning
    statements as were contained in the labeling at the time of such
    receipt of such article; or (5) for having violated section
    331(i)(2) of this title if such person acted in good faith and had
    no reason to believe that use of the punch, die, plate, stone, or
    other thing involved would result in a drug being a counterfeit
    drug, or for having violated section 331(i)(3) of this title if the
    person doing the act or causing it to be done acted in good faith
    and had no reason to believe that the drug was a counterfeit drug.
    (d) Exceptions involving misbranded food
      No person shall be subject to the penalties of subsection (a)(1)
    of this section for a violation of section 331 of this title
    involving misbranded food if the violation exists solely because
    the food is misbranded under section 343(a)(2) of this title
    because of its advertising.
    (e) Prohibited distribution of human growth hormone
      (1) Except as provided in paragraph (2), whoever knowingly
    distributes, or possesses with intent to distribute, human growth
    hormone for any use in humans other than the treatment of a disease
    or other recognized medical condition, where such use has been
    authorized by the Secretary of Health and Human Services under
    section 355 of this title and pursuant to the order of a physician,
    is guilty of an offense punishable by not more than 5 years in
    prison, such fines as are authorized by title 18, or both.
      (2) Whoever commits any offense set forth in paragraph (1) and
    such offense involves an individual under 18 years of age is
    punishable by not more than 10 years imprisonment, such fines as
    are authorized by title 18, or both.
      (3) Any conviction for a violation of paragraphs (1) and (2) of
    this subsection shall be considered a felony violation of the
    Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes
    of forfeiture under section 413 of such Act [21 U.S.C. 853].
      (4) As used in this subsection the term "human growth hormone"
    means somatrem, somatropin, or an analogue of either of them.
      (5) The Drug Enforcement Administration is authorized to
    investigate offenses punishable by this subsection.
    (f) Redesignated (g)
    (g) Violations related to devices
      (1)(A) Except as provided in subparagraph (B), any person who
    violates a requirement of this chapter which relates to devices
    shall be liable to the United States for a civil penalty in an
    amount not to exceed $15,000 for each such violation, and not to
    exceed $1,000,000 for all such violations adjudicated in a single
    proceeding. For purposes of the preceding sentence, a person
    accredited under paragraph (2) of section 374(g) of this title who
    is substantially not in compliance with the standards of
    accreditation under such section, or who poses a threat to public
    health or fails to act in a manner that is consistent with the
    purposes of such section, shall be considered to have violated a
    requirement of this chapter that relates to devices.
      (B) Subparagraph (A) shall not apply - 
        (i) to any person who violates the requirements of section
      360i(a) or 360j(f) of this title unless such violation
      constitutes (I) a significant or knowing departure from such
      requirements, or (II) a risk to public health,
        (ii) to any person who commits minor violations of section
      360i(e) or 360i(f) of this title (only with respect to correction
      reports) if such person demonstrates substantial compliance with
      such section, or
        (iii) to violations of section 351(a)(2)(A) of this title which
      involve one or more devices which are not defective.

      (2)(A) Any person who introduces into interstate commerce or
    delivers for introduction into interstate commerce an article of
    food that is adulterated within the meaning of section 342(a)(2)(B)
    of this title shall be subject to a civil money penalty of not more
    than $50,000 in the case of an individual and $250,000 in the case
    of any other person for such introduction or delivery, not to
    exceed $500,000 for all such violations adjudicated in a single
    proceeding.
      (B) This paragraph shall not apply to any person who grew the
    article of food that is adulterated. If the Secretary assesses a
    civil penalty against any person under this paragraph, the
    Secretary may not use the criminal authorities under this section
    to sanction such person for the introduction or delivery for
    introduction into interstate commerce of the article of food that
    is adulterated. If the Secretary assesses a civil penalty against
    any person under this paragraph, the Secretary may not use the
    seizure authorities of section 334 of this title or the injunction
    authorities of section 332 of this title with respect to the
    article of food that is adulterated.
      (C) In a hearing to assess a civil penalty under this paragraph,
    the presiding officer shall have the same authority with regard to
    compelling testimony or production of documents as a presiding
    officer has under section 346a(g)(2)(B) of this title. The third
    sentence of paragraph (3)(A) shall not apply to any investigation
    under this paragraph.
      (3)(A) A civil penalty under paragraph (1) or (2) shall be
    assessed by the Secretary by an order made on the record after
    opportunity for a hearing provided in accordance with this
    subparagraph and section 554 of title 5. Before issuing such an
    order, the Secretary shall give written notice to the person to be
    assessed a civil penalty under such order of the Secretary's
    proposal to issue such order and provide such person an opportunity
    for a hearing on the order. In the course of any investigation, the
    Secretary may issue subpoenas requiring the attendance and
    testimony of witnesses and the production of evidence that relates
    to the matter under investigation.
      (B) In determining the amount of a civil penalty, the Secretary
    shall take into account the nature, circumstances, extent, and
    gravity of the violation or violations and, with respect to the
    violator, ability to pay, effect on ability to continue to do
    business, any history of prior such violations, the degree of
    culpability, and such other matters as justice may require.
      (C) The Secretary may compromise, modify, or remit, with or
    without conditions, any civil penalty which may be assessed under
    paragraph (1) or (2). The amount of such penalty, when finally
    determined, or the amount agreed upon in compromise, may be
    deducted from any sums owing by the United States to the person
    charged.
      (4) Any person who requested, in accordance with paragraph
    (3)(A), a hearing respecting the assessment of a civil penalty and
    who is aggrieved by an order assessing a civil penalty may file a
    petition for judicial review of such order with the United States
    Court of Appeals for the District of Columbia Circuit or for any
    other circuit in which such person resides or transacts business.
    Such a petition may only be filed within the 60-day period
    beginning on the date the order making such assessment was issued.
      (5) If any person fails to pay an assessment of a civil penalty -
    
        (A) after the order making the assessment becomes final, and if
      such person does not file a petition for judicial review of the
      order in accordance with paragraph (4), or
        (B) after a court in an action brought under paragraph (4) has
      entered a final judgment in favor of the Secretary,

    the Attorney General shall recover the amount assessed (plus
    interest at currently prevailing rates from the date of the
    expiration of the 60-day period referred to in paragraph (4) or the
    date of such final judgment, as the case may be) in an action
    brought in any appropriate district court of the United States. In
    such an action, the validity, amount, and appropriateness of such
    penalty shall not be subject to review.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,
    ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.
    105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Secs. 7, 9(d),
    July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,
    1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.
    27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.
    502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.
    7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.
    2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),
    Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.
    1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.
    26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,
    107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.
    13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.
    3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) [title VII,
    Sec. 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.
    107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub.
    L. 108-173, title XI, Sec. 1121(b)(2), Dec. 8, 2003, 117 Stat.
    2469.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Controlled Substances Act, referred to in subsec. (e)(3), is
    title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
    amended, which is classified principally to subchapter I (Sec. 801
    et seq.) of chapter 13 of this title. For complete classification
    of this Act to the Code, see Short Title note set out under section
    801 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(6). Pub. L. 108-173, which directed amendment
    of subsec. (a)(6) by substituting "prescription drug under section
    384(b)" for "covered product pursuant to section 384(a)", was
    executed by making the substitution in subsec. (b)(6), to reflect
    the probable intent of Congress.
      2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end "For
    purposes of the preceding sentence, a person accredited under
    paragraph (2) of section 374(g) of this title who is substantially
    not in compliance with the standards of accreditation under such
    section, or who poses a threat to public health or fails to act in
    a manner that is consistent with the purposes of such section,
    shall be considered to have violated a requirement of this chapter
    that relates to devices."
      2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).
      1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added
    par. (2). Former par. (2) redesignated (3).
      Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated
    par. (2) as (3) and substituted "paragraph (1) or (2)" for
    "paragraph (1)" in subpars. (A) and (C). Former par. (3)
    redesignated (4).
      Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated
    par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph
    (2)(A)". Former par. (4) redesignated (5).
      Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated
    par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)"
    wherever appearing.
      1994 - Subsec. (e). Pub. L. 103-322 amended directory language of
    Pub. L. 101-647. See 1990 Amendment note below.
      1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the
    amendment of this section by redesignating the second subsec. (e)
    and subsec. (f) as subsecs. (f) and (g), respectively, could only
    be executed by designating subsec. (f) as (g) because this section
    did not contain a second subsec. (e) subsequent to amendment of
    Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment
    notes for subsec. (e) under this section.
      1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows:
    "Notwithstanding subsection (a) of this section, any person who
    violates section 331(t) of this title because of an importation of
    a drug in violation of section 381(d)(1) of this title, because of
    a sale, purchase, or trade of a drug or drug sample or the offer to
    sell, purchase, or trade a drug or drug sample in violation of
    section 353(c) of this title, because of the sale, purchase, or
    trade of a coupon, the offer to sell, purchase, or trade such a
    coupon, or the counterfeiting of such a coupon in violation of
    section 353(c)(2) of this title, or the distribution of drugs in
    violation of section 353(e)(2)(A) of this title shall be imprisoned
    for not more than 10 years or fined not more than $250,000, or
    both."
      Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted
    "the institution of a criminal proceeding against, and conviction
    of," for "the arrest and conviction of".
      Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),
    substituted "before the institution of a criminal proceeding
    against" for "before the arrest of" and "the institution of a
    criminal proceeding against, and conviction of," for "the arrest
    and conviction of".
      Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted "the
    institution of a criminal proceeding against, and conviction of,"
    for "the arrest and conviction of".
      Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted
    "subsection (a)(1) of this section" for "subsection (a) of this
    section".
      Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted
    "subsection (a)(1) of this section" for "subsection (a) of this
    section" and struck out ", and no person shall be subject to the
    penalties of subsection (b) of this section for such a violation
    unless the violation is committed with the intent to defraud or
    mislead" after "advertising".
      1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L. 103-
    322, amended subsec. (e) generally. Prior to amendment, subsec.
    (e) read as follows:
      "(e)(1) Except as provided in paragraph (2), any person who
    distributes or possesses with the intent to distribute any anabolic
    steroid for any use in humans other than the treatment of disease
    pursuant to the order of a physician shall be imprisoned for not
    more than three years or fined under title 18, or both.
      "(2) Any person who distributes or possesses with the intent to
    distribute to an individual under 18 years of age, any anabolic
    steroid for any use in humans other than the treatment of disease
    pursuant to the order of a physician shall be imprisoned for not
    more than six years or fined under title 18, or both."
      Subsec. (f). Pub. L. 101-629 added subsec. (f).
      1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing
    subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),
    substituted "paragraph (1)" for "subsection (a)" in par. (2), and
    added subsec. (b).
      Subsec. (e). Pub. L. 100-690 added subsec. (e).
      1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).
      1970 - Subsec. (a). Pub. L. 91-513 struck out reference to
    subsec. (b) and transferred to subsec. (b) provisions covering
    second offenses and offenses committed with intent to defraud or
    mislead.
      Subsec. (b). Pub. L. 91-513 inserted provisions covering second
    offenses and offenses committed with intent to defraud or mislead
    formerly set out in subsec. (a) and struck out provisions covering
    violations involving depressant and stimulant drugs. See section
    801 et seq. of this title.
      1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision
    in the penalties prescribed for offenses involving depressant or
    stimulant drugs, set a fine of not to exceed $10,000 or
    imprisonment of not more than 5 years for offenses involving the
    unlawful manufacturing of, sale, or disposal of, or possession with
    intent to sell, a depressant or stimulant drug or involving
    counterfeit depressant or stimulant drugs, stiffened the penalties
    for unlawful sales or other disposals by persons over 18 to persons
    under 21, and set new penalties for possession of a depressant or
    stimulant drug for purposes other than sale or other disposal.
      1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso
    limiting the penalties for depressant or stimulant drug violations
    to two years imprisonment or $5,000 fine or both for first offense
    and to two years imprisonment or $15,000 fine or both for
    subsequent offenses.
      Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical
    exception provision.
      Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).
      1960 - Subsec. (c)(3). Pub. L. 86-618 substituted "a color
    additive" for "a coal-tar color", "the color additive" for "the
    coal-tar color" and "such color additive was" for "such color was".
      1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 330015 of Pub. L. 103-322 provided that the amendment
    made by that section is effective as of the date on which section
    1904 of Pub. L. 101-647, which amended this section, took effect.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 17(b) of Pub. L. 101-629 provided that:
      "(b) Effective Date of Application to Device User Facilities. - 
        "(1) The Secretary of Health and Human Services shall conduct a
      study to determine whether there has been substantial compliance
      with the requirements of section 519(b) of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user
      facilities (as defined in section 519(b)(5)(A) of such Act). The
      Secretary shall report the results of the study to the Congress
      after the expiration of 45 months after the date of the enactment
      of this Act [Nov. 28, 1990].
        "(2)(A) If upon the expiration of 48 months after the date of
      the enactment of this Act [Nov. 28, 1990] the Secretary has not
      made the report required by paragraph (1), section 303(f) of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added
      by the amendment made by subsection (a), shall take effect with
      respect to device user facilities (as defined in section
      519(b)(5)(A) of such Act). [Secretary of Health and Human
      Services had not made the report required by par. (1) on the
      expiration of 48 months after Nov. 28, 1990.]
        "(B) If in the report under paragraph (1) the Secretary reports
      that there has been substantial compliance with the requirements
      of such section 519(b) by a type of device user facility and if
      the Secretary does not make a determination under subparagraph
      (C) with respect to such type of facility, such section 303(f)
      shall not take effect with respect to such type of facility.
        "(C) If the Secretary determines in the report under paragraph
      (1) that there is not substantial compliance with the
      requirements of such section 519(b) by a type of device user
      facility or if the Secretary makes such a determination after
      making the report under paragraph (1), such section 303(f) shall
      take effect with respect to such type of facility upon the
      effective date of the report."

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-293 effective upon expiration of 90 days
    after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
    as a note under section 353 of this title.

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
    1976, see section 502(c) of Pub. L. 94-278, set out as a note under
    section 334 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-639 applicable only with respect to
    violations of this chapter committed after Oct. 24, 1968, see
    section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
    Amendments; Transitional Provisions note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
    of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                     EFFECTIVE DATE OF 1951 AMENDMENT                 
      Section 3 of act Oct. 26, 1951, provided that: "The provisions of
    this Act [amending this section and section 353 of this title]
    shall take effect six months after the date of its enactment [Oct.
    26, 1951]."

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                                ENFORCEMENT                            
      Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,
    provided that: "For the fines authorized to be imposed under
    section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    333], see section 3623 of title 18, United States Code, for the
    period ending October 31, 1986 [probably should be October 31,
    1987], and sections 3559 and 3571 of such title for the period
    beginning November 1, 1986 [probably should be November 1, 1987]."

-FOOTNOTE-
    (!1) So in original. Words "of this section" probably should not
         appear.


-End-



-CITE-
    21 USC Sec. 333a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 333a. Repealed.

-MISC1-
    Sec. 333a. Repealed. Pub. L. 101-647, title XIX, Sec. 1905, Nov.
      29, 1990, 104 Stat. 4853.
      Section, Pub. L. 100-690, title II, Sec. 2401, Nov. 18, 1988, 102
    Stat. 4230, related to forfeiture and illegal trafficking in
    steroids or human growth hormones.

-End-



-CITE-
    21 USC Sec. 334                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 334. Seizure

-STATUTE-
    (a) Grounds and jurisdiction
      (1) Any article of food, drug, or cosmetic that is adulterated or
    misbranded when introduced into or while in interstate commerce or
    while held for sale (whether or not the first sale) after shipment
    in interstate commerce, or which may not, under the provisions of
    section 344 or 355 of this title, be introduced into interstate
    commerce, shall be liable to be proceeded against while in
    interstate commerce, or at any time thereafter, on libel of
    information and condemned in any district court of the United
    States or United States court of a Territory within the
    jurisdiction of which the article is found. No libel for
    condemnation shall be instituted under this chapter, for any
    alleged misbranding if there is pending in any court a libel for
    condemnation proceeding under this chapter based upon the same
    alleged misbranding, and not more than one such proceeding shall be
    instituted if no such proceeding is so pending, except that such
    limitations shall not apply (A) when such misbranding has been the
    basis of a prior judgment in favor of the United States, in a
    criminal, injunction, or libel for condemnation proceeding under
    this chapter, or (B) when the Secretary has probable cause to
    believe from facts found, without hearing, by him or any officer or
    employee of the Department that the misbranded article is dangerous
    to health, or that the labeling of the misbranded article is
    fraudulent, or would be in a material respect misleading to the
    injury or damage of the purchaser or consumer. In any case where
    the number of libel for condemnation proceedings is limited as
    above provided the proceeding pending or instituted shall, on
    application of the claimant, seasonably made, be removed for trial
    to any district agreed upon by stipulation between the parties, or,
    in case of failure to so stipulate within a reasonable time, the
    claimant may apply to the court of the district in which the
    seizure has been made, and such court (after giving the United
    States attorney for such district reasonable notice and opportunity
    to be heard) shall by order, unless good cause to the contrary is
    shown, specify a district of reasonable proximity to the claimant's
    principal place of business, to which the case shall be removed for
    trial.
      (2) The following shall be liable to be proceeded against at any
    time on libel of information and condemned in any district court of
    the United States or United States court of a Territory within the
    jurisdiction of which they are found: (A) Any drug that is a
    counterfeit drug, (B) Any container of a counterfeit drug, (C) Any
    punch, die, plate, stone, labeling, container, or other thing used
    or designed for use in making a counterfeit drug or drugs, and (D)
    Any adulterated or misbranded device.
      (3)(A) Except as provided in subparagraph (B), no libel for
    condemnation may be instituted under paragraph (1) or (2) against
    any food which - 
        (i) is misbranded under section 343(a)(2) of this title because
      of its advertising, and
        (ii) is being held for sale to the ultimate consumer in an
      establishment other than an establishment owned or operated by a
      manufacturer, packer, or distributor of the food.

      (B) A libel for condemnation may be instituted under paragraph
    (1) or (2) against a food described in subparagraph (A) if - 
        (i)(I) the food's advertising which resulted in the food being
      misbranded under section 343(a)(2) of this title was disseminated
      in the establishment in which the food is being held for sale to
      the ultimate consumer,
        (II) such advertising was disseminated by, or under the
      direction of, the owner or operator of such establishment, or
        (III) all or part of the cost of such advertising was paid by
      such owner or operator; and
        (ii) the owner or operator of such establishment used such
      advertising in the establishment to promote the sale of the food.
    (b) Procedure; multiplicity of pending proceedings
      The article, equipment, or other thing proceeded against shall be
    liable to seizure by process pursuant to the libel, and the
    procedure in cases under this section shall conform, as nearly as
    may be, to the procedure in admiralty; except that on demand of
    either party any issue of fact joined in any such case shall be
    tried by jury. When libel for condemnation proceedings under this
    section, involving the same claimant and the same issues of
    adulteration or misbranding, are pending in two or more
    jurisdictions, such pending proceedings, upon application of the
    claimant seasonably made to the court of one such jurisdiction,
    shall be consolidated for trial by order of such court, and tried
    in (1) any district selected by the claimant where one of such
    proceedings is pending; or (2) a district agreed upon by
    stipulation between the parties. If no order for consolidation is
    so made within a reasonable time, the claimant may apply to the
    court of one such jurisdiction and such court (after giving the
    United States attorney for such district reasonable notice and
    opportunity to be heard) shall by order, unless good cause to the
    contrary is shown, specify a district of reasonable proximity to
    the claimant's principal place of business, in which all such
    pending proceedings shall be consolidated for trial and tried. Such
    order of consolidation shall not apply so as to require the removal
    of any case the date for trial of which has been fixed. The court
    granting such order shall give prompt notification thereof to the
    other courts having jurisdiction of the cases covered thereby.
    (c) Availability of samples of seized goods prior to trial
      The court at any time after seizure up to a reasonable time
    before trial shall by order allow any party to a condemnation
    proceeding, his attorney or agent, to obtain a representative
    sample of the article seized and a true copy of the analysis, if
    any, on which the proceeding is based and the identifying marks or
    numbers, if any, of the packages from which the samples analyzed
    were obtained.
    (d) Disposition of goods after decree of condemnation; claims for
      remission or mitigation of forfeitures
      (1) Any food, drug, device, or cosmetic condemned under this
    section shall, after entry of the decree, be disposed of by
    destruction or sale as the court may, in accordance with the
    provisions of this section, direct and the proceeds thereof, if
    sold, less the legal costs and charges, shall be paid into the
    Treasury of the United States; but such article shall not be sold
    under such decree contrary to the provisions of this chapter or the
    laws of the jurisdiction in which sold. After entry of the decree
    and upon the payment of the costs of such proceedings and the
    execution of a good and sufficient bond conditioned that such
    article shall not be sold or disposed of contrary to the provisions
    of this chapter or the laws of any State or Territory in which
    sold, the court may by order direct that such article be delivered
    to the owner thereof to be destroyed or brought into compliance
    with the provisions of this chapter, under the supervision of an
    officer or employee duly designated by the Secretary, and the
    expenses of such supervision shall be paid by the person obtaining
    release of the article under bond. If the article was imported into
    the United States and the person seeking its release establishes
    (A) that the adulteration, misbranding, or violation did not occur
    after the article was imported, and (B) that he had no cause for
    believing that it was adulterated, misbranded, or in violation
    before it was released from customs custody, the court may permit
    the article to be delivered to the owner for exportation in lieu of
    destruction upon a showing by the owner that all of the conditions
    of section 381(e) of this title can and will be met. The provisions
    of this sentence shall not apply where condemnation is based upon
    violation of section 342(a)(1), (2), or (6), section 351(a)(3),
    section 352(j), or section 361(a) or (d) of this title. Where such
    exportation is made to the original foreign supplier, then
    subparagraphs (A) and (B) of section 381(e)(1) of this title and
    the preceding sentence shall not be applicable; and in all cases of
    exportation the bond shall be conditioned that the article shall
    not be sold or disposed of until the applicable conditions of
    section 381(e) of this title have been met. Any person seeking to
    export an imported article pursuant to any of the provisions of
    this subsection shall establish that the article was intended for
    export at the time the article entered commerce. Any article
    condemned by reason of its being an article which may not, under
    section 344 or 355 of this title, be introduced into interstate
    commerce, shall be disposed of by destruction.
      (2) The provisions of paragraph (1) of this subsection shall, to
    the extent deemed appropriate by the court, apply to any equipment
    or other thing which is not otherwise within the scope of such
    paragraph and which is referred to in paragraph (2) of subsection
    (a) of this section.
      (3) Whenever in any proceeding under this section, involving
    paragraph (2) of subsection (a) of this section, the condemnation
    of any equipment or thing (other than a drug) is decreed, the court
    shall allow the claim of any claimant, to the extent of such
    claimant's interest, for remission or mitigation of such forfeiture
    if such claimant proves to the satisfaction of the court (i) that
    he has not committed or caused to be committed any prohibited act
    referred to in such paragraph (2) and has no interest in any drug
    referred to therein, (ii) that he has an interest in such equipment
    or other thing as owner or lienor or otherwise, acquired by him in
    good faith, and (iii) that he at no time had any knowledge or
    reason to believe that such equipment or other thing was being or
    would be used in, or to facilitate, the violation of laws of the
    United States relating to counterfeit drugs.
    (e) Costs
      When a decree of condemnation is entered against the article,
    court costs and fees, and storage and other proper expenses, shall
    be awarded against the person, if any, intervening as claimant of
    the article.
    (f) Removal of case for trial
      In the case of removal for trial of any case as provided by
    subsection (a) or (b) of this section - 
        (1) The clerk of the court from which removal is made shall
      promptly transmit to the court in which the case is to be tried
      all records in the case necessary in order that such court may
      exercise jurisdiction.
        (2) The court to which such case was removed shall have the
      powers and be subject to the duties, for purposes of such case,
      which the court from which removal was made would have had, or to
      which such court would have been subject, if such case had not
      been removed.
    (g) Administrative restraint; detention orders
      (1) If during an inspection conducted under section 374 of this
    title of a facility or a vehicle, a device which the officer or
    employee making the inspection has reason to believe is adulterated
    or misbranded is found in such facility or vehicle, such officer or
    employee may order the device detained (in accordance with
    regulations prescribed by the Secretary) for a reasonable period
    which may not exceed twenty days unless the Secretary determines
    that a period of detention greater than twenty days is required to
    institute an action under subsection (a) of this section or section
    332 of this title, in which case he may authorize a detention
    period of not to exceed thirty days. Regulations of the Secretary
    prescribed under this paragraph shall require that before a device
    may be ordered detained under this paragraph the Secretary or an
    officer or employee designated by the Secretary approve such order.
    A detention order under this paragraph may require the labeling or
    marking of a device during the period of its detention for the
    purpose of identifying the device as detained. Any person who would
    be entitled to claim a device if it were seized under subsection
    (a) of this section may appeal to the Secretary a detention of such
    device under this paragraph. Within five days of the date an appeal
    of a detention is filed with the Secretary, the Secretary shall
    after affording opportunity for an informal hearing by order
    confirm the detention or revoke it.
      (2)(A) Except as authorized by subparagraph (B), a device subject
    to a detention order issued under paragraph (1) shall not be moved
    by any person from the place at which it is ordered detained until -
     
        (i) released by the Secretary, or
        (ii) the expiration of the detention period applicable to such
      order,

    whichever occurs first.
      (B) A device subject to a detention order under paragraph (1) may
    be moved - 
        (i) in accordance with regulations prescribed by the Secretary,
      and
        (ii) if not in final form for shipment, at the discretion of
      the manufacturer of the device for the purpose of completing the
      work required to put it in such form.
    (h) Administrative detention of foods
      (1) Detention authority
        (A) In general
          An officer or qualified employee of the Food and Drug
        Administration may order the detention, in accordance with this
        subsection, of any article of food that is found during an
        inspection, examination, or investigation under this chapter
        conducted by such officer or qualified employee, if the officer
        or qualified employee has credible evidence or information
        indicating that such article presents a threat of serious
        adverse health consequences or death to humans or animals.
        (B) Secretary's approval
          An article of food may be ordered detained under subparagraph
        (A) only if the Secretary or an official designated by the
        Secretary approves the order. An official may not be so
        designated unless the official is the director of the district
        under this chapter in which the article involved is located, or
        is an official senior to such director.
      (2) Period of detention
        An article of food may be detained under paragraph (1) for a
      reasonable period, not to exceed 20 days, unless a greater
      period, not to exceed 30 days, is necessary, to enable the
      Secretary to institute an action under subsection (a) of this
      section or section 332 of this title. The Secretary shall by
      regulation provide for procedures for instituting such action on
      an expedited basis with respect to perishable foods.
      (3) Security of detained article
        An order under paragraph (1) with respect to an article of food
      may require that such article be labeled or marked as detained,
      and shall require that the article be removed to a secure
      facility, as appropriate. An article subject to such an order
      shall not be transferred by any person from the place at which
      the article is ordered detained, or from the place to which the
      article is so removed, as the case may be, until released by the
      Secretary or until the expiration of the detention period
      applicable under such order, whichever occurs first. This
      subsection may not be construed as authorizing the delivery of
      the article pursuant to the execution of a bond while the article
      is subject to the order, and section 381(b) of this title does
      not authorize the delivery of the article pursuant to the
      execution of a bond while the article is subject to the order.
      (4) Appeal of detention order
        (A) In general
          With respect to an article of food ordered detained under
        paragraph (1), any person who would be entitled to be a
        claimant for such article if the article were seized under
        subsection (a) of this section may appeal the order to the
        Secretary. Within five days after such an appeal is filed, the
        Secretary, after providing opportunity for an informal hearing,
        shall confirm or terminate the order involved, and such
        confirmation by the Secretary shall be considered a final
        agency action for purposes of section 702 of title 5. If during
        such five-day period the Secretary fails to provide such an
        opportunity, or to confirm or terminate such order, the order
        is deemed to be terminated.
        (B) Effect of instituting court action
          The process under subparagraph (A) for the appeal of an order
        under paragraph (1) terminates if the Secretary institutes an
        action under subsection (a) of this section or section 332 of
        this title regarding the article of food involved.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 304, 52 Stat. 1044; June 24, 1948,
    ch. 613, Sec. 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, Sec. 3, 67
    Stat. 477; Pub. L. 85-250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89-
    74, Sec. 6, July 15, 1965, 79 Stat. 232; Pub. L. 90-639, Sec.
    4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91-513, title II, Sec.
    701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94-278,
    title V, Sec. 502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-
    295, Secs. 3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L.
    102-300, Sec. 6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
    Sec. 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105-115, title IV,
    Sec. 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107-188, title
    III, Sec. 303(a), June 12, 2002, 116 Stat. 663.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (h). Pub. L. 107-188 added subsec. (h).
      1997 - Subsec. (d)(1). Pub. L. 105-115 substituted "subparagraphs
    (A) and (B) of section 381(e)(1) of this title" for "paragraphs (1)
    and (2) of section 381(e) of this title" and inserted "Any person
    seeking to export an imported article pursuant to any of the
    provisions of this subsection shall establish that the article was
    intended for export at the time the article entered commerce."
    before "Any article condemned by reason".
      1993 - Subsec. (a)(1). Pub. L. 103-80, Sec. 3(f)(1), substituted
    "found. No libel" for "found: Provided, however, That no libel".
      Subsec. (d)(1). Pub. L. 103-80, Sec. 3(f)(2), substituted "sold.
    After entry" for "sold: Provided, That after entry", "met. The
    provisions of this sentence" for "met: Provided, however, That the
    provisions of this sentence", "title. Where such exportation" for
    "title: And provided further, That where such exportation", and
    "the preceding sentence shall not be applicable" for "the foregoing
    proviso shall not be applicable".
      1992 - Subsec. (d)(1). Pub. L. 102-300 substituted "381(e)" for
    "381(d)" in three places and "paragraphs" for "clauses" before "(1)
    and (2) of section 381(e)".
      1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 3(c)(1), struck out
    "device," after "Any article of food, drug,".
      Subsec. (a)(2). Pub. L. 94-295, Sec. 3(c)(2), (3), added cl. (D)
    covering adulterated or misbranded devices.
      Subsec. (a)(3). Pub. L. 94-278 added par. (3).
      Subsec. (g). Pub. L. 94-295, Sec. 7(a), added subsec. (g).
      1970 - Subsec. (a)(2). Pub. L. 91-513, Sec. 701(c), struck out
    cls. (A) and (D) which dealt with depressant or stimulant drugs,
    struck out reference to depressant or stimulant drugs in cl. (C),
    and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C),
    respectively.
      Subsec. (d)(3)(iii). Pub. L. 91-513, Sec. 701(d), struck out
    reference to depressant or stimulant drugs.
      1968 - Subsec. (a). Pub. L. 90-639 inserted references to the
    United States courts of Territories.
      1965 - Subsec. (a). Pub. L. 89-74, Sec. 6(a), designated existing
    provisions as par. (1), redesignated cls. (1) and (2) of proviso as
    (A) and (B), and added par. (2).
      Subsec. (b). Pub. L. 89-74, Sec. 6(b)(1), inserted "equipment, or
    other thing proceeded against" after "article" in first sentence.
      Subsec. (d). Pub. L. 89-74, Sec. 6(b)(2), designated existing
    provisions as par. (1), redesignated cls. (1) and (2) of the second
    sentence thereof as (A) and (B), and added pars. (2) and (3).
      1957 - Subsec. (d). Pub. L. 85-250 permitted, under certain
    circumstances, reexportation of articles condemned at places other
    than original port of entry.
      1953 - Subsec. (c). Act Aug. 7, 1953, provided that a true copy
    of the analysis in any case shall be furnished the owner.
      1948 - Subsec. (a). Act June 24, 1948, inserted "or while held
    for sale (whether or not the first sale) after shipment in
    interstate commerce" to make this subsection coextensive with
    section 331(k) of this title.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Section 502(c) of Pub. L. 94-278 provided that: "The amendments
    made by subsection (a) [amending this section and sections 321,
    333, and 343 of this title] shall take effect 180 days after the
    date of the enactment of this Act [Apr. 22, 1976]."

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-639 applicable only with respect to
    violations of this chapter committed after Oct. 24, 1968, see
    section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
    Amendments; Transitional Provisions note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
    of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for any violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 335                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335. Hearing before report of criminal violation

-STATUTE-
      Before any violation of this chapter is reported by the Secretary
    to any United States attorney for institution of a criminal
    proceeding, the person against whom such proceeding is contemplated
    shall be given appropriate notice and an opportunity to present his
    views, either orally or in writing, with regard to such
    contemplated proceeding.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 305, 52 Stat. 1045.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 335a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335a. Debarment, temporary denial of approval, and suspension

-STATUTE-
    (a) Mandatory debarment; certain drug applications
      (1) Corporations, partnerships, and associations
        If the Secretary finds that a person other than an individual
      has been convicted, after May 13, 1992, of a felony under Federal
      law for conduct relating to the development or approval,
      including the process for development or approval, of any
      abbreviated drug application, the Secretary shall debar such
      person from submitting, or assisting in the submission of, any
      such application.
      (2) Individuals
        If the Secretary finds that an individual has been convicted of
      a felony under Federal law for conduct - 
          (A) relating to the development or approval, including the
        process for development or approval, of any drug product, or
          (B) otherwise relating to the regulation of any drug product
        under this chapter,

      the Secretary shall debar such individual from providing services
      in any capacity to a person that has an approved or pending drug
      product application.
    (b) Permissive debarment; certain drug applications; food imports
      (1) In general
        The Secretary, on the Secretary's own initiative or in response
      to a petition, may, in accordance with paragraph (2), debar - 
          (A) a person other than an individual from submitting or
        assisting in the submission of any abbreviated drug
        application,
          (B) an individual from providing services in any capacity to
        a person that has an approved or pending drug product
        application, or
          (C) a person from importing an article of food or offering
        such an article for import into the United States.
      (2) Persons subject to permissive debarment; certain drug
        applications
        The following persons are subject to debarment under
      subparagraph (A) or (B) of paragraph (1):
        (A) Corporations, partnerships, and associations
          Any person other than an individual that the Secretary finds
        has been convicted - 
            (i) for conduct that - 
              (I) relates to the development or approval, including the
            process for the development or approval, of any abbreviated
            drug application; and
              (II) is a felony under Federal law (if the person was
            convicted before May 13, 1992), a misdemeanor under Federal
            law, or a felony under State law, or

            (ii) of a conspiracy to commit, or aiding or abetting, a
          criminal offense described in clause (i) or a felony
          described in subsection (a)(1) of this section,

        if the Secretary finds that the type of conduct which served as
        the basis for such conviction undermines the process for the
        regulation of drugs.
        (B) Individuals
          (i) Any individual whom the Secretary finds has been
        convicted of - 
            (I) a misdemeanor under Federal law or a felony under State
          law for conduct relating to the development or approval,
          including the process for development or approval, of any
          drug product or otherwise relating to the regulation of drug
          products under this chapter, or
            (II) a conspiracy to commit, or aiding or abetting, such
          criminal offense or a felony described in subsection (a)(2)
          of this section,

        if the Secretary finds that the type of conduct which served as
        the basis for such conviction undermines the process for the
        regulation of drugs.
          (ii) Any individual whom the Secretary finds has been
        convicted of - 
            (I) a felony which is not described in subsection (a)(2) of
          this section or clause (i) of this subparagraph and which
          involves bribery, payment of illegal gratuities, fraud,
          perjury, false statement, racketeering, blackmail, extortion,
          falsification or destruction of records, or interference
          with, obstruction of an investigation into, or prosecution
          of, any criminal offense, or
            (II) a conspiracy to commit, or aiding or abetting, such
          felony,

        if the Secretary finds, on the basis of the conviction of such
        individual and other information, that such individual has
        demonstrated a pattern of conduct sufficient to find that there
        is reason to believe that such individual may violate
        requirements under this chapter relating to drug products.
          (iii) Any individual whom the Secretary finds materially
        participated in acts that were the basis for a conviction for
        an offense described in subsection (a) of this section or in
        clause (i) or (ii) for which a conviction was obtained, if the
        Secretary finds, on the basis of such participation and other
        information, that such individual has demonstrated a pattern of
        conduct sufficient to find that there is reason to believe that
        such individual may violate requirements under this chapter
        relating to drug products.
          (iv) Any high managerial agent whom the Secretary finds - 
            (I) worked for, or worked as a consultant for, the same
          person as another individual during the period in which such
          other individual took actions for which a felony conviction
          was obtained and which resulted in the debarment under
          subsection (a)(2) of this section, or clause (i), of such
          other individual,
            (II) had actual knowledge of the actions described in
          subclause (I) of such other individual, or took action to
          avoid such actual knowledge, or failed to take action for the
          purpose of avoiding such actual knowledge,
            (III) knew that the actions described in subclause (I) were
          violative of law, and
            (IV) did not report such actions, or did not cause such
          actions to be reported, to an officer, employee, or agent of
          the Department or to an appropriate law enforcement officer,
          or failed to take other appropriate action that would have
          ensured that the process for the regulation of drugs was not
          undermined, within a reasonable time after such agent first
          knew of such actions,

        if the Secretary finds that the type of conduct which served as
        the basis for such other individual's conviction undermines the
        process for the regulation of drugs.
      (3) Persons subject to permissive debarment; food importation
        A person is subject to debarment under paragraph (1)(C) if - 
          (A) the person has been convicted of a felony for conduct
        relating to the importation into the United States of any food;
        or
          (B) the person has engaged in a pattern of importing or
        offering for import adulterated food that presents a threat of
        serious adverse health consequences or death to humans or
        animals.
      (4) Stay of certain orders
        An order of the Secretary under clause (iii) or (iv) of
      paragraph (2)(B) shall not take effect until 30 days after the
      order has been issued.
    (c) Debarment period and considerations
      (1) Effect of debarment
        The Secretary - 
          (A) shall not accept or review (other than in connection with
        an audit under this section) any abbreviated drug application
        submitted by or with the assistance of a person debarred under
        subsection (a)(1) or (b)(2)(A) of this section during the
        period such person is debarred,
          (B) shall, during the period of a debarment under subsection
        (a)(2) or (b)(2)(B) of this section, debar an individual from
        providing services in any capacity to a person that has an
        approved or pending drug product application and shall not
        accept or review (other than in connection with an audit under
        this section) an abbreviated drug application from such
        individual, and
          (C) shall, if the Secretary makes the finding described in
        paragraph (6) or (7) of section 335b(a) of this title, assess a
        civil penalty in accordance with section 335b of this title.
      (2) Debarment periods
        (A) In general
          The Secretary shall debar a person under subsection (a) or
        (b) of this section for the following periods:
            (i) The period of debarment of a person (other than an
          individual) under subsection (a)(1) of this section shall not
          be less than 1 year or more than 10 years, but if an act
          leading to a subsequent debarment under subsection (a) of
          this section occurs within 10 years after such person has
          been debarred under subsection (a)(1) of this section, the
          period of debarment shall be permanent.
            (ii) The debarment of an individual under subsection (a)(2)
          of this section shall be permanent.
            (iii) The period of debarment of any person under paragraph
          (2) or (3) of subsection (b) of this section shall not be
          more than 5 years.

        The Secretary may determine whether debarment periods shall run
        concurrently or consecutively in the case of a person debarred
        for multiple offenses.
        (B) Notification
          Upon a conviction for an offense described in subsection (a)
        or (b) of this section or upon execution of an agreement with
        the United States to plead guilty to such an offense, the
        person involved may notify the Secretary that the person
        acquiesces to debarment and such person's debarment shall
        commence upon such notification.
      (3) Considerations
        In determining the appropriateness and the period of a
      debarment of a person under subsection (b) of this section and
      any period of debarment beyond the minimum specified in
      subparagraph (A)(i) of paragraph (2), the Secretary shall
      consider where applicable - 
          (A) the nature and seriousness of any offense involved,
          (B) the nature and extent of management participation in any
        offense involved, whether corporate policies and practices
        encouraged the offense, including whether inadequate
        institutional controls contributed to the offense,
          (C) the nature and extent of voluntary steps to mitigate the
        impact on the public of any offense involved, including the
        recall or the discontinuation of the distribution of suspect
        drugs, full cooperation with any investigations (including the
        extent of disclosure to appropriate authorities of all
        wrongdoing), the relinquishing of profits on drug approvals
        fraudulently obtained, and any other actions taken to
        substantially limit potential or actual adverse effects on the
        public health,
          (D) whether the extent to which changes in ownership,
        management, or operations have corrected the causes of any
        offense involved and provide reasonable assurances that the
        offense will not occur in the future,
          (E) whether the person to be debarred is able to present
        adequate evidence that current production of drugs subject to
        abbreviated drug applications and all pending abbreviated drug
        applications are free of fraud or material false statements,
        and
          (F) prior convictions under this chapter or under other Acts
        involving matters within the jurisdiction of the Food and Drug
        Administration.
    (d) Termination of debarment
      (1) Application
        Any person that is debarred under subsection (a) of this
      section (other than a person permanently debarred) or any person
      that is debarred under subsection (b) of this section may apply
      to the Secretary for termination of the debarment under this
      subsection. Any information submitted to the Secretary under this
      paragraph does not constitute an amendment or supplement to
      pending or approved abbreviated drug applications.
      (2) Deadline
        The Secretary shall grant or deny any application respecting a
      debarment which is submitted under paragraph (1) within 180 days
      of the date the application is submitted.
      (3) Action by the Secretary
        (A) Corporations
          (i) Conviction reversal
            If the conviction which served as the basis for the
          debarment of a person under subsection (a)(1) of this section
          or paragraph (2)(A) or (3) of subsection (b) of this section
          is reversed, the Secretary shall withdraw the order of
          debarment.
          (ii) Application
            Upon application submitted under paragraph (1), the
          Secretary shall terminate the debarment of a person if the
          Secretary finds that - 
              (I) changes in ownership, management, or operations have
            fully corrected the causes of the offense involved and
            provide reasonable assurances that the offense will not
            occur in the future, and
              (II) in applicable cases, sufficient audits, conducted by
            the Food and Drug Administration or by independent experts
            acceptable to the Food and Drug Administration, demonstrate
            that pending applications and the development of drugs
            being tested before the submission of an application are
            free of fraud or material false statements.

          In the case of persons debarred under subsection (a)(1) of
          this section, such termination shall take effect no earlier
          than the expiration of one year from the date of the
          debarment.
        (B) Individuals
          (i) Conviction reversal
            If the conviction which served as the basis for the
          debarment of an individual under subsection (a)(2) of this
          section or clause (i), (ii), (iii), or (iv) of subsection
          (b)(2)(B) or subsection (b)(3) of this section is reversed,
          the Secretary shall withdraw the order of debarment.
          (ii) Application
            Upon application submitted under paragraph (1), the
          Secretary shall terminate the debarment of an individual who
          has been debarred under subsection (b)(2)(B) or subsection
          (b)(3) of this section if such termination serves the
          interests of justice and adequately protects the integrity of
          the drug approval process or the food importation process, as
          the case may be.
      (4) Special termination
        (A) Application
          Any person that is debarred under subsection (a)(1) of this
        section (other than a person permanently debarred under
        subsection (c)(2)(A)(i) of this section) or any individual who
        is debarred under subsection (a)(2) of this section may apply
        to the Secretary for special termination of debarment under
        this subsection. Any information submitted to the Secretary
        under this subparagraph does not constitute an amendment or
        supplement to pending or approved abbreviated drug
        applications.
        (B) Corporations
          Upon an application submitted under subparagraph (A), the
        Secretary may take the action described in subparagraph (D) if
        the Secretary, after an informal hearing, finds that - 
            (i) the person making the application under subparagraph
          (A) has demonstrated that the felony conviction which was the
          basis for such person's debarment involved the commission of
          an offense which was not authorized, requested, commanded,
          performed, or recklessly tolerated by the board of directors
          or by a high managerial agent acting on behalf of the person
          within the scope of the board's or agent's office or
          employment,
            (ii) all individuals who were involved in the commission of
          the offense or who knew or should have known of the offense
          have been removed from employment involving the development
          or approval of any drug subject to sections (!1) 355 of this
          title,

            (iii) the person fully cooperated with all investigations
          and promptly disclosed all wrongdoing to the appropriate
          authorities, and
            (iv) the person acted to mitigate any impact on the public
          of any offense involved, including the recall, or the
          discontinuation of the distribution, of any drug with respect
          to which the Secretary requested a recall or discontinuation
          of distribution due to concerns about the safety or efficacy
          of the drug.
        (C) Individuals
          Upon an application submitted under subparagraph (A), the
        Secretary may take the action described in subparagraph (D) if
        the Secretary, after an informal hearing, finds that such
        individual has provided substantial assistance in the
        investigations or prosecutions of offenses which are described
        in subsection (a) or (b) of this section or which relate to any
        matter under the jurisdiction of the Food and Drug
        Administration.
        (D) Secretarial action
          The action referred to in subparagraphs (B) and (C) is - 
            (i) in the case of a person other than an individual - 
              (I) terminating the debarment immediately, or
              (II) limiting the period of debarment to less than one
            year, and

            (ii) in the case of an individual, limiting the period of
          debarment to less than permanent but to no less than 1 year,

        whichever best serves the interest of justice and protects the
        integrity of the drug approval process.
    (e) Publication and list of debarred persons
      The Secretary shall publish in the Federal Register the name of
    any person debarred under subsection (a) or (b) of this section,
    the effective date of the debarment, and the period of the
    debarment. The Secretary shall also maintain and make available to
    the public a list, updated no less often than quarterly, of such
    persons, of the effective dates and minimum periods of such
    debarments, and of the termination of debarments.
    (f) Temporary denial of approval
      (1) In general
        The Secretary, on the Secretary's own initiative or in response
      to a petition, may, in accordance with paragraph (3), refuse by
      order, for the period prescribed by paragraph (2), to approve any
      abbreviated drug application submitted by any person - 
          (A) if such person is under an active Federal criminal
        investigation in connection with an action described in
        subparagraph (B),
          (B) if the Secretary finds that such person - 
            (i) has bribed or attempted to bribe, has paid or attempted
          to pay an illegal gratuity, or has induced or attempted to
          induce another person to bribe or pay an illegal gratuity to
          any officer, employee, or agent of the Department of Health
          and Human Services or to any other Federal, State, or local
          official in connection with any abbreviated drug application,
          or has conspired to commit, or aided or abetted, such
          actions, or
            (ii) has knowingly made or caused to be made a pattern or
          practice of false statements or misrepresentations with
          respect to material facts relating to any abbreviated drug
          application, or the production of any drug subject to an
          abbreviated drug application, to any officer, employee, or
          agent of the Department of Health and Human Services, or has
          conspired to commit, or aided or abetted, such actions, and

          (C) if a significant question has been raised regarding - 
            (i) the integrity of the approval process with respect to
          such abbreviated drug application, or
            (ii) the reliability of data in or concerning such person's
          abbreviated drug application.

      Such an order may be modified or terminated at any time.
      (2) Applicable period
        (A) In general
          Except as provided in subparagraph (B), a denial of approval
        of an application of a person under paragraph (1) shall be in
        effect for a period determined by the Secretary but not to
        exceed 18 months beginning on the date the Secretary finds that
        the conditions described in subparagraphs (A), (B), and (C) of
        paragraph (1) exist. The Secretary shall terminate such denial -
         
            (i) if the investigation with respect to which the finding
          was made does not result in a criminal charge against such
          person, if criminal charges have been brought and the charges
          have been dismissed, or if a judgment of acquittal has been
          entered, or
            (ii) if the Secretary determines that such finding was in
          error.
        (B) Extension
          If, at the end of the period described in subparagraph (A),
        the Secretary determines that a person has been criminally
        charged for an action described in subparagraph (B) of
        paragraph (1), the Secretary may extend the period of denial of
        approval of an application for a period not to exceed 18
        months. The Secretary shall terminate such extension if the
        charges have been dismissed, if a judgment of acquittal has
        been entered, or if the Secretary determines that the finding
        described in subparagraph (A) was in error.
      (3) Informal hearing
        Within 10 days of the date an order is issued under paragraph
      (1), the Secretary shall provide such person with an opportunity
      for an informal hearing, to be held within such 10 days, on the
      decision of the Secretary to refuse approval of an abbreviated
      drug application. Within 60 days of the date on which such
      hearing is held, the Secretary shall notify the person given such
      hearing whether the Secretary's refusal of approval will be
      continued, terminated, or otherwise modified. Such notification
      shall be final agency action.
    (g) Suspension authority
      (1) In general
        If - 
          (A) the Secretary finds - 
            (i) that a person has engaged in conduct described in
          subparagraph (B) of subsection (f)(1) of this section in
          connection with 2 or more drugs under abbreviated drug
          applications, or
            (ii) that a person has engaged in flagrant and repeated,
          material violations of good manufacturing practice or good
          laboratory practice in connection with the development,
          manufacturing, or distribution of one or more drugs approved
          under an abbreviated drug application during a 2-year period,
          and - 
              (I) such violations may undermine the safety and efficacy
            of such drugs, and
              (II) the causes of such violations have not been
            corrected within a reasonable period of time following
            notice of such violations by the Secretary, and

          (B) such person is under an active investigation by a Federal
        authority in connection with a civil or criminal action
        involving conduct described in subparagraph (A),

      the Secretary shall issue an order suspending the distribution of
      all drugs the development or approval of which was related to
      such conduct described in subparagraph (A) or suspending the
      distribution of all drugs approved under abbreviated drug
      applications of such person if the Secretary finds that such
      conduct may have affected the development or approval of a
      significant number of drugs which the Secretary is unable to
      identify. The Secretary shall exclude a drug from such order if
      the Secretary determines that such conduct was not likely to have
      influenced the safety or efficacy of such drug.
      (2) Public health waiver
        The Secretary shall, on the Secretary's own initiative or in
      response to a petition, waive the suspension under paragraph (1)
      (involving an action described in paragraph (1)(A)(i)) with
      respect to any drug if the Secretary finds that such waiver is
      necessary to protect the public health because sufficient
      quantities of the drug would not otherwise be available. The
      Secretary shall act on any petition seeking action under this
      paragraph within 180 days of the date the petition is submitted
      to the Secretary.
    (h) Termination of suspension
      The Secretary shall withdraw an order of suspension of the
    distribution of a drug under subsection (g) of this section if the
    person with respect to whom the order was issued demonstrates in a
    petition to the Secretary - 
        (1)(A) on the basis of an audit by the Food and Drug
      Administration or by experts acceptable to the Food and Drug
      Administration, or on the basis of other information, that the
      development, approval, manufacturing, and distribution of such
      drug is in substantial compliance with the applicable
      requirements of this chapter, and
        (B) changes in ownership, management, or operations - 
          (i) fully remedy the patterns or practices with respect to
        which the order was issued, and
          (ii) provide reasonable assurances that such actions will not
        occur in the future, or

        (2) the initial determination was in error.

    The Secretary shall act on a submission of a petition under this
    subsection within 180 days of the date of its submission and the
    Secretary may consider the petition concurrently with the
    suspension proceeding. Any information submitted to the Secretary
    under this subsection does not constitute an amendment or
    supplement to a pending or approved abbreviated drug application.
    (i) Procedure
      The Secretary may not take any action under subsection (a), (b),
    (c), (d)(3), (g), or (h) of this section with respect to any person
    unless the Secretary has issued an order for such action made on
    the record after opportunity for an agency hearing on disputed
    issues of material fact. In the course of any investigation or
    hearing under this subsection, the Secretary may administer oaths
    and affirmations, examine witnesses, receive evidence, and issue
    subpoenas requiring the attendance and testimony of witnesses and
    the production of evidence that relates to the matter under
    investigation.
    (j) Judicial review
      (1) In general
        Except as provided in paragraph (2), any person that is the
      subject of an adverse decision under subsection (a), (b), (c),
      (d), (f), (g), or (h) of this section may obtain a review of such
      decision by the United States Court of Appeals for the District
      of Columbia or for the circuit in which the person resides, by
      filing in such court (within 60 days following the date the
      person is notified of the Secretary's decision) a petition
      requesting that the decision be modified or set aside.
      (2) Exception
        Any person that is the subject of an adverse decision under
      clause (iii) or (iv) of subsection (b)(2)(B) of this section may
      obtain a review of such decision by the United States District
      Court for the District of Columbia or a district court of the
      United States for the district in which the person resides, by
      filing in such court (within 30 days following the date the
      person is notified of the Secretary's decision) a complaint
      requesting that the decision be modified or set aside. In such an
      action, the court shall determine the matter de novo.
    (k) Certification
      Any application for approval of a drug product shall include - 
        (1) a certification that the applicant did not and will not use
      in any capacity the services of any person debarred under
      subsection (a) or (b) of this section, in connection with such
      application, and
        (2) if such application is an abbreviated drug application, a
      list of all convictions, described in subsections (a) and (b) of
      this section which occurred within the previous 5 years, of the
      applicant and affiliated persons responsible for the development
      or submission of such application.
    (l) Applicability
      (1) Conviction
        For purposes of this section, a person is considered to have
      been convicted of a criminal offense - 
          (A) when a judgment of conviction has been entered against
        the person by a Federal or State court, regardless of whether
        there is an appeal pending,
          (B) when a plea of guilty or nolo contendere by the person
        has been accepted by a Federal or State court, or
          (C) when the person has entered into participation in a first
        offender, deferred adjudication, or other similar arrangement
        or program where judgment of conviction has been withheld.
      (2) Effective dates
        Subsection (a) of this section, subparagraph (A) of subsection
      (b)(2) of this section, clauses (i) and (ii) of subsection
      (b)(2)(B) of this section, and subsection (b)(3)(A) of this
      section shall not apply to a conviction which occurred more than
      5 years before the initiation of an agency action proposed to be
      taken under subsection (a) or (b) of this section. Clauses (iii)
      and (iv) of subsection (b)(2)(B) of this section, subsection
      (b)(3)(B) of this section, and subsections (f) and (g) of this
      section shall not apply to an act or action which occurred more
      than 5 years before the initiation of an agency action proposed
      to be taken under subsection (b), (f), or (g) of this section.
      Clause (iv) of subsection (b)(2)(B) of this section shall not
      apply to an action which occurred before June 1, 1992. Subsection
      (k) of this section shall not apply to applications submitted to
      the Secretary before June 1, 1992.
    (m) Devices; mandatory debarment regarding third-party inspections
      and reviews
      (1) In general
        If the Secretary finds that a person has been convicted of a
      felony under section 331(gg) of this title, the Secretary shall
      debar such person from being accredited under section 360m(b) or
      374(g)(2) of this title and from carrying out activities under an
      agreement described in section 383(b) of this title.
      (2) Debarment period
        The Secretary shall debar a person under paragraph (1) for the
      following periods:
          (A) The period of debarment of a person (other than an
        individual) shall not be less than 1 year or more than 10
        years, but if an act leading to a subsequent debarment under
        such paragraph occurs within 10 years after such person has
        been debarred under such paragraph, the period of debarment
        shall be permanent.
          (B) The debarment of an individual shall be permanent.
      (3) Termination of debarment; judicial review; other matters
        Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this
      section apply with respect to a person (other than an individual)
      or an individual who is debarred under paragraph (1) to the same
      extent and in the same manner as such subsections apply with
      respect to a person who is debarred under subsection (a)(1) of
      this section, or an individual who is debarred under subsection
      (a)(2) of this section, respectively.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 306, as added Pub. L. 102-282, Sec.
    2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105-115, title I,
    Sec. 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107-188,
    title III, Sec. 304(a)-(c), June 12, 2002, 116 Stat. 665, 666; Pub.
    L. 107-250, title II, Sec. 203, Oct. 26, 2002, 116 Stat. 1610.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 306 of act June 25, 1938, was renumbered section
    309 and is classified to section 336 of this title.

                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-188, Sec. 304(b)(1), substituted
    "Mandatory debarment; certain drug applications" for "Mandatory
    debarment" in heading.
      Subsec. (b). Pub. L. 107-188, Sec. 304(b)(2)(A), substituted
    "Permissive debarment; certain drug applications; food imports" for
    "Permissive debarment" in heading.
      Subsec. (b)(1)(C). Pub. L. 107-188, Sec. 304(a)(1), added subpar.
    (C).
      Subsec. (b)(2). Pub. L. 107-188, Sec. 304(b)(2)(B), substituted
    "permissive debarment; certain drug applications" for "permissive
    debarment" in heading.
      Pub. L. 107-188, Sec. 304(a)(2)(A), inserted "subparagraph (A) or
    (B) of" before "paragraph (1)" in introductory provisions.
      Subsec. (b)(3), (4). Pub. L. 107-188, Sec. 304(a)(2)(B), (C),
    added par. (3) and redesignated former par. (3) as (4).
      Subsec. (c)(2)(A)(iii). Pub. L. 107-188, Sec. 304(b)(3),
    substituted "paragraph (2) or (3) of subsection (b)" for
    "subsection (b)(2)".
      Subsec. (d)(3)(A)(i). Pub. L. 107-188, Sec. 304(b)(4)(A),
    substituted "subsection (a)(1) of this section or paragraph (2)(A)
    or (3) of subsection (b)" for "subsection (a)(1) or (b)(2)(A)".
      Subsec. (d)(3)(A)(ii)(II). Pub. L. 107-188, Sec. 304(b)(4)(B),
    inserted "in applicable cases," before "sufficient audits".
      Subsec. (d)(3)(B)(i). Pub. L. 107-188, Sec. 304(b)(4)(C),
    inserted "or subsection (b)(3)" after "subsection (b)(2)(B)".
      Subsec. (d)(3)(B)(ii). Pub. L. 107-188, Sec. 304(b)(4)(C), (D),
    inserted "or subsection (b)(3)" after "subsection (b)(2)(B)" and
    "or the food importation process, as the case may be" before
    period.
      Subsec. (l)(2). Pub. L. 107-188, Sec. 304(c), in first sentence
    struck out "and" after "subsection (b)(2) of this section," and
    inserted ", and subsection (b)(3)(A) of this section" after
    "subsection (b)(2)(B) of this section" and in second sentence
    inserted ", subsection (b)(3)(B) of this section," after
    "subsection (b)(2)(B) of this section".
      Subsec. (m). Pub. L. 107-250 added subsec. (m).
      1997 - Subsec. (d)(4)(B)(ii). Pub. L. 105-115 struck out "or 357"
    after "355".

                               CONSTRUCTION                           
      Section 7 of Pub. L. 102-282 provided that: "No amendment made by
    this Act [enacting this section and sections 335b and 335c of this
    title and amending sections 321, 336, 337, and 355 of this title]
    shall preclude any other civil, criminal, or administrative remedy
    provided under Federal or State law, including any private right of
    action against any person for the same action subject to any action
    or civil penalty under an amendment made by this Act."

                          CONGRESSIONAL FINDINGS                      
      Section 1(c) of Pub. L. 102-282 provided that: "The Congress
    finds that - 
        "(1) there is substantial evidence that significant corruption
      occurred in the Food and Drug Administration's process of
      approving drugs under abbreviated drug applications,
        "(2) there is a need to establish procedures designed to
      restore and to ensure the integrity of the abbreviated drug
      application approval process and to protect the public health,
      and
        "(3) there is a need to establish procedures to bar individuals
      who have been convicted of crimes pertaining to the regulation of
      drug products from working for companies that manufacture or
      distribute such products."

-FOOTNOTE-
    (!1) So in original. Probably should be "section".


-End-



-CITE-
    21 USC Sec. 335b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335b. Civil penalties

-STATUTE-
    (a) In general
      Any person that the Secretary finds - 
        (1) knowingly made or caused to be made, to any officer,
      employee, or agent of the Department of Health and Human
      Services, a false statement or misrepresentation of a material
      fact in connection with an abbreviated drug application,
        (2) bribed or attempted to bribe or paid or attempted to pay an
      illegal gratuity to any officer, employee, or agent of the
      Department of Health and Human Services in connection with an
      abbreviated drug application,
        (3) destroyed, altered, removed, or secreted, or procured the
      destruction, alteration, removal, or secretion of, any material
      document or other material evidence which was the property of or
      in the possession of the Department of Health and Human Services
      for the purpose of interfering with that Department's discharge
      of its responsibilities in connection with an abbreviated drug
      application,
        (4) knowingly failed to disclose, to an officer or employee of
      the Department of Health and Human Services, a material fact
      which such person had an obligation to disclose relating to any
      drug subject to an abbreviated drug application,
        (5) knowingly obstructed an investigation of the Department of
      Health and Human Services into any drug subject to an abbreviated
      drug application,
        (6) is a person that has an approved or pending drug product
      application and has knowingly - 
          (A) employed or retained as a consultant or contractor, or
          (B) otherwise used in any capacity the services of,

      a person who was debarred under section 335a of this title, or
        (7) is an individual debarred under section 335a of this title
      and, during the period of debarment, provided services in any
      capacity to a person that had an approved or pending drug product
      application,

    shall be liable to the United States for a civil penalty for each
    such violation in an amount not to exceed $250,000 in the case of
    an individual and $1,000,000 in the case of any other person.
    (b) Procedure
      (1) In general
        (A) Action by the Secretary
          A civil penalty under subsection (a) of this section shall be
        assessed by the Secretary on a person by an order made on the
        record after an opportunity for an agency hearing on disputed
        issues of material fact and the amount of the penalty. In the
        course of any investigation or hearing under this subparagraph,
        the Secretary may administer oaths and affirmations, examine
        witnesses, receive evidence, and issue subpoenas requiring the
        attendance and testimony of witnesses and the production of
        evidence that relates to the matter under investigation.
        (B) Action by the Attorney General
          In lieu of a proceeding under subparagraph (A), the Attorney
        General may, upon request of the Secretary, institute a civil
        action to recover a civil money penalty in the amount and for
        any of the acts set forth in subsection (a) of this section.
        Such an action may be instituted separately from or in
        connection with any other claim, civil or criminal, initiated
        by the Attorney General under this chapter.
      (2) Amount
        In determining the amount of a civil penalty under paragraph
      (1), the Secretary or the court shall take into account the
      nature, circumstances, extent, and gravity of the act subject to
      penalty, the person's ability to pay, the effect on the person's
      ability to continue to do business, any history of prior, similar
      acts, and such other matters as justice may require.
      (3) Limitation on actions
        No action may be initiated under this section - 
          (A) with respect to any act described in subsection (a) of
        this section that occurred before May 13, 1992, or
          (B) more than 6 years after the date when facts material to
        the act are known or reasonably should have been known by the
        Secretary but in no event more than 10 years after the date the
        act took place.
    (c) Judicial review
      Any person that is the subject of an adverse decision under
    subsection (b)(1)(A) of this section may obtain a review of such
    decision by the United States Court of Appeals for the District of
    Columbia or for the circuit in which the person resides, by filing
    in such court (within 60 days following the date the person is
    notified of the Secretary's decision) a petition requesting that
    the decision be modified or set aside.
    (d) Recovery of penalties
      The Attorney General may recover any civil penalty (plus interest
    at the currently prevailing rates from the date the penalty became
    final) assessed under subsection (b)(1)(A) of this section in an
    action brought in the name of the United States. The amount of such
    penalty may be deducted, when the penalty has become final, from
    any sums then or later owing by the United States to the person
    against whom the penalty has been assessed. In an action brought
    under this subsection, the validity, amount, and appropriateness of
    the penalty shall not be subject to judicial review.
    (e) Informants
      The Secretary may award to any individual (other than an officer
    or employee of the Federal Government or a person who materially
    participated in any conduct described in subsection (a) of this
    section) who provides information leading to the imposition of a
    civil penalty under this section an amount not to exceed - 
        (1) $250,000, or
        (2) one-half of the penalty so imposed and collected,

    whichever is less. The decision of the Secretary on such award
    shall not be reviewable.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 307, as added Pub. L. 102-282, Sec.
    3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103-80, Sec. 3(g),
    Aug. 13, 1993, 107 Stat. 776.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 307 of act June 25, 1938, was renumbered section
    310 and is classified to section 337 of this title.

                                AMENDMENTS                            
      1993 - Subsec. (b)(3)(A). Pub. L. 103-80 made technical amendment
    to reference to May 13, 1992, to reflect correction of
    corresponding provision of original act.

                               CONSTRUCTION                           
      This section not to preclude any other civil, criminal, or
    administrative remedy provided under Federal or State law,
    including any private right of action against any person for the
    same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.

-End-



-CITE-
    21 USC Sec. 335c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335c. Authority to withdraw approval of abbreviated drug
      applications

-STATUTE-
    (a) In general
      The Secretary - 
        (1) shall withdraw approval of an abbreviated drug application
      if the Secretary finds that the approval was obtained, expedited,
      or otherwise facilitated through bribery, payment of an illegal
      gratuity, or fraud or material false statement, and
        (2) may withdraw approval of an abbreviated drug application if
      the Secretary finds that the applicant has repeatedly
      demonstrated a lack of ability to produce the drug for which the
      application was submitted in accordance with the formulations or
      manufacturing practice set forth in the abbreviated drug
      application and has introduced, or attempted to introduce, such
      adulterated or misbranded drug into commerce.
    (b) Procedure
      The Secretary may not take any action under subsection (a) of
    this section with respect to any person unless the Secretary has
    issued an order for such action made on the record after
    opportunity for an agency hearing on disputed issues of material
    fact. In the course of any investigation or hearing under this
    subsection, the Secretary may administer oaths and affirmations,
    examine witnesses, receive evidence, and issue subpoenas requiring
    the attendance and testimony of witnesses and the production of
    evidence that relates to the matter under investigation.
    (c) Applicability
      Subsection (a) of this section shall apply with respect to
    offenses or acts regardless of when such offenses or acts occurred.
    (d) Judicial review
      Any person that is the subject of an adverse decision under
    subsection (a) of this section may obtain a review of such decision
    by the United States Court of Appeals for the District of Columbia
    or for the circuit in which the person resides, by filing in such
    court (within 60 days following the date the person is notified of
    the Secretary's decision) a petition requesting that the decision
    be modified or set aside.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec.
    4, May 13, 1992, 106 Stat. 160.)


-MISC1-
                               CONSTRUCTION                           
      This section not to preclude any other civil, criminal, or
    administrative remedy provided under Federal or State law,
    including any private right of action against any person for the
    same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.

-End-



-CITE-
    21 USC Sec. 336                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 336. Report of minor violations

-STATUTE-
      Nothing in this chapter shall be construed as requiring the
    Secretary to report for prosecution, or for the institution of
    libel or injunction proceedings, minor violations of this chapter
    whenever he believes that the public interest will be adequately
    served by a suitable written notice or warning.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 309, formerly Sec. 306, 52 Stat.
    1045; renumbered Sec. 309, Pub. L. 102-282, Sec. 2, May 13, 1992,
    106 Stat. 150.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 337                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 337. Proceedings in name of United States; provision as to
      subpoenas

-STATUTE-
      (a) Except as provided in subsection (b) of this section, all
    such proceedings for the enforcement, or to restrain violations, of
    this chapter shall be by and in the name of the United States.
    Subpoenas for witnesses who are required to attend a court of the
    United States, in any district, may run into any other district in
    any proceeding under this section.
      (b)(1) A State may bring in its own name and within its
    jurisdiction proceedings for the civil enforcement, or to restrain
    violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f),
    343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if
    the food that is the subject of the proceedings is located in the
    State.
      (2) No proceeding may be commenced by a State under paragraph (1)
    - 
        (A) before 30 days after the State has given notice to the
      Secretary that the State intends to bring such proceeding,
        (B) before 90 days after the State has given notice to the
      Secretary of such intent if the Secretary has, within such 30
      days, commenced an informal or formal enforcement action
      pertaining to the food which would be the subject of such
      proceeding, or
        (C) if the Secretary is diligently prosecuting a proceeding in
      court pertaining to such food, has settled such proceeding, or
      has settled the informal or formal enforcement action pertaining
      to such food.

    In any court proceeding described in subparagraph (C), a State may
    intervene as a matter of right.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 310, formerly Sec. 307, 52 Stat.
    1046; Sept. 3, 1954, ch. 1263, Sec. 37, 68 Stat. 1239; Pub. L. 101-
    535, Sec. 4, Nov. 8, 1990, 104 Stat. 2362; renumbered Sec. 310,
    Pub. L. 102-282, Sec. 2, May 13, 1992, 106 Stat. 150.)


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-535 substituted "(a) Except as provided in
    subsection (b) of this section, all" for "All" and "any proceeding
    under this section" for "any such proceeding" and added subsec.
    (b).
      1954 - Act Sept. 3, 1954, struck out reference to section 654 of
    title 28.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-535 effective 24 months after Nov. 8,
    1990, except that such amendment effective Dec. 31, 1993, with
    respect to dietary supplements of vitamins, minerals, herbs, or
    other similar nutritional substances, see section 10(a)(1)(C) of
    Pub. L. 101-535, set out as a note under section 343 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter
    authority of Secretary of Health and Human Services and Secretary
    of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
    et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
    seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
    seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER IV - FOOD                                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
                           SUBCHAPTER IV - FOOD                       

-End-



-CITE-
    21 USC Sec. 341                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 341. Definitions and standards for food

-STATUTE-
      Whenever in the judgment of the Secretary such action will
    promote honesty and fair dealing in the interest of consumers, he
    shall promulgate regulations fixing and establishing for any food,
    under its common or usual name so far as practicable, a reasonable
    definition and standard of identity, a reasonable standard of
    quality, or reasonable standards of fill of container. No
    definition and standard of identity and no standard of quality
    shall be established for fresh or dried fruits, fresh or dried
    vegetables, or butter, except that definitions and standards of
    identity may be established for avocadoes, cantaloupes, citrus
    fruits, and melons. In prescribing any standard of fill of
    container, the Secretary shall give due consideration to the
    natural shrinkage in storage and in transit of fresh natural food
    and to need for the necessary packing and protective material. In
    the prescribing of any standard of quality for any canned fruit or
    canned vegetable, consideration shall be given and due allowance
    made for the differing characteristics of the several varieties of
    such fruit or vegetable. In prescribing a definition and standard
    of identity for any food or class of food in which optional
    ingredients are permitted, the Secretary shall, for the purpose of
    promoting honesty and fair dealing in the interest of consumers,
    designate the optional ingredients which shall be named on the
    label. Any definition and standard of identity prescribed by the
    Secretary for avocadoes, cantaloupes, citrus fruits, or melons
    shall relate only to maturity and to the effects of freezing.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954,
    ch. 143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70
    Stat. 919; Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat.
    776.)


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 substituted "or reasonable standards of
    fill of container. No definition" for "and/or reasonable standards
    of fill of container: Provided, That no definition".
      1956 - Act Aug. 1, 1956, designated provisions constituting
    subsec. (a) as entire section and repealed subsec. (b) which
    provided the procedure for establishment of regulations and is
    covered by section 371(e) of this title.
      1954 - Act Apr. 15, 1954, designated existing provisions as
    subsec. (a) and added subsec. (b).

                             SAVINGS PROVISION                         
      Section 3 of act Aug. 1, 1956, provided that: "In any case in
    which, prior to the enactment of this Act [Aug. 1, 1956], a public
    hearing has been begun in accordance with section 401 of the
    Federal Food, Drug, and Cosmetic Act [341 of this title] upon a
    proposal to issue, amend, or repeal any regulation contemplated by
    such section, or has been begun in accordance with section 701(e)
    of such Act [section 371(e) of this title] upon a proposal to
    issue, amend, or repeal any regulation contemplated by section
    403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604
    of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d),
    352(h), 354, or 364 of this title], the provisions of such section
    401 or 701(e), as the case may be, as in force immediately prior to
    the date of the enactment of this Act [Aug. 1, 1956], shall be
    applicable as though this Act [amending this section and section
    371(e) of this title] had not been enacted."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                     FOOD SAFETY AND SECURITY STRATEGY                 
      Pub. L. 107-188, title III, Sec. 301, June 12, 2002, 116 Stat.
    662, provided that:
      "(a) In General. - The President's Council on Food Safety (as
    established by Executive Order No. 13100 [set out below]) shall, in
    consultation with the Secretary of Transportation, the Secretary of
    the Treasury, other relevant Federal agencies, the food industry,
    consumer and producer groups, scientific organizations, and the
    States, develop a crisis communications and education strategy with
    respect to bioterrorist threats to the food supply. Such strategy
    shall address threat assessments; technologies and procedures for
    securing food processing and manufacturing facilities and modes of
    transportation; response and notification procedures; and risk
    communications to the public.
      "(b) Authorization of Appropriations. - For the purpose of
    implementing the strategy developed under subsection (a), there are
    authorized to be appropriated $750,000 for fiscal year 2002, and
    such sums as may be necessary for each subsequent fiscal year."

                          FOOD SAFETY COMMISSION                      
      Pub. L. 107-171, title X, Sec. 10807, May 13, 2002, 116 Stat.
    527, provided that:
      "(a) Establishment. - 
        "(1) In general. - There is established a commission to be
      known as the 'Food Safety Commission' (referred to in this
      section as the 'Commission').
        "(2) Membership. - 
          "(A) Composition. - The Commission shall be composed of 15
        members (including a Chairperson, appointed by the
        President[)].
          "(B) Eligibility. - 
            "(i) In general. - Members of the Commission - 
         "(I) shall have specialized training or significant experience
          in matters under the jurisdiction of the Commission; and
         "(II) shall represent, at a minimum - 
              "(aa) consumers;
              "(bb) food scientists;
              "(cc) the food industry; and
              "(dd) health professionals.
            "(ii) Federal employees. - Not more than 3 members of the
          Commission may be Federal employees.
          "(C) Date of appointments. - The appointment of the members
        of the Commission shall be made as soon as practicable after
        the date on which funds authorized to be appropriated under
        subsection (e)(1) are made available.
          "(D) Vacancies. - A vacancy on the Commission - 
            "(i) shall not affect the powers of the Commission; and
            "(ii) shall be filled - 
         "(I) not later than 60 days after the date on which the
          vacancy occurs; and
         "(II) in the same manner as the original appointment was made.
        "(3) Meetings. - 
          "(A) Initial meeting. - The initial meeting of the Commission
        shall be conducted not later than 30 days after the date of
        appointment of the final member of the Commission.
          "(B) Other meetings. - The Commission shall meet at the call
        of the Chairperson.
        "(4) Quorum; standing rules. - 
          "(A) Quorum. - A majority of the members of the Commission
        shall constitute a quorum to conduct business.
          "(B) Standing rules. - At the first meeting of the
        Commission, the Commission shall adopt standing rules of the
        Commission to guide the conduct of business and decisionmaking
        of the Commission.
      "(b) Duties. - 
        "(1) Recommendations. - The Commission shall make specific
      recommendations to enhance the food safety system of the United
      States, including a description of how each recommendation would
      improve food safety.
        "(2) Components. - Recommendations made by the Commission under
      paragraph (1) shall address all food available commercially in
      the United States.
        "(3) Report. - Not later than 1 year after the date on which
      the Commission first meets, the Commission shall submit to the
      President and Congress - 
          "(A) the findings, conclusions, and recommendations of the
        Commission, including a description of how each recommendation
        would improve food safety;
          "(B) a summary of any other material used by the Commission
        in the preparation of the report under this paragraph; and
          "(C) if requested by 1 or more members of the Commission, a
        statement of the minority views of the Commission.
      "(c) Powers of the Commission. - 
        "(1) Hearings. - The Commission may, for the purpose of
      carrying out this section, hold such hearings, meet and act at
      such times and places, take such testimony, and receive such
      evidence as the Commission considers advisable.
        "(2) Information from federal agencies. - 
          "(A) In general. - The Commission may secure directly, from
        any Federal agency, such information as the Commission
        considers necessary to carry out this section.
          "(B) Provision of information. - 
            "(i) In general. - Subject to subparagraph (C), on the
          request of the Commission, the head of a Federal agency
          described in subparagraph (A) may furnish information
          requested by the Commission to the Commission.
            "(ii) Administration. - The furnishing of information by a
          Federal agency to the Commission shall not be considered a
          waiver of any exemption available to the agency under section
          552 of title 5, United States Code.
          "(C) Information to be kept confidential. - 
            "(i) In general. - For purposes of section 1905 of title
          18, United States Code - 
         "(I) the Commission shall be considered an agency of the
          Federal Government; and
         "(II) any individual employed by an individual, entity, or
          organization that is a party to a contract with the
          Commission under this section shall be considered an employee
          of the Commission.
            "(ii) Prohibition on disclosure. - Information obtained by
          the Commission, other than information that is available to
          the public, shall not be disclosed to any person in any
          manner except to an employee of the Commission as described
          in clause (i), for the purpose of receiving, reviewing, or
          processing the information.
      "(d) Commission Personnel Matters. - 
        "(1) Members. - 
          "(A) Compensation. - A member of the Commission shall serve
        without compensation for the services of the member on the
        Commission.
          "(B) Travel expenses. - A member of the Commission shall be
        allowed travel expenses, including per diem in lieu of
        subsistence, at rates authorized for an employee of an agency
        under subchapter I of chapter 57 of title 5, United States
        Code, while away from the home or regular place of business of
        the member in the performance of the duties of the Commission.
        "(2) Staff. - 
          "(A) In general. - The Chairperson of the Commission may,
        without regard to the civil service laws (including
        regulations), appoint and terminate the appointment of an
        executive director and such other additional personnel as are
        necessary to enable the Commission to perform the duties of the
        Commission.
          "(B) Confirmation of executive director. - The employment of
        an executive director shall be subject to confirmation by the
        Commission.
          "(C) Compensation. - 
            "(i) In general. - Except as provided in clause (ii), the
          Chairperson of the Commission may fix the compensation of the
          executive director and other personnel without regard to the
          provisions of chapter 51 and subchapter III of chapter 53 of
          title 5, United States Code, relating to classification of
          positions and General Schedule pay rates.
            "(ii) Maximum rate of pay. - The rate of pay for the
          executive director and other personnel shall not exceed the
          rate payable for level II of the Executive Schedule under
          section 5316 of title 5, United States Code.
        "(3) Detail of federal government employees. - 
          "(A) In general. - An employee of the Federal Government may
        be detailed to the Commission, without reimbursement, for such
        period of time as is permitted by law.
          "(B) Civil service status. - The detail of the employee shall
        be without interruption or loss of civil service status or
        privilege.
        "(4) Procurement of temporary and intermittent services. - The
      Chairperson of the Commission may procure temporary and
      intermittent services in accordance with section 3109(b) of title
      5, United States Code, at rates for individuals that do not
      exceed the daily equivalent of the annual rate of basic pay
      prescribed for level II of the Executive Schedule under section
      5316 of that title.
      "(e) Authorization of Appropriations. - 
        "(1) In general. - There is authorized to be appropriated such
      sums as are necessary to carry out this section.
        "(2) Limitation. - No payment may be made under subsection (d)
      except to the extent provided for in advance in an appropriations
      Act.
      "(f) Termination. - The Commission shall terminate on the date
    that is 60 days after the date on which the Commission submits the
    recommendations and report under subsection (b)(3)."


-EXEC-
          EX. ORD. NO. 13100. PRESIDENT'S COUNCIL ON FOOD SAFETY      
      Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by
    Ex. Ord. No. 13286, Sec. 16, Feb. 28, 2003, 68 F.R. 10623,
    provided:
      By the authority vested in me as President by the Constitution
    and the laws of the United States of America, and in order to
    improve the safety of the food supply through science-based
    regulation and well-coordinated inspection, enforcement, research,
    and education programs, it is hereby ordered as follows:
      Section 1. Establishment of President's Council on Food Safety.
    (a) There is established the President's Council on Food Safety
    ("Council"). The Council shall comprise the Secretaries of
    Agriculture, Commerce, Health and Human Services, and Homeland
    Security, the Director of the Office of Management and Budget
    (OMB), the Administrator of the Environmental Protection Agency,
    the Assistant to the President for Science and Technology/Director
    of the Office of Science and Technology Policy, the Assistant to
    the President for Domestic Policy, and the Director of the National
    Partnership for Reinventing Government. The Council shall consult
    with other Federal agencies and State, local, and tribal government
    agencies, and consumer, producer, scientific, and industry groups,
    as appropriate.
      (b) The Secretaries of Agriculture and of Health and Human
    Services and the Assistant to the President for Science and
    Technology/Director of the Office of Science and Technology Policy
    shall serve as Joint Chairs of the Council.
      Sec. 2. Purpose. The purpose of the Council shall be to develop a
    comprehensive strategic plan for Federal food safety activities,
    taking into consideration the findings and recommendations of the
    National Academy of Sciences report "Ensuring Safe Food from
    Production to Consumption" and other input from the public on how
    to improve the effectiveness of the current food safety system. The
    Council shall make recommendations to the President on how to
    advance Federal efforts to implement a comprehensive science-based
    strategy to improve the safety of the food supply and to enhance
    coordination among Federal agencies, State, local, and tribal
    governments, and the private sector. The Council shall advise
    Federal agencies in setting priority areas for investment in food
    safety.
      Sec. 3. Specific Activities and Functions. (a) The Council shall
    develop a comprehensive strategic Federal food safety plan that
    contains specific recommendations on needed changes, including
    measurable outcome goals. The principal goal of the plan should be
    the establishment of a seamless, science-based food safety system.
    The plan should address the steps necessary to achieve this goal,
    including the key public health, resource, and management issues
    regarding food safety. The planning process should consider both
    short-term and long-term issues including new and emerging threats
    and the special needs of vulnerable populations such as children
    and the elderly. In developing this plan, the Council shall consult
    with all interested parties, including State and local agencies,
    tribes, consumers, producers, industry, and academia.
      (b) Consistent with the comprehensive strategic Federal food
    safety plan described in section 3(a) of this order, the Council
    shall advise agencies of priority areas for investment in food
    safety and ensure that Federal agencies annually develop
    coordinated food safety budgets for submission to the OMB that
    sustain and strengthen existing capacities, eliminate duplication,
    and ensure the most effective use of resources for improving food
    safety. The Council shall also ensure that Federal agencies
    annually develop a unified budget for submission to the OMB for the
    President's Food Safety Initiative and such other food safety
    issues as the Council determines appropriate.
      (c) The Council shall ensure that the Joint Institute for Food
    Safety Research (JIFSR), in consultation with the National Science
    and Technology Council, establishes mechanisms to guide Federal
    research efforts toward the highest priority food safety needs. The
    JIFSR shall report to the Council on a regular basis on its
    efforts: (i) to develop a strategic plan for conducting food safety
    research activities consistent with the President's Food Safety
    Initiative and such other food safety activities as the JIFSR
    determines appropriate; and (ii) to coordinate efficiently, within
    the executive branch and with the private sector and academia, all
    Federal food safety research.
      Sec. 4. Cooperation. All actions taken by the Council shall, as
    appropriate, promote partnerships and cooperation with States,
    tribes, and other public and private sector efforts wherever
    possible to improve the safety of the food supply.
      Sec. 5. General Provisions. This order is intended only to
    improve the internal management of the executive branch and is not
    intended to, nor does it, create any right or benefit, substantive
    or procedural, enforceable at law by a party against the United
    States, its agencies, its officers or any person. Nothing in this
    order shall affect or alter the statutory responsibilities of any
    Federal agency charged with food safety responsibilities.

-End-



-CITE-
    21 USC Sec. 342                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 342. Adulterated food

-STATUTE-
      A food shall be deemed to be adulterated - 
    (a) Poisonous, insanitary, etc., ingredients
      (1) If it bears or contains any poisonous or deleterious
    substance which may render it injurious to health; but in case the
    substance is not an added substance such food shall not be
    considered adulterated under this clause if the quantity of such
    substance in such food does not ordinarily render it injurious to
    health.(!1) (2)(A) if it bears or contains any added poisonous or
    added deleterious substance (other than a substance that is a
    pesticide chemical residue in or on a raw agricultural commodity or
    processed food, a food additive, a color additive, or a new animal
    drug) that is unsafe within the meaning of section 346 of this
    title; or (B) if it bears or contains a pesticide chemical residue
    that is unsafe within the meaning of section 346a(a) of this title;
    or (C) if it is or if it bears or contains (i) any food additive
    that is unsafe within the meaning of section 348 of this title; or
    (ii) a new animal drug (or conversion product thereof) that is
    unsafe within the meaning of section 360b of this title; or (3) if
    it consists in whole or in part of any filthy, putrid, or
    decomposed substance, or if it is otherwise unfit for food; or (4)
    if it has been prepared, packed, or held under insanitary
    conditions whereby it may have become contaminated with filth, or
    whereby it may have been rendered injurious to health; or (5) if it
    is, in whole or in part, the product of a diseased animal or of an
    animal which has died otherwise than by slaughter; or (6) if its
    container is composed, in whole or in part, of any poisonous or
    deleterious substance which may render the contents injurious to
    health; or (7) if it has been intentionally subjected to radiation,
    unless the use of the radiation was in conformity with a regulation
    or exemption in effect pursuant to section 348 of this title.

    (b) Absence, substitution, or addition of constituents
      (1) If any valuable constituent has been in whole or in part
    omitted or abstracted therefrom; or (2) if any substance has been
    substituted wholly or in part therefor; or (3) if damage or
    inferiority has been concealed in any manner; or (4) if any
    substance has been added thereto or mixed or packed therewith so as
    to increase its bulk or weight, or reduce its quality or strength,
    or make it appear better or of greater value than it is.
    (c) Color additives
      If it is, or it bears or contains, a color additive which is
    unsafe within the meaning of section 379e(a) of this title.
    (d) Confectionery containing alcohol or nonnutritive substance
      If it is confectionery, and - 
        (1) has partially or completely imbedded therein any
      nonnutritive object, except that this subparagraph shall not
      apply in the case of any nonnutritive object if, in the judgment
      of the Secretary as provided by regulations, such object is of
      practical functional value to the confectionery product and would
      not render the product injurious or hazardous to health;
        (2) bears or contains any alcohol other than alcohol not in
      excess of one-half of 1 per centum by volume derived solely from
      the use of flavoring extracts, except that this clause shall not
      apply to confectionery which is introduced or delivered for
      introduction into, or received or held for sale in, interstate
      commerce if the sale of such confectionery is permitted under the
      laws of the State in which such confectionery is intended to be
      offered for sale;
        (3) bears or contains any nonnutritive substance, except that
      this subparagraph shall not apply to a safe nonnutritive
      substance which is in or on confectionery by reason of its use
      for some practical functional purpose in the manufacture,
      packaging, or storage of such confectionery if the use of the
      substance does not promote deception of the consumer or otherwise
      result in adulteration or misbranding in violation of any
      provision of this chapter, except that the Secretary may, for the
      purpose of avoiding or resolving uncertainty as to the
      application of this subparagraph, issue regulations allowing or
      prohibiting the use of particular nonnutritive substances.
    (e) Oleomargarine containing filthy, putrid, etc., matter
      If it is oleomargarine or margarine or butter and any of the raw
    material used therein consisted in whole or in part of any filthy,
    putrid, or decomposed substance, or such oleomargarine or margarine
    or butter is otherwise unfit for food.
    (f) Dietary supplement or ingredient: safety
      (1) If it is a dietary supplement or contains a dietary
    ingredient that - 
        (A) presents a significant or unreasonable risk of illness or
      injury under - 
          (i) conditions of use recommended or suggested in labeling,
        or
          (ii) if no conditions of use are suggested or recommended in
        the labeling, under ordinary conditions of use;

        (B) is a new dietary ingredient for which there is inadequate
      information to provide reasonable assurance that such ingredient
      does not present a significant or unreasonable risk of illness or
      injury;
        (C) the Secretary declares to pose an imminent hazard to public
      health or safety, except that the authority to make such
      declaration shall not be delegated and the Secretary shall
      promptly after such a declaration initiate a proceeding in
      accordance with sections 554 and 556 of title 5 to affirm or
      withdraw the declaration; or
        (D) is or contains a dietary ingredient that renders it
      adulterated under paragraph (a)(1) under the conditions of use
      recommended or suggested in the labeling of such dietary
      supplement.

    In any proceeding under this subparagraph, the United States shall
    bear the burden of proof on each element to show that a dietary
    supplement is adulterated. The court shall decide any issue under
    this paragraph on a de novo basis.
      (2) Before the Secretary may report to a United States attorney a
    violation of paragraph (!2) (1)(A) for a civil proceeding, the
    person against whom such proceeding would be initiated shall be
    given appropriate notice and the opportunity to present views,
    orally and in writing, at least 10 days before such notice, with
    regard to such proceeding.

    (g) Dietary supplement: manufacturing practices
      (1) If it is a dietary supplement and it has been prepared,
    packed, or held under conditions that do not meet current good
    manufacturing practice regulations, including regulations
    requiring, when necessary, expiration date labeling, issued by the
    Secretary under subparagraph (2).
      (2) The Secretary may by regulation prescribe good manufacturing
    practices for dietary supplements. Such regulations shall be
    modeled after current good manufacturing practice regulations for
    food and may not impose standards for which there is no current and
    generally available analytical methodology. No standard of current
    good manufacturing practice may be imposed unless such standard is
    included in a regulation promulgated after notice and opportunity
    for comment in accordance with chapter 5 of title 5.
    (h) Reoffer of food previously denied admission
      If it is an article of food imported or offered for import into
    the United States and the article of food has previously been
    refused admission under section 381(a) of this title, unless the
    person reoffering the article affirmatively establishes, at the
    expense of the owner or consignee of the article, that the article
    complies with the applicable requirements of this chapter, as
    determined by the Secretary.
    (i) Noncompliance with sanitary transportation practices
      If it is transported or offered for transport by a shipper,
    carrier by motor vehicle or rail vehicle, receiver, or any other
    person engaged in the transportation of food under conditions that
    are not in compliance with regulations promulgated under section
    350e of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950,
    ch. 61, Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68
    Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929,
    Sec. 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar.
    17, 1959, 73 Stat. 3; Pub. L. 86-618, title I, Secs. 102(a)(1),
    (2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89-477,
    June 29, 1966, 80 Stat. 231; Pub. L. 90-399, Sec. 104, July 13,
    1968, 82 Stat. 352; Pub. L. 99-252, Sec. 10, Feb. 27, 1986, 100
    Stat. 35; Pub. L. 102-571, title I, Sec. 107(4), Oct. 29, 1992, 106
    Stat. 4499; Pub. L. 103-80, Sec. 3(i), Aug. 13, 1993, 107 Stat.
    776; Pub. L. 103-417, Secs. 4, 9, Oct. 25, 1994, 108 Stat. 4328,
    4332; Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996, 110 Stat.
    1514; Pub. L. 107-188, title III, Sec. 309, June 12, 2002, 116
    Stat. 673; Pub. L. 109-59, title VII, Sec. 7202(a), Aug. 10, 2005,
    119 Stat. 1911.)


-MISC1-
                                AMENDMENTS                            
      2005 - Par. (i). Pub. L. 109-59 added par. (i).
      2002 - Par. (h). Pub. L. 107-188 added par. (h).
      1996 - Par. (a). Pub. L. 104-170 added subpar. (2) and struck out
    former subpar. (2) which read as follows: "(2)(A) if it bears or
    contains any added poisonous or added deleterious substance (other
    than one which is (i) a pesticide chemical in or on a raw
    agricultural commodity; (ii) a food additive; (iii) a color
    additive; or (iv) a new animal drug) which is unsafe within the
    meaning of section 346 of this title, or (B) if it is a raw
    agricultural commodity and it bears or contains a pesticide
    chemical which is unsafe within the meaning of section 346a(a) of
    this title, or (C) if it is, or if it bears or contains, any food
    additive which is unsafe within the meaning of section 348 of this
    title: Provided, That where a pesticide chemical has been used in
    or on a raw agricultural commodity in conformity with an exemption
    granted or a tolerance prescribed under section 346a of this title
    and such raw agricultural commodity has been subjected to
    processing such as canning, cooking, freezing, dehydrating, or
    milling, the residue of such pesticide chemical remaining in or on
    such processed food shall, notwithstanding the provisions of
    sections 346 and 348 of this title, not be deemed unsafe if such
    residue in or on the raw agricultural commodity has been removed to
    the extent possible in good manufacturing practice and the
    concentration of such residue in the processed food when ready to
    eat is not greater than the tolerance prescribed for the raw
    agricultural commodity, or (D) if it is, or it bears or contains, a
    new animal drug (or conversion product thereof) which is unsafe
    within the meaning of section 360b of this title;". That part of
    Pub. L. 104-170 which directed the substitution of "or (3) if it
    consists" for "(3) if it consists" was executed by making the
    substitution for "(3) If it consists" to reflect the probable
    intent of Congress.
      1994 - Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).
      Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).
      1993 - Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a
    period for "; or" at end of subpar. (1) and "If it" for "if it" at
    beginning of par. (3). That part of Pub. L. 103-80, Sec. 3(i)(1),
    which directed the substitution of a period for "; or" at end of
    subpar. (2) could not be executed because "; or" did not appear.
      Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted ", except
    that this subparagraph" for ": Provided, That this clause".
      Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted ", except
    that this subparagraph shall not apply" for ": Provided, That this
    clause shall not apply" and ", except that the Secretary may, for
    the purpose of avoiding or resolving uncertainty as to the
    application of this subparagraph" for ": And provided further, That
    the Secretary may, for the purpose of avoiding or resolving
    uncertainty as to the application of this clause".
      1992 - Par. (c). Pub. L. 102-571 substituted "379e(a)" for
    "376(a)".
      1986 - Par. (d)(2). Pub. L. 99-252 inserted provision that this
    clause not apply to confectionery introduced or delivered for
    introduction into or received or held for sale in, interstate
    commerce if the sale is permitted under the laws of the State in
    which the confectionery is intended to be offered for sale.
      1968 - Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
      1966 - Par. (d). Pub. L. 89-477 permitted the imbedding of
    nonnutritive objects in confectionery foods if in the judgment of
    the Secretary of Health, Education, and Welfare, as provided by
    regulation, the imbedding of the object is of practical functional
    value to the confectionery product and would not render it
    injurious or hazardous to health, raised to one-half of 1 per
    centum by volume the upper limit for the allowable use of alcohol
    derived solely from the use of flavoring extracts, allowed the use
    of safe nonnutritive substances in and on confectionery foods by
    reason of their use for some practical and functional purpose in
    the manufacture, packaging, or storage of the confectionery foods
    if the use of the substances does not promote deception of the
    consumer or otherwise result in adulteration or misbranding,
    authorized the Secretary to issue regulations on the use of
    particular nonnutritive substances, and removed reference to
    nonnutritive masticatory substances added to chewing gum and
    harmless flavoring, harmless resinous glaze not in excess of four-
    tenths of 1 per centum, natural gum, authorized coloring, and
    pectin.
      1960 - Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted
    "other than one which is (i) a pesticide chemical in or on a raw
    agricultural commodity; (ii) a food additive; or (iii) a color
    additive" for "(except a pesticide chemical in or on a raw
    agricultural commodity and except a food additive)" in cl. (2)(A).
      Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)
    generally, substituting provisions deeming a food adulterated if it
    is, or it bears or contains, a color additive which is unsafe
    within the meaning of section 376 of this title for provisions
    which related to food that bears or contains a coal-tar color other
    than one from a batch that has been certified in accordance with
    regulations as provided by section 346 of this title, and struck
    out provisos which related to the use of color on oranges.
      Par. (d). Pub. L. 86-618, Sec. 105(c), substituted "authorized
    coloring" for "harmless coloring".
      1959 - Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May
    1, 1959, the period during which subsection is inapplicable to
    oranges which have been colored with F.D. & C. Red 32, and inserted
    proviso requiring Secretary to establish regulations prescribing
    the conditions under which Citrus Red No. 2 may be safely used in
    coloring certain mature oranges, and providing for separately
    listing and for certification of batches of such color.
      1958 - Par. (a). Pub. L. 85-929, among other changes, inserted
    cl. (2)(C) relating to food additive unsafe within the meaning of
    section 348 of this title, and to pesticide chemical, and added cl.
    (7) relating to radiated food.
      1956 - Par. (c). Act July 9, 1956, inserted second proviso
    relating to coloring of oranges.
      1954 - Par. (a)(2). Act July 22, 1954, provided in the case of
    any raw agricultural commodity bearing or containing a pesticide
    chemical, that such commodity shall be deemed to be adulterated if
    such pesticide chemical is unsafe within the meaning of section
    346a of this title.
      1950 - Par. (e). Act Mar. 16, 1950, added par. (e).

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
    7204 of Pub. L. 109-59, set out as a note under section 331 of this
    title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

       EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
                        DESICCANT AMENDMENT OF 1959
      Effective date of par. (a)(2) as in force prior to July 22, 1954,
    with respect to particular commercial use of a nematocide, plant
    regulator, defoliant, or desiccant in or on a raw agricultural
    commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
    139, Aug. 7, 1959, 73 Stat. 288.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,
    Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78
    Stat. 1002, provided that:
      "(a) Except as provided in subsections (b) and (c) of this
    section, this Act [amending this section, sections 321, 331, 346,
    and 348 of this title, and section 210 of Title 42, The Public
    Health and Welfare, and enacting provisions set out as notes under
    sections 321 and 451 of this title] shall take effect on the date
    of its enactment [Sept. 6, 1958].
      "(b) Except as provided in subsection (c) of this section,
    section 3 of this Act [amending this section and section 346 of
    this title] shall take effect on the one hundred and eightieth day
    after the date of enactment of this Act [Sept. 6, 1958].
      "(c) With respect to any particular commercial use of a food
    additive, if such use was made of such additive before January 1,
    1958, section 3 of this Act [amending this section and section 346
    of this title] shall take effect - 
        "(1) Either (A) one year after the effective date established
      in subsection (b) of this section, or (B) at the end of such
      additional period (but not later than two years from such
      effective date established in subsection (b)) as the Secretary of
      Health, Education, and Welfare [now Health and Human Services]
      may prescribe on the basis of a finding that such extension
      involves no undue risk to the public health and that conditions
      exist which necessitate the prescribing of such an additional
      period, or
        "(2) on the date on which an order with respect to such use
      under section 409 of the Federal Food, Drug, and Cosmetic Act
      [section 348 of this title] becomes effective,
    whichever date first occurs. Whenever the Secretary has, pursuant
    to clause (1)(B) of this subsection, extended the effective date of
    section 3 of this Act [amending this section] to March 5, 1961, or
    has on that date a request for such extension pending before him,
    with respect to any such particular use of a food additive, he may,
    notwithstanding the parenthetical time limitation in that clause,
    further extend such effective date, not beyond June 30, 1964, under
    the authority of that clause (but subject to clause (2)) with
    respect to such use of the additive (or a more limited specified
    use or uses thereof) if, in addition to making the findings
    required by clause (1)(B), he finds (i) that bona fide action to
    determine the applicability of such section 409 [section 348 of
    this title] to such use or uses, or to develop the scientific data
    necessary for action under such section, was commenced by an
    interested person before March 6, 1960, and was thereafter pursued
    with reasonable diligence, and (ii) that in the Secretary's
    judgment such extension is consistent with the objective of
    carrying to completion in good faith, as soon as reasonably
    practicable, the scientific investigations necessary as a basis for
    action under such section 409 [section 348 of this title]:
    Provided, That if the Secretary has, pursuant to this sentence,
    granted an extension to June 30, 1964, he may, upon making the
    findings required by clause (1)(B) of this subsection and clauses
    (i) and (ii) of this sentence, further extend such effective date,
    but not beyond December 31, 1965. The Secretary may at any time
    terminate an extension so granted if he finds that it should not
    have been granted, or that by reason of a change in circumstances
    the basis for such extension no longer exists, or that there has
    been a failure to comply with a requirement for submission of
    progress reports or with other conditions attached to such
    extension."

                     EFFECTIVE DATE OF 1954 AMENDMENT                 
      Section 5 of act July 22, 1954, provided that: "This Act
    [amending this section and section 321 of this title and enacting
    sections 346a and 346b of this title] shall take effect upon the
    date of its enactment [July 22, 1954], except that with respect to
    pesticide chemicals for which tolerances or exemptions have not
    been established under section 408 of the Federal Food, Drug, and
    Cosmetic Act [section 346a of this title], the amendment to section
    402(a) of such Act [par. (a) of this section] made by section 2 of
    this Act shall not be effective - 
        "(1) for the period of one year following the date of the
      enactment of this Act [July 22, 1954]; or
        "(2) for such additional period following such period of one
      year, but not extending beyond two years after the date of the
      enactment of this Act [July 22, 1954] as the Secretary of Health,
      Education, and Welfare [now Health and Human Services] may
      prescribe on the basis of a finding that conditions exist which
      necessitate the prescribing of such additional period."

                     EFFECTIVE DATE OF 1950 AMENDMENT                 
      Amendment by act Mar. 16, 1950, effective July 1, 1950, see
    section 7 of act Mar. 16, 1950, set out as an Effective Date note
    under section 347 of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
    53 Stat. 853, set out as an Effective Date; Postponement in Certain
    Cases note under section 301 of this title.

                                SHORT TITLE                            
      Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:
    "That this Act [amending provisions set out as a note under this
    section and section 135 of Title 7, Agriculture] may be cited as
    the 'Food Additives Transitional Provisions Amendment of 1964'."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
    DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS
    OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COMMODITY
                             PURCHASE PROGRAMS
      Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat.
    1601, provided that: "Hereafter, notwithstanding any other
    provision of law, any domestic fish or fish product produced in
    compliance with food safety standards or procedures accepted by the
    Food and Drug Administration as satisfying the requirements of the
    'Procedures for the Safe and Sanitary Processing and Importing of
    Fish and Fish Products' (published by the Food and Drug
    Administration as a final regulation in the Federal Register of
    December 18, 1995), shall be deemed to have met any inspection
    requirements of the Department of Agriculture or other Federal
    agency for any Federal commodity purchase program, including the
    program authorized under section 32 of the Act of August 24, 1935
    (7 U.S.C. 612c) except that the Department of Agriculture or other
    Federal agency may utilize lot inspection to establish a reasonable
    degree of certainty that fish or fish products purchased under a
    Federal commodity purchase program, including the program
    authorized under section 32 of the Act of August 24, 1935 (7 U.S.C.
    612c), meet Federal product specifications."

-FOOTNOTE-
    (!1) So in original. The period probably should be "; or".

    (!2) So in original. Probably should be "subparagraph".


-End-



-CITE-
    21 USC Sec. 343                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343. Misbranded food

-STATUTE-
      A food shall be deemed to be misbranded - 
    (a) False or misleading label
      If (1) its labeling is false or misleading in any particular, or
    (2) in the case of a food to which section 350 of this title
    applies, its advertising is false or misleading in a material
    respect or its labeling is in violation of section 350(b)(2) of
    this title.
    (b) Offer for sale under another name
      If it is offered for sale under the name of another food.
    (c) Imitation of another food
      If it is an imitation of another food, unless its label bears, in
    type of uniform size and prominence, the word "imitation" and,
    immediately thereafter, the name of the food imitated.
    (d) Misleading container
      If its container is so made, formed, or filled as to be
    misleading.
    (e) Package form
      If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count, except
    that under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
    (f) Prominence of information on label
      If any word, statement, or other information required by or under
    authority of this chapter to appear on the label or labeling is not
    prominently placed thereon with such conspicuousness (as compared
    with other words, statements, designs, or devices, in the labeling)
    and in such terms as to render it likely to be read and understood
    by the ordinary individual under customary conditions of purchase
    and use.
    (g) Representation as to definition and standard of identity
      If it purports to be or is represented as a food for which a
    definition and standard of identity has been prescribed by
    regulations as provided by section 341 of this title, unless (1) it
    conforms to such definition and standard, and (2) its label bears
    the name of the food specified in the definition and standard, and,
    insofar as may be required by such regulations, the common names of
    optional ingredients (other than spices, flavoring, and coloring)
    present in such food.
    (h) Representation as to standards of quality and fill of container
      If it purports to be or is represented as - 
        (1) a food for which a standard of quality has been prescribed
      by regulations as provided by section 341 of this title, and its
      quality falls below such standard, unless its label bears, in
      such manner and form as such regulations specify, a statement
      that it falls below such standard;
        (2) a food for which a standard or standards of fill of
      container have been prescribed by regulations as provided by
      section 341 of this title, and it falls below the standard of
      fill of container applicable thereto, unless its label bears, in
      such manner and form as such regulations specify, a statement
      that it falls below such standard; or
        (3) a food that is pasteurized unless - 
          (A) such food has been subjected to a safe process or
        treatment that is prescribed as pasteurization for such food in
        a regulation promulgated under this chapter; or
          (B)(i) such food has been subjected to a safe process or
        treatment that - 
            (I) is reasonably certain to achieve destruction or
          elimination in the food of the most resistant microorganisms
          of public health significance that are likely to occur in the
          food;
            (II) is at least as protective of the public health as a
          process or treatment described in subparagraph (A);
            (III) is effective for a period that is at least as long as
          the shelf life of the food when stored under normal and
          moderate abuse conditions; and
            (IV) is the subject of a notification to the Secretary,
          including effectiveness data regarding the process or
          treatment; and

          (ii) at least 120 days have passed after the date of receipt
        of such notification by the Secretary without the Secretary
        making a determination that the process or treatment involved
        has not been shown to meet the requirements of subclauses (I)
        through (III) of clause (i).

    For purposes of paragraph (3), a determination by the Secretary
    that a process or treatment has not been shown to meet the
    requirements of subclauses (I) through (III) of subparagraph (B)(i)
    shall constitute final agency action under such subclauses.
    (i) Label where no representation as to definition and standard of
      identity
      Unless its label bears (1) the common or usual name of the food,
    if any there be, and (2) in case it is fabricated from two or more
    ingredients, the common or usual name of each such ingredient and
    if the food purports to be a beverage containing vegetable or fruit
    juice, a statement with appropriate prominence on the information
    panel of the total percentage of such fruit or vegetable juice
    contained in the food; except that spices, flavorings, and colors
    not required to be certified under section 379e(c) of this title
    (!1) unless sold as spices, flavorings, or such colors, may be
    designated as spices, flavorings, and colorings without naming
    each. To the extent that compliance with the requirements of clause
    (2) of this paragraph is impracticable, or results in deception or
    unfair competition, exemptions shall be established by regulations
    promulgated by the Secretary.

    (j) Representation for special dietary use
      If it purports to be or is represented for special dietary uses,
    unless its label bears such information concerning its vitamin,
    mineral, and other dietary properties as the Secretary determines
    to be, and by regulations prescribes as, necessary in order fully
    to inform purchasers as to its value for such uses.
    (k) Artificial flavoring, artificial coloring, or chemical
      preservatives
      If it bears or contains any artificial flavoring, artificial
    coloring, or chemical preservative, unless it bears labeling
    stating that fact, except that to the extent that compliance with
    the requirements of this paragraph is impracticable, exemptions
    shall be established by regulations promulgated by the Secretary.
    The provisions of this paragraph and paragraphs (g) and (i) with
    respect to artificial coloring shall not apply in the case of
    butter, cheese, or ice cream. The provisions of this paragraph with
    respect to chemical preservatives shall not apply to a pesticide
    chemical when used in or on a raw agricultural commodity which is
    the produce of the soil.
    (l) Pesticide chemicals on raw agricultural commodities
      If it is a raw agricultural commodity which is the produce of the
    soil, bearing or containing a pesticide chemical applied after
    harvest, unless the shipping container of such commodity bears
    labeling which declares the presence of such chemical in or on such
    commodity and the common or usual name and the function of such
    chemical, except that no such declaration shall be required while
    such commodity, having been removed from the shipping container, is
    being held or displayed for sale at retail out of such container in
    accordance with the custom of the trade.
    (m) Color additives
      If it is a color additive, unless its packaging and labeling are
    in conformity with such packaging and labeling requirements,
    applicable to such color additive, as may be contained in
    regulations issued under section 379e of this title.
    (n) Packaging or labeling of drugs in violation of regulations
      If its packaging or labeling is in violation of an applicable
    regulation issued pursuant to section 1472 or 1473 of title 15.
    (o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec. 517],
      Dec. 21, 2000, 114 Stat. 2763, 2763A-73
    (p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882
    (q) Nutrition information
      (1) Except as provided in subparagraphs (3), (4), and (5), if it
    is a food intended for human consumption and is offered for sale,
    unless its label or labeling bears nutrition information that
    provides - 
        (A)(i) the serving size which is an amount customarily consumed
      and which is expressed in a common household measure that is
      appropriate to the food, or
        (ii) if the use of the food is not typically expressed in a
      serving size, the common household unit of measure that expresses
      the serving size of the food,
        (B) the number of servings or other units of measure per
      container,
        (C) the total number of calories - 
          (i) derived from any source, and
          (ii) derived from the total fat,

      in each serving size or other unit of measure of the food,
        (D) the amount of the following nutrients: Total fat, saturated
      fat, cholesterol, sodium, total carbohydrates, complex
      carbohydrates, sugars, dietary fiber, and total protein contained
      in each serving size or other unit of measure,
        (E) any vitamin, mineral, or other nutrient required to be
      placed on the label and labeling of food under this chapter
      before October 1, 1990, if the Secretary determines that such
      information will assist consumers in maintaining healthy dietary
      practices.

    The Secretary may by regulation require any information required to
    be placed on the label or labeling by this subparagraph or
    subparagraph (2)(A) to be highlighted on the label or labeling by
    larger type, bold type, or contrasting color if the Secretary
    determines that such highlighting will assist consumers in
    maintaining healthy dietary practices.
      (2)(A) If the Secretary determines that a nutrient other than a
    nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
    be included in the label or labeling of food subject to
    subparagraph (1) for purposes of providing information regarding
    the nutritional value of such food that will assist consumers in
    maintaining healthy dietary practices, the Secretary may by
    regulation require that information relating to such additional
    nutrient be included in the label or labeling of such food.
      (B) If the Secretary determines that the information relating to
    a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
    clause (A) of this subparagraph to be included in the label or
    labeling of food is not necessary to assist consumers in
    maintaining healthy dietary practices, the Secretary may by
    regulation remove information relating to such nutrient from such
    requirement.
      (3) For food that is received in bulk containers at a retail
    establishment, the Secretary may, by regulation, provide that the
    nutrition information required by subparagraphs (1) and (2) be
    displayed at the location in the retail establishment at which the
    food is offered for sale.
      (4)(A) The Secretary shall provide for furnishing the nutrition
    information required by subparagraphs (1) and (2) with respect to
    raw agricultural commodities and raw fish by issuing voluntary
    nutrition guidelines, as provided by clause (B) or by issuing
    regulations that are mandatory as provided by clause (D).
      (B)(i) Upon the expiration of 12 months after November 8, 1990,
    the Secretary, after providing an opportunity for comment, shall
    issue guidelines for food retailers offering raw agricultural
    commodities or raw fish to provide nutrition information specified
    in subparagraphs (1) and (2). Such guidelines shall take into
    account the actions taken by food retailers during such 12-month
    period to provide to consumers nutrition information on raw
    agricultural commodities and raw fish. Such guidelines shall only
    apply - 
        (I) in the case of raw agricultural commodities, to the 20
      varieties of vegetables most frequently consumed during a year
      and the 20 varieties of fruit most frequently consumed during a
      year, and
        (II) to the 20 varieties of raw fish most frequently consumed
      during a year.

    The vegetables, fruits, and raw fish to which such guidelines apply
    shall be determined by the Secretary by regulation and the
    Secretary may apply such guidelines regionally.
      (ii) Upon the expiration of 12 months after November 8, 1990, the
    Secretary shall issue a final regulation defining the circumstances
    that constitute substantial compliance by food retailers with the
    guidelines issued under subclause (i). The regulation shall provide
    that there is not substantial compliance if a significant number of
    retailers have failed to comply with the guidelines. The size of
    the retailers and the portion of the market served by retailers in
    compliance with the guidelines shall be considered in determining
    whether the substantial-compliance standard has been met.
      (C)(i) Upon the expiration of 30 months after November 8, 1990,
    the Secretary shall issue a report on actions taken by food
    retailers to provide consumers with nutrition information for raw
    agricultural commodities and raw fish under the guidelines issued
    under clause (A). Such report shall include a determination of
    whether there is substantial compliance with the guidelines.
      (ii) If the Secretary finds that there is substantial compliance
    with the guidelines, the Secretary shall issue a report and make a
    determination of the type required in subclause (i) every two
    years.
      (D)(i) If the Secretary determines that there is not substantial
    compliance with the guidelines issued under clause (A), the
    Secretary shall at the time such determination is made issue
    proposed regulations requiring that any person who offers raw
    agricultural commodities or raw fish to consumers provide, in a
    manner prescribed by regulations, the nutrition information
    required by subparagraphs (1) and (2). The Secretary shall issue
    final regulations imposing such requirements 6 months after issuing
    the proposed regulations. The final regulations shall become
    effective 6 months after the date of their promulgation.
      (ii) Regulations issued under subclause (i) may require that the
    nutrition information required by subparagraphs (1) and (2) be
    provided for more than 20 varieties of vegetables, 20 varieties of
    fruit, and 20 varieties of fish most frequently consumed during a
    year if the Secretary finds that a larger number of such products
    are frequently consumed. Such regulations shall permit such
    information to be provided in a single location in each area in
    which raw agricultural commodities and raw fish are offered for
    sale. Such regulations may provide that information shall be
    expressed as an average or range per serving of the same type of
    raw agricultural commodity or raw fish. The Secretary shall develop
    and make available to the persons who offer such food to consumers
    the information required by subparagraphs (1) and (2).
      (iii) Regulations issued under subclause (i) shall permit the
    required information to be provided in each area of an
    establishment in which raw agricultural commodities and raw fish
    are offered for sale. The regulations shall permit food retailers
    to display the required information by supplying copies of the
    information provided by the Secretary, by making the information
    available in brochure, notebook or leaflet form, or by posting a
    sign disclosing the information. Such regulations shall also permit
    presentation of the required information to be supplemented by a
    video, live demonstration, or other media which the Secretary
    approves.
      (E) For purposes of this subparagraph, the term "fish" includes
    freshwater or marine fin fish, crustaceans, and mollusks, including
    shellfish, amphibians, and other forms of aquatic animal life.
      (F) No person who offers raw agricultural commodities or raw fish
    to consumers may be prosecuted for minor violations of this
    subparagraph if there has been substantial compliance with the
    requirements of this paragraph.
      (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
    food - 
        (i) which is served in restaurants or other establishments in
      which food is served for immediate human consumption or which is
      sold for sale or use in such establishments,
        (ii) which is processed and prepared primarily in a retail
      establishment, which is ready for human consumption, which is of
      the type described in subclause (i), and which is offered for
      sale to consumers but not for immediate human consumption in such
      establishment and which is not offered for sale outside such
      establishment,
        (iii) which is an infant formula subject to section 350a of
      this title,
        (iv) which is a medical food as defined in section 360ee(b) of
      this title, or
        (v) which is described in section 345(2) of this title.

      (B) Subparagraphs (1) and (2) shall not apply to the label of a
    food if the Secretary determines by regulations that compliance
    with such subparagraphs is impracticable because the package of
    such food is too small to comply with the requirements of such
    subparagraphs and if the label of such food does not contain any
    nutrition information.
      (C) If a food contains insignificant amounts, as determined by
    the Secretary, of all the nutrients required by subparagraphs (1)
    and (2) to be listed in the label or labeling of food, the
    requirements of such subparagraphs shall not apply to such food if
    the label, labeling, or advertising of such food does not make any
    claim with respect to the nutritional value of such food. If a food
    contains insignificant amounts, as determined by the Secretary, of
    more than one-half the nutrients required by subparagraphs (1) and
    (2) to be in the label or labeling of the food, the Secretary shall
    require the amounts of such nutrients to be stated in a simplified
    form prescribed by the Secretary.
      (D) If a person offers food for sale and has annual gross sales
    made or business done in sales to consumers which is not more than
    $500,000 or has annual gross sales made or business done in sales
    of food to consumers which is not more than $50,000, the
    requirements of subparagraphs (1), (2), (3), and (4) shall not
    apply with respect to food sold by such person to consumers unless
    the label or labeling of food offered by such person provides
    nutrition information or makes a nutrition claim.
      (E)(i) During the 12-month period for which an exemption from
    subparagraphs (1) and (2) is claimed pursuant to this subclause,
    the requirements of such subparagraphs shall not apply to any food
    product if - 
        (I) the labeling for such product does not provide nutrition
      information or make a claim subject to paragraph (r),
        (II) the person who claims for such product an exemption from
      such subparagraphs employed fewer than an average of 100 full-
      time equivalent employees,
        (III) such person provided the notice described in subclause
      (iii), and
        (IV) in the case of a food product which was sold in the 12-
      month period preceding the period for which an exemption was
      claimed, fewer than 100,000 units of such product were sold in
      the United States during such preceding period, or in the case of
      a food product which was not sold in the 12-month period
      preceding the period for which such exemption is claimed, fewer
      than 100,000 units of such product are reasonably anticipated to
      be sold in the United States during the period for which such
      exemption is claimed.

      (ii) During the 12-month period after the applicable date
    referred to in this sentence, the requirements of subparagraphs (1)
    and (2) shall not apply to any food product which was first
    introduced into interstate commerce before May 8, 1994, if the
    labeling for such product does not provide nutrition information or
    make a claim subject to paragraph (r), if such person provided the
    notice described in subclause (iii), and if - 
        (I) during the 12-month period preceding May 8, 1994, the
      person who claims for such product an exemption from such
      subparagraphs employed fewer than an average of 300 full-time
      equivalent employees and fewer than 600,000 units of such product
      were sold in the United States,
        (II) during the 12-month period preceding May 8, 1995, the
      person who claims for such product an exemption from such
      subparagraphs employed fewer than an average of 300 full-time
      equivalent employees and fewer than 400,000 units of such product
      were sold in the United States, or
        (III) during the 12-month period preceding May 8, 1996, the
      person who claims for such product an exemption from such
      subparagraphs employed fewer than an average of 200 full-time
      equivalent employees and fewer than 200,000 units of such product
      were sold in the United States.

      (iii) The notice referred to in subclauses (i) and (ii) shall be
    given to the Secretary prior to the beginning of the period during
    which the exemption under subclause (i) or (ii) is to be in effect,
    shall state that the person claiming such exemption for a food
    product has complied with the applicable requirements of subclause
    (i) or (ii), and shall - 
        (I) state the average number of full-time equivalent employees
      such person employed during the 12 months preceding the date such
      person claims such exemption,
        (II) state the approximate number of units the person claiming
      the exemption sold in the United States,
        (III) if the exemption is claimed for a food product which was
      sold in the 12-month period preceding the period for which the
      exemption was claimed, state the approximate number of units of
      such product which were sold in the United States during such
      preceding period, and, if the exemption is claimed for a food
      product which was not sold in such preceding period, state the
      number of units of such product which such person reasonably
      anticipates will be sold in the United States during the period
      for which the exemption was claimed, and
        (IV) contain such information as the Secretary may require to
      verify the information required by the preceding provisions of
      this subclause if the Secretary has questioned the validity of
      such information.

    If a person is not an importer, has fewer than 10 full-time
    equivalent employees, and sells fewer than 10,000 units of any food
    product in any year, such person is not required to file a notice
    for such product under this subclause for such year.
      (iv) In the case of a person who claimed an exemption under
    subclause (i) or (ii), if, during the period of such exemption, the
    number of full-time equivalent employees of such person exceeds the
    number in such subclause or if the number of food products sold in
    the United States exceeds the number in such subclause, such
    exemption shall extend to the expiration of 18 months after the
    date the number of full-time equivalent employees or food products
    sold exceeded the applicable number.
      (v) For any food product first introduced into interstate
    commerce after May 8, 2002, the Secretary may by regulation lower
    the employee or units of food products requirement of subclause (i)
    if the Secretary determines that the cost of compliance with such
    lower requirement will not place an undue burden on persons subject
    to such lower requirement.
      (vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v) -
    
        (I) the term "unit" means the packaging or, if there is no
      packaging, the form in which a food product is offered for sale
      to consumers,
        (II) the term "food product" means food in any sized package
      which is manufactured by a single manufacturer or which bears the
      same brand name, which bears the same statement of identity, and
      which has similar preparation methods, and
        (III) the term "person" in the case of a corporation includes
      all domestic and foreign affiliates of the corporation.

      (F) A dietary supplement product (including a food to which
    section 350 of this title applies) shall comply with the
    requirements of subparagraphs (1) and (2) in a manner which is
    appropriate for the product and which is specified in regulations
    of the Secretary which shall provide that - 
        (i) nutrition information shall first list those dietary
      ingredients that are present in the product in a significant
      amount and for which a recommendation for daily consumption has
      been established by the Secretary, except that a dietary
      ingredient shall not be required to be listed if it is not
      present in a significant amount, and shall list any other dietary
      ingredient present and identified as having no such
      recommendation;
        (ii) the listing of dietary ingredients shall include the
      quantity of each such ingredient (or of a proprietary blend of
      such ingredients) per serving;
        (iii) the listing of dietary ingredients may include the source
      of a dietary ingredient; and
        (iv) the nutrition information shall immediately precede the
      ingredient information required under subclause (i), except that
      no ingredient identified pursuant to subclause (i) shall be
      required to be identified a second time.

      (G) Subparagraphs (1), (2), (3), and (4) shall not apply to food
    which is sold by a food distributor if the food distributor
    principally sells food to restaurants or other establishments in
    which food is served for immediate human consumption and does not
    manufacture, process, or repackage the food it sells.
    (r) Nutrition levels and health-related claims
      (1) Except as provided in clauses (A) through (C) of subparagraph
    (5), if it is a food intended for human consumption which is
    offered for sale and for which a claim is made in the label or
    labeling of the food which expressly or by implication - 
        (A) characterizes the level of any nutrient which is of the
      type required by paragraph (q)(1) or (q)(2) to be in the label or
      labeling of the food unless the claim is made in accordance with
      subparagraph (2), or
        (B) characterizes the relationship of any nutrient which is of
      the type required by paragraph (q)(1) or (q)(2) to be in the
      label or labeling of the food to a disease or a health-related
      condition unless the claim is made in accordance with
      subparagraph (3) or (5)(D).

    A statement of the type required by paragraph (q) that appears as
    part of the nutrition information required or permitted by such
    paragraph is not a claim which is subject to this paragraph and a
    claim subject to clause (A) is not subject to clause (B).
      (2)(A) Except as provided in subparagraphs (4)(A)(ii) and
    (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
    claim described in subparagraph (1)(A) - 
        (i) may be made only if the characterization of the level made
      in the claim uses terms which are defined in regulations of the
      Secretary,
        (ii) may not state the absence of a nutrient unless - 
          (I) the nutrient is usually present in the food or in a food
        which substitutes for the food as defined by the Secretary by
        regulation, or
          (II) the Secretary by regulation permits such a statement on
        the basis of a finding that such a statement would assist
        consumers in maintaining healthy dietary practices and the
        statement discloses that the nutrient is not usually present in
        the food,

        (iii) may not be made with respect to the level of cholesterol
      in the food if the food contains, as determined by the Secretary
      by regulation, fat or saturated fat in an amount which increases
      to persons in the general population the risk of disease or a
      health related condition which is diet related unless - 
          (I) the Secretary finds by regulation that the level of
        cholesterol is substantially less than the level usually
        present in the food or in a food which substitutes for the food
        and which has a significant market share, or the Secretary by
        regulation permits a statement regarding the absence of
        cholesterol on the basis of a finding that cholesterol is not
        usually present in the food and that such a statement would
        assist consumers in maintaining healthy dietary practices and
        the regulation requires that the statement disclose that
        cholesterol is not usually present in the food, and
          (II) the label or labeling of the food discloses the level of
        such fat or saturated fat in immediate proximity to such claim
        and with appropriate prominence which shall be no less than one-
        half the size of the claim with respect to the level of
        cholesterol,

        (iv) may not be made with respect to the level of saturated fat
      in the food if the food contains cholesterol unless the label or
      labeling of the food discloses the level of cholesterol in the
      food in immediate proximity to such claim and with appropriate
      prominence which shall be no less than one-half the size of the
      claim with respect to the level of saturated fat,
        (v) may not state that a food is high in dietary fiber unless
      the food is low in total fat as defined by the Secretary or the
      label or labeling discloses the level of total fat in the food in
      immediate proximity to such statement and with appropriate
      prominence which shall be no less than one-half the size of the
      claim with respect to the level of dietary fiber, and
        (vi) may not be made if the Secretary by regulation prohibits
      the claim because the claim is misleading in light of the level
      of another nutrient in the food.

      (B) If a claim described in subparagraph (1)(A) is made with
    respect to a nutrient in a food and the Secretary makes a
    determination that the food contains a nutrient at a level that
    increases to persons in the general population the risk of a
    disease or health-related condition that is diet related, the label
    or labeling of such food shall contain, prominently and in
    immediate proximity to such claim, the following statement: "See
    nutrition information for ___ content." The blank shall identify
    the nutrient associated with the increased disease or health-
    related condition risk. In making the determination described in
    this clause, the Secretary shall take into account the significance
    of the food in the total daily diet.
      (C) Subparagraph (2)(A) does not apply to a claim described in
    subparagraph (1)(A) and contained in the label or labeling of a
    food if such claim is contained in the brand name of such food and
    such brand name was in use on such food before October 25, 1989,
    unless the brand name contains a term defined by the Secretary
    under subparagraph (2)(A)(i). Such a claim is subject to paragraph
    (a).
      (D) Subparagraph (2) does not apply to a claim described in
    subparagraph (1)(A) which uses the term "diet" and is contained in
    the label or labeling of a soft drink if (i) such claim is
    contained in the brand name of such soft drink, (ii) such brand
    name was in use on such soft drink before October 25, 1989, and
    (iii) the use of the term "diet" was in conformity with section
    105.66 of title 21 of the Code of Federal Regulations. Such a claim
    is subject to paragraph (a).
      (E) Subclauses (i) through (v) of subparagraph (2)(A) do not
    apply to a statement in the label or labeling of food which
    describes the percentage of vitamins and minerals in the food in
    relation to the amount of such vitamins and minerals recommended
    for daily consumption by the Secretary.
      (F) Subclause (i) clause (A) does not apply to a statement in the
    labeling of a dietary supplement that characterizes the percentage
    level of a dietary ingredient for which the Secretary has not
    established a reference daily intake, daily recommended value, or
    other recommendation for daily consumption.
      (G) A claim of the type described in subparagraph (1)(A) for a
    nutrient, for which the Secretary has not promulgated a regulation
    under clause (A)(i), shall be authorized and may be made with
    respect to a food if - 
        (i) a scientific body of the United States Government with
      official responsibility for public health protection or research
      directly relating to human nutrition (such as the National
      Institutes of Health or the Centers for Disease Control and
      Prevention) or the National Academy of Sciences or any of its
      subdivisions has published an authoritative statement, which is
      currently in effect, which identifies the nutrient level to which
      the claim refers;
        (ii) a person has submitted to the Secretary, at least 120 days
      (during which the Secretary may notify any person who is making a
      claim as authorized by clause (C) that such person has not
      submitted all the information required by such clause) before the
      first introduction into interstate commerce of the food with a
      label containing the claim, (I) a notice of the claim, which
      shall include the exact words used in the claim and shall include
      a concise description of the basis upon which such person relied
      for determining that the requirements of subclause (i) have been
      satisfied, (II) a copy of the statement referred to in subclause
      (i) upon which such person relied in making the claim, and (III)
      a balanced representation of the scientific literature relating
      to the nutrient level to which the claim refers;
        (iii) the claim and the food for which the claim is made are in
      compliance with clauses (A) and (B), and are otherwise in
      compliance with paragraph (a) and section 321(n) of this title;
      and
        (iv) the claim is stated in a manner so that the claim is an
      accurate representation of the authoritative statement referred
      to in subclause (i) and so that the claim enables the public to
      comprehend the information provided in the claim and to
      understand the relative significance of such information in the
      context of a total daily diet.

    For purposes of this clause, a statement shall be regarded as an
    authoritative statement of a scientific body described in subclause
    (i) only if the statement is published by the scientific body and
    shall not include a statement of an employee of the scientific body
    made in the individual capacity of the employee.
      (H) A claim submitted under the requirements of clause (G) may be
    made until - 
        (i) such time as the Secretary issues a regulation - 
          (I) prohibiting or modifying the claim and the regulation has
        become effective, or
          (II) finding that the requirements of clause (G) have not
        been met, including finding that the petitioner had not
        submitted all the information required by such clause; or

        (ii) a district court of the United States in an enforcement
      proceeding under subchapter III of this chapter has determined
      that the requirements of clause (G) have not been met.

      (3)(A) Except as provided in subparagraph (5), a claim described
    in subparagraph (1)(B) may only be made - 
        (i) if the claim meets the requirements of the regulations of
      the Secretary promulgated under clause (B), and
        (ii) if the food for which the claim is made does not contain,
      as determined by the Secretary by regulation, any nutrient in an
      amount which increases to persons in the general population the
      risk of a disease or health-related condition which is diet
      related, taking into account the significance of the food in the
      total daily diet, except that the Secretary may by regulation
      permit such a claim based on a finding that such a claim would
      assist consumers in maintaining healthy dietary practices and
      based on a requirement that the label contain a disclosure of the
      type required by subparagraph (2)(B).

      (B)(i) The Secretary shall promulgate regulations authorizing
    claims of the type described in subparagraph (1)(B) only if the
    Secretary determines, based on the totality of publicly available
    scientific evidence (including evidence from well-designed studies
    conducted in a manner which is consistent with generally recognized
    scientific procedures and principles), that there is significant
    scientific agreement, among experts qualified by scientific
    training and experience to evaluate such claims, that the claim is
    supported by such evidence.
      (ii) A regulation described in subclause (i) shall describe - 
        (I) the relationship between a nutrient of the type required in
      the label or labeling of food by paragraph (q)(1) or (q)(2) and a
      disease or health-related condition, and
        (II) the significance of each such nutrient in affecting such
      disease or health-related condition.

      (iii) A regulation described in subclause (i) shall require such
    claim to be stated in a manner so that the claim is an accurate
    representation of the matters set out in subclause (ii) and so that
    the claim enables the public to comprehend the information provided
    in the claim and to understand the relative significance of such
    information in the context of a total daily diet.
      (C) Notwithstanding the provisions of clauses (A)(i) and (B), a
    claim of the type described in subparagraph (1)(B) which is not
    authorized by the Secretary in a regulation promulgated in
    accordance with clause (B) shall be authorized and may be made with
    respect to a food if - 
        (i) a scientific body of the United States Government with
      official responsibility for public health protection or research
      directly relating to human nutrition (such as the National
      Institutes of Health or the Centers for Disease Control and
      Prevention) or the National Academy of Sciences or any of its
      subdivisions has published an authoritative statement, which is
      currently in effect, about the relationship between a nutrient
      and a disease or health-related condition to which the claim
      refers;
        (ii) a person has submitted to the Secretary, at least 120 days
      (during which the Secretary may notify any person who is making a
      claim as authorized by clause (C) that such person has not
      submitted all the information required by such clause) before the
      first introduction into interstate commerce of the food with a
      label containing the claim, (I) a notice of the claim, which
      shall include the exact words used in the claim and shall include
      a concise description of the basis upon which such person relied
      for determining that the requirements of subclause (i) have been
      satisfied, (II) a copy of the statement referred to in subclause
      (i) upon which such person relied in making the claim, and (III)
      a balanced representation of the scientific literature relating
      to the relationship between a nutrient and a disease or health-
      related condition to which the claim refers;
        (iii) the claim and the food for which the claim is made are in
      compliance with clause (A)(ii) and are otherwise in compliance
      with paragraph (a) and section 321(n) of this title; and
        (iv) the claim is stated in a manner so that the claim is an
      accurate representation of the authoritative statement referred
      to in subclause (i) and so that the claim enables the public to
      comprehend the information provided in the claim and to
      understand the relative significance of such information in the
      context of a total daily diet.

    For purposes of this clause, a statement shall be regarded as an
    authoritative statement of a scientific body described in subclause
    (i) only if the statement is published by the scientific body and
    shall not include a statement of an employee of the scientific body
    made in the individual capacity of the employee.
      (D) A claim submitted under the requirements of clause (C) may be
    made until - 
        (i) such time as the Secretary issues a regulation under the
      standard in clause (B)(i) - 
          (I) prohibiting or modifying the claim and the regulation has
        become effective, or
          (II) finding that the requirements of clause (C) have not
        been met, including finding that the petitioner has not
        submitted all the information required by such clause; or

        (ii) a district court of the United States in an enforcement
      proceeding under subchapter III of this chapter has determined
      that the requirements of clause (C) have not been met.

      (4)(A)(i) Any person may petition the Secretary to issue a
    regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
    claim described in subparagraph (1)(A) or (1)(B). Not later than
    100 days after the petition is received by the Secretary, the
    Secretary shall issue a final decision denying the petition or file
    the petition for further action by the Secretary. If the Secretary
    does not act within such 100 days, the petition shall be deemed to
    be denied unless an extension is mutually agreed upon by the
    Secretary and the petitioner. If the Secretary denies the petition
    or the petition is deemed to be denied, the petition shall not be
    made available to the public. If the Secretary files the petition,
    the Secretary shall deny the petition or issue a proposed
    regulation to take the action requested in the petition not later
    than 90 days after the date of such decision. If the Secretary does
    not act within such 90 days, the petition shall be deemed to be
    denied unless an extension is mutually agreed upon by the Secretary
    and the petitioner. If the Secretary issues a proposed regulation,
    the rulemaking shall be completed within 540 days of the date the
    petition is received by the Secretary. If the Secretary does not
    issue a regulation within such 540 days, the Secretary shall
    provide the Committee on Commerce of the House of Representatives
    and the Committee on Labor and Human Resources of the Senate the
    reasons action on the regulation did not occur within such 540
    days.
      (ii) Any person may petition the Secretary for permission to use
    in a claim described in subparagraph (1)(A) terms that are
    consistent with the terms defined by the Secretary under
    subparagraph (2)(A)(i). Within 90 days of the submission of such a
    petition, the Secretary shall issue a final decision denying the
    petition or granting such permission.
      (iii) Any person may petition the Secretary for permission to use
    an implied claim described in subparagraph (1)(A) in a brand name.
    After publishing notice of an opportunity to comment on the
    petition in the Federal Register and making the petition available
    to the public, the Secretary shall grant the petition if the
    Secretary finds that such claim is not misleading and is consistent
    with terms defined by the Secretary under subparagraph (2)(A)(i).
    The Secretary shall grant or deny the petition within 100 days of
    the date it is submitted to the Secretary and the petition shall be
    considered granted if the Secretary does not act on it within such
    100 days.
      (B) A petition under clause (A)(i) respecting a claim described
    in subparagraph (1)(A) or (1)(B) shall include an explanation of
    the reasons why the claim meets the requirements of this paragraph
    and a summary of the scientific data which supports such reasons.
      (C) If a petition for a regulation under subparagraph (3)(B)
    relies on a report from an authoritative scientific body of the
    United States, the Secretary shall consider such report and shall
    justify any decision rejecting the conclusions of such report.
      (5)(A) This paragraph does not apply to infant formulas subject
    to section 350a(h) of this title and medical foods as defined in
    section 360ee(b) of this title.
      (B) Subclauses (iii) through (v) of subparagraph (2)(A) and
    subparagraph (2)(B) do not apply to food which is served in
    restaurants or other establishments in which food is served for
    immediate human consumption or which is sold for sale or use in
    such establishments.
      (C) A subparagraph (1)(A) claim made with respect to a food which
    claim is required by a standard of identity issued under section
    341 of this title shall not be subject to subparagraph (2)(A)(i) or
    (2)(B).
      (D) A subparagraph (1)(B) claim made with respect to a dietary
    supplement of vitamins, minerals, herbs, or other similar
    nutritional substances shall not be subject to subparagraph (3) but
    shall be subject to a procedure and standard, respecting the
    validity of such claim, established by regulation of the Secretary.
      (6) For purposes of paragraph (r)(1)(B), a statement for a
    dietary supplement may be made if - 
        (A) the statement claims a benefit related to a classical
      nutrient deficiency disease and discloses the prevalence of such
      disease in the United States, describes the role of a nutrient or
      dietary ingredient intended to affect the structure or function
      in humans, characterizes the documented mechanism by which a
      nutrient or dietary ingredient acts to maintain such structure or
      function, or describes general well-being from consumption of a
      nutrient or dietary ingredient,
        (B) the manufacturer of the dietary supplement has
      substantiation that such statement is truthful and not
      misleading, and
        (C) the statement contains, prominently displayed and in
      boldface type, the following: "This statement has not been
      evaluated by the Food and Drug Administration. This product is
      not intended to diagnose, treat, cure, or prevent any disease.".

    A statement under this subparagraph may not claim to diagnose,
    mitigate, treat, cure, or prevent a specific disease or class of
    diseases. If the manufacturer of a dietary supplement proposes to
    make a statement described in the first sentence of this
    subparagraph in the labeling of the dietary supplement, the
    manufacturer shall notify the Secretary no later than 30 days after
    the first marketing of the dietary supplement with such statement
    that such a statement is being made.
      (7) The Secretary may make proposed regulations issued under this
    paragraph effective upon publication pending consideration of
    public comment and publication of a final regulation if the
    Secretary determines that such action is necessary - 
        (A) to enable the Secretary to review and act promptly on
      petitions the Secretary determines provide for information
      necessary to - 
          (i) enable consumers to develop and maintain healthy dietary
        practices;
          (ii) enable consumers to be informed promptly and effectively
        of important new knowledge regarding nutritional and health
        benefits of food; or
          (iii) ensure that scientifically sound nutritional and health
        information is provided to consumers as soon as possible; or

        (B) to enable the Secretary to act promptly to ban or modify a
      claim under this paragraph.

    Such proposed regulations shall be deemed final agency action for
    purposes of judicial review.
    (s) Dietary supplements
      If - 
        (1) it is a dietary supplement; and
        (2)(A) the label or labeling of the supplement fails to list - 
          (i) the name of each ingredient of the supplement that is
        described in section 321(ff) of this title; and
          (ii)(I) the quantity of each such ingredient; or
          (II) with respect to a proprietary blend of such ingredients,
        the total quantity of all ingredients in the blend;

        (B) the label or labeling of the dietary supplement fails to
      identify the product by using the term "dietary supplement",
      which term may be modified with the name of such an ingredient;
        (C) the supplement contains an ingredient described in section
      321(ff)(1)(C) of this title, and the label or labeling of the
      supplement fails to identify any part of the plant from which the
      ingredient is derived;
        (D) the supplement - 
          (i) is covered by the specifications of an official
        compendium;
          (ii) is represented as conforming to the specifications of an
        official compendium; and
          (iii) fails to so conform; or

        (E) the supplement - 
          (i) is not covered by the specifications of an official
        compendium; and
          (ii)(I) fails to have the identity and strength that the
        supplement is represented to have; or
          (II) fails to meet the quality (including tablet or capsule
        disintegration), purity, or compositional specifications, based
        on validated assay or other appropriate methods, that the
        supplement is represented to meet.

    A dietary supplement shall not be deemed misbranded solely because
    its label or labeling contains directions or conditions of use or
    warnings.
    (t) Catfish
      If it purports to be or is represented as catfish, unless it is
    fish classified within the family Ictaluridae.
    (u) Ginseng
      If it purports to be or is represented as ginseng, unless it is
    an herb or herbal ingredient derived from a plant classified within
    the genus Panax.
    (v) Failure to label; health threat
       If - 
        (1) it fails to bear a label required by the Secretary under
      section 381(n)(1) of this title (relating to food refused
      admission into the United States);
        (2) the Secretary finds that the food presents a threat of
      serious adverse health consequences or death to humans or
      animals; and
        (3) upon or after notifying the owner or consignee involved
      that the label is required under section 381 of this title, the
      Secretary informs the owner or consignee that the food presents
      such a threat.
    (w) Major food allergen labeling requirements
      (1) If it is not a raw agricultural commodity and it is, or it
    contains an ingredient that bears or contains, a major food
    allergen, unless either - 
        (A) the word "Contains", followed by the name of the food
      source from which the major food allergen is derived, is printed
      immediately after or is adjacent to the list of ingredients (in a
      type size no smaller than the type size used in the list of
      ingredients) required under subsections (g) and (i) of this
      section; or
        (B) the common or usual name of the major food allergen in the
      list of ingredients required under subsections (g) and (i) of
      this section is followed in parentheses by the name of the food
      source from which the major food allergen is derived, except that
      the name of the food source is not required when - 
          (i) the common or usual name of the ingredient uses the name
        of the food source from which the major food allergen is
        derived; or
          (ii) the name of the food source from which the major food
        allergen is derived appears elsewhere in the ingredient list,
        unless the name of the food source that appears elsewhere in
        the ingredient list appears as part of the name of a food
        ingredient that is not a major food allergen under section
        321(qq)(2)(A) or (B) of this title.

      (2) As used in this subsection, the term "name of the food source
    from which the major food allergen is derived" means the name
    described in section 321(qq)(1) of this title; provided that in the
    case of a tree nut, fish, or Crustacean shellfish, the term "name
    of the food source from which the major food allergen is derived"
    means the name of the specific type of nut or species of fish or
    Crustacean shellfish.
      (3) The information required under this subsection may appear in
    labeling in lieu of appearing on the label only if the Secretary
    finds that such other labeling is sufficient to protect the public
    health. A finding by the Secretary under this paragraph (including
    any change in an earlier finding under this paragraph) is effective
    upon publication in the Federal Register as a notice.
      (4) Notwithstanding subsection (g), (i), or (k) of this section,
    or any other law, a flavoring, coloring, or incidental additive
    that is, or that bears or contains, a major food allergen shall be
    subject to the labeling requirements of this subsection.
      (5) The Secretary may by regulation modify the requirements of
    subparagraph (A) or (B) of paragraph (1), or eliminate either the
    requirement of subparagraph (A) or the requirements of subparagraph
    (B) of paragraph (1), if the Secretary determines that the
    modification or elimination of the requirement of subparagraph (A)
    or the requirements of subparagraph (B) is necessary to protect the
    public health.
      (6)(A) Any person may petition the Secretary to exempt a food
    ingredient described in section 321(qq)(2) of this title from the
    allergen labeling requirements of this subsection.
      (B) The Secretary shall approve or deny such petition within 180
    days of receipt of the petition or the petition shall be deemed
    denied, unless an extension of time is mutually agreed upon by the
    Secretary and the petitioner.
      (C) The burden shall be on the petitioner to provide scientific
    evidence (including the analytical method used to produce the
    evidence) that demonstrates that such food ingredient, as derived
    by the method specified in the petition, does not cause an allergic
    response that poses a risk to human health.
      (D) A determination regarding a petition under this paragraph
    shall constitute final agency action.
      (E) The Secretary shall promptly post to a public site all
    petitions received under this paragraph within 14 days of receipt
    and the Secretary shall promptly post the Secretary's response to
    each.
      (7)(A) A person need not file a petition under paragraph (6) to
    exempt a food ingredient described in section 321(qq)(2) of this
    title from the allergen labeling requirements of this subsection,
    if the person files with the Secretary a notification containing - 
        (i) scientific evidence (including the analytical method used)
      that demonstrates that the food ingredient (as derived by the
      method specified in the notification, where applicable) does not
      contain allergenic protein; or
        (ii) a determination by the Secretary that the ingredient does
      not cause an allergic response that poses a risk to human health
      under a premarket approval or notification program under section
      348 of this title.

      (B) The food ingredient may be introduced or delivered for
    introduction into interstate commerce as a food ingredient that is
    not a major food allergen 90 days after the date of receipt of the
    notification by the Secretary, unless the Secretary determines
    within the 90-day period that the notification does not meet the
    requirements of this paragraph, or there is insufficient scientific
    evidence to determine that the food ingredient does not contain
    allergenic protein or does not cause an allergenic response that
    poses a risk to human health.
      (C) The Secretary shall promptly post to a public site all
    notifications received under this subparagraph within 14 days of
    receipt and promptly post any objections thereto by the Secretary.
    (x) Nonmajor food allergen labeling requirements
      Notwithstanding subsection (g), (i), or (k) of this section, or
    any other law, a spice, flavoring, coloring, or incidental additive
    that is, or that bears or contains, a food allergen (other than a
    major food allergen), as determined by the Secretary by regulation,
    shall be disclosed in a manner specified by the Secretary by
    regulation.
    (y) Dietary supplements
      If it is a dietary supplement that is marketed in the United
    States, unless the label of such dietary supplement includes a
    domestic address or domestic phone number through which the
    responsible person (as described in section 379aa-1 of this title)
    may receive a report of a serious adverse event with such dietary
    supplement.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,
    Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I, Sec.
    102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),
    formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
    L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
    Pub. L. 94-278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat.
    411; Pub. L. 95-203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat.
    1452, 1453; Pub. L. 101-535, Secs. 2(a), 3(a), 7, Nov. 8, 1990, 104
    Stat. 2353, 2357, 2364; Pub. L. 102-108, Sec. 2(a), (c), Aug. 17,
    1991, 105 Stat. 549; Pub. L. 102-571, title I, Sec. 107(5), (6),
    Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 2(b), 3(j),
    Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103-417, Secs. 6, 7(a)-
    (c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104-
    124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-115, title
    III, Secs. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub. L. 106-
    554, Sec. 1(a)(1) [title V, Sec. 517], Dec. 21, 2000, 114 Stat.
    2763, 2763A-73; Pub. L. 107-171, title X, Secs. 10806(a)(2),
    (b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L.
    107-188, title III, Sec. 308(b), June 12, 2002, 116 Stat. 672; Pub.
    L. 108-282, title II, Sec. 203(a), Aug. 2, 2004, 118 Stat. 906;
    Pub. L. 109-462, Sec. 3(c), Dec. 22, 2006, 120 Stat. 3475.)


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (y). Pub. L. 109-462 added par. (y).
      2004 - Pars. (w), (x). Pub. L. 108-282 added pars. (w) and (x).
      2002 - Par. (h). Pub. L. 107-171, Sec. 10808(b), added subpar.
    (3) and concluding provisions.
      Par. (t). Pub. L. 107-171, Sec. 10806(a)(2), added par. (t).
      Par. (u). Pub. L. 107-171, Sec. 10806(b)(2), added par. (u).
      Par. (v). Pub. L. 107-188 added par. (v).
      2000 - Par. (o). Pub. L. 106-554, which directed repeal of
    section 403(o) of the Food, Drug, and Cosmetic Act, was executed by
    repealing par. (o) of this section, which is section 403 of the
    Federal Food, Drug, and Cosmetic Act, to reflect the probable
    intent of Congress. Prior to repeal, par. (o) provided that a food
    containing saccharin was to be deemed misbranded unless a specified
    warning statement was placed in a conspicuous place on its label.
      1997 - Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)
    generally. Prior to amendment, cl. (B) read as follows: "If a claim
    described in subparagraph (1)(A) is made with respect to a nutrient
    in a food, the label or labeling of such food shall contain,
    prominently and in immediate proximity to such claim, the following
    statement: 'See _____ for nutrition information.'. In the statement
    - 
        "(i) the blank shall identify the panel on which the
      information described in the statement may be found, and
        "(ii) if the Secretary determines that the food contains a
      nutrient at a level which increases to persons in the general
      population the risk of a disease or health-related condition
      which is diet related, taking into account the significance of
      the food in the total daily diet, the statement shall also
      identify such nutrient."
      Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G)
    and (H).
      Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C)
    and (D).
      Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after
    second sentence "If the Secretary does not act within such 100
    days, the petition shall be deemed to be denied unless an extension
    is mutually agreed upon by the Secretary and the petitioner.",
    inserted "or the petition is deemed to be denied" after "If the
    Secretary denies the petition", and inserted at end "If the
    Secretary does not act within such 90 days, the petition shall be
    deemed to be denied unless an extension is mutually agreed upon by
    the Secretary and the petitioner. If the Secretary issues a
    proposed regulation, the rulemaking shall be completed within 540
    days of the date the petition is received by the Secretary. If the
    Secretary does not issue a regulation within such 540 days, the
    Secretary shall provide the Committee on Commerce of the House of
    Representatives and the Committee on Labor and Human Resources of
    the Senate the reasons action on the regulation did not occur
    within such 540 days."
      Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).
      1996 - Par. (p). Pub. L. 104-124 struck out par. (p), which
    deemed products containing saccharin and offered for sale, but not
    for immediate consumption, by retail establishment, to be
    misbranded, unless notice of information required by subsec. (o)
    was provided by manufacturer and prominently displayed near
    product.
      1994 - Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl.
    (F) generally. Prior to amendment, cl. (F) read as follows: "If a
    food to which section 350 of this title applies (as defined in
    section 350(c) of this title) contains one or more of the nutrients
    required by subparagraph (1) or (2) to be in the label or labeling
    of the food, the label or labeling of such food shall comply with
    the requirements of subparagraphs (1) and (2) in a manner which is
    appropriate for such food and which is specified in regulations of
    the Secretary."
      Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).
      Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).
      Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: "A
    dietary supplement shall not be deemed misbranded solely because
    its label or labeling contains directions or conditions of use or
    warnings."
      Pub. L. 103-417, Sec. 7(a), added par. (s).
      1993 - Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted
    "count, except that" for "count: Provided, That".
      Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted "unless sold
    as spices, flavorings, or such colors" for ", other than those sold
    as such" and "naming each. To the extent" for "naming each:
    Provided, That, to the extent".
      Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted ", except
    that" for ": Provided, That".
      Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted "chemical,
    except that" for "chemical: Provided, however, That".
      Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E)
    and redesignated former cls. (E) and (F) as (F) and (G),
    respectively.
      Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted
    "(5)(D)" for "5(D)".
      Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted
    "paragraph" for "subsection".
      1992 - Par. (i). Pub. L. 102-571, Sec. 107(5), substituted
    "379e(c)" for "376(c)".
      Par. (m). Pub. L. 102-571, Sec. 107(6), substituted "379e" for
    "376".
      1991 - Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory
    language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment
    note below.
      Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted "(D)" for
    "(C)".
      1990 - Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L.
    102-108, Sec. 2(c), substituted "Unless" for "If it is not subject
    to the provisions of paragraph (g) unless", inserted "and if the
    food purports to be a beverage containing vegetable or fruit juice,
    a statement with appropriate prominence on the information panel of
    the total percentage of such fruit or vegetable juice contained in
    the food", and substituted "colors not required to be certified
    under section 376(c) of this title" for "colorings" the first time
    appearing.
      Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).
      Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).
      1977 - Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).
      Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).
      1976 - Par. (a). Pub. L. 94-278 inserted "(1)" after "If" and
    inserted ", or (2) in the case of a food to which section 350 of
    this title applies, its advertising is false or misleading in a
    material respect or its labeling is in violation of section
    350(b)(2) of this title" after "any particular".
      1970 - Par. (n). Pub. L. 91-601 added par. (n).
      1960 - Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide
    chemicals when used in or on a raw agricultural commodity which is
    the produce of the soil.
      Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).
      Par. (m). Pub. L. 86-618 added par. (m).

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Commerce of House of Representatives changed to
    Committee on Energy and Commerce of House of Representatives, and
    jurisdiction over matters relating to securities and exchanges and
    insurance generally transferred to Committee on Financial Services
    of House of Representatives by House Resolution No. 5, One Hundred
    Seventh Congress, Jan. 3, 2001.
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.


-MISC2-
                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Pub. L. 109-462, Sec. 3(d)(1), (2), Dec. 22, 2006, 120 Stat.
    3475, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendments made by this section [enacting section 379aa-1 of this
    title and amending this section and section 331 of this title]
    shall take effect 1 year after the date of enactment of this Act
    [Dec. 22, 2006].
      "(2) Misbranding. - Section 403(y) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall
    apply to any dietary supplement labeled on or after the date that
    is 1 year after the date of enactment of this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Amendment by Pub. L. 108-282 applicable to any food that is
    labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
    282, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 7(e) of Pub. L. 103-417 provided that: "Dietary
    supplements - 
        "(1) may be labeled after the date of the enactment of this Act
      [Oct. 25, 1994] in accordance with the amendments made by this
      section [amending this section and section 350 of this title],
      and
        "(2) shall be labeled after December 31, 1996, in accordance
      with such amendments."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided
    that:
      "(1) Except as provided in paragraph (2) - 
        "(A) the amendments made by section 2 [amending this section]
      shall take effect 6 months after - 
          "(i) the date of the promulgation of all final regulations
        required to implement section 403(q) of the Federal Food, Drug,
        and Cosmetic Act [21 U.S.C. 343(q)], or
          "(ii) if such regulations are not promulgated, the date
        proposed regulations are to be considered as such final
        regulations [Nov. 8, 1992, see 57 F.R. 56347],
      except that section 403(q)(4) of such Act shall take effect as
      prescribed by such section,
        "(B) the amendments made by section 3 [amending this section]
      shall take effect 6 months after - 
          "(i) the date of the promulgation of final regulations to
        implement section 403(r) of the Federal Food, Drug, and
        Cosmetic Act, or
          "(ii) if such regulations are not promulgated, the date
        proposed regulations are to be considered as such final
        regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any
        person marketing a food the brand name of which contains a term
        defined by the Secretary under section 403(r)(2)(A)(i) of the
        Federal Food, Drug, and Cosmetic Act shall be given an
        additional 6 months to comply with section 3,
        "(C) the amendments made by section 4 [amending section 337 of
      this title] shall take effect 24 months after the date of the
      enactment of this Act [Nov. 8, 1990], except that such amendments
      shall take effect with respect to such dietary supplements
      [probably means dietary supplements of vitamins, minerals, herbs,
      or other similar nutritional substances, see section 202(a)(1) of
      Pub. L. 102-571, set out below] on December 31, 1993, and
        "(D) the amendments made by section 5 [amending sections 321
      and 345 of this title] shall take effect on the date the
      amendments made by section 3 take effect.
      "(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act
    (as added by section 2) shall not apply with respect to food which
    was labeled before the effective date of the amendments made by
    section 2 and section 403(r) of the Federal Food, Drug, and
    Cosmetic Act (as added by section 3) shall not apply with respect
    to food which was labeled before the effective date of the
    amendments made by section 3.
      "(3)(A) If the Secretary finds that a person who is subject to
    section 403(q)(4) of such Act is unable to comply with the
    requirements of such section upon the effective date of final
    regulations to implement section 403(q) of such Act or of proposed
    regulations to be considered as such final regulations because the
    Secretary has not made available to such person the information
    required by such section, the Secretary shall delay the application
    of such section to such person for such time as the Secretary may
    require to provide such information.
      "(B) If the Secretary finds that compliance with section 403(q)
    or 403(r)(2) of such Act would cause an undue economic hardship,
    the Secretary may delay the application of such sections for no
    more than one year."
      Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,
    Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,
    Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
      "(1) Except as provided in paragraphs (2) and (3), the amendments
    made by section 7 [amending this section] shall take effect one
    year after the date of the enactment of this Act [Nov. 8, 1990].
      "(2)(A) If a food subject to section 403(g) of the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or
    more colors required to be certified under section 721(c) [of the
    Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a
    label which was printed before July 1, 1991, and which is attached
    to the food before May 8, 1993, such food shall not be subject to
    the amendments made by section 7(1) and section 7(3) [amending this
    section].
      "(B) If a food described in subparagraph (A) - 
        "(i) bears a label which was printed after July 1, 1991, but
      before the date the proposed regulation described in clause (ii)
      takes effect as a final regulation and which was attached to the
      food before May 8, 1993, and
        "(ii) meets the requirements of the proposed regulation of the
      Secretary of Health and Human Services published in 56 Fed. Reg.
      28592-28636 (June 21, 1991) as it pertains to the amendments made
      by this Act [see Short Title of 1990 Amendment note set out under
      section 301 of this title],
    such food shall not be subject to the amendments made by section
    7(1) and section 7(3) [amending this section].
      "(3) A food purported to be a beverage containing a vegetable or
    fruit juice which bears a label attached to the food before May 8,
    1993, shall not be subject to the amendments made by section 7(2)
    [amending this section]."

                     EFFECTIVE DATE OF 1977 AMENDMENT                 
      Section 4(a)(2) of Pub. L. 95-203 provided that: "The amendment
    made by paragraph (1) [amending this section] shall apply only with
    respect to food introduced or delivered for introduction in
    interstate commerce on and after the 90th day after the date of the
    enactment of this Act [Nov. 23, 1977]."
      Section 4(b)(2) of Pub. L. 95-203 provided that: "The amendment
    made by paragraph (1) [amending this section] shall apply with
    respect to food which is sold in retail establishments on or after
    the 90th day after the effective date of the regulations of the
    Secretary of Health, Education, and Welfare [now Secretary of
    Health and Human Services] under paragraph (p)(4) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)]."

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
    1976, see section 502(c) of Pub. L. 94-278, set out as a note under
    section 334 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
    subsections effective July 1, 1940, as provided by regulations for
    certain lithographed labeling and containers bearing certain
    labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
    an Effective Date; Postponement in Certain Cases note under section
    301 of this title.

               CONSTRUCTION OF AMENDMENT BY PUB. L. 108-282           
      Pub. L. 108-282, title II, Sec. 203(b), Aug. 2, 2004, 118 Stat.
    908, provided that: "The amendments made by this section [amending
    this section and sections 321 and 343-1 of this title] that require
    a label or labeling for major food allergens do not alter the
    authority of the Secretary of Health and Human Services under the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to
    require a label or labeling for other food allergens."

               CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188           
      Nothing in amendment by Pub. L. 107-188 to be construed to limit
    authority of Secretary of Health and Human Services or Secretary of
    the Treasury to require marking of articles of food imported or
    offered for import into the United States which are refused
    admission, see section 308(c) of Pub. L. 107-188, set out as a note
    under section 381 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Section 9 of Pub. L. 101-535 provided that: "The amendments made
    by this Act [enacting section 343-1 of this title and amending this
    section and sections 321, 337, 345, and 371 of this title] shall
    not be construed to alter the authority of the Secretary of Health
    and Human Services and the Secretary of Agriculture under the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the
    Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry
    Products Inspection Act [21 U.S.C. 451 et seq.], and the Egg
    Products Inspection Act [21 U.S.C. 1031 et seq.]."

                                 FINDINGS                             
      Pub. L. 108-282, title II, Sec. 202, Aug. 2, 2004, 118 Stat. 905,
    provided that: "Congress finds that - 
        "(1) it is estimated that - 
          "(A) approximately 2 percent of adults and about 5 percent of
        infants and young children in the United States suffer from
        food allergies; and
          "(B) each year, roughly 30,000 individuals require emergency
        room treatment and 150 individuals die because of allergic
        reactions to food;
        "(2)(A) eight major foods or food groups - milk, eggs, fish,
      Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans -
      account for 90 percent of food allergies;
        "(B) at present, there is no cure for food allergies; and
        "(C) a food allergic consumer must avoid the food to which the
      consumer is allergic;
        "(3)(A) in a review of the foods of randomly selected
      manufacturers of baked goods, ice cream, and candy in Minnesota
      and Wisconsin in 1999, the Food and Drug Administration found
      that 25 percent of sampled foods failed to list peanuts or eggs
      as ingredients on the food labels; and
        "(B) nationally, the number of recalls because of unlabeled
      allergens rose to 121 in 2000 from about 35 a decade earlier;
        "(4) a recent study shows that many parents of children with a
      food allergy were unable to correctly identify in each of several
      food labels the ingredients derived from major food allergens;
        "(5)(A) ingredients in foods must be listed by their 'common or
      usual name';
        "(B) in some cases, the common or usual name of an ingredient
      may be unfamiliar to consumers, and many consumers may not
      realize the ingredient is derived from, or contains, a major food
      allergen; and
        "(C) in other cases, the ingredients may be declared as a
      class, including spices, flavorings, and certain colorings, or
      are exempt from the ingredient labeling requirements, such as
      incidental additives; and
        "(6)(A) celiac disease is an immune-mediated disease that
      causes damage to the gastrointestinal tract, central nervous
      system, and other organs;
        "(B) the current recommended treatment is avoidance of glutens
      in foods that are associated with celiac disease; and
        "(C) a multicenter, multiyear study estimated that the
      prevalence of celiac disease in the United States is 0.5 to 1
      percent of the general population."

                                REGULATIONS                            
      Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
    4501, provided that:
      "(1) The Secretary of Health and Human Services shall issue
    proposed regulations to implement section 403(q) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months
    after the date of the enactment of this Act [Nov. 8, 1990], except
    that the Secretary shall issue, not later than June 15, 1993,
    proposed regulations that are applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional substances
    to implement such section. Not later than 24 months after the date
    of the enactment of this Act, the Secretary shall issue final
    regulations to implement the requirements of such section, except
    that the Secretary shall issue, not later than December 31, 1993,
    such a final regulation applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional
    substances..[sic] Such regulations shall - 
        "(A) require the required information to be conveyed to the
      public in a manner which enables the public to readily observe
      and comprehend such information and to understand its relative
      significance in the context of a total daily diet,
        "(B) include regulations which establish standards, in
      accordance with paragraph (1)(A), to define serving size or other
      unit of measure for food,
        "(C) permit the label or labeling of food to include nutrition
      information which is in addition to the information required by
      such section 403(q) and which is of the type described in
      subparagraph (1) or (2) of such section, and
        "(D) permit the nutrition information on the label or labeling
      of a food to remain the same or permit the information to be
      stated as a range even though (i) there are minor variations in
      the nutritional value of the food which occur in the normal
      course of the production or processing of the food, or (ii) the
      food is comprised of an assortment of similar foods which have
      variations in nutritional value.
      "(2) If the Secretary of Health and Human Services does not
    promulgate final regulations under paragraph (1) upon the
    expiration of 24 months after the date of the enactment of this
    Act, the proposed regulations issued in accordance with paragraph
    (1) shall be considered as the final regulations upon the
    expiration of such 24 months, except that the proposed regulations
    applicable to dietary supplements of vitamins, minerals, herbs, or
    other similar nutritional substances shall not be considered to be
    final regulations until December 31, 1993. There shall be promptly
    published in the Federal Register notice of new status of the
    proposed regulations [see 57 F.R. 56347].
      "(3) If the Secretary of Health and Human Services does not
    promulgate final regulations under section 403(q)(4) of the Federal
    Food, Drug, and Cosmetic Act upon the expiration of 6 months after
    the date on which the Secretary makes a finding that there has been
    no substantial compliance with section 403(q)(4)(C) of such Act,
    the proposed regulations issued in accordance with such section
    shall be considered as the final regulations upon the expiration of
    such 6 months. There shall be promptly published in the Federal
    Register notice of new status of the proposed regulations."
      [Section 202(a)(2)(C) of Pub. L. 102-571 provided that: "The
    amendments made by subparagraph (B) [amending sections 2(b) and
    3(b) of Pub. L. 101-535, set out above and below] shall not be
    construed to modify the effective date of final regulations under
    sections 2(b) and 3(b) of the Nutrition Labeling and Education Act
    of 1990 [Pub. L. 101-535] (21 U.S.C. 343 note) with respect to
    foods that are not such dietary supplements."]
      Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
    4501, provided that:
      "(1)(A) Within 12 months of the date of the enactment of this Act
    [Nov. 8, 1990], the Secretary of Health and Human Services shall
    issue proposed regulations to implement section 403(r) of the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except
    that the Secretary shall issue, not later than June 15, 1993,
    proposed regulations that are applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional substances
    to implement such section. Such regulations - 
        "(i) shall identify claims described in section 403(r)(1)(A) of
      such Act which comply with section 403(r)(2) of such Act,
        "(ii) shall identify claims described in section 403(r)(1)(B)
      of such Act which comply with section 403(r)(3) of such Act,
        "(iii) shall, in defining terms used to characterize the level
      of any nutrient in food under section 403(r)(2)(A)(i) of such
      Act, define - 
          "(I) free,
          "(II) low,
          "(III) light or lite,
          "(IV) reduced,
          "(V) less, and
          "(VI) high,
      unless the Secretary finds that the use of any such term would be
      misleading,
        "(iv) shall permit statements describing the amount and
      percentage of nutrients in food which are not misleading and are
      consistent with the terms defined in section 403(r)(2)(A)(i) of
      such Act,
        "(v) shall provide that if multiple claims subject to section
      403(r)(1)(A) of such Act are made on a single panel of the food
      label or page of a labeling brochure, a single statement may be
      made to satisfy section 403(r)(2)(B) of such Act,
        "(vi) shall determine whether claims respecting the following
      nutrients and diseases meet the requirements of section 403(r)(3)
      of such Act: Calcium and osteoporosis, dietary fiber and cancer,
      lipids and cardiovascular disease, lipids and cancer, sodium and
      hypertension, and dietary fiber and cardiovascular disease,
        "(vii) shall not require a person who proposes to make a claim
      described in section 403(r)(1)(B) of such Act which is in
      compliance with such regulations to secure the approval of the
      Secretary before making such claim,
        "(viii) may permit a claim described in section 403(r)(1)(A) of
      such Act to be made for butter,
        "(ix) may, in defining terms under section 403(r)(2)(A)(i),
      include similar terms which are commonly understood to have the
      same meaning, and
        "(x) shall establish, as required by section 403(r)(5)(D), the
      procedure and standard respecting the validity of claims made
      with respect to a dietary supplement of vitamins, minerals,
      herbs, or other similar nutritional substances and shall
      determine whether claims respecting the following nutrients and
      diseases meet the requirements of section 403(r)(5)(D) of such
      Act: folic acid and neural tube defects, antioxident [sic]
      vitamins and cancer, zinc and immune function in the elderly, and
      omega-3 fatty acids and heart disease.
      "(B) Not later than 24 months after the date of the enactment of
    this Act, the Secretary shall issue final regulations to implement
    section 403(r) of the Federal Food, Drug, and Cosmetic Act, except
    that the Secretary shall issue, not later than December 31, 1993,
    such a final regulation applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional
    substances..[sic]
      "(2) If the Secretary does not promulgate final regulations under
    paragraph (1)(B) upon the expiration of 24 months after the date of
    the enactment of this Act, the proposed regulations issued in
    accordance with paragraph (1)(A) shall be considered as the final
    regulations upon the expiration of such 24 months, except that the
    proposed regulations applicable to dietary supplements of vitamins,
    minerals, herbs, or other similar nutritional substances shall not
    be considered to be final regulations until December 31, 1993.
    There shall be promptly published in the Federal Register notice of
    the new status of the proposed regulations [see 57 F.R. 56347]."
      [For construction of amendment made by section 202(a)(2)(B) of
    Pub. L. 102-571 to section 3(b) of Pub. L. 101-535 set out above,
    see section 202(a)(2)(C) of Pub. L. 102-571 set out above following
    section 2(b) of Pub. L. 101-535.]


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC3-
                          RULEMAKING ON LABELING                      
      Pub. L. 108-282, title II, Sec. 206, Aug. 2, 2004, 118 Stat. 910,
    provided that: "Not later than 2 years after the date of enactment
    of this Act [Aug. 2, 2004], the Secretary of Health and Human
    Services, in consultation with appropriate experts and
    stakeholders, shall issue a proposed rule to define, and permit use
    of, the term 'gluten-free' on the labeling of foods. Not later than
    4 years after the date of enactment of this Act, the Secretary
    shall issue a final rule to define, and permit use of, the term
    'gluten-free' on the labeling of foods."
      Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat.
    531, provided that: "The Secretary of Health and Human Services
    (referred to in this section as the 'Secretary') shall publish a
    proposed rule and, with due consideration to public comment, a
    final rule to revise, as appropriate, the current regulation
    governing the labeling of foods that have been treated to reduce
    pest infestation or pathogens by treatment by irradiation using
    radioactive isotope, electronic beam, or x-ray. Pending
    promulgation of the final rule required by this subsection
    [probably should be "this section"], any person may petition the
    Secretary for approval of labeling, which is not false or
    misleading in any material respect, of a food which has been
    treated by irradiation using radioactive isotope, electronic beam,
    or x-ray. The Secretary shall approve or deny such a petition
    within 180 days of receipt of the petition, or the petition shall
    be deemed denied, except to the extent additional agency review is
    mutually agreed upon by the Secretary and the petitioner. Any
    denial of a petition under this subsection shall constitute final
    agency action subject to judicial review by the United States Court
    of Appeals for the District of Columbia Circuit. Any labeling
    approved through the foregoing petition process shall be subject to
    the provisions of the final rule referred to in the first sentence
    of the subparagraph on the effective date of such final rule."

                  COMMISSION ON DIETARY SUPPLEMENT LABELS              
      Section 12 of Pub. L. 103-417 provided that:
      "(a) Establishment. - There shall be established as an
    independent agency within the executive branch a commission to be
    known as the Commission on Dietary Supplement Labels (hereafter in
    this section referred to as the 'Commission').
      "(b) Membership. - 
        "(1) Composition. - The Commission shall be composed of 7
      members who shall be appointed by the President.
        "(2) Expertise requirement. - The members of the Commission
      shall consist of individuals with expertise and experience in
      dietary supplements and in the manufacture, regulation,
      distribution, and use of such supplements. At least three of the
      members of the Commission shall be qualified by scientific
      training and experience to evaluate the benefits to health of the
      use of dietary supplements and one of such three members shall
      have experience in pharmacognosy, medical botany, traditional
      herbal medicine, or other related sciences. Members and staff of
      the Commission shall be without bias on the issue of dietary
      supplements.
      "(c) Functions of the Commission. - The Commission shall conduct
    a study on, and provide recommendations for, the regulation of
    label claims and statements for dietary supplements, including the
    use of literature in connection with the sale of dietary
    supplements and procedures for the evaluation of such claims. In
    making such recommendations, the Commission shall evaluate how best
    to provide truthful, scientifically valid, and not misleading
    information to consumers so that such consumers may make informed
    and appropriate health care choices for themselves and their
    families.
      "(d) Administrative Powers of the Commission. - 
        "(1) Hearings. - The Commission may hold hearings, sit and act
      at such times and places, take such testimony, and receive such
      evidence as the Commission considers advisable to carry out the
      purposes of this section.
        "(2) Information from federal agencies. - The Commission may
      secure directly from any Federal department or agency such
      information as the Commission considers necessary to carry out
      the provisions of this section.
        "(3) Authorization of appropriations. - There are authorized to
      be appropriated such sums as may be necessary to carry out this
      section.
      "(e) Reports and Recommendations. - 
        "(1) Final report required. - Not later than 24 months after
      the date of enactment of this Act [Oct. 25, 1994], the Commission
      shall prepare and submit to the President and to the Congress a
      final report on the study required by this section.
        "(2) Recommendations. - The report described in paragraph (1)
      shall contain such recommendations, including recommendations for
      legislation, as the Commission deems appropriate.
        "(3) Action on recommendations. - Within 90 days of the
      issuance of the report under paragraph (1), the Secretary of
      Health and Human Services shall publish in the Federal Register a
      notice of any recommendation of Commission for changes in
      regulations of the Secretary for the regulation of dietary
      supplements and shall include in such notice a notice of proposed
      rulemaking on such changes together with an opportunity to
      present views on such changes. Such rulemaking shall be completed
      not later than 2 years after the date of the issuance of such
      report. If such rulemaking is not completed on or before the
      expiration of such 2 years, regulations of the Secretary
      published in 59 FR 395-426 on January 4, 1994, shall not be in
      effect."

    EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED
                          PRIOR TO AUGUST 8, 1994
      Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: "That
    before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the
    provision of section 403(i) of such Act added by section 7(2) of
    the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-535],
    shall not apply with respect to a food product which is contained
    in a package for which the label was printed before May 8, 1994 (or
    before August 8, 1994, in the case of a juice or milk food product
    if the person responsible for the labeling of such food product
    exercised due diligence in obtaining before such date labels which
    are in compliance with such sections 403(q) and 403(r)(2) and such
    provision of section 403(i)), if, before June 15, 1994, the person
    who introduces or delivers for introduction such food product into
    interstate commerce submits to the Secretary of Health and Human
    Services a certification that such person will comply with this
    section and will comply with such sections 403(q) and 403(r)(2) and
    such provision of section 403(i) after August 8, 1994."

          LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION      
      Section 2(a) of Pub. L. 103-80 provided that:
      "(1) Before may 8, 1995. - Before May 8, 1995, the exemption
    provided by section 403(q)(5)(D) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in
    accordance with the regulations of the Secretary of Health and
    Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).
      "(2) After may 8, 1995. - After May 8, 1995, the exemption
    provided by section 403(q)(5)(D) of the Federal Food, Drug, and
    Cosmetic Act shall only be available with respect to food when it
    is sold to consumers."

     PROHIBITION ON IMPLEMENTATION OF PUB. L. 101-535 WITH RESPECT TO
                            DIETARY SUPPLEMENTS
      Section 202(a)(1) of Pub. L. 102-571 provided that:
    "Notwithstanding any other provision of law and except as provided
    in subsection (b) [set out as a note below] and in the amendment
    made by paragraph (2)(A) [amending provisions set out as notes
    above], the Secretary of Health and Human Services may not
    implement the Nutrition Labeling and Education Act of 1990 (Public
    Law 101-535; 104 Stat. 2353) [see Short Title of 1990 Amendments
    note set out under section 301 of this title], or any amendment
    made by such Act, earlier than December 15, 1993, with respect to
    dietary supplements of vitamins, minerals, herbs, or other similar
    nutritional substances."

          HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS      
      Section 202(b) of Pub. L. 102-571 provided that: "Notwithstanding
    section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions
    set out as notes above and amending provisions set out as notes
    above and under section 343-1 of this title], the Secretary of
    Health and Human Services may, earlier than December 15, 1993,
    approve claims made with respect to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional substances
    that are claims described in clauses (vi) and (x) of section
    3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990
    [Pub. L. 101-535] (21 U.S.C. 343 note)."

    UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS
      Section 203 of Pub. L. 102-571 provided that: "Notwithstanding
    any other provision of Federal law, no regulations that require the
    use of, or are based upon, recommended daily allowances of vitamins
    or minerals may be promulgated before November 8, 1993 (other than
    regulations establishing the United States recommended daily
    allowances specified at section 101.9(c)(7)(iv) of title 21, Code
    of Federal Regulations, as in effect on October 6, 1992, or
    regulations under section 403(r)(1)(A) of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such
    recommended daily allowances)."

                            CONSUMER EDUCATION                        
      Section 2(c) of Pub. L. 101-535 provided that: "The Secretary of
    Health and Human Services shall carry out activities which educate
    consumers about - 
        "(1) the availability of nutrition information in the label or
      labeling of food, and
        "(2) the importance of that information in maintaining healthy
      dietary practices."

    STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD
                AND IMPURITIES IN AND TOXICITY OF SACCHARIN
      Section 2 of Pub. L. 95-203 directed Secretary of Health,
    Education, and Welfare to conduct a study concerning carcinogenic
    and other toxic substances in food and impurities in and toxicity
    of saccharin and make a report respecting the carcinogenic and
    other substances to Committee on Human Resources of the Senate
    within 12 months of Nov. 23, 1977, and a report respecting
    saccharin to such committee within 15 months of Nov. 23, 1977.

    REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT
                           TO FORMER PAR. (O)(2)
      Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was
    to report to specified congressional committees any action taken
    under former par. (o)(2) of this section.

                     STATE OR TERRITORIAL REQUIREMENTS                 
      Section 2 of Pub. L. 86-537 provided that: "Nothing in the
    amendments made by the first section of this Act [amending this
    section] shall affect any requirement of the laws of any State or
    Territory."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 343-1                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343-1. National uniform nutrition labeling

-STATUTE-
      (a) Except as provided in subsection (b) of this section, no
    State or political subdivision of a State may directly or
    indirectly establish under any authority or continue in effect as
    to any food in interstate commerce - 
        (1) any requirement for a food which is the subject of a
      standard of identity established under section 341 of this title
      that is not identical to such standard of identity or that is not
      identical to the requirement of section 343(g) of this title,
      except that this paragraph does not apply to a standard of
      identity of a State or political subdivision of a State for maple
      syrup that is of the type required by sections 341 and 343(g) of
      this title,
        (2) any requirement for the labeling of food of the type
      required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x)
      of this title that is not identical to the requirement of such
      section, except that this paragraph does not apply to a
      requirement of a State or political subdivision of a State that
      is of the type required by section 343(c) of this title and that
      is applicable to maple syrup,
        (3) any requirement for the labeling of food of the type
      required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or
      343(k) of this title that is not identical to the requirement of
      such section, except that this paragraph does not apply to a
      requirement of a State or political subdivision of a State that
      is of the type required by section 343(h)(1) of this title and
      that is applicable to maple syrup,
        (4) any requirement for nutrition labeling of food that is not
      identical to the requirement of section 343(q) of this title,
      except a requirement for nutrition labeling of food which is
      exempt under subclause (i) or (ii) of section 343(q)(5)(A) of
      this title, or
        (5) any requirement respecting any claim of the type described
      in section 343(r)(1) of this title made in the label or labeling
      of food that is not identical to the requirement of section
      343(r) of this title, except a requirement respecting a claim
      made in the label or labeling of food which is exempt under
      section 343(r)(5)(B) of this title.

    Paragraph (3) shall take effect in accordance with section 6(b) of
    the Nutrition Labeling and Education Act of 1990.
      (b) Upon petition of a State or a political subdivision of a
    State, the Secretary may exempt from subsection (a) of this
    section, under such conditions as may be prescribed by regulation,
    any State or local requirement that - 
        (1) would not cause any food to be in violation of any
      applicable requirement under Federal law,
        (2) would not unduly burden interstate commerce, and
        (3) is designed to address a particular need for information
      which need is not met by the requirements of the sections
      referred to in subsection (a) of this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403A, as added Pub. L. 101-535, Sec.
    6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102-108, Sec.
    2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103-396, Sec. 3(a),
    Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108-282, title II, Sec.
    203(c)(2), Aug. 2, 2004, 118 Stat. 908.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 6(b) of the Nutrition Labeling and Education Act of 1990
    [Pub. L. 101-535], referred to in subsec. (a), is set out below.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (a)(2). Pub. L. 108-282 substituted "343(i)(2),
    343(w), or 343(x)" for "or 343(i)(2)".
      1994 - Subsec. (a)(1). Pub. L. 103-396, Sec. 3(a)(1), inserted at
    end "except that this paragraph does not apply to a standard of
    identity of a State or political subdivision of a State for maple
    syrup that is of the type required by sections 341 and 343(g) of
    this title,".
      Subsec. (a)(2). Pub. L. 103-396, Sec. 3(a)(2), inserted at end
    "except that this paragraph does not apply to a requirement of a
    State or political subdivision of a State that is of the type
    required by section 343(c) of this title and that is applicable to
    maple syrup,".
      Subsec. (a)(3). Pub. L. 103-396, Sec. 3(a)(3), inserted at end
    "except that this paragraph does not apply to a requirement of a
    State or political subdivision of a State that is of the type
    required by section 343(h)(1) of this title and that is applicable
    to maple syrup,".
      1991 - Subsec. (a)(5). Pub. L. 102-108 substituted "section
    343(r)(5)(B) of this title" for "clause (B) of such section".

                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Amendment by Pub. L. 108-282 applicable to any food that is
    labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
    282, set out as a note under section 321 of this title.

                              EFFECTIVE DATE                          
      Section 10(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title I, Sec. 107(16), title II, Sec. 202(a)(4), Oct. 29, 1992, 106
    Stat. 4499, 4501, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendments made by section 6 [enacting this section] shall take
    effect - 
        "(A) with respect to a requirement of a State or political
      subdivision described in paragraph (1) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this
      section], on the date of the enactment of this Act [Nov. 8,
      1990],
        "(B) with respect to a requirement of a State or political
      subdivision described in paragraph (2) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, one year after the date of
      the enactment of this Act,
        "(C) with respect to a requirement of a State or political
      subdivision described in paragraph (3) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, as prescribed by section
      6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L.
      101-535, set out below],
        "(D) with respect to a requirement of a State or political
      subdivision described in paragraph (4) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, on the date regulations to
      implement section 403(q) of such Act [21 U.S.C. 343(q)] take
      effect, and
        "(E) with respect to a requirement of a State or political
      subdivision described in paragraph (5) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, on the date regulations to
      implement section 403(r) of such Act take effect.
      "(2) Exception. - If a State or political subdivision submits a
    petition under section 403A(b) of the Federal Food, Drug, and
    Cosmetic Act for a requirement described in section 403A(a) of such
    Act within 18 months of the date of the enactment of this Act,
    paragraphs (3) through (5) of such section 403A(a) shall not apply
    with respect to such State or political subdivision requirement
    until - 
        "(A) 24 months after the date of the enactment of this Act, or
        "(B) action on the petition,
    whichever occurs later.
      "(3) Requirements pertaining to certain claims. - Notwithstanding
    subparagraphs (D) and (E) of paragraph (1) and except with respect
    to claims approved in accordance with section 202(b) of the Dietary
    Supplement Act of 1992 [Pub. L. 102-571, set out as a note under
    section 343 of this title], the requirements described in
    paragraphs (4) and (5) of section 403A(a) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4) and (5)) that pertain
    to dietary supplements of vitamins, minerals, herbs, or other
    similar nutritional substances shall not take effect until the date
    final regulations take effect to implement subsection (q) or (r),
    as appropriate, of section 403 of such Act with respect to such
    dietary supplements."
      Section 6(b) of Pub. L. 101-535 provided that:
      "(1) For the purpose of implementing section 403A(a)(3) [21
    U.S.C. 343-1(a)(3)], the Secretary of Health and Human Services
    shall enter into a contract with a public or nonprofit private
    entity to conduct a study of - 
        "(A) State and local laws which require the labeling of food
      that is of the type required by sections 403(b), 403(d), 403(f),
      403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and
      Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and
        "(B) the sections of the Federal Food, Drug, and Cosmetic Act
      referred to in subparagraph (A) and the regulations issued by the
      Secretary to enforce such sections to determine whether such
      sections and regulations adequately implement the purposes of
      such sections.
      "(2) The contract under paragraph (1) shall provide that the
    study required by such paragraph shall be completed within 6 months
    of the date of the enactment of this Act [Nov. 8, 1990].
      "(3)(A) Within 9 months of the date of the enactment of this Act,
    the Secretary shall publish a proposed list of sections which are
    adequately being implemented by regulations as determined under
    paragraph (1)(B) and sections which are not adequately being
    implemented by regulations as so determined. After publication of
    the lists, the Secretary shall provide 60 days for comments on such
    lists.
      "(B) Within 24 months of the date of the enactment of this Act,
    the Secretary shall publish a final list of sections which are
    adequately being implemented by regulations and a list of sections
    which are not adequately being implemented by regulations. With
    respect to a section which is found by the Secretary to be
    adequately implemented, no State or political subdivision of a
    State may establish or continue in effect as to any food in
    interstate commerce any requirement which is not identical to the
    requirement of such section.
      "(C) Within 24 months of the date of the enactment of this Act,
    the Secretary shall publish proposed revisions to the regulations
    found to be inadequate under subparagraph (B) and within 30 months
    of such date shall issue final revisions. Upon the effective date
    of such final revisions, no State or political subdivision may
    establish or continue in effect any requirement which is not
    identical to the requirement of the section which had its
    regulations revised in accordance with this subparagraph.
      "(D)(i) If the Secretary does not issue a final list in
    accordance with subparagraph (B), the proposed list issued under
    subparagraph (A) shall be considered the final list and States and
    political subdivisions shall be preempted with respect to sections
    found to be adequate in such proposed list in accordance with
    subparagraph (B).
      "(ii) If the Secretary does not issue final revisions of
    regulations in accordance with subparagraph (C), the proposed
    revisions issued under such subparagraph shall be considered the
    final revisions and States and political subdivisions shall be
    preempted with respect to sections the regulations of which are
    revised by the proposed revisions.
      "(E) Subsection (b) of section 403A of the Federal Food, Drug,
    and Cosmetic Act shall apply with respect to the prohibition
    prescribed by subparagraphs (B) and (C)."

                      CONSTRUCTION OF PUB. L. 101-535                  
      Section 6(c) of Pub. L. 101-535 provided that:
      "(1) The Nutrition Labeling and Education Act of 1990 [Pub. L.
    101-535, see Short Title of 1990 Amendment note set out under
    section 301 of this title] shall not be construed to preempt any
    provision of State law, unless such provision is expressly
    preempted under section 403A of the Federal Food, Drug, and
    Cosmetic Act [this section].
      "(2) The amendment made by subsection (a) [enacting this section]
    and the provisions of subsection (b) [set out as a note above]
    shall not be construed to apply to any requirement respecting a
    statement in the labeling of food that provides for a warning
    concerning the safety of the food or component of the food.
      "(3) The amendment made by subsection (a), the provisions of
    subsection (b) and paragraphs (1) and (2) of this subsection shall
    not be construed to affect preemption, express or implied, of any
    such requirement of a State or political subdivision, which may
    arise under the Constitution, any provision of the Federal Food,
    Drug, and Cosmetic Act [this chapter] not amended by subsection
    (a), any other Federal law, or any Federal regulation, order, or
    other final agency action reviewable under chapter 7 of title 5,
    United States Code."
      Amendments by Pub. L. 101-535 not to be construed to alter the
    authority of the Secretary of Health and Human Services and the
    Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21
    U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
    451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
    et seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

                DELAYED APPLICABILITY OF CERTAIN PROVISIONS            
      Pub. L. 102-408, title III, Sec. 310, Oct. 13, 1992, 106 Stat.
    2090, provided that: "Notwithstanding any other provision of law,
    section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 343-1(a)(1)) shall not apply with respect to any requirement
    of any State or political subdivision regarding maple syrup until
    September 1, 1994."

-End-



-CITE-
    21 USC Sec. 343-2                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343-2. Dietary supplement labeling exemptions

-STATUTE-
    (a) In general
      A publication, including an article, a chapter in a book, or an
    official abstract of a peer-reviewed scientific publication that
    appears in an article and was prepared by the author or the editors
    of the publication, which is reprinted in its entirety, shall not
    be defined as labeling when used in connection with the sale of a
    dietary supplement to consumers when it - 
        (1) is not false or misleading;
        (2) does not promote a particular manufacturer or brand of a
      dietary supplement;
        (3) is displayed or presented, or is displayed or presented
      with other such items on the same subject matter, so as to
      present a balanced view of the available scientific information
      on a dietary supplement;
        (4) if displayed in an establishment, is physically separate
      from the dietary supplements; and
        (5) does not have appended to it any information by sticker or
      any other method.
    (b) Application
      Subsection (a) of this section shall not apply to or restrict a
    retailer or wholesaler of dietary supplements in any way whatsoever
    in the sale of books or other publications as a part of the
    business of such retailer or wholesaler.
    (c) Burden of proof
      In any proceeding brought under subsection (a) of this section,
    the burden of proof shall be on the United States to establish that
    an article or other such matter is false or misleading.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403B, as added Pub. L. 103-417, Sec.
    5, Oct. 25, 1994, 108 Stat. 4328.)

-End-



-CITE-
    21 USC Sec. 343-3                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343-3. Disclosure

-STATUTE-
      (a) No provision of section 321(n), 343(a), or 348 of this title
    shall be construed to require on the label or labeling of a food a
    separate radiation disclosure statement that is more prominent than
    the declaration of ingredients required by section 343(i)(2) of
    this title.
      (b) In this section, the term "radiation disclosure statement"
    means a written statement that discloses that a food has been
    intentionally subject to radiation.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403C, as added Pub. L. 105-115, title
    III, Sec. 306, Nov. 21, 1997, 111 Stat. 2353.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 343a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343a. Repealed.

-MISC1-
    Sec. 343a. Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec.
      517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73.
      Section, Pub. L. 95-203, Sec. 4(c), (d), Nov. 23, 1977, 91 Stat.
    1453, 1454, related to distribution of information on health risks
    of saccharin.

-End-



-CITE-
    21 USC Sec. 344                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 344. Emergency permit control

-STATUTE-
    (a) Conditions on manufacturing, processing, etc., as health
      measure
      Whenever the Secretary finds after investigation that the
    distribution in interstate commerce of any class of food may, by
    reason of contamination with micro-organisms during the
    manufacture, processing, or packing thereof in any locality, be
    injurious to health, and that such injurious nature cannot be
    adequately determined after such articles have entered interstate
    commerce, he then, and in such case only, shall promulgate
    regulations providing for the issuance, to manufacturers,
    processors, or packers of such class of food in such locality, of
    permits to which shall be attached such conditions governing the
    manufacture, processing, or packing of such class of food, for such
    temporary period of time, as may be necessary to protect the public
    health; and after the effective date of such regulations, and
    during such temporary period, no person shall introduce or deliver
    for introduction into interstate commerce any such food
    manufactured, processed, or packed by any such manufacturer,
    processor, or packer unless such manufacturer, processor, or packer
    holds a permit issued by the Secretary as provided by such
    regulations.
    (b) Violation of permit; suspension and reinstatement
      The Secretary is authorized to suspend immediately upon notice
    any permit issued under authority of this section if it is found
    that any of the conditions of the permit have been violated. The
    holder of a permit so suspended shall be privileged at any time to
    apply for the reinstatement of such permit, and the Secretary
    shall, immediately after prompt hearing and an inspection of the
    establishment, reinstate such permit if it is found that adequate
    measures have been taken to comply with and maintain the conditions
    of the permit, as originally issued or as amended.
    (c) Inspection of permit-holding establishments
      Any officer or employee duly designated by the Secretary shall
    have access to any factory or establishment, the operator of which
    holds a permit from the Secretary, for the purpose of ascertaining
    whether or not the conditions of the permit are being complied
    with, and denial of access for such inspection shall be ground for
    suspension of the permit until such access is freely given by the
    operator.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 404, 52 Stat. 1048.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 345                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 345. Regulations making exemptions

-STATUTE-
      The Secretary shall promulgate regulations exempting from any
    labeling requirement of this chapter (1) small open containers of
    fresh fruits and fresh vegetables and (2) food which is, in
    accordance with the practice of the trade, to be processed,
    labeled, or repacked in substantial quantities at establishments
    other than those where originally processed or packed, on condition
    that such food is not adulterated or misbranded under the
    provisions of this chapter upon removal from such processing,
    labeling, or repacking establishment. This section does not apply
    to the labeling requirements of sections 343(q) and 343(r) of this
    title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 405, 52 Stat. 1049; Pub. L. 101-535,
    Sec. 5(a), Nov. 8, 1990, 104 Stat. 2362.)


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-535 inserted at end "This section does not
    apply to the labeling requirements of sections 343(q) and 343(r) of
    this title."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-535 effective six months after the date
    of the promulgation of final regulations to implement section
    343(r) of this title, or if such regulations are not promulgated,
    the date proposed regulations are to be considered as such final
    regulations (Nov. 8, 1992), with exception for persons marketing
    food the brand name of which contains a term defined by the
    Secretary under section 343(r)(2)(A)(i) of this title, see section
    10(a) of Pub. L. 101-535, set out as a note under section 343 of
    this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter
    authority of Secretary of Health and Human Services and Secretary
    of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
    et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
    seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
    seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 346                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 346. Tolerances for poisonous or deleterious substances in
      food; regulations

-STATUTE-
      Any poisonous or deleterious substance added to any food, except
    where such substance is required in the production thereof or
    cannot be avoided by good manufacturing practice shall be deemed to
    be unsafe for purposes of the application of clause (2)(A) of
    section 342(a) of this title; but when such substance is so
    required or cannot be so avoided, the Secretary shall promulgate
    regulations limiting the quantity therein or thereon to such extent
    as he finds necessary for the protection of public health, and any
    quantity exceeding the limits so fixed shall also be deemed to be
    unsafe for purposes of the application of clause (2)(A) of section
    342(a) of this title. While such a regulation is in effect limiting
    the quantity of any such substance in the case of any food, such
    food shall not, by reason of bearing or containing any added amount
    of such substance, be considered to be adulterated within the
    meaning of clause (1) of section 342(a) of this title. In
    determining the quantity of such added substance to be tolerated in
    or on different articles of food the Secretary shall take into
    account the extent to which the use of such substance is required
    or cannot be avoided in the production of each such article, and
    the other ways in which the consumer may be affected by the same or
    other poisonous or deleterious substances.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 406, 52 Stat. 1049; Pub. L. 85-929,
    Sec. 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86-618, title I,
    Sec. 103(a)(1), July 12, 1960, 74 Stat. 398.)


-MISC1-
                                AMENDMENTS                            
      1960 - Pub. L. 86-618 repealed subsec. (b) which required
    Secretary to promulgate regulations for listing of coal-tar colors.
      1958 - Subsec. (a). Pub. L. 85-929 substituted "clause (2)(A)"
    for "clause (2)" in first sentence.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

       EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
                        DESICCANT AMENDMENT OF 1959
      Effective date of subsec. (a) as in force prior to July 22, 1954,
    with respect to particular commercial use of a nematocide, plant
    regulator, defoliant, or desiccant in or on a raw agricultural
    commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
    139, Aug. 7, 1959, 73 Stat. 288.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      For effective date of amendment by Pub. L. 85-929, see section
    6(b), (c) of Pub. L. 85-929, set out as a note under section 342 of
    this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Functions vested in Secretary of Health, Education, and Welfare
    [now Health and Human Services] in establishing tolerances for
    pesticide chemicals under this section together with authority to
    monitor compliance with tolerances and effectiveness of
    surveillance and enforcement and to provide technical assistance to
    States and conduct research under this chapter and section 201 et
    seq. of Title 42, The Public Health and Welfare, transferred to
    Administrator of Environmental Protection Agency by Reorg. Plan No.
    3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
    2086, set out in the Appendix to Title 5, Government Organization
    and Employees.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration to Federal Security
    Agency, see notes set out under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 346a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 346a. Tolerances and exemptions for pesticide chemical
      residues

-STATUTE-
    (a) Requirement for tolerance or exemption
      (1) General rule
        Except as provided in paragraph (2) or (3), any pesticide
      chemical residue in or on a food shall be deemed unsafe for the
      purpose of section 342(a)(2)(B) of this title unless - 
          (A) a tolerance for such pesticide chemical residue in or on
        such food is in effect under this section and the quantity of
        the residue is within the limits of the tolerance; or
          (B) an exemption from the requirement of a tolerance is in
        effect under this section for the pesticide chemical residue.

      For the purposes of this section, the term "food", when used as a
      noun without modification, shall mean a raw agricultural
      commodity or processed food.
      (2) Processed food
        Notwithstanding paragraph (1) - 
          (A) if a tolerance is in effect under this section for a
        pesticide chemical residue in or on a raw agricultural
        commodity, a pesticide chemical residue that is present in or
        on a processed food because the food is made from that raw
        agricultural commodity shall not be considered unsafe within
        the meaning of section 342(a)(2)(B) of this title despite the
        lack of a tolerance for the pesticide chemical residue in or on
        the processed food if the pesticide chemical has been used in
        or on the raw agricultural commodity in conformity with a
        tolerance under this section, such residue in or on the raw
        agricultural commodity has been removed to the extent possible
        in good manufacturing practice, and the concentration of the
        pesticide chemical residue in the processed food is not greater
        than the tolerance prescribed for the pesticide chemical
        residue in the raw agricultural commodity; or
          (B) if an exemption for the requirement for a tolerance is in
        effect under this section for a pesticide chemical residue in
        or on a raw agricultural commodity, a pesticide chemical
        residue that is present in or on a processed food because the
        food is made from that raw agricultural commodity shall not be
        considered unsafe within the meaning of section 342(a)(2)(B) of
        this title.
      (3) Residues of degradation products
        If a pesticide chemical residue is present in or on a food
      because it is a metabolite or other degradation product of a
      precursor substance that itself is a pesticide chemical or
      pesticide chemical residue, such a residue shall not be
      considered to be unsafe within the meaning of section
      342(a)(2)(B) of this title despite the lack of a tolerance or
      exemption from the need for a tolerance for such residue in or on
      such food if - 
          (A) the Administrator has not determined that the degradation
        product is likely to pose any potential health risk from
        dietary exposure that is of a different type than, or of a
        greater significance than, any risk posed by dietary exposure
        to the precursor substance;
          (B) either - 
            (i) a tolerance is in effect under this section for
          residues of the precursor substance in or on the food, and
          the combined level of residues of the degradation product and
          the precursor substance in or on the food is at or below the
          stoichiometrically equivalent level that would be permitted
          by the tolerance if the residue consisted only of the
          precursor substance rather than the degradation product; or
            (ii) an exemption from the need for a tolerance is in
          effect under this section for residues of the precursor
          substance in or on the food; and

          (C) the tolerance or exemption for residues of the precursor
        substance does not state that it applies only to particular
        named substances and does not state that it does not apply to
        residues of the degradation product.
      (4) Effect of tolerance or exemption
        While a tolerance or exemption from the requirement for a
      tolerance is in effect under this section for a pesticide
      chemical residue with respect to any food, the food shall not by
      reason of bearing or containing any amount of such a residue be
      considered to be adulterated within the meaning of section
      342(a)(1) of this title.
    (b) Authority and standard for tolerance
      (1) Authority
        The Administrator may issue regulations establishing,
      modifying, or revoking a tolerance for a pesticide chemical
      residue in or on a food - 
          (A) in response to a petition filed under subsection (d) of
        this section; or
          (B) on the Administrator's own initiative under subsection
        (e) of this section.

      As used in this section, the term "modify" shall not mean
      expanding the tolerance to cover additional foods.
      (2) Standard
        (A) General rule
          (i) Standard
            The Administrator may establish or leave in effect a
          tolerance for a pesticide chemical residue in or on a food
          only if the Administrator determines that the tolerance is
          safe. The Administrator shall modify or revoke a tolerance if
          the Administrator determines it is not safe.
          (ii) Determination of safety
            As used in this section, the term "safe", with respect to a
          tolerance for a pesticide chemical residue, means that the
          Administrator has determined that there is a reasonable
          certainty that no harm will result from aggregate exposure to
          the pesticide chemical residue, including all anticipated
          dietary exposures and all other exposures for which there is
          reliable information.
          (iii) Rule of construction
            With respect to a tolerance, a pesticide chemical residue
          meeting the standard under clause (i) is not an eligible
          pesticide chemical residue for purposes of subparagraph (B).
        (B) Tolerances for eligible pesticide chemical residues
          (i) Definition
            As used in this subparagraph, the term "eligible pesticide
          chemical residue" means a pesticide chemical residue as to
          which - 
              (I) the Administrator is not able to identify a level of
            exposure to the residue at which the residue will not cause
            or contribute to a known or anticipated harm to human
            health (referred to in this section as a "nonthreshold
            effect");
              (II) the lifetime risk of experiencing the nonthreshold
            effect is appropriately assessed by quantitative risk
            assessment; and
              (III) with regard to any known or anticipated harm to
            human health for which the Administrator is able to
            identify a level at which the residue will not cause such
            harm (referred to in this section as a "threshold effect"),
            the Administrator determines that the level of aggregate
            exposure is safe.
          (ii) Determination of tolerance
            Notwithstanding subparagraph (A)(i), a tolerance for an
          eligible pesticide chemical residue may be left in effect or
          modified under this subparagraph if - 
              (I) at least one of the conditions described in clause
            (iii) is met; and
              (II) both of the conditions described in clause (iv) are
            met.
          (iii) Conditions regarding use
            For purposes of clause (ii), the conditions described in
          this clause with respect to a tolerance for an eligible
          pesticide chemical residue are the following:
              (I) Use of the pesticide chemical that produces the
            residue protects consumers from adverse effects on health
            that would pose a greater risk than the dietary risk from
            the residue.
              (II) Use of the pesticide chemical that produces the
            residue is necessary to avoid a significant disruption in
            domestic production of an adequate, wholesome, and
            economical food supply.
          (iv) Conditions regarding risk
            For purposes of clause (ii), the conditions described in
          this clause with respect to a tolerance for an eligible
          pesticide chemical residue are the following:
              (I) The yearly risk associated with the nonthreshold
            effect from aggregate exposure to the residue does not
            exceed 10 times the yearly risk that would be allowed under
            subparagraph (A) for such effect.
              (II) The tolerance is limited so as to ensure that the
            risk over a lifetime associated with the nonthreshold
            effect from aggregate exposure to the residue is not
            greater than twice the lifetime risk that would be allowed
            under subparagraph (A) for such effect.
          (v) Review
            Five years after the date on which the Administrator makes
          a determination to leave in effect or modify a tolerance
          under this subparagraph, and thereafter as the Administrator
          deems appropriate, the Administrator shall determine, after
          notice and opportunity for comment, whether it has been
          demonstrated to the Administrator that a condition described
          in clause (iii)(I) or clause (iii)(II) continues to exist
          with respect to the tolerance and that the yearly and
          lifetime risks from aggregate exposure to such residue
          continue to comply with the limits specified in clause (iv).
          If the Administrator determines by such date that such
          demonstration has not been made, the Administrator shall, not
          later than 180 days after the date of such determination,
          issue a regulation under subsection (e)(1) of this section to
          modify or revoke the tolerance.
          (vi) Infants and children
            Any tolerance under this subparagraph shall meet the
          requirements of subparagraph (C).
        (C) Exposure of infants and children
          In establishing, modifying, leaving in effect, or revoking a
        tolerance or exemption for a pesticide chemical residue, the
        Administrator - 
            (i) shall assess the risk of the pesticide chemical residue
          based on - 
              (I) available information about consumption patterns
            among infants and children that are likely to result in
            disproportionately high consumption of foods containing or
            bearing such residue among infants and children in
            comparison to the general population;
              (II) available information concerning the special
            susceptibility of infants and children to the pesticide
            chemical residues, including neurological differences
            between infants and children and adults, and effects of in
            utero exposure to pesticide chemicals; and
              (III) available information concerning the cumulative
            effects on infants and children of such residues and other
            substances that have a common mechanism of toxicity; and

            (ii) shall - 
              (I) ensure that there is a reasonable certainty that no
            harm will result to infants and children from aggregate
            exposure to the pesticide chemical residue; and
              (II) publish a specific determination regarding the
            safety of the pesticide chemical residue for infants and
            children.

        The Secretary of Health and Human Services and the Secretary of
        Agriculture, in consultation with the Administrator, shall
        conduct surveys to document dietary exposure to pesticides
        among infants and children. In the case of threshold effects,
        for purposes of clause (ii)(I) an additional tenfold margin of
        safety for the pesticide chemical residue and other sources of
        exposure shall be applied for infants and children to take into
        account potential pre- and post-natal toxicity and completeness
        of the data with respect to exposure and toxicity to infants
        and children. Notwithstanding such requirement for an
        additional margin of safety, the Administrator may use a
        different margin of safety for the pesticide chemical residue
        only if, on the basis of reliable data, such margin will be
        safe for infants and children.
        (D) Factors
          In establishing, modifying, leaving in effect, or revoking a
        tolerance or exemption for a pesticide chemical residue, the
        Administrator shall consider, among other relevant factors - 
            (i) the validity, completeness, and reliability of the
          available data from studies of the pesticide chemical and
          pesticide chemical residue;
            (ii) the nature of any toxic effect shown to be caused by
          the pesticide chemical or pesticide chemical residue in such
          studies;
            (iii) available information concerning the relationship of
          the results of such studies to human risk;
            (iv) available information concerning the dietary
          consumption patterns of consumers (and major identifiable
          subgroups of consumers);
            (v) available information concerning the cumulative effects
          of such residues and other substances that have a common
          mechanism of toxicity;
            (vi) available information concerning the aggregate
          exposure levels of consumers (and major identifiable
          subgroups of consumers) to the pesticide chemical residue and
          to other related substances, including dietary exposure under
          the tolerance and all other tolerances in effect for the
          pesticide chemical residue, and exposure from other non-
          occupational sources;
            (vii) available information concerning the variability of
          the sensitivities of major identifiable subgroups of
          consumers;
            (viii) such information as the Administrator may require on
          whether the pesticide chemical may have an effect in humans
          that is similar to an effect produced by a naturally
          occurring estrogen or other endocrine effects; and
            (ix) safety factors which in the opinion of experts
          qualified by scientific training and experience to evaluate
          the safety of food additives are generally recognized as
          appropriate for the use of animal experimentation data.
        (E) Data and information regarding anticipated and actual
          residue levels
          (i) Authority
            In establishing, modifying, leaving in effect, or revoking
          a tolerance for a pesticide chemical residue, the
          Administrator may consider available data and information on
          the anticipated residue levels of the pesticide chemical in
          or on food and the actual residue levels of the pesticide
          chemical that have been measured in food, including residue
          data collected by the Food and Drug Administration.
          (ii) Requirement
            If the Administrator relies on anticipated or actual
          residue levels in establishing, modifying, or leaving in
          effect a tolerance, the Administrator shall pursuant to
          subsection (f)(1) of this section require that data be
          provided five years after the date on which the tolerance is
          established, modified, or left in effect, and thereafter as
          the Administrator deems appropriate, demonstrating that such
          residue levels are not above the levels so relied on. If such
          data are not so provided, or if the data do not demonstrate
          that the residue levels are not above the levels so relied
          on, the Administrator shall, not later than 180 days after
          the date on which the data were required to be provided,
          issue a regulation under subsection (e)(1) of this section,
          or an order under subsection (f)(2) of this section, as
          appropriate, to modify or revoke the tolerance.
        (F) Percent of food actually treated
          In establishing, modifying, leaving in effect, or revoking a
        tolerance for a pesticide chemical residue, the Administrator
        may, when assessing chronic dietary risk, consider available
        data and information on the percent of food actually treated
        with the pesticide chemical (including aggregate pesticide use
        data collected by the Department of Agriculture) only if the
        Administrator - 
            (i) finds that the data are reliable and provide a valid
          basis to show what percentage of the food derived from such
          crop is likely to contain such pesticide chemical residue;
            (ii) finds that the exposure estimate does not understate
          exposure for any significant subpopulation group;
            (iii) finds that, if data are available on pesticide use
          and consumption of food in a particular area, the population
          in such area is not dietarily exposed to residues above those
          estimated by the Administrator; and
            (iv) provides for the periodic reevaluation of the estimate
          of anticipated dietary exposure.
      (3) Detection methods
        (A) General rule
          A tolerance for a pesticide chemical residue in or on a food
        shall not be established or modified by the Administrator
        unless the Administrator determines, after consultation with
        the Secretary, that there is a practical method for detecting
        and measuring the levels of the pesticide chemical residue in
        or on the food.
        (B) Detection limit
          A tolerance for a pesticide chemical residue in or on a food
        shall not be established at or modified to a level lower than
        the limit of detection of the method for detecting and
        measuring the pesticide chemical residue specified by the
        Administrator under subparagraph (A).
      (4) International standards
        In establishing a tolerance for a pesticide chemical residue in
      or on a food, the Administrator shall determine whether a maximum
      residue level for the pesticide chemical has been established by
      the Codex Alimentarius Commission. If a Codex maximum residue
      level has been established for the pesticide chemical and the
      Administrator does not propose to adopt the Codex level, the
      Administrator shall publish for public comment a notice
      explaining the reasons for departing from the Codex level.
    (c) Authority and standard for exemptions
      (1) Authority
        The Administrator may issue a regulation establishing,
      modifying, or revoking an exemption from the requirement for a
      tolerance for a pesticide chemical residue in or on food - 
          (A) in response to a petition filed under subsection (d) of
        this section; or
          (B) on the Administrator's initiative under subsection (e) of
        this section.
      (2) Standard
        (A) General rule
          (i) Standard
            The Administrator may establish or leave in effect an
          exemption from the requirement for a tolerance for a
          pesticide chemical residue in or on food only if the
          Administrator determines that the exemption is safe. The
          Administrator shall modify or revoke an exemption if the
          Administrator determines it is not safe.
          (ii) Determination of safety
            The term "safe", with respect to an exemption for a
          pesticide chemical residue, means that the Administrator has
          determined that there is a reasonable certainty that no harm
          will result from aggregate exposure to the pesticide chemical
          residue, including all anticipated dietary exposures and all
          other exposures for which there is reliable information.
        (B) Factors
          In making a determination under this paragraph, the
        Administrator shall take into account, among other relevant
        considerations, the considerations set forth in subparagraphs
        (C) and (D) of subsection (b)(2) of this section.
      (3) Limitation
        An exemption from the requirement for a tolerance for a
      pesticide chemical residue in or on food shall not be established
      or modified by the Administrator unless the Administrator
      determines, after consultation with the Secretary - 
          (A) that there is a practical method for detecting and
        measuring the levels of such pesticide chemical residue in or
        on food; or
          (B) that there is no need for such a method, and states the
        reasons for such determination in issuing the regulation
        establishing or modifying the exemption.
    (d) Petition for tolerance or exemption
      (1) Petitions and petitioners
        Any person may file with the Administrator a petition proposing
      the issuance of a regulation - 
          (A) establishing, modifying, or revoking a tolerance for a
        pesticide chemical residue in or on a food; or
          (B) establishing, modifying, or revoking an exemption from
        the requirement of a tolerance for such a residue.
      (2) Petition contents
        (A) Establishment
          A petition under paragraph (1) to establish a tolerance or
        exemption for a pesticide chemical residue shall be supported
        by such data and information as are specified in regulations
        issued by the Administrator, including - 
            (i)(I) an informative summary of the petition and of the
          data, information, and arguments submitted or cited in
          support of the petition; and
            (II) a statement that the petitioner agrees that such
          summary or any information it contains may be published as a
          part of the notice of filing of the petition to be published
          under this subsection and as part of a proposed or final
          regulation issued under this section;
            (ii) the name, chemical identity, and composition of the
          pesticide chemical residue and of the pesticide chemical that
          produces the residue;
            (iii) data showing the recommended amount, frequency,
          method, and time of application of that pesticide chemical;
            (iv) full reports of tests and investigations made with
          respect to the safety of the pesticide chemical, including
          full information as to the methods and controls used in
          conducting those tests and investigations;
            (v) full reports of tests and investigations made with
          respect to the nature and amount of the pesticide chemical
          residue that is likely to remain in or on the food, including
          a description of the analytical methods used;
            (vi) a practical method for detecting and measuring the
          levels of the pesticide chemical residue in or on the food,
          or for exemptions, a statement why such a method is not
          needed;
            (vii) a proposed tolerance for the pesticide chemical
          residue, if a tolerance is proposed;
            (viii) if the petition relates to a tolerance for a
          processed food, reports of investigations conducted using the
          processing method(s) used to produce that food;
            (ix) such information as the Administrator may require to
          make the determination under subsection (b)(2)(C) of this
          section;
            (x) such information as the Administrator may require on
          whether the pesticide chemical may have an effect in humans
          that is similar to an effect produced by a naturally
          occurring estrogen or other endocrine effects;
            (xi) information regarding exposure to the pesticide
          chemical residue due to any tolerance or exemption already
          granted for such residue;
            (xii) practical methods for removing any amount of the
          residue that would exceed any proposed tolerance; and
            (xiii) such other data and information as the Administrator
          requires by regulation to support the petition.

        If information or data required by this subparagraph is
        available to the Administrator, the person submitting the
        petition may cite the availability of the information or data
        in lieu of submitting it. The Administrator may require a
        petition to be accompanied by samples of the pesticide chemical
        with respect to which the petition is filed.
        (B) Modification or revocation
          The Administrator may by regulation establish the
        requirements for information and data to support a petition to
        modify or revoke a tolerance or to modify or revoke an
        exemption from the requirement for a tolerance.
      (3) Notice
        A notice of the filing of a petition that the Administrator
      determines has met the requirements of paragraph (2) shall be
      published by the Administrator within 30 days after such
      determination. The notice shall announce the availability of a
      description of the analytical methods available to the
      Administrator for the detection and measurement of the pesticide
      chemical residue with respect to which the petition is filed or
      shall set forth the petitioner's statement of why such a method
      is not needed. The notice shall include the summary required by
      paragraph (2)(A)(i)(I).
      (4) Actions by the Administrator
        (A) In general
          The Administrator shall, after giving due consideration to a
        petition filed under paragraph (1) and any other information
        available to the Administrator - 
            (i) issue a final regulation (which may vary from that
          sought by the petition) establishing, modifying, or revoking
          a tolerance for the pesticide chemical residue or an
          exemption of the pesticide chemical residue from the
          requirement of a tolerance (which final regulation shall be
          issued without further notice and without further period for
          public comment);
            (ii) issue a proposed regulation under subsection (e) of
          this section, and thereafter issue a final regulation under
          such subsection; or
            (iii) issue an order denying the petition.
        (B) Priorities
          The Administrator shall give priority to petitions for the
        establishment or modification of a tolerance or exemption for a
        pesticide chemical residue that appears to pose a significantly
        lower risk to human health from dietary exposure than pesticide
        chemical residues that have tolerances in effect for the same
        or similar uses.
        (C) Expedited review of certain petitions
          (i) Date certain for review
            If a person files a complete petition with the
          Administrator proposing the issuance of a regulation
          establishing a tolerance or exemption for a pesticide
          chemical residue that presents a lower risk to human health
          than a pesticide chemical residue for which a tolerance has
          been left in effect or modified under subsection (b)(2)(B) of
          this section, the Administrator shall complete action on such
          petition under this paragraph within 1 year.
          (ii) Required determinations
            If the Administrator issues a final regulation establishing
          a tolerance or exemption for a safer pesticide chemical
          residue under clause (i), the Administrator shall, not later
          than 180 days after the date on which the regulation is
          issued, determine whether a condition described in subclause
          (I) or (II) of subsection (b)(2)(B)(iii) of this section
          continues to exist with respect to a tolerance that has been
          left in effect or modified under subsection (b)(2)(B) of this
          section. If such condition does not continue to exist, the
          Administrator shall, not later than 180 days after the date
          on which the determination under the preceding sentence is
          made, issue a regulation under subsection (e)(1) of this
          section to modify or revoke the tolerance.
    (e) Action on Administrator's own initiative
      (1) General rule
        The Administrator may issue a regulation - 
          (A) establishing, modifying, suspending under subsection
        (l)(3) of this section, or revoking a tolerance for a pesticide
        chemical or a pesticide chemical residue;
          (B) establishing, modifying, suspending under subsection
        (l)(3) of this section, or revoking an exemption of a pesticide
        chemical residue from the requirement of a tolerance; or
          (C) establishing general procedures and requirements to
        implement this section.
      (2) Notice
        Before issuing a final regulation under paragraph (1), the
      Administrator shall issue a notice of proposed rulemaking and
      provide a period of not less than 60 days for public comment on
      the proposed regulation, except that a shorter period for comment
      may be provided if the Administrator for good cause finds that it
      would be in the public interest to do so and states the reasons
      for the finding in the notice of proposed rulemaking.
    (f) Special data requirements
      (1) Requiring submission of additional data
        If the Administrator determines that additional data or
      information are reasonably required to support the continuation
      of a tolerance or exemption that is in effect under this section
      for a pesticide chemical residue on a food, the Administrator
      shall - 
          (A) issue a notice requiring the person holding the pesticide
        registrations associated with such tolerance or exemption to
        submit the data or information under section 3(c)(2)(B) of the
        Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
        136a(c)(2)(B)];
          (B) issue a rule requiring that testing be conducted on a
        substance or mixture under section 4 of the Toxic Substances
        Control Act [15 U.S.C. 2603]; or
          (C) publish in the Federal Register, after first providing
        notice and an opportunity for comment of not less than 60 days'
        duration, an order - 
            (i) requiring the submission to the Administrator by one or
          more interested persons of a notice identifying the person or
          persons who will submit the required data and information;
            (ii) describing the type of data and information required
          to be submitted to the Administrator and stating why the data
          and information could not be obtained under the authority of
          section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
          Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section 4 of the
          Toxic Substances Control Act [15 U.S.C. 2603];
            (iii) describing the reports of the Administrator required
          to be prepared during and after the collection of the data
          and information;
            (iv) requiring the submission to the Administrator of the
          data, information, and reports referred to in clauses (ii)
          and (iii); and
            (v) establishing dates by which the submissions described
          in clauses (i) and (iv) must be made.

        The Administrator may under subparagraph (C) revise any such
        order to correct an error. The Administrator may under this
        paragraph require data or information pertaining to whether the
        pesticide chemical may have an effect in humans that is similar
        to an effect produced by a naturally occurring estrogen or
        other endocrine effects.
      (2) Noncompliance
        If a submission required by a notice issued in accordance with
      paragraph (1)(A), a rule issued under paragraph (1)(B), or an
      order issued under paragraph (1)(C) is not made by the time
      specified in such notice, rule, or order, the Administrator may
      by order published in the Federal Register modify or revoke the
      tolerance or exemption in question. In any review of such an
      order under subsection (g)(2) of this section, the only material
      issue shall be whether a submission required under paragraph (1)
      was not made by the time specified.
    (g) Effective date, objections, hearings, and administrative review
      (1) Effective date
        A regulation or order issued under subsection (d)(4), (e)(1),
      or (f)(2) of this section shall take effect upon publication
      unless the regulation or order specifies otherwise. The
      Administrator may stay the effectiveness of the regulation or
      order if, after issuance of such regulation or order, objections
      are filed with respect to such regulation or order pursuant to
      paragraph (2).
      (2) Further proceedings
        (A) Objections
          Within 60 days after a regulation or order is issued under
        subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or
        (n)(5)(C) of this section, any person may file objections
        thereto with the Administrator, specifying with particularity
        the provisions of the regulation or order deemed objectionable
        and stating reasonable grounds therefor. If the regulation or
        order was issued in response to a petition under subsection
        (d)(1) of this section, a copy of each objection filed by a
        person other than the petitioner shall be served by the
        Administrator on the petitioner.
        (B) Hearing
          An objection may include a request for a public evidentiary
        hearing upon the objection. The Administrator shall, upon the
        initiative of the Administrator or upon the request of an
        interested person and after due notice, hold a public
        evidentiary hearing if and to the extent the Administrator
        determines that such a public hearing is necessary to receive
        factual evidence relevant to material issues of fact raised by
        the objections. The presiding officer in such a hearing may
        authorize a party to obtain discovery from other persons and
        may upon a showing of good cause made by a party issue a
        subpoena to compel testimony or production of documents from
        any person. The presiding officer shall be governed by the
        Federal Rules of Civil Procedure in making any order for the
        protection of the witness or the content of documents produced
        and shall order the payment of reasonable fees and expenses as
        a condition to requiring testimony of the witness. On contest,
        such a subpoena may be enforced by a Federal district court.
        (C) Final decision
          As soon as practicable after receiving the arguments of the
        parties, the Administrator shall issue an order stating the
        action taken upon each such objection and setting forth any
        revision to the regulation or prior order that the
        Administrator has found to be warranted. If a hearing was held
        under subparagraph (B), such order and any revision to the
        regulation or prior order shall, with respect to questions of
        fact at issue in the hearing, be based only on substantial
        evidence of record at such hearing, and shall set forth in
        detail the findings of facts and the conclusions of law or
        policy upon which the order or regulation is based.
    (h) Judicial review
      (1) Petition
        In a case of actual controversy as to the validity of any
      regulation issued under subsection (e)(1)(C) of this section, or
      any order issued under subsection (f)(1)(C) or (g)(2)(C) of this
      section, or any regulation that is the subject of such an order,
      any person who will be adversely affected by such order or
      regulation may obtain judicial review by filing in the United
      States Court of Appeals for the circuit wherein that person
      resides or has its principal place of business, or in the United
      States Court of Appeals for the District of Columbia Circuit,
      within 60 days after publication of such order or regulation, a
      petition praying that the order or regulation be set aside in
      whole or in part.
      (2) Record and jurisdiction
        A copy of the petition under paragraph (1) shall be forthwith
      transmitted by the clerk of the court to the Administrator, or
      any officer designated by the Administrator for that purpose, and
      thereupon the Administrator shall file in the court the record of
      the proceedings on which the Administrator based the order or
      regulation, as provided in section 2112 of title 28. Upon the
      filing of such a petition, the court shall have exclusive
      jurisdiction to affirm or set aside the order or regulation
      complained of in whole or in part. As to orders issued following
      a public evidentiary hearing, the findings of the Administrator
      with respect to questions of fact shall be sustained only if
      supported by substantial evidence when considered on the record
      as a whole.
      (3) Additional evidence
        If a party applies to the court for leave to adduce additional
      evidence and shows to the satisfaction of the court that the
      additional evidence is material and that there were reasonable
      grounds for the failure to adduce the evidence in the proceeding
      before the Administrator, the court may order that the additional
      evidence (and evidence in rebuttal thereof) shall be taken before
      the Administrator in the manner and upon the terms and conditions
      the court deems proper. The Administrator may modify prior
      findings as to the facts by reason of the additional evidence so
      taken and may modify the order or regulation accordingly. The
      Administrator shall file with the court any such modified
      finding, order, or regulation.
      (4) Final judgment; Supreme Court review
        The judgment of the court affirming or setting aside, in whole
      or in part, any regulation or any order and any regulation which
      is the subject of such an order shall be final, subject to review
      by the Supreme Court of the United States as provided in section
      1254 of title 28. The commencement of proceedings under this
      subsection shall not, unless specifically ordered by the court to
      the contrary, operate as a stay of a regulation or order.
      (5) Application
        Any issue as to which review is or was obtainable under this
      subsection shall not be the subject of judicial review under any
      other provision of law.
    (i) Confidentiality and use of data
      (1) General rule
        Data and information that are or have been submitted to the
      Administrator under this section or section 348 of this title in
      support of a tolerance or an exemption from a tolerance shall be
      entitled to confidential treatment for reasons of business
      confidentiality and to exclusive use and data compensation to the
      same extent provided by sections 3 and 10 of the Federal
      Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a,
      136h].
      (2) Exceptions
        (A) In general
          Data and information that are entitled to confidential
        treatment under paragraph (1) may be disclosed, under such
        security requirements as the Administrator may provide by
        regulation, to - 
            (i) employees of the United States authorized by the
          Administrator to examine such data and information in the
          carrying out of their official duties under this chapter or
          other Federal statutes intended to protect the public health;
          or
            (ii) contractors with the United States authorized by the
          Administrator to examine such data and information in the
          carrying out of contracts under this chapter or such
          statutes.
        (B) Congress
          This subsection does not authorize the withholding of data or
        information from either House of Congress or from, to the
        extent of matter within its jurisdiction, any committee or
        subcommittee of such committee or any joint committee of
        Congress or any subcommittee of such joint committee.
      (3) Summaries
        Notwithstanding any provision of this subsection or other law,
      the Administrator may publish the informative summary required by
      subsection (d)(2)(A)(i) of this section and may, in issuing a
      proposed or final regulation or order under this section, publish
      an informative summary of the data relating to the regulation or
      order.
    (j) Status of previously issued regulations
      (1) Regulations under section 346
        Regulations affecting pesticide chemical residues in or on raw
      agricultural commodities promulgated, in accordance with section
      371(e) of this title, under the authority of section 346(a) (!1)
      of this title upon the basis of public hearings instituted before
      January 1, 1953, shall be deemed to be regulations issued under
      this section and shall be subject to modification or revocation
      under subsections (d) and (e) of this section, and shall be
      subject to review under subsection (q) of this section.

      (2) Regulations under section 348
        Regulations that established tolerances for substances that are
      pesticide chemical residues in or on processed food, or that
      otherwise stated the conditions under which such pesticide
      chemicals could be safely used, and that were issued under
      section 348 of this title on or before August 3, 1996, shall be
      deemed to be regulations issued under this section and shall be
      subject to modification or revocation under subsection (d) or (e)
      of this section, and shall be subject to review under subsection
      (q) of this section.
      (3) Regulations under section 346a
        Regulations that established tolerances or exemptions under
      this section that were issued on or before August 3, 1996, shall
      remain in effect unless modified or revoked under subsection (d)
      or (e) of this section, and shall be subject to review under
      subsection (q) of this section.
      (4) Certain substances
        With respect to a substance that is not included in the
      definition of the term "pesticide chemical" under section
      321(q)(1) of this title but was so included on the day before
      October 30, 1998, the following applies as of October 30, 1998:
          (A) Notwithstanding paragraph (2), any regulation applying to
        the use of the substance that was in effect on the day before
        October 30, 1998, and was on such day deemed in such paragraph
        to have been issued under this section, shall be considered to
        have been issued under section 348 of this title.
          (B) Notwithstanding paragraph (3), any regulation applying to
        the use of the substance that was in effect on such day and was
        issued under this section (including any such regulation issued
        before August 3, 1996) is deemed to have been issued under
        section 348 of this title.
    (k) Transitional provision
      If, on the day before August 3, 1996, a substance that is a
    pesticide chemical was, with respect to a particular pesticidal use
    of the substance and any resulting pesticide chemical residue in or
    on a particular food - 
        (1) regarded by the Administrator or the Secretary as generally
      recognized as safe for use within the meaning of the provisions
      of subsection (a) of this section or section 321(s) of this title
      as then in effect; or
        (2) regarded by the Secretary as a substance described by
      section 321(s)(4) of this title;

    such a pesticide chemical residue shall be regarded as exempt from
    the requirement for a tolerance, as of August 3, 1996. The
    Administrator shall by regulation indicate which substances are
    described by this subsection. Any exemption under this subsection
    may be modified or revoked as if it had been issued under
    subsection (c) of this section.
    (l) Harmonization with action under other laws
      (1) Coordination with FIFRA
        To the extent practicable and consistent with the review
      deadlines in subsection (q) of this section, in issuing a final
      rule under this subsection that suspends or revokes a tolerance
      or exemption for a pesticide chemical residue in or on food, the
      Administrator shall coordinate such action with any related
      necessary action under the Federal Insecticide, Fungicide, and
      Rodenticide Act [7 U.S.C. 136 et seq.].
      (2) Revocation of tolerance or exemption following cancellation
        of associated registrations
        If the Administrator, acting under the Federal Insecticide,
      Fungicide, and Rodenticide Act, cancels the registration of each
      pesticide that contains a particular pesticide chemical and that
      is labeled for use on a particular food, or requires that the
      registration of each such pesticide be modified to prohibit its
      use in connection with the production, storage, or transportation
      of such food, due in whole or in part to dietary risks to humans
      posed by residues of that pesticide chemical on that food, the
      Administrator shall revoke any tolerance or exemption that allows
      the presence of the pesticide chemical, or any pesticide chemical
      residue that results from its use, in or on that food. Subsection
      (e) of this section shall apply to actions taken under this
      paragraph. A revocation under this paragraph shall become
      effective not later than 180 days after - 
          (A) the date by which each such cancellation of a
        registration has become effective; or
          (B) the date on which the use of the canceled pesticide
        becomes unlawful under the terms of the cancellation, whichever
        is later.
      (3) Suspension of tolerance or exemption following suspension of
        associated registrations
        (A) Suspension
          If the Administrator, acting under the Federal Insecticide,
        Fungicide, and Rodenticide Act, suspends the use of each
        registered pesticide that contains a particular pesticide
        chemical and that is labeled for use on a particular food, due
        in whole or in part to dietary risks to humans posed by
        residues of that pesticide chemical on that food, the
        Administrator shall suspend any tolerance or exemption that
        allows the presence of the pesticide chemical, or any pesticide
        chemical residue that results from its use, in or on that food.
        Subsection (e) of this section shall apply to actions taken
        under this paragraph. A suspension under this paragraph shall
        become effective not later than 60 days after the date by which
        each such suspension of use has become effective.
        (B) Effect of suspension
          The suspension of a tolerance or exemption under subparagraph
        (A) shall be effective as long as the use of each associated
        registration of a pesticide is suspended under the Federal
        Insecticide, Fungicide, and Rodenticide Act. While a suspension
        of a tolerance or exemption is effective the tolerance or
        exemption shall not be considered to be in effect. If the
        suspension of use of the pesticide under that Act is
        terminated, leaving the registration of the pesticide for such
        use in effect under that Act, the Administrator shall rescind
        any associated suspension of tolerance or exemption.
      (4) Tolerances for unavoidable residues
        In connection with action taken under paragraph (2) or (3), or
      with respect to pesticides whose registrations were suspended or
      canceled prior to August 3, 1996, under the Federal Insecticide,
      Fungicide, and Rodenticide Act, if the Administrator determines
      that a residue of the canceled or suspended pesticide chemical
      will unavoidably persist in the environment and thereby be
      present in or on a food, the Administrator may establish a
      tolerance for the pesticide chemical residue. In establishing
      such a tolerance, the Administrator shall take into account both
      the factors set forth in subsection (b)(2) of this section and
      the unavoidability of the residue. Subsection (e) of this section
      shall apply to the establishment of such tolerance. The
      Administrator shall review any such tolerance periodically and
      modify it as necessary so that it allows no greater level of the
      pesticide chemical residue than is unavoidable.
      (5) Pesticide residues resulting from lawful application of
        pesticide
        Notwithstanding any other provision of this chapter, if a
      tolerance or exemption for a pesticide chemical residue in or on
      a food has been revoked, suspended, or modified under this
      section, an article of that food shall not be deemed unsafe
      solely because of the presence of such pesticide chemical residue
      in or on such food if it is shown to the satisfaction of the
      Secretary that - 
          (A) the residue is present as the result of an application or
        use of a pesticide at a time and in a manner that was lawful
        under the Federal Insecticide, Fungicide, and Rodenticide Act;
        and
          (B) the residue does not exceed a level that was authorized
        at the time of that application or use to be present on the
        food under a tolerance, exemption, food additive regulation, or
        other sanction then in effect under this chapter;

      unless, in the case of any tolerance or exemption revoked,
      suspended, or modified under this subsection or subsection (d) or
      (e) of this section, the Administrator has issued a determination
      that consumption of the legally treated food during the period of
      its likely availability in commerce will pose an unreasonable
      dietary risk.
      (6) Tolerance for use of pesticides under an emergency exemption
        If the Administrator grants an exemption under section 18 of
      the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
      136p) for a pesticide chemical, the Administrator shall establish
      a tolerance or exemption from the requirement for a tolerance for
      the pesticide chemical residue. Such a tolerance or exemption
      from a tolerance shall have an expiration date. The Administrator
      may establish such a tolerance or exemption without providing
      notice or a period for comment on the tolerance or exemption. The
      Administrator shall promulgate regulations within 365 days after
      August 3, 1996, governing the establishment of tolerances and
      exemptions under this paragraph. Such regulations shall be
      consistent with the safety standard under subsections (b)(2) and
      (c)(2) of this section and with section 18 of the Federal
      Insecticide, Fungicide, and Rodenticide Act.
    (m) Fees
      (1) Amount
        The Administrator shall by regulation require the payment of
      such fees as will in the aggregate, in the judgment of the
      Administrator, be sufficient over a reasonable term to provide,
      equip, and maintain an adequate service for the performance of
      the Administrator's functions under this section. Under the
      regulations, the performance of the Administrator's services or
      other functions under this section, including - 
          (A) the acceptance for filing of a petition submitted under
        subsection (d) of this section;
          (B) establishing, modifying, leaving in effect, or revoking a
        tolerance or establishing, modifying, leaving in effect, or
        revoking an exemption from the requirement for a tolerance
        under this section;
          (C) the acceptance for filing of objections under subsection
        (g) of this section; or
          (D) the certification and filing in court of a transcript of
        the proceedings and the record under subsection (h) of this
        section;

      may be conditioned upon the payment of such fees. The regulations
      may further provide for waiver or refund of fees in whole or in
      part when in the judgment of the Administrator such a waiver or
      refund is equitable and not contrary to the purposes of this
      subsection.
      (2) Deposit
        All fees collected under paragraph (1) shall be deposited in
      the Reregistration and Expedited Processing Fund created by
      section 4(k) of the Federal Insecticide, Fungicide, and
      Rodenticide Act [7 U.S.C. 136a-1(k)]. Such fees shall be
      available to the Administrator, without fiscal year limitation,
      for the performance of the Administrator's services or functions
      as specified in paragraph (1).
    (n) National uniformity of tolerances
      (1) "Qualifying pesticide chemical residue" defined
        For purposes of this subsection, the term "qualifying pesticide
      chemical residue" means a pesticide chemical residue resulting
      from the use, in production, processing, or storage of a food, of
      a pesticide chemical that is an active ingredient and that - 
          (A) was first approved for such use in a registration of a
        pesticide issued under section 3(c)(5) of the Federal
        Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
        136a(c)(5)] on or after April 25, 1985, on the basis of data
        determined by the Administrator to meet all applicable
        requirements for data prescribed by regulations in effect under
        that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or
          (B) was approved for such use in a reregistration eligibility
        determination issued under section 4(g) of that Act [7 U.S.C.
        136a-1(g)] on or after August 3, 1996.
      (2) "Qualifying Federal determination" defined
        For purposes of this subsection, the term "qualifying Federal
      determination" means a tolerance or exemption from the
      requirement for a tolerance for a qualifying pesticide chemical
      residue that - 
          (A) is issued under this section after August 3, 1996, and
        determined by the Administrator to meet the standard under
        subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in
        the case of an exemption) of this section; or
          (B)(i) pursuant to subsection (j) of this section is
        remaining in effect or is deemed to have been issued under this
        section, or is regarded under subsection (k) of this section as
        exempt from the requirement for a tolerance; and
          (ii) is determined by the Administrator to meet the standard
        under subsection (b)(2)(A) (in the case of a tolerance) or
        (c)(2) (in the case of an exemption) of this section.
      (3) Limitation
        The Administrator may make the determination described in
      paragraph (2)(B)(ii) only by issuing a rule in accordance with
      the procedure set forth in subsection (d) or (e) of this section
      and only if the Administrator issues a proposed rule and allows a
      period of not less than 30 days for comment on the proposed rule.
      Any such rule shall be reviewable in accordance with subsections
      (g) and (h) of this section.
      (4) State authority
        Except as provided in paragraphs (5), (6), and (8) no State or
      political subdivision may establish or enforce any regulatory
      limit on a qualifying pesticide chemical residue in or on any
      food if a qualifying Federal determination applies to the
      presence of such pesticide chemical residue in or on such food,
      unless such State regulatory limit is identical to such
      qualifying Federal determination. A State or political
      subdivision shall be deemed to establish or enforce a regulatory
      limit on a pesticide chemical residue in or on a food if it
      purports to prohibit or penalize the production, processing,
      shipping, or other handling of a food because it contains a
      pesticide residue (in excess of a prescribed limit).
      (5) Petition procedure
        (A) In general
          Any State may petition the Administrator for authorization to
        establish in such State a regulatory limit on a qualifying
        pesticide chemical residue in or on any food that is not
        identical to the qualifying Federal determination applicable to
        such qualifying pesticide chemical residue.
        (B) Petition requirements
          Any petition under subparagraph (A) shall - 
            (i) satisfy any requirements prescribed, by rule, by the
          Administrator; and
            (ii) be supported by scientific data about the pesticide
          chemical residue that is the subject of the petition or about
          chemically related pesticide chemical residues, data on the
          consumption within such State of food bearing the pesticide
          chemical residue, and data on exposure of humans within such
          State to the pesticide chemical residue.
        (C) Authorization
          The Administrator may, by order, grant the authorization
        described in subparagraph (A) if the Administrator determines
        that the proposed State regulatory limit - 
            (i) is justified by compelling local conditions; and
            (ii) would not cause any food to be a violation of Federal
          law.
        (D) Treatment
          In lieu of any action authorized under subparagraph (C), the
        Administrator may treat a petition under this paragraph as a
        petition under subsection (d) of this section to modify or
        revoke a tolerance or an exemption. If the Administrator
        determines to treat a petition under this paragraph as a
        petition under subsection (d) of this section, the
        Administrator shall thereafter act on the petition pursuant to
        subsection (d) of this section.
        (E) Review
          Any order of the Administrator granting or denying the
        authorization described in subparagraph (A) shall be subject to
        review in the manner described in subsections (g) and (h) of
        this section.
      (6) Urgent petition procedure
        Any State petition to the Administrator pursuant to paragraph
      (5) that demonstrates that consumption of a food containing such
      pesticide residue level during the period of the food's likely
      availability in the State will pose a significant public health
      threat from acute exposure shall be considered an urgent
      petition. If an order by the Administrator to grant or deny the
      requested authorization in an urgent petition is not made within
      30 days of receipt of the petition, the petitioning State may
      establish and enforce a temporary regulatory limit on a
      qualifying pesticide chemical residue in or on the food. The
      temporary regulatory limit shall be validated or terminated by
      the Administrator's final order on the petition.
      (7) Residues from lawful application
        No State or political subdivision may enforce any regulatory
      limit on the level of a pesticide chemical residue that may
      appear in or on any food if, at the time of the application of
      the pesticide that resulted in such residue, the sale of such
      food with such residue level was lawful under this section and
      under the law of such State, unless the State demonstrates that
      consumption of the food containing such pesticide residue level
      during the period of the food's likely availability in the State
      will pose an unreasonable dietary risk to the health of persons
      within such State.
      (8) Savings
        Nothing in this chapter preempts the authority of any State or
      political subdivision to require that a food containing a
      pesticide chemical residue bear or be the subject of a warning or
      other statement relating to the presence of the pesticide
      chemical residue in or on such food.
    (o) Consumer right to know
      Not later than 2 years after August 3, 1996, and annually
    thereafter, the Administrator shall, in consultation with the
    Secretary of Agriculture and the Secretary of Health and Human
    Services, publish in a format understandable to a lay person, and
    distribute to large retail grocers for public display (in a manner
    determined by the grocer), the following information, at a minimum:
        (1) A discussion of the risks and benefits of pesticide
      chemical residues in or on food purchased by consumers.
        (2) A listing of actions taken under subparagraph (B) of
      subsection (b)(2) of this section that may result in pesticide
      chemical residues in or on food that present a yearly or lifetime
      risk above the risk allowed under subparagraph (A) of such
      subsection, and the food on which the pesticide chemicals
      producing the residues are used.
        (3) Recommendations to consumers for reducing dietary exposure
      to pesticide chemical residues in a manner consistent with
      maintaining a healthy diet, including a list of food that may
      reasonably substitute for food listed under paragraph (2).

      Nothing in this subsection shall prevent retail grocers from
    providing additional information.
    (p) Estrogenic substances screening program
      (1) Development
        Not later than 2 years after August 3, 1996, the Administrator
      shall in consultation with the Secretary of Health and Human
      Services develop a screening program, using appropriate validated
      test systems and other scientifically relevant information, to
      determine whether certain substances may have an effect in humans
      that is similar to an effect produced by a naturally occurring
      estrogen, or such other endocrine effect as the Administrator may
      designate.
      (2) Implementation
        Not later than 3 years after August 3, 1996, after obtaining
      public comment and review of the screening program described in
      paragraph (1) by the scientific advisory panel established under
      section 25(d) of the Federal Insecticide, Fungicide, and
      Rodenticide Act [7 U.S.C. 136w(d)] or the science advisory board
      established by section 4365 (!2) of title 42, the Administrator
      shall implement the program.

      (3) Substances
        In carrying out the screening program described in paragraph
      (1), the Administrator - 
          (A) shall provide for the testing of all pesticide chemicals;
        and
          (B) may provide for the testing of any other substance that
        may have an effect that is cumulative to an effect of a
        pesticide chemical if the Administrator determines that a
        substantial population may be exposed to such substance.
      (4) Exemption
        Notwithstanding paragraph (3), the Administrator may, by order,
      exempt from the requirements of this section a biologic substance
      or other substance if the Administrator determines that the
      substance is anticipated not to produce any effect in humans
      similar to an effect produced by a naturally occurring estrogen.
      (5) Collection of information
        (A) In general
          The Administrator shall issue an order to a registrant of a
        substance for which testing is required under this subsection,
        or to a person who manufactures or imports a substance for
        which testing is required under this subsection, to conduct
        testing in accordance with the screening program described in
        paragraph (1), and submit information obtained from the testing
        to the Administrator, within a reasonable time period that the
        Administrator determines is sufficient for the generation of
        the information.
        (B) Procedures
          To the extent practicable the Administrator shall minimize
        duplicative testing of the same substance for the same
        endocrine effect, develop, as appropriate, procedures for fair
        and equitable sharing of test costs, and develop, as necessary,
        procedures for handling of confidential business information.
        (C) Failure of registrants to submit information
          (i) Suspension
            If a registrant of a substance referred to in paragraph
          (3)(A) fails to comply with an order under subparagraph (A)
          of this paragraph, the Administrator shall issue a notice of
          intent to suspend the sale or distribution of the substance
          by the registrant. Any suspension proposed under this
          paragraph shall become final at the end of the 30-day period
          beginning on the date that the registrant receives the notice
          of intent to suspend, unless during that period a person
          adversely affected by the notice requests a hearing or the
          Administrator determines that the registrant has complied
          fully with this paragraph.
          (ii) Hearing
            If a person requests a hearing under clause (i), the
          hearing shall be conducted in accordance with section 554 of
          title 5. The only matter for resolution at the hearing shall
          be whether the registrant has failed to comply with an order
          under subparagraph (A) of this paragraph. A decision by the
          Administrator after completion of a hearing shall be
          considered to be a final agency action.
          (iii) Termination of suspensions
            The Administrator shall terminate a suspension under this
          subparagraph issued with respect to a registrant if the
          Administrator determines that the registrant has complied
          fully with this paragraph.
        (D) Noncompliance by other persons
          Any person (other than a registrant) who fails to comply with
        an order under subparagraph (A) shall be liable for the same
        penalties and sanctions as are provided under section 16 of the
        Toxic Substances Control Act [15 U.S.C. 2615] in the case of a
        violation referred to in that section. Such penalties and
        sanctions shall be assessed and imposed in the same manner as
        provided in such section 16.
      (6) Agency action
        In the case of any substance that is found, as a result of
      testing and evaluation under this section, to have an endocrine
      effect on humans, the Administrator shall, as appropriate, take
      action under such statutory authority as is available to the
      Administrator, including consideration under other sections of
      this chapter, as is necessary to ensure the protection of public
      health.
      (7) Report to Congress
        Not later than 4 years after August 3, 1996, the Administrator
      shall prepare and submit to Congress a report containing - 
          (A) the findings of the Administrator resulting from the
        screening program described in paragraph (1);
          (B) recommendations for further testing needed to evaluate
        the impact on human health of the substances tested under the
        screening program; and
          (C) recommendations for any further actions (including any
        action described in paragraph (6)) that the Administrator
        determines are appropriate based on the findings.
    (q) Schedule for review
      (1) In general
        The Administrator shall review tolerances and exemptions for
      pesticide chemical residues in effect on the day before August 3,
      1996, as expeditiously as practicable, assuring that - 
          (A) 33 percent of such tolerances and exemptions are reviewed
        within 3 years of August 3, 1996;
          (B) 66 percent of such tolerances and exemptions are reviewed
        within 6 years of August 3, 1996; and
          (C) 100 percent of such tolerances and exemptions are
        reviewed within 10 years of August 3, 1996.

      In conducting a review of a tolerance or exemption, the
      Administrator shall determine whether the tolerance or exemption
      meets the requirements of subsections (!3) (b)(2) or (c)(2) of
      this section and shall, by the deadline for the review of the
      tolerance or exemption, issue a regulation under subsection
      (d)(4) or (e)(1) of this section to modify or revoke the
      tolerance or exemption if the tolerance or exemption does not
      meet such requirements.

      (2) Priorities
        In determining priorities for reviewing tolerances and
      exemptions under paragraph (1), the Administrator shall give
      priority to the review of the tolerances or exemptions that
      appear to pose the greatest risk to public health.
      (3) Publication of schedule
        Not later than 12 months after August 3, 1996, the
      Administrator shall publish a schedule for review of tolerances
      and exemptions established prior to August 3, 1996. The
      determination of priorities for the review of tolerances and
      exemptions pursuant to this subsection is not a rulemaking and
      shall not be subject to judicial review, except that failure to
      take final action pursuant to the schedule established by this
      paragraph shall be subject to judicial review.
    (r) Temporary tolerance or exemption
      The Administrator may, upon the request of any person who has
    obtained an experimental permit for a pesticide chemical under the
    Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136
    et seq.] or upon the Administrator's own initiative, establish a
    temporary tolerance or exemption for the pesticide chemical residue
    for the uses covered by the permit. Subsections (b)(2), (c)(2),
    (d), and (e) of this section shall apply to actions taken under
    this subsection.
    (s) Savings clause
      Nothing in this section shall be construed to amend or modify the
    provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et
    seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7
    U.S.C. 136 et seq.].

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,
    Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28,
    1958, 72 Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct.
    30, 1970, 84 Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a),
    Nov. 18, 1971, 85 Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21,
    1972, 86 Stat. 998; Pub. L. 98-620, title IV, Sec. 402(25)(A), Nov.
    8, 1984, 98 Stat. 3359; Pub. L. 102-300, Sec. 6(b)(1), June 16,
    1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(7), Oct.
    29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(k), Aug. 13, 1993,
    107 Stat. 776; Pub. L. 104-170, title IV, Sec. 405, Aug. 3, 1996,
    110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct. 30, 1998, 112
    Stat. 3036.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Rules of Civil Procedure, referred to in subsec.
    (g)(2)(B), are set out in the Appendix to Title 28, Judiciary and
    Judicial Procedure.
      Section 346 of this title, referred to in subsec. (j)(1),
    originally consisted of subsecs. (a) and (b). Subsec. (a) was
    redesignated as the entire section 346 and subsec. (b) was repealed
    by Pub. L. 86-618, title I, Sec. 103(a)(1), 74 Stat. 398.
      The Federal Insecticide, Fungicide, and Rodenticide Act, referred
    to in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947,
    ch. 125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86
    Stat. 973, which is classified generally to subchapter II (Sec. 136
    et seq.) of chapter 6 of Title 7, Agriculture. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 136 of Title 7 and Tables.
      Section 4365 of title 42, referred to in subsec. (p)(2), was in
    the original "section 8 of the Environmental Research, Development,
    and Demonstration Act of 1978", and was translated as meaning
    section 8 of the Environmental Research, Development, and
    Demonstration Authorization Act of 1978, to reflect the probable
    intent of Congress.
      The Toxic Substances Control Act, referred to in subsec. (s), is
    Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is
    classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15,
    Commerce and Trade. For complete classification of this Act to the
    Code, see Short Title note set out under section 2601 of Title 15
    and Tables.

-COD-
                               CODIFICATION                           
      August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A),
    and (p)(1), (2), (7), was in the original references to the date of
    enactment of this subsection and the date of enactment of this
    section, which was translated as meaning the date of enactment of
    Pub. L. 104-170, which amended this section generally, to reflect
    the probable intent of Congress.


-MISC1-
                                AMENDMENTS                            
      1998 - Subsec. (j)(4). Pub. L. 105-324 added par. (4).
      1996 - Pub. L. 104-170 amended section generally, substituting,
    in subsec. (a), provisions relating to requirement for tolerance or
    exemption for provisions relating to conditions for safety; in
    subsec. (b), provisions relating to authority and standard for
    tolerance for provisions relating to establishment of tolerances;
    in subsec. (c), provisions relating to authority and standard for
    exemptions for provisions relating to exemptions; in subsec. (d),
    provisions relating to petition for tolerance or exemption for
    provisions relating to regulations pursuant to petition,
    publication of notice, time for issuance, referral to advisory
    committees, effective date, and hearings; in subsec. (e),
    provisions relating to action on Administrator's own initiative for
    provisions relating to regulations pursuant to Administrator's
    proposals; in subsec. (f), provisions relating to special data
    requirements for provisions relating to data submitted as
    confidential; in subsec. (g), provisions relating to effective
    date, objections, hearings, and administrative review for
    provisions relating to advisory committees and their appointment,
    composition, compensation, and clerical assistance; in subsec. (h),
    provisions relating to judicial review for provisions relating to
    right of consultation; in subsec. (i), provisions relating to
    confidentiality and use of data for provisions relating to judicial
    review; in subsec. (j), provisions relating to status of previously
    issued regulations for provisions relating to temporary tolerances;
    in subsec. (k), provisions relating to transitions for provisions
    relating to regulations based on public hearings before January 1,
    1953; in subsec. (l), provisions relating to harmonization with
    action under other laws for provisions relating to pesticides under
    Federal Insecticide, Fungicide, and Rodenticide Act, functions of
    Administrator of Environmental Protection Agency, certifications,
    hearings, time limitations, opinions, and regulations; in subsec.
    (m), provisions relating to fees for provisions relating to
    amendment of regulations; in subsec. (n), provisions relating to
    national uniformity of tolerances for provisions relating to
    guaranties; in subsec. (o), provisions relating to consumer right
    to know for provisions relating to payment of fees, services or
    functions conditioned on payment, and waiver or refund of fees; and
    adding subsecs. (p) to (s).
      1993 - Pub. L. 103-80, Sec. 3(k)(6), substituted "Administrator"
    for "Secretary" wherever appearing except when followed by "of
    Agriculture".
      Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted
    "Administrator of the Environmental Protection Agency (hereinafter
    in this section referred to as the 'Administrator')" for "Secretary
    of Health and Human Services".
      Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted
    "section 556(c) of title 5" for "section 7(c) of the Administrative
    Procedure Act (5 U.S.C., sec. 1006(c))".
      Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted "In the
    event" for "It the event" before "a hearing is requested".
      Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical
    amendment to reference to section 333(c) of this title to reflect
    amendment of corresponding provision of original act.
      Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the
    substitution of "Administrator" for "Secretary of Health and Human
    Services" wherever appearing in the original text, was executed by
    making the substitution in the first sentence before "shall by
    regulation require", the only place "Secretary of Health and Human
    Services" appeared in the original text.
      1992 - Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102-
    300 substituted "Health and Human Services" for "Health,
    Education, and Welfare" wherever appearing in the original
    statutory text.
      Subsec. (g). Pub. L. 102-571 substituted "379e" for "376".
      1984 - Subsec. (i)(5). Pub. L. 98-620 struck out provision that
    required the court to advance on the docket and expedite the
    disposition of all causes filed therein pursuant to this section.
      1972 - Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted
    references to pesticide for references to economic poison wherever
    appearing therein.
      1971 - Subsec. (g). Pub. L. 92-157 struck out ", which the
    Secretary shall by rules and regulations prescribe," after "as
    compensation for their services a reasonable per diem" prior to
    amendment in 1970, by Pub. L. 91-515, which overlooked such
    language when amending subsec. (g) as provided in 1970 Amendment
    note.
      1970 - Subsec. (g). Pub. L. 91-515 substituted provisions
    authorizing members of an advisory committee to receive
    compensation and travel expenses in accordance with section
    376(b)(5)(D) of this title, for provisions authorizing such members
    to receive as compensation a reasonable per diem for time actually
    spent on committee work, and necessary traveling and subsistence
    expenses while serving away from their places of residence.
      1958 - Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first
    sentence, substituted "transmitted by the clerk of the court to the
    Secretary, or" for "served upon the Secretary, or upon",
    substituted "file in the court the record of the proceedings" for
    "certify and file in the court a transcript of the proceedings and
    the record", and inserted "as provided in section 2112 of title
    28", and which, in second sentence, substituted "the filing of such
    petition" for "such filing".
      Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence,
    substituted "transmitted by the clerk of the court to the Secretary
    of Agriculture, or" for "served upon the Secretary of Agriculture,
    or upon", substituted "file in the court the record of the
    proceedings" for "certify and file in the court a transcript of the
    proceedings and the record", and inserted "as provided in section
    2112 of title 28", and, in second sentence, substituted "the filing
    of such petition" for "such filing".

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by Pub. L. 98-620 not applicable to cases pending on
    Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
    Effective Date note under section 1657 of Title 28, Judiciary and
    Judicial Procedure.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,
    except if regulations are necessary for implementation of any
    provision that becomes effective on Oct. 21, 1972, and continuation
    in effect of subchapter I of chapter 6 of Title 7, Agriculture, and
    regulations thereunder, relating to control of economic poisons, as
    in existence prior to Oct. 21, 1972, until superseded by provisions
    of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub.
    L. 92-516, set out as an Effective Date note under section 136 of
    Title 7.

                              TOLERANCE FEES                          
      Pub. L. 108-199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004,
    118 Stat. 422, provided that: "Notwithstanding section 408(m)(1) of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)),
    during the period beginning on October 1, 2003, and ending on
    September 30, 2008, the Administrator of the Environmental
    Protection Agency shall not collect any tolerance fees under that
    section."

    DATA COLLECTION ACTIVITIES TO ASSURE HEALTH OF INFANTS AND CHILDREN
      Section 301 of Pub. L. 104-170 provided that:
      "(a) In General. - The Secretary of Agriculture, in consultation
    with the Administrator of the Environmental Protection Agency and
    the Secretary of Health and Human Services, shall coordinate the
    development and implementation of survey procedures to ensure that
    adequate data on food consumption patterns of infants and children
    are collected.
      "(b) Procedures. - To the extent practicable, the procedures
    referred to in subsection (a) shall include the collection of data
    on food consumption patterns of a statistically valid sample of
    infants and children.
      "(c) Residue Data Collection. - The Secretary of Agriculture
    shall ensure that the residue data collection activities conducted
    by the Department of Agriculture in cooperation with the
    Environmental Protection Agency and the Department of Health and
    Human Services, provide for the improved data collection of
    pesticide residues, including guidelines for the use of comparable
    analytical and standardized reporting methods, and the increased
    sampling of foods most likely consumed by infants and children."

-FOOTNOTE-
    (!1) See References in Text note below.

    (!2) See References in Text note below.

    (!3) So in original. Probably should be "subsection".


-End-



-CITE-
    21 USC Sec. 346b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 346b. Authorization of appropriations

-STATUTE-
      There are authorized to be appropriated, out of any moneys in the
    Treasury not otherwise appropriated, such sums as may be necessary
    for the purpose and administration of sections 321(q), (r),
    342(a)(2), and 346a of this title.

-SOURCE-
    (July 22, 1954, ch. 559, Sec. 4, 68 Stat. 517.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 347                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 347. Intrastate sales of colored oleomargarine

-STATUTE-
    (a) Law governing
      Colored oleomargarine or colored margarine which is sold in the
    same State or Territory in which it is produced shall be subject in
    the same manner and to the same extent to the provisions of this
    chapter as if it had been introduced in interstate commerce.
    (b) Labeling and packaging requirements
      No person shall sell, or offer for sale, colored oleomargarine or
    colored margarine unless - 
        (1) such oleomargarine or margarine is packaged,
        (2) the net weight of the contents of any package sold in a
      retail establishment is one pound or less,
        (3) there appears on the label of the package (A) the word
      "oleomargarine" or "margarine" in type or lettering at least as
      large as any other type or lettering on such label, and (B) a
      full and accurate statement of all the ingredients contained in
      such oleomargarine or margarine, and
        (4) each part of the contents of the package is contained in a
      wrapper which bears the word "oleomargarine" or "margarine" in
      type or lettering not smaller than 20-point type.

    The requirements of this subsection shall be in addition to and not
    in lieu of any of the other requirements of this chapter.
    (c) Sales in public eating places
      No person shall possess in a form ready for serving colored
    oleomargarine or colored margarine at a public eating place unless
    a notice that oleomargarine or margarine is served is displayed
    prominently and conspicuously in such place and in such manner as
    to render it likely to be read and understood by the ordinary
    individual being served in such eating place or is printed or is
    otherwise set forth on the menu in type or lettering not smaller
    than that normally used to designate the serving of other food
    items. No person shall serve colored oleomargarine or colored
    margarine at a public eating place, whether or not any charge is
    made therefor, unless (1) each separate serving bears or is
    accompanied by labeling identifying it as oleomargarine or
    margarine, or (2) each separate serving thereof is triangular in
    shape.
    (d) Exemption from labeling requirements
      Colored oleomargarine or colored margarine when served with meals
    at a public eating place shall at the time of such service be
    exempt from the labeling requirements of section 343 of this title
    (except paragraphs (a) and (f)) if it complies with the
    requirements of subsection (b) of this section.
    (e) Color content of oleomargarine
      For the purpose of this section colored oleomargarine or colored
    margarine is oleomargarine or margarine having a tint or shade
    containing more than one and six-tenths degrees of yellow, or of
    yellow and red collectively, but with an excess of yellow over red,
    measured in terms of Lovibond tintometer scale or its equivalent.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 407, as added Mar. 16, 1950, ch. 61,
    Sec. 3(c), 64 Stat. 20.)


-MISC1-
                              EFFECTIVE DATE                          
      Section 7 of act Mar. 16, 1950, provided that: "This Act
    [enacting this section and sections 347a and 347b of this title and
    amending sections 331 and 342 of this title and sections 45 and 55
    of Title 15, Commerce and Trade] shall become effective on July 1,
    1950."

                        TRANSFER OF APPROPRIATIONS                    
      Section 5 of act Mar. 16, 1950, provided that: "So much of the
    unexpended balances of appropriations, allocations, or other funds
    (including funds available for the fiscal year ending June 30,
    1950) for the use of the Bureau of Internal Revenue of the Treasury
    Department in the exercise of functions under the Oleomargarine Tax
    Act (26 U.S.C., Sec. 2300, subchapter A) [now section 4591 et seq.
    of Title 26, Internal Revenue Code], as the Director of the Bureau
    of the Budget [now Director of the Office of Management and Budget]
    may determine, shall be transferred to the Federal Security Agency
    (Food and Drug Administration) [now the Department of Health and
    Human Services] for use in the enforcement of this Act [see
    Effective Date note above]."

-End-



-CITE-
    21 USC Sec. 347a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 347a. Congressional declaration of policy regarding
      oleomargarine sales

-STATUTE-
      The Congress finds and declares that the sale, or the serving in
    public eating places, of colored oleomargarine or colored margarine
    without clear identification as such or which is otherwise
    adulterated or misbranded within the meaning of this chapter
    depresses the market in interstate commerce for butter and for
    oleomargarine or margarine clearly identified and neither
    adulterated nor misbranded, and constitutes a burden on interstate
    commerce in such articles. Such burden exists, irrespective of
    whether such oleomargarine or margarine originates from an
    interstate source or from the State in which it is sold.

-SOURCE-
    (Mar. 16, 1950, ch. 61, Sec. 3(a), 64 Stat. 20.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective July 1, 1950, see section 7 of act Mar. 16,
    1950, set out as a note under section 347 of this title.

-End-



-CITE-
    21 USC Sec. 347b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 347b. Contravention of State laws

-STATUTE-
      Nothing in this Act shall be construed as authorizing the
    possession, sale, or serving of colored oleomargarine or colored
    margarine in any State or Territory in contravention of the laws of
    such State or Territory.

-SOURCE-
    (Mar. 16, 1950, ch. 61, Sec. 6, 64 Stat. 22.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64
    Stat. 20, which is classified to sections 331, 342, 347 to 347b of
    this title, and sections 45 and 55 of Title 15, Commerce and Trade.
    For complete classification of this Act to the Code, see Tables.

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective July 1, 1950, see section 7 of act Mar. 16,
    1950, set out as a note under section 347 of this title.

-End-



-CITE-
    21 USC Sec. 348                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 348. Food additives

-STATUTE-
    (a) Unsafe food additives; exception for conformity with exemption
      or regulation
      A food additive shall, with respect to any particular use or
    intended use of such additives, be deemed to be unsafe for the
    purposes of the application of clause (2)(C) of section 342(a) of
    this title, unless - 
        (1) it and its use or intended use conform to the terms of an
      exemption which is in effect pursuant to subsection (j) of this
      section;
        (2) there is in effect, and it and its use or intended use are
      in conformity with, a regulation issued under this section
      prescribing the conditions under which such additive may be
      safely used; or
        (3) in the case of a food additive as defined in this chapter
      that is a food contact substance, there is - 
          (A) in effect, and such substance and the use of such
        substance are in conformity with, a regulation issued under
        this section prescribing the conditions under which such
        additive may be safely used; or
          (B) a notification submitted under subsection (h) of this
        section that is effective.

    While such a regulation relating to a food additive, or such a
    notification under subsection (h)(1) of this section relating to a
    food additive that is a food contact substance, is in effect, and
    has not been revoked pursuant to subsection (i) of this section, a
    food shall not, by reason of bearing or containing such a food
    additive in accordance with the regulation or notification, be
    considered adulterated under section 342(a)(1) of this title.
    (b) Petition for regulation prescribing conditions of safe use;
      contents; description of production methods and controls;
      samples; notice of regulation
      (1) Any person may, with respect to any intended use of a food
    additive, file with the Secretary a petition proposing the issuance
    of a regulation prescribing the conditions under which such
    additive may be safely used.
      (2) Such petition shall, in addition to any explanatory or
    supporting data, contain - 
        (A) the name and all pertinent information concerning such food
      additive, including, where available, its chemical identity and
      composition;
        (B) a statement of the conditions of the proposed use of such
      additive, including all directions, recommendations, and
      suggestions proposed for the use of such additive, and including
      specimens of its proposed labeling;
        (C) all relevant data bearing on the physical or other
      technical effect such additive is intended to produce, and the
      quantity of such additive required to produce such effect;
        (D) a description of practicable methods for determining the
      quantity of such additive in or on food, and any substance formed
      in or on food, because of its use; and
        (E) full reports of investigations made with respect to the
      safety for use of such additive, including full information as to
      the methods and controls used in conducting such investigations.

      (3) Upon request of the Secretary, the petitioner shall furnish
    (or, if the petitioner is not the manufacturer of such additive,
    the petitioner shall have the manufacturer of such additive
    furnish, without disclosure to the petitioner) a full description
    of the methods used in, and the facilities and controls used for,
    the production of such additive.
      (4) Upon request of the Secretary, the petitioner shall furnish
    samples of the food additive involved, or articles used as
    components thereof, and of the food in or on which the additive is
    proposed to be used.
      (5) Notice of the regulation proposed by the petitioner shall be
    published in general terms by the Secretary within thirty days
    after filing.
    (c) Approval or denial of petition; time for issuance of order;
      evaluation of data; factors
      (1) The Secretary shall - 
        (A) by order establish a regulation (whether or not in accord
      with that proposed by the petitioner) prescribing, with respect
      to one or more proposed uses of the food additive involved, the
      conditions under which such additive may be safely used
      (including, but not limited to, specifications as to the
      particular food or classes of food in or in which such additive
      may be used, the maximum quantity which may be used or permitted
      to remain in or on such food, the manner in which such additive
      may be added to or used in or on such food, and any directions or
      other labeling or packaging requirements for such additive deemed
      necessary by him to assure the safety of such use), and shall
      notify the petitioner of such order and the reasons for such
      action; or
        (B) by order deny the petition, and shall notify the petitioner
      of such order and of the reasons for such action.

      (2) The order required by paragraph (1)(A) or (B) of this
    subsection shall be issued within ninety days after the date of
    filing of the petition, except that the Secretary may (prior to
    such ninetieth day), by written notice to the petitioner, extend
    such ninety-day period to such time (not more than one hundred and
    eighty days after the date of filing of the petition) as the
    Secretary deems necessary to enable him to study and investigate
    the petition.
      (3) No such regulation shall issue if a fair evaluation of the
    data before the Secretary - 
        (A) fails to establish that the proposed use of the food
      additive, under the conditions of use to be specified in the
      regulation, will be safe: Provided, That no additive shall be
      deemed to be safe if it is found to induce cancer when ingested
      by man or animal, or if it is found, after tests which are
      appropriate for the evaluation of the safety of food additives,
      to induce cancer in man or animal, except that this proviso shall
      not apply with respect to the use of a substance as an ingredient
      of feed for animals which are raised for food production, if the
      Secretary finds (i) that, under the conditions of use and feeding
      specified in proposed labeling and reasonably certain to be
      followed in practice, such additive will not adversely affect the
      animals for which such feed is intended, and (ii) that no residue
      of the additive will be found (by methods of examination
      prescribed or approved by the Secretary by regulations, which
      regulations shall not be subject to subsections (f) and (g) of
      this section) in any edible portion of such animal after
      slaughter or in any food yielded by or derived from the living
      animal; or
        (B) shows that the proposed use of the additive would promote
      deception of the consumer in violation of this chapter or would
      otherwise result in adulteration or in misbranding of food within
      the meaning of this chapter.

      (4) If, in the judgment of the Secretary, based upon a fair
    evaluation of the data before him, a tolerance limitation is
    required in order to assure that the proposed use of an additive
    will be safe, the Secretary - 
        (A) shall not fix such tolerance limitation at a level higher
      than he finds to be reasonably required to accomplish the
      physical or other technical effect for which such additive is
      intended; and
        (B) shall not establish a regulation for such proposed use if
      he finds upon a fair evaluation of the data before him that such
      data do not establish that such use would accomplish the intended
      physical or other technical effect.

      (5) In determining, for the purposes of this section, whether a
    proposed use of a food additive is safe, the Secretary shall
    consider among other relevant factors - 
        (A) the probable consumption of the additive and of any
      substance formed in or on food because of the use of the
      additive;
        (B) the cumulative effect of such additive in the diet of man
      or animals, taking into account any chemically or
      pharmacologically related substance or substances in such diet;
      and
        (C) safety factors which in the opinion of experts qualified by
      scientific training and experience to evaluate the safety of food
      additives are generally recognized as appropriate for the use of
      animal experimentation data.
    (d) Regulation issued on Secretary's initiative
      The Secretary may at any time, upon his own initiative, propose
    the issuance of a regulation prescribing, with respect to any
    particular use of a food additive, the conditions under which such
    additive may be safely used, and the reasons therefor. After the
    thirtieth day following publication of such a proposal, the
    Secretary may by order establish a regulation based upon the
    proposal.
    (e) Publication and effective date of orders
      Any order, including any regulation established by such order,
    issued under subsection (c) or (d) of this section, shall be
    published and shall be effective upon publication, but the
    Secretary may stay such effectiveness if, after issuance of such
    order, a hearing is sought with respect to such order pursuant to
    subsection (f) of this section.
    (f) Objections and public hearing; basis and contents of order;
      statement
      (1) Within thirty days after publication of an order made
    pursuant to subsection (c) or (d) of this section, any person
    adversely affected by such an order may file objections thereto
    with the Secretary, specifying with particularity the provisions of
    the order deemed objectionable, stating reasonable grounds
    therefor, and requesting a public hearing upon such objections. The
    Secretary shall, after due notice, as promptly as possible hold
    such public hearing for the purpose of receiving evidence relevant
    and material to the issues raised by such objections. As soon as
    practicable after completion of the hearing, the Secretary shall by
    order act upon such objections and make such order public.
      (2) Such order shall be based upon a fair evaluation of the
    entire record at such hearing, and shall include a statement
    setting forth in detail the findings and conclusions upon which the
    order is based.
      (3) The Secretary shall specify in the order the date on which it
    shall take effect, except that it shall not be made to take effect
    prior to the ninetieth day after its publication, unless the
    Secretary finds that emergency conditions exist necessitating an
    earlier effective date, in which event the Secretary shall specify
    in the order his findings as to such conditions.
    (g) Judicial review
      (1) In a case of actual controversy as to the validity of any
    order issued under subsection (f) of this section, including any
    order thereunder with respect to amendment or repeal of a
    regulation issued under this section, any person who will be
    adversely affected by such order may obtain judicial review by
    filing in the United States Court of Appeals for the circuit
    wherein such person resides or has his principal place of business,
    or in the United States Court of Appeals for the District of
    Columbia Circuit, within sixty days after the entry of such order,
    a petition praying that the order be set aside in whole or in part.
      (2) A copy of such petition shall be forthwith transmitted by the
    clerk of the court to the Secretary, or any officer designated by
    him for that purpose, and thereupon the Secretary shall file in the
    court the record of the proceedings on which he based his order, as
    provided in section 2112 of title 28. Upon the filing of such
    petition the court shall have jurisdiction, which upon the filing
    of the record with it shall be exclusive, to affirm or set aside
    the order complained of in whole or in part. Until the filing of
    the record the Secretary may modify or set aside his order. The
    findings of the Secretary with respect to questions of fact shall
    be sustained if based upon a fair evaluation of the entire record
    at such hearing.
      (3) The court, on such judicial review, shall not sustain the
    order of the Secretary if he failed to comply with any requirement
    imposed on him by subsection (f)(2) of this section.
      (4) If application is made to the court for leave to adduce
    additional evidence, the court may order such additional evidence
    to be taken before the Secretary and to be adduced upon the hearing
    in such manner and upon such terms and conditions as to the court
    may seem proper, if such evidence is material and there were
    reasonable grounds for failure to adduce such evidence in the
    proceedings below. The Secretary may modify his findings as to the
    facts and order by reason of the additional evidence so taken, and
    shall file with the court such modified findings and order.
      (5) The judgment of the court affirming or setting aside, in
    whole or in part, any order under this section shall be final,
    subject to review by the Supreme Court of the United States upon
    certiorari or certification as provided in section 1254 of title
    28. The commencement of proceedings under this section shall not,
    unless specifically ordered by the court to the contrary, operate
    as a stay of an order.
    (h) Notification relating to food contact substance
      (1) Subject to such regulations as may be promulgated under
    paragraph (3), a manufacturer or supplier of a food contact
    substance may, at least 120 days prior to the introduction or
    delivery for introduction into interstate commerce of the food
    contact substance, notify the Secretary of the identity and
    intended use of the food contact substance, and of the
    determination of the manufacturer or supplier that the intended use
    of such food contact substance is safe under the standard described
    in subsection (c)(3)(A) of this section. The notification shall
    contain the information that forms the basis of the determination
    and all information required to be submitted by regulations
    promulgated by the Secretary.
      (2)(A) A notification submitted under paragraph (1) shall become
    effective 120 days after the date of receipt by the Secretary and
    the food contact substance may be introduced or delivered for
    introduction into interstate commerce, unless the Secretary makes a
    determination within the 120-day period that, based on the data and
    information before the Secretary, such use of the food contact
    substance has not been shown to be safe under the standard
    described in subsection (c)(3)(A) of this section, and informs the
    manufacturer or supplier of such determination.
      (B) A decision by the Secretary to object to a notification shall
    constitute final agency action subject to judicial review.
      (C) In this paragraph, the term "food contact substance" means
    the substance that is the subject of a notification submitted under
    paragraph (1), and does not include a similar or identical
    substance manufactured or prepared by a person other than the
    manufacturer identified in the notification.
      (3)(A) The process in this subsection shall be utilized for
    authorizing the marketing of a food contact substance except where
    the Secretary determines that submission and review of a petition
    under subsection (b) of this section is necessary to provide
    adequate assurance of safety, or where the Secretary and any
    manufacturer or supplier agree that such manufacturer or supplier
    may submit a petition under subsection (b) of this section.
      (B) The Secretary is authorized to promulgate regulations to
    identify the circumstances in which a petition shall be filed under
    subsection (b) of this section, and shall consider criteria such as
    the probable consumption of such food contact substance and
    potential toxicity of the food contact substance in determining the
    circumstances in which a petition shall be filed under subsection
    (b) of this section.
      (4) The Secretary shall keep confidential any information
    provided in a notification under paragraph (1) for 120 days after
    receipt by the Secretary of the notification. After the expiration
    of such 120 days, the information shall be available to any
    interested party except for any matter in the notification that is
    a trade secret or confidential commercial information.
      (5)(A)(i) Except as provided in clause (ii), the notification
    program established under this subsection shall not operate in any
    fiscal year unless - 
        (I) an appropriation equal to or exceeding the applicable
      amount under clause (iv) is made for such fiscal year for
      carrying out such program in such fiscal year; and
        (II) the Secretary certifies that the amount appropriated for
      such fiscal year for the Center for Food Safety and Applied
      Nutrition of the Food and Drug Administration (exclusive of the
      appropriation referred to in subclause (I)) equals or exceeds the
      amount appropriated for the Center for fiscal year 1997,
      excluding any amount appropriated for new programs.

      (ii) The Secretary shall, not later than April 1, 1999, begin
    accepting and reviewing notifications submitted under the
    notification program established under this subsection if - 
        (I) an appropriation equal to or exceeding the applicable
      amount under clause (iii) is made for the last six months of
      fiscal year 1999 for carrying out such program during such
      period; and
        (II) the Secretary certifies that the amount appropriated for
      such period for the Center for Food Safety and Applied Nutrition
      of the Food and Drug Administration (exclusive of the
      appropriation referred to in subclause (I)) equals or exceeds an
      amount equivalent to one-half the amount appropriated for the
      Center for fiscal year 1997, excluding any amount appropriated
      for new programs.

      (iii) For the last six months of fiscal year 1999, the applicable
    amount under this clause is $1,500,000, or the amount specified in
    the budget request of the President for the six-month period
    involved for carrying out the notification program in fiscal year
    1999, whichever is less.
      (iv) For fiscal year 2000 and subsequent fiscal years, the
    applicable amount under this clause is $3,000,000, or the amount
    specified in the budget request of the President for the fiscal
    year involved for carrying out the notification program under this
    subsection, whichever is less.
      (B) For purposes of carrying out the notification program under
    this subsection, there are authorized to be appropriated such sums
    as may be necessary for each of the fiscal years 1999 through
    fiscal year 2003, except that such authorization of appropriations
    is not effective for a fiscal year for any amount that is less than
    the applicable amount under clause (iii) or (iv) of subparagraph
    (A), whichever is applicable.
      (C) Not later than April 1 of fiscal year 1998 and February 1 of
    each subsequent fiscal year, the Secretary shall submit a report to
    the Committees on Appropriations of the House of Representatives
    and the Senate, the Committee on Commerce of the House of
    Representatives, and the Committee on Labor and Human Resources of
    the Senate that provides an estimate of the Secretary of the costs
    of carrying out the notification program established under this
    subsection for the next fiscal year.
      (6) In this section, the term "food contact substance" means any
    substance intended for use as a component of materials used in
    manufacturing, packing, packaging, transporting, or holding food if
    such use is not intended to have any technical effect in such food.
    (i) Amendment or repeal of regulations
      The Secretary shall by regulation prescribe the procedure by
    which regulations under the foregoing provisions of this section
    may be amended or repealed, and such procedure shall conform to the
    procedure provided in this section for the promulgation of such
    regulations. The Secretary shall by regulation prescribe the
    procedure by which the Secretary may deem a notification under
    subsection (h) of this section to no longer be effective.
    (j) Exemptions for investigational use
      Without regard to subsections (b) to (i), inclusive, of this
    section, the Secretary shall by regulation provide for exempting
    from the requirements of this section any food additive, and any
    food bearing or containing such additive, intended solely for
    investigational use by qualified experts when in his opinion such
    exemption is consistent with the public health.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 409, as added Pub. L. 85-929, Sec. 4,
    Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86-546, Sec. 2, June
    29, 1960, 74 Stat. 255; Pub. L. 87-781, title I, Sec. 104(f)(1),
    Oct. 10, 1962, 76 Stat. 785; Pub. L. 98-620, title IV, Sec.
    402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105-115, title
    III, Sec. 309, Nov. 21, 1997, 111 Stat. 2354.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 309(a)(4), in closing
    provisions, substituted "While such a regulation relating to a food
    additive, or such a notification under subsection (h)(1) of this
    section relating to a food additive that is a food contact
    substance, is in effect, and has not been revoked pursuant to
    subsection (i) of this section, a food shall not, by reason of
    bearing or containing such a food additive in accordance with the
    regulation or notification, be considered adulterated under section
    342(a)(1) of this title." for "While such a regulation relating to
    a food additive is in effect, a food shall not, by reason of
    bearing or containing such an additive in accordance with the
    regulation, be considered adulterated within the meaning of clause
    (1) of section 342(a) of this title."
      Subsec. (a)(1). Pub. L. 105-115, Sec. 309(a)(1), substituted
    "subsection (j)" for "subsection (i)".
      Subsec. (a)(3). Pub. L. 105-115, Sec. 309(a)(1)(B), (2), (3),
    added par. (3).
      Subsec. (h). Pub. L. 105-115, Sec. 309(b)(2), added subsec. (h).
    Former subsec. (h) redesignated (i).
      Subsec. (i). Pub. L. 105-115, Sec. 309(b)(1), (3), redesignated
    subsec. (h) as (i) and inserted at end "The Secretary shall by
    regulation prescribe the procedure by which the Secretary may deem
    a notification under subsection (h) of this section to no longer be
    effective."
      Subsec. (j). Pub. L. 105-115, Sec. 309(b)(1), (4), redesignated
    subsec. (i) as (j) and substituted "subsections (b) to (i)" for
    "subsections (b) to (h)".
      1984 - Subsec. (g)(2). Pub. L. 98-620 struck out provision that
    required the court to advance on the docket and expedite the
    disposition of all causes filed therein pursuant to this section.
      1962 - Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from
    applying to use of a substance as an ingredient of feed for animals
    raised for food production, if under conditions of use specified in
    proposed labeling, and which conditions are reasonably certain to
    be followed in practice, such additive will not adversely affect
    the animals and no residue will be found in any edible portion of
    such animal after slaughter, or in any food from the living animal.
      1960 - Subsec. (g)(2). Pub. L. 86-546 substituted "forthwith
    transmitted by the clerk of the court to the Secretary, or any
    officer" for "served upon the Secretary, or upon any officer",
    "shall file in the court the record of the proceedings on which he
    based his order, as provided in section 2112 of title 28" for
    "shall certify and file in the court a transcript of the
    proceedings and the record on which he based his order", and "Upon
    the filing of such petition the court shall have jurisdiction,
    which upon the filing of the record with it shall be exclusive,"
    for "Upon such filing, the court shall have exclusive
    jurisdiction", and inserted sentence authorizing the Secretary to
    modify or set aside his order until the filing of the record.

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Commerce of House of Representatives changed to
    Committee on Energy and Commerce of House of Representatives, and
    jurisdiction over matters relating to securities and exchanges and
    insurance generally transferred to Committee on Financial Services
    of House of Representatives by House Resolution No. 5, One Hundred
    Seventh Congress, Jan. 3, 2001.
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.


-MISC2-
                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by Pub. L. 98-620 not applicable to cases pending on
    Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
    Effective Date note under section 1657 of Title 28, Judiciary and
    Judicial Procedure.

               EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS           
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as an Effective Date of 1962
    Amendment note under section 321 of this title.

                              EFFECTIVE DATE                          
      Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85-
    929, set out as an Effective Date of 1958 Amendment note under
    section 342 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Functions vested in Secretary of Health, Education, and Welfare
    [now Health and Human Services] in establishing tolerances for
    pesticide chemicals under this section together with authority to
    monitor compliance with tolerances and effectiveness of
    surveillance and enforcement and to provide technical assistance to
    States and conduct research under this chapter and section 201 et
    seq. of Title 42, The Public Health and Welfare, transferred to
    Administrator of Environmental Protection Agency by Reorg. Plan No.
    3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
    2086, set out in the Appendix to Title 5, Government Organization
    and Employees.


-MISC3-
                          GLASS AND CERAMIC WARE                      
      Section 308 of Pub. L. 105-115 provided that:
      "(a) In General. - The Secretary may not implement any
    requirement which would ban, as an unapproved food additive, lead
    and cadmium based enamel in the lip and rim area of glass and
    ceramic ware before the expiration of one year after the date such
    requirement is published.
      "(b) Lead and Cadmium Based Enamel. - Unless the Secretary
    determines, based on available data, that lead and cadmium based
    enamel on glass and ceramic ware - 
        "(1) which has less than 60 millimeters of decorating area
      below the external rim, and
        "(2) which is not, by design, representation, or custom of
      usage intended for use by children,
    is unsafe, the Secretary shall not take any action before January
    1, 2003, to ban lead and cadmium based enamel on such glass and
    ceramic ware. Any action taken after January 1, 2003, to ban such
    enamel on such glass and ceramic ware as an unapproved food
    additive shall be taken by regulation and such regulation shall
    provide that such products shall not be removed from the market
    before 1 year after publication of the final regulation."

      MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN  
      Pub. L. 95-203, Sec. 3, Nov. 23, 1977, 91 Stat. 1452, as amended
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695; Pub. L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42,
    Sec. 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98-22, Sec. 2, Apr.
    22, 1983, 97 Stat. 173; Pub. L. 99-46, May 24, 1985, 99 Stat. 81;
    Pub. L. 100-71, title I, Sec. 101, July 11, 1987, 101 Stat. 431;
    Pub. L. 102-142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L.
    104-180, title VI, Sec. 602, Aug. 6, 1996, 110 Stat. 1594, provided
    that: "During the period ending May 1, 2002, the Secretary - 
        "(1) may not amend or revoke the interim food additive
      regulation of the Food and Drug Administration of the Department
      of Health and Human Services applicable to saccharin and
      published on March 15, 1977 (section 180.37 of part 180,
      subchapter B, chapter 1, title 21, Code of Federal Regulations
      (42 Fed. Reg. 14638)), or
        "(2) may, except as provided in section 4 [enacting section
      343a of this title, amending sections 321 and 343 of this title,
      and enacting provisions set out as notes under section 343 of
      this title] and the amendments made by such section, not take any
      other action under the Federal Food, Drug, and Cosmetic Act [this
      chapter] to prohibit or restrict the sale or distribution of
      saccharin, any food permitted by such interim food additive
      regulation to contain saccharin, or any drug or cosmetic
      containing saccharin,
    solely on the basis of the carcinogenic or other toxic effect of
    saccharin as determined by any study made available to the
    Secretary before the date of the enactment of this Act [Nov. 23,
    1977] which involved human studies or animal testing, or both."
      For definition of "saccharin" as used in this note, see section
    2(d) of Pub. L. 95-203.

-End-



-CITE-
    21 USC Sec. 349                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 349. Bottled drinking water standards; publication in Federal
      Register

-STATUTE-
      (a) Except as provided in subsection (b) of this section,
    whenever the Administrator of the Environmental Protection Agency
    prescribes interim or revised national primary drinking water
    regulations under section 1412 of the Public Health Service Act [42
    U.S.C. 300g-1], the Secretary shall consult with the Administrator
    and within 180 days after the promulgation of such drinking water
    regulations either promulgate amendments to regulations under this
    chapter applicable to bottled drinking water or publish in the
    Federal Register his reasons for not making such amendments.
      (b)(1) Not later than 180 days before the effective date of a
    national primary drinking water regulation promulgated by the
    Administrator of the Environmental Protection Agency for a
    contaminant under section 1412 of the Safe Drinking Water Act (42
    U.S.C. 300g-1), the Secretary shall promulgate a standard of
    quality regulation under this subsection for that contaminant in
    bottled water or make a finding that such a regulation is not
    necessary to protect the public health because the contaminant is
    contained in water in public water systems (as defined under
    section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water
    used for bottled drinking water. The effective date for any such
    standard of quality regulation shall be the same as the effective
    date for such national primary drinking water regulation, except
    for any standard of quality of regulation promulgated by the
    Secretary before August 6, 1996, for which (as of August 6, 1996)
    an effective date had not been established. In the case of a
    standard of quality regulation to which such exception applies, the
    Secretary shall promulgate monitoring requirements for the
    contaminants covered by the regulation not later than 2 years after
    August 6, 1996.
      (2) A regulation issued by the Secretary as provided in this
    subsection shall include any monitoring requirements that the
    Secretary determines appropriate for bottled water.
      (3) A regulation issued by the Secretary as provided in this
    subsection shall require the following:
        (A) In the case of contaminants for which a maximum contaminant
      level is established in a national primary drinking water
      regulation under section 1412 of the Safe Drinking Water Act (42
      U.S.C. 300g-1), the regulation under this subsection shall
      establish a maximum contaminant level for the contaminant in
      bottled water which is no less stringent than the maximum
      contaminant level provided in the national primary drinking water
      regulation.
        (B) In the case of contaminants for which a treatment technique
      is established in a national primary drinking water regulation
      under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-
      1), the regulation under this subsection shall require that
      bottled water be subject to requirements no less protective of
      the public health than those applicable to water provided by
      public water systems using the treatment technique required by
      the national primary drinking water regulation.

      (4)(A) If the Secretary does not promulgate a regulation under
    this subsection within the period described in paragraph (1), the
    national primary drinking water regulation referred to in paragraph
    (1) shall be considered, as of the date on which the Secretary is
    required to establish a regulation under paragraph (1), as the
    regulation applicable under this subsection to bottled water.
      (B) In the case of a national primary drinking water regulation
    that pursuant to subparagraph (A) is considered to be a standard of
    quality regulation, the Secretary shall, not later than the
    applicable date referred to in such subparagraph, publish in the
    Federal Register a notice - 
        (i) specifying the contents of such regulation, including
      monitoring requirements; and
        (ii) providing that for purposes of this paragraph the
      effective date for such regulation is the same as the effective
      date for the regulation for purposes of the Safe Drinking Water
      Act [42 U.S.C. 300f et seq.] (or, if the exception under
      paragraph (1) applies to the regulation, that the effective date
      for the regulation is not later than 2 years and 180 days after
      August 6, 1996).

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 410, as added Pub. L. 93-523, Sec. 4,
    Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104-182, title III,
    Sec. 305, Aug. 6, 1996, 110 Stat. 1684.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Safe Drinking Water Act, referred to in subsec.
    (b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16,
    1974, Pub. L. 93-523, Sec. 2(a), 88 Stat. 1660, as amended, which
    is classified generally to subchapter XII (Sec. 300f et seq.) of
    chapter 6A of Title 42, The Public Health and Welfare. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 201 of Title 42 and Tables.


-MISC1-
                                AMENDMENTS                            
      1996 - Pub. L. 104-182 substituted "(a) Except as provided in
    subsection (b) of this section, whenever" for "Whenever" and added
    subsec. (b).

                            BOTTLED WATER STUDY                        
      Section 114(b) of Pub. L. 104-182 provided that: "Not later than
    18 months after the date of enactment of this Act [Aug. 6, 1996],
    the Administrator of the Food and Drug Administration, in
    consultation with the Administrator of the Environmental Protection
    Agency, shall publish for public notice and comment a draft study
    on the feasibility of appropriate methods, if any, of informing
    customers of the contents of bottled water. The Administrator of
    the Food and Drug Administration shall publish a final study not
    later than 30 months after the date of enactment of this Act."

-End-



-CITE-
    21 USC Sec. 350                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350. Vitamins and minerals

-STATUTE-
    (a) Authority and limitations of Secretary; applicability
      (1) Except as provided in paragraph (2) - 
        (A) the Secretary may not establish, under section 321(n), 341,
      or 343 of this title, maximum limits on the potency of any
      synthetic or natural vitamin or mineral within a food to which
      this section applies;
        (B) the Secretary may not classify any natural or synthetic
      vitamin or mineral (or combination thereof) as a drug solely
      because it exceeds the level of potency which the Secretary
      determines is nutritionally rational or useful;
        (C) the Secretary may not limit, under section 321(n), 341, or
      343 of this title, the combination or number of any synthetic or
      natural - 
          (i) vitamin,
          (ii) mineral, or
          (iii) other ingredient of food,

      within a food to which this section applies.

      (2) Paragraph (1) shall not apply in the case of a vitamin,
    mineral, other ingredient of food, or food, which is represented
    for use by individuals in the treatment or management of specific
    diseases or disorders, by children, or by pregnant or lactating
    women. For purposes of this subparagraph,(!1) the term "children"
    means individuals who are under the age of twelve years.

    (b) Labeling and advertising requirements for foods
      (1) A food to which this section applies shall not be deemed
    under section 343 of this title to be misbranded solely because its
    label bears, in accordance with section 343(i)(2) of this title,
    all the ingredients in the food or its advertising contains
    references to ingredients in the food which are not vitamins or
    minerals.
      (2) The labeling for any food to which this section applies may
    not list its ingredients which are not dietary supplement
    ingredients described in section 321(ff) of this title (i) except
    as a part of a list of all the ingredients of such food, and (ii)
    unless such ingredients are listed in accordance with applicable
    regulations under section 343 of this title. To the extent that
    compliance with clause (i) of this subparagraph is impracticable or
    results in deception or unfair competition, exemptions shall be
    established by regulations promulgated by the Secretary.
    (c) Definitions
      (1) For purposes of this section, the term "food to which this
    section applies" means a food for humans which is a food for
    special dietary use - 
        (A) which is or contains any natural or synthetic vitamin or
      mineral, and
        (B) which - 
          (i) is intended for ingestion in tablet, capsule, powder,
        softgel, gelcap, or liquid form, or
          (ii) if not intended for ingestion in such a form, is not
        represented as conventional food and is not represented for use
        as a sole item of a meal or of the diet.

      (2) For purposes of paragraph (1)(B)(i), a food shall be
    considered as intended for ingestion in liquid form only if it is
    formulated in a fluid carrier and it is intended for ingestion in
    daily quantities measured in drops or similar small units of
    measure.
      (3) For purposes of paragraph (1) and of section 343(j) of this
    title insofar as that section is applicable to food to which this
    section applies, the term "special dietary use" as applied to food
    used by man means a particular use for which a food purports or is
    represented to be used, including but not limited to the following:
        (A) Supplying a special dietary need that exists by reason of a
      physical, physiological, pathological, or other condition,
      including but not limited to the condition of disease,
      convalescence, pregnancy, lactation, infancy, allergic
      hypersensitivity to food, underweight, overweight, or the need to
      control the intake of sodium.
        (B) Supplying a vitamin, mineral, or other ingredient for use
      by man to supplement his diet by increasing the total dietary
      intake.
        (C) Supplying a special dietary need by reason of being a food
      for use as the sole item of the diet.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 411, as added Pub. L. 94-278, title
    V, Sec. 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103-
    417, Secs. 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (b)(2). Pub. L. 103-417, Sec. 7(d), redesignated
    subpar. (A) as par. (2), substituted "dietary supplement
    ingredients described in section 321(ff) of this title" for
    "vitamins or minerals", and struck out former subpar. (B), which
    read as follows: "Notwithstanding the provisions of subparagraph
    (A), the labeling and advertising for any food to which this
    section applies may not give prominence to or emphasize ingredients
    which are not - 
        "(i) vitamins,
        "(ii) minerals, or
        "(iii) represented as a source of vitamins or minerals."
      Subsec. (c)(1)(B)(i). Pub. L. 103-417, Sec. 3(c)(1), inserted
    "powder, softgel, gelcap," after "capsule,".
      Subsec. (c)(1)(B)(ii). Pub. L. 103-417, Sec. 3(c)(2), struck out
    "does not simulate and" after "in such a form,".

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      For provision that dietary supplements may be labeled after Oct.
    25, 1994, in accordance with amendments made by section 7(d) of
    Pub. L. 103-417, and shall be so labeled after Dec. 31, 1996, see
    section 7(e) of Pub. L. 103-417, set out as a note under section
    343 of this title.

            AMENDMENT OF INCONSISTENT REGULATIONS BY SECRETARY        
      Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88,
    title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that:
    "The Secretary of Health and Human Services shall amend any
    regulation promulgated under the Federal Food, Drug, and Cosmetic
    Act [this chapter] which is inconsistent with section 411 of such
    Act [section 350 of this title] (as added by subsection (a)) and
    such amendments shall be promulgated in accordance with section 553
    of title 5, United States Code."

-FOOTNOTE-
    (!1) So in original. Probably should be "paragraph".


-End-



-CITE-
    21 USC Sec. 350a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350a. Infant formulas

-STATUTE-
    (a) Adulteration
      An infant formula, including an infant formula powder, shall be
    deemed to be adulterated if - 
        (1) such infant formula does not provide nutrients as required
      by subsection (i) of this section,
        (2) such infant formula does not meet the quality factor
      requirements prescribed by the Secretary under subsection (b)(1)
      of this section, or
        (3) the processing of such infant formula is not in compliance
      with the good manufacturing practices and the quality control
      procedures prescribed by the Secretary under subsection (b)(2) of
      this section.
    (b) Requirements for quality factors, good manufacturing practices,
      and retention of records
      (1) The Secretary shall by regulation establish requirements for
    quality factors for infant formulas to the extent possible
    consistent with current scientific knowledge, including quality
    factor requirements for the nutrients required by subsection (i) of
    this section.
      (2)(A) The Secretary shall by regulation establish good
    manufacturing practices for infant formulas, including quality
    control procedures that the Secretary determines are necessary to
    assure that an infant formula provides nutrients in accordance with
    this subsection and subsection (i) of this section and is
    manufactured in a manner designed to prevent adulteration of the
    infant formula.
      (B) The good manufacturing practices and quality control
    procedures prescribed by the Secretary under subparagraph (A) shall
    include requirements for - 
        (i) the testing, in accordance with paragraph (3) and by the
      manufacturer of an infant formula or an agent of such
      manufacturer, of each batch of infant formula for each nutrient
      required by subsection (i) of this section before the
      distribution of such batch,
        (ii) regularly scheduled testing, by the manufacturer of an
      infant formula or an agent of such manufacturer, of samples of
      infant formulas during the shelf life of such formulas to ensure
      that such formulas are in compliance with this section,
        (iii) in-process controls including, where necessary, testing
      required by good manufacturing practices designed to prevent
      adulteration of each batch of infant formula, and
        (iv) the conduct by the manufacturer of an infant formula or an
      agent of such manufacturer of regularly scheduled audits to
      determine that such manufacturer has complied with the
      regulations prescribed under subparagraph (A).

    In prescribing requirements for audits under clause (iv), the
    Secretary shall provide that such audits be conducted by
    appropriately trained individuals who do not have any direct
    responsibility for the manufacture or production of infant formula.
      (3)(A) At the final product stage, each batch of infant formula
    shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E
    to ensure that such infant formula is in compliance with the
    requirements of this subsection and subsection (i) of this section
    relating to such vitamins.
      (B) Each nutrient premix used in the manufacture of an infant
    formula shall be tested for each relied upon nutrient required by
    subsection (i) of this section which is contained in such premix to
    ensure that such premix is in compliance with its specifications or
    certifications by a premix supplier.
      (C) During the manufacturing process or at the final product
    stage and before distribution of an infant formula, an infant
    formula shall be tested for all nutrients required to be included
    in such formula by subsection (i) of this section for which testing
    has not been conducted pursuant to subparagraph (A) or (B). Testing
    under this subparagraph shall be conducted to - 
        (i) ensure that each batch of such infant formula is in
      compliance with the requirements of subsection (i) of this
      section relating to such nutrients, and
        (ii) confirm that nutrients contained in any nutrient premix
      used in such infant formula are present in each batch of such
      infant formula in the proper concentration.

      (D) If the Secretary adds a nutrient to the list of nutrients in
    the table in subsection (i) of this section, the Secretary shall by
    regulation require that the manufacturer of an infant formula test
    each batch of such formula for such new nutrient in accordance with
    subparagraph (A), (B), or (C).
      (E) For purposes of this paragraph, the term "final product
    stage" means the point in the manufacturing process, before
    distribution of an infant formula, at which an infant formula is
    homogenous and is not subject to further degradation.
      (4)(A) The Secretary shall by regulation establish requirements
    respecting the retention of records. Such requirements shall
    provide for - 
        (i) the retention of all records necessary to demonstrate
      compliance with the good manufacturing practices and quality
      control procedures prescribed by the Secretary under paragraph
      (2), including records containing the results of all testing
      required under paragraph (2)(B),
        (ii) the retention of all certifications or guarantees of
      analysis by premix suppliers,
        (iii) the retention by a premix supplier of all records
      necessary to confirm the accuracy of all premix certifications
      and guarantees of analysis,
        (iv) the retention of - 
          (I) all records pertaining to the microbiological quality and
        purity of raw materials used in infant formula powder and in
        finished infant formula, and
          (II) all records pertaining to food packaging materials which
        show that such materials do not cause an infant formula to be
        adulterated within the meaning of section 342(a)(2)(C) of this
        title,

        (v) the retention of all records of the results of regularly
      scheduled audits conducted pursuant to the requirements
      prescribed by the Secretary under paragraph (2)(B)(iv), and
        (vi) the retention of all complaints and the maintenance of
      files with respect to, and the review of, complaints concerning
      infant formulas which may reveal the possible existence of a
      hazard to health.

      (B)(i) Records required under subparagraph (A) with respect to an
    infant formula shall be retained for at least one year after the
    expiration of the shelf life of such infant formula. Except as
    provided in clause (ii), such records shall be made available to
    the Secretary for review and duplication upon request of the
    Secretary.
      (ii) A manufacturer need only provide written assurances to the
    Secretary that the regularly scheduled audits required by paragraph
    (2)(B)(iv) are being conducted by the manufacturer, and need not
    make available to the Secretary the actual written reports of such
    audits.
    (c) Registration of persons distributing new infant formula
      (1) No person shall introduce or deliver for introduction into
    interstate commerce any new infant formula unless - 
        (A) such person has, before introducing such new infant
      formula, or delivering such new infant formula for introduction,
      into interstate commerce, registered with the Secretary the name
      of such person, the place of business of such person, and all
      establishments at which such person intends to manufacture such
      new infant formula, and
        (B) such person has at least 90 days before marketing such new
      infant formula, made the submission to the Secretary required by
      subsection (c)(1) of this section.

      (2) For purposes of paragraph (1), the term "new infant formula"
    includes - 
        (A) an infant formula manufactured by a person which has not
      previously manufactured an infant formula, and
        (B) an infant formula manufactured by a person which has
      previously manufactured infant formula and in which there is a
      major change, in processing or formulation, from a current or any
      previous formulation produced by such manufacturer.

    For purposes of this paragraph, the term "major change" has the
    meaning given to such term in section 106.30(c)(2) of title 21,
    Code of Federal Regulations (as in effect on August 1, 1986), and
    guidelines issued thereunder.
    (d) Submission of information about new infant formula required
      (1) A person shall, with respect to any infant formula subject to
    subsection (c) of this section, make a submission to the Secretary
    which shall include - 
        (A) the quantitative formulation of the infant formula,
        (B) a description of any reformulation of the formula or change
      in processing of the infant formula,
        (C) assurances that the infant formula will not be marketed
      unless it meets the requirements of subsections (b)(1) and (i) of
      this section, as demonstrated by the testing required under
      subsection (b)(3) of this section, and
        (D) assurances that the processing of the infant formula
      complies with subsection (b)(2) of this section.

      (2) After the first production of an infant formula subject to
    subsection (c) of this section, and before the introduction into
    interstate commerce of such formula, the manufacturer of such
    formula shall submit to the Secretary, in such form as may be
    prescribed by the Secretary, a written verification which
    summarizes test results and records demonstrating that such formula
    complies with the requirements of subsections (b)(1), (b)(2)(A),
    (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this
    section.
      (3) If the manufacturer of an infant formula for commercial or
    charitable distribution for human consumption determines that a
    change in the formulation of the formula or a change in the
    processing of the formula may affect whether the formula is
    adulterated under subsection (a) of this section, the manufacturer
    shall, before the first processing of such formula, make the
    submission to the Secretary required by paragraph (1).
    (e) Additional notice requirements for manufacturer
      (1) If the manufacturer of an infant formula has knowledge which
    reasonably supports the conclusion that an infant formula which has
    been processed by the manufacturer and which has left an
    establishment subject to the control of the manufacturer - 
        (A) may not provide the nutrients required by subsection (i) of
      this section, or
        (B) may be otherwise adulterated or misbranded,

    the manufacturer shall promptly notify the Secretary of such
    knowledge. If the Secretary determines that the infant formula
    presents a risk to human health, the manufacturer shall immediately
    take all actions necessary to recall shipments of such infant
    formula from all wholesale and retail establishments, consistent
    with recall regulations and guidelines issued by the Secretary.
      (2) For purposes of paragraph (1), the term "knowledge" as
    applied to a manufacturer means (A) the actual knowledge that the
    manufacturer had, or (B) the knowledge which a reasonable person
    would have had under like circumstances or which would have been
    obtained upon the exercise of due care.
    (f) Procedures applicable to recalls by manufacturer; regulatory
      oversight
      (1) If a recall of infant formula is begun by a manufacturer, the
    recall shall be carried out in accordance with such requirements as
    the Secretary shall prescribe under paragraph (2) and - 
        (A) the Secretary shall, not later than the 15th day after the
      beginning of such recall and at least once every 15 days
      thereafter until the recall is terminated, review the actions
      taken under the recall to determine whether the recall meets the
      requirements prescribed under paragraph (2), and
        (B) the manufacturer shall, not later than the 14th day after
      the beginning of such recall and at least once every 14 days
      thereafter until the recall is terminated, report to the
      Secretary the actions taken to implement the recall.

      (2) The Secretary shall by regulation prescribe the scope and
    extent of recalls of infant formulas necessary and appropriate for
    the degree of risks to human health presented by the formula
    subject to the recall.
      (3) The Secretary shall by regulation require each manufacturer
    of an infant formula who begins a recall of such formula because of
    a risk to human health to request each retail establishment at
    which such formula is sold or available for sale to post at the
    point of purchase of such formula a notice of such recall at such
    establishment for such time that the Secretary determines necessary
    to inform the public of such recall.
    (g) Recordkeeping requirements for manufacturer; regulatory
      oversight and enforcement
      (1) Each manufacturer of an infant formula shall make and retain
    such records respecting the distribution of the infant formula
    through any establishment owned or operated by such manufacturer as
    may be necessary to effect and monitor recalls of the formula. Such
    records shall be retained for at least one year after the
    expiration of the shelf life of the infant formula.
      (2) To the extent that the Secretary determines that records are
    not being made or maintained in accordance with paragraph (1), the
    Secretary may by regulation prescribe the records required to be
    made under paragraph (1) and requirements respecting the retention
    of such records under such paragraph. Such regulations shall take
    effect on such date as the Secretary prescribes but not sooner than
    the 180th day after the date such regulations are promulgated. Such
    regulations shall apply only with respect to distributions of
    infant formulas made after such effective date.
    (h) Exemptions; regulatory oversight
      (1) Any infant formula which is represented and labeled for use
    by an infant - 
        (A) who has an inborn error of metabolism or a low birth
      weight, or
        (B) who otherwise has an unusual medical or dietary problem,

    is exempt from the requirements of subsections (a), (b), and (c) of
    this section. The manufacturer of an infant formula exempt under
    this paragraph shall, in the case of the exempt formula, be
    required to provide the notice required by subsection (e)(1) of
    this section only with respect to adulteration or misbranding
    described in subsection (e)(1)(B) of this section and to comply
    with the regulations prescribed by the Secretary under paragraph
    (2).
      (2) The Secretary may by regulation establish terms and
    conditions for the exemption of an infant formula from the
    requirements of subsections (a), (b), and (c) of this section. An
    exemption of an infant formula under paragraph (1) may be withdrawn
    by the Secretary if such formula is not in compliance with
    applicable terms and conditions prescribed under this paragraph.
    (i) Nutrient requirements
      (1) An infant formula shall contain nutrients in accordance with
    the table set out in this subsection or, if revised by the
    Secretary under paragraph (2), as so revised.
      (2) The Secretary may by regulation - 
        (A) revise the list of nutrients in the table in this
      subsection, and
        (B) revise the required level for any nutrient required by the
      table.



                                 NUTRIENTS                             
    --------------------------------------------------------------------
                 Nutrient                          Minimum       Maximum  
                                                   <sup>a         <sup>a  
                                                   </sup>         </sup>  
    --------------------------------------------------------------------
    Protein (gm)                          1.8                  4.5.       
                                          <su                             
                                          p>b                             
                                          </s                             
                                          up>                             
    Fat:                                                                  
      gm                                  3.3                  6.0.       
      percent cal                        30.0                  54.0.      
    Essential fatty acids                                                 
     (linoeate):                                                          
      percent cal                         2.7                             
      mg                                300.0                             
    Vitamins:                                                             
      A (IU)                            250.0  (75             750.0 (225 
                                                &micro;g        &micro    
                                                )<sup>c</sup>   ;g).<s    
                                                                up>c      
                                                                </sup>    
      D (IU)                             40.0                  100.0.     
      K (&micro;g)                        4.0                             
      E (IU)                              0.7  (with 0.7                  
                                                IU/gm                     
                                                linoleic acid)             
      C (ascorbic acid) (mg)              8.0                             
      B<sub>1</sub> (thiamine)           40.0                             
       (&micro;g)                                                         
      B<sub>2</sub> (riboflavin)         60.0                             
       (&micro;g)                                                         
      B<sub>6</sub> (pyridoxine)         35.0  (with 15                   
       (&micro;g)                               &micro;g/gm               
                                                of protein in             
                                                formula)                  
      B<sub>12</sub> (&micro;g)          0.15                             
      Niacin (&micro;g)                 250.0                             
      Folic acid (&micro;g)               4.0                             
      Pantothenic acid (&micro;g)       300.0                             
      Biotin (&micro;g)                   1.5                             
                                          <su                             
                                          p>d                             
                                          </s                             
                                          up>                             
      Choline (mg)                        7.0                             
                                          <su                             
                                          p>d                             
                                          </s                             
                                          up>                             
      Inositol (mg)                       4.0                             
                                          <su                             
                                          p>d                             
                                          </s                             
                                          up>                             
    Minerals:                                                             
      Calcium (mg)                       50.0                             
                                          <su                             
                                          p>e                             
                                          </s                             
                                          up>                             
      Phosphorus (mg)                    25.0                             
                                          <su                             
                                          p>e                             
                                          </s                             
                                          up>                             
      Magnesium (mg)                      6.0                             
      Iron (mg)                          0.15                             
      Iodine (&micro;g)                   5.0                             
      Zinc (mg)                           0.5                             
      Copper (&micro;g)                  60.0                             
      Manganese (&micro;g)                5.0                             
      Sodium (mg)                        20.0                  60.0.      
      Potassium (mg)                     80.0                  200.0.     
      Chloride (mg)                      55.0                  150.0.     

      <sup>a</sup> Stated per 100 kilocalories.
      <sup>b</sup> The source of protein shall be at least
    nutritionally equivalent to casein.
      <sup>c</sup> Retinol equivalents.
      <sup>d</sup> Required to be included in this amount only in
    formulas which are not milk-based.
      <sup>e</sup> Calcium to phosphorus ratio must be no less than 1.1
    nor more than 2.0.
    --------------------------------------------------------------------


-SOURCE-
    (June 25, 1938, ch. 675, Sec. 412, as added Pub. L. 96-359, Sec. 2,
    Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99-570, title IV,
    Sec. 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207-116, 3207-120;
    Pub. L. 103-80, Sec. 3(l), Aug. 13, 1993, 107 Stat. 777.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (h)(1). Pub. L. 103-80 substituted "(e)(1)(B) of
    this section" for "(c)(1)(B) of this section," in concluding
    provisions.
      1986 - Subsecs. (a) to (d). Pub. L. 99-570, Sec. 4014(a)(7),
    added subsecs. (a) to (d) and struck out former subsecs. (a)
    relating to adulteration and regulatory oversight, (b) relating to
    notice to the Secretary by a manufacturer and requirements and
    scope of that notice, (c) relating to additional notice
    requirements for the manufacturer, and (d) relating to procedures
    applicable to recalls by a manufacturer.
      Subsecs. (e), (f). Pub. L. 99-570, Sec. 4014(a)(1), (7), added
    subsecs. (e) and (f) and redesignated former subsecs. (e) and (f)
    as (g) and (h), respectively.
      Subsec. (g). Pub. L. 99-570, Sec. 4014(a)(1), (2), redesignated
    subsec. (e) as (g) and substituted "Such records shall be retained
    for at least one year after the expiration of the shelf life of the
    infant formula" for "No manufacturer shall be required under this
    subsection to retain any record respecting the distribution of an
    infant formula for a period of longer than 2 years from the date
    the record was made". Former subsec. (g) redesignated (i).
      Subsec. (h). Pub. L. 99-570, Sec. 4014(a)(1), redesignated
    subsec. (f) as (h).
      Subsec. (h)(1). Pub. L. 99-570, Sec. 4014(a)(3), (4), substituted
    "(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)".
      Pub. L. 99-570, Sec. 4014(a)(5), which directed that "(d)(1)(B)"
    be substituted for "(e)(1)(B)" in second sentence could not be
    executed because "(e)(1)(B)" did not appear. See 1993 Amendment
    note above.
      Subsec. (h)(2). Pub. L. 99-570, Sec. 4014(a)(6), substituted
    "(a), (b), and (c)" for "(a) and (b)".
      Subsec. (i). Pub. L. 99-570, Sec. 4014(a)(1), (b)(1),
    redesignated subsec. (g) as (i), designated existing provisions as
    par. (1), substituted "paragraph (2)" for "subsection (a)(2) of
    this section", substituted a period for the colon after "as so
    revised", and added par. (2).

                     EFFECTIVE DATE OF 1980 AMENDMENT                 
      Section 6 of Pub. L. 96-359 provided that: "Section 412 of the
    Federal Food, Drug, and Cosmetic Act (added by section 2) [this
    section] shall apply with respect to infant formulas manufactured
    on or after the 90th day after the date of the enactment of this
    Act [Sept. 26, 1980]."

-End-



-CITE-
    21 USC Sec. 350b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350b. New dietary ingredients

-STATUTE-
    (a) In general
      A dietary supplement which contains a new dietary ingredient
    shall be deemed adulterated under section 342(f) of this title
    unless it meets one of the following requirements:
        (1) The dietary supplement contains only dietary ingredients
      which have been present in the food supply as an article used for
      food in a form in which the food has not been chemically altered.
        (2) There is a history of use or other evidence of safety
      establishing that the dietary ingredient when used under the
      conditions recommended or suggested in the labeling of the
      dietary supplement will reasonably be expected to be safe and, at
      least 75 days before being introduced or delivered for
      introduction into interstate commerce, the manufacturer or
      distributor of the dietary ingredient or dietary supplement
      provides the Secretary with information, including any citation
      to published articles, which is the basis on which the
      manufacturer or distributor has concluded that a dietary
      supplement containing such dietary ingredient will reasonably be
      expected to be safe.

    The Secretary shall keep confidential any information provided
    under paragraph (2) for 90 days following its receipt. After the
    expiration of such 90 days, the Secretary shall place such
    information on public display, except matters in the information
    which are trade secrets or otherwise confidential, commercial
    information.
    (b) Petition
      Any person may file with the Secretary a petition proposing the
    issuance of an order prescribing the conditions under which a new
    dietary ingredient under its intended conditions of use will
    reasonably be expected to be safe. The Secretary shall make a
    decision on such petition within 180 days of the date the petition
    is filed with the Secretary. For purposes of chapter 7 of title 5,
    the decision of the Secretary shall be considered final agency
    action.
    (c) "New dietary ingredient" defined
      For purposes of this section, the term "new dietary ingredient"
    means a dietary ingredient that was not marketed in the United
    States before October 15, 1994 and does not include any dietary
    ingredient which was marketed in the United States before October
    15, 1994.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 413, as added Pub. L. 103-417, Sec.
    8, Oct. 25, 1994, 108 Stat. 4331.)

-End-



-CITE-
    21 USC Sec. 350c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350c. Maintenance and inspection of records

-STATUTE-
    (a) Records inspection
      If the Secretary has a reasonable belief that an article of food
    is adulterated and presents a threat of serious adverse health
    consequences or death to humans or animals, each person (excluding
    farms and restaurants) who manufactures, processes, packs,
    distributes, receives, holds, or imports such article shall, at the
    request of an officer or employee duly designated by the Secretary,
    permit such officer or employee, upon presentation of appropriate
    credentials and a written notice to such person, at reasonable
    times and within reasonable limits and in a reasonable manner, to
    have access to and copy all records relating to such article that
    are needed to assist the Secretary in determining whether the food
    is adulterated and presents a threat of serious adverse health
    consequences or death to humans or animals. The requirement under
    the preceding sentence applies to all records relating to the
    manufacture, processing, packing, distribution, receipt, holding,
    or importation of such article maintained by or on behalf of such
    person in any format (including paper and electronic formats) and
    at any location.
    (b) Regulations concerning recordkeeping
      The Secretary, in consultation and coordination, as appropriate,
    with other Federal departments and agencies with responsibilities
    for regulating food safety, may by regulation establish
    requirements regarding the establishment and maintenance, for not
    longer than two years, of records by persons (excluding farms and
    restaurants) who manufacture, process, pack, transport, distribute,
    receive, hold, or import food, which records are needed by the
    Secretary for inspection to allow the Secretary to identify the
    immediate previous sources and the immediate subsequent recipients
    of food, including its packaging, in order to address credible
    threats of serious adverse health consequences or death to humans
    or animals. The Secretary shall take into account the size of a
    business in promulgating regulations under this section.
    (c) Protection of sensitive information
      The Secretary shall take appropriate measures to ensure that
    there are in effect effective procedures to prevent the
    unauthorized disclosure of any trade secret or confidential
    information that is obtained by the Secretary pursuant to this
    section.
    (d) Limitations
      This section shall not be construed - 
        (1) to limit the authority of the Secretary to inspect records
      or to require establishment and maintenance of records under any
      other provision of this chapter;
        (2) to authorize the Secretary to impose any requirements with
      respect to a food to the extent that it is within the exclusive
      jurisdiction of the Secretary of Agriculture pursuant to the
      Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
      Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
      Products Inspection Act (21 U.S.C. 1031 et seq.);
        (3) to have any legal effect on section 552 of title 5 or
      section 1905 of title 18; or
        (4) to extend to recipes for food, financial data, pricing
      data, personnel data, research data, or sales data (other than
      shipment data regarding sales).

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 414, as added Pub. L. 107-188, title
    III, Sec. 306(a), June 12, 2002, 116 Stat. 669.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Meat Inspection Act, referred to in subsec. (d)(2),
    is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L.
    90-201, Dec. 15, 1967, 81 Stat. 584, and amended, which are
    classified generally to subchapters I to IV (Sec. 601 et seq.) of
    chapter 12 of this title. For complete classification of this Act
    to the Code, see Short Title note set out under section 601 of this
    title and Tables.
      The Poultry Products Inspection Act, referred to in subsec.
    (d)(2), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended,
    which is classified generally to chapter 10 (Sec. 451 et seq.) of
    this title. For complete classification of this Act to the Code,
    see Short Title note set out under section 451 of this title and
    Tables.
      The Egg Products Inspection Act, referred to in subsec. (d)(2),
    is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as amended, which
    is classified generally to chapter 15 (Sec. 1031 et seq.) of this
    title. For complete classification of this Act to the Code, see
    Short Title note set out under section 1031 of this title and
    Tables.


-MISC1-
                           EXPEDITED RULEMAKING                       
      Pub. L. 107-188, title III, Sec. 306(d), June 12, 2002, 116 Stat.
    670, provided that: "Not later than 18 months after the date of the
    enactment of this Act [June 12, 2002], the Secretary shall
    promulgate proposed and final regulations establishing
    recordkeeping requirements under subsection 414(b) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by
    subsection (a))."

-End-



-CITE-
    21 USC Sec. 350d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350d. Registration of food facilities

-STATUTE-
    (a) Registration
      (1) In general
        The Secretary shall by regulation require that any facility
      engaged in manufacturing, processing, packing, or holding food
      for consumption in the United States be registered with the
      Secretary. To be registered - 
          (A) for a domestic facility, the owner, operator, or agent in
        charge of the facility shall submit a registration to the
        Secretary; and
          (B) for a foreign facility, the owner, operator, or agent in
        charge of the facility shall submit a registration to the
        Secretary and shall include with the registration the name of
        the United States agent for the facility.
      (2) Registration
        An entity (referred to in this section as the "registrant")
      shall submit a registration under paragraph (1) to the Secretary
      containing information necessary to notify the Secretary of the
      name and address of each facility at which, and all trade names
      under which, the registrant conducts business and, when
      determined necessary by the Secretary through guidance, the
      general food category (as identified under section 170.3 of title
      21, Code of Federal Regulations) of any food manufactured,
      processed, packed, or held at such facility. The registrant shall
      notify the Secretary in a timely manner of changes to such
      information.
      (3) Procedure
        Upon receipt of a completed registration described in paragraph
      (1), the Secretary shall notify the registrant of the receipt of
      such registration and assign a registration number to each
      registered facility.
      (4) List
        The Secretary shall compile and maintain an up-to-date list of
      facilities that are registered under this section. Such list and
      any registration documents submitted pursuant to this subsection
      shall not be subject to disclosure under section 552 of title 5.
      Information derived from such list or registration documents
      shall not be subject to disclosure under section 552 of title 5
      to the extent that it discloses the identity or location of a
      specific registered person.
    (b) Facility
      For purposes of this section:
        (1) The term "facility" includes any factory, warehouse, or
      establishment (including a factory, warehouse, or establishment
      of an importer) that manufactures, processes, packs, or holds
      food. Such term does not include farms; restaurants; other retail
      food establishments; nonprofit food establishments in which food
      is prepared for or served directly to the consumer; or fishing
      vessels (except such vessels engaged in processing as defined in
      section 123.3(k) of title 21, Code of Federal Regulations).
        (2) The term "domestic facility" means a facility located in
      any of the States or Territories.
        (3)(A) The term "foreign facility" means a facility that
      manufacturers, processes, packs, or holds food, but only if food
      from such facility is exported to the United States without
      further processing or packaging outside the United States.
        (B) A food may not be considered to have undergone further
      processing or packaging for purposes of subparagraph (A) solely
      on the basis that labeling was added or that any similar activity
      of a de minimis nature was carried out with respect to the food.
    (c) Rule of construction
      Nothing in this section shall be construed to authorize the
    Secretary to require an application, review, or licensing process.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 415, as added Pub. L. 107-188, title
    III, Sec. 305(a), June 12, 2002, 116 Stat. 667.)


-MISC1-
                                REGULATIONS                            
      Pub. L. 107-188, title III, Sec. 305(e), June 12, 2002, 116 Stat.
    669, provided that: "Not later than 18 months after the date of the
    enactment of this Act [June 12, 2002], the Secretary of Health and
    Human Services shall promulgate proposed and final regulations for
    the requirement of registration under section 415 of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by
    subsection (a) of this section). Such requirement of registration
    takes effect - 
        "(1) upon the effective date of such final regulations; or
        "(2) upon the expiration of such 18-month period if the final
      regulations have not been made effective as of the expiration of
      such period, subject to compliance with the final regulations
      when the final regulations are made effective."

                             ELECTRONIC FILING                         
      Pub. L. 107-188, title III, Sec. 305(d), June 12, 2002, 116 Stat.
    668, provided that: "For the purpose of reducing paperwork and
    reporting burdens, the Secretary of Health and Human Services may
    provide for, and encourage the use of, electronic methods of
    submitting to the Secretary registrations required pursuant to this
    section [enacting this section, amending sections 331 and 381 of
    this title, and enacting provisions set out as a note under this
    section]. In providing for the electronic submission of such
    registrations, the Secretary shall ensure adequate authentication
    protocols are used to enable identification of the registrant and
    validation of the data as appropriate."

-End-



-CITE-
    21 USC Sec. 350e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350e. Sanitary transportation practices

-STATUTE-
    (a) Definitions
      In this section:
      (1) Bulk vehicle
        The term "bulk vehicle" includes a tank truck, hopper truck,
      rail tank car, hopper car, cargo tank, portable tank, freight
      container, or hopper bin, and any other vehicle in which food is
      shipped in bulk, with the food coming into direct contact with
      the vehicle.
      (2) Transportation
        The term "transportation" means any movement in commerce by
      motor vehicle or rail vehicle.
    (b) Regulations
      The Secretary shall by regulation require shippers, carriers by
    motor vehicle or rail vehicle, receivers, and other persons engaged
    in the transportation of food to use sanitary transportation
    practices prescribed by the Secretary to ensure that food is not
    transported under conditions that may render the food adulterated.
    (c) Contents
      The regulations under subsection (b) of this section shall - 
        (1) prescribe such practices as the Secretary determines to be
      appropriate relating to - 
          (A) sanitation;
          (B) packaging, isolation, and other protective measures;
          (C) limitations on the use of vehicles;
          (D) information to be disclosed - 
            (i) to a carrier by a person arranging for the transport of
          food; and
            (ii) to a manufacturer or other person that - 
              (I) arranges for the transportation of food by a carrier;
            or
              (II) furnishes a tank vehicle or bulk vehicle for the
            transportation of food; and

          (E) recordkeeping; and

        (2) include - 
          (A) a list of nonfood products that the Secretary determines
        may, if shipped in a bulk vehicle, render adulterated food that
        is subsequently transported in the same vehicle; and
          (B) a list of nonfood products that the Secretary determines
        may, if shipped in a motor vehicle or rail vehicle (other than
        a tank vehicle or bulk vehicle), render adulterated food that
        is simultaneously or subsequently transported in the same
        vehicle.
    (d) Waivers
      (1) In general
        The Secretary may waive any requirement under this section,
      with respect to any class of persons, vehicles, food, or nonfood
      products, if the Secretary determines that the waiver - 
          (A) will not result in the transportation of food under
        conditions that would be unsafe for human or animal health; and
          (B) will not be contrary to the public interest.
      (2) Publication
        The Secretary shall publish in the Federal Register any waiver
      and the reasons for the waiver.
    (e) Preemption
      (1) In general
        A requirement of a State or political subdivision of a State
      that concerns the transportation of food is preempted if - 
          (A) complying with a requirement of the State or political
        subdivision and a requirement of this section, or a regulation
        prescribed under this section, is not possible; or
          (B) the requirement of the State or political subdivision as
        applied or enforced is an obstacle to accomplishing and
        carrying out this section or a regulation prescribed under this
        section.
      (2) Applicability
        This subsection applies to transportation that occurs on or
      after the effective date of the regulations promulgated under
      subsection (b) of this section.
    (f) Assistance of other agencies
      The Secretary of Transportation, the Secretary of Agriculture,
    the Administrator of the Environmental Protection Agency, and the
    heads of other Federal agencies, as appropriate, shall provide
    assistance on request, to the extent resources are available, to
    the Secretary for the purposes of carrying out this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 416, as added Pub. L. 109-59, title
    VII, Sec. 7202(b), Aug. 10, 2005, 119 Stat. 1911.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109-
    59, set out as an Effective Date of 2005 Amendment note under
    section 331 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER V - DRUGS AND DEVICES                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES

-HEAD-
                     SUBCHAPTER V - DRUGS AND DEVICES                 

-End-


-CITE-
    21 USC Part A - Drugs and Devices                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
                        PART A - DRUGS AND DEVICES                    

-End-



-CITE-
    21 USC Sec. 351                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 351. Adulterated drugs and devices

-STATUTE-
      A drug or device shall be deemed to be adulterated - 
    (a) Poisonous, insanitary, etc., ingredients; adequate controls in
      manufacture
      (1) If it consists in whole or in part of any filthy, putrid, or
    decomposed substance; or (2)(A) if it has been prepared, packed, or
    held under insanitary conditions whereby it may have been
    contaminated with filth, or whereby it may have been rendered
    injurious to health; or (B) if it is a drug and the methods used
    in, or the facilities or controls used for, its manufacture,
    processing, packing, or holding do not conform to or are not
    operated or administered in conformity with current good
    manufacturing practice to assure that such drug meets the
    requirements of this chapter as to safety and has the identity and
    strength, and meets the quality and purity characteristics, which
    it purports or is represented to possess; or (C) if it is a
    compounded positron emission tomography drug and the methods used
    in, or the facilities and controls used for, its compounding,
    processing, packing, or holding do not conform to or are not
    operated or administered in conformity with the positron emission
    tomography compounding standards and the official monographs of the
    United States Pharmacopoeia to assure that such drug meets the
    requirements of this chapter as to safety and has the identity and
    strength, and meets the quality and purity characteristics, that it
    purports or is represented to possess; or (3) if its container is
    composed, in whole or in part, of any poisonous or deleterious
    substance which may render the contents injurious to health; or (4)
    if (A) it bears or contains, for purposes of coloring only, a color
    additive which is unsafe within the meaning of section 379e(a) of
    this title, or (B) it is a color additive the intended use of which
    in or on drugs or devices is for purposes of coloring only and is
    unsafe within the meaning of section 379e(a) of this title; or (5)
    if it is a new animal drug which is unsafe within the meaning of
    section 360b of this title; or (6) if it is an animal feed bearing
    or containing a new animal drug, and such animal feed is unsafe
    within the meaning of section 360b of this title.
    (b) Strength, quality, or purity differing from official compendium
      If it purports to be or is represented as a drug the name of
    which is recognized in an official compendium, and its strength
    differs from, or its quality or purity falls below, the standard
    set forth in such compendium. Such determination as to strength,
    quality, or purity shall be made in accordance with the tests or
    methods of assay set forth in such compendium, except that whenever
    tests or methods of assay have not been prescribed in such
    compendium, or such tests or methods of assay as are prescribed
    are, in the judgment of the Secretary, insufficient for the making
    of such determination, the Secretary shall bring such fact to the
    attention of the appropriate body charged with the revision of such
    compendium, and if such body fails within a reasonable time to
    prescribe tests or methods of assay which, in the judgment of the
    Secretary, are sufficient for purposes of this paragraph, then the
    Secretary shall promulgate regulations prescribing appropriate
    tests or methods of assay in accordance with which such
    determination as to strength, quality, or purity shall be made. No
    drug defined in an official compendium shall be deemed to be
    adulterated under this paragraph because it differs from the
    standard of strength, quality, or purity therefor set forth in such
    compendium, if its difference in strength, quality, or purity from
    such standard is plainly stated on its label. Whenever a drug is
    recognized in both the United States Pharmacopoeia and the
    Homoeopathic Pharmacopoeia of the United States it shall be subject
    to the requirements of the United States Pharmacopoeia unless it is
    labeled and offered for sale as a homoeopathic drug, in which case
    it shall be subject to the provisions of the Homoeopathic
    Pharmacopoeia of the United States and not to those of the United
    States Pharmacopoeia.
    (c) Misrepresentation of strength, etc., where drug is unrecognized
      in compendium
      If it is not subject to the provisions of paragraph (b) of this
    section and its strength differs from, or its purity or quality
    falls below, that which it purports or is represented to possess.
    (d) Mixture with or substitution of another substance
      If it is a drug and any substance has been (1) mixed or packed
    therewith so as to reduce its quality or strength or (2)
    substituted wholly or in part therefor.
    (e) Devices not in conformity with performance standards
      (1) If it is, or purports to be or is represented as, a device
    which is subject to a performance standard established under
    section 360d of this title unless such device is in all respects in
    conformity with such standard.
      (2) If it is declared to be, purports to be, or is represented
    as, a device that is in conformity with any standard recognized
    under section 360d(c) of this title unless such device is in all
    respects in conformity with such standard.
    (f) Certain class III devices
      (1) If it is a class III device - 
        (A)(i) which is required by a regulation promulgated under
      subsection (b) of section 360e of this title to have an approval
      under such section of an application for premarket approval and
      which is not exempt from section 360e of this title under section
      360j(g) of this title, and
        (ii)(I) for which an application for premarket approval or a
      notice of completion of a product development protocol was not
      filed with the Secretary within the ninety-day period beginning
      on the date of the promulgation of such regulation, or
        (II) for which such an application was filed and approval of
      the application has been denied, suspended, or withdrawn, or such
      a notice was filed and has been declared not completed or the
      approval of the device under the protocol has been withdrawn;
        (B)(i) which was classified under section 360c(f) of this title
      into class III, which under section 360e(a) of this title is
      required to have in effect an approved application for premarket
      approval, and which is not exempt from section 360e of this title
      under section 360j(g) of this title, and
        (ii) which has an application which has been suspended or is
      otherwise not in effect; or
        (C) which was classified under section 360j(l) of this title
      into class III, which under such section is required to have in
      effect an approved application under section 360e of this title,
      and which has an application which has been suspended or is
      otherwise not in effect.

      (2)(A) In the case of a device classified under section 360c(f)
    of this title into class III and intended solely for
    investigational use, paragraph (!1) (1)(B) shall not apply with
    respect to such device during the period ending on the ninetieth
    day after the date of the promulgation of the regulations
    prescribing the procedures and conditions required by section
    360j(g)(2) of this title.

      (B) In the case of a device subject to a regulation promulgated
    under subsection (b) of section 360e of this title, paragraph (!1)
    (1) shall not apply with respect to such device during the period
    ending - 
        (i) on the last day of the thirtieth calendar month beginning
      after the month in which the classification of the device in
      class III became effective under section 360c of this title, or
        (ii) on the ninetieth day after the date of the promulgation of
      such regulation,

    whichever occurs later.
    (g) Banned devices
      If it is a banned device.
    (h) Manufacture, packing, storage, or installation of device not in
      conformity with applicable requirements or conditions
      If it is a device and the methods used in, or the facilities or
    controls used for, its manufacture, packing, storage, or
    installation are not in conformity with applicable requirements
    under section 360j(f)(1) of this title or an applicable condition
    prescribed by an order under section 360j(f)(2) of this title.
    (i) Failure to comply with requirements under which device was
      exempted for investigational use
      If it is a device for which an exemption has been granted under
    section 360j(g) of this title for investigational use and the
    person who was granted such exemption or any investigator who uses
    such device under such exemption fails to comply with a requirement
    prescribed by or under such section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 501, 52 Stat. 1049; Pub. L. 86-618,
    title I, Sec. 102(b)(1), July 12, 1960, 74 Stat. 398; Pub. L. 87-
    781, title I, Sec. 101, Oct. 10, 1962, 76 Stat. 780; Pub. L. 90-
    399, Sec. 101(a), July 13, 1968, 82 Stat. 343; Pub. L. 94-295,
    Secs. 3(d), 9(b)(1), May 28, 1976, 90 Stat. 576, 583; Pub. L. 101-
    629, Sec. 9(b), Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102-571,
    title I, Sec. 107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105-
    115, title I, Sec. 121(b)(1), title II, Sec. 204(c), Nov. 21,
    1997, 111 Stat. 2320, 2336.)


-MISC1-
                                AMENDMENTS                            
      1997 - Par. (a)(2)(C). Pub. L. 105-115, Sec. 121(b)(1), inserted
    "; or (C) if it is a compounded positron emission tomography drug
    and the methods used in, or the facilities and controls used for,
    its compounding, processing, packing, or holding do not conform to
    or are not operated or administered in conformity with the positron
    emission tomography compounding standards and the official
    monographs of the United States Pharmacopoeia to assure that such
    drug meets the requirements of this chapter as to safety and has
    the identity and strength, and meets the quality and purity
    characteristics, that it purports or is represented to possess;"
    before "or (3)".
      Par. (e). Pub. L. 105-115, Sec. 204(c), designated existing
    provisions as subpar. (1) and added subpar. (2).
      1992 - Par. (a)(4). Pub. L. 102-571 substituted "379e(a)" for
    "376(a)" in cls. (A) and (B).
      1990 - Par. (f)(1). Pub. L. 101-629, Sec. 9(b), which directed
    the amendment of subpars. (A) to (C) of par. (f), was executed by
    making the amendments in cls. (A) to (C) of subpar. (1) of par. (f)
    as follows to reflect the probable intent of Congress: in cl.
    (A)(ii)(II), substituted ", suspended, or withdrawn" for "or
    withdrawn"; in cl. (B)(ii), substituted "which has an application
    which has been suspended or is otherwise not in effect" for "which
    does not have such an application in effect"; and in cl. (C),
    substituted "which has an application which has been suspended or
    is otherwise not in effect" for "which does not have such an
    application in effect".
      1976 - Par. (a). Pub. L. 94-295, Sec. 9(b)(1), substituted "(3)
    if its" for "(3) if it is a drug and its" in cl. (3), substituted
    "(4) if (A) it bears or contains" for "(4) if (A) it is a drug
    which bears or contains" in cl. (4)(A), and substituted "drugs or
    devices" for "drugs" in cl. (4)(B).
      Pars. (e) to (i). Pub. L. 94-295, Sec. 3(d), added pars. (e) to
    (i).
      1968 - Par. (a). Pub. L. 90-399 added cls. (5) and (6).
      1962 - Par. (a). Pub. L. 87-781 designated existing provisions of
    cl. (2) as (A) and added (B).
      1960 - Par. (a). Pub. L. 86-618 substituted provisions in cl. (4)
    relating to unsafe color additives for provisions which related to
    a coal-tar color other than one from a batch that has been
    certified in accordance with regulations as provided by section 354
    of this title.

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Section 121(b)(2) of Pub. L. 105-115 provided that: "Section
    501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    351(a)(2)(C)) shall not apply 4 years after the date of enactment
    of this Act [Nov. 21, 1997] or 2 years after the date on which the
    Secretary of Health and Human Services establishes the requirements
    described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L.
    105-115, set out as a note under section 355 of this title],
    whichever is later."
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as an Effective Date of 1997 Amendment note under
    section 321 of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

               EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS           
      Amendment by Pub. L. 87-781 effective on first day of seventh
    calendar month following October 1962, see section 107 of Pub. L.
    87-781, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch.
    242, 53 Stat. 853, set out as an Effective Date; Postponement in
    Certain Cases note under section 301 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-FOOTNOTE-
    (!1) So in original. Probably should be "subparagraph".


-End-



-CITE-
    21 USC Sec. 352                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 352. Misbranded drugs and devices

-STATUTE-
      A drug or device shall be deemed to be misbranded - 
    (a) False or misleading label
      If its labeling is false or misleading in any particular. Health
    care economic information provided to a formulary committee, or
    other similar entity, in the course of the committee or the entity
    carrying out its responsibilities for the selection of drugs for
    managed care or other similar organizations, shall not be
    considered to be false or misleading under this paragraph if the
    health care economic information directly relates to an indication
    approved under section 355 of this title or under section 262(a) of
    title 42 for such drug and is based on competent and reliable
    scientific evidence. The requirements set forth in section 355(a)
    of this title or in section 262(a) of title 42 shall not apply to
    health care economic information provided to such a committee or
    entity in accordance with this paragraph. Information that is
    relevant to the substantiation of the health care economic
    information presented pursuant to this paragraph shall be made
    available to the Secretary upon request. In this paragraph, the
    term "health care economic information" means any analysis that
    identifies, measures, or compares the economic consequences,
    including the costs of the represented health outcomes, of the use
    of a drug to the use of another drug, to another health care
    intervention, or to no intervention.
    (b) Package form; contents of label
      If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count: Provided,
    That under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
    (c) Prominence of information on label
      If any word, statement, or other information required by or under
    authority of this chapter to appear on the label or labeling is not
    prominently placed thereon with such conspicuousness (as compared
    with other words, statements, designs, or devices, in the labeling)
    and in such terms as to render it likely to be read and understood
    by the ordinary individual under customary conditions of purchase
    and use.
    (d) Repealed. Pub. L. 105-115, title I, Sec. 126(b), Nov. 21, 1997,
      111 Stat. 2327
    (e) Designation of drugs or devices by established names
      (1)(A) If it is a drug, unless its label bears, to the exclusion
    of any other nonproprietary name (except the applicable systematic
    chemical name or the chemical formula) - 
        (i) the established name (as defined in subparagraph (3)) of
      the drug, if there is such a name;
        (ii) the established name and quantity or, if determined to be
      appropriate by the Secretary, the proportion of each active
      ingredient, including the quantity, kind, and proportion of any
      alcohol, and also including whether active or not the established
      name and quantity or if determined to be appropriate by the
      Secretary, the proportion of any bromides, ether, chloroform,
      acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,
      hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,
      mercury, ouabain, strophanthin, strychnine, thyroid, or any
      derivative or preparation of any such substances, contained
      therein, except that the requirement for stating the quantity of
      the active ingredients, other than the quantity of those
      specifically named in this subclause, shall not apply to
      nonprescription drugs not intended for human use; and
        (iii) the established name of each inactive ingredient listed
      in alphabetical order on the outside container of the retail
      package and, if determined to be appropriate by the Secretary, on
      the immediate container, as prescribed in regulation promulgated
      by the Secretary, except that nothing in this subclause shall be
      deemed to require that any trade secret be divulged, and except
      that the requirements of this subclause with respect to
      alphabetical order shall apply only to nonprescription drugs that
      are not also cosmetics and that this subclause shall not apply to
      nonprescription drugs not intended for human use.

      (B) For any prescription drug the established name of such drug
    or ingredient, as the case may be, on such label (and on any
    labeling on which a name for such drug or ingredient is used) shall
    be printed prominently and in type at least half as large as that
    used thereon for any proprietary name or designation for such drug
    or ingredient, except that to the extent that compliance with the
    requirements of subclause (ii) or (iii) of clause (A) or this
    clause is impracticable, exemptions shall be established by
    regulations promulgated by the Secretary.
      (2) If it is a device and it has an established name, unless its
    label bears, to the exclusion of any other nonproprietary name, its
    established name (as defined in subparagraph (4)) prominently
    printed in type at least half as large as that used thereon for any
    proprietary name or designation for such device, except that to the
    extent compliance with the requirements of this subparagraph is
    impracticable, exemptions shall be established by regulations
    promulgated by the Secretary.
      (3) As used in subparagraph (1), the term "established name",
    with respect to a drug or ingredient thereof, means (A) the
    applicable official name designated pursuant to section 358 of this
    title, or (B), if there is no such name and such drug, or such
    ingredient, is an article recognized in an official compendium,
    then the official title thereof in such compendium, or (C) if
    neither clause (A) nor clause (B) of this subparagraph applies,
    then the common or usual name, if any, of such drug or of such
    ingredient, except that where clause (B) of this subparagraph
    applies to an article recognized in the United States Pharmacopeia
    and in the Homoeopathic Pharmacopoeia under different official
    titles, the official title used in the United States Pharmacopeia
    shall apply unless it is labeled and offered for sale as a
    homoeopathic drug, in which case the official title used in the
    Homoeopathic Pharmacopoeia shall apply.
      (4) As used in subparagraph (2), the term "established name" with
    respect to a device means (A) the applicable official name of the
    device designated pursuant to section 358 of this title, (B) if
    there is no such name and such device is an article recognized in
    an official compendium, then the official title thereof in such
    compendium, or (C) if neither clause (A) nor clause (B) of this
    subparagraph applies, then any common or usual name of such device.
    (f) Directions for use and warnings on label
      Unless its labeling bears (1) adequate directions for use; and
    (2) such adequate warnings against use in those pathological
    conditions or by children where its use may be dangerous to health,
    or against unsafe dosage or methods or duration of administration
    or application, in such manner and form, as are necessary for the
    protection of users, except that where any requirement of clause
    (1) of this paragraph, as applied to any drug or device, is not
    necessary for the protection of the public health, the Secretary
    shall promulgate regulations exempting such drug or device from
    such requirement. Required labeling for prescription devices
    intended for use in health care facilities or by a health care
    professional and required labeling for in vitro diagnostic devices
    intended for use by health care professionals or in blood
    establishments may be made available solely by electronic means,
    provided that the labeling complies with all applicable
    requirements of law, and that the manufacturer affords such users
    the opportunity to request the labeling in paper form, and after
    such request, promptly provides the requested information without
    additional cost.
    (g) Representations as recognized drug; packing and labeling;
      inconsistent requirements for designation of drug
      If it purports to be a drug the name of which is recognized in an
    official compendium, unless it is packaged and labeled as
    prescribed therein. The method of packing may be modified with the
    consent of the Secretary. Whenever a drug is recognized in both the
    United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of
    the United States, it shall be subject to the requirements of the
    United States Pharmacopoeia with respect to packaging and labeling
    unless it is labeled and offered for sale as a homoeopathic drug,
    in which case it shall be subject to the provisions of the
    Homoeopathic Pharmacopoeia of the United States, and not those of
    the United States Pharmacopoeia, except that in the event of
    inconsistency between the requirements of this paragraph and those
    of paragraph (e) as to the name by which the drug or its
    ingredients shall be designated, the requirements of paragraph (e)
    shall prevail.
    (h) Deteriorative drugs; packing and labeling
      If it has been found by the Secretary to be a drug liable to
    deterioration, unless it is packaged in such form and manner, and
    its label bears a statement of such precautions, as the Secretary
    shall by regulations require as necessary for the protection of the
    public health. No such regulation shall be established for any drug
    recognized in an official compendium until the Secretary shall have
    informed the appropriate body charged with the revision of such
    compendium of the need for such packaging or labeling requirements
    and such body shall have failed within a reasonable time to
    prescribe such requirements.
    (i) Drug; misleading container; imitation; offer for sale under
      another name
      (1) If it is a drug and its container is so made, formed, or
    filled as to be misleading; or (2) if it is an imitation of another
    drug; or (3) if it is offered for sale under the name of another
    drug.
    (j) Health-endangering when used as prescribed
      If it is dangerous to health when used in the dosage or manner,
    or with the frequency or duration prescribed, recommended, or
    suggested in the labeling thereof.
    (k), (l) Repealed. Pub. L. 105-115, title I, Sec. 125(a)(2)(B),
      (b)(2)(D), Nov. 21, 1997, 111 Stat. 2325
    (m) Color additives; packing and labeling
      If it is a color additive the intended use of which is for the
    purpose of coloring only, unless its packaging and labeling are in
    conformity with such packaging and labeling requirements applicable
    to such color additive, as may be contained in regulations issued
    under section 379e of this title.
    (n) Prescription drug advertisements: established name;
      quantitative formula; side effects, contraindications, and
      effectiveness; prior approval; false advertising; labeling;
      construction of the Convention on Psychotropic Substances
      In the case of any prescription drug distributed or offered for
    sale in any State, unless the manufacturer, packer, or distributor
    thereof includes in all advertisements and other descriptive
    printed matter issued or caused to be issued by the manufacturer,
    packer, or distributor with respect to that drug a true statement
    of (1) the established name as defined in paragraph (e) of this
    section, printed prominently and in type at least half as large as
    that used for any trade or brand name thereof, (2) the formula
    showing quantitatively each ingredient of such drug to the extent
    required for labels under paragraph (e) of this section, and (3)
    such other information in brief summary relating to side effects,
    contraindications, and effectiveness as shall be required in
    regulations which shall be issued by the Secretary in accordance
    with the procedure specified in section 371(e) of this title,
    except that (A) except in extraordinary circumstances, no
    regulation issued under this paragraph shall require prior approval
    by the Secretary of the content of any advertisement, and (B) no
    advertisement of a prescription drug, published after the effective
    date of regulations issued under this paragraph applicable to
    advertisements of prescription drugs, shall with respect to the
    matters specified in this paragraph or covered by such regulations,
    be subject to the provisions of sections 52 to 57 of title 15. This
    paragraph (n) shall not be applicable to any printed matter which
    the Secretary determines to be labeling as defined in section
    321(m) of this title. Nothing in the Convention on Psychotropic
    Substances, signed at Vienna, Austria, on February 21, 1971, shall
    be construed to prevent drug price communications to consumers.
    (o) Drugs or devices from nonregistered establishments
      If it was manufactured, prepared, propagated, compounded, or
    processed in an establishment in any State not duly registered
    under section 360 of this title, if it was not included in a list
    required by section 360(j) of this title, if a notice or other
    information respecting it was not provided as required by such
    section or section 360(k) of this title, or if it does not bear
    such symbols from the uniform system for identification of devices
    prescribed under section 360(e) of this title as the Secretary by
    regulation requires.
    (p) Packaging or labeling of drugs in violation of regulations
      If it is a drug and its packaging or labeling is in violation of
    an applicable regulation issued pursuant to section 1472 or 1473 of
    title 15.
    (q) Restricted devices using false or misleading advertising or
      used in violation of regulations
      In the case of any restricted device distributed or offered for
    sale in any State, if (1) its advertising is false or misleading in
    any particular, or (2) it is sold, distributed, or used in
    violation of regulations prescribed under section 360j(e) of this
    title.
    (r) Restricted devices not carrying requisite accompanying
      statements in advertisements and other descriptive printed matter
      In the case of any restricted device distributed or offered for
    sale in any State, unless the manufacturer, packer, or distributor
    thereof includes in all advertisements and other descriptive
    printed matter issued or caused to be issued by the manufacturer,
    packer, or distributor with respect to that device (1) a true
    statement of the device's established name as defined in subsection
    (e) of this section, printed prominently and in type at least half
    as large as that used for any trade or brand name thereof, and (2)
    a brief statement of the intended uses of the device and relevant
    warnings, precautions, side effects, and contraindications and, in
    the case of specific devices made subject to a finding by the
    Secretary after notice and opportunity for comment that such action
    is necessary to protect the public health, a full description of
    the components of such device or the formula showing quantitatively
    each ingredient of such device to the extent required in
    regulations which shall be issued by the Secretary after an
    opportunity for a hearing. Except in extraordinary circumstances,
    no regulation issued under this paragraph shall require prior
    approval by the Secretary of the content of any advertisement and
    no advertisement of a restricted device, published after the
    effective date of this paragraph shall, with respect to the matters
    specified in this paragraph or covered by regulations issued
    hereunder, be subject to the provisions of sections 52 through 55
    of title 15. This paragraph shall not be applicable to any printed
    matter which the Secretary determines to be labeling as defined in
    section 321(m) of this title.
    (s) Devices subject to performance standards not bearing requisite
      labeling
      If it is a device subject to a performance standard established
    under section 360d of this title, unless it bears such labeling as
    may be prescribed in such performance standard.
    (t) Devices for which there has been a failure or refusal to give
      required notification or to furnish required material or
      information
      If it is a device and there was a failure or refusal (1) to
    comply with any requirement prescribed under section 360h of this
    title respecting the device, (2) to furnish any material or
    information required by or under section 360i of this title
    respecting the device, or (3) to comply with a requirement under
    section 360l of this title.
    (u) Identification of manufacturer
      (1) Subject to paragraph (2), if it is a reprocessed single-use
    device, unless it, or an attachment thereto, prominently and
    conspicuously bears the name of the manufacturer of the reprocessed
    device, a generally recognized abbreviation of such name, or a
    unique and generally recognized symbol identifying such
    manufacturer.
      (2) If the original device or an attachment thereto does not
    prominently and conspicuously bear the name of the manufacturer of
    the original device, a generally recognized abbreviation of such
    name, or a unique and generally recognized symbol identifying such
    manufacturer, a reprocessed device may satisfy the requirements of
    paragraph (1) through the use of a detachable label on the
    packaging that identifies the manufacturer and is intended to be
    affixed to the medical record of a patient.
    (v) Reprocessed single-use devices
      If it is a reprocessed single-use device, unless all labeling of
    the device prominently and conspicuously bears the statement
    "Reprocessed device for single use. Reprocessed by __." The name of
    the manufacturer of the reprocessed device shall be placed in the
    space identifying the person responsible for reprocessing.
    (w) New animal drugs
      If it is a new animal drug - 
        (1) that is conditionally approved under section 360ccc of this
      title and its labeling does not conform with the approved
      application or section 360ccc(f) of this title, or that is not
      conditionally approved under section 360ccc of this title and its
      label bears the statement set forth in section 360ccc(f)(1)(A) of
      this title; or
        (2) that is indexed under section 360ccc-1 of this title and
      its labeling does not conform with the index listing under
      section 360ccc-1(e) of this title or 360ccc-1(h) of this title,
      or that has not been indexed under section 360ccc-1 of this title
      and its label bears the statement set forth in section 360ccc-
      1(h) of this title.
    (x) Nonprescription drugs
      If it is a nonprescription drug (as defined in section 379aa of
    this title) that is marketed in the United States, unless the label
    of such drug includes a domestic address or domestic phone number
    through which the responsible person (as described in section 379aa
    of this title) may receive a report of a serious adverse event (as
    defined in section 379aa of this title) with such drug.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 502, 52 Stat. 1050; June 23, 1939,
    ch. 242, Sec. 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, Sec. 2, 55
    Stat. 851; July 6, 1945, ch. 281, Sec. 2, 59 Stat. 463; Mar. 10,
    1947, ch. 16, Sec. 2, 61 Stat. 11; July 13, 1949, ch. 305, Sec. 1,
    63 Stat. 409; Aug. 5, 1953, ch. 334, Sec. 1, 67 Stat. 389; Pub. L.
    86-618, title I, Sec. 102(b)(2), July 12, 1960, 74 Stat. 398; Pub.
    L. 87-781, title I, Secs. 105(c), 112(a), (b), 131(a), title III,
    Sec. 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90-
    399, Sec. 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601,
    Sec. 6(d), formerly Sec. 7(d), Dec. 30, 1970, 84 Stat. 1673,
    renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
    95 Stat. 716; Pub. L. 94-295, Secs. 3(e), 4(b)(2), 5(a), 9(b)(2),
    May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, Sec.
    111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, Sec. 3(a)(2),
    June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, Sec.
    107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(m),
    Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
    114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, Sec. 412(c),
    Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250,
    title II, Sec. 206, title III, Secs. 301(a), 302(a)(1), Oct. 26,
    2002, 116 Stat. 1613, 1616; Pub. L. 108-214, Sec. 2(b)(2)(B), Apr.
    1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, Sec.
    102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-43, Sec.
    2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109-462, Sec. 2(d),
    Dec. 22, 2006, 120 Stat. 3472.)


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (x). Pub. L. 109-462 added par. (x).
      2005 - Par. (u). Pub. L. 109-43 amended par. (u) generally. Prior
    to amendment, par. (u) read as follows: "If it is a device, unless
    it, or an attachment thereto, prominently and conspicuously bears
    the name of the manufacturer of the device, a generally recognized
    abbreviation of such name, or a unique and generally recognized
    symbol identifying such manufacturer, except that the Secretary may
    waive any requirement under this paragraph for the device if the
    Secretary determines that compliance with the requirement is not
    feasible for the device or would compromise the provision of
    reasonable assurance of the safety or effectiveness of the device."
      2004 - Par. (f). Pub. L. 108-214, in last sentence, inserted "or
    by a health care professional and required labeling for in vitro
    diagnostic devices intended for use by health care professionals or
    in blood establishments" after "in health care facilities",
    inserted comma after "means", substituted "requirements of law, and
    that the manufacturer affords such users the opportunity" for
    "requirements of law and, that the manufacturer affords health care
    facilities the opportunity", and struck out "the health care
    facility" after "promptly provides".
      Par. (w). Pub. L. 108-282 added par. (w).
      2002 - Par. (f). Pub. L. 107-250, Sec. 206, inserted at end
    "Required labeling for prescription devices intended for use in
    health care facilities may be made available solely by electronic
    means provided that the labeling complies with all applicable
    requirements of law and, that the manufacturer affords health care
    facilities the opportunity to request the labeling in paper form,
    and after such request, promptly provides the health care facility
    the requested information without additional cost."
      Par. (u). Pub. L. 107-250, Sec. 301(a), which directed amendment
    of section by adding par. (u) at end, was executed by adding par.
    (u) before par. (v) to reflect the probable intent of Congress.
      Par. (v). Pub. L. 107-250, Sec. 302(a)(1), added par. (v).
      1997 - Par. (a). Pub. L. 105-115, Sec. 114(a), inserted at end
    "Health care economic information provided to a formulary
    committee, or other similar entity, in the course of the committee
    or the entity carrying out its responsibilities for the selection
    of drugs for managed care or other similar organizations, shall not
    be considered to be false or misleading under this paragraph if the
    health care economic information directly relates to an indication
    approved under section 355 of this title or under section 262(a) of
    title 42 for such drug and is based on competent and reliable
    scientific evidence. The requirements set forth in section 355(a)
    of this title or in section 262(a) of title 42 shall not apply to
    health care economic information provided to such a committee or
    entity in accordance with this paragraph. Information that is
    relevant to the substantiation of the health care economic
    information presented pursuant to this paragraph shall be made
    available to the Secretary upon request. In this paragraph, the
    term 'health care economic information' means any analysis that
    identifies, measures, or compares the economic consequences,
    including the costs of the represented health outcomes, of the use
    of a drug to the use of another drug, to another health care
    intervention, or to no intervention."
      Par. (d). Pub. L. 105-115, Sec. 126(b), struck out par. (d) which
    read as follows: "If it is for use by man and contains any quantity
    of the narcotic or hypnotic substance alpha eucaine, barbituric
    acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,
    cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde,
    peyote, or sulphonmethane; or any chemical derivative of such
    substance, which derivative has been by the Secretary, after
    investigation, found to be, and by regulations designated as, habit
    forming; unless its label bears the name and quantity or proportion
    of such substance or derivative and in juxtaposition therewith the
    statement 'Warning - May be habit forming.' "
      Par. (e)(1). Pub. L. 105-115, Sec. 412(c), amended subpar. (1)
    generally. Prior to amendment, subpar. (1) read as follows: "If it
    is a drug, unless (A) its label bears, to the exclusion of any
    other nonproprietary name (except the applicable systematic
    chemical name or the chemical formula), (i) the established name
    (as defined in subparagraph (3)) of the drug, if such there be, and
    (ii), in case it is fabricated from two or more ingredients, the
    established name and quantity of each active ingredient, including
    the quantity, kind, and proportion of any alcohol, and also
    including, whether active or not, the established name and quantity
    or proportion of any bromides, ether, chloroform, acetanilid,
    acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
    hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury
    ouabain strophanthin, strychnine, thyroid, or any derivative or
    preparation of any such substances, contained therein; Provided,
    That the requirement for stating the quantity of the active
    ingredients, other than the quantity of those specifically named in
    this paragraph, shall apply only to prescription drugs; and (B) for
    any prescription drug the established name of such drug or
    ingredient, as the case may be, on such label (and on any labeling
    on which a name for such drug or ingredient is used) is printed
    prominently and in type at least half as large as that used thereon
    for any proprietary name or designation for such drug or
    ingredient: Provided, That to the extent that compliance with the
    requirements of clause (A)(ii) or clause (B) of this subparagraph
    is impracticable, exemptions shall be established by regulations
    promulgated by the Secretary."
      Par. (k). Pub. L. 105-115, Sec. 125(a)(2)(B), struck out par. (k)
    which read as follows: "If it is, or purports to be, or is
    represented as a drug composed wholly or partly of insulin, unless
    (1) it is from a batch with respect to which a certificate or
    release has been issued pursuant to section 356 of this title, and
    (2) such certificate or release is in effect with respect to such
    drug."
      Par. (l). Pub. L. 105-115, Sec. 125(b)(2)(D), struck out par. (l)
    which read as follows: "If it is, or purports to be, or is
    represented as a drug (except a drug for use in animals other than
    man) composed wholly or partly of any kind of penicillin,
    streptomycin, chlortetracycline, chloramphenicol, bacitracin, or
    any other antibiotic drug, or any derivative thereof, unless (1) it
    is from a batch with respect to which a certificate or release has
    been issued pursuant to section 357 of this title, and (2) such
    certificate or release is in effect with respect to such drug:
    Provided, That this paragraph shall not apply to any drug or class
    of drugs exempted by regulations promulgated under section 357(c)
    or (d) of this title."
      1993 - Par. (e)(3). Pub. L. 103-80, Sec. 3(m)(1), substituted "of
    such ingredient, except that" for "of such ingredient: Provided,
    That".
      Par. (f). Pub. L. 103-80, Sec. 3(m)(2), substituted "users,
    except that where" for "users: Provided, That where".
      Par. (g). Pub. L. 103-80, Sec. 3(m)(3), substituted "prescribed
    therein. The method" for "prescribed therein: Provided, That the
    method" and "Pharmacopoeia, except that" for "Pharmacopoeia:
    Provided further, That,".
      Par. (n). Pub. L. 103-80, Sec. 3(m)(4), substituted ", except
    that (A)" for ": Provided, That (A)".
      1992 - Par. (m). Pub. L. 102-571 substituted "379e" for "376".
      Par. (t)(3). Pub. L. 102-300 added cl. (3).
      1978 - Par. (n). Pub. L. 95-633 inserted provision relating to
    the construction of the Convention on Psychotropic Substances.
      1976 - Par. (e). Pub. L. 94-295, Sec. 5(a), substituted
    "subparagraph (3)" for "subparagraph (2)" in subpar. (1), added
    subpar. (2), redesignated former subpar. (2) as (3) and in subpar.
    (3) as so redesignated substituted "subparagraph (1)" for "this
    paragraph (e)", and added subpar. (4).
      Par. (j). Pub. L. 94-295, Sec. 3(e)(2), substituted "dosage or
    manner," for "dosage,".
      Par. (m). Pub. L. 94-295, Sec. 9(b)(2), substituted "the intended
    use of which is for" for "the intended use of which in or on drugs
    is for".
      Par. (o). Pub. L. 94-295, Sec. 4(b)(2), substituted "If it was
    manufactured" for "If it is a drug and was manufactured" and
    inserted ", if it was not included in a list required by section
    360(j) of this title, if a notice or other information respecting
    it was not provided as required by such section or section 360(k)
    of this title, or if it does not bear such symbols from the uniform
    system for identification of devices prescribed under section
    360(e) of this title as the Secretary by regulation requires".
      Pars. (q) to (t). Pub. L. 94-295, Sec. 3(e)(1), added pars. (q)
    to (t).
      1970 - Par. (p). Pub. L. 91-601 added par. (p).
      1968 - Par. (l). Pub. L. 90-399 inserted "(except a drug for use
    in animals other than man)" after "represented as a drug".
      1962 - Par. (e). Pub. L. 87-781, Sec. 112(a), designated existing
    provisions as subpar. (1), substituted ", unless (A) its label
    bears, to the exclusion of any other nonproprietary name (except
    the applicable systematic chemical name or the chemical formula),
    (i) the established name (as defined in subparagraph (2) of this
    subsection) of the drug, if such there be, and (ii), in case it is
    fabricated from two or more ingredients, the established name and
    quantity" for "and is not designated solely by a name recognized in
    an official compendium unless its label bears (1) the common or
    usual name of the drug, if such there be; and (2), in case it is
    fabricated from two or more ingredients, the common or usual name",
    and "the established name" for "the name", provided that the
    requirement for stating the quantity of active ingredients, other
    than those specified in this par., applies only to prescription
    drugs, and that the established name of a drug on a label is to be
    printed prominently and in type at least half as large as used for
    any proprietary designation, and added subpar. (2) defining
    "established name".
      Par. (g). Pub. L. 87-781, Sec. 112(b), provided that if there is
    an inconsistency between the provisions of this par. and those of
    par. (e), as to the name of a drug, the requirements of par. (e)
    should prevail.
      Par. (l). Pub. L. 87-781, Sec. 105(c), substituted "bacitracin,
    or any other antibiotic drug" for "or bacitracin."
      Par. (n). Pub. L. 87-781, Sec. 131(a), added par. (n).
      Par. (o). Pub. L. 87-781, Sec. 305, added par. (o).
      1960 - Par. (m). Pub. L. 86-618 added par. (m).
      1953 - Par. (l). Act Aug. 5, 1953, substituted
    "chlortetracycline" for "aureomycin".
      1949 - Par. (l). Act July 13, 1949, inserted ", aureomycin,
    chloramphenicol, or bacitracin" after "streptomycin".
      1947 - Par. (l). Act Mar. 10, 1947, inserted "or streptomycin"
    after "penicillin".
      1945 - Par. (l). Act July 6, 1945, added par. (l).
      1941 - Par. (k). Act Dec. 22, 1941, added par. (k).
      1939 - Par. (d). Act June 29, 1939, substituted "name, and
    quality or proportion" for "name, quantity, and percentage".

                     EFFECTIVE DATES OF 2006 AMENDMENT                 
      Pub. L. 109-462, Sec. 2(e)(1), (2), Dec. 22, 2006, 120 Stat.
    3472, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendments made by this section [enacting section 379aa of this
    title and amending this section and section 331 of this title]
    shall take effect 1 year after the date of enactment of this Act
    [Dec. 22, 2006].
      "(2) Misbranding. - Section 502(x) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 352(x)] (as added by this section) shall
    apply to any nonprescription drug (as defined in such section
    502(x)) labeled on or after the date that is 1 year after the date
    of enactment of this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-250, title III, Sec. 301(b), Oct. 26, 2002, 116 Stat.
    1616, as amended by Pub. L. 108-214, Sec. 2(c)(1), Apr. 1, 2004,
    118 Stat. 575; Pub. L. 109-43, Sec. 2(d), Aug. 1, 2005, 119 Stat.
    441, provided that: "Section 502(u) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the
    Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109-43])
    - 
        "(1) shall be effective - 
          "(A) with respect to devices described under paragraph (1) of
        such section, 12 months after the date of enactment of the
        Medical Device User Fee Stabilization Act of 2005 [Aug. 1,
        2005], or the date on which the original device first bears the
        name of the manufacturer of the original device, a generally
        recognized abbreviation of such name, or a unique and generally
        recognized symbol identifying such manufacturer, whichever is
        later; and
          "(B) with respect to devices described under paragraph (2) of
        such section 502(u), 12 months after such date of enactment;
        and
        "(2) shall apply only to devices reprocessed and introduced or
      delivered for introduction in interstate commerce after such
      applicable effective date."
      Pub. L. 107-250, title III, Sec. 302(a)(2), Oct. 26, 2002, 116
    Stat. 1616, provided that: "The amendment made by paragraph (1)
    [amending this section] takes effect 15 months after the date of
    the enactment of this Act [Oct. 26, 2002], and only applies to
    devices introduced or delivered for introduction into interstate
    commerce after such effective date."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105-
    115 effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Section 112(c) of Pub. L. 87-781 provided that: "This section
    [amending this section] shall take effect on the first day of the
    seventh calendar month following the month in which this Act is
    enacted [October 1962]."
      Section 131(b) of Pub. L. 87-781 provided that: "No drug which
    was being commercially distributed prior to the date of enactment
    of this Act [Oct. 10, 1962] shall be deemed to be misbranded under
    paragraph (n) of section 502 of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until
    the earlier of the following dates: (1) the first day of the
    seventh month following the month in which this Act is enacted; or
    (2) the effective date of regulations first issued under clause (3)
    of such paragraph (n) in accordance with the procedure specified in
    section 701(e) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 371(e)]."
      Amendment by Pub. L. 87-781 effective on first day of seventh
    calendar month following October 1962, see section 107 of Pub. L.
    87-781, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such
    paragraphs effective July 1, 1940, as provided by regulations for
    certain lithographed labeling and containers bearing certain
    labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
    an Effective Date: Postponement in Certain Cases note under section
    301 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                       GUIDANCE; MISBRANDED DEVICES                   
      Pub. L. 109-43, Sec. 2(c)(2), Aug. 1, 2005, 119 Stat. 441,
    provided that: "Not later than 180 days after the date of enactment
    of this Act [Aug. 1, 2005], the Secretary of Health and Human
    Services shall issue guidance to identify circumstances in which
    the name of the manufacturer of the original device, a generally
    recognized abbreviation of such name, or a unique and generally
    recognized symbol identifying such manufacturer, is not 'prominent
    and conspicuous', as used in section 502(u) of Federal Food, Drug,
    and Cosmetic Act [21 U.S.C. 352(u)] (as amended by paragraph (1))."

    STUDY ON MAKING PRESCRIPTION PHARMACEUTICAL INFORMATION ACCESSIBLE
                FOR BLIND AND VISUALLY-IMPAIRED INDIVIDUALS
      Pub. L. 108-173, title I, Sec. 107(f), Dec. 8, 2003, 117 Stat.
    2171, directed the Secretary of Health and Human Services to
    undertake a study of how to make prescription pharmaceutical
    information, including drug labels and usage instructions,
    accessible to blind and visually-impaired individuals, and to
    submit a report to Congress not later than 18 months after Dec. 8,
    2003.

                             STUDY AND REPORT                         
      Section 114(b) of Pub. L. 105-115 provided that: "The Comptroller
    General of the United States shall conduct a study of the
    implementation of the provisions added by the amendment made by
    subsection (a) [amending this section]. Not later than 4 years and
    6 months after the date of enactment of this Act [Nov. 21, 1997],
    the Comptroller General of the United States shall prepare and
    submit to Congress a report containing the findings of the study."

    COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF
                                  POLICY
      Section 9(a) of Pub. L. 89-74, July 15, 1965, 79 Stat. 234,
    provided that: "The Congress finds and declares that there is a
    substantial traffic in counterfeit drugs simulating the brand or
    other identifying mark or device of the manufacturer of the genuine
    article; that such traffic poses a serious hazard to the health of
    innocent consumers of such drugs because of the lack of proper
    qualifications, facilities, and manufacturing controls on the part
    of the counterfeiter, whose operations are clandestine; that, while
    such drugs are deemed misbranded within the meaning of section
    502(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    352(i)], the controls for the suppression of the traffic in such
    drugs are inadequate because of the difficulty of determining the
    place of interstate origin of such drugs and, if that place is
    discovered, the fact that the implements for counterfeiting are not
    subject to seizure, and that these factors require enactment of
    additional controls with respect to such drugs without regard to
    their interstate or intrastate origins."
      Provisions as effective Feb. 1, 1966, see section 11 of Pub. L.
    89-74, set out as an Effective Date of 1965 Amendment note under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 353                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 353. Exemptions and consideration for certain drugs, devices,
      and biological products

-STATUTE-
    (a) Regulations for goods to be processed, labeled, or repacked
      elsewhere
      The Secretary is directed to promulgate regulations exempting
    from any labeling or packaging requirement of this chapter drugs
    and devices which are, in accordance with the practice of the
    trade, to be processed, labeled, or repacked in substantial
    quantities at establishments other than those where originally
    processed or packed, on condition that such drugs and devices are
    not adulterated or misbranded under the provisions of this chapter
    upon removal from such processing, labeling, or repacking
    establishment.
    (b) Prescription by physician; exemption from labeling and
      prescription requirements; misbranded drugs; compliance with
      narcotic and marihuana laws
      (1) A drug intended for use by man which - 
        (A) because of its toxicity or other potentiality for harmful
      effect, or the method of its use, or the collateral measures
      necessary to its use, is not safe for use except under the
      supervision of a practitioner licensed by law to administer such
      drug; or
        (B) is limited by an approved application under section 355 of
      this title to use under the professional supervision of a
      practitioner licensed by law to administer such drug;

    shall be dispensed only (i) upon a written prescription of a
    practitioner licensed by law to administer such drug, or (ii) upon
    an oral prescription of such practitioner which is reduced promptly
    to writing and filed by the pharmacist, or (iii) by refilling any
    such written or oral prescription if such refilling is authorized
    by the prescriber either in the original prescription or by oral
    order which is reduced promptly to writing and filed by the
    pharmacist. The act of dispensing a drug contrary to the provisions
    of this paragraph shall be deemed to be an act which results in the
    drug being misbranded while held for sale.
      (2) Any drug dispensed by filling or refilling a written or oral
    prescription of a practitioner licensed by law to administer such
    drug shall be exempt from the requirements of section 352 of this
    title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the
    packaging requirements of paragraphs (g), (h), and (p), if the drug
    bears a label containing the name and address of the dispenser, the
    serial number and date of the prescription or of its filling, the
    name of the prescriber, and, if stated in the prescription, the
    name of the patient, and the directions for use and cautionary
    statements, if any, contained in such prescription. This exemption
    shall not apply to any drug dispensed in the course of the conduct
    of a business of dispensing drugs pursuant to diagnosis by mail, or
    to a drug dispensed in violation of paragraph (1) of this
    subsection.
      (3) The Secretary may by regulation remove drugs subject to
    section 355 of this title from the requirements of paragraph (1) of
    this subsection when such requirements are not necessary for the
    protection of the public health.
      (4)(A) A drug that is subject to paragraph (1) shall be deemed to
    be misbranded if at any time prior to dispensing the label of the
    drug fails to bear, at a minimum, the symbol "Rx only".
      (B) A drug to which paragraph (1) does not apply shall be deemed
    to be misbranded if at any time prior to dispensing the label of
    the drug bears the symbol described in subparagraph (A).
      (5) Nothing in this subsection shall be construed to relieve any
    person from any requirement prescribed by or under authority of law
    with respect to drugs now included or which may hereafter be
    included within the classifications stated in sections 4721, 6001,
    and 6151 of title 26, or to marihuana as defined in section 4761 of
    title 26.
    (c) Sales restrictions
      (1) No person may sell, purchase, or trade or offer to sell,
    purchase, or trade any drug sample. For purposes of this paragraph
    and subsection (d) of this section, the term "drug sample" means a
    unit of a drug, subject to subsection (b) of this section, which is
    not intended to be sold and is intended to promote the sale of the
    drug. Nothing in this paragraph shall subject an officer or
    executive of a drug manufacturer or distributor to criminal
    liability solely because of a sale, purchase, trade, or offer to
    sell, purchase, or trade in violation of this paragraph by other
    employees of the manufacturer or distributor.
      (2) No person may sell, purchase, or trade, offer to sell,
    purchase, or trade, or counterfeit any coupon. For purposes of this
    paragraph, the term "coupon" means a form which may be redeemed, at
    no cost or at a reduced cost, for a drug which is prescribed in
    accordance with subsection (b) of this section.
      (3)(A) No person may sell, purchase, or trade, or offer to sell,
    purchase, or trade, any drug - 
        (i) which is subject to subsection (b) of this section, and
        (ii)(I) which was purchased by a public or private hospital or
      other health care entity, or
        (II) which was donated or supplied at a reduced price to a
      charitable organization described in section 501(c)(3) of title
      26.

      (B) Subparagraph (A) does not apply to - 
        (i) the purchase or other acquisition by a hospital or other
      health care entity which is a member of a group purchasing
      organization of a drug for its own use from the group purchasing
      organization or from other hospitals or health care entities
      which are members of such organization,
        (ii) the sale, purchase, or trade of a drug or an offer to
      sell, purchase, or trade a drug by an organization described in
      subparagraph (A)(ii)(II) to a nonprofit affiliate of the
      organization to the extent otherwise permitted by law,
        (iii) a sale, purchase, or trade of a drug or an offer to sell,
      purchase, or trade a drug among hospitals or other health care
      entities which are under common control,
        (iv) a sale, purchase, or trade of a drug or an offer to sell,
      purchase, or trade a drug for emergency medical reasons, or
        (v) a sale, purchase, or trade of a drug, an offer to sell,
      purchase, or trade a drug, or the dispensing of a drug pursuant
      to a prescription executed in accordance with subsection (b) of
      this section.

    For purposes of this paragraph, the term "entity" does not include
    a wholesale distributor of drugs or a retail pharmacy licensed
    under State law and the term "emergency medical reasons" includes
    transfers of a drug between health care entities or from a health
    care entity to a retail pharmacy undertaken to alleviate temporary
    shortages of the drug arising from delays in or interruptions of
    regular distribution schedules.
    (d) Distribution of drug samples
      (1) Except as provided in paragraphs (2) and (3), no person may
    distribute any drug sample. For purposes of this subsection, the
    term "distribute" does not include the providing of a drug sample
    to a patient by a - 
        (A) practitioner licensed to prescribe such drug,
        (B) health care professional acting at the direction and under
      the supervision of such a practitioner, or
        (C) pharmacy of a hospital or of another health care entity
      that is acting at the direction of such a practitioner and that
      received such sample pursuant to paragraph (2) or (3).

      (2)(A) The manufacturer or authorized distributor of record of a
    drug subject to subsection (b) of this section may, in accordance
    with this paragraph, distribute drug samples by mail or common
    carrier to practitioners licensed to prescribe such drugs or, at
    the request of a licensed practitioner, to pharmacies of hospitals
    or other health care entities. Such a distribution of drug samples
    may only be made - 
        (i) in response to a written request for drug samples made on a
      form which meets the requirements of subparagraph (B), and
        (ii) under a system which requires the recipient of the drug
      sample to execute a written receipt for the drug sample upon its
      delivery and the return of the receipt to the manufacturer or
      authorized distributor of record.

      (B) A written request for a drug sample required by subparagraph
    (A)(i) shall contain - 
        (i) the name, address, professional designation, and signature
      of the practitioner making the request,
        (ii) the identity of the drug sample requested and the quantity
      requested,
        (iii) the name of the manufacturer of the drug sample
      requested, and
        (iv) the date of the request.

      (C) Each drug manufacturer or authorized distributor of record
    which makes distributions by mail or common carrier under this
    paragraph shall maintain, for a period of 3 years, the request
    forms submitted for such distributions and the receipts submitted
    for such distributions and shall maintain a record of distributions
    of drug samples which identifies the drugs distributed and the
    recipients of the distributions. Forms, receipts, and records
    required to be maintained under this subparagraph shall be made
    available by the drug manufacturer or authorized distributor of
    record to Federal and State officials engaged in the regulation of
    drugs and in the enforcement of laws applicable to drugs.
      (3) The manufacturer or authorized distributor of record of a
    drug subject to subsection (b) of this section may, by means other
    than mail or common carrier, distribute drug samples only if the
    manufacturer or authorized distributor of record makes the
    distributions in accordance with subparagraph (A) and carries out
    the activities described in subparagraphs (B) through (F) as
    follows:
        (A) Drug samples may only be distributed - 
          (i) to practitioners licensed to prescribe such drugs if they
        make a written request for the drug samples, or
          (ii) at the written request of such a licensed practitioner,
        to pharmacies of hospitals or other health care entities.

      A written request for drug samples shall be made on a form which
      contains the practitioner's name, address, and professional
      designation, the identity of the drug sample requested, the
      quantity of drug samples requested, the name of the manufacturer
      or authorized distributor of record of the drug sample, the date
      of the request and signature of the practitioner making the
      request.
        (B) Drug manufacturers or authorized distributors of record
      shall store drug samples under conditions that will maintain
      their stability, integrity, and effectiveness and will assure
      that the drug samples will be free of contamination,
      deterioration, and adulteration.
        (C) Drug manufacturers or authorized distributors of record
      shall conduct, at least annually, a complete and accurate
      inventory of all drug samples in the possession of
      representatives of the manufacturer or authorized distributor of
      record. Drug manufacturers or authorized distributors of record
      shall maintain lists of the names and address of each of their
      representatives who distribute drug samples and of the sites
      where drug samples are stored. Drug manufacturers or authorized
      distributors of record shall maintain records for at least 3
      years of all drug samples distributed, destroyed, or returned to
      the manufacturer or authorized distributor of record, of all
      inventories maintained under this subparagraph, of all thefts or
      significant losses of drug samples, and of all requests made
      under subparagraph (A) for drug samples. Records and lists
      maintained under this subparagraph shall be made available by the
      drug manufacturer or authorized distributor of record to the
      Secretary upon request.
        (D) Drug manufacturers or authorized distributors of record
      shall notify the Secretary of any significant loss of drug
      samples and any known theft of drug samples.
        (E) Drug manufacturers or authorized distributors of record
      shall report to the Secretary any conviction of their
      representatives for violations of subsection (c)(1) of this
      section or a State law because of the sale, purchase, or trade of
      a drug sample or the offer to sell, purchase, or trade a drug
      sample.
        (F) Drug manufacturers or authorized distributors of record
      shall provide to the Secretary the name and telephone number of
      the individual responsible for responding to a request for
      information respecting drug samples.
    (e) Wholesale distributors; guidelines for licensing; definitions
      (1)(A) Each person who is engaged in the wholesale distribution
    of a drug subject to subsection (b) of this section and who is not
    the manufacturer or an authorized distributor of record of such
    drug shall, before each wholesale distribution of such drug
    (including each distribution to an authorized distributor of record
    or to a retail pharmacy), provide to the person who receives the
    drug a statement (in such form and containing such information as
    the Secretary may require) identifying each prior sale, purchase,
    or trade of such drug (including the date of the transaction and
    the names and addresses of all parties to the transaction).
      (B) Each manufacturer of a drug subject to subsection (b) of this
    section shall maintain at its corporate offices a current list of
    the authorized distributors of record of such drug.
      (2)(A) No person may engage in the wholesale distribution in
    interstate commerce of drugs subject to subsection (b) of this
    section in a State unless such person is licensed by the State in
    accordance with the guidelines issued under subparagraph (B).
      (B) The Secretary shall by regulation issue guidelines
    establishing minimum standards, terms, and conditions for the
    licensing of persons to make wholesale distributions in interstate
    commerce of drugs subject to subsection (b) of this section. Such
    guidelines shall prescribe requirements for the storage and
    handling of such drugs and for the establishment and maintenance of
    records of the distributions of such drugs.
      (3) For the purposes of this subsection and subsection (d) of
    this section - 
        (A) the term "authorized distributors of record" means those
      distributors with whom a manufacturer has established an ongoing
      relationship to distribute such manufacturer's products, and
        (B) the term "wholesale distribution" means distribution of
      drugs subject to subsection (b) of this section to other than the
      consumer or patient but does not include intracompany sales and
      does not include distributions of drugs described in subsection
      (c)(3)(B) of this section.
    (f) Veterinary prescription drugs
      (1)(A) A drug intended for use by animals other than man, other
    than a veterinary feed directive drug intended for use in animal
    feed or an animal feed bearing or containing a veterinary feed
    directive drug, which - 
        (i) because of its toxicity or other potentiality for harmful
      effect, or the method of its use, or the collateral measures
      necessary for its use, is not safe for animal use except under
      the professional supervision of a licensed veterinarian, or
        (ii) is limited by an approved application under subsection (b)
      of section 360b of this title, a conditionally-approved
      application under section 360ccc of this title, or an index
      listing under section 360ccc-1 of this title to use under the
      professional supervision of a licensed veterinarian,

    shall be dispensed only by or upon the lawful written or oral order
    of a licensed veterinarian in the course of the veterinarian's
    professional practice.
      (B) For purposes of subparagraph (A), an order is lawful if the
    order - 
        (i) is a prescription or other order authorized by law,
        (ii) is, if an oral order, promptly reduced to writing by the
      person lawfully filling the order, and filed by that person, and
        (iii) is refilled only if authorized in the original order or
      in a subsequent oral order promptly reduced to writing by the
      person lawfully filling the order, and filed by that person.

      (C) The act of dispensing a drug contrary to the provisions of
    this paragraph shall be deemed to be an act which results in the
    drug being misbranded while held for sale.
      (2) Any drug when dispensed in accordance with paragraph (1) of
    this subsection - 
        (A) shall be exempt from the requirements of section 352 of
      this title, except subsections (a), (g), (h), (i)(2), (i)(3), and
      (p) of such section, and
        (B) shall be exempt from the packaging requirements of
      subsections (g), (h), and (p) of such section, if - 
          (i) when dispensed by a licensed veterinarian, the drug bears
        a label containing the name and address of the practitioner and
        any directions for use and cautionary statements specified by
        the practitioner, or
          (ii) when dispensed by filling the lawful order of a licensed
        veterinarian, the drug bears a label containing the name and
        address of the dispenser, the serial number and date of the
        order or of its filling, the name of the licensed veterinarian,
        and the directions for use and cautionary statements, if any,
        contained in such order.

    The preceding sentence shall not apply to any drug dispensed in the
    course of the conduct of a business of dispensing drugs pursuant to
    diagnosis by mail.
      (3) The Secretary may by regulation exempt drugs for animals
    other than man subject to section 360b, 360ccc, or 360ccc-1 of this
    title from the requirements of paragraph (1) when such requirements
    are not necessary for the protection of the public health.
      (4) A drug which is subject to paragraph (1) shall be deemed to
    be misbranded if at any time prior to dispensing its label fails to
    bear the statement "Caution: Federal law restricts this drug to use
    by or on the order of a licensed veterinarian.". A drug to which
    paragraph (1) does not apply shall be deemed to be misbranded if at
    any time prior to dispensing its label bears the statement
    specified in the preceding sentence.
    (g) Regulation of combination products
      (1) The Secretary shall in accordance with this subsection assign
    an agency center to regulate products that constitute a combination
    of a drug, device, or biological product. The Secretary shall
    determine the primary mode of action of the combination product. If
    the Secretary determines that the primary mode of action is that of
    - 
        (A) a drug (other than a biological product), the agency center
      charged with premarket review of drugs shall have primary
      jurisdiction,
        (B) a device, the agency center charged with premarket review
      of devices shall have primary jurisdiction, or
        (C) a biological product, the agency center charged with
      premarket review of biological products shall have primary
      jurisdiction.

      (2) Nothing in this subsection shall prevent the Secretary from
    using any agency resources of the Food and Drug Administration
    necessary to ensure adequate review of the safety, effectiveness,
    or substantial equivalence of an article.
      (3) The Secretary shall promulgate regulations to implement
    market clearance procedures in accordance with paragraphs (1) and
    (2) not later than 1 year after November 28, 1990.
      (4)(A) Not later than 60 days after October 26, 2002, the
    Secretary shall establish within the Office of the Commissioner of
    Food and Drugs an office to ensure the prompt assignment of
    combination products to agency centers, the timely and effective
    premarket review of such products, and consistent and appropriate
    postmarket regulation of like products subject to the same
    statutory requirements to the extent permitted by law.
    Additionally, the office shall, in determining whether a product is
    to be designated a combination product, consult with the component
    within the Office of the Commissioner of Food and Drugs that is
    responsible for such determinations. Such office (referred to in
    this paragraph as the "Office") shall have appropriate scientific
    and medical expertise, and shall be headed by a director.
      (B) In carrying out this subsection, the Office shall, for each
    combination product, promptly assign an agency center with primary
    jurisdiction in accordance with paragraph (1) for the premarket
    review of such product.
      (C)(i) In carrying out this subsection, the Office shall ensure
    timely and effective premarket reviews by overseeing the timeliness
    of and coordinating reviews involving more than one agency center.
      (ii) In order to ensure the timeliness of the premarket review of
    a combination product, the agency center with primary jurisdiction
    for the product, and the consulting agency center, shall be
    responsible to the Office with respect to the timeliness of the
    premarket review.
      (D) In carrying out this subsection, the Office shall ensure the
    consistency and appropriateness of postmarket regulation of like
    products subject to the same statutory requirements to the extent
    permitted by law.
      (E)(i) Any dispute regarding the timeliness of the premarket
    review of a combination product may be presented to the Office for
    resolution, unless the dispute is clearly premature.
      (ii) During the review process, any dispute regarding the
    substance of the premarket review may be presented to the
    Commissioner of Food and Drugs after first being considered by the
    agency center with primary jurisdiction of the premarket review,
    under the scientific dispute resolution procedures for such center.
    The Commissioner of Food and Drugs shall consult with the Director
    of the Office in resolving the substantive dispute.
      (F) The Secretary, acting through the Office, shall review each
    agreement, guidance, or practice of the Secretary that is specific
    to the assignment of combination products to agency centers and
    shall determine whether the agreement, guidance, or practice is
    consistent with the requirements of this subsection. In carrying
    out such review, the Secretary shall consult with stakeholders and
    the directors of the agency centers. After such consultation, the
    Secretary shall determine whether to continue in effect, modify,
    revise, or eliminate such agreement, guidance, or practice, and
    shall publish in the Federal Register a notice of the availability
    of such modified or revised agreement, guidance or practice.
    Nothing in this paragraph shall be construed as preventing the
    Secretary from following each agreement, guidance, or practice
    until continued, modified, revised, or eliminated.
      (G) Not later than one year after October 26, 2002, and annually
    thereafter, the Secretary shall report to the appropriate
    committees of Congress on the activities and impact of the Office.
    The report shall include provisions - 
        (i) describing the numbers and types of combination products
      under review and the timeliness in days of such assignments,
      reviews, and dispute resolutions;
        (ii) identifying the number of premarket reviews of such
      products that involved a consulting agency center; and
        (iii) describing improvements in the consistency of postmarket
      regulation of combination products.

      (H) Nothing in this paragraph shall be construed to limit the
    regulatory authority of any agency center.
      (5) As used in this subsection:
        (A) The term "agency center" means a center or alternative
      organizational component of the Food and Drug Administration.
        (B) The term "biological product" has the meaning given the
      term in section 262(i) of title 42.
        (C) The term "market clearance" includes - 
          (i) approval of an application under section 355, 357,(!1)
        360e, or 360j(g) of this title,

          (ii) a finding of substantial equivalence under this part,
        and
          (iii) approval of a biologics license application under
        subsection (a) of section 262 of title 42.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 503, 52 Stat. 1051; Oct. 26, 1951,
    ch. 578, Sec. 1, 65 Stat. 648; Pub. L. 87-781, title I, Sec.
    104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91-601, Sec. 6(e),
    formerly Sec. 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
    L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
    Pub. L. 100-293, Secs. 4-6, Apr. 22, 1988, 102 Stat. 96-98; Pub. L.
    100-670, title I, Sec. 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L.
    101-629, Sec. 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-
    108, Sec. 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102-300,
    Sec. 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, Secs.
    2(a)-(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104-250,
    Sec. 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105-115, title I,
    Secs. 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324,
    2327, 2328; Pub. L. 107-250, title II, Sec. 204, Oct. 26, 2002, 116
    Stat. 1611; Pub. L. 108-282, title I, Sec. 102(b)(5)(F), Aug. 2,
    2004, 118 Stat. 903.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 357 of this title, referred to in subsec. (g)(5)(C)(i),
    was repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
    1997, 111 Stat. 2325.

-COD-
                               CODIFICATION                           
      In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26"
    and "section 4761 of title 26" substituted for "section 3220 of the
    Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the
    Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on
    authority of section 7852(b) of Title 26, Internal Revenue Code.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (f)(1)(A)(ii). Pub. L. 108-282, Sec.
    102(b)(5)(F)(i), substituted "360b of this title, a conditionally-
    approved application under section 360ccc of this title, or an
    index listing under section 360ccc-1 of this title" for "360b of
    this title".
      Subsec. (f)(3). Pub. L. 108-282, Sec. 102(b)(5)(F)(ii),
    substituted "section 360b, 360ccc, or 360ccc-1" for "section 360b".
      2002 - Subsec. (g)(1). Pub. L. 107-250, Sec. 204(1)(A),
    substituted "shall in accordance with this subsection assign an
    agency center" for "shall designate a component of the Food and
    Drug Administration" in first sentence of introductory provisions.
      Subsec. (g)(1)(A) to (C). Pub. L. 107-250, Sec. 204(1)(B),
    substituted "the agency center charged" for "the persons charged".
      Subsec. (g)(4). Pub. L. 107-250, Sec. 204(3), added par. (4).
    Former par. (4) redesignated (5).
      Subsec. (g)(5). Pub. L. 107-250, Sec. 204(2), (4), redesignated
    par. (4) as (5), added subpar. (A), and redesignated former
    subpars. (A) and (B) as (B) and (C), respectively.
      1997 - Subsec. (b)(1)(A) to (C). Pub. L. 105-115, Sec. 126(c)(1),
    redesignated subpars. (B) and (C) as (A) and (B), respectively, and
    struck out former subpar. (A), which read as follows: "is a habit-
    forming drug to which section 352(d) of this title applies; or".
      Subsec. (b)(3). Pub. L. 105-115, Sec. 126(c)(2), struck out
    reference to section 352(d) of this title before "355".
      Subsec. (b)(4). Pub. L. 105-115, Sec. 126(a), amended par. (4)
    generally. Prior to amendment, par. (4) read as follows: "A drug
    which is subject to paragraph (1) of this subsection shall be
    deemed to be misbranded if at any time prior to dispensing its
    label fails to bear the statement 'Caution: Federal law prohibits
    dispensing without prescription'. A drug to which paragraph (1) of
    this subsection does not apply shall be deemed to be misbranded if
    at any time prior to dispensing its label bears the caution
    statement quoted in the preceding sentence."
      Subsec. (g)(4)(A). Pub. L. 105-115, Sec. 123(e)(1), substituted
    "section 262(i) of title 42" for "section 262(a) of title 42".
      Subsec. (g)(4)(B)(iii). Pub. L. 105-115, Sec. 123(e)(2),
    substituted "biologics license application under subsection (a)"
    for "product or establishment license under subsection (a) or (d)".
      1996 - Subsec. (f)(1)(A). Pub. L. 104-250 inserted ", other than
    a veterinary feed directive drug intended for use in animal feed or
    an animal feed bearing or containing a veterinary feed directive
    drug," after "other than man" in introductory provisions.
      1992 - Subsec. (d)(1). Pub. L. 102-353, Sec. 4(1), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows:
    "Except as provided in paragraphs (2) and (3), no representative of
    a drug manufacturer or distributor may distribute any drug sample."
      Subsec. (d)(2). Pub. L. 102-353, Sec. 4(2), substituted
    "authorized distributor of record" for "distributor" wherever
    appearing.
      Subsec. (d)(3). Pub. L. 102-353, Sec. 4(2), substituted
    "authorized distributor of record" for "distributor" and
    "authorized distributors of record" for "distributors" wherever
    appearing.
      Subsec. (e)(1). Pub. L. 102-353, Sec. 4(3), amended par. (1)
    generally. Prior to amendment, par. (1) read as follows: "Each
    person who is engaged in the wholesale distribution of drugs
    subject to subsection (b) of this section and who is not an
    authorized distributor of record of such drugs shall provide to
    each wholesale distributor of such drugs a statement identifying
    each sale of the drug (including the date of the sale) before the
    sale to such wholesale distributor. Each manufacturer shall
    maintain at its corporate offices a current list of such authorized
    distributors."
      Subsec. (e)(2)(A). Pub. L. 102-353, Sec. 2(a), (d), temporarily
    inserted "or has registered with the Secretary in accordance with
    paragraph (3)". See Termination Date of 1992 Amendment note below.
      Subsec. (e)(3). Pub. L. 102-353, Sec. 2(b), (d), temporarily
    added par. (3). Former par. (3) redesignated (4). See Termination
    Date of 1992 Amendment note below.
      Subsec. (e)(4). Pub. L. 102-353, Sec. 4(4), inserted "and
    subsection (d) of this section" after "For the purposes of this
    subsection".
      Pub. L. 102-353, Sec. 2(b), (d), temporarily redesignated par.
    (3) as (4). See Termination Date of 1992 Amendment note below.
      Subsec. (f)(1)(B). Pub. L. 102-353, Sec. 2(c), which directed the
    substitution of "an order" for "and order", could not be executed
    because "and order" did not appear in subpar. (B).
      Subsec. (g)(3). Pub. L. 102-300 substituted "clearance" for
    "approval".
      1991 - Subsec. (c). Pub. L. 102-108, Sec. 2(d)(3), redesignated
    subsec. (c), relating to veterinary prescription drugs, as (f).
    Former subsec. (f) redesignated (g).
      Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, Sec. 2(d)(1), made
    technical amendment to reference to subsection (b) of this section
    involving corresponding provision of original act.
      Subsec. (d)(3)(E). Pub. L. 102-108, Sec. 2(d)(2), made technical
    amendment to reference to subsection (c)(1) of this section
    involving corresponding provision of original act.
      Subsec. (f). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
    (f), relating to regulation of combination products, as (g).
      Pub. L. 102-108, Sec. 2(d)(3), redesignated subsec. (c), relating
    to veterinary prescription drugs, as (f).
      Subsec. (g). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
    (f), relating to regulation of combination products, as (g).
      1990 - Pub. L. 101-629, Sec. 16(a)(1), substituted "Exemptions
    and consideration for certain drugs, devices, and biological
    products" for "Exemptions in case of drugs and devices" in section
    catchline.
      Subsec. (f). Pub. L. 101-629, Sec. 16(a)(2), added subsec. (f).
      1988 - Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to
    veterinary prescription drugs.
      Pub. L. 100-293, Sec. 4, added subsec. (c) relating to sales
    restrictions.
      Subsec. (d). Pub. L. 100-293, Sec. 5, added subsec. (d).
      Subsec. (e). Pub. L. 100-293, Sec. 6, added subsec. (e).
      1970 - Subsec. (b)(2). Pub. L. 91-601 included exemption from
    packaging requirements of subsec. (p) of section 352 of this title.
      1962 - Subsec. (b)(1)(C). Pub. L. 87-781 substituted "approved"
    for "effective".
      1951 - Subsec. (b). Act Oct. 26, 1951, amended subsec. (b)
    generally to protect the public from abuses in the sale of potent
    prescription drugs, and to relieve retail pharmacists and the
    public from unnecessary restrictions on the dispensation of drugs
    that are safe to use without supervision of a doctor.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                    TERMINATION DATE OF 1992 AMENDMENT                
      Section 2(d) of Pub. L. 102-353 provided that: "Effective
    September 14, 1994, the amendments made by subsections (a) and (b)
    [amending this section] shall no longer be in effect."

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Section 8 of Pub. L. 100-293 provided that:
      "(a) General Rule. - Except as provided in subsection (b), this
    Act and the amendments made by this Act [amending this section and
    sections 331, 333, and 381 of this title and enacting provisions
    set out as notes under this section and section 301 of this title]
    shall take effect upon the expiration of 90 days after the date of
    the enactment of this Act [Apr. 22, 1988].
      "(b) Exception. - 
        "(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take
      effect upon the expiration of 180 days after the date of the
      enactment of this Act [Apr. 22, 1988].
        "(2) The Secretary of Health and Human Services shall by
      regulation issue the guidelines required by section 503(e)(2)(B)
      of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
      353(e)(2)(B)] (as added by section 6 of this Act) not later than
      180 days after the date of the enactment of this Act. Section
      503(e)(2)(A) of such Act shall take effect upon the expiration of
      2 years after the date such regulations are promulgated and take
      effect."

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1951 AMENDMENT                 
      Amendment by act Oct. 26, 1951, effective six months after Oct.
    26, 1951, see section 3 of act Oct. 26, 1951, set out as a note
    under section 333 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                        EFFECTIVE MEDICATION GUIDES                    
      Pub. L. 104-180, title VI, Sec. 601, Aug. 6, 1996, 110 Stat.
    1593, provided that:
      "(a) In General. - Not later than 30 days after the date of
    enactment of this Act [Aug. 6, 1996], the Secretary of the
    Department of Health and Human Services shall request that national
    organizations representing health care professionals, consumer
    organizations, voluntary health agencies, the pharmaceutical
    industry, drug wholesalers, patient drug information database
    companies, and other relevant parties collaborate to develop a long-
    range comprehensive action plan to achieve goals consistent with
    the goals of the proposed rule of the Food and Drug Administration
    on 'Prescription Drug Product Labeling: Medication Guide
    Requirements' (60 Fed. Reg. 44182; relating to the provision of
    oral and written prescription information to consumers).
      "(b) Goals. - Goals consistent with the proposed rule described
    in subsection (a) are the distribution of useful written
    information to 75 percent of individuals receiving new precriptions
    [sic] by the year 2000 and to 95 percent by the year 2006.
      "(c) Plan. - The plan described in subsection (a) shall - 
        "(1) identify the plan goals;
        "(2) assess the effectiveness of the current private-sector
      approaches used to provide oral and written prescription
      information to consumers;
        "(3) develop guidelines for providing effective oral and
      written prescription information consistent with the findings of
      any such assessment;
        "(4) contain elements necessary to ensure the transmittal of
      useful information to the consuming public, including being
      scientifically accurate, non-promotional in tone and content,
      sufficiently specific and comprehensive as to adequately inform
      consumers about the use of the product, and in an understandable,
      legible format that is readily comprehensible and not confusing
      to consumers expected to use the product.[;]
        "(5) develop a mechanism to assess periodically the quality of
      the oral and written prescription information and the frequency
      with which the information is provided to consumers; and
        "(6) provide for compliance with relevant State board
      regulations.
      "(d) Limitation on the Authority of the Secretary. - The
    Secretary of the Department of Health and Human Services shall have
    no authority to implement the proposed rule described in subsection
    (a), or to develop any similar regulation, policy statement, or
    other guideline specifying a uniform content or format for written
    information voluntarily provided to consumers about prescription
    drugs if, (1) not later than 120 days after the date of enactment
    of this Act [Aug. 6, 1996], the national organizations described in
    subsection (a) develop and submit to the Secretary for Health and
    Human Services a comprehensive, long-range action plan (as
    described in subsection (a)) which shall be acceptable to the
    Secretary of Health and Human Services; (2) the aforementioned plan
    is submitted to the Secretary of Health and Human Services for
    review and acceptance: Provided, That the Secretary shall give due
    consideration to the submitted plan and that any such acceptance
    shall not be arbitrarily withheld; and (3) the implementation of
    (a) a plan accepted by the Secretary commences within 30 days of
    the Secretary's acceptance of such plan, or (b) the plan submitted
    to the Secretary commences within 60 days of the submission of such
    plan if the Secretary fails to take any action on the plan within
    30 days of the submission of the plan. The Secretary shall accept,
    reject or suggest modifications to the plan submitted within 30
    days of its submission. The Secretary may confer with and assist
    private parties in the development of the plan described in
    subsections (a) and (b).
      "(e) Secretary Review. - Not later than January 1, 2001, the
    Secretary of the Department of Health and Human Services shall
    review the status of private-sector initiatives designed to achieve
    the goals of the plan described in subsection (a), and if such
    goals are not achieved, the limitation in subsection (d) shall not
    apply, and the Secretary shall seek public comment on other
    initiatives that may be carried out to meet such goals."

                          CONGRESSIONAL FINDINGS                      
      Section 2 of Pub. L. 100-293 provided that: "The Congress finds
    the following:
        "(1) American consumers cannot purchase prescription drugs with
      the certainty that the products are safe and effective.
        "(2) The integrity of the distribution system for prescription
      drugs is insufficient to prevent the introduction and eventual
      retail sale of substandard, ineffective, or even counterfeit
      drugs.
        "(3) The existence and operation of a wholesale submarket,
      commonly known as the 'diversion market', prevents effective
      control over or even routine knowledge of the true sources of
      prescription drugs in a significant number of cases.
        "(4) Large amounts of drugs are being reimported to the United
      States as American goods returned. These imports are a health and
      safety risk to American consumers because they may have become
      subpotent or adulterated during foreign handling and shipping.
        "(5) The ready market for prescription drug reimports has been
      the catalyst for a continuing series of frauds against American
      manufacturers and has provided the cover for the importation of
      foreign counterfeit drugs.
        "(6) The existing system of providing drug samples to
      physicians through manufacturer's representatives has been abused
      for decades and has resulted in the sale to consumers of
      misbranded, expired, and adulterated pharmaceuticals.
        "(7) The bulk resale of below wholesale priced prescription
      drugs by health care entities, for ultimate sale at retail, helps
      fuel the diversion market and is an unfair form of competition to
      wholesalers and retailers that must pay otherwise prevailing
      market prices.
        "(8) The effect of these several practices and conditions is to
      create an unacceptable risk that counterfeit, adulterated,
      misbranded, subpotent, or expired drugs will be sold to American
      consumers."

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 353a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 353a. Pharmacy compounding

-STATUTE-
    (a) In general
      Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not
    apply to a drug product if the drug product is compounded for an
    identified individual patient based on the unsolicited receipt of a
    valid prescription order or a notation, approved by the prescribing
    practitioner, on the prescription order that a compounded product
    is necessary for the identified patient, if the drug product meets
    the requirements of this section, and if the compounding - 
        (1) is by - 
          (A) a licensed pharmacist in a State licensed pharmacy or a
        Federal facility, or
          (B) a licensed physician,

      on the prescription order for such individual patient made by a
      licensed physician or other licensed practitioner authorized by
      State law to prescribe drugs; or
        (2)(A) is by a licensed pharmacist or licensed physician in
      limited quantities before the receipt of a valid prescription
      order for such individual patient; and
        (B) is based on a history of the licensed pharmacist or
      licensed physician receiving valid prescription orders for the
      compounding of the drug product, which orders have been generated
      solely within an established relationship between - 
          (i) the licensed pharmacist or licensed physician; and
          (ii)(I) such individual patient for whom the prescription
        order will be provided; or
          (II) the physician or other licensed practitioner who will
        write such prescription order.
    (b) Compounded drug
      (1) Licensed pharmacist and licensed physician
        A drug product may be compounded under subsection (a) of this
      section if the licensed pharmacist or licensed physician - 
          (A) compounds the drug product using bulk drug substances, as
        defined in regulations of the Secretary published at section
        207.3(a)(4) of title 21 of the Code of Federal Regulations - 
            (i) that - 
              (I) comply with the standards of an applicable United
            States Pharmacopoeia or National Formulary monograph, if a
            monograph exists, and the United States Pharmacopoeia
            chapter on pharmacy compounding;
              (II) if such a monograph does not exist, are drug
            substances that are components of drugs approved by the
            Secretary; or
              (III) if such a monograph does not exist and the drug
            substance is not a component of a drug approved by the
            Secretary, that appear on a list developed by the Secretary
            through regulations issued by the Secretary under
            subsection (d) of this section;

            (ii) that are manufactured by an establishment that is
          registered under section 360 of this title (including a
          foreign establishment that is registered under section 360(i)
          of this title); and
            (iii) that are accompanied by valid certificates of
          analysis for each bulk drug substance;

          (B) compounds the drug product using ingredients (other than
        bulk drug substances) that comply with the standards of an
        applicable United States Pharmacopoeia or National Formulary
        monograph, if a monograph exists, and the United States
        Pharmacopoeia chapter on pharmacy compounding;
          (C) does not compound a drug product that appears on a list
        published by the Secretary in the Federal Register of drug
        products that have been withdrawn or removed from the market
        because such drug products or components of such drug products
        have been found to be unsafe or not effective; and
          (D) does not compound regularly or in inordinate amounts (as
        defined by the Secretary) any drug products that are
        essentially copies of a commercially available drug product.
      (2) Definition
        For purposes of paragraph (1)(D), the term "essentially a copy
      of a commercially available drug product" does not include a drug
      product in which there is a change, made for an identified
      individual patient, which produces for that patient a significant
      difference, as determined by the prescribing practitioner,
      between the compounded drug and the comparable commercially
      available drug product.
      (3) Drug product
        A drug product may be compounded under subsection (a) only if -
      
          (A) such drug product is not a drug product identified by the
        Secretary by regulation as a drug product that presents
        demonstrable difficulties for compounding that reasonably
        demonstrate an adverse effect on the safety or effectiveness of
        that drug product; and
          (B) such drug product is compounded in a State - 
            (i) that has entered into a memorandum of understanding
          with the Secretary which addresses the distribution of
          inordinate amounts of compounded drug products interstate and
          provides for appropriate investigation by a State agency of
          complaints relating to compounded drug products distributed
          outside such State; or
            (ii) that has not entered into the memorandum of
          understanding described in clause (i) and the licensed
          pharmacist, licensed pharmacy, or licensed physician
          distributes (or causes to be distributed) compounded drug
          products out of the State in which they are compounded in
          quantities that do not exceed 5 percent of the total
          prescription orders dispensed or distributed by such pharmacy
          or physician.

      The Secretary shall, in consultation with the National
      Association of Boards of Pharmacy, develop a standard memorandum
      of understanding for use by the States in complying with
      subparagraph (B)(i).
    (c) Advertising and promotion
      A drug may be compounded under subsection (a) of this section
    only if the pharmacy, licensed pharmacist, or licensed physician
    does not advertise or promote the compounding of any particular
    drug, class of drug, or type of drug. The pharmacy, licensed
    pharmacist, or licensed physician may advertise and promote the
    compounding service provided by the licensed pharmacist or licensed
    physician.
    (d) Regulations
      (1) In general
        The Secretary shall issue regulations to implement this
      section. Before issuing regulations to implement subsections
      (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A) of this section, the
      Secretary shall convene and consult an advisory committee on
      compounding unless the Secretary determines that the issuance of
      such regulations before consultation is necessary to protect the
      public health. The advisory committee shall include
      representatives from the National Association of Boards of
      Pharmacy, the United States Pharmacopoeia, pharmacy, physician,
      and consumer organizations, and other experts selected by the
      Secretary.
      (2) Limiting compounding
        The Secretary, in consultation with the United States
      Pharmacopoeia Convention, Incorporated, shall promulgate
      regulations identifying drug substances that may be used in
      compounding under subsection (b)(1)(A)(i)(III) of this section
      for which a monograph does not exist or which are not components
      of drug products approved by the Secretary. The Secretary shall
      include in the regulation the criteria for such substances, which
      shall include historical use, reports in peer reviewed medical
      literature, or other criteria the Secretary may identify.
    (e) Application
      This section shall not apply to - 
        (1) compounded positron emission tomography drugs as defined in
      section 321(ii) of this title; or
        (2) radiopharmaceuticals.
    (f) "Compounding" defined
      As used in this section, the term "compounding" does not include
    mixing, reconstituting, or other such acts that are performed in
    accordance with directions contained in approved labeling provided
    by the product's manufacturer and other manufacturer directions
    consistent with that labeling.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 503A, as added Pub. L. 105-115, title
    I, Sec. 127(a), Nov. 21, 1997, 111 Stat. 2328.)


-MISC1-
                              EFFECTIVE DATE                          
      Section 127(b) of Pub. L. 105-115 provided that: "Section 503A of
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by
    subsection (a), shall take effect upon the expiration of the 1-year
    period beginning on the date of the enactment of this Act [Nov. 21,
    1997]."

-End-



-CITE-
    21 USC Sec. 354                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 354. Veterinary feed directive drugs

-STATUTE-
    (a) Lawful veterinary feed directive requirement
      (1) A drug intended for use in or on animal feed which is limited
    by an approved application filed pursuant to section 360b(b) of
    this title, a conditionally-approved application filed pursuant to
    section 360ccc of this title, or an index listing pursuant to
    section 360ccc-1 of this title to use under the professional
    supervision of a licensed veterinarian is a veterinary feed
    directive drug. Any animal feed bearing or containing a veterinary
    feed directive drug shall be fed to animals only by or upon a
    lawful veterinary feed directive issued by a licensed veterinarian
    in the course of the veterinarian's professional practice. When
    labeled, distributed, held, and used in accordance with this
    section, a veterinary feed directive drug and any animal feed
    bearing or containing a veterinary feed directive drug shall be
    exempt from section 352(f) of this title.
      (2) A veterinary feed directive is lawful if it - 
        (A) contains such information as the Secretary may by general
      regulation or by order require; and
        (B) is in compliance with the conditions and indications for
      use of the drug set forth in the notice published pursuant to
      section 360b(i) of this title, or the index listing pursuant to
      section 360ccc-1(e) of this title.

      (3)(A) Any persons involved in the distribution or use of animal
    feed bearing or containing a veterinary feed directive drug and the
    licensed veterinarian issuing the veterinary feed directive shall
    maintain a copy of the veterinary feed directive applicable to each
    such feed, except in the case of a person distributing such feed to
    another person for further distribution. Such person distributing
    the feed shall maintain a written acknowledgment from the person to
    whom the feed is shipped stating that that person shall not ship or
    move such feed to an animal production facility without a
    veterinary feed directive or ship such feed to another person for
    further distribution unless that person has provided the same
    written acknowledgment to its immediate supplier.
      (B) Every person required under subparagraph (A) to maintain
    records, and every person in charge or custody thereof, shall, upon
    request of an officer or employee designated by the Secretary,
    permit such officer or employee at all reasonable times to have
    access to and copy and verify such records.
      (C) Any person who distributes animal feed bearing or containing
    a veterinary feed directive drug shall upon first engaging in such
    distribution notify the Secretary of that person's name and place
    of business. The failure to provide such notification shall be
    deemed to be an act which results in the drug being misbranded.
    (b) Labeling and advertising
      A veterinary feed directive drug and any feed bearing or
    containing a veterinary feed directive drug shall be deemed to be
    misbranded if their labeling fails to bear such cautionary
    statement and such other information as the Secretary may by
    general regulation or by order prescribe, or their advertising
    fails to conform to the conditions and indications for use
    published pursuant to section 360b(i) of this title, or the index
    listing pursuant to section 360ccc-1(e) of this title or fails to
    contain the general cautionary statement prescribed by the
    Secretary.
    (c) Nonprescription status
      Neither a drug subject to this section, nor animal feed bearing
    or containing such a drug, shall be deemed to be a prescription
    article under any Federal or State law.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 504, as added Pub. L. 104-250, Sec.
    5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108-282, title
    I, Sec. 102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 354, act June 25, 1938, ch. 675, Sec. 504, 52
    Stat. 1052, which directed Secretary to promulgate regulations for
    listing of coal-tar colors, was repealed effective July 12, 1960,
    subject to provisions of section 203 of Pub. L. 86-618, by Pub. L.
    86-618, title I, Sec. 103(a)(2), title II, Sec. 202, July 12, 1960,
    74 Stat. 398, 404.

                                AMENDMENTS                            
      2004 - Subsec. (a)(1). Pub. L. 108-282, Sec. 102(b)(5)(G),
    substituted "360b(b) of this title, a conditionally-approved
    application filed pursuant to section 360ccc of this title, or an
    index listing pursuant to section 360ccc-1 of this title" for
    "360b(b) of this title".
      Subsecs. (a)(2)(B), (b). Pub. L. 108-282, Sec. 102(b)(5)(H),
    substituted "360b(i) of this title, or the index listing pursuant
    to section 360ccc-1(e) of this title" for "360b(i) of this title".

-End-



-CITE-
    21 USC Sec. 355                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355. New drugs

-STATUTE-
    (a) Necessity of effective approval of application
      No person shall introduce or deliver for introduction into
    interstate commerce any new drug, unless an approval of an
    application filed pursuant to subsection (b) or (j) of this section
    is effective with respect to such drug.
    (b) Filing application; contents
      (1) Any person may file with the Secretary an application with
    respect to any drug subject to the provisions of subsection (a) of
    this section. Such person shall submit to the Secretary as a part
    of the application (A) full reports of investigations which have
    been made to show whether or not such drug is safe for use and
    whether such drug is effective in use; (B) a full list of the
    articles used as components of such drug; (C) a full statement of
    the composition of such drug; (D) a full description of the methods
    used in, and the facilities and controls used for, the manufacture,
    processing, and packing of such drug; (E) such samples of such drug
    and of the articles used as components thereof as the Secretary may
    require; (F) specimens of the labeling proposed to be used for such
    drug, and (G) any assessments required under section 355c of this
    title. The applicant shall file with the application the patent
    number and the expiration date of any patent which claims the drug
    for which the applicant submitted the application or which claims a
    method of using such drug and with respect to which a claim of
    patent infringement could reasonably be asserted if a person not
    licensed by the owner engaged in the manufacture, use, or sale of
    the drug. If an application is filed under this subsection for a
    drug and a patent which claims such drug or a method of using such
    drug is issued after the filing date but before approval of the
    application, the applicant shall amend the application to include
    the information required by the preceding sentence. Upon approval
    of the application, the Secretary shall publish information
    submitted under the two preceding sentences. The Secretary shall,
    in consultation with the Director of the National Institutes of
    Health and with representatives of the drug manufacturing industry,
    review and develop guidance, as appropriate, on the inclusion of
    women and minorities in clinical trials required by clause (A).
      (2) An application submitted under paragraph (1) for a drug for
    which the investigations described in clause (A) of such paragraph
    and relied upon by the applicant for approval of the application
    were not conducted by or for the applicant and for which the
    applicant has not obtained a right of reference or use from the
    person by or for whom the investigations were conducted shall also
    include - 
        (A) a certification, in the opinion of the applicant and to the
      best of his knowledge, with respect to each patent which claims
      the drug for which such investigations were conducted or which
      claims a use for such drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under paragraph (1) or subsection (c) of
      this section - 
          (i) that such patent information has not been filed,
          (ii) that such patent has expired,
          (iii) of the date on which such patent will expire, or
          (iv) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new drug for which the
        application is submitted; and

        (B) if with respect to the drug for which investigations
      described in paragraph (1)(A) were conducted information was
      filed under paragraph (1) or subsection (c) of this section for a
      method of use patent which does not claim a use for which the
      applicant is seeking approval under this subsection, a statement
      that the method of use patent does not claim such a use.

      (3) Notice of opinion that patent is invalid or will not be
    infringed. - 
        (A) Agreement to give notice. - An applicant that makes a
      certification described in paragraph (2)(A)(iv) shall include in
      the application a statement that the applicant will give notice
      as required by this paragraph.
        (B) Timing of notice. - An applicant that makes a certification
      described in paragraph (2)(A)(iv) shall give notice as required
      under this paragraph - 
          (i) if the certification is in the application, not later
        than 20 days after the date of the postmark on the notice with
        which the Secretary informs the applicant that the application
        has been filed; or
          (ii) if the certification is in an amendment or supplement to
        the application, at the time at which the applicant submits the
        amendment or supplement, regardless of whether the applicant
        has already given notice with respect to another such
        certification contained in the application or in an amendment
        or supplement to the application.

        (C) Recipients of notice. - An applicant required under this
      paragraph to give notice shall give notice to - 
          (i) each owner of the patent that is the subject of the
        certification (or a representative of the owner designated to
        receive such a notice); and
          (ii) the holder of the approved application under this
        subsection for the drug that is claimed by the patent or a use
        of which is claimed by the patent (or a representative of the
        holder designated to receive such a notice).

        (D) Contents of notice. - A notice required under this
      paragraph shall - 
          (i) state that an application that contains data from
        bioavailability or bioequivalence studies has been submitted
        under this subsection for the drug with respect to which the
        certification is made to obtain approval to engage in the
        commercial manufacture, use, or sale of the drug before the
        expiration of the patent referred to in the certification; and
          (ii) include a detailed statement of the factual and legal
        basis of the opinion of the applicant that the patent is
        invalid or will not be infringed.

      (4)(A) An applicant may not amend or supplement an application
    referred to in paragraph (2) to seek approval of a drug that is a
    different drug than the drug identified in the application as
    submitted to the Secretary.
      (B) With respect to the drug for which such an application is
    submitted, nothing in this subsection or subsection (c)(3) of this
    section prohibits an applicant from amending or supplementing the
    application to seek approval of a different strength.
      (5)(A) The Secretary shall issue guidance for the individuals who
    review applications submitted under paragraph (1) or under section
    262 of title 42, which shall relate to promptness in conducting the
    review, technical excellence, lack of bias and conflict of
    interest, and knowledge of regulatory and scientific standards, and
    which shall apply equally to all individuals who review such
    applications.
      (B) The Secretary shall meet with a sponsor of an investigation
    or an applicant for approval for a drug under this subsection or
    section 262 of title 42 if the sponsor or applicant makes a
    reasonable written request for a meeting for the purpose of
    reaching agreement on the design and size of clinical trials
    intended to form the primary basis of an effectiveness claim. The
    sponsor or applicant shall provide information necessary for
    discussion and agreement on the design and size of the clinical
    trials. Minutes of any such meeting shall be prepared by the
    Secretary and made available to the sponsor or applicant upon
    request.
      (C) Any agreement regarding the parameters of the design and size
    of clinical trials of a new drug under this paragraph that is
    reached between the Secretary and a sponsor or applicant shall be
    reduced to writing and made part of the administrative record by
    the Secretary. Such agreement shall not be changed after the
    testing begins, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (D) by the director of the reviewing division, that
      a substantial scientific issue essential to determining the
      safety or effectiveness of the drug has been identified after the
      testing has begun.

      (D) A decision under subparagraph (C)(ii) by the director shall
    be in writing and the Secretary shall provide to the sponsor or
    applicant an opportunity for a meeting at which the director and
    the sponsor or applicant will be present and at which the director
    will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by, the
    field or compliance division personnel unless such field or
    compliance division personnel demonstrate to the reviewing division
    why such decision should be modified.
      (F) No action by the reviewing division may be delayed because of
    the unavailability of information from or action by field personnel
    unless the reviewing division determines that a delay is necessary
    to assure the marketing of a safe and effective drug.
      (G) For purposes of this paragraph, the reviewing division is the
    division responsible for the review of an application for approval
    of a drug under this subsection or section 262 of title 42
    (including all scientific and medical matters, chemistry,
    manufacturing, and controls).
    (c) Period for approval of application; period for, notice, and
      expedition of hearing; period for issuance of order
      (1) Within one hundred and eighty days after the filing of an
    application under subsection (b) of this section, or such
    additional period as may be agreed upon by the Secretary and the
    applicant, the Secretary shall either - 
        (A) approve the application if he then finds that none of the
      grounds for denying approval specified in subsection (d) of this
      section applies, or
        (B) give the applicant notice of an opportunity for a hearing
      before the Secretary under subsection (d) of this section on the
      question whether such application is approvable. If the applicant
      elects to accept the opportunity for hearing by written request
      within thirty days after such notice, such hearing shall commence
      not more than ninety days after the expiration of such thirty
      days unless the Secretary and the applicant otherwise agree. Any
      such hearing shall thereafter be conducted on an expedited basis
      and the Secretary's order thereon shall be issued within ninety
      days after the date fixed by the Secretary for filing final
      briefs.

      (2) If the patent information described in subsection (b) of this
    section could not be filed with the submission of an application
    under subsection (b) of this section because the application was
    filed before the patent information was required under subsection
    (b) of this section or a patent was issued after the application
    was approved under such subsection, the holder of an approved
    application shall file with the Secretary the patent number and the
    expiration date of any patent which claims the drug for which the
    application was submitted or which claims a method of using such
    drug and with respect to which a claim of patent infringement could
    reasonably be asserted if a person not licensed by the owner
    engaged in the manufacture, use, or sale of the drug. If the holder
    of an approved application could not file patent information under
    subsection (b) of this section because it was not required at the
    time the application was approved, the holder shall file such
    information under this subsection not later than thirty days after
    September 24, 1984, and if the holder of an approved application
    could not file patent information under subsection (b) of this
    section because no patent had been issued when an application was
    filed or approved, the holder shall file such information under
    this subsection not later than thirty days after the date the
    patent involved is issued. Upon the submission of patent
    information under this subsection, the Secretary shall publish it.
      (3) The approval of an application filed under subsection (b) of
    this section which contains a certification required by paragraph
    (2) of such subsection shall be made effective on the last
    applicable date determined by applying the following to each
    certification made under subsection (b)(2)(A) of this section:
        (A) If the applicant only made a certification described in
      clause (i) or (ii) of subsection (b)(2)(A) of this section or in
      both such clauses, the approval may be made effective
      immediately.
        (B) If the applicant made a certification described in clause
      (iii) of subsection (b)(2)(A) of this section, the approval may
      be made effective on the date certified under clause (iii).
        (C) If the applicant made a certification described in clause
      (iv) of subsection (b)(2)(A) of this section, the approval shall
      be made effective immediately unless, before the expiration of 45
      days after the date on which the notice described in subsection
      (b)(3) of this section is received, an action is brought for
      infringement of the patent that is the subject of the
      certification and for which information was submitted to the
      Secretary under paragraph (2) or subsection (b)(1) of this
      section before the date on which the application (excluding an
      amendment or supplement to the application) was submitted. If
      such an action is brought before the expiration of such days, the
      approval may be made effective upon the expiration of the thirty-
      month period beginning on the date of the receipt of the notice
      provided under subsection (b)(3) of this section or such shorter
      or longer period as the court may order because either party to
      the action failed to reasonably cooperate in expediting the
      action, except that - 
          (i) if before the expiration of such period the district
        court decides that the patent is invalid or not infringed
        (including any substantive determination that there is no cause
        of action for patent infringement or invalidity), the approval
        shall be made effective on - 
            (I) the date on which the court enters judgment reflecting
          the decision; or
            (II) the date of a settlement order or consent decree
          signed and entered by the court stating that the patent that
          is the subject of the certification is invalid or not
          infringed;

          (ii) if before the expiration of such period the district
        court decides that the patent has been infringed - 
            (I) if the judgment of the district court is appealed, the
          approval shall be made effective on - 
              (aa) the date on which the court of appeals decides that
            the patent is invalid or not infringed (including any
            substantive determination that there is no cause of action
            for patent infringement or invalidity); or
              (bb) the date of a settlement order or consent decree
            signed and entered by the court of appeals stating that the
            patent that is the subject of the certification is invalid
            or not infringed; or

            (II) if the judgment of the district court is not appealed
          or is affirmed, the approval shall be made effective on the
          date specified by the district court in a court order under
          section 271(e)(4)(A) of title 35;

          (iii) if before the expiration of such period the court
        grants a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent is
        invalid or not infringed, the approval shall be made effective
        as provided in clause (i); or
          (iv) if before the expiration of such period the court grants
        a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent has been
        infringed, the approval shall be made effective as provided in
        clause (ii).

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action.
        (D) Civil action to obtain patent certainty. - 
          (i) Declaratory judgment absent infringement action. - 
            (I) In general. - No action may be brought under section
          2201 of title 28 by an applicant referred to in subsection
          (b)(2) of this section for a declaratory judgment with
          respect to a patent which is the subject of the certification
          referred to in subparagraph (C) unless - 
              (aa) the 45-day period referred to in such subparagraph
            has expired;
              (bb) neither the owner of such patent nor the holder of
            the approved application under subsection (b) of this
            section for the drug that is claimed by the patent or a use
            of which is claimed by the patent brought a civil action
            against the applicant for infringement of the patent before
            the expiration of such period; and
              (cc) in any case in which the notice provided under
            paragraph (2)(B) relates to noninfringement, the notice was
            accompanied by a document described in subclause (III).

            (II) Filing of civil action. - If the conditions described
          in items (aa), (bb), and as applicable, (cc) of subclause (I)
          have been met, the applicant referred to in such subclause
          may, in accordance with section 2201 of title 28, bring a
          civil action under such section against the owner or holder
          referred to in such subclause (but not against any owner or
          holder that has brought such a civil action against the
          applicant, unless that civil action was dismissed without
          prejudice) for a declaratory judgment that the patent is
          invalid or will not be infringed by the drug for which the
          applicant seeks approval, except that such civil action may
          be brought for a declaratory judgment that the patent will
          not be infringed only in a case in which the condition
          described in subclause (I)(cc) is applicable. A civil action
          referred to in this subclause shall be brought in the
          judicial district where the defendant has its principal place
          of business or a regular and established place of business.
            (III) Offer of confidential access to application. - For
          purposes of subclause (I)(cc), the document described in this
          subclause is a document providing an offer of confidential
          access to the application that is in the custody of the
          applicant referred to in subsection (b)(2) of this section
          for the purpose of determining whether an action referred to
          in subparagraph (C) should be brought. The document providing
          the offer of confidential access shall contain such
          restrictions as to persons entitled to access, and on the use
          and disposition of any information accessed, as would apply
          had a protective order been entered for the purpose of
          protecting trade secrets and other confidential business
          information. A request for access to an application under an
          offer of confidential access shall be considered acceptance
          of the offer of confidential access with the restrictions as
          to persons entitled to access, and on the use and disposition
          of any information accessed, contained in the offer of
          confidential access, and those restrictions and other terms
          of the offer of confidential access shall be considered terms
          of an enforceable contract. Any person provided an offer of
          confidential access shall review the application for the sole
          and limited purpose of evaluating possible infringement of
          the patent that is the subject of the certification under
          subsection (b)(2)(A)(iv) of this section and for no other
          purpose, and may not disclose information of no relevance to
          any issue of patent infringement to any person other than a
          person provided an offer of confidential access. Further, the
          application may be redacted by the applicant to remove any
          information of no relevance to any issue of patent
          infringement.

          (ii) Counterclaim to infringement action. - 
            (I) In general. - If an owner of the patent or the holder
          of the approved application under subsection (b) of this
          section for the drug that is claimed by the patent or a use
          of which is claimed by the patent brings a patent
          infringement action against the applicant, the applicant may
          assert a counterclaim seeking an order requiring the holder
          to correct or delete the patent information submitted by the
          holder under subsection (b) of this section or this
          subsection on the ground that the patent does not claim
          either - 
              (aa) the drug for which the application was approved; or
              (bb) an approved method of using the drug.

            (II) No independent cause of action. - Subclause (I) does
          not authorize the assertion of a claim described in subclause
          (I) in any civil action or proceeding other than a
          counterclaim described in subclause (I).

          (iii) No damages. - An applicant shall not be entitled to
        damages in a civil action under clause (i) or a counterclaim
        under clause (ii).

        (E)(i) If an application (other than an abbreviated new drug
      application) submitted under subsection (b) of this section for a
      drug, no active ingredient (including any ester or salt of the
      active ingredient) of which has been approved in any other
      application under subsection (b) of this section, was approved
      during the period beginning January 1, 1982, and ending on
      September 24, 1984, the Secretary may not make the approval of
      another application for a drug for which the investigations
      described in clause (A) of subsection (b)(1) of this section and
      relied upon by the applicant for approval of the application were
      not conducted by or for the applicant and for which the applicant
      has not obtained a right of reference or use from the person by
      or for whom the investigations were conducted effective before
      the expiration of ten years from the date of the approval of the
      application previously approved under subsection (b) of this
      section.
        (ii) If an application submitted under subsection (b) of this
      section for a drug, no active ingredient (including any ester or
      salt of the active ingredient) of which has been approved in any
      other application under subsection (b) of this section, is
      approved after September 24, 1984, no application which refers to
      the drug for which the subsection (b) application was submitted
      and for which the investigations described in clause (A) of
      subsection (b)(1) of this section and relied upon by the
      applicant for approval of the application were not conducted by
      or for the applicant and for which the applicant has not obtained
      a right of reference or use from the person by or for whom the
      investigations were conducted may be submitted under subsection
      (b) of this section before the expiration of five years from the
      date of the approval of the application under subsection (b) of
      this section, except that such an application may be submitted
      under subsection (b) of this section after the expiration of four
      years from the date of the approval of the subsection (b)
      application if it contains a certification of patent invalidity
      or noninfringement described in clause (iv) of subsection
      (b)(2)(A) of this section. The approval of such an application
      shall be made effective in accordance with this paragraph except
      that, if an action for patent infringement is commenced during
      the one-year period beginning forty-eight months after the date
      of the approval of the subsection (b) application, the thirty-
      month period referred to in subparagraph (C) shall be extended
      by such amount of time (if any) which is required for seven and
      one-half years to have elapsed from the date of approval of the
      subsection (b) application.
        (iii) If an application submitted under subsection (b) of this
      section for a drug, which includes an active ingredient
      (including any ester or salt of the active ingredient) that has
      been approved in another application approved under subsection
      (b) of this section, is approved after September 24, 1984, and if
      such application contains reports of new clinical investigations
      (other than bioavailability studies) essential to the approval of
      the application and conducted or sponsored by the applicant, the
      Secretary may not make the approval of an application submitted
      under subsection (b) of this section for the conditions of
      approval of such drug in the approved subsection (b) application
      effective before the expiration of three years from the date of
      the approval of the application under subsection (b) of this
      section if the investigations described in clause (A) of
      subsection (b)(1) of this section and relied upon by the
      applicant for approval of the application were not conducted by
      or for the applicant and if the applicant has not obtained a
      right of reference or use from the person by or for whom the
      investigations were conducted.
        (iv) If a supplement to an application approved under
      subsection (b) of this section is approved after September 24,
      1984, and the supplement contains reports of new clinical
      investigations (other than bioavailabilty (!1) studies) essential
      to the approval of the supplement and conducted or sponsored by
      the person submitting the supplement, the Secretary may not make
      the approval of an application submitted under subsection (b) of
      this section for a change approved in the supplement effective
      before the expiration of three years from the date of the
      approval of the supplement under subsection (b) of this section
      if the investigations described in clause (A) of subsection
      (b)(1) of this section and relied upon by the applicant for
      approval of the application were not conducted by or for the
      applicant and if the applicant has not obtained a right of
      reference or use from the person by or for whom the
      investigations were conducted.

        (v) If an application (or supplement to an application)
      submitted under subsection (b) of this section for a drug, which
      includes an active ingredient (including any ester or salt of the
      active ingredient) that has been approved in another application
      under subsection (b) of this section, was approved during the
      period beginning January 1, 1982, and ending on September 24,
      1984, the Secretary may not make the approval of an application
      submitted under this subsection and for which the investigations
      described in clause (A) of subsection (b)(1) of this section and
      relied upon by the applicant for approval of the application were
      not conducted by or for the applicant and for which the applicant
      has not obtained a right of reference or use from the person by
      or for whom the investigations were conducted and which refers to
      the drug for which the subsection (b) application was submitted
      effective before the expiration of two years from September 24,
      1984.

      (4) A drug manufactured in a pilot or other small facility may be
    used to demonstrate the safety and effectiveness of the drug and to
    obtain approval for the drug prior to manufacture of the drug in a
    larger facility, unless the Secretary makes a determination that a
    full scale production facility is necessary to ensure the safety or
    effectiveness of the drug.
    (d) Grounds for refusing application; approval of application;
      "substantial evidence" defined
      If the Secretary finds, after due notice to the applicant in
    accordance with subsection (c) of this section and giving him an
    opportunity for a hearing, in accordance with said subsection, that
    (1) the investigations, reports of which are required to be
    submitted to the Secretary pursuant to subsection (b) of this
    section, do not include adequate tests by all methods reasonably
    applicable to show whether or not such drug is safe for use under
    the conditions prescribed, recommended, or suggested in the
    proposed labeling thereof; (2) the results of such tests show that
    such drug is unsafe for use under such conditions or do not show
    that such drug is safe for use under such conditions; (3) the
    methods used in, and the facilities and controls used for, the
    manufacture, processing, and packing of such drug are inadequate to
    preserve its identity, strength, quality, and purity; (4) upon the
    basis of the information submitted to him as part of the
    application, or upon the basis of any other information before him
    with respect to such drug, he has insufficient information to
    determine whether such drug is safe for use under such conditions;
    or (5) evaluated on the basis of the information submitted to him
    as part of the application and any other information before him
    with respect to such drug, there is a lack of substantial evidence
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the proposed labeling thereof; or (6) the application
    failed to contain the patent information prescribed by subsection
    (b) of this section; or (7) based on a fair evaluation of all
    material facts, such labeling is false or misleading in any
    particular; he shall issue an order refusing to approve the
    application. If, after such notice and opportunity for hearing, the
    Secretary finds that clauses (1) through (6) do not apply, he shall
    issue an order approving the application. As used in this
    subsection and subsection (e) of this section, the term
    "substantial evidence" means evidence consisting of adequate and
    well-controlled investigations, including clinical investigations,
    by experts qualified by scientific training and experience to
    evaluate the effectiveness of the drug involved, on the basis of
    which it could fairly and responsibly be concluded by such experts
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the labeling or proposed labeling thereof. If the
    Secretary determines, based on relevant science, that data from one
    adequate and well-controlled clinical investigation and
    confirmatory evidence (obtained prior to or after such
    investigation) are sufficient to establish effectiveness, the
    Secretary may consider such data and evidence to constitute
    substantial evidence for purposes of the preceding sentence.
    (e) Withdrawal of approval; grounds; immediate suspension upon
      finding imminent hazard to public health
      The Secretary shall, after due notice and opportunity for hearing
    to the applicant, withdraw approval of an application with respect
    to any drug under this section if the Secretary finds (1) that
    clinical or other experience, tests, or other scientific data show
    that such drug is unsafe for use under the conditions of use upon
    the basis of which the application was approved; (2) that new
    evidence of clinical experience, not contained in such application
    or not available to the Secretary until after such application was
    approved, or tests by new methods, or tests by methods not deemed
    reasonably applicable when such application was approved, evaluated
    together with the evidence available to the Secretary when the
    application was approved, shows that such drug is not shown to be
    safe for use under the conditions of use upon the basis of which
    the application was approved; or (3) on the basis of new
    information before him with respect to such drug, evaluated
    together with the evidence available to him when the application
    was approved, that there is a lack of substantial evidence that the
    drug will have the effect it purports or is represented to have
    under the conditions of use prescribed, recommended, or suggested
    in the labeling thereof; or (4) the patent information prescribed
    by subsection (c) of this section was not filed within thirty days
    after the receipt of written notice from the Secretary specifying
    the failure to file such information; or (5) that the application
    contains any untrue statement of a material fact: Provided, That if
    the Secretary (or in his absence the officer acting as Secretary)
    finds that there is an imminent hazard to the public health, he may
    suspend the approval of such application immediately, and give the
    applicant prompt notice of his action and afford the applicant the
    opportunity for an expedited hearing under this subsection; but the
    authority conferred by this proviso to suspend the approval of an
    application shall not be delegated. The Secretary may also, after
    due notice and opportunity for hearing to the applicant, withdraw
    the approval of an application submitted under subsection (b) or
    (j) of this section with respect to any drug under this section if
    the Secretary finds (1) that the applicant has failed to establish
    a system for maintaining required records, or has repeatedly or
    deliberately failed to maintain such records or to make required
    reports, in accordance with a regulation or order under subsection
    (k) of this section or to comply with the notice requirements of
    section 360(k)(2) of this title, or the applicant has refused to
    permit access to, or copying or verification of, such records as
    required by paragraph (2) of such subsection; or (2) that on the
    basis of new information before him, evaluated together with the
    evidence before him when the application was approved, the methods
    used in, or the facilities and controls used for, the manufacture,
    processing, and packing of such drug are inadequate to assure and
    preserve its identity, strength, quality, and purity and were not
    made adequate within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of; or
    (3) that on the basis of new information before him, evaluated
    together with the evidence before him when the application was
    approved, the labeling of such drug, based on a fair evaluation of
    all material facts, is false or misleading in any particular and
    was not corrected within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of. Any
    order under this subsection shall state the findings upon which it
    is based.
    (f) Revocation of order refusing, withdrawing or suspending
      approval of application
      Whenever the Secretary finds that the facts so require, he shall
    revoke any previous order under subsection (d) or (e) of this
    section refusing, withdrawing, or suspending approval of an
    application and shall approve such application or reinstate such
    approval, as may be appropriate.
    (g) Service of orders
      Orders of the Secretary issued under this section shall be served
    (1) in person by any officer or employee of the department
    designated by the Secretary or (2) by mailing the order by
    registered mail or by certified mail addressed to the applicant or
    respondent at his last-known address in the records of the
    Secretary.
    (h) Appeal from order
      An appeal may be taken by the applicant from an order of the
    Secretary refusing or withdrawing approval of an application under
    this section. Such appeal shall be taken by filing in the United
    States court of appeals for the circuit wherein such applicant
    resides or has his principal place of business, or in the United
    States Court of Appeals for the District of Columbia Circuit,
    within sixty days after the entry of such order, a written petition
    praying that the order of the Secretary be set aside. A copy of
    such petition shall be forthwith transmitted by the clerk of the
    court to the Secretary, or any officer designated by him for that
    purpose, and thereupon the Secretary shall certify and file in the
    court the record upon which the order complained of was entered, as
    provided in section 2112 of title 28. Upon the filing of such
    petition such court shall have exclusive jurisdiction to affirm or
    set aside such order, except that until the filing of the record
    the Secretary may modify or set aside his order. No objection to
    the order of the Secretary shall be considered by the court unless
    such objection shall have been urged before the Secretary or unless
    there were reasonable grounds for failure so to do. The finding of
    the Secretary as to the facts, if supported by substantial
    evidence, shall be conclusive. If any person shall apply to the
    court for leave to adduce additional evidence, and shall show to
    the satisfaction of the court that such additional evidence is
    material and that there were reasonable grounds for failure to
    adduce such evidence in the proceeding before the Secretary, the
    court may order such additional evidence to be taken before the
    Secretary and to be adduced upon the hearing in such manner and
    upon such terms and conditions as to the court may seem proper. The
    Secretary may modify his findings as to the facts by reason of the
    additional evidence so taken, and he shall file with the court such
    modified findings which, if supported by substantial evidence,
    shall be conclusive, and his recommendation, if any, for the
    setting aside of the original order. The judgment of the court
    affirming or setting aside any such order of the Secretary shall be
    final, subject to review by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28. The commencement of proceedings under this subsection
    shall not, unless specifically ordered by the court to the
    contrary, operate as a stay of the Secretary's order.
    (i) Exemptions of drugs for research; discretionary and mandatory
      conditions; direct reports to Secretary
      (1) The Secretary shall promulgate regulations for exempting from
    the operation of the foregoing subsections of this section drugs
    intended solely for investigational use by experts qualified by
    scientific training and experience to investigate the safety and
    effectiveness of drugs. Such regulations may, within the discretion
    of the Secretary, among other conditions relating to the protection
    of the public health, provide for conditioning such exemption upon -
     
        (A) the submission to the Secretary, before any clinical
      testing of a new drug is undertaken, of reports, by the
      manufacturer or the sponsor of the investigation of such drug, of
      preclinical tests (including tests on animals) of such drug
      adequate to justify the proposed clinical testing;
        (B) the manufacturer or the sponsor of the investigation of a
      new drug proposed to be distributed to investigators for clinical
      testing obtaining a signed agreement from each of such
      investigators that patients to whom the drug is administered will
      be under his personal supervision, or under the supervision of
      investigators responsible to him, and that he will not supply
      such drug to any other investigator, or to clinics, for
      administration to human beings;
        (C) the establishment and maintenance of such records, and the
      making of such reports to the Secretary, by the manufacturer or
      the sponsor of the investigation of such drug, of data (including
      but not limited to analytical reports by investigators) obtained
      as the result of such investigational use of such drug, as the
      Secretary finds will enable him to evaluate the safety and
      effectiveness of such drug in the event of the filing of an
      application pursuant to subsection (b) of this section; and
        (D) the submission to the Secretary by the manufacturer or the
      sponsor of the investigation of a new drug of a statement of
      intent regarding whether the manufacturer or sponsor has plans
      for assessing pediatric safety and efficacy.

      (2) Subject to paragraph (3), a clinical investigation of a new
    drug may begin 30 days after the Secretary has received from the
    manufacturer or sponsor of the investigation a submission
    containing such information about the drug and the clinical
    investigation, including - 
        (A) information on design of the investigation and adequate
      reports of basic information, certified by the applicant to be
      accurate reports, necessary to assess the safety of the drug for
      use in clinical investigation; and
        (B) adequate information on the chemistry and manufacturing of
      the drug, controls available for the drug, and primary data
      tabulations from animal or human studies.

      (3)(A) At any time, the Secretary may prohibit the sponsor of an
    investigation from conducting the investigation (referred to in
    this paragraph as a "clinical hold") if the Secretary makes a
    determination described in subparagraph (B). The Secretary shall
    specify the basis for the clinical hold, including the specific
    information available to the Secretary which served as the basis
    for such clinical hold, and confirm such determination in writing.
      (B) For purposes of subparagraph (A), a determination described
    in this subparagraph with respect to a clinical hold is that - 
        (i) the drug involved represents an unreasonable risk to the
      safety of the persons who are the subjects of the clinical
      investigation, taking into account the qualifications of the
      clinical investigators, information about the drug, the design of
      the clinical investigation, the condition for which the drug is
      to be investigated, and the health status of the subjects
      involved; or
        (ii) the clinical hold should be issued for such other reasons
      as the Secretary may by regulation establish (including reasons
      established by regulation before November 21, 1997).

      (C) Any written request to the Secretary from the sponsor of an
    investigation that a clinical hold be removed shall receive a
    decision, in writing and specifying the reasons therefor, within 30
    days after receipt of such request. Any such request shall include
    sufficient information to support the removal of such clinical
    hold.
      (4) Regulations under paragraph (1) shall provide that such
    exemption shall be conditioned upon the manufacturer, or the
    sponsor of the investigation, requiring that experts using such
    drugs for investigational purposes certify to such manufacturer or
    sponsor that they will inform any human beings to whom such drugs,
    or any controls used in connection therewith, are being
    administered, or their representatives, that such drugs are being
    used for investigational purposes and will obtain the consent of
    such human beings or their representatives, except where it is not
    feasible or it is contrary to the best interests of such human
    beings. Nothing in this subsection shall be construed to require
    any clinical investigator to submit directly to the Secretary
    reports on the investigational use of drugs.
    (j) Abbreviated new drug applications
      (1) Any person may file with the Secretary an abbreviated
    application for the approval of a new drug.
      (2)(A) An abbreviated application for a new drug shall contain - 
        (i) information to show that the conditions of use prescribed,
      recommended, or suggested in the labeling proposed for the new
      drug have been previously approved for a drug listed under
      paragraph (7) (hereinafter in this subsection referred to as a
      "listed drug");
        (ii)(I) if the listed drug referred to in clause (i) has only
      one active ingredient, information to show that the active
      ingredient of the new drug is the same as that of the listed
      drug;
        (II) if the listed drug referred to in clause (i) has more than
      one active ingredient, information to show that the active
      ingredients of the new drug are the same as those of the listed
      drug, or
        (III) if the listed drug referred to in clause (i) has more
      than one active ingredient and if one of the active ingredients
      of the new drug is different and the application is filed
      pursuant to the approval of a petition filed under subparagraph
      (C), information to show that the other active ingredients of the
      new drug are the same as the active ingredients of the listed
      drug, information to show that the different active ingredient is
      an active ingredient of a listed drug or of a drug which does not
      meet the requirements of section 321(p) of this title, and such
      other information respecting the different active ingredient with
      respect to which the petition was filed as the Secretary may
      require;
        (iii) information to show that the route of administration, the
      dosage form, and the strength of the new drug are the same as
      those of the listed drug referred to in clause (i) or, if the
      route of administration, the dosage form, or the strength of the
      new drug is different and the application is filed pursuant to
      the approval of a petition filed under subparagraph (C), such
      information respecting the route of administration, dosage form,
      or strength with respect to which the petition was filed as the
      Secretary may require;
        (iv) information to show that the new drug is bioequivalent to
      the listed drug referred to in clause (i), except that if the
      application is filed pursuant to the approval of a petition filed
      under subparagraph (C), information to show that the active
      ingredients of the new drug are of the same pharmacological or
      therapeutic class as those of the listed drug referred to in
      clause (i) and the new drug can be expected to have the same
      therapeutic effect as the listed drug when administered to
      patients for a condition of use referred to in clause (i);
        (v) information to show that the labeling proposed for the new
      drug is the same as the labeling approved for the listed drug
      referred to in clause (i) except for changes required because of
      differences approved under a petition filed under subparagraph
      (C) or because the new drug and the listed drug are produced or
      distributed by different manufacturers;
        (vi) the items specified in clauses (B) through (F) of
      subsection (b)(1) of this section;
        (vii) a certification, in the opinion of the applicant and to
      the best of his knowledge, with respect to each patent which
      claims the listed drug referred to in clause (i) or which claims
      a use for such listed drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under subsection (b) or (c) of this section -
       
          (I) that such patent information has not been filed,
          (II) that such patent has expired,
          (III) of the date on which such patent will expire, or
          (IV) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new drug for which the
        application is submitted; and

        (viii) if with respect to the listed drug referred to in clause
      (i) information was filed under subsection (b) or (c) of this
      section for a method of use patent which does not claim a use for
      which the applicant is seeking approval under this subsection, a
      statement that the method of use patent does not claim such a
      use.

    The Secretary may not require that an abbreviated application
    contain information in addition to that required by clauses (i)
    through (viii).
      (B) Notice of opinion that patent is invalid or will not be
    infringed. - 
        (i) Agreement to give notice. - An applicant that makes a
      certification described in subparagraph (A)(vii)(IV) shall
      include in the application a statement that the applicant will
      give notice as required by this subparagraph.
        (ii) Timing of notice. - An applicant that makes a
      certification described in subparagraph (A)(vii)(IV) shall give
      notice as required under this subparagraph - 
          (I) if the certification is in the application, not later
        than 20 days after the date of the postmark on the notice with
        which the Secretary informs the applicant that the application
        has been filed; or
          (II) if the certification is in an amendment or supplement to
        the application, at the time at which the applicant submits the
        amendment or supplement, regardless of whether the applicant
        has already given notice with respect to another such
        certification contained in the application or in an amendment
        or supplement to the application.

        (iii) Recipients of notice. - An applicant required under this
      subparagraph to give notice shall give notice to - 
          (I) each owner of the patent that is the subject of the
        certification (or a representative of the owner designated to
        receive such a notice); and
          (II) the holder of the approved application under subsection
        (b) of this section for the drug that is claimed by the patent
        or a use of which is claimed by the patent (or a representative
        of the holder designated to receive such a notice).

        (iv) Contents of notice. - A notice required under this
      subparagraph shall - 
          (I) state that an application that contains data from
        bioavailability or bioequivalence studies has been submitted
        under this subsection for the drug with respect to which the
        certification is made to obtain approval to engage in the
        commercial manufacture, use, or sale of the drug before the
        expiration of the patent referred to in the certification; and
          (II) include a detailed statement of the factual and legal
        basis of the opinion of the applicant that the patent is
        invalid or will not be infringed.

      (C) If a person wants to submit an abbreviated application for a
    new drug which has a different active ingredient or whose route of
    administration, dosage form, or strength differ from that of a
    listed drug, such person shall submit a petition to the Secretary
    seeking permission to file such an application. The Secretary shall
    approve or disapprove a petition submitted under this subparagraph
    within ninety days of the date the petition is submitted. The
    Secretary shall approve such a petition unless the Secretary finds -
     
        (i) that investigations must be conducted to show the safety
      and effectiveness of the drug or of any of its active
      ingredients, the route of administration, the dosage form, or
      strength which differ from the listed drug; or
        (ii) that any drug with a different active ingredient may not
      be adequately evaluated for approval as safe and effective on the
      basis of the information required to be submitted in an
      abbreviated application.

      (D)(i) An applicant may not amend or supplement an application to
    seek approval of a drug referring to a different listed drug from
    the listed drug identified in the application as submitted to the
    Secretary.
      (ii) With respect to the drug for which an application is
    submitted, nothing in this subsection prohibits an applicant from
    amending or supplementing the application to seek approval of a
    different strength.
      (iii) Within 60 days after December 8, 2003, the Secretary shall
    issue guidance defining the term "listed drug" for purposes of this
    subparagraph.
      (3)(A) The Secretary shall issue guidance for the individuals who
    review applications submitted under paragraph (1), which shall
    relate to promptness in conducting the review, technical
    excellence, lack of bias and conflict of interest, and knowledge of
    regulatory and scientific standards, and which shall apply equally
    to all individuals who review such applications.
      (B) The Secretary shall meet with a sponsor of an investigation
    or an applicant for approval for a drug under this subsection if
    the sponsor or applicant makes a reasonable written request for a
    meeting for the purpose of reaching agreement on the design and
    size of bioavailability and bioequivalence studies needed for
    approval of such application. The sponsor or applicant shall
    provide information necessary for discussion and agreement on the
    design and size of such studies. Minutes of any such meeting shall
    be prepared by the Secretary and made available to the sponsor or
    applicant.
      (C) Any agreement regarding the parameters of design and size of
    bioavailability and bioequivalence studies of a drug under this
    paragraph that is reached between the Secretary and a sponsor or
    applicant shall be reduced to writing and made part of the
    administrative record by the Secretary. Such agreement shall not be
    changed after the testing begins, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (D) by the director of the reviewing division, that
      a substantial scientific issue essential to determining the
      safety or effectiveness of the drug has been identified after the
      testing has begun.

      (D) A decision under subparagraph (C)(ii) by the director shall
    be in writing and the Secretary shall provide to the sponsor or
    applicant an opportunity for a meeting at which the director and
    the sponsor or applicant will be present and at which the director
    will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by, the
    field or compliance office personnel unless such field or
    compliance office personnel demonstrate to the reviewing division
    why such decision should be modified.
      (F) No action by the reviewing division may be delayed because of
    the unavailability of information from or action by field personnel
    unless the reviewing division determines that a delay is necessary
    to assure the marketing of a safe and effective drug.
      (G) For purposes of this paragraph, the reviewing division is the
    division responsible for the review of an application for approval
    of a drug under this subsection (including scientific matters,
    chemistry, manufacturing, and controls).
      (4) Subject to paragraph (5), the Secretary shall approve an
    application for a drug unless the Secretary finds - 
        (A) the methods used in, or the facilities and controls used
      for, the manufacture, processing, and packing of the drug are
      inadequate to assure and preserve its identity, strength,
      quality, and purity;
        (B) information submitted with the application is insufficient
      to show that each of the proposed conditions of use have been
      previously approved for the listed drug referred to in the
      application;
        (C)(i) if the listed drug has only one active ingredient,
      information submitted with the application is insufficient to
      show that the active ingredient is the same as that of the listed
      drug;
        (ii) if the listed drug has more than one active ingredient,
      information submitted with the application is insufficient to
      show that the active ingredients are the same as the active
      ingredients of the listed drug, or
        (iii) if the listed drug has more than one active ingredient
      and if the application is for a drug which has an active
      ingredient different from the listed drug, information submitted
      with the application is insufficient to show - 
          (I) that the other active ingredients are the same as the
        active ingredients of the listed drug, or
          (II) that the different active ingredient is an active
        ingredient of a listed drug or a drug which does not meet the
        requirements of section 321(p) of this title,

      or no petition to file an application for the drug with the
      different ingredient was approved under paragraph (2)(C);
        (D)(i) if the application is for a drug whose route of
      administration, dosage form, or strength of the drug is the same
      as the route of administration, dosage form, or strength of the
      listed drug referred to in the application, information submitted
      in the application is insufficient to show that the route of
      administration, dosage form, or strength is the same as that of
      the listed drug, or
        (ii) if the application is for a drug whose route of
      administration, dosage form, or strength of the drug is different
      from that of the listed drug referred to in the application, no
      petition to file an application for the drug with the different
      route of administration, dosage form, or strength was approved
      under paragraph (2)(C);
        (E) if the application was filed pursuant to the approval of a
      petition under paragraph (2)(C), the application did not contain
      the information required by the Secretary respecting the active
      ingredient, route of administration, dosage form, or strength
      which is not the same;
        (F) information submitted in the application is insufficient to
      show that the drug is bioequivalent to the listed drug referred
      to in the application or, if the application was filed pursuant
      to a petition approved under paragraph (2)(C), information
      submitted in the application is insufficient to show that the
      active ingredients of the new drug are of the same
      pharmacological or therapeutic class as those of the listed drug
      referred to in paragraph (2)(A)(i) and that the new drug can be
      expected to have the same therapeutic effect as the listed drug
      when administered to patients for a condition of use referred to
      in such paragraph;
        (G) information submitted in the application is insufficient to
      show that the labeling proposed for the drug is the same as the
      labeling approved for the listed drug referred to in the
      application except for changes required because of differences
      approved under a petition filed under paragraph (2)(C) or because
      the drug and the listed drug are produced or distributed by
      different manufacturers;
        (H) information submitted in the application or any other
      information available to the Secretary shows that (i) the
      inactive ingredients of the drug are unsafe for use under the
      conditions prescribed, recommended, or suggested in the labeling
      proposed for the drug, or (ii) the composition of the drug is
      unsafe under such conditions because of the type or quantity of
      inactive ingredients included or the manner in which the inactive
      ingredients are included;
        (I) the approval under subsection (c) of this section of the
      listed drug referred to in the application under this subsection
      has been withdrawn or suspended for grounds described in the
      first sentence of subsection (e) of this section, the Secretary
      has published a notice of opportunity for hearing to withdraw
      approval of the listed drug under subsection (c) of this section
      for grounds described in the first sentence of subsection (e) of
      this section, the approval under this subsection of the listed
      drug referred to in the application under this subsection has
      been withdrawn or suspended under paragraph (6), or the Secretary
      has determined that the listed drug has been withdrawn from sale
      for safety or effectiveness reasons;
        (J) the application does not meet any other requirement of
      paragraph (2)(A); or
        (K) the application contains an untrue statement of material
      fact.

      (5)(A) Within one hundred and eighty days of the initial receipt
    of an application under paragraph (2) or within such additional
    period as may be agreed upon by the Secretary and the applicant,
    the Secretary shall approve or disapprove the application.
      (B) The approval of an application submitted under paragraph (2)
    shall be made effective on the last applicable date determined by
    applying the following to each certification made under paragraph
    (2)(A)(vii):
        (i) If the applicant only made a certification described in
      subclause (I) or (II) of paragraph (2)(A)(vii) or in both such
      subclauses, the approval may be made effective immediately.
        (ii) If the applicant made a certification described in
      subclause (III) of paragraph (2)(A)(vii), the approval may be
      made effective on the date certified under subclause (III).
        (iii) If the applicant made a certification described in
      subclause (IV) of paragraph (2)(A)(vii), the approval shall be
      made effective immediately unless, before the expiration of 45
      days after the date on which the notice described in paragraph
      (2)(B) is received, an action is brought for infringement of the
      patent that is the subject of the certification and for which
      information was submitted to the Secretary under subsection
      (b)(1) or (c)(2) of this section before the date on which the
      application (excluding an amendment or supplement to the
      application), which the Secretary later determines to be
      substantially complete, was submitted. If such an action is
      brought before the expiration of such days, the approval shall be
      made effective upon the expiration of the thirty-month period
      beginning on the date of the receipt of the notice provided under
      paragraph (2)(B)(i) or such shorter or longer period as the court
      may order because either party to the action failed to reasonably
      cooperate in expediting the action, except that - 
          (I) if before the expiration of such period the district
        court decides that the patent is invalid or not infringed
        (including any substantive determination that there is no cause
        of action for patent infringement or invalidity), the approval
        shall be made effective on - 
            (aa) the date on which the court enters judgment reflecting
          the decision; or
            (bb) the date of a settlement order or consent decree
          signed and entered by the court stating that the patent that
          is the subject of the certification is invalid or not
          infringed;

          (II) if before the expiration of such period the district
        court decides that the patent has been infringed - 
            (aa) if the judgment of the district court is appealed, the
          approval shall be made effective on - 
              (AA) the date on which the court of appeals decides that
            the patent is invalid or not infringed (including any
            substantive determination that there is no cause of action
            for patent infringement or invalidity); or
              (BB) the date of a settlement order or consent decree
            signed and entered by the court of appeals stating that the
            patent that is the subject of the certification is invalid
            or not infringed; or

            (bb) if the judgment of the district court is not appealed
          or is affirmed, the approval shall be made effective on the
          date specified by the district court in a court order under
          section 271(e)(4)(A) of title 35;

          (III) if before the expiration of such period the court
        grants a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent is
        invalid or not infringed, the approval shall be made effective
        as provided in subclause (I); or
          (IV) if before the expiration of such period the court grants
        a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent has been
        infringed, the approval shall be made effective as provided in
        subclause (II).

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action.
        (iv) 180-day exclusivity period. - 
          (I) Effectiveness of application. - Subject to subparagraph
        (D), if the application contains a certification described in
        paragraph (2)(A)(vii)(IV) and is for a drug for which a first
        applicant has submitted an application containing such a
        certification, the application shall be made effective on the
        date that is 180 days after the date of the first commercial
        marketing of the drug (including the commercial marketing of
        the listed drug) by any first applicant.
          (II) Definitions. - In this paragraph:
            (aa) 180-day exclusivity period. - The term "180-day
          exclusivity period" means the 180-day period ending on the
          day before the date on which an application submitted by an
          applicant other than a first applicant could become effective
          under this clause.
            (bb) First applicant. - As used in this subsection, the
          term "first applicant" means an applicant that, on the first
          day on which a substantially complete application containing
          a certification described in paragraph (2)(A)(vii)(IV) is
          submitted for approval of a drug, submits a substantially
          complete application that contains and lawfully maintains a
          certification described in paragraph (2)(A)(vii)(IV) for the
          drug.
            (cc) Substantially complete application. - As used in this
          subsection, the term "substantially complete application"
          means an application under this subsection that on its face
          is sufficiently complete to permit a substantive review and
          contains all the information required by paragraph (2)(A).
            (dd) Tentative approval. - 
              (AA) In general. - The term "tentative approval" means
            notification to an applicant by the Secretary that an
            application under this subsection meets the requirements of
            paragraph (2)(A), but cannot receive effective approval
            because the application does not meet the requirements of
            this subparagraph, there is a period of exclusivity for the
            listed drug under subparagraph (F) or section 355a of this
            title, or there is a 7-year period of exclusivity for the
            listed drug under section 360cc of this title.
              (BB) Limitation. - A drug that is granted tentative
            approval by the Secretary is not an approved drug and shall
            not have an effective approval until the Secretary issues
            an approval after any necessary additional review of the
            application.

      (C) Civil action to obtain patent certainty. - 
        (i) Declaratory judgment absent infringement action. - 
          (I) In general. - No action may be brought under section 2201
        of title 28 by an applicant under paragraph (2) for a
        declaratory judgment with respect to a patent which is the
        subject of the certification referred to in subparagraph
        (B)(iii) unless - 
            (aa) the 45-day period referred to in such subparagraph has
          expired;
            (bb) neither the owner of such patent nor the holder of the
          approved application under subsection (b) of this section for
          the drug that is claimed by the patent or a use of which is
          claimed by the patent brought a civil action against the
          applicant for infringement of the patent before the
          expiration of such period; and
            (cc) in any case in which the notice provided under
          paragraph (2)(B) relates to noninfringement, the notice was
          accompanied by a document described in subclause (III).

          (II) Filing of civil action. - If the conditions described in
        items (aa), (bb), and as applicable, (cc) of subclause (I) have
        been met, the applicant referred to in such subclause may, in
        accordance with section 2201 of title 28, bring a civil action
        under such section against the owner or holder referred to in
        such subclause (but not against any owner or holder that has
        brought such a civil action against the applicant, unless that
        civil action was dismissed without prejudice) for a declaratory
        judgment that the patent is invalid or will not be infringed by
        the drug for which the applicant seeks approval, except that
        such civil action may be brought for a declaratory judgment
        that the patent will not be infringed only in a case in which
        the condition described in subclause (I)(cc) is applicable. A
        civil action referred to in this subclause shall be brought in
        the judicial district where the defendant has its principal
        place of business or a regular and established place of
        business.
          (III) Offer of confidential access to application. - For
        purposes of subclause (I)(cc), the document described in this
        subclause is a document providing an offer of confidential
        access to the application that is in the custody of the
        applicant under paragraph (2) for the purpose of determining
        whether an action referred to in subparagraph (B)(iii) should
        be brought. The document providing the offer of confidential
        access shall contain such restrictions as to persons entitled
        to access, and on the use and disposition of any information
        accessed, as would apply had a protective order been entered
        for the purpose of protecting trade secrets and other
        confidential business information. A request for access to an
        application under an offer of confidential access shall be
        considered acceptance of the offer of confidential access with
        the restrictions as to persons entitled to access, and on the
        use and disposition of any information accessed, contained in
        the offer of confidential access, and those restrictions and
        other terms of the offer of confidential access shall be
        considered terms of an enforceable contract. Any person
        provided an offer of confidential access shall review the
        application for the sole and limited purpose of evaluating
        possible infringement of the patent that is the subject of the
        certification under paragraph (2)(A)(vii)(IV) and for no other
        purpose, and may not disclose information of no relevance to
        any issue of patent infringement to any person other than a
        person provided an offer of confidential access. Further, the
        application may be redacted by the applicant to remove any
        information of no relevance to any issue of patent
        infringement.

        (ii) Counterclaim to infringement action. - 
          (I) In general. - If an owner of the patent or the holder of
        the approved application under subsection (b) of this section
        for the drug that is claimed by the patent or a use of which is
        claimed by the patent brings a patent infringement action
        against the applicant, the applicant may assert a counterclaim
        seeking an order requiring the holder to correct or delete the
        patent information submitted by the holder under subsection (b)
        or (c) of this section on the ground that the patent does not
        claim either - 
            (aa) the drug for which the application was approved; or
            (bb) an approved method of using the drug.

          (II) No independent cause of action. - Subclause (I) does not
        authorize the assertion of a claim described in subclause (I)
        in any civil action or proceeding other than a counterclaim
        described in subclause (I).

        (iii) No damages. - An applicant shall not be entitled to
      damages in a civil action under clause (i) or a counterclaim
      under clause (ii).

      (D) Forfeiture of 180-day exclusivity period. - 
        (i) Definition of forfeiture event. - In this subparagraph, the
      term "forfeiture event", with respect to an application under
      this subsection, means the occurrence of any of the following:
          (I) Failure to market. - The first applicant fails to market
        the drug by the later of - 
            (aa) the earlier of the date that is - 
              (AA) 75 days after the date on which the approval of the
            application of the first applicant is made effective under
            subparagraph (B)(iii); or
              (BB) 30 months after the date of submission of the
            application of the first applicant; or

            (bb) with respect to the first applicant or any other
          applicant (which other applicant has received tentative
          approval), the date that is 75 days after the date as of
          which, as to each of the patents with respect to which the
          first applicant submitted and lawfully maintained a
          certification qualifying the first applicant for the 180-day
          exclusivity period under subparagraph (B)(iv), at least 1 of
          the following has occurred:
              (AA) In an infringement action brought against that
            applicant with respect to the patent or in a declaratory
            judgment action brought by that applicant with respect to
            the patent, a court enters a final decision from which no
            appeal (other than a petition to the Supreme Court for a
            writ of certiorari) has been or can be taken that the
            patent is invalid or not infringed.
              (BB) In an infringement action or a declaratory judgment
            action described in subitem (AA), a court signs a
            settlement order or consent decree that enters a final
            judgment that includes a finding that the patent is invalid
            or not infringed.
              (CC) The patent information submitted under subsection
            (b) or (c) of this section is withdrawn by the holder of
            the application approved under subsection (b) of this
            section.

          (II) Withdrawal of application. - The first applicant
        withdraws the application or the Secretary considers the
        application to have been withdrawn as a result of a
        determination by the Secretary that the application does not
        meet the requirements for approval under paragraph (4).
          (III) Amendment of certification. - The first applicant
        amends or withdraws the certification for all of the patents
        with respect to which that applicant submitted a certification
        qualifying the applicant for the 180-day exclusivity period.
          (IV) Failure to obtain tentative approval. - The first
        applicant fails to obtain tentative approval of the application
        within 30 months after the date on which the application is
        filed, unless the failure is caused by a change in or a review
        of the requirements for approval of the application imposed
        after the date on which the application is filed.
          (V) Agreement with another applicant, the listed drug
        application holder, or a patent owner. - The first applicant
        enters into an agreement with another applicant under this
        subsection for the drug, the holder of the application for the
        listed drug, or an owner of the patent that is the subject of
        the certification under paragraph (2)(A)(vii)(IV), the Federal
        Trade Commission or the Attorney General files a complaint, and
        there is a final decision of the Federal Trade Commission or
        the court with regard to the complaint from which no appeal
        (other than a petition to the Supreme Court for a writ of
        certiorari) has been or can be taken that the agreement has
        violated the antitrust laws (as defined in section 12 of title
        15, except that the term includes section 45 of title 15 to the
        extent that that section applies to unfair methods of
        competition).
          (VI) Expiration of all patents. - All of the patents as to
        which the applicant submitted a certification qualifying it for
        the 180-day exclusivity period have expired.

        (ii) Forfeiture. - The 180-day exclusivity period described in
      subparagraph (B)(iv) shall be forfeited by a first applicant if a
      forfeiture event occurs with respect to that first applicant.
        (iii) Subsequent applicant. - If all first applicants forfeit
      the 180-day exclusivity period under clause (ii) - 
          (I) approval of any application containing a certification
        described in paragraph (2)(A)(vii)(IV) shall be made effective
        in accordance with subparagraph (B)(iii); and
          (II) no applicant shall be eligible for a 180-day exclusivity
        period.

      (E) If the Secretary decides to disapprove an application, the
    Secretary shall give the applicant notice of an opportunity for a
    hearing before the Secretary on the question of whether such
    application is approvable. If the applicant elects to accept the
    opportunity for hearing by written request within thirty days after
    such notice, such hearing shall commence not more than ninety days
    after the expiration of such thirty days unless the Secretary and
    the applicant otherwise agree. Any such hearing shall thereafter be
    conducted on an expedited basis and the Secretary's order thereon
    shall be issued within ninety days after the date fixed by the
    Secretary for filing final briefs.
      (F)(i) If an application (other than an abbreviated new drug
    application) submitted under subsection (b) of this section for a
    drug, no active ingredient (including any ester or salt of the
    active ingredient) of which has been approved in any other
    application under subsection (b) of this section, was approved
    during the period beginning January 1, 1982, and ending on
    September 24, 1984, the Secretary may not make the approval of an
    application submitted under this subsection which refers to the
    drug for which the subsection (b) application was submitted
    effective before the expiration of ten years from the date of the
    approval of the application under subsection (b) of this section.
      (ii) If an application submitted under subsection (b) of this
    section for a drug, no active ingredient (including any ester or
    salt of the active ingredient) of which has been approved in any
    other application under subsection (b) of this section, is approved
    after September 24, 1984, no application may be submitted under
    this subsection which refers to the drug for which the subsection
    (b) application was submitted before the expiration of five years
    from the date of the approval of the application under subsection
    (b) of this section, except that such an application may be
    submitted under this subsection after the expiration of four years
    from the date of the approval of the subsection (b) application if
    it contains a certification of patent invalidity or noninfringement
    described in subclause (IV) of paragraph (2)(A)(vii). The approval
    of such an application shall be made effective in accordance with
    subparagraph (B) except that, if an action for patent infringement
    is commenced during the one-year period beginning forty-eight
    months after the date of the approval of the subsection (b)
    application, the thirty-month period referred to in subparagraph
    (B)(iii) shall be extended by such amount of time (if any) which is
    required for seven and one-half years to have elapsed from the date
    of approval of the subsection (b) application.
      (iii) If an application submitted under subsection (b) of this
    section for a drug, which includes an active ingredient (including
    any ester or salt of the active ingredient) that has been approved
    in another application approved under subsection (b) of this
    section, is approved after September 24, 1984, and if such
    application contains reports of new clinical investigations (other
    than bioavailability studies) essential to the approval of the
    application and conducted or sponsored by the applicant, the
    Secretary may not make the approval of an application submitted
    under this subsection for the conditions of approval of such drug
    in the subsection (b) application effective before the expiration
    of three years from the date of the approval of the application
    under subsection (b) of this section for such drug.
      (iv) If a supplement to an application approved under subsection
    (b) of this section is approved after September 24, 1984, and the
    supplement contains reports of new clinical investigations (other
    than bioavailability studies) essential to the approval of the
    supplement and conducted or sponsored by the person submitting the
    supplement, the Secretary may not make the approval of an
    application submitted under this subsection for a change approved
    in the supplement effective before the expiration of three years
    from the date of the approval of the supplement under subsection
    (b) of this section.
      (v) If an application (or supplement to an application) submitted
    under subsection (b) of this section for a drug, which includes an
    active ingredient (including any ester or salt of the active
    ingredient) that has been approved in another application under
    subsection (b) of this section, was approved during the period
    beginning January 1, 1982, and ending on September 24, 1984, the
    Secretary may not make the approval of an application submitted
    under this subsection which refers to the drug for which the
    subsection (b) application was submitted or which refers to a
    change approved in a supplement to the subsection (b) application
    effective before the expiration of two years from September 24,
    1984.
      (6) If a drug approved under this subsection refers in its
    approved application to a drug the approval of which was withdrawn
    or suspended for grounds described in the first sentence of
    subsection (e) of this section or was withdrawn or suspended under
    this paragraph or which, as determined by the Secretary, has been
    withdrawn from sale for safety or effectiveness reasons, the
    approval of the drug under this subsection shall be withdrawn or
    suspended - 
        (A) for the same period as the withdrawal or suspension under
      subsection (e) of this section or this paragraph, or
        (B) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

      (7)(A)(i) Within sixty days of September 24, 1984, the Secretary
    shall publish and make available to the public - 
        (I) a list in alphabetical order of the official and
      proprietary name of each drug which has been approved for safety
      and effectiveness under subsection (c) of this section before
      September 24, 1984;
        (II) the date of approval if the drug is approved after 1981
      and the number of the application which was approved; and
        (III) whether in vitro or in vivo bioequivalence studies, or
      both such studies, are required for applications filed under this
      subsection which will refer to the drug published.

      (ii) Every thirty days after the publication of the first list
    under clause (i) the Secretary shall revise the list to include
    each drug which has been approved for safety and effectiveness
    under subsection (c) of this section or approved under this
    subsection during the thirty-day period.
      (iii) When patent information submitted under subsection (b) or
    (c) of this section respecting a drug included on the list is to be
    published by the Secretary, the Secretary shall, in revisions made
    under clause (ii), include such information for such drug.
      (B) A drug approved for safety and effectiveness under subsection
    (c) of this section or approved under this subsection shall, for
    purposes of this subsection, be considered to have been published
    under subparagraph (A) on the date of its approval or September 24,
    1984, whichever is later.
      (C) If the approval of a drug was withdrawn or suspended for
    grounds described in the first sentence of subsection (e) of this
    section or was withdrawn or suspended under paragraph (6) or if the
    Secretary determines that a drug has been withdrawn from sale for
    safety or effectiveness reasons, it may not be published in the
    list under subparagraph (A) or, if the withdrawal or suspension
    occurred after its publication in such list, it shall be
    immediately removed from such list - 
        (i) for the same period as the withdrawal or suspension under
      subsection (e) of this section or paragraph (6), or
        (ii) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

    A notice of the removal shall be published in the Federal Register.
      (8) For purposes of this subsection:
        (A)(i) The term "bioavailability" means the rate and extent to
      which the active ingredient or therapeutic ingredient is absorbed
      from a drug and becomes available at the site of drug action.
        (ii) For a drug that is not intended to be absorbed into the
      bloodstream, the Secretary may assess bioavailability by
      scientifically valid measurements intended to reflect the rate
      and extent to which the active ingredient or therapeutic
      ingredient becomes available at the site of drug action.
        (B) A drug shall be considered to be bioequivalent to a listed
      drug if - 
          (i) the rate and extent of absorption of the drug do not show
        a significant difference from the rate and extent of absorption
        of the listed drug when administered at the same molar dose of
        the therapeutic ingredient under similar experimental
        conditions in either a single dose or multiple doses; or
          (ii) the extent of absorption of the drug does not show a
        significant difference from the extent of absorption of the
        listed drug when administered at the same molar dose of the
        therapeutic ingredient under similar experimental conditions in
        either a single dose or multiple doses and the difference from
        the listed drug in the rate of absorption of the drug is
        intentional, is reflected in its proposed labeling, is not
        essential to the attainment of effective body drug
        concentrations on chronic use, and is considered medically
        insignificant for the drug.

        (C) For a drug that is not intended to be absorbed into the
      bloodstream, the Secretary may establish alternative,
      scientifically valid methods to show bioequivalence if the
      alternative methods are expected to detect a significant
      difference between the drug and the listed drug in safety and
      therapeutic effect.

      (9) The Secretary shall, with respect to each application
    submitted under this subsection, maintain a record of - 
        (A) the name of the applicant,
        (B) the name of the drug covered by the application,
        (C) the name of each person to whom the review of the chemistry
      of the application was assigned and the date of such assignment,
      and
        (D) the name of each person to whom the bioequivalence review
      for such application was assigned and the date of such
      assignment.

    The information the Secretary is required to maintain under this
    paragraph with respect to an application submitted under this
    subsection shall be made available to the public after the approval
    of such application.
    (k) Records and reports; required information; regulations and
      orders; access to records
      (1) In the case of any drug for which an approval of an
    application filed under subsection (b) or (j) of this section is in
    effect, the applicant shall establish and maintain such records,
    and make such reports to the Secretary, of data relating to
    clinical experience and other data or information, received or
    otherwise obtained by such applicant with respect to such drug, as
    the Secretary may by general regulation, or by order with respect
    to such application, prescribe on the basis of a finding that such
    records and reports are necessary in order to enable the Secretary
    to determine, or facilitate a determination, whether there is or
    may be ground for invoking subsection (e) of this section.
    Regulations and orders issued under this subsection and under
    subsection (i) of this section shall have due regard for the
    professional ethics of the medical profession and the interests of
    patients and shall provide, where the Secretary deems it to be
    appropriate, for the examination, upon request, by the persons to
    whom such regulations or orders are applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this section to maintain records,
    and every person in charge or custody thereof, shall, upon request
    of an officer or employee designated by the Secretary, permit such
    officer or employee at all reasonable times to have access to and
    copy and verify such records.
    (l) Public disclosure of safety and effectiveness data
      Safety and effectiveness data and information which has been
    submitted in an application under subsection (b) of this section
    for a drug and which has not previously been disclosed to the
    public shall be made available to the public, upon request, unless
    extraordinary circumstances are shown - 
        (1) if no work is being or will be undertaken to have the
      application approved,
        (2) if the Secretary has determined that the application is not
      approvable and all legal appeals have been exhausted,
        (3) if approval of the application under subsection (c) of this
      section is withdrawn and all legal appeals have been exhausted,
        (4) if the Secretary has determined that such drug is not a new
      drug, or
        (5) upon the effective date of the approval of the first
      application under subsection (j) of this section which refers to
      such drug or upon the date upon which the approval of an
      application under subsection (j) of this section which refers to
      such drug could be made effective if such an application had been
      submitted.
    (m) "Patent" defined
      For purposes of this section, the term "patent" means a patent
    issued by the United States Patent and Trademark Office.
    (n) Scientific advisory panels
      (1) For the purpose of providing expert scientific advice and
    recommendations to the Secretary regarding a clinical investigation
    of a drug or the approval for marketing of a drug under this
    section or section 262 of title 42, the Secretary shall establish
    panels of experts or use panels of experts established before
    November 21, 1997, or both.
      (2) The Secretary may delegate the appointment and oversight
    authority granted under section 394 of this title to a director of
    a center or successor entity within the Food and Drug
    Administration.
      (3) The Secretary shall make appointments to each panel
    established under paragraph (1) so that each panel shall consist of
    - 
        (A) members who are qualified by training and experience to
      evaluate the safety and effectiveness of the drugs to be referred
      to the panel and who, to the extent feasible, possess skill and
      experience in the development, manufacture, or utilization of
      such drugs;
        (B) members with diverse expertise in such fields  as  clinical
       and  administrative  medicine, pharmacy, pharmacology,
      pharmacoeconomics, biological and physical sciences, and other
      related professions;
        (C) a representative of consumer interests, and a
      representative of interests of the drug manufacturing industry
      not directly affected by the matter to be brought before the
      panel; and
        (D) two or more members who are specialists or have other
      expertise in the particular disease or condition for which the
      drug under review is proposed to be indicated.

    Scientific, trade, and consumer organizations shall be afforded an
    opportunity to nominate individuals for appointment to the panels.
    No individual who is in the regular full-time employ of the United
    States and engaged in the administration of this chapter may be a
    voting member of any panel. The Secretary shall designate one of
    the members of each panel to serve as chairman thereof.
      (4) Each member of a panel shall publicly disclose all conflicts
    of interest that member may have with the work to be undertaken by
    the panel. No member of a panel may vote on any matter where the
    member or the immediate family of such member could gain
    financially from the advice given to the Secretary. The Secretary
    may grant a waiver of any conflict of interest requirement upon
    public disclosure of such conflict of interest if such waiver is
    necessary to afford the panel essential expertise, except that the
    Secretary may not grant a waiver for a member of a panel when the
    member's own scientific work is involved.
      (5) The Secretary shall, as appropriate, provide education and
    training to each new panel member before such member participates
    in a panel's activities, including education regarding requirements
    under this chapter and related regulations of the Secretary, and
    the administrative processes and procedures related to panel
    meetings.
      (6) Panel members (other than officers or employees of the United
    States), while attending meetings or conferences of a panel or
    otherwise engaged in its business, shall be entitled to receive
    compensation for each day so engaged, including traveltime, at
    rates to be fixed by the Secretary, but not to exceed the daily
    equivalent of the rate in effect for positions classified above
    grade GS-15 of the General Schedule. While serving away from their
    homes or regular places of business, panel members may be allowed
    travel expenses (including per diem in lieu of subsistence) as
    authorized by section 5703 of title 5, for persons in the
    Government service employed intermittently.
      (7) The Secretary shall ensure that scientific advisory panels
    meet regularly and at appropriate intervals so that any matter to
    be reviewed by such a panel can be presented to the panel not more
    than 60 days after the matter is ready for such review. Meetings of
    the panel may be held using electronic communication to convene the
    meetings.
      (8) Within 90 days after a scientific advisory panel makes
    recommendations on any matter under its review, the Food and Drug
    Administration official responsible for the matter shall review the
    conclusions and recommendations of the panel, and notify the
    affected persons of the final decision on the matter, or of the
    reasons that no such decision has been reached. Each such final
    decision shall be documented including the rationale for the
    decision.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 505, 52 Stat. 1052; Pub. L. 86-507,
    Sec. 1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I,
    Secs. 102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76
    Stat. 781-783, 784, 785; Pub. L. 92-387, Sec. 4(d), Aug. 16, 1972,
    86 Stat. 562; Pub. L. 98-417, title I, Secs. 101, 102(a)-(b)(5),
    103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L.
    102-282, Sec. 5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, Sec.
    3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
    115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315,
    2316, 2318, 2324; Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title
    IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584;
    Pub. L. 107-109, Sec. 15(c)(1), Jan. 4, 2002, 115 Stat. 1420; Pub.
    L. 108-155, Sec. 2(b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
    173, title XI, Secs. 1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003,
    117 Stat. 2448, 2452, 2457, 2460.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The General Schedule, referred to in subsec. (n)(6), is set out
    under section 5332 of Title 5, Government Organization and
    Employees.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(1). Pub. L. 108-155, in second sentence,
    substituted "(F)" for "and (F)" and inserted ", and (G) any
    assessments required under section 355c of this title" before
    period at end.
      Subsec. (b)(3). Pub. L. 108-173, Sec. 1101(b)(1)(A), added par.
    (3) and struck out former par. (3) which, in subpar. (A), required
    an applicant making a certification under par. (2)(A)(iv) to
    include statement that applicant will give notice to each owner of
    the patent which is the subject of the certification and to the
    holder of the approved application, in subpar. (B), directed that
    notice state that an application has been submitted and include a
    detailed statement of the applicant's opinion that the patent is
    not valid or will not be infringed, and, in subpar. (C), provided
    that if an application is amended, notice shall be given when the
    amended application is submitted.
      Subsec. (b)(4), (5). Pub. L. 108-173, Sec. 1101(b)(1)(B), added
    par. (4) and redesignated former par. (4) as (5).
      Subsec. (c)(3). Pub. L. 108-173, Sec. 1101(b)(2)(A), substituted
    "by applying the following to each certification made under
    subsection (b)(2)(A) of this section" for "under the following" in
    introductory provisions.
      Subsec. (c)(3)(C). Pub. L. 108-173, Sec. 1101(b)(2)(B)(iii),
    which directed the substitution of "subsection (b)(3) of this
    section" for "paragraph (3)(B)" in third sentence, could not be
    executed because such words do not appear. See note below.
      Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(VI), in concluding
    provisions, struck out "Until the expiration of forty-five days
    from the date the notice made under paragraph (3)(B) is received,
    no action may be brought under section 2201 of title 28 for a
    declaratory judgment with respect to the patent. Any action brought
    under such section 2201 shall be brought in the judicial district
    where the defendant has its principal place of business or a
    regular and established place of business." after "expediting the
    action."
      Pub. L. 108-173, Sec. 1101(b)(2)(B)(i), (ii)(I), in first
    sentence of introductory provisions, substituted "unless, before
    the expiration of 45 days after the date on which the notice
    described in subsection (b)(3) of this section is received, an
    action is brought for infringement of the patent that is the
    subject of the certification and for which information was
    submitted to the Secretary under paragraph (2) or subsection (b)(1)
    of this section before the date on which the application (excluding
    an amendment or supplement to the application) was submitted" for
    "unless an action is brought for infringement of a patent which is
    the subject of the certification before the expiration of forty-
    five days from the date the notice provided under paragraph (3)(B)
    is received" and, in second sentence of introductory provisions,
    substituted "subsection (b)(3) of this section" for "paragraph
    (3)(B)".
      Subsec. (c)(3)(C)(i). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i)
    which read as follows: "if before the expiration of such period the
    court decides that such patent is invalid or not infringed, the
    approval may be made effective on the date of the court decision,".
      Subsec. (c)(3)(C)(ii). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl.
    (ii) which read as follows: "if before the expiration of such
    period the court decides that such patent has been infringed, the
    approval may be made effective on such date as the court orders
    under section 271(e)(4)(A) of title 35, or".
      Subsec. (c)(3)(C)(iii). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(IV), substituted "as provided in clause (i); or"
    for "on the date of such court decision."
      Subsec. (c)(3)(C)(iv). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(V), added cl. (iv).
      Subsec. (c)(3)(D), (E). Pub. L. 108-173, Sec. 1101(b)(2)(C), (D),
    added subpar. (D) and redesignated former subpar. (D) as (E).
      Subsec. (j)(2)(B). Pub. L. 108-173, Sec. 1101(a)(1)(A), added
    subpar. (B) and struck out former subpar. (B) which, in cl. (i),
    required that an applicant making a certification under subpar.
    (A)(vii)(IV) include in the application a statement that notice
    would be given to each owner of the patent and the holder of the
    approved application, in cl. (ii), required that notice would state
    that an application had been submitted and that it would include a
    detailed statement of the basis of the applicant's opinion, and, in
    cl. (iii), directed that notice of an amended application be given
    when the amended application had been submitted.
      Subsec. (j)(2)(D). Pub. L. 108-173, Sec. 1101(a)(1)(B), added
    subpar. (D).
      Subsec. (j)(5)(B). Pub. L. 108-173, Sec. 1101(a)(2)(A)(i),
    substituted "by applying the following to each certification made
    under paragraph (2)(A)(vii)" for "under the following" in
    introductory provisions.
      Subsec. (j)(5)(B)(iii). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second
    sentence of subsec. (j)(5)(B)(iii) by striking "Until the
    expiration" and all that follows in the matter after and below
    subclause (IV), was executed by striking "Until the expiration of
    forty-five days from the date the notice made under paragraph
    (2)(B)(i) is received, no action may be brought under section 2201
    of title 28, for a declaratory judgment with respect to the patent.
    Any action brought under section 2201 shall be brought in the
    judicial district where the defendant has its principal place of
    business or a regular and established place of business." after
    "expediting the action." in concluding provisions, to reflect the
    probable intent of Congress.
      Pub. L. 108-173, Sec. 1101(a)(2)(A)(ii)(I), in introductory
    provisions, substituted "unless, before the expiration of 45 days
    after the date on which the notice described in paragraph (2)(B) is
    received, an action is brought for infringement of the patent that
    is the subject of the certification and for which information was
    submitted to the Secretary under subsection (b)(1) or (c)(2) of
    this section before the date on which the application (excluding an
    amendment or supplement to the application), which the Secretary
    later determines to be substantially complete, was submitted" for
    "unless an action is brought for infringement of a patent which is
    the subject of the certification before the expiration of forty-
    five days from the date the notice provided under paragraph
    (2)(B)(i) is received".
      Subsec. (j)(5)(B)(iii)(I). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former
    subcl. (I) which read as follows: "if before the expiration of such
    period the court decides that such patent is invalid or not
    infringed, the approval shall be made effective on the date of the
    court decision,".
      Subsec. (j)(5)(B)(iii)(II). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former
    subcl. (II) which read as follows: "if before the expiration of
    such period the court decides that such patent has been infringed,
    the approval shall be made effective on such date as the court
    orders under section 271(e)(4)(A) of title 35, or".
      Subsec. (j)(5)(B)(iii)(III). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(cc), substituted "as provided in subclause
    (I); or" for "on the date of such court decision."
      Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).
      Subsec. (j)(5)(B)(iv). Pub. L. 108-173, Sec. 1102(a)(1), added
    cl. (iv) and struck out former cl. (iv) which read as follows: "If
    the application contains a certification described in subclause
    (IV) of paragraph (2)(A)(vii) and is for a drug for which a
    previous application has been submitted under this subsection
    continuing such a certification, the application shall be made
    effective not earlier than one hundred and eighty days after - 
        "(I) the date the Secretary receives notice from the applicant
      under the previous application of the first commercial marketing
      of the drug under the previous application, or
        "(II) the date of a decision of a court in an action described
      in clause (iii) holding the patent which is the subject of the
      certification to be invalid or not infringed,
    whichever is earlier."
      Subsec. (j)(5)(C). Pub. L. 108-173, Sec. 1101(a)(2)(B), (C),
    added subpar. (C). Former subpar. (C) redesignated (E).
      Subsec. (j)(5)(D). Pub. L. 108-173, Sec. 1102(a)(2), added
    subpar. (D).
      Pub. L. 108-173, Sec. 1101(a)(2)(B), redesignated subpar. (D) as
    (F).
      Subsec. (j)(5)(E), (F). Pub. L. 108-173, Sec. 1101(a)(2)(B),
    redesignated subpars. (C) and (D) as (E) and (F), respectively.
      Subsec. (j)(8)(A). Pub. L. 108-173, Sec. 1103(a)(1), added
    subpar. (A) and struck out former subpar. (A) which read as
    follows: "The term 'bioavailability' means the rate and extent to
    which the active ingredient or therapeutic ingredient is absorbed
    from a drug and becomes available at the site of drug action."
      Subsec. (j)(8)(C). Pub. L. 108-173, Sec. 1103(a)(2), added
    subpar. (C).
      2002 - Subsec. (i)(1)(D). Pub. L. 107-109 added subpar. (D).
      1999 - Subsec. (m). Pub. L. 106-113 substituted "United States
    Patent and Trademark Office" for "Patent and Trademark Office of
    the Department of Commerce".
      1997 - Subsec. (b)(1). Pub. L. 105-115, Sec. 115(b), inserted at
    end "The Secretary shall, in consultation with the Director of the
    National Institutes of Health and with representatives of the drug
    manufacturing industry, review and develop guidance, as
    appropriate, on the inclusion of women and minorities in clinical
    trials required by clause (A)."
      Subsec. (b)(4). Pub. L. 105-115, Sec. 119(a), added par. (4).
      Subsec. (c)(4). Pub. L. 105-115, Sec. 124(a), added par. (4).
      Subsec. (d). Pub. L. 105-115, Sec. 115(a), inserted at end "If
    the Secretary determines, based on relevant science, that data from
    one adequate and well-controlled clinical investigation and
    confirmatory evidence (obtained prior to or after such
    investigation) are sufficient to establish effectiveness, the
    Secretary may consider such data and evidence to constitute
    substantial evidence for purposes of the preceding sentence."
      Subsec. (i). Pub. L. 105-115, Sec. 117, inserted "(1)" after
    "(i)", redesignated former pars. (1) to (3) as subpars. (A) to (C),
    respectively, of par. (1), added pars. (2) to (4), and struck out
    closing provisions which read as follows: "Such regulations shall
    provide that such exemption shall be conditioned upon the
    manufacturer, or the sponsor of the investigation, requiring that
    experts using such drugs for investigational purposes certify to
    such manufacturer or sponsor that they will inform any human beings
    to whom such drugs, or any controls used in connection therewith,
    are being administered, or their representatives, that such drugs
    are being used for investigational purposes and will obtain the
    consent of such human beings or their representatives, except where
    they deem it not feasible or, in their professional judgment,
    contrary to the best interests of such human beings. Nothing in
    this subsection shall be construed to require any clinical
    investigator to submit directly to the Secretary reports on the
    investigational use of drugs."
      Subsec. (j)(2)(A)(i). Pub. L. 105-115, Sec. 119(b)(2)(A),
    substituted "paragraph (7)" for "paragraph (6)".
      Subsec. (j)(3). Pub. L. 105-115, Sec. 119(b)(1)(B), added par.
    (3). Former par. (3) redesignated (4).
      Subsec. (j)(4). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(B),
    redesignated par. (3) as (4) and in introductory provisions
    substituted "paragraph (5)" for "paragraph (4)". Former par. (4)
    redesignated (5).
      Subsec. (j)(4)(I). Pub. L. 105-115, Sec. 119(b)(2)(C),
    substituted "paragraph (6)" for "paragraph (5)".
      Subsec. (j)(5), (6). Pub. L. 105-115, Sec. 119(b)(1)(A),
    redesignated pars. (4) and (5) as (5) and (6), respectively. Former
    par. (6) redesignated (7).
      Subsec. (j)(7). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(D),
    redesignated par. (6) as (7) and in subpar. (C) substituted
    "paragraph (6)" for "paragraph (5)" in two places. Former par. (7)
    redesignated (8).
      Subsec. (j)(8), (9). Pub. L. 105-115, Sec. 119(b)(1)(A),
    redesignated pars. (7) and (8) as (8) and (9), respectively.
      Subsec. (n). Pub. L. 105-115, Sec. 120, added subsec. (n).
      1993 - Subsec. (j)(6)(A)(ii). Pub. L. 103-80, Sec. 3(n)(1)(A),
    substituted "Secretary" for "Secretry".
      Subsec. (j)(6)(A)(iii). Pub. L. 103-80, Sec. 3(n)(1)(B), inserted
    comma after "published by the Secretary".
      Subsec. (k)(1). Pub. L. 103-80, Sec. 3(n)(2), substituted
    "section. Regulations" for "section: Provided, however, That
    regulations".
      1992 - Subsec. (j)(8). Pub. L. 102-282 added par. (8).
      1984 - Subsec. (a). Pub. L. 98-417, Sec. 102(b)(1), inserted "or
    (j)" after "subsection (b)".
      Subsec. (b). Pub. L. 98-417, Secs. 102(a)(1), 103(a), designated
    existing provisions of subsec. (b) as par. (1) thereof and
    redesignated existing cls. (1) through (6) of such par. (1) as cls.
    (A) through (F) thereof, respectively, inserted requirement that
    the applicant file with the application the patent number and the
    expiration date of any patent which claims the drug for which the
    applicant submitted the application or which claims a method of
    using such drug and with respect to which a claim of patent
    infringement could reasonably by asserted if a person not licensed
    by the owner engaged in the manufacture, use, or sale of the drug,
    that the applicant amend the application to include such
    information if an application is filed under this subsection for a
    drug and a patent which claims such drug or a method of using such
    drug is issued after the filing date but before approval of the
    application, and that upon approval of the application, the
    Secretary publish the information submitted, and added pars. (2)
    and (3).
      Subsec. (c). Pub. L. 98-417, Secs. 102(a)(2), (b)(2), 103(b),
    designated existing provisions of subsec. (c) as par. (1) thereof
    and in par. (1) as so designated substituted "subsection (b) of
    this section" for "this subsection" and redesignated former pars.
    (1) and (2) as subpars. (A) and (B), respectively, and added pars.
    (2) and (3).
      Subsec. (d)(6), (7). Pub. L. 98-417, Sec. 102(a)(3)(A), added cl.
    (6) relating to the failure of the application to contain the
    patent information prescribed by subsec. (b) of this section, and
    redesignated former cl. (6) as (7).
      Subsec. (e). Pub. L. 98-417, Sec. 102(a)(3)(B), in first
    sentence, added a new cl. (4) relating to the failure to file the
    patent information prescribed by subsec. (c) of this section within
    30 days after the receipt of written notice from the Secretary
    specifying the failure to file such information, and redesignated
    former cl. (4) as (5).
      Pub. L. 98-417, Sec. 102(b)(3), (4), in second sentence, inserted
    in provisions preceding cl. (1) "submitted under subsection (b) or
    (j) of this section" and in cl. (1) substituted "under subsection
    (k) of this section or to comply with the notice requirements of
    section 360(k)(2) of this title" for "under subsection (j) of this
    section or to comply with the notice requirements of section
    360(j)(2) of this title".
      Subsecs. (j), (k). Pub. L. 98-417, Sec. 101, added subsec. (j)
    and redesignated former subsec. (j) as (k).
      Subsec. (k)(1). Pub. L. 98-417, Sec. 102(b)(5), substituted
    "under subsection (b) or (j) of this section" for "pursuant to this
    section".
      Subsecs. (l), (m). Pub. L. 98-417, Sec. 104, added subsecs. (l)
    and (m).
      1972 - Subsec. (e). Pub. L. 92-387 inserted "or to comply with
    the notice requirements of section 360(j)(2) of this title" in cl.
    (1) of second sentence relating to the maintenance of records.
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 104(a), inserted "an
    approval of" before "an application".
      Subsec. (b). Pub. L. 87-781, Sec. 102(b), inserted "and whether
    such drug is effective in use" after "is safe for use".
      Subsec. (c). Pub. L. 87-781, Sec. 104(b), substituted provisions
    requiring the Secretary, within 180 days after filing an
    application, or such additional period as the Secretary and the
    applicant agree upon, to either approve the application, if meeting
    the requirements of subsec. (d) of this section, or give notice of
    opportunity for hearing on question of whether such application is
    approvable, and providing that if applicant requests hearing in
    writing within 30 days, the hearing shall begin within 90 days
    after expiration of said 30 days, unless the Secretary and
    applicant agree otherwise, that such hearing shall be expedited,
    and that the Secretary's order shall be issued within 90 days after
    date for filing final briefs, for provisions which had an
    application become effective on the sixtieth day after filing
    thereof unless prior thereto the Secretary postponed the date by
    written notice to such time, but not more than 180 days after
    filing, as the Secretary deemed necessary to study and investigate
    the application.
      Subsec. (d). Pub. L. 87-781, Sec. 102(c), inserted references to
    subsec. (c), added cls. (5) and (6), provided that if after notice
    and opportunity for hearing, the Secretary finds that cls. (1) to
    (6) do not apply, he shall approve the application, and defined
    "substantial evidence" as used in this subsection and subsec. (e)
    of this section.
      Subsec. (e). Pub. L. 87-781, Sec. 102(d), amended subsec. (e)
    generally, and among other changes, directed the Secretary to
    withdraw approval of an application if by tests, other scientific
    data or experience, or new evidence of clinical experience not
    contained in the application or available at the time of its
    approval, the drug is shown to be unsafe, or on the basis of new
    information, there is shown a lack of substantial evidence that the
    drug has the effect it is represented to have, and provided that if
    the Secretary, or acting Secretary, finds there is an imminent
    hazard to the public health, he may suspend approval immediately,
    notify the applicant, and give him opportunity for an expedited
    hearing, that the Secretary may withdraw approval if the applicant
    fails to establish a system for maintaining required records, or
    has repeatedly or deliberately failed to maintain records and make
    reports, or has refused access to, or copying or verification of
    such records, or if the Secretary finds on new evidence that the
    methods, facilities and controls in the manufacturing, processing,
    and packing are inadequate to assure and preserve the drugs'
    identity, strength, quality and purity, and were not made adequate
    within a reasonable time after receipt of written notice thereof,
    or finds on new evidence, that the labeling is false or misleading
    and was not corrected within a reasonable time after receipt of
    written notice thereof.
      Subsec. (f). Pub. L. 87-781, Sec. 104(c), substituted provisions
    requiring the Secretary to revoke any previous order under subsecs.
    (d) or (e) of this section refusing, withdrawing, or suspending
    approval of an application and to approve such application or
    reinstate such approval, for provisions which required him to
    revoke an order refusing effectiveness to an application.
      Subsec. (h). Pub. L. 87-781, Sec. 104(d)(1), (2), inserted "as
    provided in section 2112 of title 28", and "except that until the
    filing of the record the Secretary may modify or set aside his
    order", substituted "or withdrawing approval of an application
    under this section" for "to permit the application to become
    effective, or suspending the effectiveness of the application",
    "United States court of appeals for the circuit" for "district
    court of the United States within any district", "Court of Appeals
    for the District of Columbia Circuit" for "District Court for the
    District of Columbia", "transmitted by the clerk of the court to"
    for "served upon", and "by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28" for "as provided in sections 225, 346, and 347 of title
    28, as amended, and in section 7, as amended, of the Act entitled
    'An Act to establish a Court of Appeals for the District of
    Columbia', approved February 9, 1893", and eliminated "upon" before
    "any officer designated", "a transcript of" before "the record" and
    "and decree" before "of the court affirming".
      Subsec. (i). Pub. L. 87-781, Sec. 103(b), inserted "the foregoing
    subsections of" after "operation of", and "and effectiveness" after
    "safety", and provided that the regulations may condition
    exemptions upon the submission of reports of preclinical tests to
    justify the proposed clinical testing, upon the obtaining by the
    manufacturer or sponsor of the investigation of a new drug of a
    signed agreement from each of the investigators that patients to
    whom the drug is administered will be under his supervision or
    under investigators responsible to him, and that he will not supply
    such drug to any other investigator, or to clinics, for
    administration to human beings, or upon the establishment and
    maintenance of records and reports of data obtained by the
    investigational use of such drug, as the Secretary finds will
    enable him to evaluate the safety and effectiveness of such drug,
    and provided that the regulations shall condition an exemption upon
    the manufacturer or sponsor of the investigation requiring that
    experts using such drugs certify that they will inform humans to
    whom such drugs or any controls connected therewith are
    administered, or their representatives, and will obtain the consent
    of such people where feasible and not contrary to the best
    interests of such people, and that reports on the investigational
    use of drugs are not required to be submitted directly to the
    Secretary.
      Subsec. (j). Pub. L. 87-781, Sec. 103(a), added subsec. (j).
      1960 - Subsec. (g). Pub. L. 86-507 inserted "or by certified
    mail" after "registered mail".

                     EFFECTIVE DATE OF 2003 AMENDMENTS                 
      Pub. L. 108-173, title XI, Sec. 1101(c), Dec. 8, 2003, 117 Stat.
    2456, provided that:
      "(1) In general. - Except as provided in paragraphs (2) and (3),
    the amendments made by subsections (a) and (b) [amending this
    section] apply to any proceeding under section 505 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or
    after the date of the enactment of this Act [Dec. 8, 2003]
    regardless of the date on which the proceeding was commenced or is
    commenced.
      "(2) Notice of opinion that patent is invalid or will not be
    infringed. - The amendments made by subsections (a)(1) and (b)(1)
    apply with respect to any certification under subsection
    (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after
    August 18, 2003, in an application filed under subsection (b) or
    (j) of that section or in an amendment or supplement to an
    application filed under subsection (b) or (j) of that section.
      "(3) Effective date of approval. - The amendments made by
    subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to
    any patent information submitted under subsection (b)(1) or (c)(2)
    of section 505 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 355) on or after August 18, 2003."
      Pub. L. 108-173, title XI, Sec. 1102(b), Dec. 8, 2003, 117 Stat.
    2460, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendment made by subsection (a) [amending this section] shall be
    effective only with respect to an application filed under section
    505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    355(j)) after the date of the enactment of this Act [Dec. 8, 2003]
    for a listed drug for which no certification under section
    505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
    enactment of this Act.
      "(2) Collusive agreements. - If a forfeiture event described in
    section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an
    applicant, the applicant shall forfeit the 180-day period under
    section 505(j)(5)(B)(iv) of that Act without regard to when the
    first certification under section 505(j)(2)(A)(vii)(IV) of that Act
    for the listed drug was made.
      "(3) Decision of a court when the 180-day exclusivity period has
    not been triggered. - With respect to an application filed before,
    on, or after the date of the enactment of this Act [Dec. 8, 2003]
    for a listed drug for which a certification under section
    505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
    enactment of this Act and for which neither of the events described
    in subclause (I) or (II) of section 505(j)(5)(B)(iv) of that Act
    (as in effect on the day before the date of the enactment of this
    Act) has occurred on or before the date of the enactment of this
    Act, the term 'decision of a court' as used in clause (iv) of
    section 505(j)(5)(B) of that Act means a final decision of a court
    from which no appeal (other than a petition to the Supreme Court
    for a writ of certiorari) has been or can be taken."
      Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
    otherwise provided, see section 4 of Pub. L. 108-155, set out as an
    Effective Date note under section 355c of this title.

                     EFFECTIVE DATE OF 1999 AMENDMENT                 
      Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
    1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
    113, set out as a note under section 1 of Title 35, Patents.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Section 105 of Pub. L. 98-417 provided that:
      "(a) The Secretary of Health and Human Services shall promulgate,
    in accordance with the notice and comment requirements of section
    553 of title 5, United States Code, such regulations as may be
    necessary for the administration of section 505 of the Federal
    Food, Drug, and Cosmetic Act [this section], as amended by sections
    101, 102, and 103 of this Act, within one year of the date of
    enactment of this Act [Sept. 24, 1984].
      "(b) During the period beginning sixty days after the date of the
    enactment of this Act [Sept. 24, 1984], and ending on the date
    regulations promulgated under subsection (a) take effect,
    abbreviated new drug applications may be submitted in accordance
    with the provisions of section 314.2 of title 21 of the Code of
    Federal Regulations and shall be considered as suitable for any
    drug which has been approved for safety and effectiveness under
    section 505(c) of the Federal Food, Drug, and Cosmetic Act [subsec.
    (c) of this section] before the date of the enactment of this Act.
    If any such provision is inconsistent with the requirements of
    section 505(j) of the Federal Food, Drug, and Cosmetic Act, the
    Secretary shall consider the application under the applicable
    requirements of such section. The Secretary of Health and Human
    Services may not approve such an abbreviated new drug application
    which is filed for a drug which is described in sections
    505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and
    Cosmetic Act, except in accordance with such section."

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-387 effective on first day of sixth month
    beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
    out as a note under section 360 of this title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective on first day of seventh
    calendar month following October 1962, see section 107 of Pub. L.
    87-781, set out as a note under section 321 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282           
      Amendment by Pub. L. 102-282 not to preclude any other civil,
    criminal, or administrative remedy provided under Federal or State
    law, including any private right of action against any person for
    the same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
      EFFECT OF AMENDMENT BY PUB. L. 108-173 ON ABBREVIATED NEW DRUG
                               APPLICATIONS
      Pub. L. 108-173, title XI, Sec. 1103(b), Dec. 8, 2003, 117 Stat.
    2461, provided that: "The amendment made by subsection (a)
    [amending this section] does not alter the standards for approval
    of drugs under section 505(j) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 355(j))."

                      FEDERAL TRADE COMMISSION REVIEW                  
      Pub. L. 108-173, title XI, subtitle B, Dec. 8, 2003, 117 Stat.
    2461, provided that:

      "SEC. 1111. DEFINITIONS.
      "In this subtitle:
        "(1) ANDA. - The term 'ANDA' means an abbreviated drug
      application, as defined under section 201(aa) of the Federal
      Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].
        "(2) Assistant attorney general. - The term 'Assistant Attorney
      General' means the Assistant Attorney General in charge of the
      Antitrust Division of the Department of Justice.
        "(3) Brand name drug. - The term 'brand name drug' means a drug
      for which an application is approved under section 505(c) of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)],
      including an application referred to in section 505(b)(2) of such
      Act [21 U.S.C. 355(b)(2)].
        "(4) Brand name drug company. - The term 'brand name drug
      company' means the party that holds the approved application
      referred to in paragraph (3) for a brand name drug that is a
      listed drug in an ANDA, or a party that is the owner of a patent
      for which information is submitted for such drug under subsection
      (b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic
      Act [21 U.S.C. 355(b), (c)].
        "(5) Commission. - The term 'Commission' means the Federal
      Trade Commission.
        "(6) Generic drug. - The term 'generic drug' means a drug for
      which an application under section 505(j) of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.
        "(7) Generic drug applicant. - The term 'generic drug
      applicant' means a person who has filed or received approval for
      an ANDA under section 505(j) of the Federal Food, Drug, and
      Cosmetic Act [21 U.S.C. 355(j)].
        "(8) Listed drug. - The term 'listed drug' means a brand name
      drug that is listed under section 505(j)(7) of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].

      "SEC. 1112. NOTIFICATION OF AGREEMENTS.
      "(a) Agreement With Brand Name Drug Company. - 
        "(1) Requirement. - A generic drug applicant that has submitted
      an ANDA containing a certification under section
      505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 355(j)(2)(A)(vii)(IV)] and a brand name drug company
      that enter into an agreement described in paragraph (2) shall
      each file the agreement in accordance with subsection (c). The
      agreement shall be filed prior to the date of the first
      commercial marketing of the generic drug that is the subject of
      the ANDA.
        "(2) Subject matter of agreement. - An agreement described in
      this paragraph between a generic drug applicant and a brand name
      drug company is an agreement regarding - 
          "(A) the manufacture, marketing or sale of the brand name
        drug that is the listed drug in the ANDA involved;
          "(B) the manufacture, marketing, or sale of the generic drug
        for which the ANDA was submitted; or
          "(C) the 180-day period referred to in section
        505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act
        [21 U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to
        any other ANDA based on the same brand name drug.
      "(b) Agreement With Another Generic Drug Applicant. - 
        "(1) Requirement. - A generic drug applicant that has submitted
      an ANDA containing a certification under section
      505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug
      and another generic drug applicant that has submitted an ANDA
      containing such a certification for the same listed drug shall
      each file the agreement in accordance with subsection (c). The
      agreement shall be filed prior to the date of the first
      commercial marketing of either of the generic drugs for which
      such ANDAs were submitted.
        "(2) Subject matter of agreement. - An agreement described in
      this paragraph between two generic drug applicants is an
      agreement regarding the 180-day period referred to in section
      505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21
      U.S.C. 355(j)(5)(B)(iv)] as it applies to the ANDAs with which
      the agreement is concerned.
      "(c) Filing. - 
        "(1) Agreement. - The parties that are required in subsection
      (a) or (b) to file an agreement in accordance with this
      subsection shall file with the Assistant Attorney General and the
      Commission the text of any such agreement, except that such
      parties are not required to file an agreement that solely
      concerns - 
          "(A) purchase orders for raw material supplies;
          "(B) equipment and facility contracts;
          "(C) employment or consulting contracts; or
          "(D) packaging and labeling contracts.
        "(2) Other agreements. - The parties that are required in
      subsection (a) or (b) to file an agreement in accordance with
      this subsection shall file with the Assistant Attorney General
      and the Commission the text of any agreements between the parties
      that are not described in such subsections and are contingent
      upon, provide a contingent condition for, or are otherwise
      related to an agreement that is required in subsection (a) or (b)
      to be filed in accordance with this subsection.
        "(3) Description. - In the event that any agreement required in
      subsection (a) or (b) to be filed in accordance with this
      subsection has not been reduced to text, each of the parties
      involved shall file written descriptions of such agreement that
      are sufficient to disclose all the terms and conditions of the
      agreement.

      "SEC. 1113. FILING DEADLINES.
      "Any filing required under section 1112 shall be filed with the
    Assistant Attorney General and the Commission not later than 10
    business days after the date the agreements are executed.

      "SEC. 1114. DISCLOSURE EXEMPTION.
      "Any information or documentary material filed with the Assistant
    Attorney General or the Commission pursuant to this subtitle shall
    be exempt from disclosure under section 552 of title 5, United
    States Code, and no such information or documentary material may be
    made public, except as may be relevant to any administrative or
    judicial action or proceeding. Nothing in this section is intended
    to prevent disclosure to either body of the Congress or to any duly
    authorized committee or subcommittee of the Congress.

      "SEC. 1115. ENFORCEMENT.
      "(a) Civil Penalty. - Any brand name drug company or generic drug
    applicant which fails to comply with any provision of this subtitle
    shall be liable for a civil penalty of not more than $11,000, for
    each day during which such entity is in violation of this subtitle.
    Such penalty may be recovered in a civil action brought by the
    United States, or brought by the Commission in accordance with the
    procedures established in section 16(a)(1) of the Federal Trade
    Commission Act (15 U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).
      "(b) Compliance and Equitable Relief. - If any brand name drug
    company or generic drug applicant fails to comply with any
    provision of this subtitle, the United States district court may
    order compliance, and may grant such other equitable relief as the
    court in its discretion determines necessary or appropriate, upon
    application of the Assistant Attorney General or the Commission.

      "SEC. 1116. RULEMAKING.
      "The Commission, with the concurrence of the Assistant Attorney
    General and by rule in accordance with section 553 of title 5,
    United States Code, consistent with the purposes of this subtitle -
    
        "(1) may define the terms used in this subtitle;
        "(2) may exempt classes of persons or agreements from the
      requirements of this subtitle; and
        "(3) may prescribe such other rules as may be necessary and
      appropriate to carry out the purposes of this subtitle.

      "SEC. 1117. SAVINGS CLAUSE.
      "Any action taken by the Assistant Attorney General or the
    Commission, or any failure of the Assistant Attorney General or the
    Commission to take action, under this subtitle shall not at any
    time bar any proceeding or any action with respect to any agreement
    between a brand name drug company and a generic drug applicant, or
    any agreement between generic drug applicants, under any other
    provision of law, nor shall any filing under this subtitle
    constitute or create a presumption of any violation of any
    competition laws.

      "SEC. 1118. EFFECTIVE DATE.
      "This subtitle shall - 
        "(1) take effect 30 days after the date of the enactment of
      this Act [Dec. 8, 2003]; and
        "(2) shall apply to agreements described in section 1112 that
      are entered into 30 days after the date of the enactment of this
      Act."

     REPORT ON PATIENT ACCESS TO NEW THERAPEUTIC AGENTS FOR PEDIATRIC
                                  CANCER
      Pub. L. 107-109, Sec. 15(d), Jan. 4, 2002, 115 Stat. 1421,
    provided that: "Not later than January 31, 2003, the Secretary of
    Health and Human Services, acting through the Commissioner of Food
    and Drugs and in consultation with the Director of the National
    Institutes of Health, shall submit to the Committee on Health,
    Education, Labor, and Pensions of the Senate and the Committee on
    Energy and Commerce of the House of Representatives a report on
    patient access to new therapeutic agents for pediatric cancer,
    including access to single patient use of new therapeutic agents."

                 DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS             
      Section 118 of Pub. L. 105-115 provided that: "Within 12 months
    after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services, acting through the
    Commissioner of Food and Drugs, shall issue guidance that describes
    when abbreviated study reports may be submitted, in lieu of full
    reports, with a new drug application under section 505(b) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a
    biologics license application under section 351 of the Public
    Health Service Act (42 U.S.C. 262) for certain types of studies.
    Such guidance shall describe the kinds of studies for which
    abbreviated reports are appropriate and the appropriate abbreviated
    report formats."

      REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT GOOD
         MANUFACTURING PRACTICES FOR POSITRON EMISSION TECHNOLOGY
      Section 121(c) of Pub. L. 105-115 provided that:
      "(1) Procedures and requirements. - 
        "(A) In general. - In order to take account of the special
      characteristics of positron emission tomography drugs and the
      special techniques and processes required to produce these drugs,
      not later than 2 years after the date of enactment of this Act
      [Nov. 21, 1997], the Secretary of Health and Human Services shall
      establish - 
          "(i) appropriate procedures for the approval of positron
        emission tomography drugs pursuant to section 505 of the
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
          "(ii) appropriate current good manufacturing practice
        requirements for such drugs.
        "(B) Considerations and consultation. - In establishing the
      procedures and requirements required by subparagraph (A), the
      Secretary of Health and Human Services shall take due account of
      any relevant differences between not-for-profit institutions that
      compound the drugs for their patients and commercial
      manufacturers of the drugs. Prior to establishing the procedures
      and requirements, the Secretary of Health and Human Services
      shall consult with patient advocacy groups, professional
      associations, manufacturers, and physicians and scientists
      licensed to make or use positron emission tomography drugs.
      "(2) Submission of new drug applications and abbreviated new drug
    applications. - 
        "(A) In general. - Except as provided in subparagraph (B), the
      Secretary of Health and Human Services shall not require the
      submission of new drug applications or abbreviated new drug
      applications under subsection (b) or (j) of section 505 (21
      U.S.C. 355), for compounded positron emission tomography drugs
      that are not adulterated drugs described in section 501(a)(2)(C)
      of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
      351(a)(2)(C)) (as amended by subsection (b)), for a period of 4
      years after the date of enactment of this Act [Nov. 21, 1997], or
      for 2 years after the date on which the Secretary establishes
      procedures and requirements under paragraph (1), whichever is
      longer.
        "(B) Exception. - Nothing in this Act [see Short Title of 1997
      Amendment note set out under section 301 of this title] shall
      prohibit the voluntary submission of such applications or the
      review of such applications by the Secretary of Health and Human
      Services. Nothing in this Act shall constitute an exemption for a
      positron emission tomography drug from the requirements of
      regulations issued under section 505(i) of the Federal Food,
      Drug, and Cosmetic Act (21 U.S.C. 355(i))."

          "COMPOUNDED POSITRON EMISSION TOPOGRAPHY DRUG" DEFINED      
      Section 121(e) of Pub. L. 105-115 provided that: "As used in this
    section [amending sections 321 and 351 of this title and enacting
    provisions set out as notes under this section and section 351 of
    this title], the term 'compounded positron emission tomography
    drug' has the meaning given the term in section 201 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 321)."

                   REQUIREMENTS FOR RADIOPHARMACEUTICALS               
      Section 122 of Pub. L. 105-115 provided that:
      "(a) Requirements. - 
        "(1) Regulations. - 
          "(A) Proposed regulations. - Not later than 180 days after
        the date of enactment of this Act [Nov. 21, 1997], the
        Secretary of Health and Human Services, after consultation with
        patient advocacy groups, associations, physicians licensed to
        use radiopharmaceuticals, and the regulated industry, shall
        issue proposed regulations governing the approval of
        radiopharmaceuticals. The regulations shall provide that the
        determination of the safety and effectiveness of such a
        radiopharmaceutical under section 505 of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the
        Public Health Service Act (42 U.S.C. 262) shall include
        consideration of the proposed use of the radiopharmaceutical in
        the practice of medicine, the pharmacological and toxicological
        activity of the radiopharmaceutical (including any carrier or
        ligand component of the radiopharmaceutical), and the estimated
        absorbed radiation dose of the radiopharmaceutical.
          "(B) Final regulations. - Not later than 18 months after the
        date of enactment of this Act, the Secretary shall promulgate
        final regulations governing the approval of the
        radiopharmaceuticals.
        "(2) Special rule. - In the case of a radiopharmaceutical, the
      indications for which such radiopharmaceutical is approved for
      marketing may, in appropriate cases, refer to manifestations of
      disease (such as biochemical, physiological, anatomic, or
      pathological processes) common to, or present in, one or more
      disease states.
      "(b) Definition. - In this section, the term
    'radiopharmaceutical' means - 
        "(1) an article - 
          "(A) that is intended for use in the diagnosis or monitoring
        of a disease or a manifestation of a disease in humans; and
          "(B) that exhibits spontaneous disintegration of unstable
        nuclei with the emission of nuclear particles or photons; or
        "(2) any nonradioactive reagent kit or nuclide generator that
      is intended to be used in the preparation of any such article."

                               SPECIAL RULE                           
      Section 123(f) of Pub. L. 105-115 provided that: "The Secretary
    of Health and Human Services shall take measures to minimize
    differences in the review and approval of products required to have
    approved biologics license applications under section 351 of the
    Public Health Service Act (42 U.S.C. 262) and products required to
    have approved new drug applications under section 505(b)(1) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))."

                                TRANSITION                            
      Section 125(d) of Pub. L. 105-115 provided that:
      "(1) In general. - An application that was approved by the
    Secretary of Health and Human Services before the date of the
    enactment of this Act [Nov. 21, 1997] for the marketing of an
    antibiotic drug under section 507 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 357), as in effect on the day before the
    date of the enactment of this Act, shall, on and after such date of
    enactment, be considered to be an application that was submitted
    and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and
    approved for safety and effectiveness under section 505(c) of such
    Act (21 U.S.C. 355(c)), except that if such application for
    marketing was in the form of an abbreviated application, the
    application shall be considered to have been filed and approved
    under section 505(j) of such Act (21 U.S.C. 355(j)).
      "(2) Exception. - The following subsections of section 505 (21
    U.S.C. 355) shall not apply to any application for marketing in
    which the drug that is the subject of the application contains an
    antibiotic drug and the antibiotic drug was the subject of any
    application for marketing received by the Secretary of Health and
    Human Services under section 507 of such Act (21 U.S.C. 357) before
    the date of the enactment of this Act [Nov. 21, 1997]:
        "(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
      (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
        "(ii) The third and fourth sentences of subsection (b)(1)
      (regarding the filing and publication of patent information); and
        "(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if
      the investigations relied upon by the applicant for approval of
      the application were not conducted by or for the applicant and
      for which the applicant has not obtained a right of reference or
      use from the person by or for whom the investigations were
      conducted.
      "(3) Publication. - For purposes of this section, the Secretary
    is authorized to make available to the public the established name
    of each antibiotic drug that was the subject of any application for
    marketing received by the Secretary for Health and Human Services
    under section 507 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 357) before the date of enactment of this Act [Nov. 21,
    1997]."

                      TERMINATION OF ADVISORY PANELS                  
      Advisory panels established after Jan. 5, 1973, to terminate not
    later than the expiration of the 2-year period beginning on the
    date of their establishment, unless, in the case of a panel
    established by the President or an officer of the Federal
    Government, such panel is renewed by appropriate action prior to
    the expiration of such 2-year period, or in the case of a panel
    established by Congress, its duration is otherwise provided for by
    law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 770, 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

                  APPEALS TAKEN PRIOR TO OCTOBER 10, 1962              
      Section 104(d)(3) of Pub. L. 87-781 made amendments to subsec.
    (h) of this section inapplicable to any appeal taken prior to Oct.
    10, 1962.

-FOOTNOTE-
    (!1) So in original. Probably should be "bioavailability".


-End-



-CITE-
    21 USC Sec. 355a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355a. Pediatric studies of drugs

-STATUTE-
    (a) Definitions
      As used in this section, the term "pediatric studies" or
    "studies" means at least one clinical investigation (that, at the
    Secretary's discretion, may include pharmacokinetic studies) in
    pediatric age groups (including neonates in appropriate cases) in
    which a drug is anticipated to be used.
    (b) Market exclusivity for new drugs
      If, prior to approval of an application that is submitted under
    section 355(b)(1) of this title, the Secretary determines that
    information relating to the use of a new drug in the pediatric
    population may produce health benefits in that population, the
    Secretary makes a written request for pediatric studies (which
    shall include a timeframe for completing such studies), and such
    studies are completed within any such timeframe and the reports
    thereof submitted in accordance with subsection (d)(2) of this
    section or accepted in accordance with subsection (d)(3) of this
    section - 
        (1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
      section 355 of this title, and in subsection (j)(5)(F)(ii) of
      such section, is deemed to be five years and six months rather
      than five years, and the references in subsections (c)(3)(D)(ii)
      and (j)(5)(F)(ii) of such section to four years, to forty-eight
      months, and to seven and one-half years are deemed to be four and
      one-half years, fifty-four months, and eight years, respectively;
      or
        (ii) the period referred to in clauses (iii) and (iv) of
      subsection (c)(3)(D) of such section, and in clauses (iii) and
      (iv) of subsection (j)(5)(F) of such section, is deemed to be
      three years and six months rather than three years; and
        (B) if the drug is designated under section 360bb of this title
      for a rare disease or condition, the period referred to in
      section 360cc(a) of this title is deemed to be seven years and
      six months rather than seven years; and
        (2)(A) if the drug is the subject of - 
          (i) a listed patent for which a certification has been
        submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
        of section 355 of this title and for which pediatric studies
        were submitted prior to the expiration of the patent (including
        any patent extensions); or
          (ii) a listed patent for which a certification has been
        submitted under subsections (b)(2)(A)(iii) or
        (j)(2)(A)(vii)(III) of section 355 of this title,

      the period during which an application may not be approved under
      section 355(c)(3) of this title or section 355(j)(5)(B) of this
      title shall be extended by a period of six months after the date
      the patent expires (including any patent extensions); or
        (B) if the drug is the subject of a listed patent for which a
      certification has been submitted under subsection (b)(2)(A)(iv)
      or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the
      patent infringement litigation resulting from the certification
      the court determines that the patent is valid and would be
      infringed, the period during which an application may not be
      approved under section 355(c)(3) of this title or section
      355(j)(5)(B) of this title shall be extended by a period of six
      months after the date the patent expires (including any patent
      extensions).
    (c) Market exclusivity for already-marketed drugs
      If the Secretary determines that information relating to the use
    of an approved drug in the pediatric population may produce health
    benefits in that population and makes a written request to the
    holder of an approved application under section 355(b)(1) of this
    title for pediatric studies (which shall include a timeframe for
    completing such studies), the holder agrees to the request, the
    studies are completed within any such timeframe, and the reports
    thereof are submitted in accordance with subsection (d)(2) of this
    section or accepted in accordance with subsection (d)(3) of this
    section - 
        (1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
      section 355 of this title, and in subsection (j)(5)(F)(ii) of
      such section, is deemed to be five years and six months rather
      than five years, and the references in subsections (c)(3)(D)(ii)
      and (j)(5)(F)(ii) of such section to four years, to forty-eight
      months, and to seven and one-half years are deemed to be four and
      one-half years, fifty-four months, and eight years, respectively;
      or
        (ii) the period referred to in clauses (iii) and (iv) of
      subsection (c)(3)(D) of such section, and in clauses (iii) and
      (iv) of subsection (j)(5)(F) of such section, is deemed to be
      three years and six months rather than three years; and
        (B) if the drug is designated under section 360bb of this title
      for a rare disease or condition, the period referred to in
      section 360cc(a) of this title is deemed to be seven years and
      six months rather than seven years; and
        (2)(A) if the drug is the subject of - 
          (i) a listed patent for which a certification has been
        submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
        of section 355 of this title and for which pediatric studies
        were submitted prior to the expiration of the patent (including
        any patent extensions); or
          (ii) a listed patent for which a certification has been
        submitted under subsection (b)(2)(A)(iii) or
        (j)(2)(A)(vii)(III) of section 355 of this title,

      the period during which an application may not be approved under
      section 355(c)(3) of this title or section 355(j)(5)(B) of this
      title shall be extended by a period of six months after the date
      the patent expires (including any patent extensions); or
        (B) if the drug is the subject of a listed patent for which a
      certification has been submitted under subsection (b)(2)(A)(iv)
      or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the
      patent infringement litigation resulting from the certification
      the court determines that the patent is valid and would be
      infringed, the period during which an application may not be
      approved under section 355(c)(3) of this title or section
      355(j)(5)(B) of this title shall be extended by a period of six
      months after the date the patent expires (including any patent
      extensions).
    (d) Conduct of pediatric studies
      (1) Agreement for studies
        The Secretary may, pursuant to a written request from the
      Secretary under subsection (b) or (c) of this section, after
      consultation with - 
          (A) the sponsor of an application for an investigational new
        drug under section 355(i) of this title;
          (B) the sponsor of an application for a new drug under
        section 355(b)(1) of this title; or
          (C) the holder of an approved application for a drug under
        section 355(b)(1) of this title,

      agree with the sponsor or holder for the conduct of pediatric
      studies for such drug. Such agreement shall be in writing and
      shall include a timeframe for such studies.
      (2) Written protocols to meet the studies requirement
        If the sponsor or holder and the Secretary agree upon written
      protocols for the studies, the studies requirement of subsection
      (b) or (c) of this section is satisfied upon the completion of
      the studies and submission of the reports thereof in accordance
      with the original written request and the written agreement
      referred to in paragraph (1). In reaching an agreement regarding
      written protocols, the Secretary shall take into account adequate
      representation of children of ethnic and racial minorities. Not
      later than 60 days after the submission of the report of the
      studies, the Secretary shall determine if such studies were or
      were not conducted in accordance with the original written
      request and the written agreement and reported in accordance with
      the requirements of the Secretary for filing and so notify the
      sponsor or holder.
      (3) Other methods to meet the studies requirement
        If the sponsor or holder and the Secretary have not agreed in
      writing on the protocols for the studies, the studies requirement
      of subsection (b) or (c) of this section is satisfied when such
      studies have been completed and the reports accepted by the
      Secretary. Not later than 90 days after the submission of the
      reports of the studies, the Secretary shall accept or reject such
      reports and so notify the sponsor or holder. The Secretary's only
      responsibility in accepting or rejecting the reports shall be to
      determine, within the 90 days, whether the studies fairly respond
      to the written request, have been conducted in accordance with
      commonly accepted scientific principles and protocols, and have
      been reported in accordance with the requirements of the
      Secretary for filing.
      (4) Written request to holders of approved applications for drugs
        that have market exclusivity
        (A) Request and response
          If the Secretary makes a written request for pediatric
        studies (including neonates, as appropriate) under subsection
        (c) of this section to the holder of an application approved
        under section 355(b)(1) of this title, the holder, not later
        than 180 days after receiving the written request, shall
        respond to the Secretary as to the intention of the holder to
        act on the request by - 
            (i) indicating when the pediatric studies will be
          initiated, if the holder agrees to the request; or
            (ii) indicating that the holder does not agree to the
          request.
        (B) No agreement to request
          (i) Referral
            If the holder does not agree to a written request within
          the time period specified in subparagraph (A), and if the
          Secretary determines that there is a continuing need for
          information relating to the use of the drug in the pediatric
          population (including neonates, as appropriate), the
          Secretary shall refer the drug to the Foundation for the
          National Institutes of Health established under section 290b
          of title 42 (referred to in this paragraph as the
          "Foundation") for the conduct of the pediatric studies
          described in the written request.
          (ii) Public notice
            The Secretary shall give public notice of the name of the
          drug, the name of the manufacturer, and the indications to be
          studied made in a referral under clause (i).
        (C) Lack of funds
          On referral of a drug under subparagraph (B)(i), the
        Foundation shall issue a proposal to award a grant to conduct
        the requested studies unless the Foundation certifies to the
        Secretary, within a timeframe that the Secretary determines is
        appropriate through guidance, that the Foundation does not have
        funds available under section 290b(j)(9)(B)(i) (!1) of title 42
        to conduct the requested studies. If the Foundation so
        certifies, the Secretary shall refer the drug for inclusion on
        the list established under section 284m of title 42 for the
        conduct of the studies.

        (D) Effect of subsection
          Nothing in this subsection (including with respect to
        referrals from the Secretary to the Foundation) alters or
        amends section 331(j) of this title or section 552 of title 5
        or section 1905 of title 18.
        (E) No requirement to refer
          Nothing in this subsection shall be construed to require that
        every declined written request shall be referred to the
        Foundation.
        (F) Written requests under subsection (b)
          For drugs under subsection (b) of this section for which
        written requests have not been accepted, if the Secretary
        determines that there is a continuing need for information
        relating to the use of the drug in the pediatric population
        (including neonates, as appropriate), the Secretary shall issue
        a written request under subsection (c) of this section after
        the date of approval of the drug.
    (e) Delay of effective date for certain application
      If the Secretary determines that the acceptance or approval of an
    application under section 355(b)(2) or 355(j) of this title for a
    new drug may occur after submission of reports of pediatric studies
    under this section, which were submitted prior to the expiration of
    the patent (including any patent extension) or the applicable
    period under clauses (ii) through (iv) of section 355(c)(3)(D) of
    this title or clauses (ii) through (iv) of section 355(j)(5)(F) of
    this title, but before the Secretary has determined whether the
    requirements of subsection (d) of this section have been satisfied,
    the Secretary shall delay the acceptance or approval under section
    355(b)(2) or 355(j) of this title until the determination under
    subsection (d) of this section is made, but any such delay shall
    not exceed 90 days. In the event that requirements of this section
    are satisfied, the applicable six-month period under subsection (b)
    or (c) of this section shall be deemed to have been running during
    the period of delay.
    (f) Notice of determinations on studies requirement
      The Secretary shall publish a notice of any determination that
    the requirements of subsection (d) of this section have been met
    and that submissions and approvals under subsection (b)(2) or (j)
    of section 355 of this title for a drug will be subject to the
    provisions of this section.
    (g) Limitations
      A drug to which the six-month period under subsection (b) or (c)
    of this section has already been applied - 
        (1) may receive an additional six-month period under subsection
      (c)(1)(A)(ii) of this section for a supplemental application if
      all other requirements under this section are satisfied, except
      that such a drug may not receive any additional such period under
      subsection (c)(2) of this section; and
        (2) may not receive any additional such period under subsection
      (c)(1)(B) of this section.
    (h) Relationship to pediatric research requirements
      Notwithstanding any other provision of law, if any pediatric
    study is required by a provision of law (including a regulation)
    other than this section and such study meets the completeness,
    timeliness, and other requirements of this section, such study
    shall be deemed to satisfy the requirement for market exclusivity
    pursuant to this section.
    (i) Labeling supplements
      (1) Priority status for pediatric supplements
        Any supplement to an application under section 355 of this
      title proposing a labeling change pursuant to a report on a
      pediatric study under this section - 
          (A) shall be considered to be a priority supplement; and
          (B) shall be subject to the performance goals established by
        the Commissioner for priority drugs.
      (2) Dispute resolution
        (A) Request for labeling change and failure to agree
          If the Commissioner determines that an application with
        respect to which a pediatric study is conducted under this
        section is approvable and that the only open issue for final
        action on the application is the reaching of an agreement
        between the sponsor of the application and the Commissioner on
        appropriate changes to the labeling for the drug that is the
        subject of the application, not later than 180 days after the
        date of submission of the application - 
            (i) the Commissioner shall request that the sponsor of the
          application make any labeling change that the Commissioner
          determines to be appropriate; and
            (ii) if the sponsor of the application does not agree to
          make a labeling change requested by the Commissioner, the
          Commissioner shall refer the matter to the Pediatric Advisory
          Committee.
        (B) Action by the Pediatric Advisory Committee
          Not later than 90 days after receiving a referral under
        subparagraph (A)(ii), the Pediatric Advisory Committee shall - 
            (i) review the pediatric study reports; and
            (ii) make a recommendation to the Commissioner concerning
          appropriate labeling changes, if any.
        (C) Consideration of recommendations
          The Commissioner shall consider the recommendations of the
        Pediatric Advisory Committee and, if appropriate, not later
        than 30 days after receiving the recommendation, make a request
        to the sponsor of the application to make any labeling change
        that the Commissioner determines to be appropriate.
        (D) Misbranding
          If the sponsor of the application, within 30 days after
        receiving a request under subparagraph (C), does not agree to
        make a labeling change requested by the Commissioner, the
        Commissioner may deem the drug that is the subject of the
        application to be misbranded.
        (E) No effect on authority
          Nothing in this subsection limits the authority of the United
        States to bring an enforcement action under this chapter when a
        drug lacks appropriate pediatric labeling. Neither course of
        action (the Pediatric Advisory Committee process or an
        enforcement action referred to in the preceding sentence) shall
        preclude, delay, or serve as the basis to stay the other course
        of action.
    (j) Dissemination of pediatric information
      (1) In general
        Not later than 180 days after the date of submission of a
      report on a pediatric study under this section, the Commissioner
      shall make available to the public a summary of the medical and
      clinical pharmacology reviews of pediatric studies conducted for
      the supplement, including by publication in the Federal Register.
      (2) Effect of subsection
        Nothing in this subsection alters or amends section 331(j) of
      this title or section 552 of title 5 or section 1905 of title 18.
    (k) Clarification of interaction of market exclusivity under this
      section and market exclusivity awarded to an applicant for
      approval of a drug under section 355(j) of this title
      If a 180-day period under section 355(j)(5)(B)(iv) of this title
    overlaps with a 6-month exclusivity period under this section, so
    that the applicant for approval of a drug under section 355(j) of
    this title entitled to the 180-day period under that section loses
    a portion of the 180-day period to which the applicant is entitled
    for the drug, the 180-day period shall be extended from - 
        (1) the date on which the 180-day period would have expired by
      the number of days of the overlap, if the 180-day period would,
      but for the application of this subsection, expire after the 6-
      month exclusivity period; or
        (2) the date on which the 6-month exclusivity period expires,
      by the number of days of the overlap if the 180-day period would,
      but for the application of this subsection, expire during the six-
      month exclusivity period.
    (l) Prompt approval of drugs under section 355(j) of this title
      when pediatric information is added to labeling
      (1) General rule
        A drug for which an application has been submitted or approved
      under section 355(j) of this title shall not be considered
      ineligible for approval under that section or misbranded under
      section 352 of this title on the basis that the labeling of the
      drug omits a pediatric indication or any other aspect of labeling
      pertaining to pediatric use when the omitted indication or other
      aspect is protected by patent or by exclusivity under clause
      (iii) or (iv) of section 355(j)(5)(F) of this title.
      (2) Labeling
        Notwithstanding clauses (iii) and (iv) of section 355(j)(5)(F)
      of this title, the Secretary may require that the labeling of a
      drug approved under section 355(j) of this title that omits a
      pediatric indication or other aspect of labeling as described in
      paragraph (1) include - 
          (A) a statement that, because of marketing exclusivity for a
        manufacturer - 
            (i) the drug is not labeled for pediatric use; or
            (ii) in the case of a drug for which there is an additional
          pediatric use not referred to in paragraph (1), the drug is
          not labeled for the pediatric use under paragraph (1); and

          (B) a statement of any appropriate pediatric
        contraindications, warnings, or precautions that the Secretary
        considers necessary.
      (3) Preservation of pediatric exclusivity and other provisions
        This subsection does not affect - 
          (A) the availability or scope of exclusivity under this
        section;
          (B) the availability or scope of exclusivity under section
        355 of this title for pediatric formulations;
          (C) the question of the eligibility for approval of any
        application under section 355(j) of this title that omits any
        other conditions of approval entitled to exclusivity under
        clause (iii) or (iv) of section 355(j)(5)(F) of this title; or
          (D) except as expressly provided in paragraphs (1) and (2),
        the operation of section 355 of this title.
    (m) Report
      The Secretary shall conduct a study and report to Congress not
    later than January 1, 2001, based on the experience under the
    program established under this section. The study and report shall
    examine all relevant issues, including - 
        (1) the effectiveness of the program in improving information
      about important pediatric uses for approved drugs;
        (2) the adequacy of the incentive provided under this section;
        (3) the economic impact of the program on taxpayers and
      consumers, including the impact of the lack of lower cost generic
      drugs on patients, including on lower income patients; and
        (4) any suggestions for modification that the Secretary
      determines to be appropriate.
    (n) Sunset
      A drug may not receive any 6-month period under subsection (b) or
    (c) of this section unless - 
        (1) on or before October 1, 2007, the Secretary makes a written
      request for pediatric studies of the drug;
        (2) on or before October 1, 2007, an application for the drug
      is accepted for filing under section 355(b) of this title; and
        (3) all requirements of this section are met.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 505A, as added Pub. L. 105-115, title
    I, Sec. 111, Nov. 21, 1997, 111 Stat. 2305; amended Pub. L. 107-
    109, Secs. 2, 4, 5(b)(2), 7-11(a), 18(a), 19, Jan. 4, 2002, 115
    Stat. 1408, 1411, 1413-1415, 1423, 1424; Pub. L. 108-155, Secs.
    2(b)(2), 3(a), (b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
    173, title XI, Sec. 1104, Dec. 8, 2003, 117 Stat. 2461.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 290b(j)(9)(B)(i) of title 42, referred to in subsec.
    (d)(4)(C), was in the original "section 499(j)(9)(B)(i)" and was
    translated as meaning section 499(j)(9)(B)(i) of the Public Health
    Service Act to reflect the probable intent of Congress because
    there is no section 499 of the Federal Food, Drug, and Cosmetic Act
    and section 499 of the Public Health Service Act relates to the
    establishment and duties of the National Foundation for Biomedical
    Research.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(1)(A)(i). Pub. L. 108-173, Sec. 1104(1),
    substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.
      Subsec. (b)(1)(A)(ii). Pub. L. 108-173, Sec. 1104(2), substituted
    "(j)(5)(F)" for "(j)(5)(D)".
      Subsec. (b)(2). Pub. L. 108-155, Sec. 3(a), substituted
    "355(j)(5)(B)" for "355(j)(4)(B)" in two places.
      Subsec. (c)(1)(A)(i). Pub. L. 108-173, Sec. 1104(1), substituted
    "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.
      Subsec. (c)(1)(A)(ii). Pub. L. 108-173, Sec. 1104(2), substituted
    "(j)(5)(F)" for "(j)(5)(D)".
      Subsec. (c)(2). Pub. L. 108-155, Sec. 3(a), substituted
    "355(j)(5)(B)" for "355(j)(4)(B)" in two places.
      Subsec. (e). Pub. L. 108-173, Sec. 1104(3), substituted
    "355(j)(5)(F)" for "355(j)(5)(D)".
      Subsec. (h). Pub. L. 108-155, Sec. 2(b)(2), substituted
    "pediatric research requirements" for "regulations" in heading and
    "by a provision of law (including a regulation) other than this
    section" for "pursuant to regulations promulgated by the Secretary"
    in text.
      Subsec. (i)(2). Pub. L. 108-155, Sec. 3(b)(1), struck out
    "Advisory Subcommittee of the Anti-Infective Drugs" before
    "Advisory Committee" wherever appearing.
      Subsec. (l). Pub. L. 108-173, Sec. 1104(3), substituted
    "355(j)(5)(F)" for "355(j)(5)(D)" wherever appearing.
      2002 - Subsec. (a). Pub. L. 107-109, Sec. 19(2), (3),
    redesignated subsec. (g) as (a). Former subsec. (a) redesignated
    (b).
      Subsec. (a)(1)(A). Pub. L. 107-109, Sec. 19(1)(A), (B),
    substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in
    cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).
      Subsec. (b). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (a) as (b).
      Pub. L. 107-109, Sec. 2(1), struck out heading and text of
    subsec. (b). Text read as follows: "Not later than 180 days after
    November 21, 1997, the Secretary, after consultation with experts
    in pediatric research shall develop, prioritize, and publish an
    initial list of approved drugs for which additional pediatric
    information may produce health benefits in the pediatric
    population. The Secretary shall annually update the list."
      Subsec. (c). Pub. L. 107-109, Sec. 2(2), in introductory
    provisions, inserted "determines that information relating to the
    use of an approved drug in the pediatric population may produce
    health benefits in that population and" after "the Secretary" and
    struck out "concerning a drug identified in the list described in
    subsection (b) of this section" after "such studies)".
      Subsec. (c)(1)(A). Pub. L. 107-109, Sec. 19(1)(A), (B),
    substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in
    cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).
      Subsec. (d)(1). Pub. L. 107-109, Sec. 19(4), substituted
    "subsection (b) or (c)" for "subsection (a) or (c)" in introductory
    provisions.
      Subsec. (d)(2). Pub. L. 107-109, Secs. 18(a), 19(4), substituted
    "subsection (b) or (c)" for "subsection (a) or (c)" and inserted
    "In reaching an agreement regarding written protocols, the
    Secretary shall take into account adequate representation of
    children of ethnic and racial minorities." after first sentence.
      Subsec. (d)(3). Pub. L. 107-109, Sec. 19(4), substituted
    "subsection (b) or (c)" for "subsection (a) or (c)".
      Subsec. (d)(4). Pub. L. 107-109, Sec. 4, added par. (4).
      Subsec. (e). Pub. L. 107-109, Sec. 19(1)(C), (4), substituted
    "section 355(j)(5)(D)" for "section 355(j)(4)(D)" and "subsection
    (b) or (c)" for "subsection (a) or (c)".
      Subsec. (g). Pub. L. 107-109, Sec. 19(2), (3), (5), redesignated
    subsec. (h) as (g) and substituted "subsection (b) or (c)" for
    "subsection (a) or (b)" in introductory provisions. Former subsec.
    (g) redesignated (a).
      Pub. L. 107-109, Sec. 7, inserted "(including neonates in
    appropriate cases)" after "pediatric age groups".
      Subsec. (h). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (i) as (h). Former subsec. (h) redesignated (g).
      Subsec. (i). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (l) as (i). Former subsec. (i) redesignated (h).
      Subsec. (j). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (m) as (j). Former subsec. (j) redesignated (n).
      Pub. L. 107-109, Sec. 8, added subsec. (j) and struck out heading
    and text of former subsec. (j). Text read as follows: "A drug may
    not receive any six-month period under subsection (a) or (c) of
    this section unless the application for the drug under section
    355(b)(1) of this title is submitted on or before January 1, 2002.
    After January 1, 2002, a drug shall receive a six-month period
    under subsection (c) of this section if - 
        "(1) the drug was in commercial distribution as of November 21,
      1997;
        "(2) the drug was included by the Secretary on the list under
      subsection (b) of this section as of January 1, 2002;
        "(3) the Secretary determines that there is a continuing need
      for information relating to the use of the drug in the pediatric
      population and that the drug may provide health benefits in that
      population; and
        "(4) all requirements of this section are met."
      Subsec. (k). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (n) as (k). Former subsec. (k) redesignated (m).
      Subsec. (l). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (o) as (l). Former subsec. (l) redesignated (i).
      Pub. L. 107-109, Sec. 5(b)(2), added subsec. (l).
      Subsec. (m). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (k) as (m). Former subsec. (m) redesignated (j).
      Pub. L. 107-109, Sec. 9, added subsec. (m).
      Subsec. (n). Pub. L. 107-109, Sec. 19(4), which directed
    substitution of "subsection (b) or (c)" for "subsection (a) or (c)"
    in subsec. (m), was executed by making the substitution in
    introductory provisions of subsec. (n), to reflect the probable
    intent of Congress.
      Pub. L. 107-109, Sec. 19(2), (3), redesignated subsec. (j) as
    (n). Former subsec. (n) redesignated (k).
      Pub. L. 107-109, Sec. 10, added subsec. (n).
      Subsec. (o). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (o) as (l).
      Pub. L. 107-109, Sec. 11(a), added subsec. (o).

                     EFFECTIVE DATE OF 2003 AMENDMENT                 
      Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
    otherwise provided, see section 4 of Pub. L. 108-155, set out as an
    Effective Date note under section 355c of this title.

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-109, Sec. 11(b), Jan. 4, 2002, 115 Stat. 1416,
    provided that: "The amendment made by subsection (a) [amending this
    section] takes effect on the date of enactment of this Act [Jan. 4,
    2002], including with respect to applications under section 505(j)
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that
    are approved or pending on that date."

                  REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM              
      Pub. L. 107-109, Sec. 16, Jan. 4, 2002, 115 Stat. 1421, as
    amended by Pub. L. 108-155, Sec. 3(b)(4), Dec. 3, 2003, 117 Stat.
    1942, provided that: "Not later than October 1, 2006, the
    Comptroller General of the United States, in consultation with the
    Secretary of Health and Human Services, shall submit to Congress a
    report that addresses the following issues, using publicly
    available data or data otherwise available to the Government that
    may be used and disclosed under applicable law:
        "(1) The effectiveness of section 505A of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 355a] and section 409I of the
      Public Health Service Act [42 U.S.C. 284m] (as added by this Act)
      in ensuring that medicines used by children are tested and
      properly labeled, including - 
          "(A) the number and importance of drugs for children that are
        being tested as a result of this legislation and the importance
        for children, health care providers, parents, and others of
        labeling changes made as a result of such testing;
          "(B) the number and importance of drugs for children that are
        not being tested for their use notwithstanding the provisions
        of this legislation, and possible reasons for the lack of
        testing; and
          "(C) the number of drugs for which testing is being done,
        exclusivity granted, and labeling changes required, including
        the date pediatric exclusivity is granted and the date labeling
        changes are made and which labeling changes required the use of
        the dispute resolution process established pursuant to the
        amendments made by this Act [see Short Title of 2002 Amendment
        note set out under section 301 of this title], together with a
        description of the outcomes of such process, including a
        description of the disputes and the recommendations of the
        Pediatric Advisory Committee.
        "(2) The economic impact of section 505A of the Federal Food,
      Drug, and Cosmetic Act and section 409I of the Public Health
      Service Act (as added by this Act), including an estimate of - 
          "(A) the costs to taxpayers in the form of higher
        expenditures by medicaid and other Government programs;
          "(B) sales for each drug during the 6-month period for which
        exclusivity is granted, as attributable to such exclusivity;
          "(C) costs to consumers and private insurers as a result of
        any delay in the availability of lower cost generic equivalents
        of drugs tested and granted exclusivity under the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and loss of
        revenue by the generic drug industry and retail pharmacies as a
        result of any such delay; and
          "(D) the benefits to the government, to private insurers, and
        to consumers resulting from decreased health care costs,
        including - 
            "(i) decreased hospitalizations and fewer medical errors,
          due to more appropriate and more effective use of medications
          in children as a result of testing and re-labeling because of
          the amendments made by this Act;
            "(ii) direct and indirect benefits associated with fewer
          physician visits not related to hospitalization;
            "(iii) benefits to children from missing less time at
          school and being less affected by chronic illnesses, thereby
          allowing a better quality of life;
            "(iv) benefits to consumers from lower health insurance
          premiums due to lower treatment costs and hospitalization
          rates; and
            "(v) benefits to employers from reduced need for employees
          to care for family members.
        "(3) The nature and type of studies in children for each drug
      granted exclusivity under the Federal Food, Drug, and Cosmetic
      Act (21 U.S.C. 301 et seq.), including - 
          "(A) a description of the complexity of the studies;
          "(B) the number of study sites necessary to obtain
        appropriate data;
          "(C) the number of children involved in any clinical studies;
        and
          "(D) the estimated cost of each of the studies.
        "(4) Any recommendations for modifications to the programs
      established under section 505A of the Federal Food, Drug, and
      Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public
      Health Service Act [42 U.S.C. 284m] (as added by section 3) that
      the Secretary determines to be appropriate, including a detailed
      rationale for each recommendation.
        "(5) The increased private and Government-funded pediatric
      research capability associated with this Act and the amendments
      made by this Act.
        "(6) The number of written requests and additional letters of
      recommendation that the Secretary issues.
        "(7) The prioritized list of off-patent drugs for which the
      Secretary issues written requests.
        "(8)(A) The efforts made by the Secretary to increase the
      number of studies conducted in the neonate population; and
        "(B) the results of those efforts, including efforts made to
      encourage the conduct of appropriate studies in neonates by
      companies with products that have sufficient safety and other
      information to make the conduct of studies ethical and safe."

                    STUDY BY GENERAL ACCOUNTING OFFICE                
      Pub. L. 107-109, Sec. 18(b), Jan. 4, 2002, 115 Stat. 1423,
    required the Comptroller General, not later than Jan. 10, 2003, to
    conduct a study relating to the representation of children of
    ethnic and racial minorities in studies under section 355a of this
    title and to submit a report to Congress describing the findings of
    the study.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 355b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355b. Adverse-event reporting

-STATUTE-
    (a) Toll-free number in labeling
      Not later than one year after January 4, 2002, the Secretary of
    Health and Human Services shall promulgate a final rule requiring
    that the labeling of each drug for which an application is approved
    under section 505 of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 355] (regardless of the date on which approved) include the
    toll-free number maintained by the Secretary for the purpose of
    receiving reports of adverse events regarding drugs and a statement
    that such number is to be used for reporting purposes only, not to
    receive medical advice. With respect to the final rule:
        (1) The rule shall provide for the implementation of such
      labeling requirement in a manner that the Secretary considers to
      be most likely to reach the broadest consumer audience.
        (2) In promulgating the rule, the Secretary shall seek to
      minimize the cost of the rule on the pharmacy profession.
        (3) The rule shall take effect not later than 60 days after the
      date on which the rule is promulgated.
    (b) Drugs with pediatric market exclusivity
      (1) In general
        During the one year beginning on the date on which a drug
      receives a period of market exclusivity under 505A (!1) of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report
      of an adverse event regarding the drug that the Secretary of
      Health and Human Services receives shall be referred to the
      Office of Pediatric Therapeutics established under section 393a
      of this title. In considering the report, the Director of such
      Office shall provide for the review of the report by the
      Pediatric Advisory Committee, including obtaining any
      recommendations of such subcommittee (!2) regarding whether the
      Secretary should take action under the Federal Food, Drug, and
      Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.


      (2) Rule of construction
        Paragraph (1) may not be construed as restricting the authority
      of the Secretary of Health and Human Services to continue
      carrying out the activities described in such paragraph regarding
      a drug after the one-year period described in such paragraph
      regarding the drug has expired.

-SOURCE-
    (Pub. L. 107-109, Sec. 17, Jan. 4, 2002, 115 Stat. 1422; Pub. L.
    108-155, Sec. 3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to this chapter. For complete
    classification of this Act to the Code, see section 301 of this
    title and Tables.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Best Pharmaceuticals for
    Children Act, and not as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(1). Pub. L. 108-155 struck out "Advisory
    Subcommittee of the Anti-Infective Drugs" before "Advisory
    Committee".

                     EFFECTIVE DATE OF 2003 AMENDMENT                 
      Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
    otherwise provided, see section 4 of Pub. L. 108-155, set out as an
    Effective Date note under section 355c of this title.

-FOOTNOTE-
    (!1) So in original. Probably should be preceded by "section".

    (!2) So in original. Probably should be "Committee".


-End-



-CITE-
    21 USC Sec. 355c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355c. Research into pediatric uses for drugs and biological
      products

-STATUTE-
    (a) New drugs and biological products
      (1) In general
        A person that submits an application (or supplement to an
      application) - 
          (A) under section 355 of this title for a new active
        ingredient, new indication, new dosage form, new dosing
        regimen, or new route of administration; or
          (B) under section 262 of title 42 for a new active
        ingredient, new indication, new dosage form, new dosing
        regimen, or new route of administration;

      shall submit with the application the assessments described in
      paragraph (2).
      (2) Assessments
        (A) In general
          The assessments referred to in paragraph (1) shall contain
        data, gathered using appropriate formulations for each age
        group for which the assessment is required, that are adequate -
        
            (i) to assess the safety and effectiveness of the drug or
          the biological product for the claimed indications in all
          relevant pediatric subpopulations; and
            (ii) to support dosing and administration for each
          pediatric subpopulation for which the drug or the biological
          product is safe and effective.
        (B) Similar course of disease or similar effect of drug or
          biological product
          (i) In general
            If the course of the disease and the effects of the drug
          are sufficiently similar in adults and pediatric patients,
          the Secretary may conclude that pediatric effectiveness can
          be extrapolated from adequate and well-controlled studies in
          adults, usually supplemented with other information obtained
          in pediatric patients, such as pharmacokinetic studies.
          (ii) Extrapolation between age groups
            A study may not be needed in each pediatric age group if
          data from one age group can be extrapolated to another age
          group.
      (3) Deferral
        On the initiative of the Secretary or at the request of the
      applicant, the Secretary may defer submission of some or all
      assessments required under paragraph (1) until a specified date
      after approval of the drug or issuance of the license for a
      biological product if - 
          (A) the Secretary finds that - 
            (i) the drug or biological product is ready for approval
          for use in adults before pediatric studies are complete;
            (ii) pediatric studies should be delayed until additional
          safety or effectiveness data have been collected; or
            (iii) there is another appropriate reason for deferral; and

          (B) the applicant submits to the Secretary - 
            (i) certification of the grounds for deferring the
          assessments;
            (ii) a description of the planned or ongoing studies; and
            (iii) evidence that the studies are being conducted or will
          be conducted with due diligence and at the earliest possible
          time.
      (4) Waivers
        (A) Full waiver
          On the initiative of the Secretary or at the request of an
        applicant, the Secretary shall grant a full waiver, as
        appropriate, of the requirement to submit assessments for a
        drug or biological product under this subsection if the
        applicant certifies and the Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          is so small or the patients are geographically dispersed);
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in all
          pediatric age groups; or
            (iii) the drug or biological product - 
              (I) does not represent a meaningful therapeutic benefit
            over existing therapies for pediatric patients; and
              (II) is not likely to be used in a substantial number of
            pediatric patients.
        (B) Partial waiver
          On the initiative of the Secretary or at the request of an
        applicant, the Secretary shall grant a partial waiver, as
        appropriate, of the requirement to submit assessments for a
        drug or biological product under this subsection with respect
        to a specific pediatric age group if the applicant certifies
        and the Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          in that age group is so small or patients in that age group
          are geographically dispersed);
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in that age
          group;
            (iii) the drug or biological product - 
              (I) does not represent a meaningful therapeutic benefit
            over existing therapies for pediatric patients in that age
            group; and
              (II) is not likely to be used by a substantial number of
            pediatric patients in that age group; or

            (iv) the applicant can demonstrate that reasonable attempts
          to produce a pediatric formulation necessary for that age
          group have failed.
        (C) Pediatric formulation not possible
          If a waiver is granted on the ground that it is not possible
        to develop a pediatric formulation, the waiver shall cover only
        the pediatric groups requiring that formulation.
        (D) Labeling requirement
          If the Secretary grants a full or partial waiver because
        there is evidence that a drug or biological product would be
        ineffective or unsafe in pediatric populations, the information
        shall be included in the labeling for the drug or biological
        product.
    (b) Marketed drugs and biological products
      (1) In general
        After providing notice in the form of a letter and an
      opportunity for written response and a meeting, which may include
      an advisory committee meeting, the Secretary may (by order in the
      form of a letter) require the holder of an approved application
      for a drug under section 355 of this title or the holder of a
      license for a biological product under section 262 of title 42 to
      submit by a specified date the assessments described in
      subsection (a)(2) of this section if the Secretary finds that - 
          (A)(i) the drug or biological product is used for a
        substantial number of pediatric patients for the labeled
        indications; and
          (ii) the absence of adequate labeling could pose significant
        risks to pediatric patients; or
          (B)(i) there is reason to believe that the drug or biological
        product would represent a meaningful therapeutic benefit over
        existing therapies for pediatric patients for one or more of
        the claimed indications; and
          (ii) the absence of adequate labeling could pose significant
        risks to pediatric patients.
      (2) Waivers
        (A) Full waiver
          At the request of an applicant, the Secretary shall grant a
        full waiver, as appropriate, of the requirement to submit
        assessments under this subsection if the applicant certifies
        and the Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          in that age group is so small or patients in that age group
          are geographically dispersed); or
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in all
          pediatric age groups.
        (B) Partial waiver
          At the request of an applicant, the Secretary shall grant a
        partial waiver, as appropriate, of the requirement to submit
        assessments under this subsection with respect to a specific
        pediatric age group if the applicant certifies and the
        Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          in that age group is so small or patients in that age group
          are geographically dispersed);
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in that age
          group;
            (iii)(I) the drug or biological product - 
              (aa) does not represent a meaningful therapeutic benefit
            over existing therapies for pediatric patients in that age
            group; and
              (bb) is not likely to be used in a substantial number of
            pediatric patients in that age group; and

            (II) the absence of adequate labeling could not pose
          significant risks to pediatric patients; or
            (iv) the applicant can demonstrate that reasonable attempts
          to produce a pediatric formulation necessary for that age
          group have failed.
        (C) Pediatric formulation not possible
          If a waiver is granted on the ground that it is not possible
        to develop a pediatric formulation, the waiver shall cover only
        the pediatric groups requiring that formulation.
        (D) Labeling requirement
          If the Secretary grants a full or partial waiver because
        there is evidence that a drug or biological product would be
        ineffective or unsafe in pediatric populations, the information
        shall be included in the labeling for the drug or biological
        product.
      (3) Relationship to other pediatric provisions
        (A) No assessment without written request
          No assessment may be required under paragraph (1) for a drug
        subject to an approved application under section 355 of this
        title unless - 
            (i) the Secretary has issued a written request for a
          related pediatric study under section 355a(c) of this title
          or section 284m of title 42;
            (ii)(I) if the request was made under section 355a(c) of
          this title - 
              (aa) the recipient of the written request does not agree
            to the request; or
              (bb) the Secretary does not receive a response as
            specified under section 355a(d)(4)(A) of this title; or

            (II) if the request was made under section 284m of title 42
          - 
              (aa) the recipient of the written request does not agree
            to the request; or
              (bb) the Secretary does not receive a response as
            specified under section 284m(c)(2) of title 42; and

            (iii)(I) the Secretary certifies under subparagraph (B)
          that there are insufficient funds under sections 284m and
          290b of title 42 to conduct the study; or
            (II) the Secretary publishes in the Federal Register a
          certification that certifies that - 
              (aa) no contract or grant has been awarded under section
            284m or 290b of title 42; and
              (bb) not less than 270 days have passed since the date of
            a certification under subparagraph (B) that there are
            sufficient funds to conduct the study.
        (B) No agreement to request
          Not later than 60 days after determining that no holder will
        agree to the written request (including a determination that
        the Secretary has not received a response specified under
        section 355a(d) of this title or section 284m of title 42,(!1)
        the Secretary shall certify whether the Secretary has
        sufficient funds to conduct the study under section 284m or
        290b of title 42, taking into account the prioritization under
        section 284m of title 42.

    (c) Meaningful therapeutic benefit
      For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I)
    of subsection (a) of this section and paragraphs (1)(B)(i) and
    (2)(B)(iii)(I)(aa) of subsection (b) of this section, a drug or
    biological product shall be considered to represent a meaningful
    therapeutic benefit over existing therapies if the Secretary
    estimates that - 
        (1) if approved, the drug or biological product would represent
      a significant improvement in the treatment, diagnosis, or
      prevention of a disease, compared with marketed products
      adequately labeled for that use in the relevant pediatric
      population; or
        (2) the drug or biological product is in a class of products or
      for an indication for which there is a need for additional
      options.
    (d) Submission of assessments
      If a person fails to submit an assessment described in subsection
    (a)(2) of this section, or a request for approval of a pediatric
    formulation described in subsection (a) or (b) of this section, in
    accordance with applicable provisions of subsections (a) and (b) of
    this section - 
        (1) the drug or biological product that is the subject of the
      assessment or request may be considered misbranded solely because
      of that failure and subject to relevant enforcement action
      (except that the drug or biological product shall not be subject
      to action under section 333 of this title); but
        (2) the failure to submit the assessment or request shall not
      be the basis for a proceeding - 
          (A) to withdraw approval for a drug under section 355(e) of
        this title; or
          (B) to revoke the license for a biological product under
        section 262 of title 42.
    (e) Meetings
      Before and during the investigational process for a new drug or
    biological product, the Secretary shall meet at appropriate times
    with the sponsor of the new drug or biological product to discuss -
    
        (1) information that the sponsor submits on plans and timelines
      for pediatric studies; or
        (2) any planned request by the sponsor for waiver or deferral
      of pediatric studies.
    (f) Scope of authority
      Nothing in this section provides to the Secretary any authority
    to require a pediatric assessment of any drug or biological
    product, or any assessment regarding other populations or uses of a
    drug or biological product, other than the pediatric assessments
    described in this section.
    (g) Orphan drugs
      Unless the Secretary requires otherwise by regulation, this
    section does not apply to any drug for an indication for which
    orphan designation has been granted under section 360bb of this
    title.
    (h) Integration with other pediatric studies
      The authority under this section shall remain in effect so long
    as an application subject to this section may be accepted for
    filing by the Secretary on or before the date specified in section
    355a(n) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 505B, as added Pub. L. 108-155, Sec.
    2(a), Dec. 3, 2003, 117 Stat. 1936.)


-MISC1-
                              EFFECTIVE DATE                          
      Pub. L. 108-155, Sec. 4, Dec. 3, 2003, 117 Stat. 1942, provided
    that:
      "(a) In General. - Subject to subsection (b), this Act [enacting
    this section, amending sections 355, 355a, and 355b of this title
    and sections 262 and 284m of Title 42, The Public Health and
    Welfare, enacting provisions set out as a note under section 301 of
    this title, and amending provisions set out as notes under section
    355a of this title and section 284m of Title 42] and the amendments
    made by this Act take effect on the date of enactment of this Act
    [Dec. 3, 2003].
      "(b) Applicability to New Drugs and Biological Products. - 
        "(1) In general. - Subsection (a) of section 505B of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)] (as
      added by section 2) shall apply to an application described in
      paragraph (1) of that subsection submitted to the Secretary of
      Health and Human Services on or after April 1, 1999.
        "(2) Waivers and deferrals. - 
          "(A) Waiver or deferral granted. - If, with respect to an
        application submitted to the Secretary of Health and Human
        Services between April 1, 1999, and the date of enactment of
        this Act [Dec. 3, 2003], a waiver or deferral of pediatric
        assessments was granted under regulations of the Secretary then
        in effect, the waiver or deferral shall be a waiver or deferral
        under subsection (a) of section 505B of the Federal Food, Drug,
        and Cosmetic Act [21 U.S.C. 355c(a)], except that any date
        specified in such a deferral shall be extended by the number of
        days that is equal to the number of days between October 17,
        2002, and the date of enactment of this Act.
          "(B) Waiver and deferral not granted. - If, with respect to
        an application submitted to the Secretary of Health and Human
        Services between April 1, 1999, and the date of enactment of
        this Act [Dec. 3, 2003], neither a waiver nor deferral of
        pediatric assessments was granted under regulations of the
        Secretary then in effect, the person that submitted the
        application shall be required to submit assessments under
        subsection (a)(2) of section 505B of the Federal Food, Drug,
        and Cosmetic Act [21 U.S.C. 355c(a)(2)] on the date that is the
        later of - 
            "(i) the date that is 1 year after the date of enactment of
          this Act; or
            "(ii) such date as the Secretary may specify under
          subsection (a)(3) of that section;
      unless the Secretary grants a waiver under subsection (a)(4) of
      that section.
      "(c) No Limitation of Authority. - Neither the lack of guidance
    or regulations to implement this Act or the amendments made by this
    Act nor the pendency of the process for issuing guidance or
    regulations shall limit the authority of the Secretary of Health
    and Human Services under, or defer any requirement under, this Act
    or those amendments."

-FOOTNOTE-
    (!1) So in original. A closing parenthesis probably should precede
         the comma.


-End-



-CITE-
    21 USC Sec. 356                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356. Fast track products

-STATUTE-
    (a) Designation of drug as fast track product
      (1) In general
        The Secretary shall, at the request of the sponsor of a new
      drug, facilitate the development and expedite the review of such
      drug if it is intended for the treatment of a serious or life-
      threatening condition and it demonstrates the potential to
      address unmet medical needs for such a condition. (In this
      section, such a drug is referred to as a "fast track product".)
      (2) Request for designation
        The sponsor of a new drug may request the Secretary to
      designate the drug as a fast track product. A request for the
      designation may be made concurrently with, or at any time after,
      submission of an application for the investigation of the drug
      under section 355(i) of this title or section 262(a)(3) of title
      42.
      (3) Designation
        Within 60 calendar days after the receipt of a request under
      paragraph (2), the Secretary shall determine whether the drug
      that is the subject of the request meets the criteria described
      in paragraph (1). If the Secretary finds that the drug meets the
      criteria, the Secretary shall designate the drug as a fast track
      product and shall take such actions as are appropriate to
      expedite the development and review of the application for
      approval of such product.
    (b) Approval of application for fast track product
      (1) In general
        The Secretary may approve an application for approval of a fast
      track product under section 355(c) of this title or section 262
      of title 42 upon a determination that the product has an effect
      on a clinical endpoint or on a surrogate endpoint that is
      reasonably likely to predict clinical benefit.
      (2) Limitation
        Approval of a fast track product under this subsection may be
      subject to the requirements - 
          (A) that the sponsor conduct appropriate post-approval
        studies to validate the surrogate endpoint or otherwise confirm
        the effect on the clinical endpoint; and
          (B) that the sponsor submit copies of all promotional
        materials related to the fast track product during the
        preapproval review period and, following approval and for such
        period thereafter as the Secretary determines to be
        appropriate, at least 30 days prior to dissemination of the
        materials.
      (3) Expedited withdrawal of approval
        The Secretary may withdraw approval of a fast track product
      using expedited procedures (as prescribed by the Secretary in
      regulations which shall include an opportunity for an informal
      hearing) if - 
          (A) the sponsor fails to conduct any required post-approval
        study of the fast track drug with due diligence;
          (B) a post-approval study of the fast track product fails to
        verify clinical benefit of the product;
          (C) other evidence demonstrates that the fast track product
        is not safe or effective under the conditions of use; or
          (D) the sponsor disseminates false or misleading promotional
        materials with respect to the product.
    (c) Review of incomplete applications for approval of fast track
      product
      (1) In general
        If the Secretary determines, after preliminary evaluation of
      clinical data submitted by the sponsor, that a fast track product
      may be effective, the Secretary shall evaluate for filing, and
      may commence review of portions of, an application for the
      approval of the product before the sponsor submits a complete
      application. The Secretary shall commence such review only if the
      applicant - 
          (A) provides a schedule for submission of information
        necessary to make the application complete; and
          (B) pays any fee that may be required under section 379h of
        this title.
      (2) Exception
        Any time period for review of human drug applications that has
      been agreed to by the Secretary and that has been set forth in
      goals identified in letters of the Secretary (relating to the use
      of fees collected under section 379h of this title to expedite
      the drug development process and the review of human drug
      applications) shall not apply to an application submitted under
      paragraph (1) until the date on which the application is
      complete.
    (d) Awareness efforts
      The Secretary shall - 
        (1) develop and disseminate to physicians, patient
      organizations, pharmaceutical and biotechnology companies, and
      other appropriate persons a description of the provisions of this
      section applicable to fast track products; and
        (2) establish a program to encourage the development of
      surrogate endpoints that are reasonably likely to predict
      clinical benefit for serious or life-threatening conditions for
      which there exist significant unmet medical needs.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506, as added Pub. L. 105-115, title
    I, Sec. 112(a), Nov. 21, 1997, 111 Stat. 2309.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 356, act June 25, 1938, ch. 675, Sec. 506, as
    added Dec. 22, 1941, ch. 613, Sec. 3, 55 Stat. 851; amended Pub. L.
    102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-
    80, Sec. 3(o), Aug. 13, 1993, 107 Stat. 777, related to
    certification of drugs containing insulin, prior to repeal by Pub.
    L. 105-115, title I, Sec. 125(a)(1), Nov. 21, 1997, 111 Stat. 2325.

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

                                 GUIDANCE                             
      Section 112(b) of Pub. L. 105-115 provided that: "Within 1 year
    after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services shall issue guidance for
    fast track products (as defined in section 506(a)(1) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(1)]) that describes
    the policies and procedures that pertain to section 506 of such
    Act."

-End-



-CITE-
    21 USC Sec. 356-1                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356-1. Accelerated approval of priority countermeasures

-STATUTE-
    (a) In general
      The Secretary of Health and Human Services may designate a
    priority countermeasure as a fast-track product pursuant to section
    356 of this title or as a device granted review priority pursuant
    to section 360e(d)(5) of this title. Such a designation may be made
    prior to the submission of - 
        (1) a request for designation by the sponsor or applicant; or
        (2) an application for the investigation of the drug under
      section 355(i) of this title or section 262(a)(3) of title 42.

    Nothing in this subsection shall be construed to prohibit a sponsor
    or applicant from declining such a designation.
    (b) Use of animal trials
      A drug for which approval is sought under section 355(b) of this
    title or section 262 of title 42 on the basis of evidence of
    effectiveness that is derived from animal studies pursuant to
    section 123 (!1) may be designated as a fast track product for
    purposes of this section.

    (c) Priority review of drugs and biological products
      A priority countermeasure that is a drug or biological product
    shall be considered a priority drug or biological product for
    purposes of performance goals for priority drugs or biological
    products agreed to by the Commissioner of Food and Drugs.
    (d) Definitions
      For purposes of this title: (!1)
        (1) The term "priority countermeasure" has the meaning given
      such term in section 247d-6(h)(4) of title 42.
        (2) The term "priority drugs or biological products" means a
      drug or biological product that is the subject of a drug or
      biologics application referred to in section 101(4) of the Food
      and Drug Administration Modernization Act of 1997.

-SOURCE-
    (Pub. L. 107-188, title I, Sec. 122, June 12, 2002, 116 Stat. 613.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 123, referred to in subsec. (b), is section 123 of Pub.
    L. 107-188, title I, June 12, 2002, 116 Stat. 613, which is not
    classified to the Code.
      This title, referred to in subsec. (d), is title I of Pub. L. 107-
    188, June 12, 2002, 116 Stat. 596, which enacted this section,
    section 669a of Title 29, Labor, and sections 244, 245, 247d-3a,
    247d-3b, 247d-7a to 247d-7d, 300hh, 300hh-11 to 300hh-13, 1320b-5,
    and 7257d of Title 42, The Public Health and Welfare, amended
    sections 247d to 247d-6, 264, 266, 290hh-1, and 5196b of Title 42,
    and enacted provisions set out as notes preceding section 8101 of
    Title 38, Veterans' Benefits, and under sections 201, 244, 247d,
    247d-6, 300hh, 300hh-12, and 1320b-5 of Title 42. For complete
    classification of this title to the Code, see Tables.
      Section 101(4) of the Food and Drug Administration Modernization
    Act of 1997, referred to in subsec. (d)(2), is section 101(4) of
    Pub. L. 105-115, which is set out as a note under section 379g of
    this title.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002, and not as part
    of the Federal Food, Drug, and Cosmetic Act which comprises this
    chapter.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 356a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356a. Manufacturing changes

-STATUTE-
    (a) In general
      With respect to a drug for which there is in effect an approved
    application under section 355 or 360b of this title or a license
    under section 262 of title 42, a change from the manufacturing
    process approved pursuant to such application or license may be
    made, and the drug as made with the change may be distributed, if -
    
        (1) the holder of the approved application or license (referred
      to in this section as a "holder") has validated the effects of
      the change in accordance with subsection (b) of this section; and
        (2)(A) in the case of a major manufacturing change, the holder
      has complied with the requirements of subsection (c) of this
      section; or
        (B) in the case of a change that is not a major manufacturing
      change, the holder complies with the applicable requirements of
      subsection (d) of this section.
    (b) Validation of effects of changes
      For purposes of subsection (a)(1) of this section, a drug made
    with a manufacturing change (whether a major manufacturing change
    or otherwise) may be distributed only if, before distribution of
    the drug as so made, the holder involved validates the effects of
    the change on the identity, strength, quality, purity, and potency
    of the drug as the identity, strength, quality, purity, and potency
    may relate to the safety or effectiveness of the drug.
    (c) Major manufacturing changes
      (1) Requirement of supplemental application
        For purposes of subsection (a)(2)(A) of this section, a drug
      made with a major manufacturing change may be distributed only
      if, before the distribution of the drug as so made, the holder
      involved submits to the Secretary a supplemental application for
      such change and the Secretary approves the application. The
      application shall contain such information as the Secretary
      determines to be appropriate, and shall include the information
      developed under subsection (b) of this section by the holder in
      validating the effects of the change.
      (2) Changes qualifying as major changes
        For purposes of subsection (a)(2)(A) of this section, a major
      manufacturing change is a manufacturing change that is determined
      by the Secretary to have substantial potential to adversely
      affect the identity, strength, quality, purity, or potency of the
      drug as they may relate to the safety or effectiveness of a drug.
      Such a change includes a change that - 
          (A) is made in the qualitative or quantitative formulation of
        the drug involved or in the specifications in the approved
        application or license referred to in subsection (a) of this
        section for the drug (unless exempted by the Secretary by
        regulation or guidance from the requirements of this
        subsection);
          (B) is determined by the Secretary by regulation or guidance
        to require completion of an appropriate clinical study
        demonstrating equivalence of the drug to the drug as
        manufactured without the change; or
          (C) is another type of change determined by the Secretary by
        regulation or guidance to have a substantial potential to
        adversely affect the safety or effectiveness of the drug.
    (d) Other manufacturing changes
      (1) In general
        For purposes of subsection (a)(2)(B) of this section, the
      Secretary may regulate drugs made with manufacturing changes that
      are not major manufacturing changes as follows:
          (A) The Secretary may in accordance with paragraph (2)
        authorize holders to distribute such drugs without submitting a
        supplemental application for such changes.
          (B) The Secretary may in accordance with paragraph (3)
        require that, prior to the distribution of such drugs, holders
        submit to the Secretary supplemental applications for such
        changes.
          (C) The Secretary may establish categories of such changes
        and designate categories to which subparagraph (A) applies and
        categories to which subparagraph (B) applies.
      (2) Changes not requiring supplemental application
        (A) Submission of report
          A holder making a manufacturing change to which paragraph
        (1)(A) applies shall submit to the Secretary a report on the
        change, which shall contain such information as the Secretary
        determines to be appropriate, and which shall include the
        information developed under subsection (b) of this section by
        the holder in validating the effects of the change. The report
        shall be submitted by such date as the Secretary may specify.
        (B) Authority regarding annual reports
          In the case of a holder that during a single year makes more
        than one manufacturing change to which paragraph (1)(A)
        applies, the Secretary may in carrying out subparagraph (A)
        authorize the holder to comply with such subparagraph by
        submitting a single report for the year that provides the
        information required in such subparagraph for all the changes
        made by the holder during the year.
      (3) Changes requiring supplemental application
        (A) Submission of supplemental application
          The supplemental application required under paragraph (1)(B)
        for a manufacturing change shall contain such information as
        the Secretary determines to be appropriate, which shall include
        the information developed under subsection (b) of this section
        by the holder in validating the effects of the change.
        (B) Authority for distribution
          In the case of a manufacturing change to which paragraph
        (1)(B) applies:
            (i) The holder involved may commence distribution of the
          drug involved 30 days after the Secretary receives the
          supplemental application under such paragraph, unless the
          Secretary notifies the holder within such 30-day period that
          prior approval of the application is required before
          distribution may be commenced.
            (ii) The Secretary may designate a category of such changes
          for the purpose of providing that, in the case of a change
          that is in such category, the holder involved may commence
          distribution of the drug involved upon the receipt by the
          Secretary of a supplemental application for the change.
            (iii) If the Secretary disapproves the supplemental
          application, the Secretary may order the manufacturer to
          cease the distribution of the drugs that have been made with
          the manufacturing change.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506A, as added Pub. L. 105-115, title
    I, Sec. 116(a), Nov. 21, 1997, 111 Stat. 2313.)


-MISC1-
                              EFFECTIVE DATE                          
      Section 116(b) of Pub. L. 105-115 provided that: "The amendment
    made by subsection (a) [enacting this section] takes effect upon
    the effective date of regulations promulgated by the Secretary of
    Health and Human Services to implement such amendment, or upon the
    expiration of the 24-month period beginning on the date of the
    enactment of this Act [Nov. 21, 1997], whichever occurs first."

-End-



-CITE-
    21 USC Sec. 356b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356b. Reports of postmarketing studies

-STATUTE-
    (a) Submission
      (1) In general
        A sponsor of a drug that has entered into an agreement with the
      Secretary to conduct a postmarketing study of a drug shall submit
      to the Secretary, within 1 year after the approval of such drug
      and annually thereafter until the study is completed or
      terminated, a report of the progress of the study or the reasons
      for the failure of the sponsor to conduct the study. The report
      shall be submitted in such form as is prescribed by the Secretary
      in regulations issued by the Secretary.
      (2) Agreements prior to effective date
        Any agreement entered into between the Secretary and a sponsor
      of a drug, prior to November 21, 1997, to conduct a postmarketing
      study of a drug shall be subject to the requirements of paragraph
      (1). An initial report for such an agreement shall be submitted
      within 6 months after the date of the issuance of the regulations
      under paragraph (1).
    (b) Consideration of information as public information
      Any information pertaining to a report described in subsection
    (a) of this section shall be considered to be public information to
    the extent that the information is necessary - 
        (1) to identify the sponsor; and
        (2) to establish the status of a study described in subsection
      (a) of this section and the reasons, if any, for any failure to
      carry out the study.
    (c) Status of studies and reports
      The Secretary shall annually develop and publish in the Federal
    Register a report that provides information on the status of the
    postmarketing studies - 
        (1) that sponsors have entered into agreements to conduct; and
        (2) for which reports have been submitted under subsection
      (a)(1) of this section.
    (d) Disclosure
      If a sponsor fails to complete an agreed upon study required by
    this section by its original or otherwise negotiated deadline, the
    Secretary shall publish a statement on the Internet site of the
    Food and Drug Administration stating that the study was not
    completed and, if the reasons for such failure to complete the
    study were not satisfactory to the Secretary, a statement that such
    reasons were not satisfactory to the Secretary.
    (e) Notification
      With respect to studies of the type required under section
    356(b)(2)(A) of this title or under section 314.510 or 601.41 of
    title 21, Code of Federal Regulations, as each of such sections was
    in effect on the day before the effective date of this subsection,
    the Secretary may require that a sponsor who, for reasons not
    satisfactory to the Secretary, fails to complete by its deadline a
    study under any of such sections of such type for a drug or
    biological product (including such a study conducted after such
    effective date) notify practitioners who prescribe such drug or
    biological product of the failure to complete such study and the
    questions of clinical benefit, and, where appropriate, questions of
    safety, that remain unanswered as a result of the failure to
    complete such study. Nothing in this subsection shall be construed
    as altering the requirements of the types of studies required under
    section 356(b)(2)(A) of this title or under section 314.510 or
    601.41 of title 21, Code of Federal Regulations, as so in effect,
    or as prohibiting the Secretary from modifying such sections of
    title 21 of such Code to provide for studies in addition to those
    of such type.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506B, as added Pub. L. 105-115, title
    I, Sec. 130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107-
    188, title V, Sec. 506, June 12, 2002, 116 Stat. 693.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The effective date of this subsection, referred to in subsec.
    (e), is Oct. 1, 2002, see Effective Date of 2002 Amendment note set
    out below.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsecs. (d), (e). Pub. L. 107-188 added subsecs. (d) and
    (e).

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-188, title V, Sec. 508, June 12, 2002, 116 Stat. 694,
    provided that: "The amendments made by this subtitle [subtitle A
    (Secs. 501-509) of title V of Pub. L. 107-188, amending this
    section and sections 379g and 379h of this title] shall take effect
    October 1, 2002."

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

                    REPORT TO CONGRESSIONAL COMMITTEES                
      Pub. L. 105-115, title I, Sec. 130(b), Nov. 21, 1997, 111 Stat.
    2331, provided that not later than Oct. 1, 2001, the Secretary was
    to submit to Congress a report containing a summary of the reports
    submitted under section 356b of this title and an evaluation and
    legislative recommendations relating to postmarketing studies of
    drugs.

-End-



-CITE-
    21 USC Sec. 356c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356c. Discontinuance of life saving product

-STATUTE-
    (a) In general
      A manufacturer that is the sole manufacturer of a drug - 
        (1) that is - 
          (A) life-supporting;
          (B) life-sustaining; or
          (C) intended for use in the prevention of a debilitating
        disease or condition;

        (2) for which an application has been approved under section
      355(b) or 355(j) of this title; and
        (3) that is not a product that was originally derived from
      human tissue and was replaced by a recombinant product,

    shall notify the Secretary of a discontinuance of the manufacture
    of the drug at least 6 months prior to the date of the
    discontinuance.
    (b) Reduction in notification period
      The notification period required under subsection (a) of this
    section for a manufacturer may be reduced if the manufacturer
    certifies to the Secretary that good cause exists for the
    reduction, such as a situation in which - 
        (1) a public health problem may result from continuation of the
      manufacturing for the 6-month period;
        (2) a biomaterials shortage prevents the continuation of the
      manufacturing for the 6-month period;
        (3) a liability problem may exist for the manufacturer if the
      manufacturing is continued for the 6-month period;
        (4) continuation of the manufacturing for the 6-month period
      may cause substantial economic hardship for the manufacturer;
        (5) the manufacturer has filed for bankruptcy under chapter 7
      or 11 of title 11; or
        (6) the manufacturer can continue the distribution of the drug
      involved for 6 months.
    (c) Distribution
      To the maximum extent practicable, the Secretary shall distribute
    information on the discontinuation of the drugs described in
    subsection (a) of this section to appropriate physician and patient
    organizations.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506C, as added Pub. L. 105-115, title
    I, Sec. 131(a), Nov. 21, 1997, 111 Stat. 2332.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 357                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 357. Repealed.

-MISC1-
    Sec. 357. Repealed. Pub. L. 105-115, title I, Sec. 125(b)(1), Nov.
      21, 1997, 111 Stat. 2325.
      Section, act June 25, 1938, ch. 675, Sec. 507, as added July 6,
    1945, ch. 281, Sec. 3, 59 Stat. 463; amended Mar. 10, 1947, ch. 16,
    Sec. 3, 61 Stat. 12; July 13, 1949, ch. 305, Sec. 2, 63 Stat. 409;
    Aug. 5, 1953, ch. 334, Sec. 2, 67 Stat. 389; Pub. L. 87-781, title
    I, Secs. 105(a), (b), (d)-(f), 106(a), (b), Oct. 10, 1962, 76 Stat.
    785, 786, 787; Pub. L. 90-399, Sec. 105(b), July 13, 1968, 82 Stat.
    352; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
    Pub. L. 103-80, Sec. 3(p), Aug. 13, 1993, 107 Stat. 777, related to
    certification of drugs containing penicillin, streptomycin,
    chlortetracycline, chloramphenicol, bacitracin, or any other
    antibiotic drug.

-End-



-CITE-
    21 USC Sec. 358                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 358. Authority to designate official names

-STATUTE-
    (a) Necessity or desirability; use in official compendiums;
      infringement of trademarks
      The Secretary may designate an official name for any drug or
    device if he determines that such action is necessary or desirable
    in the interest of usefulness and simplicity. Any official name
    designated under this section for any drug or device shall be the
    only official name of that drug or device used in any official
    compendium published after such name has been prescribed or for any
    other purpose of this chapter. In no event, however, shall the
    Secretary establish an official name so as to infringe a valid
    trademark.
    (b) Review of names in official compendiums
      Within a reasonable time after October 10, 1962, and at such
    other times as he may deem necessary, the Secretary shall cause a
    review to be made of the official names by which drugs are
    identified in the official United States Pharmacopoeia, the
    official Homoeopathic Pharmacopoeia of the United States, and the
    official National Formulary, and all supplements thereto, and at
    such times as he may deem necessary shall cause a review to be made
    of the official names by which devices are identified in any
    official compendium (and all supplements thereto) to determine
    whether revision of any of those names is necessary or desirable in
    the interest of usefulness and simplicity.
    (c) Determinations of complexity, usefulness, multiplicity, or lack
      of name; designation by Secretary
      Whenever he determines after any such review that (1) any such
    official name is unduly complex or is not useful for any other
    reason, (2) two or more official names have been applied to a
    single drug or device, or to two or more drugs which are identical
    in chemical structure and pharmacological action and which are
    substantially identical in strength, quality, and purity, or to two
    or more devices which are substantially equivalent in design and
    purpose or (3) no official name has been applied to a medically
    useful drug or device, he shall transmit in writing to the compiler
    of each official compendium in which that drug or drugs or device
    are identified and recognized his request for the recommendation of
    a single official name for such drug or drugs or device which will
    have usefulness and simplicity. Whenever such a single official
    name has not been recommended within one hundred and eighty days
    after such request, or the Secretary determines that any name so
    recommended is not useful for any reason, he shall designate a
    single official name for such drug or drugs or device. Whenever he
    determines that the name so recommended is useful, he shall
    designate that name as the official name of such drug or drugs or
    device. Such designation shall be made as a regulation upon public
    notice and in accordance with the procedure set forth in section
    553 of title 5.
    (d) Revised official names; compilation, publication, and public
      distribution of listings
      After each such review, and at such other times as the Secretary
    may determine to be necessary or desirable, the Secretary shall
    cause to be compiled, published, and publicly distributed a list
    which shall list all revised official names of drugs or devices
    designated under this section and shall contain such descriptive
    and explanatory matter as the Secretary may determine to be
    required for the effective use of those names.
    (e) Request by compiler of official compendium for designation of
      name
      Upon a request in writing by any compiler of an official
    compendium that the Secretary exercise the authority granted to him
    under subsection (a) of this section, he shall upon public notice
    and in accordance with the procedure set forth in section 553 of
    title 5 designate the official name of the drug or device for which
    the request is made.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 508, as added Pub. L. 87-781, title
    I, Sec. 111(a), Oct. 10, 1962, 76 Stat. 789; amended Pub. L. 94-
    295, Sec. 5(b), May 28, 1976, 90 Stat. 581; Pub. L. 103-80, Sec.
    3(q), Aug. 13, 1993, 107 Stat. 777.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsecs. (c), (e). Pub. L. 103-80 substituted reference to
    section 553 of title 5 for "section 4 of the Administrative
    Procedure Act (5 U.S.C. 1003)".
      1976 - Subsec. (a). Pub. L. 94-295 substituted "drug or device"
    for "drug" wherever appearing.
      Subsec. (b). Pub. L. 94-295 substituted "National Formulary, and
    all supplements thereto, and at such times as he may deem necessary
    shall cause a review to be made of the official names by which
    devices are identified in any official compendium (and all
    supplements thereto)" for "National Formulary, and all supplements
    thereto,".
      Subsec. (c)(2). Pub. L. 94-295 inserted "or device" after "single
    drug", and "or to two or more devices which are substantially
    equivalent in design and purpose" after "purity,".
      Subsec. (c)(3). Pub. L. 94-295 inserted "or device" after "useful
    drug" and after "drug or drugs" wherever appearing.
      Subsec. (d). Pub. L. 94-295 inserted "or devices" after "drugs".
      Subsec. (e). Pub. L. 94-295 substituted "drug or device" for
    "drug".

                              EFFECTIVE DATE                          
      Section 111(b) of Pub. L. 87-781 provided that: "This section
    [enacting this section] shall take effect on the date of its
    enactment [Oct. 10, 1962]."

-End-



-CITE-
    21 USC Sec. 359                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 359. Nonapplicability of subchapter to cosmetics

-STATUTE-
      This subchapter, as amended by the Drug Amendments of 1962, shall
    not apply to any cosmetic unless such cosmetic is also a drug or
    device or component thereof.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 509, as added Pub. L. 87-781, title
    I, Sec. 113, Oct. 10, 1962, 76 Stat. 791.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, as amended by the Drug Amendments of 1962,
    referred to in text, means the amendment of this subchapter by Pub.
    L. 87-781 which enacted sections 358 to 360 of this title, amended
    sections 351 to 353, 355, and 357 of this title, and enacted
    provisions set out as notes under sections 352, 355, 358, and 360
    of this title.
      The Drug Amendments of 1962, referred to in text, is Pub. L. 87-
    781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete
    classification of this Act to the Code, see Short Title of 1962
    Amendment note set out under section 301 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 360                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360. Registration of producers of drugs or devices

-STATUTE-
    (a) Definitions
      As used in this section - 
        (1) the term "manufacture, preparation, propagation,
      compounding, or processing" shall include repackaging or
      otherwise changing the container, wrapper, or labeling of any
      drug package or device package in furtherance of the distribution
      of the drug or device from the original place of manufacture to
      the person who makes final delivery or sale to the ultimate
      consumer or user; and
        (2) the term "name" shall include in the case of a partnership
      the name of each partner and, in the case of a corporation, the
      name of each corporate officer and director, and the State of
      incorporation.
    (b) Annual registration
      On or before December 31 of each year every person who owns or
    operates any establishment in any State engaged in the manufacture,
    preparation, propagation, compounding, or processing of a drug or
    drugs or a device or devices shall register with the Secretary his
    name, places of business, and all such establishments.
    (c) New producers
      Every person upon first engaging in the manufacture, preparation,
    propagation, compounding, or processing of a drug or drugs or a
    device or devices in any establishment which he owns or operates in
    any State shall immediately register with the Secretary his name,
    place of business, and such establishment.
    (d) Additional establishments
      Every person duly registered in accordance with the foregoing
    subsections of this section shall immediately register with the
    Secretary any additional establishment which he owns or operates in
    any State and in which he begins the manufacture, preparation,
    propagation, compounding, or processing of a drug or drugs or a
    device or devices.
    (e) Registration number; uniform system for identification of
      devices intended for human use
      The Secretary may assign a registration number to any person or
    any establishment registered in accordance with this section. The
    Secretary may also assign a listing number to each drug or class of
    drugs listed under subsection (j) of this section. Any number
    assigned pursuant to the preceding sentence shall be the same as
    that assigned pursuant to the National Drug Code. The Secretary may
    by regulation prescribe a uniform system for the identification of
    devices intended for human use and may require that persons who are
    required to list such devices pursuant to subsection (j) of this
    section shall list such devices in accordance with such system.
    (f) Availability of registrations for inspection
      The Secretary shall make available for inspection, to any person
    so requesting, any registration filed pursuant to this section;
    except that any list submitted pursuant to paragraph (3) of
    subsection (j) of this section and the information accompanying any
    list or notice filed under paragraph (1) or (2) of that subsection
    shall be exempt from such inspection unless the Secretary finds
    that such an exemption would be inconsistent with protection of the
    public health.
    (g) Exclusions from application of section
      The foregoing subsections of this section shall not apply to - 
        (1) pharmacies which maintain establishments in conformance
      with any applicable local laws regulating the practice of
      pharmacy and medicine and which are regularly engaged in
      dispensing prescription drugs or devices, upon prescriptions of
      practitioners licensed to administer such drugs or devices to
      patients under the care of such practitioners in the course of
      their professional practice, and which do not manufacture,
      prepare, propagate, compound, or process drugs or devices for
      sale other than in the regular course of their business of
      dispensing or selling drugs or devices at retail;
        (2) practitioners licensed by law to prescribe or administer
      drugs or devices and who manufacture, prepare, propagate,
      compound, or process drugs or devices solely for use in the
      course of their professional practice;
        (3) persons who manufacture, prepare, propagate, compound, or
      process drugs or devices solely for use in research, teaching, or
      chemical analysis and not for sale;
        (4) any distributor who acts as a wholesale distributor of
      devices, and who does not manufacture, repackage, process, or
      relabel a device; or
        (5) such other classes of persons as the Secretary may by
      regulation exempt from the application of this section upon a
      finding that registration by such classes of persons in
      accordance with this section is not necessary for the protection
      of the public health.

    In this subsection, the term "wholesale distributor" means any
    person (other than the manufacturer or the initial importer) who
    distributes a device from the original place of manufacture to the
    person who makes the final delivery or sale of the device to the
    ultimate consumer or user.
    (h) Inspection of premises
      Every establishment in any State registered with the Secretary
    pursuant to this section shall be subject to inspection pursuant to
    section 374 of this title and every such establishment engaged in
    the manufacture, propagation, compounding, or processing of a drug
    or drugs or of a device or devices classified in class II or III
    shall be so inspected by one or more officers or employees duly
    designated by the Secretary, or by persons accredited to conduct
    inspections under section 374(g) of this title, at least once in
    the two-year period beginning with the date of registration of such
    establishment pursuant to this section and at least once in every
    successive two-year period thereafter.
    (i) Registration of foreign establishments
      (1) On or before December 31 of each year, any establishment
    within any foreign country engaged in the manufacture, preparation,
    propagation, compounding, or processing of a drug or a device that
    is imported or offered for import into the United States shall,
    through electronic means in accordance with the criteria of the
    Secretary, register with the Secretary the name and place of
    business of the establishment, the name of the United States agent
    for the establishment, the name of each importer of such drug or
    device in the United States that is known to the establishment, and
    the name of each person who imports or offers for import such drug
    or device to the United States for purposes of importation.
      (2) The establishment shall also provide the information required
    by subsection (j) of this section.
      (3) The Secretary is authorized to enter into cooperative
    arrangements with officials of foreign countries to ensure that
    adequate and effective means are available for purposes of
    determining, from time to time, whether drugs or devices
    manufactured, prepared, propagated, compounded, or processed by an
    establishment described in paragraph (1), if imported or offered
    for import into the United States, shall be refused admission on
    any of the grounds set forth in section 381(a) of this title.
    (j) Filing of lists of drugs and devices manufactured, prepared,
      propagated and compounded by registrants; statements;
      accompanying disclosures
      (1) Every person who registers with the Secretary under
    subsection (b), (c), (d), or (i) of this section shall, at the time
    of registration under any such subsection, file with the Secretary
    a list of all drugs and a list of all devices and a brief statement
    of the basis for believing that each device included in the list is
    a device rather than a drug (with each drug and device in each list
    listed by its established name (as defined in section 352(e) of
    this title) and by any proprietary name) which are being
    manufactured, prepared, propagated, compounded, or processed by him
    for commercial distribution and which he has not included in any
    list of drugs or devices filed by him with the Secretary under this
    paragraph or paragraph (2) before such time of registration. Such
    list shall be prepared in such form and manner as the Secretary may
    prescribe and shall be accompanied by - 
        (A) in the case of a drug contained in the applicable list and
      subject to section 355 or 360b of this title, or a device
      intended for human use contained in the applicable list with
      respect to which a performance standard has been established
      under section 360d of this title or which is subject to section
      360e of this title, a reference to the authority for the
      marketing of such drug or device and a copy of all labeling for
      such drug or device;
        (B) in the case of any other drug or device contained in an
      applicable list - 
          (i) which drug is subject to section 353(b)(1) of this title,
        or which device is a restricted device, a copy of all labeling
        for such drug or device, a representative sampling of
        advertisements for such drug or device, and, upon request made
        by the Secretary for good cause, a copy of all advertisements
        for a particular drug product or device, or
          (ii) which drug is not subject to section 353(b)(1) of this
        title or which device is not a restricted device, the label and
        package insert for such drug or device and a representative
        sampling of any other labeling for such drug or device;

        (C) in the case of any drug contained in an applicable list
      which is described in subparagraph (B), a quantitative listing of
      its active ingredient or ingredients, except that with respect to
      a particular drug product the Secretary may require the
      submission of a quantitative listing of all ingredients if he
      finds that such submission is necessary to carry out the purposes
      of this chapter; and
        (D) if the registrant filing a list has determined that a
      particular drug product or device contained in such list is not
      subject to section 355 or 360b of this title, or the particular
      device contained in such list is not subject to a performance
      standard established under section 360d of this title or to
      section 360e of this title or is not a restricted device a brief
      statement of the basis upon which the registrant made such
      determination if the Secretary requests such a statement with
      respect to that particular drug product or device.

      (2) Each person who registers with the Secretary under this
    section shall report to the Secretary once during the month of June
    of each year and once during the month of December of each year the
    following information:
        (A) A list of each drug or device introduced by the registrant
      for commercial distribution which has not been included in any
      list previously filed by him with the Secretary under this
      subparagraph or paragraph (1) of this subsection. A list under
      this subparagraph shall list a drug or device by its established
      name (as defined in section 352(e) of this title), and by any
      proprietary name it may have and shall be accompanied by the
      other information required by paragraph (1).
        (B) If since the date the registrant last made a report under
      this paragraph (or if he has not made a report under this
      paragraph, since February 1, 1973) he has discontinued the
      manufacture, preparation, propagation, compounding, or processing
      for commercial distribution of a drug or device included in a
      list filed by him under subparagraph (A) or paragraph (1); notice
      of such discontinuance, the date of such discontinuance, and the
      identity (by established name (as defined in section 352(e) of
      this title) and by any proprietary name) of such drug or device.
        (C) If since the date the registrant reported pursuant to
      subparagraph (B) a notice of discontinuance he has resumed the
      manufacture, preparation, propagation, compounding, or processing
      for commercial distribution of the drug or device with respect to
      which such notice of discontinuance was reported; notice of such
      resumption, the date of such resumption, the identity of such
      drug or device (each by established name (as defined in section
      352(e) of this title) and by any proprietary name), and the other
      information required by paragraph (1), unless the registrant has
      previously reported such resumption to the Secretary pursuant to
      this subparagraph.
        (D) Any material change in any information previously submitted
      pursuant to this paragraph or paragraph (1).

      (3) The Secretary may also require each registrant under this
    section to submit a list of each drug product which (A) the
    registrant is manufacturing, preparing, propagating, compounding,
    or processing for commercial distribution, and (B) contains a
    particular ingredient. The Secretary may not require the submission
    of such a list unless he has made a finding that the submission of
    such a list is necessary to carry out the purposes of this chapter.
    (k) Report preceding introduction of devices into interstate
      commerce
      Each person who is required to register under this section and
    who proposes to begin the introduction or delivery for introduction
    into interstate commerce for commercial distribution of a device
    intended for human use shall, at least ninety days before making
    such introduction or delivery, report to the Secretary or person
    who is accredited under section 360m(a) of this title (in such form
    and manner as the Secretary shall by regulation prescribe) - 
        (1) the class in which the device is classified under section
      360c of this title or if such person determines that the device
      is not classified under such section, a statement of that
      determination and the basis for such person's determination that
      the device is or is not so classified, and
        (2) action taken by such person to comply with requirements
      under section 360d or 360e of this title which are applicable to
      the device.
    (l) Exemption from reporting requirements
      A report under subsection (k) of this section is not required for
    a device intended for human use that is exempted from the
    requirements of this subsection under subsection (m) of this
    section or is within a type that has been classified into class I
    under section 360c of this title. The exception established in the
    preceding sentence does not apply to any class I device that is
    intended for a use which is of substantial importance in preventing
    impairment of human health, or to any class I device that presents
    a potential unreasonable risk of illness or injury.
    (m) List of exempt class II devices; determination by Secretary;
      publication in Federal Register
      (1) Not later than 60 days after November 21, 1997, the Secretary
    shall publish in the Federal Register a list of each type of class
    II device that does not require a report under subsection (k) of
    this section to provide reasonable assurance of safety and
    effectiveness. Each type of class II device identified by the
    Secretary as not requiring the report shall be exempt from the
    requirement to provide a report under subsection (k) of this
    section as of the date of the publication of the list in the
    Federal Register. The Secretary shall publish such list on the
    Internet site of the Food and Drug Administration. The list so
    published shall be updated not later than 30 days after each
    revision of the list by the Secretary.
      (2) Beginning on the date that is 1 day after the date of the
    publication of a list under this subsection, the Secretary may
    exempt a class II device from the requirement to submit a report
    under subsection (k) of this section, upon the Secretary's own
    initiative or a petition of an interested person, if the Secretary
    determines that such report is not necessary to assure the safety
    and effectiveness of the device. The Secretary shall publish in the
    Federal Register notice of the intent of the Secretary to exempt
    the device, or of the petition, and provide a 30-day period for
    public comment. Within 120 days after the issuance of the notice in
    the Federal Register, the Secretary shall publish an order in the
    Federal Register that sets forth the final determination of the
    Secretary regarding the exemption of the device that was the
    subject of the notice. If the Secretary fails to respond to a
    petition within 180 days of receiving it, the petition shall be
    deemed to be granted.
    (n) Review of report; time for determination by Secretary
      The Secretary shall review the report required in subsection (k)
    of this section and make a determination under section 360c(f)(1)
    of this title not later than 90 days after receiving the report.
    (o) Reprocessed single-use devices
      (1) With respect to reprocessed single-use devices for which
    reports are required under subsection (k) of this section:
        (A) The Secretary shall identify such devices or types of
      devices for which reports under such subsection must, in order to
      ensure that the device is substantially equivalent to a predicate
      device, include validation data, the types of which shall be
      specified by the Secretary, regarding cleaning and sterilization,
      and functional performance demonstrating that the single-use
      device will remain substantially equivalent to its predicate
      device after the maximum number of times the device is
      reprocessed as intended by the person submitting the premarket
      notification. Within six months after October 26, 2002, the
      Secretary shall publish in the Federal Register a list of the
      types so identified, and shall revise the list as appropriate.
      Reports under subsection (k) of this section for devices or types
      of devices within a type included on the list are, upon
      publication of the list, required to include such validation
      data.
        (B) In the case of each report under subsection (k) of this
      section that was submitted to the Secretary before the
      publication of the initial list under subparagraph (A), or any
      revision thereof, and was for a device or type of device included
      on such list, the person who submitted the report under
      subsection (k) of this section shall submit validation data as
      described in subparagraph (A) to the Secretary not later than
      nine months after the publication of the list. During such nine-
      month period, the Secretary may not take any action under this
      chapter against such device solely on the basis that the
      validation data for the device have not been submitted to the
      Secretary. After the submission of the validation data to the
      Secretary, the Secretary may not determine that the device is
      misbranded under section 352(o) of this title or adulterated
      under section 351(f)(1)(B) of this title, or take action against
      the device under section 331(p) of this title for failure to
      provide any information required by subsection (k) of this
      section until (i) the review is terminated by withdrawal of the
      submission of the report under subsection (k) of this section;
      (ii) the Secretary finds the data to be acceptable and issues a
      letter; or (iii) the Secretary determines that the device is not
      substantially equivalent to a predicate device. Upon a
      determination that a device is not substantially equivalent to a
      predicate device, or if such submission is withdrawn, the device
      can no longer be legally marketed.
        (C) In the case of a report under subsection (k) of this
      section for a device identified under subparagraph (A) that is of
      a type for which the Secretary has not previously received a
      report under such subsection, the Secretary may, in advance of
      revising the list under subparagraph (A) to include such type,
      require that the report include the validation data specified in
      subparagraph (A).
        (D) Section 352(o) of this title applies with respect to the
      failure of a report under subsection (k) of this section to
      include validation data required under subparagraph (A).

      (2) With respect to critical or semi-critical reprocessed single-
    use devices that, under subsection (l) or (m) of this section, are
    exempt from the requirement of submitting reports under subsection
    (k) of this section:
        (A) The Secretary shall identify such devices or types of
      devices for which such exemptions should be terminated in order
      to provide a reasonable assurance of the safety and effectiveness
      of the devices. The Secretary shall publish in the Federal
      Register a list of the devices or types of devices so identified,
      and shall revise the list as appropriate. The exemption for each
      device or type included on the list is terminated upon the
      publication of the list. For each report under subsection (k) of
      this section submitted pursuant to this subparagraph the
      Secretary shall require the validation data described in
      paragraph (1)(A).
        (B) For each device or type of device included on the list
      under subparagraph (A), a report under subsection (k) of this
      section shall be submitted to the Secretary not later than 15
      months after the publication of the initial list, or a revision
      of the list, whichever terminates the exemption for the device.
      During such 15-month period, the Secretary may not take any
      action under this chapter against such device solely on the basis
      that such report has not been submitted to the Secretary. After
      the submission of the report to the Secretary the Secretary may
      not determine that the device is misbranded under section 352(o)
      of this title or adulterated under section 351(f)(1)(B) of this
      title, or take action against the device under section 331(p) of
      this title for failure to provide any information required by
      subsection (k) of this section until (i) the review is terminated
      by withdrawal of the submission; (ii) the Secretary determines by
      order that the device is substantially equivalent to a predicate
      device; or (iii) the Secretary determines by order that the
      device is not substantially equivalent to a predicate device.
      Upon a determination that a device is not substantially
      equivalent to a predicate device, the device can no longer be
      legally marketed.
        (C) In the case of semi-critical devices, the initial list
      under subparagraph (A) shall be published not later than 18
      months after the effective date of this subsection. In the case
      of critical devices, the initial list under such subparagraph
      shall be published not later than six months after such effective
      date.
        (D) Section 352(o) of this title applies with respect to the
      failure to submit a report under subsection (k) of this section
      that is required pursuant to subparagraph (A), including a
      failure of the report to include validation data required in such
      subparagraph.
        (E) The termination under subparagraph (A) of an exemption
      under subsection (l) or (m) of this section for a critical or
      semi-critical reprocessed single-use device does not terminate
      the exemption under subsection (l) or (m) of this section for the
      original device.
    (p) Electronic registration
      Registrations under subsections (b), (c), (d), and (i) of this
    section (including the submission of updated information) shall be
    submitted to the Secretary by electronic means, upon a finding by
    the Secretary that the electronic receipt of such registrations is
    feasible, unless the Secretary grants a request for waiver of such
    requirement because use of electronic means is not reasonable for
    the person requesting such waiver.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 510, as added Pub. L. 87-781, title
    III, Sec. 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89-74,
    Sec. 4, July 15, 1965, 79 Stat. 231; Pub. L. 91-513, title II, Sec.
    701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92-387, Secs. 3, 4(a)-
    (c), Aug. 16, 1972, 86 Stat. 560-562; Pub. L. 94-295, Sec. 4(a),
    May 28, 1976, 90 Stat. 579; Pub. L. 105-115, title I, Sec.
    125(a)(2)(C), title II, Secs. 206(a), 209(a), 213(b), title IV,
    Sec. 417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379;
    Pub. L. 107-188, title III, Sec. 321(a), June 12, 2002, 116 Stat.
    675; Pub. L. 107-250, title II, Secs. 201(e), 207, 211, title III,
    Sec. 302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub.
    L. 108-214, Sec. 2(c)(2), Apr. 1, 2004, 118 Stat. 576.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The effective date of this subsection, referred to in subsec.
    (o)(2)(C), probably means the date of the enactment of Pub. L. 107-
    250, which enacted subsec. (o) of this section and was approved
    Oct. 26, 2002.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (o)(1)(B), (2)(B). Pub. L. 108-214, Sec.
    2(c)(2)(A), (B)(i), substituted "or adulterated" for ",
    adulterated".
      Subsec. (o)(2)(E). Pub. L. 108-214, Sec. 2(c)(2)(B)(ii),
    substituted "semi-critical" for "semicritical".
      2002 - Subsec. (h). Pub. L. 107-250, Sec. 201(e), inserted ", or
    by persons accredited to conduct inspections under section 374(g)
    of this title," after "duly designated by the Secretary".
      Subsec. (i)(1). Pub. L. 107-188, Sec. 321(a)(1), substituted "On
    or before December 31 of each year, any establishment" for "Any
    establishment" and "shall, through electronic means in accordance
    with the criteria of the Secretary, register with the Secretary the
    name and place of business of the establishment, the name of the
    United States agent for the establishment, the name of each
    importer of such drug or device in the United States that is known
    to the establishment, and the name of each person who imports or
    offers for import such drug or device to the United States for
    purposes of importation" for "shall register with the Secretary the
    name and place of business of the establishment and the name of the
    United States agent for the establishment".
      Subsec. (j)(1). Pub. L. 107-188, Sec. 321(a)(2), substituted
    "subsection (b), (c), (d), or (i)" for "subsection (b), (c), or
    (d)" in first sentence.
      Subsec. (m)(1). Pub. L. 107-250, Sec. 211, inserted at end "The
    Secretary shall publish such list on the Internet site of the Food
    and Drug Administration. The list so published shall be updated not
    later than 30 days after each revision of the list by the
    Secretary."
      Subsec. (o). Pub. L. 107-250, Sec. 302(b), added subsec. (o).
      Subsec. (p). Pub. L. 107-250, Sec. 207, added subsec. (p).
      1997 - Subsec. (g). Pub. L. 105-115, Sec. 213(b)(3), inserted at
    end "In this subsection, the term 'wholesale distributor' means any
    person (other than the manufacturer or the initial importer) who
    distributes a device from the original place of manufacture to the
    person who makes the final delivery or sale of the device to the
    ultimate consumer or user."
      Subsec. (g)(4), (5). Pub. L. 105-115, Sec. 213(b)(1), (2), added
    par. (4) and redesignated former par. (4) as (5).
      Subsec. (i). Pub. L. 105-115, Sec. 417, amended subsec. (i)
    generally. Prior to amendment, subsec. (i) read as follows: "Any
    establishment within any foreign country engaged in the
    manufacture, preparation, propagation, compounding, or processing
    of a drug or drugs, or a device or devices, shall be permitted to
    register under this section pursuant to regulations promulgated by
    the Secretary. Such regulations shall require such establishment to
    provide the information required by subsection (j) of this section
    and shall require such establishment to provide the information
    required by subsection (j) of this section in the case of a device
    or devices and shall include provisions for registration of any
    such establishment upon condition that adequate and effective means
    are available, by arrangement with the government of such foreign
    country or otherwise, to enable the Secretary to determine from
    time to time whether drugs or devices manufactured, prepared,
    propagated, compounded, or processed in such establishment, if
    imported or offered for import into the United States, shall be
    refused admission on any of the grounds set forth in section 381(a)
    of this title."
      Subsec. (j)(1)(A), (D). Pub. L. 105-115, Sec. 125(a)(2)(C),
    struck out ", 356, 357," before "or 360b of this title".
      Subsec. (k). Pub. L. 105-115, Sec. 206(a)(1), inserted "or person
    who is accredited under section 360m(a) of this title" after
    "report to the Secretary".
      Subsecs. (l), (m). Pub. L. 105-115, Sec. 206(a)(2), added
    subsecs. (l) and (m).
      Subsec. (n). Pub. L. 105-115, Sec. 209(a), added subsec. (n).
      1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 4(a)(2), substituted
    "drug package or device package" for "drug package", "distribution
    of the drug or device" for "distribution of the drug", and
    "ultimate consumer or user" for "ultimate consumer".
      Subsecs. (b) to (d). Pub. L. 94-295, Sec. 4(a)(3), inserted "or a
    device or devices" after "drug or drugs".
      Subsec. (e). Pub. L. 94-295, Sec. 4(a)(4), authorized the
    Secretary to prescribe by regulation a uniform system for the
    identification of devices intended for human use and authorized
    him, in addition, to require that persons who are required to list
    devices pursuant to subsec. (j) also list such devices in
    accordance with the system.
      Subsec. (g)(1) to (3). Pub. L. 94-295, Sec. 4(a)(5), substituted
    "drugs or devices" for "drugs".
      Subsec. (h). Pub. L. 94-295, Sec. 4(a)(6), inserted reference to
    establishments engaged in the manufacture, propagation,
    compounding, or processing of a drug or drugs or of a device or
    devices classified in class II or III.
      Subsec. (i). Pub. L. 94-295, Sec. 4(a)(7), inserted reference to
    devices and inserted requirement that regulations require
    establishments to provide the information required by subsection
    (j) of this section in the case of a device or devices.
      Subsec. (j)(1). Pub. L. 94-295, Sec. 4(a)(8)(A), in introductory
    provisions substituted "a list of all drugs and a list of all
    devices and a brief statement of the basis for believing that each
    device included in the list is a device rather than a drug (with
    each drug and device in each list listed by its established name"
    for "a list of all drugs (by established name" and "drugs or
    devices filed" for "drugs filed".
      Subsec. (j)(1)(A). Pub. L. 94-295, Sec. 4(a)(8)(B), substituted
    "the applicable list" for "such list", inserted "or a device
    intended for human use contained in the applicable list with
    respect to which a performance standard has been established under
    section 360d of this title or which is subject to section 360e of
    this title," after "360b of this title,", and substituted "such
    drug or device" for "such drug" wherever appearing.
      Subsec. (j)(1)(B). Pub. L. 94-295, Sec. 4(a)(8)(C), in
    introductory provisions substituted "drug or device contained in an
    applicable list" for "drug contained in such list".
      Subsec. (j)(1)(B)(i). Pub. L. 94-295, Sec. 4(a)(8)(D),
    substituted "which drug is subject to section 353(b)(1) of this
    title, or which device is a restricted device, a copy of all
    labeling for such drug or device, a representative sampling of
    advertisements for such drug or device, and, upon request made by
    the Secretary for good cause, a copy of all advertisements for a
    particular drug product or device, or" for "which is subject to
    section 353(b)(1) of this title, a copy of all labeling for such
    drug, a representative sampling of advertisements for such drug,
    and, upon request made by the Secretary for good cause, a copy of
    all advertisements for a particular drug product, or".
      Subsec. (j)(1)(B)(ii). Pub. L. 94-295, Sec. 4(a)(8)(E),
    substituted "which drug is not subject to section 353(b)(1) of this
    title or which device is not a restricted device, the label and
    package insert for such drug or device and a representative
    sampling of any other labeling for such drug or device" for "which
    is not subject to section 353(b)(1) of this title, the label and
    package insert for such drug and a representative sampling of any
    other labeling for such drug".
      Subsec. (j)(1)(C). Pub. L. 94-295, Sec. 4(a)(8)(F), substituted
    "an applicable list" for "such list".
      Subsec. (j)(1)(D). Pub. L. 94-295, Sec. 4(a)(8)(G), substituted
    "a list" for "the list", inserted "or the particular device
    contained in such list is not subject to a performance standard
    established under section 360d of this title or to section 360e of
    this title or is not a restricted device" after "or 360b of this
    title,", and substituted "particular drug product or device" for
    "particular drug product" wherever appearing.
      Subsec. (j)(2). Pub. L. 94-295, Sec. 4(a)(8)(H), substituted
    "drug or device" for "drug" in subpars. (A), (B), and (C), and
    substituted "(each by established name" for "(by established name"
    in subpar. (C).
      Subsec. (k). Pub. L. 94-295, Sec. 4(a)(9), added subsec. (k).
      1972 - Subsec. (e). Pub. L. 92-387, Sec. 4(a), inserted provision
    that the Secretary may assign a listing number to each drug or
    class of drugs listed under subsec. (j).
      Subsec. (f). Pub. L. 92-387, Sec. 4(b), inserted exception that
    the list submitted under subsec. (j)(3) and information submitted
    under subsec. (j)(1), (2) shall be exempt from inspection unless
    the Secretary determines otherwise.
      Subsec. (i). Pub. L. 92-387, Sec. 4(c), inserted provision that
    the regulations shall require such establishment to provide the
    information required by subsec. (j).
      Subsec. (j). Pub. L. 92-387, Sec. 3, added subsec. (j).
      1970 - Subsec. (a). Pub. L. 91-513 struck out provisions defining
    the wholesaling, jobbing, or distributing of depressant or
    stimulant drugs.
      Subsec. (b). Pub. L. 91-513 struck out provisions covering
    establishments engaged in the wholesaling, jobbing, or distributing
    of depressant or stimulant drugs and the inclusion of the fact of
    such activity in the annual registration.
      Subsec. (c). Pub. L. 91-513 struck out provisions covering new
    registrations of persons first engaging in the wholesaling,
    jobbing, or distributing of depressant or stimulant drugs and the
    inclusion of the fact of such activity in the registration.
      Subsec. (d). Pub. L. 91-513 struck out number designation "(1)"
    preceding first sentence, struck out portion of such redesignated
    provisions covering the wholesaling, jobbing, or distributing of
    depressant or stimulant drugs, and struck out par. (2) covering the
    filing of supplemental registration whenever a person not
    previously engaged or involved with depressant or stimulant drugs
    goes into the manufacturing, preparation, or processing thereof.
      1965 - Pub. L. 89-74, Sec. 4(e), included certain wholesalers in
    section catchline.
      Subsec. (a)(2), (3). Pub. L. 89-74, Sec. 4(a), added par. (2) and
    redesignated former par. (2) as (3).
      Subsecs. (b), (c). Pub. L. 89-74, Sec. 4(b), (c), inserted "or in
    the wholesaling, jobbing, or distributing of any depressant or
    stimulant drug" after "drug or drugs" and inserted requirement that
    establishment indicate activity in depressant or stimulant drugs at
    time of registration.
      Subsec. (d). Pub. L. 89-74 Sec. 4(d), designated existing
    provisions as par. (1), inserted "or the wholesaling, jobbing, or
    distributing of any depressant or stimulant drug" and the
    requirement that the additional establishment indicate activity in
    depressant or stimulant drugs at time of registration, and added
    par. (2).

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Amendment by Pub. L. 107-188 effective upon the expiration of the
    180-day period beginning June 12, 2002, see section 321(c) of Pub.
    L. 107-188, set out as a note under section 331 of this title.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 206(a), 209(a), 213(b), and 417 of Pub. L.
    105-115 effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Section 5 of Pub. L. 92-387 provided that: "The amendments made
    by this Act [amending this section and sections 331 and 335 of this
    title and enacting provisions set out below] shall take effect on
    the first day of the sixth month beginning after the date of
    enactment of this Act [Aug. 16, 1972]."

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, subject to
    registration with Secretary of names, places of business,
    establishments, and other prescribed information prior to Feb. 1,
    1966, see section 11 of Pub. L. 89-74, set out as a note under
    section 321 of this title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for any violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.

     CONGRESSIONAL DECLARATION OF NEED FOR REGISTRATION AND INSPECTION
                          OF DRUG ESTABLISHMENTS
      Section 301 of Pub. L. 87-781 provided that: "The Congress hereby
    finds and declares that in order to make regulation of interstate
    commerce in drugs effective, it is necessary to provide for
    registration and inspection of all establishments in which drugs
    are manufactured, prepared, propagated, compounded, or processed;
    that the products of all such establishments are likely to enter
    the channels of interstate commerce and directly affect such
    commerce; and that the regulation of interstate commerce in drugs
    without provision for registration and inspection of establishments
    that may be engaged only in intrastate commerce in such drugs would
    discriminate against and depress interstate commerce in such drugs,
    and adversely burden, obstruct, and affect such interstate
    commerce."

             DECLARATION OF POLICY OF DRUG LISTING ACT OF 1972         
      Section 2 of Pub. L. 92-387 provided that: "The Federal
    Government which is responsible for regulating drugs has no ready
    means of determining what drugs are actually being manufactured or
    packed by establishments registered under the Federal Food, Drug,
    and Cosmetic Act [this chapter] except by periodic inspection of
    such registered establishments. Knowledge of which particular drugs
    are being manufactured or packed by each registered establishment
    would substantially assist in the enforcement of Federal laws
    requiring that such drugs be pure, safe, effective, and properly
    labeled. Information on the discontinuance of a particular drug
    could serve to alleviate the burden of reviewing and implementing
    enforcement actions against drugs which, although commercially
    discontinued, remain active for regulatory purposes. Information on
    the type and number of different drugs being manufactured or packed
    by drug establishments could permit more effective and timely
    regulation by the agencies of the Federal Government responsible
    for regulating drugs, including identification of which drugs in
    interstate commerce are subject to section 505 or 507 [section 355
    or 357 of this title], or to other provisions of the Federal Food,
    Drug, and Cosmetic Act."

         REGISTRATION OF CERTAIN PERSONS OWNING OR OPERATING DRUG
                   ESTABLISHMENTS PRIOR TO OCT. 10, 1962
      Section 303 of Pub. L. 87-781 provided that any person who, on
    the day immediately preceding Oct. 10, 1962, owned or operated an
    establishment which manufactured or processed drugs, registered
    before the first day of the seventh month following October, 1962,
    would be deemed to be registered in accordance with subsec. (b) of
    this section for the calendar year 1962 and if registered within
    this period and effected in 1963, be deemed in compliance for that
    calendar year.

-End-



-CITE-
    21 USC Sec. 360a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360a. Repealed.

-MISC1-
    Sec. 360a. Repealed. Pub. L. 91-513, title II, Sec. 701(a), Oct.
      27, 1970, 84 Stat. 1281.
      Section, act June 25, 1938, ch. 675, Sec. 511, as added July 15,
    1965, Pub. L. 89-74, Sec. 3(b), 79 Stat. 227; amended Oct. 24,
    1968, Pub. L. 90-639, Sec. 2(a), 82 Stat. 1361, regulated the
    manufacture, compounding, and processing of depressant and
    stimulant drugs and their sale, delivery, disposal, possession, and
    recordkeeping activities connected therewith. See section 801 et
    seq. of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                             SAVINGS PROVISION                         
      Repeal not to affect or abate any prosecutions for violation of
    law or any civil seizures or forfeitures and injunctive proceedings
    commenced prior to the effective date of such repeal, and all
    administrative proceedings pending before the Bureau of Narcotics
    and Dangerous Drugs [now Drug Enforcement Administration] on Oct.
    27, 1970, to be continued and brought to final determination in
    accord with laws and regulations in effect prior to Oct. 27, 1970,
    see section 702 of Pub. L. 91-513, set out as a note under section
    321 of this title.

-End-



-CITE-
    21 USC Sec. 360b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360b. New animal drugs

-STATUTE-
    (a) Unsafe new animal drugs and animal feed containing such drugs;
      conditions of safety; exemption of drugs for research; import
      tolerances
      (1) A new animal drug shall, with respect to any particular use
    or intended use of such drug, be deemed unsafe for purposes of
    section 351(a)(5) of this title and section 342(a)(2)(C)(ii) of
    this title unless - 
        (A) there is in effect an approval of an application filed
      pursuant to subsection (b) of this section with respect to such
      use or intended use of such drug, and such drug, its labeling,
      and such use conform to such approved application;
        (B) there is in effect a conditional approval of an application
      filed pursuant to section 360ccc of this title with respect to
      such use or intended use of such drug, and such drug, its
      labeling, and such use conform to such conditionally approved
      application; or
        (C) there is in effect an index listing pursuant to section
      360ccc-1 of this title with respect to such use or intended use
      of such drug in a minor species, and such drug, its labeling, and
      such use conform to such index listing.

    A new animal drug shall also be deemed unsafe for such purposes in
    the event of removal from the establishment of a manufacturer,
    packer, or distributor of such drug for use in the manufacture of
    animal feed in any State unless at the time of such removal such
    manufacturer, packer, or distributor has an unrevoked written
    statement from the consignee of such drug, or notice from the
    Secretary, to the effect that, with respect to the use of such drug
    in animal feed, such consignee (i) holds a license issued under
    subsection (m) of this section and has in its possession current
    approved labeling for such drug in animal feed; or (ii) will, if
    the consignee is not a user of the drug, ship such drug only to a
    holder of a license issued under subsection (m) of this section.
      (2) An animal feed bearing or containing a new animal drug shall,
    with respect to any particular use or intended use of such animal
    feed be deemed unsafe for purposes of section 351(a)(6) of this
    title unless - 
        (A) there is in effect - 
          (i) an approval of an application filed pursuant to
        subsection (b) of this section with respect to such drug, as
        used in such animal feed, and such animal feed and its
        labeling, distribution, holding, and use conform to such
        approved application;
          (ii) a conditional approval of an application filed pursuant
        to section 360ccc of this title with respect to such drug, as
        used in such animal feed, and such animal feed and its
        labeling, distribution, holding, and use conform to such
        conditionally approved application; or
          (iii) an index listing pursuant to section 360ccc-1 of this
        title with respect to such drug, as used in such animal feed,
        and such animal feed and its labeling, distribution, holding,
        and use conform to such index listing; and

        (B) such animal feed is manufactured at a site for which there
      is in effect a license issued pursuant to subsection (m)(1) of
      this section to manufacture such animal feed.

      (3) A new animal drug or an animal feed bearing or containing a
    new animal drug shall not be deemed unsafe for the purposes of
    section 351(a)(5) or (6) of this title if such article is for
    investigational use and conforms to the terms of an exemption in
    effect with respect thereto under subsection (j) of this section.
      (4)(A) Except as provided in subparagraph (B), if an approval of
    an application filed under subsection (b) of this section is in
    effect with respect to a particular use or intended use of a new
    animal drug, the drug shall not be deemed unsafe for the purposes
    of paragraph (1) and shall be exempt from the requirements of
    section 352(f) of this title with respect to a different use or
    intended use of the drug, other than a use in or on animal feed, if
    such use or intended use - 
        (i) is by or on the lawful written or oral order of a licensed
      veterinarian within the context of a veterinarian-client-patient
      relationship, as defined by the Secretary; and
        (ii) is in compliance with regulations promulgated by the
      Secretary that establish the conditions for such different use or
      intended use.

    The regulations promulgated by the Secretary under clause (ii) may
    prohibit particular uses of an animal drug and shall not permit
    such different use of an animal drug if the labeling of another
    animal drug that contains the same active ingredient and which is
    in the same dosage form and concentration provides for such
    different use.
      (B) If the Secretary finds that there is a reasonable probability
    that a use of an animal drug authorized under subparagraph (A) may
    present a risk to the public health, the Secretary may - 
        (i) establish a safe level for a residue of an animal drug when
      it is used for such different use authorized by subparagraph (A);
      and
        (ii) require the development of a practical, analytical method
      for the detection of residues of such drug above the safe level
      established under clause (i).

    The use of an animal drug that results in residues exceeding a safe
    level established under clause (i) shall be considered an unsafe
    use of such drug under paragraph (1). Safe levels may be
    established under clause (i) either by regulation or order.
      (C) The Secretary may by general regulation provide access to the
    records of veterinarians to ascertain any use or intended use
    authorized under subparagraph (A) that the Secretary has determined
    may present a risk to the public health.
      (D) If the Secretary finds, after affording an opportunity for
    public comment, that a use of an animal drug authorized under
    subparagraph (A) presents a risk to the public health or that an
    analytical method required under subparagraph (B) has not been
    developed and submitted to the Secretary, the Secretary may, by
    order, prohibit any such use.
      (5) If the approval of an application filed under section 355 of
    this title is in effect, the drug under such application shall not
    be deemed unsafe for purposes of paragraph (1) and shall be exempt
    from the requirements of section 352(f) of this title with respect
    to a use or intended use of the drug in animals if such use or
    intended use - 
        (A) is by or on the lawful written or oral order of a licensed
      veterinarian within the context of a veterinarian-client-patient
      relationship, as defined by the Secretary; and
        (B) is in compliance with regulations promulgated by the
      Secretary that establish the conditions for the use or intended
      use of the drug in animals.
      (6) For purposes of section 342(a)(2)(D) (!1) of this title, a
    use or intended use of a new animal drug shall not be deemed unsafe
    under this section if the Secretary establishes a tolerance for
    such drug and any edible portion of any animal imported into the
    United States does not contain residues exceeding such tolerance.
    In establishing such tolerance, the Secretary shall rely on data
    sufficient to demonstrate that a proposed tolerance is safe based
    on similar food safety criteria used by the Secretary to establish
    tolerances for applications for new animal drugs filed under
    subsection (b)(1) of this section. The Secretary may consider and
    rely on data submitted by the drug manufacturer, including data
    submitted to appropriate regulatory authorities in any country
    where the new animal drug is lawfully used or data available from a
    relevant international organization, to the extent such data are
    not inconsistent with the criteria used by the Secretary to
    establish a tolerance for applications for new animal drugs filed
    under subsection (b)(1) of this section. For purposes of this
    paragraph, "relevant international organization" means the Codex
    Alimenterius (!2) Commission or other international organization
    deemed appropriate by the Secretary. The Secretary may, under
    procedures specified by regulation, revoke a tolerance established
    under this paragraph if information demonstrates that the use of
    the new animal drug under actual use conditions results in food
    being imported into the United States with residues exceeding the
    tolerance or if scientific evidence shows the tolerance to be
    unsafe.


    (b) Filing application for uses of new animal drug; contents;
      patent information; abbreviated application; presubmission
      conference
      (1) Any person may file with the Secretary an application with
    respect to any intended use or uses of a new animal drug. Such
    person shall submit to the Secretary as a part of the application
    (A) full reports of investigations which have been made to show
    whether or not such drug is safe and effective for use; (B) a full
    list of the articles used as components of such drug; (C) a full
    statement of the composition of such drug; (D) a full description
    of the methods used in, and the facilities and controls used for,
    the manufacture, processing, and packing of such drug; (E) such
    samples of such drug and of the articles used as components
    thereof, of any animal feed for use in or on which such drug is
    intended, and of the edible portions or products (before or after
    slaughter) of animals to which such drug (directly or in or on
    animal feed) is intended to be administered, as the Secretary may
    require; (F) specimens of the labeling proposed to be used for such
    drug, or in case such drug is intended for use in animal feed,
    proposed labeling appropriate for such use, and specimens of the
    labeling for the drug to be manufactured, packed, or distributed by
    the applicant; (G) a description of practicable methods for
    determining the quantity, if any, of such drug in or on food, and
    any substance formed in or on food, because of its use; and (H) the
    proposed tolerance or withdrawal period or other use restrictions
    for such drug if any tolerance or withdrawal period or other use
    restrictions are required in order to assure that the proposed use
    of such drug will be safe. The applicant shall file with the
    application the patent number and the expiration date of any patent
    which claims the new animal drug for which the applicant filed the
    application or which claims a method of using such drug and with
    respect to which a claim of patent infringement could reasonably be
    asserted if a person not licensed by the owner engaged in the
    manufacture, use, or sale of the drug. If an application is filed
    under this subsection for a drug and a patent which claims such
    drug or a method of using such drug is issued after the filing date
    but before approval of the application, the applicant shall amend
    the application to include the information required by the
    preceding sentence. Upon approval of the application, the Secretary
    shall publish information submitted under the two preceding
    sentences.
      (2) Any person may file with the Secretary an abbreviated
    application for the approval of a new animal drug. An abbreviated
    application shall contain the information required by subsection
    (n) of this section.
      (3) Any person intending to file an application under paragraph
    (1), section 360ccc of this title, or a request for an
    investigational exemption under subsection (j) of this section
    shall be entitled to one or more conferences prior to such
    submission to reach an agreement acceptable to the Secretary
    establishing a submission or an investigational requirement, which
    may include a requirement for a field investigation. A decision
    establishing a submission or an investigational requirement shall
    bind the Secretary and the applicant or requestor unless (A) the
    Secretary and the applicant or requestor mutually agree to modify
    the requirement, or (B) the Secretary by written order determines
    that a substantiated scientific requirement essential to the
    determination of safety or effectiveness of the animal drug
    involved has appeared after the conference. No later than 25
    calendar days after each such conference, the Secretary shall
    provide a written order setting forth a scientific justification
    specific to the animal drug and intended uses under consideration
    if the agreement referred to in the first sentence requires more
    than one field investigation as being essential to provide
    substantial evidence of effectiveness for the intended uses of the
    drug. Nothing in this paragraph shall be construed as compelling
    the Secretary to require a field investigation.
    (c) Period for submission and approval of application; period for
      notice and expedition of hearing; period for issuance of order;
      abbreviated applications; withdrawal periods; effective date of
      approval; relationship to other applications; withdrawal or
      suspension of approval; bioequivalence; filing of additional
      patent information
      (1) Within one hundred and eighty days after the filing of an
    application pursuant to subsection (b) of this section, or such
    additional period as may be agreed upon by the Secretary and the
    applicant, the Secretary shall either (A) issue an order approving
    the application if he then finds that none of the grounds for
    denying approval specified in subsection (d) of this section
    applies, or (B) give the applicant notice of an opportunity for a
    hearing before the Secretary under subsection (d) of this section
    on the question whether such application is approvable. If the
    applicant elects to accept the opportunity for a hearing by written
    request within thirty days after such notice, such hearing shall
    commence not more than ninety days after the expiration of such
    thirty days unless the Secretary and the applicant otherwise agree.
    Any such hearing shall thereafter be conducted on an expedited
    basis and the Secretary's order thereon shall be issued within
    ninety days after the date fixed by the Secretary for filing final
    briefs.
      (2)(A) Subject to subparagraph (C), the Secretary shall approve
    an abbreviated application for a drug unless the Secretary finds - 
        (i) the methods used in, or the facilities and controls used
      for, the manufacture, processing, and packing of the drug are
      inadequate to assure and preserve its identity, strength,
      quality, and purity;
        (ii) the conditions of use prescribed, recommended, or
      suggested in the proposed labeling are not reasonably certain to
      be followed in practice or, except as provided in subparagraph
      (B), information submitted with the application is insufficient
      to show that each of the proposed conditions of use or similar
      limitations (whether in the labeling or published pursuant to
      subsection (i) of this section) have been previously approved for
      the approved new animal drug referred to in the application;
        (iii) information submitted with the application is
      insufficient to show that the active ingredients are the same as
      those of the approved new animal drug referred to in the
      application;
        (iv)(I) if the application is for a drug whose active
      ingredients, route of administration, dosage form, strength, or
      use with other animal drugs in animal feed is the same as the
      active ingredients, route of administration, dosage form,
      strength, or use with other animal drugs in animal feed of the
      approved new animal drug referred to in the application,
      information submitted in the application is insufficient to show
      that the active ingredients, route of administration, dosage
      form, strength, or use with other animal drugs in animal feed is
      the same as that of the approved new animal drug, or
        (II) if the application is for a drug whose active ingredients,
      route of administration, dosage form, strength, or use with other
      animal drugs in animal feed is different from that of the
      approved new animal drug referred to in the application, no
      petition to file an application for the drug with the different
      active ingredients, route of administration, dosage form,
      strength, or use with other animal drugs in animal feed was
      approved under subsection (n)(3) of this section;
        (v) if the application was filed pursuant to the approval of a
      petition under subsection (n)(3) of this section, the application
      did not contain the information required by the Secretary
      respecting the active ingredients, route of administration,
      dosage form, strength, or use with other animal drugs in animal
      feed which is not the same;
        (vi) information submitted in the application is insufficient
      to show that the drug is bioequivalent to the approved new animal
      drug referred to in the application, or if the application is
      filed under a petition approved pursuant to subsection (n)(3) of
      this section, information submitted in the application is
      insufficient to show that the active ingredients of the new
      animal drug are of the same pharmacological or therapeutic class
      as the pharmacological or therapeutic class of the approved new
      animal drug and that the new animal drug can be expected to have
      the same therapeutic effect as the approved new animal drug when
      used in accordance with the labeling;
        (vii) information submitted in the application is insufficient
      to show that the labeling proposed for the drug is the same as
      the labeling approved for the approved new animal drug referred
      to in the application except for changes required because of
      differences approved under a petition filed under subsection
      (n)(3) of this section, because of a different withdrawal period,
      or because the drug and the approved new animal drug are produced
      or distributed by different manufacturers;
        (viii) information submitted in the application or any other
      information available to the Secretary shows that (I) the
      inactive ingredients of the drug are unsafe for use under the
      conditions prescribed, recommended, or suggested in the labeling
      proposed for the drug, (II) the composition of the drug is unsafe
      under such conditions because of the type or quantity of inactive
      ingredients included or the manner in which the inactive
      ingredients are included, or (III) in the case of a drug for food
      producing animals, the inactive ingredients of the drug or its
      composition may be unsafe with respect to human food safety;
        (ix) the approval under subsection (b)(1) of this section of
      the approved new animal drug referred to in the application filed
      under subsection (b)(2) of this section has been withdrawn or
      suspended for grounds described in paragraph (1) of subsection
      (e) of this section, the Secretary has published a notice of a
      hearing to withdraw approval of the approved new animal drug for
      such grounds, the approval under this paragraph of the new animal
      drug for which the application under subsection (b)(2) of this
      section was filed has been withdrawn or suspended under
      subparagraph (G) for such grounds, or the Secretary has
      determined that the approved new animal drug has been withdrawn
      from sale for safety or effectiveness reasons;
        (x) the application does not meet any other requirement of
      subsection (n) of this section; or
        (xi) the application contains an untrue statement of material
      fact.

      (B) If the Secretary finds that a new animal drug for which an
    application is submitted under subsection (b)(2) of this section is
    bioequivalent to the approved new animal drug referred to in such
    application and that residues of the new animal drug are consistent
    with the tolerances established for such approved new animal drug
    but at a withdrawal period which is different than the withdrawal
    period approved for such approved new animal drug, the Secretary
    may establish, on the basis of information submitted, such
    different withdrawal period as the withdrawal period for the new
    animal drug for purposes of the approval of such application for
    such drug.
      (C) Within 180 days of the initial receipt of an application
    under subsection (b)(2) of this section or within such additional
    period as may be agreed upon by the Secretary and the applicant,
    the Secretary shall approve or disapprove the application.
      (D) The approval of an application filed under subsection (b)(2)
    of this section shall be made effective on the last applicable date
    determined under the following:
        (i) If the applicant only made a certification described in
      clause (i) or (ii) of subsection (n)(1)(G) of this section or in
      both such clauses, the approval may be made effective
      immediately.
        (ii) If the applicant made a certification described in clause
      (iii) of subsection (n)(1)(G) of this section, the approval may
      be made effective on the date certified under clause (iii).
        (iii) If the applicant made a certification described in clause
      (iv) of subsection (n)(1)(G) of this section, the approval shall
      be made effective immediately unless an action is brought for
      infringement of a patent which is the subject of the
      certification before the expiration of 45 days from the date the
      notice provided under subsection (n)(2)(B)(i) of this section is
      received. If such an action is brought before the expiration of
      such days, the approval shall be made effective upon the
      expiration of the 30 month period beginning on the date of the
      receipt of the notice provided under subsection (n)(2)(B) of this
      section or such shorter or longer period as the court may order
      because either party to the action failed to reasonably cooperate
      in expediting the action, except that if before the expiration of
      such period - 
          (I) the court decides that such patent is invalid or not
        infringed, the approval shall be made effective on the date of
        the court decision,
          (II) the court decides that such patent has been infringed,
        the approval shall be made effective on such date as the court
        orders under section 271(e)(4)(A) of title 35, or
          (III) the court grants a preliminary injunction prohibiting
        the applicant from engaging in the commercial manufacture or
        sale of the drug until the court decides the issues of patent
        validity and infringement and if the court decides that such
        patent is invalid or not infringed, the approval shall be made
        effective on the date of such court decision.

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action. Until the expiration of 45 days from
      the date the notice made under subsection (n)(2)(B) of this
      section is received, no action may be brought under section 2201
      of title 28 for a declaratory judgment with respect to the
      patent. Any action brought under section 2201 of title 28 shall
      be brought in the judicial district where the defendant has its
      principal place of business or a regular and established place of
      business.
        (iv) If the application contains a certification described in
      clause (iv) of subsection (n)(1)(G) of this section and is for a
      drug for which a previous application has been filed under this
      subsection containing such a certification, the application shall
      be made effective not earlier than 180 days after - 
          (I) the date the Secretary receives notice from the applicant
        under the previous application of the first commercial
        marketing of the drug under the previous application, or
          (II) the date of a decision of a court in an action described
        in subclause (III) (!3) holding the patent which is the subject
        of the certification to be invalid or not infringed,


      whichever is earlier.

      (E) If the Secretary decides to disapprove an application, the
    Secretary shall give the applicant notice of an opportunity for a
    hearing before the Secretary on the question of whether such
    application is approvable. If the applicant elects to accept the
    opportunity for hearing by written request within 30 days after
    such notice, such hearing shall commence not more than 90 days
    after the expiration of such 30 days unless the Secretary and the
    applicant otherwise agree. Any such hearing shall thereafter be
    conducted on an expedited basis and the Secretary's order thereon
    shall be issued within 90 days after the date fixed by the
    Secretary for filing final briefs.
      (F)(i) If an application submitted under subsection (b)(1) of
    this section for a drug, no active ingredient (including any ester
    or salt of the active ingredient) of which has been approved in any
    other application under subsection (b)(1) of this section, is
    approved after November 16, 1988, no application may be submitted
    under subsection (b)(2) of this section which refers to the drug
    for which the subsection (b)(1) application was submitted before
    the expiration of 5 years from the date of the approval of the
    application under subsection (b)(1) of this section, except that
    such an application may be submitted under subsection (b)(2) of
    this section after the expiration of 4 years from the date of the
    approval of the subsection (b)(1) application if it contains a
    certification of patent invalidity or noninfringement described in
    clause (iv) of subsection (n)(1)(G) of this section. The approval
    of such an application shall be made effective in accordance with
    subparagraph (B) except that, if an action for patent infringement
    is commenced during the one-year period beginning 48 months after
    the date of the approval of the subsection (b) application, the 30
    month period referred to in subparagraph (D)(iii) shall be extended
    by such amount of time (if any) which is required for seven and one-
    half years to have elapsed from the date of approval of the
    subsection (b) application.
      (ii) If an application submitted under subsection (b)(1) of this
    section for a drug, which includes an active ingredient (including
    any ester or salt of the active ingredient) that has been approved
    in another application approved under such subsection, is approved
    after November 16, 1988, and if such application contains
    substantial evidence of the effectiveness of the drug involved, any
    studies of animal safety, or, in the case of food producing
    animals, human food safety studies (other than bioequivalence
    studies or residue depletion studies, except residue depletion
    studies for minor uses or minor species) required for the approval
    of the application and conducted or sponsored by the applicant, the
    Secretary may not make the approval of an application submitted
    under subsection (b)(2) of this section for the conditions of
    approval of such drug in the subsection (b)(1) application
    effective before the expiration of 3 years from the date of the
    approval of the application under subsection (b)(1) of this section
    for such drug.
      (iii) If a supplement to an application approved under subsection
    (b)(1) of this section is approved after November 16, 1988, and the
    supplement contains substantial evidence of the effectiveness of
    the drug involved, any studies of animal safety, or, in the case of
    food producing animals, human food safety studies (other than
    bioequivalence studies or residue depletion studies, except residue
    depletion studies for minor uses or minor species) required for the
    approval of the supplement and conducted or sponsored by the person
    submitting the supplement, the Secretary may not make the approval
    of an application submitted under subsection (b)(2) of this section
    for a change approved in the supplement effective before the
    expiration of 3 years from the date of the approval of the
    supplement.
      (iv) An applicant under subsection (b)(1) of this section who
    comes within the provisions of clause (i) of this subparagraph as a
    result of an application which seeks approval for a use solely in
    non-food producing animals, may elect, within 10 days of receiving
    such approval, to waive clause (i) of this subparagraph, in which
    event the limitation on approval of applications submitted under
    subsection (b)(2) of this section set forth in clause (ii) of this
    subparagraph shall be applicable to the subsection (b)(1)
    application.
      (v) If an application (including any supplement to a new animal
    drug application) submitted under subsection (b)(1) of this section
    for a new animal drug for a food-producing animal use, which
    includes an active ingredient (including any ester or salt of the
    active ingredient) which has been the subject of a waiver under
    clause (iv) is approved after November 16, 1988, and if the
    application contains substantial evidence of the effectiveness of
    the drug involved, any studies of animal safety, or human food
    safety studies (other than bioequivalence studies or residue
    depletion studies, except residue depletion studies for minor uses
    or minor species) required for the new approval of the application
    and conducted or sponsored by the applicant, the Secretary may not
    make the approval of an application (including any supplement to
    such application) submitted under subsection (b)(2) of this section
    for the new conditions of approval of such drug in the subsection
    (b)(1) application effective before the expiration of five years
    from the date of approval of the application under subsection
    (b)(1) of this section for such drug. The provisions of this
    paragraph shall apply only to the first approval for a food-
    producing animal use for the same applicant after the waiver under
    clause (iv).
      (G) If an approved application submitted under subsection (b)(2)
    of this section for a new animal drug refers to a drug the approval
    of which was withdrawn or suspended for grounds described in
    paragraph (1) or (2) of subsection (e) of this section or was
    withdrawn or suspended under this subparagraph or which, as
    determined by the Secretary, has been withdrawn from sale for
    safety or effectiveness reasons, the approval of the drug under
    this paragraph shall be withdrawn or suspended - 
        (i) for the same period as the withdrawal or suspension under
      subsection (e) of this section or this subparagraph, or
        (ii) if the approved new animal drug has been withdrawn from
      sale, for the period of withdrawal from sale or, if earlier, the
      period ending on the date the Secretary determines that the
      withdrawal from sale is not for safety or effectiveness reasons.

      (H) For purposes of this paragraph:
        (i) The term "bioequivalence" means the rate and extent to
      which the active ingredient or therapeutic ingredient is absorbed
      from a new animal drug and becomes available at the site of drug
      action.
        (ii) A new animal drug shall be considered to be bioequivalent
      to the approved new animal drug referred to in its application
      under subsection (n) of this section if - 
          (I) the rate and extent of absorption of the drug do not show
        a significant difference from the rate and extent of absorption
        of the approved new animal drug referred to in the application
        when administered at the same dose of the active ingredient
        under similar experimental conditions in either a single dose
        or multiple doses;
          (II) the extent of absorption of the drug does not show a
        significant difference from the extent of absorption of the
        approved new animal drug referred to in the application when
        administered at the same dose of the active ingredient under
        similar experimental conditions in either a single dose or
        multiple doses and the difference from the approved new animal
        drug in the rate of absorption of the drug is intentional, is
        reflected in its proposed labeling, is not essential to the
        attainment of effective drug concentrations in use, and is
        considered scientifically insignificant for the drug in
        attaining the intended purposes of its use and preserving human
        food safety; or
          (III) in any case in which the Secretary determines that the
        measurement of the rate and extent of absorption or excretion
        of the new animal drug in biological fluids is inappropriate or
        impractical, an appropriate acute pharmacological effects test
        or other test of the new animal drug and, when deemed
        scientifically necessary, of the approved new animal drug
        referred to in the application in the species to be tested or
        in an appropriate animal model does not show a significant
        difference between the new animal drug and such approved new
        animal drug when administered at the same dose under similar
        experimental conditions.

      If the approved new animal drug referred to in the application
      for a new animal drug under subsection (n) of this section is
      approved for use in more than one animal species, the
      bioequivalency information described in subclauses (I), (II), and
      (III) shall be obtained for one species, or if the Secretary
      deems appropriate based on scientific principles, shall be
      obtained for more than one species. The Secretary may prescribe
      the dose to be used in determining bioequivalency under subclause
      (I), (II), or (III). To assure that the residues of the new
      animal drug will be consistent with the established tolerances
      for the approved new animal drug referred to in the application
      under subsection (b)(2) of this section upon the expiration of
      the withdrawal period contained in the application for the new
      animal drug, the Secretary shall require bioequivalency data or
      residue depletion studies of the new animal drug or such other
      data or studies as the Secretary considers appropriate based on
      scientific principles. If the Secretary requires one or more
      residue studies under the preceding sentence, the Secretary may
      not require that the assay methodology used to determine the
      withdrawal period of the new animal drug be more rigorous than
      the methodology used to determine the withdrawal period for the
      approved new animal drug referred to in the application. If such
      studies are required and if the approved new animal drug,
      referred to in the application for the new animal drug for which
      such studies are required, is approved for use in more than one
      animal species, such studies shall be conducted for one species,
      or if the Secretary deems appropriate based on scientific
      principles, shall be conducted for more than one species.

      (3) If the patent information described in subsection (b)(1) of
    this section could not be filed with the submission of an
    application under subsection (b)(1) of this section because the
    application was filed before the patent information was required
    under subsection (b)(1) of this section or a patent was issued
    after the application was approved under such subsection, the
    holder of an approved application shall file with the Secretary the
    patent number and the expiration date of any patent which claims
    the new animal drug for which the application was filed or which
    claims a method of using such drug and with respect to which a
    claim of patent infringement could reasonably be asserted if a
    person not licensed by the owner engaged in the manufacture, use,
    or sale of the drug. If the holder of an approved application could
    not file patent information under subsection (b)(1) of this section
    because it was not required at the time the application was
    approved, the holder shall file such information under this
    subsection not later than 30 days after November 16, 1988, and if
    the holder of an approved application could not file patent
    information under subsection (b)(1) of this section because no
    patent had been issued when an application was filed or approved,
    the holder shall file such information under this subsection not
    later than 30 days after the date the patent involved is issued.
    Upon the submission of patent information under this subsection,
    the Secretary shall publish it.
      (4) A drug manufactured in a pilot or other small facility may be
    used to demonstrate the safety and effectiveness of the drug and to
    obtain approval for the drug prior to manufacture of the drug in a
    larger facility, unless the Secretary makes a determination that a
    full scale production facility is necessary to ensure the safety or
    effectiveness of the drug.
    (d) Grounds for refusing application; approval of application;
      factors; "substantial evidence" defined; combination drugs
      (1) If the Secretary finds, after due notice to the applicant in
    accordance with subsection (c) of this section and giving him an
    opportunity for a hearing, in accordance with said subsection, that
    - 
        (A) the investigations, reports of which are required to be
      submitted to the Secretary pursuant to subsection (b) of this
      section, do not include adequate tests by all methods reasonably
      applicable to show whether or not such drug is safe for use under
      the conditions prescribed, recommended, or suggested in the
      proposed labeling thereof;
        (B) the results of such tests show that such drug is unsafe for
      use under such conditions or do not show that such drug is safe
      for use under such conditions;
        (C) the methods used in, and the facilities and controls used
      for, the manufacture, processing, and packing of such drug are
      inadequate to preserve its identity, strength, quality, and
      purity;
        (D) upon the basis of the information submitted to him as part
      of the application, or upon the basis of any other information
      before him with respect to such drug, he has insufficient
      information to determine whether such drug is safe for use under
      such conditions;
        (E) evaluated on the basis of the information submitted to him
      as part of the application and any other information before him
      with respect to such drug, there is a lack of substantial
      evidence that the drug will have the effect it purports or is
      represented to have under the conditions of use prescribed,
      recommended, or suggested in the proposed labeling thereof;
        (F) upon the basis of information submitted to the Secretary as
      part of the application or any other information before the
      Secretary with respect to such drug, any use prescribed,
      recommended, or suggested in labeling proposed for such drug will
      result in a residue of such drug in excess of a tolerance found
      by the Secretary to be safe for such drug;
        (G) the application failed to contain the patent information
      prescribed by subsection (b)(1) of this section;
        (H) based on a fair evaluation of all material facts, such
      labeling is false or misleading in any particular; or
        (I) such drug induces cancer when ingested by man or animal or,
      after tests which are appropriate for the evaluation of the
      safety of such drug, induces cancer in man or animal, except that
      the foregoing provisions of this subparagraph shall not apply
      with respect to such drug if the Secretary finds that, under the
      conditions of use specified in proposed labeling and reasonably
      certain to be followed in practice (i) such drug will not
      adversely affect the animals for which it is intended, and (ii)
      no residue of such drug will be found (by methods of examination
      prescribed or approved by the Secretary by regulations, which
      regulations shall not be subject to subsections (c), (d), and (h)
      of this section), in any edible portion of such animals after
      slaughter or in any food yielded by or derived from the living
      animals;

    he shall issue an order refusing to approve the application. If,
    after such notice and opportunity for hearings, the Secretary finds
    that subparagraphs (A) through (I) do not apply, he shall issue an
    order approving the application.
      (2) In determining whether such drug is safe for use under the
    conditions prescribed, recommended, or suggested in the proposed
    labeling thereof, the Secretary shall consider, among other
    relevant factors, (A) the probable consumption of such drug and of
    any substance formed in or on food because of the use of such drug,
    (B) the cumulative effect on man or animal of such drug, taking
    into account any chemically or pharmacologically related substance,
    (C) safety factors which in the opinion of experts, qualified by
    scientific training and experience to evaluate the safety of such
    drugs, are appropriate for the use of animal experimentation data,
    and (D) whether the conditions of use prescribed, recommended, or
    suggested in the proposed labeling are reasonably certain to be
    followed in practice. Any order issued under this subsection
    refusing to approve an application shall state the findings upon
    which it is based.
      (3) As used in this section, the term "substantial evidence"
    means evidence consisting of one or more adequate and well
    controlled investigations, such as - 
        (A) a study in a target species;
        (B) a study in laboratory animals;
        (C) any field investigation that may be required under this
      section and that meets the requirements of subsection (b)(3) of
      this section if a presubmission conference is requested by the
      applicant;
        (D) a bioequivalence study; or
        (E) an in vitro study;

    by experts qualified by scientific training and experience to
    evaluate the effectiveness of the drug involved, on the basis of
    which it could fairly and reasonably be concluded by such experts
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the labeling or proposed labeling thereof.
      (4) In a case in which an animal drug contains more than one
    active ingredient, or the labeling of the drug prescribes,
    recommends, or suggests use of the drug in combination with one or
    more other animal drugs, and the active ingredients or drugs
    intended for use in the combination have previously been separately
    approved pursuant to an application submitted under subsection
    (b)(1) of this section for particular uses and conditions of use
    for which they are intended for use in the combination - 
        (A) the Secretary shall not issue an order under paragraph
      (1)(A), (1)(B), or (1)(D) refusing to approve the application for
      such combination on human food safety grounds unless the
      Secretary finds that the application fails to establish that - 
          (i) none of the active ingredients or drugs intended for use
        in the combination, respectively, at the longest withdrawal
        time of any of the active ingredients or drugs in the
        combination, respectively, exceeds its established tolerance;
        or
          (ii) none of the active ingredients or drugs in the
        combination interferes with the methods of analysis for another
        of the active ingredients or drugs in the combination,
        respectively;

        (B) the Secretary shall not issue an order under paragraph
      (1)(A), (1)(B), or (1)(D) refusing to approve the application for
      such combination on target animal safety grounds unless the
      Secretary finds that - 
          (i)(I) there is a substantiated scientific issue, specific to
        one or more of the active ingredients or animal drugs in the
        combination, that cannot adequately be evaluated based on
        information contained in the application for the combination
        (including any investigations, studies, or tests for which the
        applicant has a right of reference or use from the person by or
        for whom the investigations, studies, or tests were conducted);
        or
          (II) there is a scientific issue raised by target animal
        observations contained in studies submitted to the Secretary as
        part of the application; and
          (ii) based on the Secretary's evaluation of the information
        contained in the application with respect to the issues
        identified in clauses (i)(I) and (II), paragraph (1)(A), (B),
        or (D) apply;

        (C) except in the case of a combination that contains a
      nontopical antibacterial ingredient or animal drug, the Secretary
      shall not issue an order under paragraph (1)(E) refusing to
      approve an application for a combination animal drug intended for
      use other than in animal feed or drinking water unless the
      Secretary finds that the application fails to demonstrate that - 
          (i) there is substantial evidence that any active ingredient
        or animal drug intended only for the same use as another active
        ingredient or animal drug in the combination makes a
        contribution to labeled effectiveness;
          (ii) each active ingredient or animal drug intended for at
        least one use that is different from all other active
        ingredients or animal drugs used in the combination provides
        appropriate concurrent use for the intended target population;
        or
          (iii) where based on scientific information the Secretary has
        reason to believe the active ingredients or animal drugs may be
        physically incompatible or have disparate dosing regimens, such
        active ingredients or animal drugs are physically compatible or
        do not have disparate dosing regimens; and

        (D) the Secretary shall not issue an order under paragraph
      (1)(E) refusing to approve an application for a combination
      animal drug intended for use in animal feed or drinking water
      unless the Secretary finds that the application fails to
      demonstrate that - 
          (i) there is substantial evidence that any active ingredient
        or animal drug intended only for the same use as another active
        ingredient or animal drug in the combination makes a
        contribution to the labeled effectiveness;
          (ii) each of the active ingredients or animal drugs intended
        for at least one use that is different from all other active
        ingredients or animal drugs used in the combination provides
        appropriate concurrent use for the intended target population;
          (iii) where a combination contains more than one nontopical
        antibacterial ingredient or animal drug, there is substantial
        evidence that each of the nontopical antibacterial ingredients
        or animal drugs makes a contribution to the labeled
        effectiveness, except that for purposes of this clause,
        antibacterial ingredient or animal drug does not include the
        ionophore or arsenical classes of animal drugs; or
          (iv) where based on scientific information the Secretary has
        reason to believe the active ingredients or animal drugs
        intended for use in drinking water may be physically
        incompatible, such active ingredients or animal drugs intended
        for use in drinking water are physically compatible.

      (5) In reviewing an application that proposes a change to add an
    intended use for a minor use or a minor species to an approved new
    animal drug application, the Secretary shall reevaluate only the
    relevant information in the approved application to determine
    whether the application for the minor use or minor species can be
    approved. A decision to approve the application for the minor use
    or minor species is not, implicitly or explicitly, a reaffirmation
    of the approval of the original application.
    (e) Withdrawal of approval; grounds; immediate suspension upon
      finding imminent hazard to health of man or animals
      (1) The Secretary shall, after due notice and opportunity for
    hearing to the applicant, issue an order withdrawing approval of an
    application filed pursuant to subsection (b) of this section with
    respect to any new animal drug if the Secretary finds - 
        (A) that experience or scientific data show that such drug is
      unsafe for use under the conditions of use upon the basis of
      which the application was approved or the condition of use
      authorized under subsection (a)(4)(A) of this section;
        (B) that new evidence not contained in such application or not
      available to the Secretary until after such application was
      approved, or tests by new methods, or tests by methods not deemed
      reasonably applicable when such application was approved,
      evaluated together with the evidence available to the Secretary
      when the application was approved, shows that such drug is not
      shown to be safe for use under the conditions of use upon the
      basis of which the application was approved or that subparagraph
      (I) of paragraph (1) of subsection (d) of this section applies to
      such drug;
        (C) on the basis of new information before him with respect to
      such drug, evaluated together with the evidence available to him
      when the application was approved, that there is a lack of
      substantial evidence that such drug will have the effect it
      purports or is represented to have under the conditions of use
      prescribed, recommended, or suggested in the labeling thereof;
        (D) the patent information prescribed by subsection (c)(3) of
      this section was not filed within 30 days after the receipt of
      written notice from the Secretary specifying the failure to file
      such information;
        (E) that the application contains any untrue statement of a
      material fact; or
        (F) that the applicant has made any changes from the standpoint
      of safety or effectiveness beyond the variations provided for in
      the application unless he has supplemented the application by
      filing with the Secretary adequate information respecting all
      such changes and unless there is in effect an approval of the
      supplemental application. The supplemental application shall be
      treated in the same manner as the original application.

    If the Secretary (or in his absence the officer acting as
    Secretary) finds that there is an imminent hazard to the health of
    man or of the animals for which such drug is intended, he may
    suspend the approval of such application immediately, and give the
    applicant prompt notice of his action and afford the applicant the
    opportunity for an expedited hearing under this subsection; but the
    authority conferred by this sentence to suspend the approval of an
    application shall not be delegated.
      (2) The Secretary may also, after due notice and opportunity for
    hearing to the applicant, issue an order withdrawing the approval
    of an application with respect to any new animal drug under this
    section if the Secretary finds - 
        (A) that the applicant has failed to establish a system for
      maintaining required records, or has repeatedly or deliberately
      failed to maintain such records or to make required reports in
      accordance with a regulation or order under subsection (1) of
      this section, or the applicant has refused to permit access to,
      or copying or verification of, such records as required by
      paragraph (2) of such subsection;
        (B) that on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, the methods used in, or the facilities and controls
      used for, the manufacture, processing, and packing of such drug
      are inadequate to assure and preserve its identity, strength,
      quality, and purity and were not made adequate within a
      reasonable time after receipt of written notice from the
      Secretary specifying the matter complained of; or
        (C) that on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, the labeling of such drug, based on a fair evaluation
      of all material facts, is false or misleading in any particular
      and was not corrected within a reasonable time after receipt of
      written notice from the Secretary specifying the matter
      complained of.

      (3) Any order under this subsection shall state the findings upon
    which it is based.
    (f) Revocation of order refusing, withdrawing or suspending
      approval of application
      Whenever the Secretary finds that the facts so require, he shall
    revoke any previous order under subsection (d), (e), or (m) of this
    section, or section 360ccc(c), (d), or (e) of this title refusing,
    withdrawing, or suspending approval of an application and shall
    approve such application or reinstate such approval, as may be
    appropriate.
    (g) Service of orders
      Orders of the Secretary issued under this section, or section
    360ccc of this title (other than orders issuing, amending, or
    repealing regulations) shall be served (1) in person by any officer
    or employee of the department designated by the Secretary or (2) by
    mailing the order by registered mail or by certified mail addressed
    to the applicant or respondent at his last known address in the
    records of the Secretary.
    (h) Appeal from order
      An appeal may be taken by the applicant from an order of the
    Secretary refusing or withdrawing approval of an application filed
    under subsection (b) or (m) of this section. The provisions of
    subsection (h) of section 355 of this title shall govern any such
    appeal.
    (i) Publication in Federal Register; effective date and revocation
      or suspension of regulation
      When a new animal drug application filed pursuant to subsection
    (b) of this section or section 360ccc of this title is approved,
    the Secretary shall by notice, which upon publication shall be
    effective as a regulation, publish in the Federal Register the name
    and address of the applicant and the conditions and indications of
    use of the new animal drug covered by such application, including
    any tolerance and withdrawal period or other use restrictions and,
    if such new animal drug is intended for use in animal feed,
    appropriate purposes and conditions of use (including special
    labeling requirements and any requirement that an animal feed
    bearing or containing the new animal drug be limited to use under
    the professional supervision of a licensed veterinarian) applicable
    to any animal feed for use in which such drug is approved, and such
    other information, upon the basis of which such application was
    approved, as the Secretary deems necessary to assure the safe and
    effective use of such drug. Upon withdrawal of approval of such new
    animal drug application or upon its suspension or upon failure to
    renew a conditional approval under section 360ccc of this title,
    the Secretary shall forthwith revoke or suspend, as the case may
    be, the regulation published pursuant to this subsection (i)
    insofar as it is based on the approval of such application.
    (j) Exemption of drugs for research; discretionary and mandatory
      conditions
      To the extent consistent with the public health, the Secretary
    shall promulgate regulations for exempting from the operation of
    this section new animal drugs, and animal feeds bearing or
    containing new animal drugs, intended solely for investigational
    use by experts qualified by scientific training and experience to
    investigate the safety and effectiveness of animal drugs. Such
    regulations may, in the discretion of the Secretary, among other
    conditions relating to the protection of the public health, provide
    for conditioning such exemption upon the establishment and
    maintenance of such records, and the making of such reports to the
    Secretary, by the manufacturer or the sponsor of the investigation
    of such article, of data (including but not limited to analytical
    reports by investigators) obtained as a result of such
    investigational use of such article, as the Secretary finds will
    enable him to evaluate the safety and effectiveness of such article
    in the event of the filing of an application pursuant to this
    section. Such regulations, among other things, shall set forth the
    conditions (if any) upon which animals treated with such articles,
    and any products of such animals (before or after slaughter), may
    be marketed for food use.
    (k) Food containing new animal drug considered unadulterated while
      approval of application for such drug is effective
      While approval of an application for a new animal drug is
    effective, a food shall not, by reason of bearing or containing
    such drug or any substance formed in or on the food because of its
    use in accordance with such application (including the conditions
    and indications of use prescribed pursuant to subsection (i) of
    this section), be considered adulterated within the meaning of
    clause (1) of section 342(a) of this title.
    (l) Records and reports; required information; regulations and
      orders; examination of data; access to records
      (1) In the case of any new animal drug for which an approval of
    an application filed pursuant to subsection (b) of this section or
    section 360ccc of this title is in effect, the applicant shall
    establish and maintain such records, and make such reports to the
    Secretary, of data relating to experience, including experience
    with uses authorized under subsection (a)(4)(A) of this section,
    and other data or information, received or otherwise obtained by
    such applicant with respect to such drug, or with respect to animal
    feeds bearing or containing such drug, as the Secretary may by
    general regulation, or by order with respect to such application,
    prescribe on the basis of a finding that such records and reports
    are necessary in order to enable the Secretary to determine, or
    facilitate a determination, whether there is or may be ground for
    invoking subsection (e) or subsection (m)(4) of this section. Such
    regulation or order shall provide, where the Secretary deems it to
    be appropriate, for the examination, upon request, by the persons
    to whom such regulation or order is applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this subsection to maintain
    records, and every person in charge or custody thereof, shall, upon
    request of an officer or employee designated by the Secretary,
    permit such officer or employee at all reasonable times to have
    access to and copy and verify such records.
    (m) Feed mill licenses
      (1) Any person may file with the Secretary an application for a
    license to manufacture animal feeds bearing or containing new
    animal drugs. Such person shall submit to the Secretary as part of
    the application (A) a full statement of the business name and
    address of the specific facility at which the manufacturing is to
    take place and the facility's registration number, (B) the name and
    signature of the responsible individual or individuals for that
    facility, (C) a certification that the animal feeds bearing or
    containing new animal drugs are manufactured and labeled in
    accordance with the applicable regulations published pursuant to
    subsection (i) of this section or for indexed new animal drugs in
    accordance with the index listing published pursuant to section
    360ccc-1(e)(2) of this title and the labeling requirements set
    forth in section 360ccc-1(h) of this title, and (D) a certification
    that the methods used in, and the facilities and controls used for,
    manufacturing, processing, packaging, and holding such animal feeds
    are in conformity with current good manufacturing practice as
    described in section 351(a)(2)(B) of this title.
      (2) Within 90 days after the filing of an application pursuant to
    paragraph (1), or such additional period as may be agreed upon by
    the Secretary and the applicant, the Secretary shall (A) issue an
    order approving the application if the Secretary then finds that
    none of the grounds for denying approval specified in paragraph (3)
    applies, or (B) give the applicant notice of an opportunity for a
    hearing before the Secretary under paragraph (3) on the question
    whether such application is approvable. The procedure governing
    such a hearing shall be the procedure set forth in the last two
    sentences of subsection (c)(1) of this section.
      (3) If the Secretary, after due notice to the applicant in
    accordance with paragraph (2) and giving the applicant an
    opportunity for a hearing in accordance with such paragraph, finds,
    on the basis of information submitted to the Secretary as part of
    the application, on the basis of a preapproval inspection, or on
    the basis of any other information before the Secretary - 
        (A) that the application is incomplete, false, or misleading in
      any particular;
        (B) that the methods used in, and the facilities and controls
      used for, the manufacture, processing, and packing of such animal
      feed are inadequate to preserve the identity, strength, quality,
      and purity of the new animal drug therein; or
        (C) that the facility manufactures animal feeds bearing or
      containing new animal drugs in a manner that does not accord with
      the specifications for manufacture or labels animal feeds bearing
      or containing new animal drugs in a manner that does not accord
      with the conditions or indications of use that are published
      pursuant to subsection (i) of this section or an index listing
      pursuant to section 360ccc-1(e) of this title,

    the Secretary shall issue an order refusing to approve the
    application. If, after such notice and opportunity for hearing, the
    Secretary finds that subparagraphs (A) through (C) do not apply,
    the Secretary shall issue an order approving the application. An
    order under this subsection approving an application for a license
    to manufacture animal feeds bearing or containing new animal drugs
    shall permit a facility to manufacture only those animal feeds
    bearing or containing new animal drugs for which there are in
    effect regulations pursuant to subsection (i) of this section or an
    index listing pursuant to section 360ccc-1(e) of this title
    relating to the use of such drugs in or on such animal feed.
      (4)(A) The Secretary shall, after due notice and opportunity for
    hearing to the applicant, revoke a license to manufacture animal
    feeds bearing or containing new animal drugs under this subsection
    if the Secretary finds - 
        (i) that the application for such license contains any untrue
      statement of a material fact; or
        (ii) that the applicant has made changes that would cause the
      application to contain any untrue statements of material fact or
      that would affect the safety or effectiveness of the animal feeds
      manufactured at the facility unless the applicant has
      supplemented the application by filing with the Secretary
      adequate information respecting all such changes and unless there
      is in effect an approval of the supplemental application.

    If the Secretary (or in the Secretary's absence the officer acting
    as the Secretary) finds that there is an imminent hazard to the
    health of humans or of the animals for which such animal feed is
    intended, the Secretary may suspend the license immediately, and
    give the applicant prompt notice of the action and afford the
    applicant the opportunity for an expedited hearing under this
    subsection; but the authority conferred by this sentence shall not
    be delegated.
      (B) The Secretary may also, after due notice and opportunity for
    hearing to the applicant, revoke a license to manufacture animal
    feed under this subsection if the Secretary finds - 
        (i) that the applicant has failed to establish a system for
      maintaining required records, or has repeatedly or deliberately
      failed to maintain such records or to make required reports in
      accordance with a regulation or order under paragraph (5)(A) of
      this subsection or section 354(a)(3)(A) of this title, or the
      applicant has refused to permit access to, or copying or
      verification of, such records as required by subparagraph (B) of
      such paragraph or section 354(a)(3)(B) of this title;
        (ii) that on the basis of new information before the Secretary,
      evaluated together with the evidence before the Secretary when
      such license was issued, the methods used in, or the facilities
      and controls used for, the manufacture, processing, packing, and
      holding of such animal feed are inadequate to assure and preserve
      the identity, strength, quality, and purity of the new animal
      drug therein, and were not made adequate within a reasonable time
      after receipt of written notice from the Secretary, specifying
      the matter complained of;
        (iii) that on the basis of new information before the
      Secretary, evaluated together with the evidence before the
      Secretary when such license was issued, the labeling of any
      animal feeds, based on a fair evaluation of all material facts,
      is false or misleading in any particular and was not corrected
      within a reasonable time after receipt of written notice from the
      Secretary specifying the matter complained of; or
        (iv) that on the basis of new information before the Secretary,
      evaluated together with the evidence before the Secretary when
      such license was issued, the facility has manufactured,
      processed, packed, or held animal feed bearing or containing a
      new animal drug adulterated under section 351(a)(6) of this title
      and the facility did not discontinue the manufacture, processing,
      packing, or holding of such animal feed within a reasonable time
      after receipt of written notice from the Secretary specifying the
      matter complained of.

      (C) The Secretary may also revoke a license to manufacture animal
    feeds under this subsection if an applicant gives notice to the
    Secretary of intention to discontinue the manufacture of all animal
    feed covered under this subsection and waives an opportunity for a
    hearing on the matter.
      (D) Any order under this paragraph shall state the findings upon
    which it is based.
      (5) When a license to manufacture animal feeds bearing or
    containing new animal drugs has been issued - 
        (A) the applicant shall establish and maintain such records,
      and make such reports to the Secretary, or (at the option of the
      Secretary) to the appropriate person or persons holding an
      approved application filed under subsection (b) of this section,
      as the Secretary may by general regulation, or by order with
      respect to such application, prescribe on the basis of a finding
      that such records and reports are necessary in order to enable
      the Secretary to determine, or facilitate a determination,
      whether there is or may be ground for invoking subsection (e) of
      this section or paragraph (4); and
        (B) every person required under this subsection to maintain
      records, and every person in charge or custody thereof, shall,
      upon request of an officer or employee designated by the
      Secretary, permit such officer or employee at all reasonable
      times to have access to and copy and verify such records.

      (6) To the extent consistent with the public health, the
    Secretary may promulgate regulations for exempting from the
    operation of this subsection facilities that manufacture, process,
    pack, or hold animal feeds bearing or containing new animal drugs.
    (n) Abbreviated applications for new animal drugs; contents,
      filing, etc.; lists of approved drugs
      (1) An abbreviated application for a new animal drug shall
    contain - 
        (A)(i) except as provided in clause (ii), information to show
      that the conditions of use or similar limitations (whether in the
      labeling or published pursuant to subsection (i) of this section)
      prescribed, recommended, or suggested in the labeling proposed
      for the new animal drug have been previously approved for a new
      animal drug listed under paragraph (4) (hereinafter in this
      subsection referred to as an "approved new animal drug"), and
        (ii) information to show that the withdrawal period at which
      residues of the new animal drug will be consistent with the
      tolerances established for the approved new animal drug is the
      same as the withdrawal period previously established for the
      approved new animal drug or, if the withdrawal period is proposed
      to be different, information showing that the residues of the new
      animal drug at the proposed different withdrawal period will be
      consistent with the tolerances established for the approved new
      animal drug;
        (B)(i) information to show that the active ingredients of the
      new animal drug are the same as those of the approved new animal
      drug, and
        (ii) if the approved new animal drug has more than one active
      ingredient, and if one of the active ingredients of the new
      animal drug is different from one of the active ingredients of
      the approved new animal drug and the application is filed
      pursuant to the approval of a petition filed under paragraph (3) -
       
          (I) information to show that the other active ingredients of
        the new animal drug are the same as the active ingredients of
        the approved new animal drug,
          (II) information to show either that the different active
        ingredient is an active ingredient of another approved new
        animal drug or of an animal drug which does not meet the
        requirements of section 321(v) of this title, and
          (III) such other information respecting the different active
        ingredients as the Secretary may require;

        (C)(i) if the approved new animal drug is permitted to be used
      with one or more animal drugs in animal feed, information to show
      that the proposed uses of the new animal drug with other animal
      drugs in animal feed are the same as the uses of the approved new
      animal drug, and
        (ii) if the approved new animal drug is permitted to be used
      with one or more other animal drugs in animal feed, and one of
      the other animal drugs proposed for use with the new animal drug
      in animal feed is different from one of the other animal drugs
      permitted to be used in animal feed with the approved new animal
      drug, and the application is filed pursuant to the approval of a
      petition filed under paragraph (3) - 
          (I) information to show either that the different animal drug
        proposed for use with the approved new animal drug in animal
        feed is an approved new animal drug permitted to be used in
        animal feed or does not meet the requirements of section 321(v)
        of this title when used with another animal drug in animal
        feed,
          (II) information to show that other animal drugs proposed for
        use with the new animal drug in animal feed are the same as the
        other animal drugs permitted to be used with the approved new
        animal drug, and
          (III) such other information respecting the different animal
        drug or combination with respect to which the petition was
        filed as the Secretary may require,

        (D) information to show that the route of administration, the
      dosage form, and the strength of the new animal drug are the same
      as those of the approved new animal drug or, if the route of
      administration, the dosage form, or the strength of the new
      animal drug is different and the application is filed pursuant to
      the approval of a petition filed under paragraph (3), such
      information respecting the route of administration, dosage form,
      or strength with respect to which the petition was filed as the
      Secretary may require;
        (E) information to show that the new animal drug is
      bioequivalent to the approved new animal drug, except that if the
      application is filed pursuant to the approval of a petition filed
      under paragraph (3) for the purposes described in subparagraph
      (B) or (C), information to show that the active ingredients of
      the new animal drug are of the same pharmacological or
      therapeutic class as the pharmacological or therapeutic class of
      the approved new animal drug and that the new animal drug can be
      expected to have the same therapeutic effect as the approved new
      animal drug when used in accordance with the labeling;
        (F) information to show that the labeling proposed for the new
      animal drug is the same as the labeling approved for the approved
      new animal drug except for changes required because of
      differences approved under a petition filed under paragraph (3),
      because of a different withdrawal period, or because the new
      animal drug and the approved new animal drug are produced or
      distributed by different manufacturers;
        (G) the items specified in clauses (B) through (F) of
      subsection (b)(1) of this section;
        (H) a certification, in the opinion of the applicant and to the
      best of his knowledge, with respect to each patent which claims
      the approved new animal drug or which claims a use for such
      approved new animal drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under subsection (b)(1) or (c)(3) of this
      section - 
          (i) that such patent information has not been filed,
          (ii) that such patent has expired,
          (iii) of the date on which such patent will expire, or
          (iv) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new animal drug for which
        the application is filed; and

        (I) if with respect to the approved new animal drug information
      was filed under subsection (b)(1) or (c)(3) of this section for a
      method of use patent which does not claim a use for which the
      applicant is seeking approval of an application under subsection
      (c)(2) of this section, a statement that the method of use patent
      does not claim such a use.

    The Secretary may not require that an abbreviated application
    contain information in addition to that required by subparagraphs
    (A) through (I).
      (2)(A) An applicant who makes a certification described in
    paragraph (1)(G)(iv) shall include in the application a statement
    that the applicant will give the notice required by subparagraph
    (B) to - 
        (i) each owner of the patent which is the subject of the
      certification or the representative of such owner designated to
      receive such notice, and
        (ii) the holder of the approved application under subsection
      (c)(1) of this section for the drug which is claimed by the
      patent or a use of which is claimed by the patent or the
      representative of such holder designated to receive such notice.

      (B) The notice referred to in subparagraph (A) shall state that
    an application, which contains data from bioequivalence studies,
    has been filed under this subsection for the drug with respect to
    which the certification is made to obtain approval to engage in the
    commercial manufacture, use, or sale of such drug before the
    expiration of the patent referred to in the certification. Such
    notice shall include a detailed statement of the factual and legal
    basis of the applicant's opinion that the patent is not valid or
    will not be infringed.
      (C) If an application is amended to include a certification
    described in paragraph (1)(G)(iv), the notice required by
    subparagraph (B) shall be given when the amended application is
    filed.
      (3) If a person wants to submit an abbreviated application for a
    new animal drug - 
        (A) whose active ingredients, route of administration, dosage
      form, or strength differ from that of an approved new animal
      drug, or
        (B) whose use with other animal drugs in animal feed differs
      from that of an approved new animal drug,

    such person shall submit a petition to the Secretary seeking
    permission to file such an application. The Secretary shall approve
    a petition for a new animal drug unless the Secretary finds that - 
        (C) investigations must be conducted to show the safety and
      effectiveness, in animals to be treated with the drug, of the
      active ingredients, route of administration, dosage form,
      strength, or use with other animal drugs in animal feed which
      differ from the approved new animal drug, or
        (D) investigations must be conducted to show the safety for
      human consumption of any residues in food resulting from the
      proposed active ingredients, route of administration, dosage
      form, strength, or use with other animal drugs in animal feed for
      the new animal drug which is different from the active
      ingredients, route of administration, dosage form, strength, or
      use with other animal drugs in animal feed of the approved new
      animal drug.

    The Secretary shall approve or disapprove a petition submitted
    under this paragraph within 90 days of the date the petition is
    submitted.
      (4)(A)(i) Within 60 days of November 16, 1988, the Secretary
    shall publish and make available to the public a list in
    alphabetical order of the official and proprietary name of each new
    animal drug which has been approved for safety and effectiveness
    before November 16, 1988.
      (ii) Every 30 days after the publication of the first list under
    clause (i) the Secretary shall revise the list to include each new
    animal drug which has been approved for safety and effectiveness
    under subsection (c) of this section during the 30 day period.
      (iii) When patent information submitted under subsection (b)(1)
    or (c)(3) of this section respecting a new animal drug included on
    the list is to be published by the Secretary, the Secretary shall,
    in revisions made under clause (ii), include such information for
    such drug.
      (B) A new animal drug approved for safety and effectiveness
    before November 16, 1988, or approved for safety and effectiveness
    under subsection (c) of this section shall, for purposes of this
    subsection, be considered to have been published under subparagraph
    (A) on the date of its approval or November 16, 1988, whichever is
    later.
      (C) If the approval of a new animal drug was withdrawn or
    suspended under subsection (c)(2)(G) of this section or for grounds
    described in subsection (e) of this section or if the Secretary
    determines that a drug has been withdrawn from sale for safety or
    effectiveness reasons, it may not be published in the list under
    subparagraph (A) or, if the withdrawal or suspension occurred after
    its publication in such list, it shall be immediately removed from
    such list - 
        (i) for the same period as the withdrawal or suspension under
      subsection (c)(2)(G) or (e) of this section, or
        (ii) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

    A notice of the removal shall be published in the Federal Register.
      (5) If an application contains the information required by
    clauses (A), (G), and (H) of subsection (b)(1) of this section and
    such information - 
        (A) is relied on by the applicant for the approval of the
      application, and
        (B) is not information derived either from investigations,
      studies, or tests conducted by or for the applicant or for which
      the applicant had obtained a right of reference or use from the
      person by or for whom the investigations, studies, or tests were
      conducted,

    such application shall be considered to be an application filed
    under subsection (b)(2) of this section.
    (o) "Patent" defined
      For purposes of this section, the term "patent" means a patent
    issued by the United States Patent and Trademark Office.
    (p) Safety and effectiveness data
      (1) Safety and effectiveness data and information which has been
    submitted in an application filed under subsection (b)(1) of this
    section or section 360ccc(a) of this title for a drug and which has
    not previously been disclosed to the public shall be made available
    to the public, upon request, unless extraordinary circumstances are
    shown - 
        (A) if no work is being or will be undertaken to have the
      application approved,
        (B) if the Secretary has determined that the application is not
      approvable and all legal appeals have been exhausted,
        (C) if approval of the application under subsection (c) of this
      section is withdrawn and all legal appeals have been exhausted,
        (D) if the Secretary has determined that such drug is not a new
      drug, or
        (E) upon the effective date of the approval of the first
      application filed under subsection (b)(2) of this section which
      refers to such drug or upon the date upon which the approval of
      an application filed under subsection (b)(2) of this section
      which refers to such drug could be made effective if such an
      application had been filed.

      (2) Any request for data and information pursuant to paragraph
    (1) shall include a verified statement by the person making the
    request that any data or information received under such paragraph
    shall not be disclosed by such person to any other person - 
        (A) for the purpose of, or as part of a plan, scheme, or device
      for, obtaining the right to make, use, or market, or making,
      using, or marketing, outside the United States, the drug
      identified in the application filed under subsection (b)(1) of
      this section or section 360ccc(a) of this title, and
        (B) without obtaining from any person to whom the data and
      information are disclosed an identical verified statement, a copy
      of which is to be provided by such person to the Secretary, which
      meets the requirements of this paragraph.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 512, as added Pub. L. 90-399, Sec.
    101(b), July 13, 1968, 82 Stat. 343; amended Pub. L. 100-670, title
    I, Secs. 101, 102, 104, 107(a)(2), Nov. 16, 1988, 102 Stat. 3971,
    3981, 3982, 3984; Pub. L. 102-108, Sec. 2(e), Aug. 17, 1991, 105
    Stat. 550; Pub. L. 103-80, Sec. 3(r), Aug. 13, 1993, 107 Stat. 777;
    Pub. L. 103-396, Sec. 2(a), (b)(2), (3), Oct. 22, 1994, 108 Stat.
    4153, 4154; Pub. L. 104-250, Secs. 2(a)-(d), 3-5(c), 6(a), (b),
    Oct. 9, 1996, 110 Stat. 3151-3153, 3155-3157; Pub. L. 105-115,
    title I, Sec. 124(b), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 105-
    277, div. A, Sec. 101(a) [title VII, Sec. 737], Oct. 21, 1998, 112
    Stat. 2681, 2681-30; Pub. L. 106-113, div. B, Sec. 1000(a)(9)
    [title IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-
    584; Pub. L. 108-282, title I, Sec. 102(b)(2), (3), (5)(I)-(S),
    Aug. 2, 2004, 118 Stat. 892, 903, 904.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 342(a)(2) of this title, referred to in subsec. (a)(6),
    was amended by Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996,
    110 Stat. 1514, and, as so amended, no longer contains a subcl.
    (D). See section 342(a)(2)(C)(ii) of this title.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (a)(1), (2). Pub. L. 108-282, Sec. 102(b)(5)(I),
    added pars. (1) and (2) and struck out former pars. (1) and (2)
    which deemed as unsafe new animal drugs and animal feed bearing or
    containing a new animal drug which did not have in effect certain
    approvals.
      Subsec. (b)(3). Pub. L. 108-282, Sec. 102(b)(5)(J), substituted
    "under paragraph (1), section 360ccc of this title, or a request
    for an investigational exemption under subsection (j)" for "under
    paragraph (1) or a request for an investigational exemption under
    subsection (j)".
      Subsec. (c)(2)(F)(ii), (iii), (v). Pub. L. 108-282, Sec.
    102(b)(2), substituted "(other than bioequivalence studies or
    residue depletion studies, except residue depletion studies for
    minor uses or minor species)" for "(other than bioequivalence or
    residue studies)".
      Subsec. (d)(4). Pub. L. 108-282, Sec. 102(b)(5)(K), substituted
    "have previously been separately approved pursuant to an
    application submitted under subsection (b)(1) of this section" for
    "have previously been separately approved" in introductory
    provisions.
      Subsec. (d)(5). Pub. L. 108-282, Sec. 102(b)(3), added par. (5).
      Subsec. (f). Pub. L. 108-282, Sec. 102(b)(5)(L), substituted
    "subsection (d), (e), or (m) of this section, or section 360ccc(c),
    (d), or (e) of this title" for "subsection (d), (e), or (m) of this
    section".
      Subsec. (g). Pub. L. 108-282, Sec. 102(b)(5)(M), substituted
    "this section, or section 360ccc of this title" for "this section".
      Subsec. (i). Pub. L. 108-282, Sec. 102(b)(5)(N), substituted
    "subsection (b) of this section or section 360ccc of this title"
    for "subsection (b) of this section" and inserted "or upon failure
    to renew a conditional approval under section 360ccc of this title"
    after "or upon its suspension".
      Subsec. (l)(1). Pub. L. 108-282, Sec. 102(b)(5)(O), substituted
    "subsection (b) of this section or section 360ccc of this title"
    for "subsection (b) of this section".
      Subsec. (m)(1)(C). Pub. L. 108-282, Sec. 102(b)(5)(P),
    substituted "applicable regulations published pursuant to
    subsection (i) of this section or for indexed new animal drugs in
    accordance with the index listing published pursuant to section
    360ccc-1(e)(2) of this title and the labeling requirements set
    forth in section 360ccc-1(h) of this title" for "applicable
    regulations published pursuant to subsection (i) of this section".
      Subsec. (m)(3). Pub. L. 108-282, Sec. 102(b)(5)(Q), inserted "or
    an index listing pursuant to section 360ccc-1(e) of this title"
    after "subsection (i) of this section" in subpar. (C) and
    concluding provisions.
      Subsec. (p)(1), (2)(A). Pub. L. 108-282, Sec. 102(b)(5)(R), (S),
    substituted "subsection (b)(1) of this section or section 360ccc(a)
    of this title" for "subsection (b)(1) of this section".
      1999 - Subsec. (o). Pub. L. 106-113 substituted "United States
    Patent and Trademark Office" for "Patent and Trademark Office of
    the Department of Commerce".
      1998 - Subsec. (d)(4)(D)(iii). Pub. L. 105-277 inserted before
    semicolon ", except that for purposes of this clause, antibacterial
    ingredient or animal drug does not include the ionophore or
    arsenical classes of animal drugs".
      1997 - Subsec. (c)(4). Pub. L. 105-115 added par. (4).
      1996 - Subsec. (a)(1). Pub. L. 104-250, Sec. 6(a), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows: "A new
    animal drug shall, with respect to any particular use or intended
    use of such drug, be deemed unsafe for the purposes of section
    351(a)(5) and section 342(a)(2)(D) of this title unless - 
        "(A) there is in effect an approval of an application filed
      pursuant to subsection (b) of this section with respect to such
      use or intended use of such drug, and
        "(B) such drug, its labeling, and such use conform to such
      approved application.
    A new animal drug shall also be deemed unsafe for such purposes in
    the event of removal from the establishment of a manufacturer,
    packer, or distributor of such drug for use in the manufacture of
    animal feed in any State unless at the time of such removal such
    manufacturer, packer, or distributor has an unrevoked written
    statement from the consignee of such drug, or notice from the
    Secretary, to the effect that, with respect to the use of such drug
    in animal feed, such consignee - 
        "(i) is the holder of an approved application under subsection
      (m) of this section; or
        "(ii) will, if the consignee is not a user of the drug, ship
      such drug only to a holder of an approved application under
      subsection (m) of this section."
      Subsec. (a)(2). Pub. L. 104-250, Sec. 6(a), amended par. (2)
    generally. Prior to amendment, par. (2) read as follows: "An animal
    feed bearing or containing a new animal drug shall, with respect to
    any particular use or intended use of such animal feed, be deemed
    unsafe for the purposes of section 351(a)(6) of this title unless -
    
        "(A) there is in effect an approval of an application filed
      pursuant to subsection (b) of this section with respect to such
      drugs, as used in such animal feed,
        "(B) there is in effect an approval of an application pursuant
      to subsection (m)(1) of this section with respect to such animal
      feed, and
        "(C) such animal feed, its labeling, and such use conform to
      the conditions and indications of use published pursuant to
      subsection (i) of this section and to the application with
      respect thereto approved under subsection (m) of this section."
      Subsec. (a)(6). Pub. L. 104-250, Sec. 4, added par. (6).
      Subsec. (b)(3). Pub. L. 104-250, Sec. 2(d), added par. (3).
      Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104-250, Sec. 2(b)(1),
    substituted "substantial evidence of the effectiveness of the drug
    involved, any studies of animal safety, or," for "reports of new
    clinical or field investigations (other than bioequivalence or
    residue studies) and," and "required for the approval" for
    "essential to the approval".
      Subsec. (c)(2)(F)(v). Pub. L. 104-250, Sec. 2(b)(2), substituted
    "clause (iv)" for "subparagraph (B)(iv)" in two places,
    "substantial evidence of the effectiveness of the drug involved,
    any studies of animal safety," for "reports of clinical or field
    investigations" and "required for the new approval" for "essential
    to the new approval".
      Subsec. (d)(1)(F). Pub. L. 104-250, Sec. 3, amended subpar. (F)
    generally. Prior to amendment, subpar. (F) read as follows: "upon
    the basis of the information submitted to him as part of the
    application or any other information before him with respect to
    such drug, the tolerance limitation proposed, if any, exceeds that
    reasonably required to accomplish the physical or other technical
    effect for which the drug is intended;".
      Subsec. (d)(3). Pub. L. 104-250, Sec. 2(a), amended par. (3)
    generally. Prior to amendment, par. (3) read as follows: "As used
    in this subsection and subsection (e) of this section, the term
    'substantial evidence' means evidence consisting of adequate and
    well-controlled investigations, including field investigation, by
    experts qualified by scientific training and experience to evaluate
    the effectiveness of the drug involved, on the basis of which it
    could fairly and reasonably be concluded by such experts that the
    drug will have the effect it purports or is represented to have
    under the conditions of use prescribed, recommended, or suggested
    in the labeling or proposed labeling thereof."
      Subsec. (d)(4). Pub. L. 104-250, Sec. 2(c), added par. (4).
      Subsec. (i). Pub. L. 104-250, Sec. 5(c), inserted "and any
    requirement that an animal feed bearing or containing the new
    animal drug be limited to use under the professional supervision of
    a licensed veterinarian" after "(including special labeling
    requirements".
      Subsec. (m). Pub. L. 104-250, Sec. 6(b), amended subsec. (m)
    generally, substituting provisions relating to application for feed
    mill licenses, including approval, refusal, revocation, and
    suspension of such licenses, and provisions for record and
    reporting requirements for, as well as exemption from, such
    licenses, for provisions relating to application for uses of animal
    feed containing new animal drug, including required contents,
    approval, refusal, and withdrawal of approval or suspension of such
    usage applications, and provisions for record and reporting
    requirements of such usage applications.
      1994 - Subsec. (a)(4), (5). Pub. L. 103-396, Sec. 2(a), added
    pars. (4) and (5).
      Subsec. (e)(1)(A). Pub. L. 103-396, Sec. 2(b)(2), inserted before
    semicolon at end "or the condition of use authorized under
    subsection (a)(4)(A) of this section".
      Subsec. (l)(1). Pub. L. 103-396, Sec. 2(b)(3), substituted
    "relating to experience, including experience with uses authorized
    under subsection (a)(4)(A) of this section," for "relating to
    experience".
      1993 - Subsec. (c)(2)(A)(ii). Pub. L. 103-80, Sec. 3(r)(1),
    inserted "in" after "except as provided".
      Subsec. (c)(2)(F)(i). Pub. L. 103-80, Sec. 3(r)(2), substituted
    "subparagraph (D)(iii)" for "subparagraph (C)(iii)".
      Subsec. (c)(2)(H)(ii). Pub. L. 103-80, Sec. 3(r)(3), substituted
    "subclauses" for "subclause" after "bioequivalency information
    described in" in concluding provisions.
      Subsec. (d)(1). Pub. L. 103-80, Sec. 3(r)(4), substituted
    "subparagraphs (A) through (I)" for "subparagraphs (A) through (G)"
    in concluding provisions.
      Subsec. (n)(1). Pub. L. 103-80, Sec. 3(r)(5), substituted
    "section 321(v) of this title" for "section 321(w) of this title"
    in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted "through
    (I)" for "through (H)" in concluding provisions.
      1991 - Subsec. (e)(1)(B). Pub. L. 102-108 substituted "(I)" for
    "(H)".
      1988 - Subsec. (a)(1)(C). Pub. L. 100-670, Sec. 107(a)(2), struck
    out subpar. (C) which read as follows: "in the case of a new animal
    drug subject to subsection (n) of this section and not exempted
    therefrom by regulations it is from a batch with respect to which a
    certificate or release issued pursuant to subsection (n) of this
    section is in effect with respect to such drug."
      Subsec. (b). Pub. L. 100-670, Secs. 101(a), 102(a), designated
    existing provisions as par. (1), redesignated cls. (1) to (8) as
    cls. (A) to (H), respectively, added par. (2), and inserted
    provisions at end of par. (1) which require applicant to file with
    application, patent number and expiration date of any patent which
    claims new animal drug, to amend application to include such
    information if patent which claims such drug or method of using
    such drug is issued after filing date but before approval of
    application, and to publish such information upon approval.
      Subsec. (c). Pub. L. 100-670, Secs. 101(c), 102(b)(1), designated
    existing provisions as par. (1), redesignated cls. (1) and (2) as
    cls. (A) and (B), respectively, and added pars. (2) and (3).
      Subsec. (d)(1). Pub. L. 100-670, Sec. 102(b)(3), substituted
    "(G)" for "(H)" in last sentence.
      Subsec. (d)(1)(G) to (I). Pub. L. 100-670, Sec. 102(b)(2), added
    subpar. (G) and redesignated former subpars. (G) and (H) as (H) and
    (I), respectively.
      Subsec. (e)(1)(D) to (F). Pub. L. 100-670, Sec. 102(b)(4), added
    subpar. (D) and redesignated former subpars. (D) and (E) as (E) and
    (F), respectively.
      Subsecs. (n) to (p). Pub. L. 100-670, Sec. 101(b), added subsecs.
    (n) to (p) and struck out former subsec. (n) which related to
    certification of new drugs containing penicillin, streptomycin,
    chlortetracycline, chloramphenicol, or bacitracin, and release
    prior to certification.

                     EFFECTIVE DATE OF 1999 AMENDMENT                 
      Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
    1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
    113, set out as a note under section 1 of Title 35, Patents.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 2(d) of Pub. L. 103-396 provided that: "The amendments
    made by this section [amending this section and section 331 of this
    title] shall take effect upon the adoption of the final regulations
    under subsection (c) [set out below]." [Final regulations were
    dated Oct. 22, 1996, filed Nov. 6, 1996, published Nov. 7, 1996, 61
    F.R. 57732, and effective Dec. 9, 1996.]

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Section 108 of Pub. L. 100-670 provided that: "The Secretary of
    Health and Human Services may not make an approval of an
    application submitted under section 512(b)(2) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before
    January 1, 1991."

                EFFECTIVE DATE AND TRANSITIONAL PROVISIONS            
      Pub. L. 90-399, Sec. 108, July 13, 1968, 82 Stat. 353, as amended
    by Pub. L. 108-282, title I, Sec. 102(b)(5)(T), Aug. 2, 2004, 118
    Stat. 905, provided that:
      "(a) Except as otherwise provided in this section, the amendments
    made by the foregoing sections [see Short Title of 1968 Amendment
    note set out under section 301 of this title] shall take effect on
    the first day of the thirteenth calendar month which begins after
    the date of enactment of this Act [July 13, 1968].
      "(b)(1) As used in this subsection, the term 'effective date'
    means the effective date specified in subsection (a) of this
    section; the term 'basic Act' means the Federal Food, Drug, and
    Cosmetic Act [this chapter]; and other terms used both in this
    section and the basic Act shall have the same meaning as they have,
    or had, at the time referred to in the context, under the basic
    Act.
      "(2) Any approval, prior to the effective date, of a new animal
    drug or of an animal feed bearing or containing a new animal drug,
    whether granted by approval of a new-drug application, master file,
    antibiotic regulation, or food additive regulations, shall continue
    in effect, and shall be subject to change in accordance with the
    provisions of the basic Act as amended by this Act [see Short Title
    of 1968 Amendment note set out under section 301 of this title].
      "(3) In the case of any drug (other than a drug subject to
    section 512(n) of the basic Act as amended by this Act) [subsection
    (n) of this section] intended for use in animals other than man
    which, on October 9, 1962, (A) was commercially used or sold in the
    United States, (B) was not a new drug as defined by section 201(p)
    of the basic Act [section 321(p) of this title] as then in force,
    and (C) was not covered by an effective application under section
    505 of that Act [section 355 of this title], the words
    'effectiveness' and 'effective' contained in section 201(v) to the
    basic Act [sic] [section 321(v) of this title] shall not apply to
    such drug when intended solely for use under conditions prescribed,
    recommended, or suggested in labeling with respect to such drug on
    that day.
      "(4) Regulations providing for fees (and advance deposits to
    cover fees) which on the day preceding the effective date
    applicable under subsection (a) of this section were in effect
    pursuant to section 507 of the basic Act [section 357 of this
    title] shall, except as the Secretary may otherwise prescribe, be
    deemed to apply also under section 512(n) of the basic Act
    [subsection (n) of this section], and appropriations of fees (and
    of advance deposits to cover fees) available for the purposes
    specified in such section 507 [section 357 of this title] as in
    effect prior to the effective date shall also be available for the
    purposes specified in section 512(n) [subsection (n) of this
    section], including preparatory work or proceedings prior to that
    date."

                                REGULATIONS                            
      Section 2(e) of Pub. L. 104-250 provided that:
      "(1) In general. - Not later than 6 months after the date of
    enactment of this Act [Oct. 9, 1996], the Secretary of Health and
    Human Services shall issue proposed regulations implementing the
    amendments made by this Act as described in paragraph (2)(A) of
    this subsection, and not later than 18 months after the date of
    enactment of this Act, the Secretary shall issue final regulations
    implementing such amendments. Not later than 12 months after the
    date of enactment of this Act, the Secretary shall issue proposed
    regulations implementing the other amendments made by this Act as
    described in paragraphs (2)(B) and (2)(C) of this subsection, and
    not later than 24 months after the date of enactment of this Act,
    the Secretary shall issue final regulations implementing such
    amendments.
      "(2) Contents. - In issuing regulations implementing the
    amendments made by this Act [see Short Title of 1996 Amendments
    note set out under section 301 of this title], and in taking an
    action to review an application for approval of a new animal drug
    under section 512 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 360b), or a request for an investigational exemption for a
    new animal drug under subsection (j) of such section, that is
    pending or has been submitted prior to the effective date of the
    regulations, the Secretary shall - 
        "(A) further define the term 'adequate and well controlled', as
      used in subsection (d)(3) of section 512 of such Act, to require
      that field investigations be designed and conducted in a
      scientifically sound manner, taking into account practical
      conditions in the field and differences between field conditions
      and laboratory conditions;
        "(B) further define the term 'substantial evidence', as defined
      in subsection (d)(3) of such section, in a manner that encourages
      the submission of applications and supplemental applications; and
        "(C) take into account the proposals contained in the citizen
      petition (FDA Docket No. 91P-0434/CP) jointly submitted by the
      American Veterinary Medical Association and the Animal Health
      Institute, dated October 21, 1991.
    Until the regulations required by subparagraph (A) are issued,
    nothing in the regulations published at 21 C.F.R. 514.111(a)(5)
    (April 1, 1996) shall be construed to compel the Secretary of
    Health and Human Services to require a field investigation under
    section 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 360b(d)(1)(E)) or to apply any of its provisions in a
    manner inconsistent with the considerations for scientifically
    sound field investigations set forth in subparagraph (A)."
      Section 2(c) of Pub. L. 103-396 provided that: "Not later than 2
    years after the date of the enactment of this Act [Oct. 22, 1994],
    the Secretary of Health and Human Services shall promulgate
    regulations to implement paragraphs (4)(A) and (5) of section
    512(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    360b(a)(4)(A), (5)] (as amended by subsection (a))."
      Section 103 of Pub. L. 100-670 provided that:
      "(a) General Rule. - The Secretary of Health and Human Services
    shall promulgate, in accordance with the notice and comment
    requirements of section 553 of title 5, United States Code, such
    regulations as may be necessary for the administration of section
    512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b],
    as amended by sections 101 through 103 of this title, within one
    year of the date of enactment of this Act [Nov. 16, 1988].
      "(b) Transition. - During the period beginning 60 days after the
    date of enactment of this Act [Nov. 16, 1988] and ending on the
    date regulations promulgated under subsection (a) take effect,
    abbreviated new animal drug applications may be submitted in
    accordance with the provisions of section 314.55 and part 320 of
    title 21 of the Code of Federal Regulations and shall be considered
    as suitable for any drug which has been approved for safety and
    effectiveness under section 512(c) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 360b(c)] before the date of enactment of
    this Act. If any such provision of section 314.55 or part 320 is
    inconsistent with the requirements of section 512 of the Federal
    Food, Drug, and Cosmetic Act (as amended by this title), the
    Secretary shall consider the application under the applicable
    requirements of section 512 (as so amended)."

              DRUGS INTENDED FOR MINOR SPECIES AND MINOR USES          
      Section 2(f) of Pub. L. 104-250 provided that: "The Secretary of
    Health and Human Services shall consider legislative and regulatory
    options for facilitating the approval under section 512 of the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b] of animal
    drugs intended for minor species and for minor uses and, within 18
    months after the date of enactment of this Act [Oct. 9, 1996],
    announce proposals for legislative or regulatory change to the
    approval process under such section for animal drugs intended for
    use in minor species or for minor uses."

    TRANSITIONAL PROVISION REGARDING IMPLEMENTATION OF PUB. L. 104-250;
            APPROVED MEDICATED FEED APPLICATION DEEMED LICENSE
      Section 6(c) of Pub. L. 104-250 provided that: "A person engaged
    in the manufacture of animal feeds bearing or containing new animal
    drugs who holds at least one approved medicated feed application
    for an animal feed bearing or containing new animal drugs, the
    manufacture of which was not otherwise exempt from the requirement
    for an approved medicated feed application on the date of the
    enactment of this Act [Oct. 9, 1996], shall be deemed to hold a
    license for the manufacturing site identified in the approved
    medicated feed application. The revocation of license provisions of
    section 512(m)(4) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360b(m)(4)], as amended by this Act, shall apply to such
    licenses. Such license shall expire within 18 months from the date
    of enactment of this Act unless the person submits to the Secretary
    a completed license application for the manufacturing site
    accompanied by a copy of an approved medicated feed application for
    such site, which license application shall be deemed to be approved
    upon receipt by the Secretary."

             DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY         
      Section 106 of Pub. L. 100-670 provided that: "Notwithstanding
    section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360b(b)(2)], the Secretary of Health and Human Services may
    not approve an abbreviated application submitted under such section
    for a new animal drug which is primarily manufactured using
    recombinant DNA, recombinant RNA, hybridoma technology, or other
    processes involving site specific genetic manipulation techniques."

-FOOTNOTE-
    (!1) See References in Text note below.

    (!2) So in original. Probably should be "Alimentarius".

    (!3) So in original. Probably should be "clause (iii)(III)".


-End-



-CITE-
    21 USC Sec. 360c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360c. Classification of devices intended for human use

-STATUTE-
    (a) Classes of devices
      (1) There are established the following classes of devices
    intended for human use:
        (A) Class I, General Controls. - 
          (i) A device for which the controls authorized by or under
        section 351, 352, 360, 360f, 360h, 360i, or 360j of this title
        or any combination of such sections are sufficient to provide
        reasonable assurance of the safety and effectiveness of the
        device.
          (ii) A device for which insufficient information exists to
        determine that the controls referred to in clause (i) are
        sufficient to provide reasonable assurance of the safety and
        effectiveness of the device or to establish special controls to
        provide such assurance, but because it - 
            (I) is not purported or represented to be for a use in
          supporting or sustaining human life or for a use which is of
          substantial importance in preventing impairment of human
          health, and
            (II) does not present a potential unreasonable risk of
          illness or injury,

        is to be regulated by the controls referred to in clause (i).

        (B) Class II, Special Controls. - A device which cannot be
      classified as a class I device because the general controls by
      themselves are insufficient to provide reasonable assurance of
      the safety and effectiveness of the device, and for which there
      is sufficient information to establish special controls to
      provide such assurance, including the promulgation of performance
      standards, postmarket surveillance, patient registries,
      development and dissemination of guidelines (including guidelines
      for the submission of clinical data in premarket notification
      submissions in accordance with section 360(k) of this title),
      recommendations, and other appropriate actions as the Secretary
      deems necessary to provide such assurance. For a device that is
      purported or represented to be for a use in supporting or
      sustaining human life, the Secretary shall examine and identify
      the special controls, if any, that are necessary to provide
      adequate assurance of safety and effectiveness and describe how
      such controls provide such assurance.
        (C) Class III, Premarket Approval. - A device which because - 
          (i) it (I) cannot be classified as a class I device because
        insufficient information exists to determine that the
        application of general controls are sufficient to provide
        reasonable assurance of the safety and effectiveness of the
        device, and (II) cannot be classified as a class II device
        because insufficient information exists to determine that the
        special controls described in subparagraph (B) would provide
        reasonable assurance of its safety and effectiveness, and
          (ii)(I) is purported or represented to be for a use in
        supporting or sustaining human life or for a use which is of
        substantial importance in preventing impairment of human
        health, or
          (II) presents a potential unreasonable risk of illness or
        injury,

      is to be subject, in accordance with section 360e of this title,
      to premarket approval to provide reasonable assurance of its
      safety and effectiveness.

    If there is not sufficient information to establish a performance
    standard for a device to provide reasonable assurance of its safety
    and effectiveness, the Secretary may conduct such activities as may
    be necessary to develop or obtain such information.
      (2) For purposes of this section and sections 360d and 360e of
    this title, the safety and effectiveness of a device are to be
    determined - 
        (A) with respect to the persons for whose use the device is
      represented or intended,
        (B) with respect to the conditions of use prescribed,
      recommended, or suggested in the labeling of the device, and
        (C) weighing any probable benefit to health from the use of the
      device against any probable risk of injury or illness from such
      use.

      (3)(A) Except as authorized by subparagraph (B), the
    effectiveness of a device is, for purposes of this section and
    sections 360d and 360e of this title, to be determined, in
    accordance with regulations promulgated by the Secretary, on the
    basis of well-controlled investigations, including 1 or more
    clinical investigations where appropriate, by experts qualified by
    training and experience to evaluate the effectiveness of the
    device, from which investigations it can fairly and responsibly be
    concluded by qualified experts that the device will have the effect
    it purports or is represented to have under the conditions of use
    prescribed, recommended, or suggested in the labeling of the
    device.
      (B) If the Secretary determines that there exists valid
    scientific evidence (other than evidence derived from
    investigations described in subparagraph (A)) - 
        (i) which is sufficient to determine the effectiveness of a
      device, and
        (ii) from which it can fairly and responsibly be concluded by
      qualified experts that the device will have the effect it
      purports or is represented to have under the conditions of use
      prescribed, recommended, or suggested in the labeling of the
      device,

    then, for purposes of this section and sections 360d and 360e of
    this title, the Secretary may authorize the effectiveness of the
    device to be determined on the basis of such evidence.
      (C) In making a determination of a reasonable assurance of the
    effectiveness of a device for which an application under section
    360e of this title has been submitted, the Secretary shall consider
    whether the extent of data that otherwise would be required for
    approval of the application with respect to effectiveness can be
    reduced through reliance on postmarket controls.
      (D)(i) The Secretary, upon the written request of any person
    intending to submit an application under section 360e of this
    title, shall meet with such person to determine the type of valid
    scientific evidence (within the meaning of subparagraphs (A) and
    (B)) that will be necessary to demonstrate for purposes of approval
    of an application the effectiveness of a device for the conditions
    of use proposed by such person. The written request shall include a
    detailed description of the device, a detailed description of the
    proposed conditions of use of the device, a proposed plan for
    determining whether there is a reasonable assurance of
    effectiveness, and, if available, information regarding the
    expected performance from the device. Within 30 days after such
    meeting, the Secretary shall specify in writing the type of valid
    scientific evidence that will provide a reasonable assurance that a
    device is effective under the conditions of use proposed by such
    person.
      (ii) Any clinical data, including one or more well-controlled
    investigations, specified in writing by the Secretary for
    demonstrating a reasonable assurance of device effectiveness shall
    be specified as result of a determination by the Secretary that
    such data are necessary to establish device effectiveness. The
    Secretary shall consider, in consultation with the applicant, the
    least burdensome appropriate means of evaluating device
    effectiveness that would have a reasonable likelihood of resulting
    in approval.
      (iii) The determination of the Secretary with respect to the
    specification of valid scientific evidence under clauses (i) and
    (ii) shall be binding upon the Secretary, unless such determination
    by the Secretary could be contrary to the public health.
    (b) Classification panels
      (1) For purposes of - 
        (A) determining which devices intended for human use should be
      subject to the requirements of general controls, performance
      standards, or premarket approval, and
        (B) providing notice to the manufacturers and importers of such
      devices to enable them to prepare for the application of such
      requirements to devices manufactured or imported by them,

    the Secretary shall classify all such devices (other than devices
    classified by subsection (f) of this section) into the classes
    established by subsection (a) of this section. For the purpose of
    securing recommendations with respect to the classification of
    devices, the Secretary shall establish panels of experts or use
    panels of experts established before May 28, 1976, or both. Section
    14 of the Federal Advisory Committee Act shall not apply to the
    duration of a panel established under this paragraph.
      (2) The Secretary shall appoint to each panel established under
    paragraph (1) persons who are qualified by training and experience
    to evaluate the safety and effectiveness of the devices to be
    referred to the panel and who, to the extent feasible, possess
    skill in the use of, or experience in the development, manufacture,
    or utilization of, such devices. The Secretary shall make
    appointments to each panel so that each panel shall consist of
    members with adequately diversified expertise in such fields as
    clinical and administrative medicine, engineering, biological and
    physical sciences, and other related professions. In addition, each
    panel shall include as nonvoting members a representative of
    consumer interests and a representative of interests of the device
    manufacturing industry. Scientific, trade, and consumer
    organizations shall be afforded an opportunity to nominate
    individuals for appointment to the panels. No individual who is in
    the regular full-time employ of the United States and engaged in
    the administration of this chapter may be a member of any panel.
    The Secretary shall designate one of the members of each panel to
    serve as chairman thereof.
      (3) Panel members (other than officers or employees of the United
    States), while attending meetings or conferences of a panel or
    otherwise engaged in its business, shall be entitled to receive
    compensation at rates to be fixed by the Secretary, but not at
    rates exceeding the daily equivalent of the rate in effect for
    grade GS-18 of the General Schedule, for each day so engaged,
    including traveltime; and while so serving away from their homes or
    regular places of business each member may be allowed travel
    expenses (including per diem in lieu of subsistence) as authorized
    by section 5703 of title 5, for persons in the Government service
    employed intermittently.
      (4) The Secretary shall furnish each panel with adequate clerical
    and other necessary assistance.
      (5) Classification panels covering each type of device shall be
    scheduled to meet at such times as may be appropriate for the
    Secretary to meet applicable statutory deadlines.
      (6)(A) Any person whose device is specifically the subject of
    review by a classification panel shall have - 
        (i) the same access to data and information submitted to a
      classification panel (except for data and information that are
      not available for public disclosure under section 552 of title 5)
      as the Secretary;
        (ii) the opportunity to submit, for review by a classification
      panel, information that is based on the data or information
      provided in the application submitted under section 360e of this
      title by the person, which information shall be submitted to the
      Secretary for prompt transmittal to the classification panel; and
        (iii) the same opportunity as the Secretary to participate in
      meetings of the panel.

      (B) Any meetings of a classification panel shall provide adequate
    time for initial presentations and for response to any differing
    views by persons whose devices are specifically the subject of a
    classification panel review, and shall encourage free and open
    participation by all interested persons.
      (7) After receiving from a classification panel the conclusions
    and recommendations of the panel on a matter that the panel has
    reviewed, the Secretary shall review the conclusions and
    recommendations, shall make a final decision on the matter in
    accordance with section 360e(d)(2) of this title, and shall notify
    the affected persons of the decision in writing and, if the
    decision differs from the conclusions and recommendations of the
    panel, shall include the reasons for the difference.
      (8) A classification panel under this subsection shall not be
    subject to the annual chartering and annual report requirements of
    the Federal Advisory Committee Act.
    (c) Classification panel organization and operation
      (1) The Secretary shall organize the panels according to the
    various fields of clinical medicine and fundamental sciences in
    which devices intended for human use are used. The Secretary shall
    refer a device to be classified under this section to an
    appropriate panel established or authorized to be used under
    subsection (b) of this section for its review and for its
    recommendation respecting the classification of the device. The
    Secretary shall by regulation prescribe the procedure to be
    followed by the panels in making their reviews and recommendations.
    In making their reviews of devices, the panels, to the maximum
    extent practicable, shall provide an opportunity for interested
    persons to submit data and views on the classification of the
    devices.
      (2)(A) Upon completion of a panel's review of a device referred
    to it under paragraph (1), the panel shall, subject to
    subparagraphs (B) and (C), submit to the Secretary its
    recommendation for the classification of the device. Any such
    recommendation shall (i) contain (I) a summary of the reasons for
    the recommendation, (II) a summary of the data upon which the
    recommendation is based, and (III) an identification of the risks
    to health (if any) presented by the device with respect to which
    the recommendation is made, and (ii) to the extent practicable,
    include a recommendation for the assignment of a priority for the
    application of the requirements of section 360d or 360e of this
    title to a device recommended to be classified in class II or class
    III.
      (B) A recommendation of a panel for the classification of a
    device in class I shall include a recommendation as to whether the
    device should be exempted from the requirements of section 360,
    360i, or 360j(f) of this title.
      (C) In the case of a device which has been referred under
    paragraph (1) to a panel, and which - 
        (i) is intended to be implanted in the human body or is
      purported or represented to be for a use in supporting or
      sustaining human life, and
        (ii)(I) has been introduced or delivered for introduction into
      interstate commerce for commercial distribution before May 28,
      1976, or
        (II) is within a type of device which was so introduced or
      delivered before such date and is substantially equivalent to
      another device within that type,

    such panel shall recommend to the Secretary that the device be
    classified in class III unless the panel determines that
    classification of the device in such class is not necessary to
    provide reasonable assurance of its safety and effectiveness. If a
    panel does not recommend that such a device be classified in class
    III, it shall in its recommendation to the Secretary for the
    classification of the device set forth the reasons for not
    recommending classification of the device in such class.
      (3) The panels shall submit to the Secretary within one year of
    the date funds are first appropriated for the implementation of
    this section their recommendations respecting all devices of a type
    introduced or delivered for introduction into interstate commerce
    for commercial distribution before May 28, 1976.
    (d) Panel recommendation; publication; priorities
      (1) Upon receipt of a recommendation from a panel respecting a
    device, the Secretary shall publish in the Federal Register the
    panel's recommendation and a proposed regulation classifying such
    device and shall provide interested persons an opportunity to
    submit comments on such recommendation and the proposed regulation.
    After reviewing such comments, the Secretary shall, subject to
    paragraph (2), by regulation classify such device.
      (2)(A) A regulation under paragraph (1) classifying a device in
    class I shall prescribe which, if any, of the requirements of
    section 360, 360i, or 360j(f) of this title shall not apply to the
    device. A regulation which makes a requirement of section 360,
    360i, or 360j(f) of this title inapplicable to a device shall be
    accompanied by a statement of the reasons of the Secretary for
    making such requirement inapplicable.
      (B) A device described in subsection (c)(2)(C) of this section
    shall be classified in class III unless the Secretary determines
    that classification of the device in such class is not necessary to
    provide reasonable assurance of its safety and effectiveness. A
    proposed regulation under paragraph (1) classifying such a device
    in a class other than class III shall be accompanied by a full
    statement of the reasons of the Secretary (and supporting
    documentation and data) for not classifying such device in such
    class and an identification of the risks to health (if any)
    presented by such device.
      (3) In the case of devices classified in class II and devices
    classified under this subsection in class III and described in
    section 360e(b)(1) of this title the Secretary may establish
    priorities which, in his discretion, shall be used in applying
    sections 360d and 360e of this title, as appropriate, to such
    devices.
    (e) Classification changes
      (1) Based on new information respecting a device, the Secretary
    may, upon his own initiative or upon petition of an interested
    person, by regulation (A) change such device's classification, and
    (B) revoke, because of the change in classification, any regulation
    or requirement in effect under section 360d or 360e of this title
    with respect to such device. In the promulgation of such a
    regulation respecting a device's classification, the Secretary may
    secure from the panel to which the device was last referred
    pursuant to subsection (c) of this section a recommendation
    respecting the proposed change in the device's classification and
    shall publish in the Federal Register any recommendation submitted
    to the Secretary by the panel respecting such change. A regulation
    under this subsection changing the classification of a device from
    class III to class II may provide that such classification shall
    not take effect until the effective date of a performance standard
    established under section 360d of this title for such device.
      (2) By regulation promulgated under paragraph (1), the Secretary
    may change the classification of a device from class III - 
        (A) to class II if the Secretary determines that special
      controls would provide reasonable assurance of the safety and
      effectiveness of the device and that general controls would not
      provide reasonable assurance of the safety and effectiveness of
      the device, or
        (B) to class I if the Secretary determines that general
      controls would provide reasonable assurance of the safety and
      effectiveness of the device.
    (f) Initial classification and reclassification of certain devices
      (1) Any device intended for human use which was not introduced or
    delivered for introduction into interstate commerce for commercial
    distribution before May 28, 1976, is classified in class III unless
    - 
        (A) the device - 
          (i) is within a type of device (I) which was introduced or
        delivered for introduction into interstate commerce for
        commercial distribution before such date and which is to be
        classified pursuant to subsection (b) of this section, or (II)
        which was not so introduced or delivered before such date and
        has been classified in class I or II, and
          (ii) is substantially equivalent to another device within
        such type, or

        (B) the Secretary in response to a petition submitted under
      paragraph (3) has classified such device in class I or II.

    A device classified in class III under this paragraph shall be
    classified in that class until the effective date of an order of
    the Secretary under paragraph (2) or (3) classifying the device in
    class I or II.
      (2)(A) Any person who submits a report under section 360(k) of
    this title for a type of device that has not been previously
    classified under this chapter, and that is classified into class
    III under paragraph (1), may request, within 30 days after
    receiving written notice of such a classification, the Secretary to
    classify the device under the criteria set forth in subparagraphs
    (A) through (C) of subsection (a)(1) of this section. The person
    may, in the request, recommend to the Secretary a classification
    for the device. Any such request shall describe the device and
    provide detailed information and reasons for the recommended
    classification.
      (B)(i) Not later than 60 days after the date of the submission of
    the request under subparagraph (A), the Secretary shall by written
    order classify the device involved. Such classification shall be
    the initial classification of the device for purposes of paragraph
    (1) and any device classified under this paragraph shall be a
    predicate device for determining substantial equivalence under
    paragraph (1).
      (ii) A device that remains in class III under this subparagraph
    shall be deemed to be adulterated within the meaning of section
    351(f)(1)(B) of this title until approved under section 360e of
    this title or exempted from such approval under section 360j(g) of
    this title.
      (C) Within 30 days after the issuance of an order classifying a
    device under this paragraph, the Secretary shall publish a notice
    in the Federal Register announcing such classification.
      (3)(A) The Secretary may initiate the reclassification of a
    device classified into class III under paragraph (1) of this
    subsection or the manufacturer or importer of a device classified
    under paragraph (1) may petition the Secretary (in such form and
    manner as he shall prescribe) for the issuance of an order
    classifying the device in class I or class II. Within thirty days
    of the filing of such a petition, the Secretary shall notify the
    petitioner of any deficiencies in the petition which prevent the
    Secretary from making a decision on the petition.
      (B)(i) Upon determining that a petition does not contain any
    deficiency which prevents the Secretary from making a decision on
    the petition, the Secretary may for good cause shown refer the
    petition to an appropriate panel established or authorized to be
    used under subsection (b) of this section. A panel to which such a
    petition has been referred shall not later than ninety days after
    the referral of the petition make a recommendation to the Secretary
    respecting approval or denial of the petition. Any such
    recommendation shall contain (I) a summary of the reasons for the
    recommendation, (II) a summary of the data upon which the
    recommendation is based, and (III) an identification of the risks
    to health (if any) presented by the device with respect to which
    the petition was filed. In the case of a petition for a device
    which is intended to be implanted in the human body or which is
    purported or represented to be for a use in supporting or
    sustaining human life, the panel shall recommend that the petition
    be denied unless the panel determines that the classification in
    class III of the device is not necessary to provide reasonable
    assurance of its safety and effectiveness. If the panel recommends
    that such petition be approved, it shall in its recommendation to
    the Secretary set forth its reasons for such recommendation.
      (ii) The requirements of paragraphs (1) and (2) of subsection (c)
    of this section (relating to opportunities for submission of data
    and views and recommendations respecting priorities and exemptions
    from sections 360, 360i, and 360j(f) of this title) shall apply
    with respect to consideration by panels of petitions submitted
    under subparagraph (A).
      (C)(i) Within ninety days from the date the Secretary receives
    the recommendation of a panel respecting a petition (but not later
    than 210 days after the filing of such petition) the Secretary
    shall by order deny or approve the petition. If the Secretary
    approves the petition, the Secretary shall order the classification
    of the device into class I or class II in accordance with the
    criteria prescribed by subsection (a)(1)(A) or (a)(1)(B) of this
    section. In the case of a petition for a device which is intended
    to be implanted in the human body or which is purported or
    represented to be for a use in supporting or sustaining human life,
    the Secretary shall deny the petition unless the Secretary
    determines that the classification in class III of the device is
    not necessary to provide reasonable assurance of its safety and
    effectiveness. An order approving such petition shall be
    accompanied by a full statement of the reasons of the Secretary
    (and supporting documentation and data) for approving the petition
    and an identification of the risks to health (if any) presented by
    the device to which such order applies.
      (ii) The requirements of paragraphs (1) and (2)(A) of subsection
    (d) of this section (relating to publication of recommendations,
    opportunity for submission of comments, and exemption from sections
    360, 360i, and 360j(f) of this title) shall apply with respect to
    action by the Secretary on petitions submitted under subparagraph
    (A).
      (4) If a manufacturer reports to the Secretary under section
    360(k) of this title that a device is substantially equivalent to
    another device - 
        (A) which the Secretary has classified as a class III device
      under subsection (b) of this section,
        (B) which was introduced or delivered for introduction into
      interstate commerce for commercial distribution before December
      1, 1990, and
        (C) for which no final regulation requiring premarket approval
      has been promulgated under section 360e(b) of this title,

    the manufacturer shall certify to the Secretary that the
    manufacturer has conducted a reasonable search of all information
    known or otherwise available to the manufacturer respecting such
    other device and has included in the report under section 360(k) of
    this title a summary of and a citation to all adverse safety and
    effectiveness data respecting such other device and respecting the
    device for which the section 360(k) report is being made and which
    has not been submitted to the Secretary under section 360i of this
    title. The Secretary may require the manufacturer to submit the
    adverse safety and effectiveness data described in the report.
      (5) The Secretary may not withhold a determination of the initial
    classification of a device under paragraph (1) because of a failure
    to comply with any provision of this chapter unrelated to a
    substantial equivalence decision, including a finding that the
    facility in which the device is manufactured is not in compliance
    with good manufacturing requirements as set forth in regulations of
    the Secretary under section 360j(f) of this title (other than a
    finding that there is a substantial likelihood that the failure to
    comply with such regulations will potentially present a serious
    risk to human health).
    (g) Information
      Within sixty days of the receipt of a written request of any
    person for information respecting the class in which a device has
    been classified or the requirements applicable to a device under
    this chapter, the Secretary shall provide such person a written
    statement of the classification (if any) of such device and the
    requirements of this chapter applicable to the device.
    (h) Definitions
      For purposes of this section and sections 351, 360, 360d, 360e,
    360f, 360i, and 360j of this title
        (1) a reference to "general controls" is a reference to the
      controls authorized by or under sections 351, 352, 360, 360f,
      360h, 360i, and 360j of this title,
        (2) a reference to "class I", "class II", or "class III" is a
      reference to a class of medical devices described in subparagraph
      (A), (B), or (C) of subsection (a)(1) of this section, and
        (3) a reference to a "panel under section 360c of this title"
      is a reference to a panel established or authorized to be used
      under this section.
    (i) Substantial equivalence
      (1)(A) For purposes of determinations of substantial equivalence
    under subsection (f) of this section and section 360j(l) of this
    title, the term "substantially equivalent" or "substantial
    equivalence" means, with respect to a device being compared to a
    predicate device, that the device has the same intended use as the
    predicate device and that the Secretary by order has found that the
    device - 
        (i) has the same technological characteristics as the predicate
      device, or
        (ii)(I) has different technological characteristics and the
      information submitted that the device is substantially equivalent
      to the predicate device contains information, including
      appropriate clinical or scientific data if deemed necessary by
      the Secretary or a person accredited under section 360m of this
      title, that demonstrates that the device is as safe and effective
      as a legally marketed device, and (II) does not raise different
      questions of safety and effectiveness than the predicate device.

      (B) For purposes of subparagraph (A), the term "different
    technological characteristics" means, with respect to a device
    being compared to a predicate device, that there is a significant
    change in the materials, design, energy source, or other features
    of the device from those of the predicate device.
      (C) To facilitate reviews of reports submitted to the Secretary
    under section 360(k) of this title, the Secretary shall consider
    the extent to which reliance on postmarket controls may expedite
    the classification of devices under subsection (f)(1) of this
    section.
      (D) Whenever the Secretary requests information to demonstrate
    that devices with differing technological characteristics are
    substantially equivalent, the Secretary shall only request
    information that is necessary to making substantial equivalence
    determinations. In making such request, the Secretary shall
    consider the least burdensome means of demonstrating substantial
    equivalence and request information accordingly.
      (E)(i) Any determination by the Secretary of the intended use of
    a device shall be based upon the proposed labeling submitted in a
    report for the device under section 360(k) of this title. However,
    when determining that a device can be found substantially
    equivalent to a legally marketed device, the director of the
    organizational unit responsible for regulating devices (in this
    subparagraph referred to as the "Director") may require a statement
    in labeling that provides appropriate information regarding a use
    of the device not identified in the proposed labeling if, after
    providing an opportunity for consultation with the person who
    submitted such report, the Director determines and states in
    writing - 
        (I) that there is a reasonable likelihood that the device will
      be used for an intended use not identified in the proposed
      labeling for the device; and
        (II) that such use could cause harm.

      (ii) Such determination shall - 
        (I) be provided to the person who submitted the report within
      10 days from the date of the notification of the Director's
      concerns regarding the proposed labeling;
        (II) specify the limitations on the use of the device not
      included in the proposed labeling; and
        (III) find the device substantially equivalent if the
      requirements of subparagraph (A) are met and if the labeling for
      such device conforms to the limitations specified in subclause
      (II).

      (iii) The responsibilities of the Director under this
    subparagraph may not be delegated.
      (F) Not later than 270 days after November 21, 1997, the
    Secretary shall issue guidance specifying the general principles
    that the Secretary will consider in determining when a specific
    intended use of a device is not reasonably included within a
    general use of such device for purposes of a determination of
    substantial equivalence under subsection (f) of this section or
    section 360j(l) of this title.
      (2) A device may not be found to be substantially equivalent to a
    predicate device that has been removed from the market at the
    initiative of the Secretary or that has been determined to be
    misbranded or adulterated by a judicial order.
      (3)(A) As part of a submission under section 360(k) of this title
    respecting a device, the person required to file a premarket
    notification under such section shall provide an adequate summary
    of any information respecting safety and effectiveness or state
    that such information will be made available upon request by any
    person.
      (B) Any summary under subparagraph (A) respecting a device shall
    contain detailed information regarding data concerning adverse
    health effects and shall be made available to the public by the
    Secretary within 30 days of the issuance of a determination that
    such device is substantially equivalent to another device.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 513, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 540; amended Pub. L. 101-629, Secs. 4(a),
    5(a)-(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515,
    4517, 4518, 4523, 4528; Pub. L. 102-300, Sec. 6(e), June 16, 1992,
    106 Stat. 240; Pub. L. 103-80, Sec. 3(s), Aug. 13, 1993, 107 Stat.
    778; Pub. L. 105-115, title II, Secs. 205(a), (b), 206(b), (c),
    207, 208, 217, Nov. 21, 1997, 111 Stat. 2336, 2337, 2339, 2340,
    2350; Pub. L. 107-250, title II, Sec. 208, Oct. 26, 2002, 116 Stat.
    1613.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Advisory Committee Act, referred to in subsec.
    (b)(1), (8), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as
    amended, which is set out in the Appendix to Title 5, Government
    Organization and Employees.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (i)(1)(E)(iv). Pub. L. 107-250 struck out cl. (iv)
    which read as follows: "This subparagraph has no legal effect after
    the expiration of the five-year period beginning on November 21,
    1997."
      1997 - Subsec. (a)(3)(A). Pub. L. 105-115, Sec. 217, substituted
    "1 or more clinical investigations" for "clinical investigations".
      Subsec. (a)(3)(C), (D). Pub. L. 105-115, Sec. 205(a), added
    subpars. (C) and (D).
      Subsec. (b)(5) to (8). Pub. L. 105-115, Sec. 208, added pars. (5)
    to (8).
      Subsec. (f)(1). Pub. L. 105-115, Sec. 207(1)(B), substituted
    "paragraph (2) or (3)" for "paragraph (2)" in closing provisions.
      Subsec. (f)(1)(B). Pub. L. 105-115, Sec. 207(1)(A), substituted
    "paragraph (3)" for "paragraph (2)".
      Subsec. (f)(2) to (4). Pub. L. 105-115, Sec. 207(2), (3), added
    par. (2) and redesignated former pars. (2) and (3) as (3) and (4),
    respectively.
      Subsec. (f)(5). Pub. L. 105-115, Sec. 206(b), added par. (5).
      Subsec. (i)(1)(A)(ii). Pub. L. 105-115, Sec. 206(c)(1),
    substituted "appropriate clinical or scientific data" for "clinical
    data", inserted "or a person accredited under section 360m of this
    title" after "Secretary", and substituted "effectiveness" for
    "efficacy".
      Subsec. (i)(1)(C) to (E). Pub. L. 105-115, Sec. 205(b), added
    subpars. (C) to (E).
      Subsec. (i)(1)(F). Pub. L. 105-115, Sec. 206(c)(2), added subpar.
    (F).
      1993 - Subsec. (b)(3). Pub. L. 103-80 substituted "5703" for
    "5703(b)".
      1992 - Subsec. (f)(3). Pub. L. 102-300 redesignated clauses (i)
    to (iii) as subpars. (A) to (C), respectively, and substituted "the
    section 360(k) report" for "the 360(k) report" in closing
    provisions.
      1990 - Subsec. (a)(1)(A)(ii). Pub. L. 101-629, Sec. 5(a)(1),
    substituted "or to establish special controls" for "or to establish
    a performance standard".
      Subsec. (a)(1)(B). Pub. L. 101-629, Sec. 5(a)(2), amended subpar.
    (B) generally. Prior to amendment, subpar. (B) read as follows:
    "Class II, Performance Standards. - A device which cannot be
    classified as a class I device because the controls authorized by
    or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this
    title by themselves are insufficient to provide reasonable
    assurance of the safety and effectiveness of the device, for which
    there is sufficient information to establish a performance standard
    to provide such assurance, and for which it is therefore necessary
    to establish for the device a performance standard under section
    360d of this title to provide reasonable assurance of its safety
    and effectiveness."
      Subsec. (a)(1)(C)(i). Pub. L. 101-629, Sec. 5(a)(3), amended cl.
    (i) generally. Prior to amendment, cl. (i) read as follows: "it (I)
    cannot be classified as a class I device because insufficient
    information exists to determine that the controls authorized by or
    under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this
    title are sufficient to provide reasonable assurance of the safety
    and effectiveness of the device and (II) cannot be classified as a
    class II device because insufficient information exists for the
    establishment of a performance standard to provide reasonable
    assurance of its safety and effectiveness, and".
      Subsec. (e). Pub. L. 101-629, Sec. 5(b), designated existing
    provisions as par. (1), redesignated cls. (1) and (2) as (A) and
    (B), respectively, and added par. (2).
      Subsec. (f). Pub. L. 101-629, Sec. 5(c)(3), inserted "and
    reclassification" before "of" in heading.
      Subsec. (f)(2)(A). Pub. L. 101-629, Sec. 5(c)(1), substituted
    "The Secretary may initiate the reclassification of a device
    classified into class III under paragraph (1) of this subsection or
    the manufacturer" for "The manufacturer".
      Subsec. (f)(2)(B)(i). Pub. L. 101-629, Sec. 18(a), substituted
    "the Secretary may for good cause shown" for "the Secretary shall".
      Subsec. (f)(3). Pub. L. 101-629, Sec. 4(a), added par. (3).
      Subsec. (i). Pub. L. 101-629, Sec. 12(a), added subsec. (i).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                       SHORT TITLE OF 1976 AMENDMENT                   
      Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
    that: "This Act [enacting sections 360c to 360k, 379, and 379a of
    this title and section 3512 of Title 42, The Public Health and
    Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,
    374, 379e, and 381 of this title and section 55 of Title 15,
    Commerce and Trade] may be cited as the 'Medical Device Amendments
    of 1976'."

                                REGULATIONS                            
      Section 12(b) of Pub. L. 101-629 provided that: "Within 12 months
    of the date of the enactment of this Act [Nov. 28, 1990], the
    Secretary of Health and Human Services shall issue regulations
    establishing the requirements of the summaries under section
    513(i)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    360c(i)(3)], as added by the amendment made by subsection (a)."

    DAILY WEAR SOFT OR DAILY WEAR NONHYDROPHILIC PLASTIC CONTACT LENSES
      Section 4(b)(3) of Pub. L. 101-629 provided that:
      "(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug,
    and Cosmetic Act [21 U.S.C. 360j(l)(5)], the Secretary of Health
    and Human Services shall not retain any daily wear soft or daily
    wear nonhydrophilic plastic contact lens in class III under such
    Act [this chapter] unless the Secretary finds that it meets the
    criteria set forth in section 513(a)(1)(C) of such Act [21 U.S.C.
    360c(a)(1)(C)]. The finding and the grounds for the finding shall
    be published in the Federal Register. For any such lens, the
    Secretary shall make the determination respecting reclassification
    required in section 520(l)(5)(B) of such Act within 24 months of
    the date of the enactment of this paragraph [Nov. 28, 1990].
      "(B) The Secretary of Health and Human Services may by notice
    published in the Federal Register extend the two-year period
    prescribed by subparagraph (A) for a lens for an additional period
    not to exceed one year.
      "(C)(i) Before classifying a lens in class II pursuant to
    subparagraph (A), the Secretary of Health and Human Services shall
    pursuant to section 513(a)(1)(B) of such Act assure that
    appropriate regulatory safeguards are in effect which provide
    reasonable assurance of the safety and effectiveness of such lens,
    including clinical and preclinical data if deemed necessary by the
    Secretary.
      "(ii) Prior to classifying a lens in class I pursuant to
    subparagraph (A), the Secretary shall assure that appropriate
    regulatory safeguards are in effect which provide reasonable
    assurance of the safety and effectiveness of such lens, including
    clinical and preclinical data if deemed necessary by the Secretary.
      "(D) Notwithstanding section 520(l)(5) of such Act, if the
    Secretary of Health and Human Services has not made the finding and
    published the finding required by subparagraph (A) within 36 months
    of the date of the enactment of this subparagraph [Nov. 28, 1990],
    the Secretary shall issue an order placing the lens in class II.
      "(E) Any person adversely affected by a final regulation under
    this paragraph revising the classification of a lens may challenge
    the revision of the classification of such lens only by filing a
    petition under section 513(e) for a classification change."

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Sec. 360d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360d. Performance standards

-STATUTE-
    (a) Reasonable assurance of safe and effective performance;
      periodic evaluation
      (1) The special controls required by section 360c(a)(1)(B) of
    this title shall include performance standards for a class II
    device if the Secretary determines that a performance standard is
    necessary to provide reasonable assurance of the safety and
    effectiveness of the device. A class III device may also be
    considered a class II device for purposes of establishing a
    standard for the device under subsection (b) of this section if the
    device has been reclassified as a class II device under a
    regulation under section 360c(e) of this title but such regulation
    provides that the reclassification is not to take effect until the
    effective date of such a standard for the device.
      (2) A performance standard established under subsection (b) of
    this section for a device - 
        (A) shall include provisions to provide reasonable assurance of
      its safe and effective performance;
        (B) shall, where necessary to provide reasonable assurance of
      its safe and effective performance, include - 
          (i) provisions respecting the construction, components,
        ingredients, and properties of the device and its compatibility
        with power systems and connections to such systems,
          (ii) provisions for the testing (on a sample basis or, if
        necessary, on an individual basis) of the device or, if it is
        determined that no other more practicable means are available
        to the Secretary to assure the conformity of the device to the
        standard, provisions for the testing (on a sample basis or, if
        necessary, on an individual basis) by the Secretary or by
        another person at the direction of the Secretary,
          (iii) provisions for the measurement of the performance
        characteristics of the device,
          (iv) provisions requiring that the results of each or of
        certain of the tests of the device required to be made under
        clause (ii) show that the device is in conformity with the
        portions of the standard for which the test or tests were
        required, and
          (v) a provision requiring that the sale and distribution of
        the device be restricted but only to the extent that the sale
        and distribution of a device may be restricted under a
        regulation under section 360j(e) of this title; and

        (C) shall, where appropriate, require the use and prescribe the
      form and content of labeling for the proper installation,
      maintenance, operation, and use of the device.

      (3) The Secretary shall provide for periodic evaluation of
    performance standards established under subsection (b) of this
    section to determine if such standards should be changed to reflect
    new medical, scientific, or other technological data.
      (4) In carrying out his duties under this subsection and
    subsection (b) of this section, the Secretary shall, to the maximum
    extent practicable - 
        (A) use personnel, facilities, and other technical support
      available in other Federal agencies,
        (B) consult with other Federal agencies concerned with standard-
      setting and other nationally or internationally recognized
      standard-setting entities, and
        (C) invite appropriate participation, through joint or other
      conferences, workshops, or other means, by informed persons
      representative of scientific, professional, industry, or consumer
      organizations who in his judgment can make a significant
      contribution.
    (b) Establishment of a standard
      (1)(A) The Secretary shall publish in the Federal Register a
    notice of proposed rulemaking for the establishment, amendment, or
    revocation of any performance standard for a device.
      (B) A notice of proposed rulemaking for the establishment or
    amendment of a performance standard for a device shall - 
        (i) set forth a finding with supporting justification that the
      performance standard is appropriate and necessary to provide
      reasonable assurance of the safety and effectiveness of the
      device,
        (ii) set forth proposed findings with respect to the risk of
      illness or injury that the performance standard is intended to
      reduce or eliminate,
        (iii) invite interested persons to submit to the Secretary,
      within 30 days of the publication of the notice, requests for
      changes in the classification of the device pursuant to section
      360c(e) of this title based on new information relevant to the
      classification, and
        (iv) invite interested persons to submit an existing
      performance standard for the device, including a draft or
      proposed performance standard, for consideration by the
      Secretary.

      (C) A notice of proposed rulemaking for the revocation of a
    performance standard shall set forth a finding with supporting
    justification that the performance standard is no longer necessary
    to provide reasonable assurance of the safety and effectiveness of
    a device.
      (D) The Secretary shall provide for a comment period of not less
    than 60 days.
      (2) If, after publication of a notice in accordance with
    paragraph (1), the Secretary receives a request for a change in the
    classification of the device, the Secretary shall, within 60 days
    of the publication of the notice, after consultation with the
    appropriate panel under section 360c of this title, either deny the
    request or give notice of an intent to initiate such change under
    section 360c(e) of this title.
      (3)(A) After the expiration of the period for comment on a notice
    of proposed rulemaking published under paragraph (1) respecting a
    performance standard and after consideration of such comments and
    any report from an advisory committee under paragraph (5), the
    Secretary shall (i) promulgate a regulation establishing a
    performance standard and publish in the Federal Register findings
    on the matters referred to in paragraph (1), or (ii) publish a
    notice terminating the proceeding for the development of the
    standard together with the reasons for such termination. If a
    notice of termination is published, the Secretary shall (unless
    such notice is issued because the device is a banned device under
    section 360f of this title) initiate a proceeding under section
    360c(e) of this title to reclassify the device subject to the
    proceeding terminated by such notice.
      (B) A regulation establishing a performance standard shall set
    forth the date or dates upon which the standard shall take effect,
    but no such regulation may take effect before one year after the
    date of its publication unless (i) the Secretary determines that an
    earlier effective date is necessary for the protection of the
    public health and safety, or (ii) such standard has been
    established for a device which, effective upon the effective date
    of the standard, has been reclassified from class III to class II.
    Such date or dates shall be established so as to minimize,
    consistent with the public health and safety, economic loss to, and
    disruption or dislocation of, domestic and international trade.
      (4)(A) The Secretary, upon his own initiative or upon petition of
    an interested person may by regulation, promulgated in accordance
    with the requirements of paragraphs (1), (2), and (3)(B) of this
    subsection, amend or revoke a performance standard.
      (B) The Secretary may declare a proposed amendment of a
    performance standard to be effective on and after its publication
    in the Federal Register and until the effective date of any final
    action taken on such amendment if he determines that making it so
    effective is in the public interest. A proposed amendment of a
    performance standard made so effective under the preceding sentence
    may not prohibit, during the period in which it is so effective,
    the introduction or delivery for introduction into interstate
    commerce of a device which conforms to such standard without the
    change or changes provided by such proposed amendment.
      (5)(A) The Secretary - 
        (i) may on his own initiative refer a proposed regulation for
      the establishment, amendment, or revocation of a performance
      standard, or
        (ii) shall, upon the request of an interested person which
      demonstrates good cause for referral and which is made before the
      expiration of the period for submission of comments on such
      proposed regulation refer such proposed regulation,

    to an advisory committee of experts, established pursuant to
    subparagraph (B), for a report and recommendation with respect to
    any matter involved in the proposed regulation which requires the
    exercise of scientific judgment. If a proposed regulation is
    referred under this subparagraph to an advisory committee, the
    Secretary shall provide the advisory committee with the data and
    information on which such proposed regulation is based. The
    advisory committee shall, within sixty days of the referral of a
    proposed regulation and after independent study of the data and
    information furnished to it by the Secretary and other data and
    information before it, submit to the Secretary a report and
    recommendation respecting such regulation, together with all
    underlying data and information and a statement of the reason or
    basis for the recommendation. A copy of such report and
    recommendation shall be made public by the Secretary.
      (B) The Secretary shall establish advisory committees (which may
    not be panels under section 360c of this title) to receive
    referrals under subparagraph (A). The Secretary shall appoint as
    members of any such advisory committee persons qualified in the
    subject matter to be referred to the committee and of appropriately
    diversified professional background, except that the Secretary may
    not appoint to such a committee any individual who is in the
    regular full-time employ of the United States and engaged in the
    administration of this chapter. Each such committee shall include
    as nonvoting members a representative of consumer interests and a
    representative of interests of the device manufacturing industry.
    Members of an advisory committee who are not officers or employees
    of the United States, while attending conferences or meetings of
    their committee or otherwise serving at the request of the
    Secretary, shall be entitled to receive compensation at rates to be
    fixed by the Secretary, which rates may not exceed the daily
    equivalent of the rate in effect for grade GS-18 of the General
    Schedule, for each day (including traveltime) they are so engaged;
    and while so serving away from their homes or regular places of
    business each member may be allowed travel expenses, including per
    diem in lieu of subsistence, as authorized by section 5703 of title
    5 for persons in the Government service employed intermittently.
    The Secretary shall designate one of the members of each advisory
    committee to serve as chairman thereof. The Secretary shall furnish
    each advisory committee with clerical and other assistance, and
    shall by regulation prescribe the procedures to be followed by each
    such committee in acting on referrals made under subparagraph (A).
    (c) Recognition of standard
      (1)(A) In addition to establishing a performance standard under
    this section, the Secretary shall, by publication in the Federal
    Register, recognize all or part of an appropriate standard
    established by a nationally or internationally recognized standard
    development organization for which a person may submit a
    declaration of conformity in order to meet a premarket submission
    requirement or other requirement under this chapter to which such
    standard is applicable.
      (B) If a person elects to use a standard recognized by the
    Secretary under subparagraph (A) to meet the requirements described
    in such subparagraph, the person shall provide a declaration of
    conformity to the Secretary that certifies that the device is in
    conformity with such standard. A person may elect to use data, or
    information, other than data required by a standard recognized
    under subparagraph (A) to meet any requirement regarding devices
    under this chapter.
      (2) The Secretary may withdraw such recognition of a standard
    through publication of a notice in the Federal Register if the
    Secretary determines that the standard is no longer appropriate for
    meeting a requirement regarding devices under this chapter.
      (3)(A) Subject to subparagraph (B), the Secretary shall accept a
    declaration of conformity that a device is in conformity with a
    standard recognized under paragraph (1) unless the Secretary finds -
     
        (i) that the data or information submitted to support such
      declaration does not demonstrate that the device is in conformity
      with the standard identified in the declaration of conformity; or
        (ii) that the standard identified in the declaration of
      conformity is not applicable to the particular device under
      review.

      (B) The Secretary may request, at any time, the data or
    information relied on by the person to make a declaration of
    conformity with respect to a standard recognized under paragraph
    (1).
      (C) A person making a declaration of conformity with respect to a
    standard recognized under paragraph (1) shall maintain the data and
    information demonstrating conformity of the device to the standard
    for a period of two years after the date of the classification or
    approval of the device by the Secretary or a period equal to the
    expected design life of the device, whichever is longer.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 514, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 546; amended Pub. L. 94-460, title III, Sec.
    304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101-629, Secs. 6(a),
    (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102-
    300, Sec. 6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103-80, Sec.
    4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105-115, title II,
    Sec. 204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 204(d)(1),
    substituted "under subsection (b) of this section" for "under this
    section".
      Subsec. (a)(2). Pub. L. 105-115, Sec. 204(d)(2), substituted
    "under subsection (b) of this section" for "under this section" in
    introductory provisions.
      Subsec. (a)(3). Pub. L. 105-115, Sec. 204(d)(3), substituted
    "under subsection (b) of this section" for "under this section".
      Subsec. (a)(4). Pub. L. 105-115, Sec. 204(d)(4), substituted
    "this subsection and subsection (b) of this section" for "this
    section" in introductory provisions.
      Subsec. (c). Pub. L. 105-115, Sec. 204(a), added subsec. (c).
      1993 - Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103-80 amended
    directory language of Pub. L. 101-619, Sec. 18(b), identical to
    amendment by Pub. L. 102-300, Sec. 6(g)(1). See 1992 and 1990
    Amendment notes below.
      1992 - Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102-300 made
    technical corrections to directory language of Pub. L. 101-629,
    Sec. 18(b)(1), (2). See 1990 Amendment note below.
      1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 6(a)(1), substituted
    "The special controls required by section 360c(a)(1)(B) of this
    title shall include performance standards for a class II device if
    the Secretary determines that a performance standard is necessary
    to provide reasonable assurance of the safety and effectiveness of
    the device." for "The Secretary may by regulation, promulgated in
    accordance with this section, establish a performance standard for
    a class II device."
      Subsec. (b). Pub. L. 101-629, Sec. 6(a)(2), (3), redesignated
    subsec. (g) as (b) and struck out former subsec. (b) which read as
    follows:
      "(1) A proceeding for the development of a performance standard
    for a device shall be initiated by the Secretary by the publication
    in the Federal Register of notice of the opportunity to submit to
    the Secretary a request (within fifteen days of the date of the
    publication of the notice) for a change in the classification of
    the device based on new information relevant to its classification.
      "(2) If, after publication of a notice pursuant to paragraph (1)
    the Secretary receives a request for a change in the device's
    classification, he shall, within sixty days of the publication of
    such notice and after consultation with the appropriate panel under
    section 360c of this title, by order published in the Federal
    Register, either deny the request for change in classification or
    give notice of his intent to initiate such a change under section
    360c(e) of this title."
      Subsec. (b)(1), (2). Pub. L. 101-629, Sec. 6(a)(4), amended pars.
    (1) and (2) generally. Prior to amendment, pars. (1) and (2) read
    as follows:
      "(1)(A) After publication pursuant to subsection (c) of this
    section of a notice respecting a performance standard for a device,
    the Secretary shall either - 
        "(i) publish, in the Federal Register in a notice of proposed
      rulemaking, a proposed performance standard for the device (I)
      developed by an offeror under such notice and accepted by the
      Secretary, (II) developed under subsection (c)(4) of this
      section, (III) accepted by the Secretary under subsection (d) of
      this section, or (IV) developed by him under subsection (f) of
      this section, or
        "(ii) issue a notice in the Federal Register that the
      proceeding is terminated together with the reasons for such
      termination.
      "(B) If the Secretary issues under subparagraph (A)(ii) a notice
    of termination of a proceeding to establish a performance standard
    for a device, he shall (unless such notice is issued because the
    device is a banned device under section 360f of this title)
    initiate a proceeding under section 360c(e) of this title to
    reclassify the device subject to the proceeding terminated by such
    notice.
      "(2) A notice of proposed rulemaking for the establishment of a
    performance standard for a device published under paragraph
    (1)(A)(i) shall set forth proposed findings with respect to the
    degree of the risk of illness or injury designed to be eliminated
    or reduced by the proposed standard and the benefit to the public
    from the device."
      Subsec. (b)(3)(A)(i). Pub. L. 101-629, Sec. 6(b)(1)(A),
    substituted "paragraph (1)" for "paragraph (2)".
      Subsec. (b)(4)(A). Pub. L. 101-629, Sec. 6(b)(1)(B), substituted
    "paragraphs (1), (2), and (3)(B)" for "paragraphs (2) and (3)(B)".
      Subsec. (b)(4)(B). Pub. L. 101-629, Sec. 18(b)(1), as amended by
    Pub. L. 102-300, Sec. 6(g)(1), (2), and Pub. L. 103-80, Sec.
    4(a)(1), struck out ", after affording all interested persons an
    opportunity for an informal hearing," after "if he determines".
      Subsec. (b)(5)(A)(ii). Pub. L. 101-629, Sec. 18(b)(2), as amended
    by Pub. L. 102-300, Sec. 6(g)(1), (3), and Pub. L. 103-80, Sec.
    4(a)(1), substituted "which demonstrates good cause for referral
    and which is made before the expiration of the period for
    submission of comments on such proposed regulation refer such
    proposed regulation," for "unless the Secretary finds the request
    to be without good cause or the request is made after the
    expiration of the period for submission of comments on such
    proposed regulation refer such proposed regulation,".
      Subsecs. (c) to (f). Pub. L. 101-629, Sec. 6(a)(2), struck out
    subsec. (c) relating to invitations for standards, subsec. (d)
    relating to acceptance of certain existing standards, subsec. (e)
    relating to acceptance of offers to develop standards, and subsec.
    (f) relating to development of standards by the Secretary after
    publication of notice inviting submissions or offers of standards.
      Subsec. (g). Pub. L. 101-629, Sec. 6(a)(3), redesignated subsec.
    (g) as (b).
      1976 - Subsec. (a). Pub. L. 94-460 redesignated pars. (4) and (5)
    as (3) and (4), respectively. Section as originally enacted
    contained no par. (3).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

-End-



-CITE-
    21 USC Sec. 360e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360e. Premarket approval

-STATUTE-
    (a) General requirement
      A class III device - 
        (1) which is subject to a regulation promulgated under
      subsection (b) of this section; or
        (2) which is a class III device because of section 360c(f) of
      this title,

    is required to have, unless exempt under section 360j(g) of this
    title, an approval under this section of an application for
    premarket approval or, as applicable, an approval under subsection
    (c)(2) of this section of a report seeking premarket approval.
    (b) Regulation to require premarket approval
      (1) In the case of a class III device which - 
        (A) was introduced or delivered for introduction into
      interstate commerce for commercial distribution before May 28,
      1976; or
        (B) is (i) of a type so introduced or delivered, and (ii) is
      substantially equivalent to another device within that type,

    the Secretary shall by regulation, promulgated in accordance with
    this subsection, require that such device have an approval under
    this section of an application for premarket approval.
      (2)(A) A proceeding for the promulgation of a regulation under
    paragraph (1) respecting a device shall be initiated by the
    publication in the Federal Register of a notice of proposed
    rulemaking. Such notice shall contain - 
        (i) the proposed regulation;
        (ii) proposed findings with respect to the degree of risk of
      illness or injury designed to be eliminated or reduced by
      requiring the device to have an approved application for
      premarket approval and the benefit to the public from use of the
      device;
        (iii) opportunity for the submission of comments on the
      proposed regulation and the proposed findings; and
        (iv) opportunity to request a change in the classification of
      the device based on new information relevant to the
      classification of the device.

      (B) If, within fifteen days after publication of a notice under
    subparagraph (A), the Secretary receives a request for a change in
    the classification of a device, he shall, within sixty days of the
    publication of such notice and after consultation with the
    appropriate panel under section 360c of this title, by order
    published in the Federal Register, either deny the request for
    change in classification or give notice of his intent to initiate
    such a change under section 360c(e) of this title.
      (3) After the expiration of the period for comment on a proposed
    regulation and proposed findings published under paragraph (2) and
    after consideration of comments submitted on such proposed
    regulation and findings, the Secretary shall (A) promulgate such
    regulation and publish in the Federal Register findings on the
    matters referred to in paragraph (2)(A)(ii), or (B) publish a
    notice terminating the proceeding for the promulgation of the
    regulation together with the reasons for such termination. If a
    notice of termination is published, the Secretary shall (unless
    such notice is issued because the device is a banned device under
    section 360f of this title) initiate a proceeding under section
    360c(e) of this title to reclassify the device subject to the
    proceeding terminated by such notice.
      (4) The Secretary, upon his own initiative or upon petition of an
    interested person, may by regulation amend or revoke any regulation
    promulgated under this subsection. A regulation to amend or revoke
    a regulation under this subsection shall be promulgated in
    accordance with the requirements prescribed by this subsection for
    the promulgation of the regulation to be amended or revoked.
    (c) Application for premarket approval
      (1) Any person may file with the Secretary an application for
    premarket approval for a class III device. Such an application for
    a device shall contain - 
        (A) full reports of all information, published or known to or
      which should reasonably be known to the applicant, concerning
      investigations which have been made to show whether or not such
      device is safe and effective;
        (B) a full statement of the components, ingredients, and
      properties and of the principle or principles of operation, of
      such device;
        (C) a full description of the methods used in, and the
      facilities and controls used for, the manufacture, processing,
      and, when relevant, packing and installation of, such device;
        (D) an identifying reference to any performance standard under
      section 360d of this title which would be applicable to any
      aspect of such device if it were a class II device, and either
      adequate information to show that such aspect of such device
      fully meets such performance standard or adequate information to
      justify any deviation from such standard;
        (E) such samples of such device and of components thereof as
      the Secretary may reasonably require, except that where the
      submission of such samples is impracticable or unduly burdensome,
      the requirement of this subparagraph may be met by the submission
      of complete information concerning the location of one or more
      such devices readily available for examination and testing;
        (F) specimens of the labeling proposed to be used for such
      device; and
        (G) such other information relevant to the subject matter of
      the application as the Secretary, with the concurrence of the
      appropriate panel under section 360c of this title, may require.

      (2)(A) Any person may file with the Secretary a report seeking
    premarket approval for a class III device referred to in subsection
    (a) of this section that is a reprocessed single-use device. Such a
    report shall contain the following:
        (i) The device name, including both the trade or proprietary
      name and the common or usual name.
        (ii) The establishment registration number of the owner or
      operator submitting the report.
        (iii) Actions taken to comply with performance standards under
      section 360d of this title.
        (iv) Proposed labels, labeling, and advertising sufficient to
      describe the device, its intended use, and directions for use.
        (v) Full reports of all information, published or known to or
      which should be reasonably known to the applicant, concerning
      investigations which have been made to show whether or not the
      device is safe or effective.
        (vi) A description of the device's components, ingredients, and
      properties.
        (vii) A full description of the methods used in, and the
      facilities and controls used for, the reprocessing and packing of
      the device.
        (viii) Such samples of the device that the Secretary may
      reasonably require.
        (ix) A financial certification or disclosure statement or both,
      as required by part 54 of title 21, Code of Federal Regulations.
        (x) A statement that the applicant believes to the best of the
      applicant's knowledge that all data and information submitted to
      the Secretary are truthful and accurate and that no material fact
      has been omitted in the report.
        (xi) Any additional data and information, including information
      of the type required in paragraph (1) for an application under
      such paragraph, that the Secretary determines is necessary to
      determine whether there is reasonable assurance of safety and
      effectiveness for the reprocessed device.
        (xii) Validation data described in section 360(o)(1)(A) of this
      title that demonstrates that the reasonable assurance of the
      safety or effectiveness of the device will remain after the
      maximum number of times the device is reprocessed as intended by
      the person submitting such report.

      (B) In the case of a class III device referred to in subsection
    (a) of this section that is a reprocessed single-use device:
        (i) Subparagraph (A) of this paragraph applies in lieu of
      paragraph (1).
        (ii) Subject to clause (i), the provisions of this section
      apply to a report under subparagraph (A) to the same extent and
      in the same manner as such provisions apply to an application
      under paragraph (1).
        (iii) Each reference in other sections of this chapter to an
      application under this section, other than such a reference in
      section 379i or 379j of this title, shall be considered to be a
      reference to a report under subparagraph (A).
        (iv) Each reference in other sections of this chapter to a
      device for which an application under this section has been
      approved, or has been denied, suspended, or withdrawn, other than
      such a reference in section 379i or 379j of this title, shall be
      considered to be a reference to a device for which a report under
      subparagraph (A) has been approved, or has been denied,
      suspended, or withdrawn, respectively.
      (3) Upon receipt of an application meeting the requirements set
    forth in paragraph (1), the Secretary - 
        (A) may on the Secretary's own initiative, or
        (B) shall, upon the request of an applicant unless the
      Secretary finds that the information in the application which
      would be reviewed by a panel substantially duplicates information
      which has previously been reviewed by a panel appointed under
      section 360c of this title,

    refer such application to the appropriate panel under section 360c
    of this title for study and for submission (within such period as
    he may establish) of a report and recommendation respecting
    approval of the application, together with all underlying data and
    the reasons or basis for the recommendation. Where appropriate, the
    Secretary shall ensure that such panel includes, or consults with,
    one or more pediatric experts.
      (4)(A) Prior to the submission of an application under this
    subsection, the Secretary shall accept and review any portion of
    the application that the applicant and the Secretary agree is
    complete, ready, and appropriate for review, except that such
    requirement does not apply, and the Secretary has discretion
    whether to accept and review such portion, during any period in
    which, under section 379j(g) of this title, the Secretary does not
    have the authority to collect fees under section 379j(a) of this
    title.
      (B) Each portion of a submission reviewed under subparagraph (A)
    and found acceptable by the Secretary shall not be further reviewed
    after receipt of an application that satisfies the requirements of
    paragraph (1), unless a significant issue of safety or
    effectiveness provides the Secretary reason to review such accepted
    portion.
      (C) Whenever the Secretary determines that a portion of a
    submission under subparagraph (A) is unacceptable, the Secretary
    shall, in writing, provide to the applicant a description of any
    deficiencies in such portion and identify the information that is
    required to correct these deficiencies, unless the applicant is no
    longer pursuing the application.
    (d) Action on application for premarket approval
      (1)(A) As promptly as possible, but in no event later than one
    hundred and eighty days after the receipt of an application under
    subsection (c) of this section (except as provided in section
    360j(l)(3)(D)(ii) of this title or unless, in accordance with
    subparagraph (B)(i), an additional period as agreed upon by the
    Secretary and the applicant), the Secretary, after considering the
    report and recommendation submitted under paragraph (2) of such
    subsection, shall - 
        (i) issue an order approving the application if he finds that
      none of the grounds for denying approval specified in paragraph
      (2) of this subsection applies; or
        (ii) deny approval of the application if he finds (and sets
      forth the basis for such finding as part of or accompanying such
      denial) that one or more grounds for denial specified in
      paragraph (2) of this subsection apply.

    In making the determination whether to approve or deny the
    application, the Secretary shall rely on the conditions of use
    included in the proposed labeling as the basis for determining
    whether or not there is a reasonable assurance of safety and
    effectiveness, if the proposed labeling is neither false nor
    misleading. In determining whether or not such labeling is false or
    misleading, the Secretary shall fairly evaluate all material facts
    pertinent to the proposed labeling.
      (B)(i) The Secretary may not enter into an agreement to extend
    the period in which to take action with respect to an application
    submitted for a device subject to a regulation promulgated under
    subsection (b) of this section unless he finds that the continued
    availability of the device is necessary for the public health.
      (ii) An order approving an application for a device may require
    as a condition to such approval that the sale and distribution of
    the device be restricted but only to the extent that the sale and
    distribution of a device may be restricted under a regulation under
    section 360j(e) of this title.
      (iii) The Secretary shall accept and review statistically valid
    and reliable data and any other information from investigations
    conducted under the authority of regulations required by section
    360j(g) of this title to make a determination of whether there is a
    reasonable assurance of safety and effectiveness of a device
    subject to a pending application under this section if - 
        (I) the data or information is derived from investigations of
      an earlier version of the device, the device has been modified
      during or after the investigations (but prior to submission of an
      application under subsection (c) of this section) and such a
      modification of the device does not constitute a significant
      change in the design or in the basic principles of operation of
      the device that would invalidate the data or information; or
        (II) the data or information relates to a device approved under
      this section, is available for use under this chapter, and is
      relevant to the design and intended use of the device for which
      the application is pending.

      (2) The Secretary shall deny approval of an application for a
    device if, upon the basis of the information submitted to the
    Secretary as part of the application and any other information
    before him with respect to such device, the Secretary finds that - 
        (A) there is a lack of a showing of reasonable assurance that
      such device is safe under the conditions of use prescribed,
      recommended, or suggested in the proposed labeling thereof;
        (B) there is a lack of a showing of reasonable assurance that
      the device is effective under the conditions of use prescribed,
      recommended, or suggested in the proposed labeling thereof;
        (C) the methods used in, or the facilities or controls used
      for, the manufacture, processing, packing, or installation of
      such device do not conform to the requirements of section 360j(f)
      of this title;
        (D) based on a fair evaluation of all material facts, the
      proposed labeling is false or misleading in any particular; or
        (E) such device is not shown to conform in all respects to a
      performance standard in effect under section 360d of this title
      compliance with which is a condition to approval of the
      application and there is a lack of adequate information to
      justify the deviation from such standard.

    Any denial of an application shall, insofar as the Secretary
    determines to be practicable, be accompanied by a statement
    informing the applicant of the measures required to place such
    application in approvable form (which measures may include further
    research by the applicant in accordance with one or more protocols
    prescribed by the Secretary).
      (3)(A)(i) The Secretary shall, upon the written request of an
    applicant, meet with the applicant, not later than 100 days after
    the receipt of an application that has been filed as complete under
    subsection (c) of this section, to discuss the review status of the
    application.
      (ii) The Secretary shall, in writing and prior to the meeting,
    provide to the applicant a description of any deficiencies in the
    application that, at that point, have been identified by the
    Secretary based on an interim review of the entire application and
    identify the information that is required to correct those
    deficiencies.
      (iii) The Secretary shall notify the applicant promptly of - 
        (I) any additional deficiency identified in the application, or
        (II) any additional information required to achieve completion
      of the review and final action on the application,

    that was not described as a deficiency in the written description
    provided by the Secretary under clause (ii).
      (B) The Secretary and the applicant may, by mutual consent,
    establish a different schedule for a meeting required under this
    paragraph.
      (4) An applicant whose application has been denied approval may,
    by petition filed on or before the thirtieth day after the date
    upon which he receives notice of such denial, obtain review thereof
    in accordance with either paragraph (1) or (2) of subsection (g) of
    this section, and any interested person may obtain review, in
    accordance with paragraph (1) or (2) of subsection (g) of this
    section, of an order of the Secretary approving an application.
      (5) In order to provide for more effective treatment or diagnosis
    of life-threatening or irreversibly debilitating human diseases or
    conditions, the Secretary shall provide review priority for devices
    - 
        (A) representing breakthrough technologies,
        (B) for which no approved alternatives exist,
        (C) which offer significant advantages over existing approved
      alternatives, or
        (D) the availability of which is in the best interest of the
      patients.

      (6)(A)(i) A supplemental application shall be required for any
    change to a device subject to an approved application under this
    subsection that affects safety or effectiveness, unless such change
    is a modification in a manufacturing procedure or method of
    manufacturing and the holder of the approved application submits a
    written notice to the Secretary that describes in detail the
    change, summarizes the data or information supporting the change,
    and informs the Secretary that the change has been made under the
    requirements of section 360j(f) of this title.
      (ii) The holder of an approved application who submits a notice
    under clause (i) with respect to a manufacturing change of a device
    may distribute the device 30 days after the date on which the
    Secretary receives the notice, unless the Secretary within such 30-
    day period notifies the holder that the notice is not adequate and
    describes such further information or action that is required for
    acceptance of such change. If the Secretary notifies the holder
    that a supplemental application is required, the Secretary shall
    review the supplement within 135 days after the receipt of the
    supplement. The time used by the Secretary to review the notice of
    the manufacturing change shall be deducted from the 135-day review
    period if the notice meets appropriate content requirements for
    premarket approval supplements.
      (B)(i) Subject to clause (ii), in reviewing a supplement to an
    approved application, for an incremental change to the design of a
    device that affects safety or effectiveness, the Secretary shall
    approve such supplement if - 
        (I) nonclinical data demonstrate that the design modification
      creates the intended additional capacity, function, or
      performance of the device; and
        (II) clinical data from the approved application and any
      supplement to the approved application provide a reasonable
      assurance of safety and effectiveness for the changed device.

      (ii) The Secretary may require, when necessary, additional
    clinical data to evaluate the design modification of the device to
    provide a reasonable assurance of safety and effectiveness.
    (e) Withdrawal and temporary suspension of approval of application
      (1) The Secretary shall, upon obtaining, where appropriate,
    advice on scientific matters from a panel or panels under section
    360c of this title, and after due notice and opportunity for
    informal hearing to the holder of an approved application for a
    device, issue an order withdrawing approval of the application if
    the Secretary finds - 
        (A) that such device is unsafe or ineffective under the
      conditions of use prescribed, recommended, or suggested in the
      labeling thereof;
        (B) on the basis of new information before him with respect to
      such device, evaluated together with the evidence available to
      him when the application was approved, that there is a lack of a
      showing of reasonable assurance that the device is safe or
      effective under the conditions of use prescribed, recommended, or
      suggested in the labeling thereof;
        (C) that the application contained or was accompanied by an
      untrue statement of a material fact;
        (D) that the applicant (i) has failed to establish a system for
      maintaining records, or has repeatedly or deliberately failed to
      maintain records or to make reports, required by an applicable
      regulation under section 360i(a) of this title, (ii) has refused
      to permit access to, or copying or verification of, such records
      as required by section 374 of this title, or (iii) has not
      complied with the requirements of section 360 of this title;
        (E) on the basis of new information before him with respect to
      such device, evaluated together with the evidence before him when
      the application was approved, that the methods used in, or the
      facilities and controls used for, the manufacture, processing,
      packing, or installation of such device do not conform with the
      requirements of section 360j(f) of this title and were not
      brought into conformity with such requirements within a
      reasonable time after receipt of written notice from the
      Secretary of nonconformity;
        (F) on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, that the labeling of such device, based on a fair
      evaluation of all material facts, is false or misleading in any
      particular and was not corrected within a reasonable time after
      receipt of written notice from the Secretary of such fact; or
        (G) on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, that such device is not shown to conform in all
      respects to a performance standard which is in effect under
      section 360d of this title compliance with which was a condition
      to approval of the application and that there is a lack of
      adequate information to justify the deviation from such standard.

      (2) The holder of an application subject to an order issued under
    paragraph (1) withdrawing approval of the application may, by
    petition filed on or before the thirtieth day after the date upon
    which he receives notice of such withdrawal, obtain review thereof
    in accordance with either paragraph (1) or (2) of subsection (g) of
    this section.
      (3) If, after providing an opportunity for an informal hearing,
    the Secretary determines there is reasonable probability that the
    continuation of distribution of a device under an approved
    application would cause serious, adverse health consequences or
    death, the Secretary shall by order temporarily suspend the
    approval of the application approved under this section. If the
    Secretary issues such an order, the Secretary shall proceed
    expeditiously under paragraph (1) to withdraw such application.
    (f) Product development protocol
      (1) In the case of a class III device which is required to have
    an approval of an application submitted under subsection (c) of
    this section, such device shall be considered as having such an
    approval if a notice of completion of testing conducted in
    accordance with a product development protocol approved under
    paragraph (4) has been declared completed under paragraph (6).
      (2) Any person may submit to the Secretary a proposed product
    development protocol with respect to a device. Such a protocol
    shall be accompanied by data supporting it. If, within thirty days
    of the receipt of such a protocol, the Secretary determines that it
    appears to be appropriate to apply the requirements of this
    subsection to the device with respect to which the protocol is
    submitted, the Secretary - 
        (A) may, at the initiative of the Secretary, refer the proposed
      protocol to the appropriate panel under section 360c of this
      title for its recommendation respecting approval of the protocol;
      or
        (B) shall so refer such protocol upon the request of the
      submitter, unless the Secretary finds that the proposed protocol
      and accompanying data which would be reviewed by such panel
      substantially duplicate a product development protocol and
      accompanying data which have previously been reviewed by such a
      panel.

      (3) A proposed product development protocol for a device may be
    approved only if - 
        (A) the Secretary determines that it is appropriate to apply
      the requirements of this subsection to the device in lieu of the
      requirement of approval of an application submitted under
      subsection (c) of this section; and
        (B) the Secretary determines that the proposed protocol
      provides - 
          (i) a description of the device and the changes which may be
        made in the device,
          (ii) a description of the preclinical trials (if any) of the
        device and a specification of (I) the results from such trials
        to be required before the commencement of clinical trials of
        the device, and (II) any permissible variations in preclinical
        trials and the results therefrom,
          (iii) a description of the clinical trials (if any) of the
        device and a specification of (I) the results from such trials
        to be required before the filing of a notice of completion of
        the requirements of the protocol, and (II) any permissible
        variations in such trials and the results therefrom,
          (iv) a description of the methods to be used in, and the
        facilities and controls to be used for, the manufacture,
        processing, and, when relevant, packing and installation of the
        device,
          (v) an identifying reference to any performance standard
        under section 360d of this title to be applicable to any aspect
        of such device,
          (vi) if appropriate, specimens of the labeling proposed to be
        used for such device,
          (vii) such other information relevant to the subject matter
        of the protocol as the Secretary, with the concurrence of the
        appropriate panel or panels under section 360c of this title,
        may require, and
          (viii) a requirement for submission of progress reports and,
        when completed, records of the trials conducted under the
        protocol which records are adequate to show compliance with the
        protocol.

      (4) The Secretary shall approve or disapprove a proposed product
    development protocol submitted under paragraph (2) within one
    hundred and twenty days of its receipt unless an additional period
    is agreed upon by the Secretary and the person who submitted the
    protocol. Approval of a protocol or denial of approval of a
    protocol is final agency action subject to judicial review under
    chapter 7 of title 5.
      (5) At any time after a product development protocol for a device
    has been approved pursuant to paragraph (4), the person for whom
    the protocol was approved may submit a notice of completion - 
        (A) stating (i) his determination that the requirements of the
      protocol have been fulfilled and that, to the best of his
      knowledge, there is no reason bearing on safety or effectiveness
      why the notice of completion should not become effective, and
      (ii) the data and other information upon which such determination
      was made, and
        (B) setting forth the results of the trials required by the
      protocol and all the information required by subsection (c)(1) of
      this section.

      (6)(A) The Secretary may, after providing the person who has an
    approved protocol and opportunity for an informal hearing and at
    any time prior to receipt of notice of completion of such protocol,
    issue a final order to revoke such protocol if he finds that - 
        (i) such person has failed substantially to comply with the
      requirements of the protocol,
        (ii) the results of the trials obtained under the protocol
      differ so substantially from the results required by the protocol
      that further trials cannot be justified, or
        (iii) the results of the trials conducted under the protocol or
      available new information do not demonstrate that the device
      tested under the protocol does not present an unreasonable risk
      to health and safety.

      (B) After the receipt of a notice of completion of an approved
    protocol the Secretary shall, within the ninety-day period
    beginning on the date such notice is received, by order either
    declare the protocol completed or declare it not completed. An
    order declaring a protocol not completed may take effect only after
    the Secretary has provided the person who has the protocol
    opportunity for an informal hearing on the order. Such an order may
    be issued only if the Secretary finds - 
        (i) such person has failed substantially to comply with the
      requirements of the protocol,
        (ii) the results of the trials obtained under the protocol
      differ substantially from the results required by the protocol,
      or
        (iii) there is a lack of a showing of reasonable assurance of
      the safety and effectiveness of the device under the conditions
      of use prescribed, recommended, or suggested in the proposed
      labeling thereof.

      (C) A final order issued under subparagraph (A) or (B) shall be
    in writing and shall contain the reasons to support the conclusions
    thereof.
      (7) At any time after a notice of completion has become
    effective, the Secretary may issue an order (after due notice and
    opportunity for an informal hearing to the person for whom the
    notice is effective) revoking the approval of a device provided by
    a notice of completion which has become effective as provided in
    subparagraph (B) if he finds that any of the grounds listed in
    subparagraphs (A) through (G) of subsection (e)(1) of this section
    apply. Each reference in such subparagraphs to an application shall
    be considered for purposes of this paragraph as a reference to a
    protocol and the notice of completion of such protocol, and each
    reference to the time when an application was approved shall be
    considered for purposes of this paragraph as a reference to the
    time when a notice of completion took effect.
      (8) A person who has an approved protocol subject to an order
    issued under paragraph (6)(A) revoking such protocol, a person who
    has an approved protocol with respect to which an order under
    paragraph (6)(B) was issued declaring that the protocol had not
    been completed, or a person subject to an order issued under
    paragraph (7) revoking the approval of a device may, by petition
    filed on or before the thirtieth day after the date upon which he
    receives notice of such order, obtain review thereof in accordance
    with either paragraph (1) or (2) of subsection (g) of this section.
    (g) Review
      (1) Upon petition for review of - 
        (A) an order under subsection (d) of this section approving or
      denying approval of an application or an order under subsection
      (e) of this section withdrawing approval of an application, or
        (B) an order under subsection (f)(6)(A) of this section
      revoking an approved protocol, under subsection (f)(6)(B) of this
      section declaring that an approved protocol has not been
      completed, or under subsection (f)(7) of this section revoking
      the approval of a device,

    the Secretary shall, unless he finds the petition to be without
    good cause or unless a petition for review of such order has been
    submitted under paragraph (2), hold a hearing, in accordance with
    section 554 of title 5, on the order. The panel or panels which
    considered the application, protocol, or device subject to such
    order shall designate a member to appear and testify at any such
    hearing upon request of the Secretary, the petitioner, or the
    officer conducting the hearing, but this requirement does not
    preclude any other member of the panel or panels from appearing and
    testifying at any such hearing. Upon completion of such hearing and
    after considering the record established in such hearing, the
    Secretary shall issue an order either affirming the order subject
    to the hearing or reversing such order and, as appropriate,
    approving or denying approval of the application, reinstating the
    application's approval, approving the protocol, or placing in
    effect a notice of completion.
      (2)(A) Upon petition for review of - 
        (i) an order under subsection (d) of this section approving or
      denying approval of an application or an order under subsection
      (e) of this section withdrawing approval of an application, or
        (ii) an order under subsection (f)(6)(A) of this section
      revoking an approved protocol, under subsection (f)(6)(B) of this
      section declaring that an approved protocol has not been
      completed, or under subsection (f)(7) of this section revoking
      the approval of a device,

    the Secretary shall refer the application or protocol subject to
    the order and the basis for the order to an advisory committee of
    experts established pursuant to subparagraph (B) for a report and
    recommendation with respect to the order. The advisory committee
    shall, after independent study of the data and information
    furnished to it by the Secretary and other data and information
    before it, submit to the Secretary a report and recommendation,
    together with all underlying data and information and a statement
    of the reasons or basis for the recommendation. A copy of such
    report shall be promptly supplied by the Secretary to any person
    who petitioned for such referral to the advisory committee.
      (B) The Secretary shall establish advisory committees (which may
    not be panels under section 360c of this title) to receive
    referrals under subparagraph (A). The Secretary shall appoint as
    members of any such advisory committee persons qualified in the
    subject matter to be referred to the committee and of appropriately
    diversified professional backgrounds, except that the Secretary may
    not appoint to such a committee any individual who is in the
    regular full-time employ of the United States and engaged in the
    administration of this chapter. Members of an advisory committee
    (other than officers or employees of the United States), while
    attending conferences or meetings of their committee or otherwise
    serving at the request of the Secretary, shall be entitled to
    receive compensation at rates to be fixed by the Secretary, which
    rates may not exceed the daily equivalent for grade GS-18 of the
    General Schedule for each day (including traveltime) they are so
    engaged; and while so serving away from their homes or regular
    places of business each member may be allowed travel expenses,
    including per diem in lieu of subsistence, as authorized by section
    5703 of title 5 for persons in the Government service employed
    intermittently. The Secretary shall designate the chairman of an
    advisory committee from its members. The Secretary shall furnish
    each advisory committee with clerical and other assistance, and
    shall by regulation prescribe the procedures to be followed by each
    such committee in acting on referrals made under subparagraph (A).
      (C) The Secretary shall make public the report and recommendation
    made by an advisory committee with respect to an application and
    shall by order, stating the reasons therefor, either affirm the
    order referred to the advisory committee or reverse such order and,
    if appropriate, approve or deny approval of the application,
    reinstate the application's approval, approve the protocol, or
    place in effect a notice of completion.
    (h) Service of orders
      Orders of the Secretary under this section shall be served (1) in
    person by any officer or employee of the department designated by
    the Secretary, or (2) by mailing the order by registered mail or
    certified mail addressed to the applicant at his last known address
    in the records of the Secretary.
    (i) Revision
      (1) Before December 1, 1995, the Secretary shall by order require
    manufacturers of devices, which were introduced or delivered for
    introduction into interstate commerce for commercial distribution
    before May 28, 1976, and which are subject to revision of
    classification under paragraph (2), to submit to the Secretary a
    summary of and citation to any information known or otherwise
    available to the manufacturer respecting such devices, including
    adverse safety or effectiveness information which has not been
    submitted under section 360i of this title. The Secretary may
    require the manufacturer to submit the adverse safety or
    effectiveness data for which a summary and citation were submitted,
    if such data are available to the manufacturer.
      (2) After the issuance of an order under paragraph (1) but before
    December 1, 1995, the Secretary shall publish a regulation in the
    Federal Register for each device - 
        (A) which the Secretary has classified as a class III device,
      and
        (B) for which no final regulation has been promulgated under
      subsection (b) of this section,

    revising the classification of the device so that the device is
    classified into class I or class II, unless the regulation requires
    the device to remain in class III. In determining whether to revise
    the classification of a device or to require a device to remain in
    class III, the Secretary shall apply the criteria set forth in
    section 360c(a) of this title. Before the publication of a
    regulation requiring a device to remain in class III or revising
    its classification, the Secretary shall publish a proposed
    regulation respecting the classification of a device under this
    paragraph and provide reasonable opportunity for the submission of
    comments on any such regulation. No regulation requiring a device
    to remain in class III or revising its classification may take
    effect before the expiration of 90 days from the date of its
    publication in the Federal Register as a proposed regulation.
      (3) The Secretary shall, as promptly as is reasonably achievable,
    but not later than 12 months after the effective date of the
    regulation requiring a device to remain in class III, establish a
    schedule for the promulgation of a subsection (b) of this section
    regulation for each device which is subject to the regulation
    requiring the device to remain in class III.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 515, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 552; amended Pub. L. 101-629, Secs. 4(b)(1),
    9(a), 18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103-
    80, Sec. 3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115,
    title II, Secs. 201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997,
    111 Stat. 2334, 2338, 2341, 2349; Pub. L. 107-250, title II, Secs.
    209, 210, title III, Sec. 302(c), Oct. 26, 2002, 116 Stat. 1613,
    1614, 1618; Pub. L. 108-214, Sec. 2(d)(1), Apr. 1, 2004, 118 Stat.
    576.)


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (c)(3). Pub. L. 108-214, Sec. 2(d)(1)(B), amended
    directory language of Pub. L. 107-250, Sec. 210. See 2002 Amendment
    note below.
      Pub. L. 108-214, Sec. 2(d)(1)(A)(i), redesignated par. (3)
    relating to acceptance and review of any portion of the application
    prior to submission as (4).
      Subsec. (c)(4). Pub. L. 108-214, Sec. 2(d)(1)(A), redesignated
    par. (3) relating to acceptance and review of any portion of the
    application prior to submission as (4) and substituted "unless a
    significant issue of safety" for "unless an issue of safety" in
    subpar. (B).
      2002 - Subsec. (a). Pub. L. 107-250, Sec. 302(c)(1), inserted
    "or, as applicable, an approval under subsection (c)(2) of this
    section of a report seeking premarket approval" before period in
    concluding provisions.
      Subsec. (c)(2). Pub. L. 107-250, Sec. 302(c)(2)(B), added par.
    (2). Former par. (2) redesignated (3).
      Subsec. (c)(3). Pub. L. 107-250, Sec. 302(c)(2)(A), redesignated
    par. (2) relating to Secretary's referral of application to
    appropriate panel as (3).
      Pub. L. 107-250, Sec. 210, as amended by Pub. L. 108-214, Sec.
    2(d)(1)(B), inserted "Where appropriate, the Secretary shall ensure
    that such panel includes, or consults with, one or more pediatric
    experts." at the end of the concluding provisions of par. (3) as
    redesignated by Pub. L. 107-250, Sec. 302(c)(2)(A).
      Pub. L. 107-250, Sec. 209, added par. (3) relating to acceptance
    and review of any portion of the application prior to submission.
      1997 - Subsec. (d)(1)(A). Pub. L. 105-115, Sec. 205(c)(1),
    inserted at end "In making the determination whether to approve or
    deny the application, the Secretary shall rely on the conditions of
    use included in the proposed labeling as the basis for determining
    whether or not there is a reasonable assurance of safety and
    effectiveness, if the proposed labeling is neither false nor
    misleading. In determining whether or not such labeling is false or
    misleading, the Secretary shall fairly evaluate all material facts
    pertinent to the proposed labeling."
      Subsec. (d)(1)(B)(iii). Pub. L. 105-115, Sec. 201(b), added cl.
    (iii).
      Subsec. (d)(3), (4). Pub. L. 105-115, Sec. 202(1), 209(b), added
    par. (3) and redesignated former par. (3) as (4).
      Subsec. (d)(5). Pub. L. 105-115, Sec. 202(2), added par. (5).
      Subsec. (d)(6). Pub. L. 105-115, Sec. 205(c)(2), added par. (6).
      Subsec. (f)(2). Pub. L. 105-115, Sec. 216(b), substituted "the
    Secretary - " and subpars. (A) and (B) for "he shall refer the
    proposed protocol to the appropriate panel under section 360c of
    this title for its recommendation respecting approval of the
    protocol."
      1993 - Subsec. (c)(2)(A). Pub. L. 103-80 struck out "refer such
    application" after "own initiative".
      1990 - Subsec. (c)(2). Pub. L. 101-629, Sec. 18(c), substituted
    "the Secretary - " for "the Secretary shall" and added subpars. (A)
    and (B).
      Subsec. (e). Pub. L. 101-629, Sec. 9(a)(2), inserted "and
    temporary suspension" after "Withdrawal" in heading.
      Subsec. (e)(3). Pub. L. 101-629, Sec. 9(a)(1), added par. (3).
      Subsec. (i). Pub. L. 101-629, Sec. 4(b)(1), added subsec. (i).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

                         REPORT ON CERTAIN DEVICES                     
      Pub. L. 107-250, title II, Sec. 205, Oct. 26, 2002, 116 Stat.
    1612, directed the Secretary of Health and Human Services, not
    later than one year after Oct. 26, 2002, to report to the
    appropriate committees of Congress on the timeliness and
    effectiveness of device premarket reviews by centers other than the
    Center for Devices and Radiological Health, including information
    on the times required to log in and review original submissions and
    supplements, times required to review manufacturers' replies to
    submissions, times to approve or clear such devices, and
    recommendations on improvement of performance and reassignment of
    responsibility for regulating such devices.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Sec. 360f                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360f. Banned devices

-STATUTE-
    (a) General rule
      Whenever the Secretary finds, on the basis of all available data
    and information, that - 
        (1) a device intended for human use presents substantial
      deception or an unreasonable and substantial risk of illness or
      injury; and
        (2) in the case of substantial deception or an unreasonable and
      substantial risk of illness or injury which the Secretary
      determined could be corrected or eliminated by labeling or change
      in labeling and with respect to which the Secretary provided
      written notice to the manufacturer specifying the deception or
      risk of illness or injury, the labeling or change in labeling to
      correct the deception or eliminate or reduce such risk, and the
      period within which such labeling or change in labeling was to be
      done, such labeling or change in labeling was not done within
      such period;

    he may initiate a proceeding to promulgate a regulation to make
    such device a banned device.
    (b) Special effective date
      The Secretary may declare a proposed regulation under subsection
    (a) of this section to be effective upon its publication in the
    Federal Register and until the effective date of any final action
    taken respecting such regulation if (1) he determines, on the basis
    of all available data and information, that the deception or risk
    of illness or injury associated with the use of the device which is
    subject to the regulation presents an unreasonable, direct, and
    substantial danger to the health of individuals, and (2) before the
    date of the publication of such regulation, the Secretary notifies
    the manufacturer of such device that such regulation is to be made
    so effective. If the Secretary makes a proposed regulation so
    effective, he shall, as expeditiously as possible, give interested
    persons prompt notice of his action under this subsection, provide
    reasonable opportunity for an informal hearing on the proposed
    regulation, and either affirm, modify, or revoke such proposed
    regulation.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 516, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 18(d),
    Nov. 28, 1990, 104 Stat. 4529.)


-MISC1-
                                AMENDMENTS                            
      1990 - Subsec. (a). Pub. L. 101-629 struck out "and after
    consultation with the appropriate panel or panels under section
    360c of this title" after "data and information" in introductory
    provisions and struck out at end "The Secretary shall afford all
    interested persons opportunity for an informal hearing on a
    regulation proposed under this subsection."

-End-



-CITE-
    21 USC Sec. 360g                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360g. Judicial review

-STATUTE-
    (a) Petition; record
      Not later than thirty days after - 
        (1) the promulgation of a regulation under section 360c of this
      title classifying a device in class I or changing the
      classification of a device to class I or an order under
      subsection (f)(2) of such section reclassifying a device or
      denying a petition for reclassification of a device,
        (2) the promulgation of a regulation under section 360d of this
      title establishing, amending, or revoking a performance standard
      for a device,
        (3) the issuance of an order under section 360d(b)(2) or
      360e(b)(2)(B) of this title denying a request for
      reclassification of a device,
        (4) the promulgation of a regulation under paragraph (3) of
      section 360e(b) of this title requiring a device to have an
      approval of a premarket application, a regulation under paragraph
      (4) of that section amending or revoking a regulation under
      paragraph (3), or an order pursuant to section 360e(g)(1) or
      360e(g)(2)(C) of this title,
        (5) the promulgation of a regulation under section 360f of this
      title (other than a proposed regulation made effective under
      subsection (b) of such section upon the regulation's publication)
      making a device a banned device,
        (6) the issuance of an order under section 360j(f)(2) of this
      title,
        (7) an order under section 360j(g)(4) of this title
      disapproving an application for an exemption of a device for
      investigational use or an order under section 360j(g)(5) of this
      title withdrawing such an exemption for a device,
        (8) an order pursuant to section 360c(i) of this title, or
        (9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of
      this title,

    any person adversely affected by such regulation or order may file
    a petition with the United States Court of Appeals for the District
    of Columbia or for the circuit wherein such person resides or has
    his principal place of business for judicial review of such
    regulation or order. A copy of the petition shall be transmitted by
    the clerk of the court to the Secretary or other officer designated
    by him for that purpose. The Secretary shall file in the court the
    record of the proceedings on which the Secretary based his
    regulation or order as provided in section 2112 of title 28. For
    purposes of this section, the term "record" means all notices and
    other matter published in the Federal Register with respect to the
    regulation or order reviewed, all information submitted to the
    Secretary with respect to such regulation or order, proceedings of
    any panel or advisory committee with respect to such regulation or
    order, any hearing held with respect to such regulation or order,
    and any other information identified by the Secretary, in the
    administrative proceeding held with respect to such regulation or
    order, as being relevant to such regulation or order.
    (b) Additional data, views, and arguments
      If the petitioner applies to the court for leave to adduce
    additional data, views, or arguments respecting the regulation or
    order being reviewed and shows to the satisfaction of the court
    that such additional data, views, or arguments are material and
    that there were reasonable grounds for the petitioner's failure to
    adduce such data, views, or arguments in the proceedings before the
    Secretary, the court may order the Secretary to provide additional
    opportunity for the oral presentation of data, views, or arguments
    and for written submissions. The Secretary may modify his findings,
    or make new findings by reason of the additional data, views, or
    arguments so taken and shall file with the court such modified or
    new findings, and his recommendation, if any, for the modification
    or setting aside of the regulation or order being reviewed, with
    the return of such additional data, views, or arguments.
    (c) Standard for review
      Upon the filing of the petition under subsection (a) of this
    section for judicial review of a regulation or order, the court
    shall have jurisdiction to review the regulation or order in
    accordance with chapter 7 of title 5 and to grant appropriate
    relief, including interim relief, as provided in such chapter. A
    regulation described in paragraph (2) or (5) of subsection (a) of
    this section and an order issued after the review provided by
    section 360e(g) of this title shall not be affirmed if it is found
    to be unsupported by substantial evidence on the record taken as a
    whole.
    (d) Finality of judgments
      The judgment of the court affirming or setting aside, in whole or
    in part, any regulation or order shall be final, subject to review
    by the Supreme Court of the United States upon certiorari or
    certification, as provided in section 1254 of title 28.
    (e) Remedies
      The remedies provided for in this section shall be in addition to
    and not in lieu of any other remedies provided by law.
    (f) Statement of reasons
      To facilitate judicial review under this section or under any
    other provision of law of a regulation or order issued under
    section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this
    title each such regulation or order shall contain a statement of
    the reasons for its issuance and the basis, in the record of the
    proceedings held in connection with its issuance, for its issuance.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 517, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 13, Nov.
    28, 1990, 104 Stat. 4524; Pub. L. 102-300, Sec. 6(f), June 16,
    1992, 106 Stat. 240; Pub. L. 105-115, title II, Sec. 216(a)(2),
    Nov. 21, 1997, 111 Stat. 2349.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a)(8). Pub. L. 105-115, Sec. 216(a)(2)(A),
    inserted "or" at end.
      Subsec. (a)(9). Pub. L. 105-115, Sec. 216(a)(2)(B), substituted
    comma for ", or" at end.
      Subsec. (a)(10). Pub. L. 105-115, Sec. 216(a)(2)(C), struck out
    par. (10) which read as follows: "an order under section
    360j(h)(4)(B) of this title,".
      1992 - Subsec. (a)(10). Pub. L. 102-300 substituted
    "360j(h)(4)(B)" for "360j(c)(4)(B)".
      1990 - Subsec. (a)(8) to (10). Pub. L. 101-629 added pars. (8) to
    (10).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 360h                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360h. Notification and other remedies

-STATUTE-
    (a) Notification
      If the Secretary determines that - 
        (1) a device intended for human use which is introduced or
      delivered for introduction into interstate commerce for
      commercial distribution presents an unreasonable risk of
      substantial harm to the public health, and
        (2) notification under this subsection is necessary to
      eliminate the unreasonable risk of such harm and no more
      practicable means is available under the provisions of this
      chapter (other than this section) to eliminate such risk,

    the Secretary may issue such order as may be necessary to assure
    that adequate notification is provided in an appropriate form, by
    the persons and means best suited under the circumstances involved,
    to all health professionals who prescribe or use the device and to
    any other person (including manufacturers, importers, distributors,
    retailers, and device users) who should properly receive such
    notification in order to eliminate such risk. An order under this
    subsection shall require that the individuals subject to the risk
    with respect to which the order is to be issued be included in the
    persons to be notified of the risk unless the Secretary determines
    that notice to such individuals would present a greater danger to
    the health of such individuals than no such notification. If the
    Secretary makes such a determination with respect to such
    individuals, the order shall require that the health professionals
    who prescribe or use the device provide for the notification of the
    individuals whom the health professionals treated with the device
    of the risk presented by the device and of any action which may be
    taken by or on behalf of such individuals to eliminate or reduce
    such risk. Before issuing an order under this subsection, the
    Secretary shall consult with the persons who are to give notice
    under the order.
    (b) Repair, replacement, or refund
      (1)(A) If, after affording opportunity for an informal hearing,
    the Secretary determines that - 
        (i) a device intended for human use which is introduced or
      delivered for introduction into interstate commerce for
      commercial distribution presents an unreasonable risk of
      substantial harm to the public health,
        (ii) there are reasonable grounds to believe that the device
      was not properly designed or manufactured with reference to the
      state of the art as it existed at the time of its design or
      manufacture,
        (iii) there are reasonable grounds to believe that the
      unreasonable risk was not caused by failure of a person other
      than a manufacturer, importer, distributor, or retailer of the
      device to exercise due care in the installation, maintenance,
      repair, or use of the device, and
        (iv) the notification authorized by subsection (a) of this
      section would not by itself be sufficient to eliminate the
      unreasonable risk and action described in paragraph (2) of this
      subsection is necessary to eliminate such risk,

    the Secretary may order the manufacturer, importer, or any
    distributor of such device, or any combination of such persons, to
    submit to him within a reasonable time a plan for taking one or
    more of the actions described in paragraph (2). An order issued
    under the preceding sentence which is directed to more than one
    person shall specify which person may decide which action shall be
    taken under such plan and the person specified shall be the person
    who the Secretary determines bears the principal, ultimate
    financial responsibility for action taken under the plan unless the
    Secretary cannot determine who bears such responsibility or the
    Secretary determines that the protection of the public health
    requires that such decision be made by a person (including a device
    user or health professional) other than the person he determines
    bears such responsibility.
      (B) The Secretary shall approve a plan submitted pursuant to an
    order issued under subparagraph (A) unless he determines (after
    affording opportunity for an informal hearing) that the action or
    actions to be taken under the plan or the manner in which such
    action or actions are to be taken under the plan will not assure
    that the unreasonable risk with respect to which such order was
    issued will be eliminated. If the Secretary disapproves a plan, he
    shall order a revised plan to be submitted to him within a
    reasonable time. If the Secretary determines (after affording
    opportunity for an informal hearing) that the revised plan is
    unsatisfactory or if no revised plan or no initial plan has been
    submitted to the Secretary within the prescribed time, the
    Secretary shall (i) prescribe a plan to be carried out by the
    person or persons to whom the order issued under subparagraph (A)
    was directed, or (ii) after affording an opportunity for an
    informal hearing, by order prescribe a plan to be carried out by a
    person who is a manufacturer, importer, distributor, or retailer of
    the device with respect to which the order was issued but to whom
    the order under subparagraph (A) was not directed.
      (2) The actions which may be taken under a plan submitted under
    an order issued under paragraph (1) are as follows:
        (A) To repair the device so that it does not present the
      unreasonable risk of substantial harm with respect to which the
      order under paragraph (1) was issued.
        (B) To replace the device with a like or equivalent device
      which is in conformity with all applicable requirements of this
      chapter.
        (C) To refund the purchase price of the device (less a
      reasonable allowance for use if such device has been in the
      possession of the device user for one year or more - 
          (i) at the time of notification ordered under subsection (a)
        of this section, or
          (ii) at the time the device user receives actual notice of
        the unreasonable risk with respect to which the order was
        issued under paragraph (1),

      whichever first occurs).

      (3) No charge shall be made to any person (other than a
    manufacturer, importer, distributor or retailer) for availing
    himself of any remedy, described in paragraph (2) and provided
    under an order issued under paragraph (1), and the person subject
    to the order shall reimburse each person (other than a
    manufacturer, importer, distributor, or retailer) who is entitled
    to such a remedy for any reasonable and foreseeable expenses
    actually incurred by such person in availing himself of such
    remedy.
    (c) Reimbursement
      An order issued under subsection (b) of this section with respect
    to a device may require any person who is a manufacturer, importer,
    distributor, or retailer of the device to reimburse any other
    person who is a manufacturer, importer, distributor, or retailer of
    such device for such other person's expenses actually incurred in
    connection with carrying out the order if the Secretary determines
    such reimbursement is required for the protection of the public
    health. Any such requirement shall not affect any rights or
    obligations under any contract to which the person receiving
    reimbursement or the person making such reimbursement is a party.
    (d) Effect on other liability
      Compliance with an order issued under this section shall not
    relieve any person from liability under Federal or State law. In
    awarding damages for economic loss in an action brought for the
    enforcement of any such liability, the value to the plaintiff in
    such action of any remedy provided him under such order shall be
    taken into account.
    (e) Recall authority
      (1) If the Secretary finds that there is a reasonable probability
    that a device intended for human use would cause serious, adverse
    health consequences or death, the Secretary shall issue an order
    requiring the appropriate person (including the manufacturers,
    importers, distributors, or retailers of the device) - 
        (A) to immediately cease distribution of such device, and
        (B) to immediately notify health professionals and device user
      facilities of the order and to instruct such professionals and
      facilities to cease use of such device.

    The order shall provide the person subject to the order with an
    opportunity for an informal hearing, to be held not later than 10
    days after the date of the issuance of the order, on the actions
    required by the order and on whether the order should be amended to
    require a recall of such device. If, after providing an opportunity
    for such a hearing, the Secretary determines that inadequate
    grounds exist to support the actions required by the order, the
    Secretary shall vacate the order.
      (2)(A) If, after providing an opportunity for an informal hearing
    under paragraph (1), the Secretary determines that the order should
    be amended to include a recall of the device with respect to which
    the order was issued, the Secretary shall, except as provided in
    subparagraphs (B) and (C), amend the order to require a recall. The
    Secretary shall specify a timetable in which the device recall will
    occur and shall require periodic reports to the Secretary
    describing the progress of the recall.
      (B) An amended order under subparagraph (A) - 
        (i) shall - 
          (I) not include recall of a device from individuals, and
          (II) not include recall of a device from device user
        facilities if the Secretary determines that the risk of
        recalling such device from the facilities presents a greater
        health risk than the health risk of not recalling the device
        from use, and

        (ii) shall provide for notice to individuals subject to the
      risks associated with the use of such device.

    In providing the notice required by clause (ii), the Secretary may
    use the assistance of health professionals who prescribed or used
    such a device for individuals. If a significant number of such
    individuals cannot be identified, the Secretary shall notify such
    individuals pursuant to section 375(b) of this title.
      (3) The remedy provided by this subsection shall be in addition
    to remedies provided by subsections (a), (b), and (c) of this
    section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 518, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 562; amended Pub. L. 101-629, Sec. 8, Nov.
    28, 1990, 104 Stat. 4520; Pub. L. 102-300, Sec. 4, June 16, 1992,
    106 Stat. 239.)


-MISC1-
                                AMENDMENTS                            
      1992 - Subsec. (b)(1)(A)(ii). Pub. L. 102-300 substituted "or"
    for "and" after "properly designed" and "time of its design".
      1990 - Subsec. (e). Pub. L. 101-629 added subsec. (e).

-End-



-CITE-
    21 USC Sec. 360i                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360i. Records and reports on devices

-STATUTE-
    (a) General rule
      Every person who is a manufacturer or importer of a device
    intended for human use shall establish and maintain such records,
    make such reports, and provide such information, as the Secretary
    may by regulation reasonably require to assure that such device is
    not adulterated or misbranded and to otherwise assure its safety
    and effectiveness. Regulations prescribed under the preceding
    sentence - 
        (1) shall require a device manufacturer or importer to report
      to the Secretary whenever the manufacturer or importer receives
      or otherwise becomes aware of information that reasonably
      suggests that one of its marketed devices - 
          (A) may have caused or contributed to a death or serious
        injury, or
          (B) has malfunctioned and that such device or a similar
        device marketed by the manufacturer or importer would be likely
        to cause or contribute to a death or serious injury if the
        malfunction were to recur;

        (2) shall define the term "serious injury" to mean an injury
      that - 
          (A) is life threatening,
          (B) results in permanent impairment of a body function or
        permanent damage to a body structure, or
          (C) necessitates medical or surgical intervention to preclude
        permanent impairment of a body function or permanent damage to
        a body structure;

        (3) shall require reporting of other significant adverse device
      experiences as determined by the Secretary to be necessary to be
      reported;
        (4) shall not impose requirements unduly burdensome to a device
      manufacturer or importer taking into account his cost of
      complying with such requirements and the need for the protection
      of the public health and the implementation of this chapter;
        (5) which prescribe the procedure for making requests for
      reports or information shall require that each request made under
      such regulations for submission of a report or information to the
      Secretary state the reason or purpose for such request and
      identify to the fullest extent practicable such report or
      information;
        (6) which require submission of a report or information to the
      Secretary shall state the reason or purpose for the submission of
      such report or information and identify to the fullest extent
      practicable such report or information;
        (7) may not require that the identity of any patient be
      disclosed in records, reports, or information required under this
      subsection unless required for the medical welfare of an
      individual, to determine the safety or effectiveness of a device,
      or to verify a record, report, or information submitted under
      this chapter; and
        (8) may not require a manufacturer or importer of a class I
      device to - 
          (A) maintain for such a device records respecting information
        not in the possession of the manufacturer or importer, or
          (B) to submit for such a device to the Secretary any report
        or information - 
            (i) not in the possession of the manufacturer or importer,
          or
            (ii) on a periodic basis,

      unless such report or information is necessary to determine if
      the device should be reclassified or if the device is adulterated
      or misbranded. and (!1)


    In prescribing such regulations, the Secretary shall have due
    regard for the professional ethics of the medical profession and
    the interests of patients. The prohibitions of paragraph (7) of
    this subsection continue to apply to records, reports, and
    information concerning any individual who has been a patient,
    irrespective of whether or when he ceases to be a patient. The
    Secretary shall by regulation require distributors to keep records
    and make such records available to the Secretary upon request.
    Paragraphs (4) and (8) apply to distributors to the same extent and
    in the same manner as such paragraphs apply to manufacturers and
    importers.
    (b) User reports
      (1)(A) Whenever a device user facility receives or otherwise
    becomes aware of information that reasonably suggests that a device
    has or may have caused or contributed to the death of a patient of
    the facility, the facility shall, as soon as practicable but not
    later than 10 working days after becoming aware of the information,
    report the information to the Secretary and, if the identity of the
    manufacturer is known, to the manufacturer of the device. In the
    case of deaths, the Secretary may by regulation prescribe a shorter
    period for the reporting of such information.
      (B) Whenever a device user facility receives or otherwise becomes
    aware of - 
        (i) information that reasonably suggests that a device has or
      may have caused or contributed to the serious illness of, or
      serious injury to, a patient of the facility, or
        (ii) other significant adverse device experiences as determined
      by the Secretary by regulation to be necessary to be reported,

    the facility shall, as soon as practicable but not later than 10
    working days after becoming aware of the information, report the
    information to the manufacturer of the device or to the Secretary
    if the identity of the manufacturer is not known.
      (C) Each device user facility shall submit to the Secretary on an
    annual basis a summary of the reports made under subparagraphs (A)
    and (B). Such summary shall be submitted on January 1 of each year.
    The summary shall be in such form and contain such information from
    such reports as the Secretary may require and shall include - 
        (i) sufficient information to identify the facility which made
      the reports for which the summary is submitted,
        (ii) in the case of any product which was the subject of a
      report, the product name, serial number, and model number,
        (iii) the name and the address of the manufacturer of such
      device, and
        (iv) a brief description of the event reported to the
      manufacturer.

      (D) For purposes of subparagraphs (A), (B), and (C), a device
    user facility shall be treated as having received or otherwise
    become aware of information with respect to a device of that
    facility when medical personnel who are employed by or otherwise
    formally affiliated with the facility receive or otherwise become
    aware of information with respect to that device in the course of
    their duties.
      (2) The Secretary may not disclose the identity of a device user
    facility which makes a report under paragraph (1) except in
    connection with - 
        (A) an action brought to enforce section 331(q) of this title,
      or
        (B) a communication to a manufacturer of a device which is the
      subject of a report under paragraph (1).

    This paragraph does not prohibit the Secretary from disclosing the
    identity of a device user facility making a report under paragraph
    (1) or any information in such a report to employees of the
    Department of Health and Human Services, to the Department of
    Justice, or to the duly authorized committees and subcommittees of
    the Congress.
      (3) No report made under paragraph (1) by - 
        (A) a device user facility,
        (B) an individual who is employed by or otherwise formally
      affiliated with such a facility, or
        (C) a physician who is not required to make such a report,

    shall be admissible into evidence or otherwise used in any civil
    action involving private parties unless the facility, individual,
    or physician who made the report had knowledge of the falsity of
    the information contained in the report.
      (4) A report made under paragraph (1) does not affect any
    obligation of a manufacturer who receives the report to file a
    report as required under subsection (a) of this section.
      (5) With respect to device user facilities:
        (A) The Secretary shall by regulation plan and implement a
      program under which the Secretary limits user reporting under
      paragraphs (1) through (4) to a subset of user facilities that
      constitutes a representative profile of user reports for device
      deaths and serious illnesses or serious injuries.
        (B) During the period of planning the program under
      subparagraph (A), paragraphs (1) through (4) continue to apply.
        (C) During the period in which the Secretary is providing for a
      transition to the full implementation of the program, paragraphs
      (1) through (4) apply except to the extent that the Secretary
      determines otherwise.
        (D) On and after the date on which the program is fully
      implemented, paragraphs (1) through (4) do not apply to a user
      facility unless the facility is included in the subset referred
      to in subparagraph (A).
        (E) Not later than 2 years after November 21, 1997, the
      Secretary shall submit to the Committee on Commerce of the House
      of Representatives, and to the Committee on Labor and Human
      Resources of the Senate, a report describing the plan developed
      by the Secretary under subparagraph (A) and the progress that has
      been made toward the implementation of the plan.

      (6) For purposes of this subsection:
        (A) The term "device user facility" means a hospital,
      ambulatory surgical facility, nursing home, or outpatient
      treatment facility which is not a physician's office. The
      Secretary may by regulation include an outpatient diagnostic
      facility which is not a physician's office in such term.
        (B) The terms "serious illness" and "serious injury" mean
      illness or injury, respectively, that - 
          (i) is life threatening,
          (ii) results in permanent impairment of a body function or
        permanent damage to a body structure, or
          (iii) necessitates medical or surgical intervention to
        preclude permanent impairment of a body function or permanent
        damage to a body structure.
    (c) Persons exempt
      Subsection (a) of this section shall not apply to - 
        (1) any practitioner who is licensed by law to prescribe or
      administer devices intended for use in humans and who
      manufactures or imports devices solely for use in the course of
      his professional practice;
        (2) any person who manufactures or imports devices intended for
      use in humans solely for such person's use in research or
      teaching and not for sale (including any person who uses a device
      under an exemption granted under section 360j(g) of this title);
      and
        (3) any other class of persons as the Secretary may by
      regulation exempt from subsection (a) of this section upon a
      finding that compliance with the requirements of such subsection
      by such class with respect to a device is not necessary to (A)
      assure that a device is not adulterated or misbranded or (B)
      otherwise to assure its safety and effectiveness.
    (d) Repealed. Pub. L. 105-115, title II, Sec. 213(a)(2), Nov. 21,
      1997, 111 Stat. 2347
    (e) Device tracking
      (1) The Secretary may by order require a manufacturer to adopt a
    method of tracking a class II or class III device - 
        (A) the failure of which would be reasonably likely to have
      serious adverse health consequences; or
        (B) which is - 
          (i) intended to be implanted in the human body for more than
        one year, or
          (ii) a life sustaining or life supporting device used outside
        a device user facility.

      (2) Any patient receiving a device subject to tracking under
    paragraph (1) may refuse to release, or refuse permission to
    release, the patient's name, address, social security number, or
    other identifying information for the purpose of tracking.
    (f) Reports of removals and corrections
      (1) Except as provided in paragraph (2), the Secretary shall by
    regulation require a manufacturer or importer of a device to report
    promptly to the Secretary any correction or removal of a device
    undertaken by such manufacturer or importer if the removal or
    correction was undertaken - 
        (A) to reduce a risk to health posed by the device, or
        (B) to remedy a violation of this chapter caused by the device
      which may present a risk to health.

    A manufacturer or importer of a device who undertakes a correction
    or removal of a device which is not required to be reported under
    this paragraph shall keep a record of such correction or removal.
      (2) No report of the corrective action or removal of a device may
    be required under paragraph (1) if a report of the corrective
    action or removal is required and has been submitted under
    subsection (a) of this section.
      (3) For purposes of paragraphs (1) and (2), the terms
    "correction" and "removal" do not include routine servicing.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 519, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 564; amended Pub. L. 101-629, Secs. 2(a),
    3(a)(1), (b)(1), 7, Nov. 28, 1990, 104 Stat. 4511, 4513, 4514,
    4520; Pub. L. 102-300, Sec. 5(a), June 16, 1992, 106 Stat. 239;
    Pub. L. 103-80, Sec. 3(u), Aug. 13, 1993, 107 Stat. 778; Pub. L.
    105-115, title II, Secs. 211, 213(a), (c), Nov. 21, 1997, 111 Stat.
    2345-2347.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 213(a)(1)(A), (F), in
    introductory provisions, substituted "manufacturer or importer" for
    "manufacturer, importer, or distributor" and, in closing
    provisions, inserted at end "The Secretary shall by regulation
    require distributors to keep records and make such records
    available to the Secretary upon request. Paragraphs (4) and (8)
    apply to distributors to the same extent and in the same manner as
    such paragraphs apply to manufacturers and importers."
      Subsec. (a)(4). Pub. L. 105-115, Sec. 213(a)(1)(B), substituted
    "manufacturer or importer" for "manufacturer, importer, or
    distributor".
      Subsec. (a)(7). Pub. L. 105-115, Sec. 213(a)(1)(C), inserted
    "and" after semicolon at end.
      Subsec. (a)(8). Pub. L. 105-115, Sec. 213(a)(1)(D), substituted
    "manufacturer or importer" for "manufacturer, importer, or
    distributor" wherever appearing and substituted period for
    semicolon after "misbranded".
      Subsec. (a)(9). Pub. L. 105-115, Sec. 213(a)(1)(E), struck out
    par. (9) which read as follows: "shall require distributors who
    submit such reports to submit copies of the reports to the
    manufacturer of the device for which the report was made."
      Subsec. (b)(1)(C). Pub. L. 105-115, Sec. 213(c)(1)(A), in
    introductory provisions, substituted "on an annual basis" for "on a
    semi-annual basis" and struck out "and July 1" after "January 1"
    and struck out closing provisions which read as follows: "The
    Secretary may by regulation alter the frequency and timing of
    reports required by this subparagraph."
      Subsec. (b)(2)(A). Pub. L. 105-115, Sec. 213(c)(1)(B)(i),
    inserted "or" after comma at end.
      Subsec. (b)(2)(B). Pub. L. 105-115, Sec. 213(c)(1)(B)(ii),
    substituted period for ", or" at end.
      Subsec. (b)(2)(C). Pub. L. 105-115, Sec. 213(c)(1)(B)(iii),
    struck out subpar. (C) which read as follows: "a disclosure
    required under subsection (a) of this section."
      Subsec. (b)(5), (6). Pub. L. 105-115, Sec. 213(c)(2), added par.
    (5) and redesignated former par. (5) as (6).
      Subsec. (d). Pub. L. 105-115, Sec. 213(a)(2), struck out heading
    and text of subsec. (d). Text read as follows: "Each manufacturer,
    importer, and distributor required to make reports under subsection
    (a) of this section shall submit to the Secretary annually a
    statement certifying that - 
        "(1) the manufacturer, importer, or distributor did file a
      certain number of such reports, or
        "(2) the manufacturer, importer, or distributor did not file
      any report under subsection (a) of this section."
      Subsec. (e). Pub. L. 105-115, Sec. 211, amended heading and text
    of subsec. (e) generally. Prior to amendment, text read as follows:
    "Every person who registers under section 360 of this title and is
    engaged in the manufacture of - 
        "(1) a device the failure of which would be reasonably likely
      to have serious adverse health consequences and which is (A) a
      permanently implantable device, or (B) a life sustaining or life
      supporting device used outside a device user facility, or
        "(2) any other device which the Secretary may designate,
    shall adopt a method of device tracking."
      Subsec. (f)(1). Pub. L. 105-115, Sec. 213(a)(3), substituted "or
    importer" for ", importer, or distributor" wherever appearing.
      1993 - Subsec. (a). Pub. L. 103-80 substituted "paragraph (7)"
    for "paragraph (4)" in last sentence.
      1992 - Subsec. (a). Pub. L. 102-300, Sec. 5(a)(1), added pars.
    (1) to (3) and redesignated former pars. (1) to (6) as (4) to (9),
    respectively.
      Subsec. (b)(1)(A). Pub. L. 102-300, Sec. 5(a)(2)(A), substituted
    "a device has or may have" for "there is a probability that a
    device has".
      Subsec. (b)(1)(B). Pub. L. 102-300, Sec. 5(a)(2)(A), (B),
    substituted "a device has or may have" for "there is a probability
    that a device has", designated existing provisions as cl. (i), and
    added cl. (ii).
      Subsec. (b)(5)(B)(iii). Pub. L. 102-300, Sec. 5(a)(2)(C), struck
    out "immediate" before "medical".
      1990 - Subsec. (a)(6). Pub. L. 101-629, Sec. 3(a)(1), added par.
    (6).
      Subsecs. (b), (c). Pub. L. 101-629, Sec. 2(a), added subsec. (b)
    and redesignated former subsec. (b) as (c).
      Subsecs. (d), (e). Pub. L. 101-629, Sec. 3(b)(1), added subsecs.
    (d) and (e).
      Subsec. (f). Pub. L. 101-629, Sec. 7, added subsec. (f).

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.


-MISC2-
                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 211 of Pub. L. 105-115 provided in part that the
    amendment made by that section is effective 90 days after Nov. 21,
    1997.
      Amendment by section 213(a), (c) of Pub. L. 105-115 effective 90
    days after Nov. 21, 1997, except as otherwise provided, see section
    501 of Pub. L. 105-115, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1992 AMENDMENT                 
      Section 2(b) of Pub. L. 102-300 provided that: "The amendments
    made by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub.
    L. 101-629, set out as notes below] shall take effect as of May 27,
    1992 and any rule to implement section 519(e) of the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 360i(e)] proposed under section
    3(c)(2) of the Safe Medical Devices Act of 1990 [Pub. L. 101-629,
    set out as a note below] shall revert to its proposed status as of
    such date."
      Section 5(b) of Pub. L. 102-300 provided that: "The amendments
    made by subsection (a) [amending this section] shall take effect - 
        "(1) 1 year after the date of the enactment of this Act [June
      16, 1992]; or
        "(2) on the effective date of regulations of the Secretary to
      implement such amendments,
    whichever occurs first."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 2(c) of Pub. L. 101-629 provided that: "Section 519(b) of
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as
    added by the amendment made by subsection (a), shall take effect - 
        "(1) upon the effective date of regulations promulgated under
      subsection (b) [set out below], or
        "(2) upon the expiration of 12 months from the date of the
      enactment of this Act [Nov. 28, 1990],
    whichever occurs first."
      Section 3(a)(2) of Pub. L. 101-629 provided that: "Section
    519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by
    paragraph (1), shall take effect upon the effective date of final
    regulations under subsection (c) [set out below]."
      Section 3(b)(3) of Pub. L. 101-629, as amended by Pub. L. 102-
    300, Sec. 2(a)(1), June 16, 1992, 106 Stat. 238, provided that:
    "Section 519(e) [21 U.S.C. 360i(e)], as added by the amendment made
    by paragraph (1), shall take effect upon the expiration of 9 months
    after the issuance of final regulations under subsection (c) [set
    out below]."
      [For effective date of amendment by Pub. L. 102-300, see section
    2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992
    Amendment note.]

                                REGULATIONS                            
      Section 2(b) of Pub. L. 101-629 provided that: "The Secretary of
    Health and Human Services shall promulgate regulations to implement
    section 519(b) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360i(b)], as added by the amendment made by subsection (a)
    (including a definition of the summary required by paragraph (1)(C)
    of such section) not later than 12 months after the date of
    enactment of this Act [Nov. 28, 1990]. In promulgating the
    regulations, the Secretary shall minimize the administrative
    burdens on device user facilities consistent with the need to
    assure adequate information."
      Section 3(c) of Pub. L. 101-629, as amended by Pub. L. 102-300,
    Sec. 2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:
      "(1)(A) Not later than 9 months after the date of the enactment
    of this Act [Nov. 28, 1990], the Secretary of Health and Human
    Services shall issue proposed regulations - 
        "(i) to require distributors of devices to establish and
      maintain records and to make reports (including reports required
      by part 803 of title 21 of the Code of Federal Regulations) under
      section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act [21
      U.S.C. 360i(a)(6)], and
        "(ii) to implement section 519(e) of such Act.
    The Secretary may exempt from regulations described in clause (i)
    classes of distributors of class I and class II devices from whom
    reports are not necessary for the protection of the public health.
      "(B) Regulations under subparagraph (A) shall - 
        "(i) require appropriate methods for maintenance of records to
      ensure that patients who receive devices can be provided the
      notification required by such Act [this chapter],
        "(ii) require that manufacturers adopt effective methods of
      tracking devices,
        "(iii) take into account the position of distributors in the
      device distribution process, and
        "(iv) include such other requirements as the Secretary deems
      necessary for the adoption of an effective user tracking program
      under section 519(e) of such Act.
      "(2) Not later than 18 months after the date of the enactment of
    this Act, the Secretary shall issue final regulations to implement
    sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic
    Act. If the Secretary does not promulgate such final regulations
    upon the expiration of such 18 months, the Congress finds that
    there is good cause for the proposed regulations to be considered
    as the final regulations without response to comment because the
    implementation of sections [sic] 519(a)(6) of such Act is essential
    to protect the health of patients who use such devices.
    Consequently, in such event, the proposed regulations issued under
    paragraph (1) shall become final regulations as of the expiration
    of such 18 months. There shall be promptly published in the Federal
    Register notice of the new status of the proposed regulations.
      "(3) Not later than November 28, 1992, the Secretary shall issue
    final regulations to implement section 519(e) of the Federal Food,
    Drug, and Cosmetic Act. If the Secretary does not promulgate such
    final regulations by November 28, 1992, the Congress finds that
    there is good cause for the proposed regulations to be considered
    as the final regulations without response to comment because the
    implementation of section 519(e) of such Act is essential to
    protect the health of patients who use devices. In such event, the
    proposed regulations issued under paragraph (1) shall become the
    issued final regulations on November 29, 1992. There shall be
    promptly published in the Federal Register notice of the new status
    of the proposed regulations."
      [For effective date of amendment by Pub. L. 102-300, see section
    2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992
    Amendment note.]

       INFORMATION CONCERNING REPORTING REQUIREMENTS FOR DEVICE USER
                                FACILITIES
      Section 2(d) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, during the 18-month period beginning on Nov. 28,
    1990, to inform device user facilities (as defined in 21 U.S.C.
    360i(b)(5)(A)) and manufacturers and distributors of devices
    respecting the requirements of 21 U.S.C. 360i(b), and, to the
    extent practicable, provide persons subject to such requirements
    assistance in the form of publications regarding such requirements.

        STUDY OF REPORTING REQUIREMENTS; COMPLIANCE BY DEVICE USER
         FACILITIES; ACTIONS BY MANUFACTURERS; COST EFFECTIVENESS;
                              RECOMMENDATIONS
      Section 2(e) of Pub. L. 101-629 directed Comptroller General of
    the United States, not more than 36 months after Nov. 28, 1990, to
    conduct a study of compliance by device user facilities with the
    requirements of 21 U.S.C. 360i(b), actions taken by manufacturers
    of devices in response to reports made to them, cost effectiveness
    of such requirements and their implementation, and any
    recommendations for improvements to such requirements, with
    Comptroller General to complete the study and submit a report on
    the study not later than 45 months from Nov. 28, 1990, to
    appropriate committees of Congress.

       REPORT TO CONGRESS ON REPORTING REQUIREMENTS FOR DEVICE USER
                                FACILITIES
      Section 2(f) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, not later than 36 months after Nov. 28, 1990, to
    prepare and submit to appropriate committees of Congress a report
    containing an evaluation of the requirements of 21 U.S.C. 360i(b),
    consisting of an evaluation of the safety benefits of the
    requirements, the burdens placed on the Food and Drug
    Administration and on device user facilities by the requirements,
    and the cost-effectiveness of the requirements and recommendations
    for legislative reform.

-FOOTNOTE-               

    (!1) So in original. The word "and" probably should not appear.


-End-



-CITE-
    21 USC Sec. 360j                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360j. General provisions respecting control of devices
      intended for human use

-STATUTE-
    (a) General rule
      Any requirement authorized by or under section 351, 352, 360, or
    360i of this title applicable to a device intended for human use
    shall apply to such device until the applicability of the
    requirement to the device has been changed by action taken under
    section 360c, 360d, or 360e of this title or under subsection (g)
    of this section, and any requirement established by or under
    section 351, 352, 360, or 360i of this title which is inconsistent
    with a requirement imposed on such device under section 360d or
    360e of this title or under subsection (g) of this section shall
    not apply to such device.
    (b) Custom devices
      Sections 360d and 360e of this title do not apply to any device
    which, in order to comply with the order of an individual physician
    or dentist (or any other specially qualified person designated
    under regulations promulgated by the Secretary after an opportunity
    for an oral hearing) necessarily deviates from an otherwise
    applicable performance standard or requirement prescribed by or
    under section 360e of this title if (1) the device is not generally
    available in finished form for purchase or for dispensing upon
    prescription and is not offered through labeling or advertising by
    the manufacturer, importer, or distributor thereof for commercial
    distribution, and (2) such device - 
        (A)(i) is intended for use by an individual patient named in
      such order of such physician or dentist (or other specially
      qualified person so designated) and is to be made in a specific
      form for such patient, or
        (ii) is intended to meet the special needs of such physician or
      dentist (or other specially qualified person so designated) in
      the course of the professional practice of such physician or
      dentist (or other specially qualified person so designated), and
        (B) is not generally available to or generally used by other
      physicians or dentists (or other specially qualified persons so
      designated).
    (c) Trade secrets
      Any information reported to or otherwise obtained by the
    Secretary or his representative under section 360c, 360d, 360e,
    360f, 360h, 360i, or 374 of this title or under subsection (f) or
    (g) of this section which is exempt from disclosure pursuant to
    subsection (a) of section 552 of title 5 by reason of subsection
    (b)(4) of such section shall be considered confidential and shall
    not be disclosed and may not be used by the Secretary as the basis
    for the reclassification of a device from class III to class II or
    class I or as the basis for the establishment or amendment of a
    performance standard under section 360d of this title for a device
    reclassified from class III to class II, except (1) in accordance
    with subsection (h) of this section, and (2) that such information
    may be disclosed to other officers or employees concerned with
    carrying out this chapter or when relevant in any proceeding under
    this chapter (other than section 360c or 360d of this title).
    (d) Notices and findings
      Each notice of proposed rulemaking under section 360c, 360d,
    360e, 360f, 360h, or 360i of this title, or under this section, any
    other notice which is published in the Federal Register with
    respect to any other action taken under any such section and which
    states the reasons for such action, and each publication of
    findings required to be made in connection with rulemaking under
    any such section shall set forth - 
        (1) the manner in which interested persons may examine data and
      other information on which the notice or findings is based, and
        (2) the period within which interested persons may present
      their comments on the notice or findings (including the need
      therefor) orally or in writing, which period shall be at least
      sixty days but may not exceed ninety days unless the time is
      extended by the Secretary by a notice published in the Federal
      Register stating good cause therefor.
    (e) Restricted devices
      (1) The Secretary may by regulation require that a device be
    restricted to sale, distribution, or use - 
        (A) only upon the written or oral authorization of a
      practitioner licensed by law to administer or use such device, or
        (B) upon such other conditions as the Secretary may prescribe
      in such regulation,

    if, because of its potentiality for harmful effect or the
    collateral measures necessary to its use, the Secretary determines
    that there cannot otherwise be reasonable assurance of its safety
    and effectiveness. No condition prescribed under subparagraph (B)
    may restrict the use of a device to persons with specific training
    or experience in its use or to persons for use in certain
    facilities unless the Secretary determines that such a restriction
    is required for the safe and effective use of the device. No such
    condition may exclude a person from using a device solely because
    the person does not have the training or experience to make him
    eligible for certification by a certifying board recognized by the
    American Board of Medical Specialties or has not been certified by
    such a Board. A device subject to a regulation under this
    subsection is a restricted device.
      (2) The label of a restricted device shall bear such appropriate
    statements of the restrictions required by a regulation under
    paragraph (1) as the Secretary may in such regulation prescribe.
    (f) Good manufacturing practice requirements
      (1)(A) The Secretary may, in accordance with subparagraph (B),
    prescribe regulations requiring that the methods used in, and the
    facilities and controls used for, the manufacture, pre-production
    design validation (including a process to assess the performance of
    a device but not including an evaluation of the safety or
    effectiveness of a device), packing, storage, and installation of a
    device conform to current good manufacturing practice, as
    prescribed in such regulations, to assure that the device will be
    safe and effective and otherwise in compliance with this chapter.
      (B) Before the Secretary may promulgate any regulation under
    subparagraph (A) he shall - 
        (i) afford the advisory committee established under paragraph
      (3) an opportunity to submit recommendations to him with respect
      to the regulation proposed to be promulgated;
        (ii) afford opportunity for an oral hearing; and
        (iii) ensure that such regulation conforms, to the extent
      practicable, with internationally recognized standards defining
      quality systems, or parts of the standards, for medical devices.

    The Secretary shall provide the advisory committee a reasonable
    time to make its recommendation with respect to proposed
    regulations under subparagraph (A).
      (2)(A) Any person subject to any requirement prescribed by
    regulations under paragraph (1) may petition the Secretary for an
    exemption or variance from such requirement. Such a petition shall
    be submitted to the Secretary in such form and manner as he shall
    prescribe and shall - 
        (i) in the case of a petition for an exemption from a
      requirement, set forth the basis for the petitioner's
      determination that compliance with the requirement is not
      required to assure that the device will be safe and effective and
      otherwise in compliance with this chapter,
        (ii) in the case of a petition for a variance from a
      requirement, set forth the methods proposed to be used in, and
      the facilities and controls proposed to be used for, the
      manufacture, packing, storage, and installation of the device in
      lieu of the methods, facilities, and controls prescribed by the
      requirement, and
        (iii) contain such other information as the Secretary shall
      prescribe.

      (B) The Secretary may refer to the advisory committee established
    under paragraph (3) any petition submitted under subparagraph (A).
    The advisory committee shall report its recommendations to the
    Secretary with respect to a petition referred to it within sixty
    days of the date of the petition's referral. Within sixty days
    after - 
        (i) the date the petition was submitted to the Secretary under
      subparagraph (A), or
        (ii) if the petition was referred to an advisory committee, the
      expiration of the sixty-day period beginning on the date the
      petition was referred to the advisory committee,

    whichever occurs later, the Secretary shall by order either deny
    the petition or approve it.
      (C) The Secretary may approve - 
        (i) a petition for an exemption for a device from a requirement
      if he determines that compliance with such requirement is not
      required to assure that the device will be safe and effective and
      otherwise in compliance with this chapter, and
        (ii) a petition for a variance for a device from a requirement
      if he determines that the methods to be used in, and the
      facilities and controls to be used for, the manufacture, packing,
      storage, and installation of the device in lieu of the methods,
      controls, and facilities prescribed by the requirement are
      sufficient to assure that the device will be safe and effective
      and otherwise in compliance with this chapter.

    An order of the Secretary approving a petition for a variance shall
    prescribe such conditions respecting the methods used in, and the
    facilities and controls used for, the manufacture, packing,
    storage, and installation of the device to be granted the variance
    under the petition as may be necessary to assure that the device
    will be safe and effective and otherwise in compliance with this
    chapter.
      (D) After the issuance of an order under subparagraph (B)
    respecting a petition, the petitioner shall have an opportunity for
    an informal hearing on such order.
      (3) The Secretary shall establish an advisory committee for the
    purpose of advising and making recommendations to him with respect
    to regulations proposed to be promulgated under paragraph (1)(A)
    and the approval or disapproval of petitions submitted under
    paragraph (2). The advisory committee shall be composed of nine
    members as follows:
        (A) Three of the members shall be appointed from persons who
      are officers or employees of any State or local government or of
      the Federal Government.
        (B) Two of the members shall be appointed from persons who are
      representative of interests of the device manufacturing industry;
      two of the members shall be appointed from persons who are
      representative of the interests of physicians and other health
      professionals; and two of the members shall be representative of
      the interests of the general public.

    Members of the advisory committee who are not officers or employees
    of the United States, while attending conferences or meetings of
    the committee or otherwise engaged in its business, shall be
    entitled to receive compensation at rates to be fixed by the
    Secretary, which rates may not exceed the daily equivalent of the
    rate in effect for grade GS-18 of the General Schedule, for each
    day (including traveltime) they are so engaged; and while so
    serving away from their homes or regular places of business each
    member may be allowed travel expenses, including per diem in lieu
    of subsistence, as authorized by section 5703 of title 5 for
    persons in the Government service employed intermittently. The
    Secretary shall designate one of the members of the advisory
    committee to serve as its chairman. The Secretary shall furnish the
    advisory committee with clerical and other assistance. Section 14
    of the Federal Advisory Committee Act shall not apply with respect
    to the duration of the advisory committee established under this
    paragraph.
    (g) Exemption for devices for investigational use
      (1) It is the purpose of this subsection to encourage, to the
    extent consistent with the protection of the public health and
    safety and with ethical standards, the discovery and development of
    useful devices intended for human use and to that end to maintain
    optimum freedom for scientific investigators in their pursuit of
    that purpose.
      (2)(A) The Secretary shall, within the one hundred and twenty-day
    period beginning on May 28, 1976, by regulation prescribe
    procedures and conditions under which devices intended for human
    use may upon application be granted an exemption from the
    requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e
    of this title or subsection (e) or (f) of this section or from any
    combination of such requirements to permit the investigational use
    of such devices by experts qualified by scientific training and
    experience to investigate the safety and effectiveness of such
    devices.
      (B) The conditions prescribed pursuant to subparagraph (A) shall
    include the following:
        (i) A requirement that an application be submitted to the
      Secretary before an exemption may be granted and that the
      application be submitted in such form and manner as the Secretary
      shall specify.
        (ii) A requirement that the person applying for an exemption
      for a device assure the establishment and maintenance of such
      records, and the making of such reports to the Secretary of data
      obtained as a result of the investigational use of the device
      during the exemption, as the Secretary determines will enable him
      to assure compliance with such conditions, review the progress of
      the investigation, and evaluate the safety and effectiveness of
      the device.
        (iii) Such other requirements as the Secretary may determine to
      be necessary for the protection of the public health and safety.

      (C) Procedures and conditions prescribed pursuant to subparagraph
    (A) for an exemption may appropriately vary depending on (i) the
    scope and duration of clinical testing to be conducted under such
    exemption, (ii) the number of human subjects that are to be
    involved in such testing, (iii) the need to permit changes to be
    made in the device subject to the exemption during testing
    conducted in accordance with a clinical testing plan required under
    paragraph (3)(A), and (iv) whether the clinical testing of such
    device is for the purpose of developing data to obtain approval for
    the commercial distribution of such device.
      (3) Procedures and conditions prescribed pursuant to paragraph
    (2)(A) shall require, as a condition to the exemption of any device
    to be the subject of testing involving human subjects, that the
    person applying for the exemption - 
        (A) submit a plan for any proposed clinical testing of the
      device and a report of prior investigations of the device
      (including, where appropriate, tests on animals) adequate to
      justify the proposed clinical testing - 
          (i) to the local institutional review committee which has
        been established in accordance with regulations of the
        Secretary to supervise clinical testing of devices in the
        facilities where the proposed clinical testing is to be
        conducted, or
          (ii) to the Secretary, if - 
            (I) no such committee exists, or
            (II) the Secretary finds that the process of review by such
          committee is inadequate (whether or not the plan for such
          testing has been approved by such committee),

        for review for adequacy to justify the commencement of such
        testing; and, unless the plan and report are submitted to the
        Secretary, submit to the Secretary a summary of the plan and a
        report of prior investigations of the device (including, where
        appropriate, tests on animals);

        (B) promptly notify the Secretary (under such circumstances and
      in such manner as the Secretary prescribes) of approval by a
      local institutional review committee of any clinical testing plan
      submitted to it in accordance with subparagraph (A);
        (C) in the case of a device to be distributed to investigators
      for testing, obtain signed agreements from each of such
      investigators that any testing of the device involving human
      subjects will be under such investigator's supervision and in
      accordance with subparagraph (D) and submit such agreements to
      the Secretary; and
        (D) assure that informed consent will be obtained from each
      human subject (or his representative) of proposed clinical
      testing involving such device, except where subject to such
      conditions as the Secretary may prescribe, the investigator
      conducting or supervising the proposed clinical testing of the
      device determines in writing that there exists a life threatening
      situation involving the human subject of such testing which
      necessitates the use of such device and it is not feasible to
      obtain informed consent from the subject and there is not
      sufficient time to obtain such consent from his representative.

    The determination required by subparagraph (D) shall be concurred
    in by a licensed physician who is not involved in the testing of
    the human subject with respect to which such determination is made
    unless immediate use of the device is required to save the life of
    the human subject of such testing and there is not sufficient time
    to obtain such concurrence.
      (4)(A) An application, submitted in accordance with the
    procedures prescribed by regulations under paragraph (2), for an
    exemption for a device (other than an exemption from section 360f
    of this title) shall be deemed approved on the thirtieth day after
    the submission of the application to the Secretary unless on or
    before such day the Secretary by order disapproves the application
    and notifies the applicant of the disapproval of the application.
      (B) The Secretary may disapprove an application only if he finds
    that the investigation with respect to which the application is
    submitted does not conform to procedures and conditions prescribed
    under regulations under paragraph (2). Such a notification shall
    contain the order of disapproval and a complete statement of the
    reasons for the Secretary's disapproval of the application and
    afford the applicant opportunity for an informal hearing on the
    disapproval order.
      (5) The Secretary may by order withdraw an exemption granted
    under this subsection for a device if the Secretary determines that
    the conditions applicable to the device under this subsection for
    such exemption are not met. Such an order may be issued only after
    opportunity for an informal hearing, except that such an order may
    be issued before the provision of an opportunity for an informal
    hearing if the Secretary determines that the continuation of
    testing under the exemption with respect to which the order is to
    be issued will result in an unreasonable risk to the public health.
      (6)(A) Not later than 1 year after November 21, 1997, the
    Secretary shall by regulation establish, with respect to a device
    for which an exemption under this subsection is in effect,
    procedures and conditions that, without requiring an additional
    approval of an application for an exemption or the approval of a
    supplement to such an application, permit - 
        (i) developmental changes in the device (including
      manufacturing changes) that do not constitute a significant
      change in design or in basic principles of operation and that are
      made in response to information gathered during the course of an
      investigation; and
        (ii) changes or modifications to clinical protocols that do not
      affect - 
          (I) the validity of data or information resulting from the
        completion of an approved protocol, or the relationship of
        likely patient risk to benefit relied upon to approve a
        protocol;
          (II) the scientific soundness of an investigational plan
        submitted under paragraph (3)(A); or
          (III) the rights, safety, or welfare of the human subjects
        involved in the investigation.

      (B) Regulations under subparagraph (A) shall provide that a
    change or modification described in such subparagraph may be made
    if - 
        (i) the sponsor of the investigation determines, on the basis
      of credible information (as defined by the Secretary) that the
      applicable conditions under subparagraph (A) are met; and
        (ii) the sponsor submits to the Secretary, not later than 5
      days after making the change or modification, a notice of the
      change or modification.

      (7)(A) In the case of a person intending to investigate the
    safety or effectiveness of a class III device or any implantable
    device, the Secretary shall ensure that the person has an
    opportunity, prior to submitting an application to the Secretary or
    to an institutional review committee, to submit to the Secretary,
    for review, an investigational plan (including a clinical
    protocol). If the applicant submits a written request for a meeting
    with the Secretary regarding such review, the Secretary shall, not
    later than 30 days after receiving the request, meet with the
    applicant for the purpose of reaching agreement regarding the
    investigational plan (including a clinical protocol). The written
    request shall include a detailed description of the device, a
    detailed description of the proposed conditions of use of the
    device, a proposed plan (including a clinical protocol) for
    determining whether there is a reasonable assurance of
    effectiveness, and, if available, information regarding the
    expected performance from the device.
      (B) Any agreement regarding the parameters of an investigational
    plan (including a clinical protocol) that is reached between the
    Secretary and a sponsor or applicant shall be reduced to writing
    and made part of the administrative record by the Secretary. Any
    such agreement shall not be changed, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (C) by the director of the office in which the
      device involved is reviewed, that a substantial scientific issue
      essential to determining the safety or effectiveness of the
      device involved has been identified.

      (C) A decision under subparagraph (B)(ii) by the director shall
    be in writing, and may be made only after the Secretary has
    provided to the sponsor or applicant an opportunity for a meeting
    at which the director and the sponsor or applicant are present and
    at which the director documents the scientific issue involved.
    (h) Release of information respecting safety and effectiveness
      (1) The Secretary shall promulgate regulations under which a
    detailed summary of information respecting the safety and
    effectiveness of a device which information was submitted to the
    Secretary and which was the basis for - 
        (A) an order under section 360e(d)(1)(A) of this title
      approving an application for premarket approval for the device or
      denying approval of such an application or an order under section
      360e(e) of this title withdrawing approval of such an application
      for the device,
        (B) an order under section 360e(f)(6)(A) of this title revoking
      an approved protocol for the device, an order under section
      360e(f)(6)(B) of this title declaring a protocol for the device
      completed or not completed, or an order under section 360e(f)(7)
      of this title revoking the approval of the device, or
        (C) an order approving an application under subsection (g) of
      this section for an exemption for the device from section 360f of
      this title or an order disapproving, or withdrawing approval of,
      an application for an exemption under such subsection for the
      device,

    shall be made available to the public upon issuance of the order.
    Summaries of information made available pursuant to this paragraph
    respecting a device shall include information respecting any
    adverse effects on health of the device.
      (2) The Secretary shall promulgate regulations under which each
    advisory committee established under section 360e(g)(2)(B) of this
    title shall make available to the public a detailed summary of
    information respecting the safety and effectiveness of a device
    which information was submitted to the advisory committee and which
    was the basis for its recommendation to the Secretary made pursuant
    to section 360e(g)(2)(A) of this title. A summary of information
    upon which such a recommendation is based shall be made available
    pursuant to this paragraph only after the issuance of the order
    with respect to which the recommendation was made and each summary
    shall include information respecting any adverse effect on health
    of the device subject to such order.
      (3) Except as provided in paragraph (4), any information
    respecting a device which is made available pursuant to paragraph
    (1) or (2) of this subsection (A) may not be used to establish the
    safety or effectiveness of another device for purposes of this
    chapter by any person other than the person who submitted the
    information so made available, and (B) shall be made available
    subject to subsection (c) of this section.
      (4)(A) Any information contained in an application for premarket
    approval filed with the Secretary pursuant to section 360e(c) of
    this title (including information from clinical and preclinical
    tests or studies that demonstrate the safety and effectiveness of a
    device, but excluding descriptions of methods of manufacture and
    product composition and other trade secrets) shall be available, 6
    years after the application has been approved by the Secretary, for
    use by the Secretary in - 
        (i) approving another device;
        (ii) determining whether a product development protocol has
      been completed, under section 360e of this title for another
      device;
        (iii) establishing a performance standard or special control
      under this chapter; or
        (iv) classifying or reclassifying another device under section
      360c of this title and subsection (l)(2) of this section.

      (B) The publicly available detailed summaries of information
    respecting the safety and effectiveness of devices required by
    paragraph (1)(A) shall be available for use by the Secretary as the
    evidentiary basis for the agency actions described in subparagraph
    (A).
    (i) Proceedings of advisory panels and committees
      Each panel under section 360c of this title and each advisory
    committee established under section 360d(b)(5)(B) or 360e(g) of
    this title or under subsection (f) of this section shall make and
    maintain a transcript of any proceeding of the panel or committee.
    Each such panel and committee shall delete from any transcript made
    pursuant to this subsection information which under subsection (c)
    of this section is to be considered confidential.
    (j) Traceability
      Except as provided in section 360i(e) of this title, no
    regulation under this chapter may impose on a type or class of
    device requirements for the traceability of such type or class of
    device unless such requirements are necessary to assure the
    protection of the public health.
    (k) Research and development
      The Secretary may enter into contracts for research, testing, and
    demonstrations respecting devices and may obtain devices for
    research, testing, and demonstration purposes without regard to
    section 3324(a) and (b) of title 31 and section 5 of title 41.
    (l) Transitional provisions for devices considered as new drugs
      (1) Any device intended for human use - 
        (A) for which on May 28, 1976 (hereinafter in this subsection
      referred to as the "enactment date") an approval of an
      application submitted under section 355(b) of this title was in
      effect;
        (B) for which such an application was filed on or before the
      enactment date and with respect to which application no order of
      approval or refusing to approve had been issued on such date
      under subsection (c) or (d) of such section;
        (C) for which on the enactment date an exemption under
      subsection (i) of such section was in effect;
        (D) which is within a type of device described in subparagraph
      (A), (B), or (C) and is substantially equivalent to another
      device within that type;
        (E) which the Secretary in a notice published in the Federal
      Register before the enactment date has declared to be a new drug
      subject to section 355 of this title; or
        (F) with respect to which on the enactment date an action is
      pending in a United States court under section 332, 333, or 334
      of this title for an alleged violation of a provision of section
      331 of this title which enforces a requirement of section 355 of
      this title or for an alleged violation of section 355(a) of this
      title,

    is classified in class III unless the Secretary in response to a
    petition submitted under paragraph (2) has classified such device
    in class I or II.
      (2) The Secretary may initiate the reclassification of a device
    classified into class III under paragraph (1) of this subsection or
    the manufacturer or importer of a device classified under paragraph
    (1) may petition the Secretary (in such form and manner as he shall
    prescribe) for the issuance of an order classifying the device in
    class I or class II. Within thirty days of the filing of such a
    petition, the Secretary shall notify the petitioner of any
    deficiencies in the petition which prevent the Secretary from
    making a decision on the petition. Except as provided in paragraph
    (3)(D)(ii), within one hundred and eighty days after the filing of
    a petition under this paragraph, the Secretary shall, after
    consultation with the appropriate panel under section 360c of this
    title, by order either deny the petition or order the
    classification, in accordance with the criteria prescribed by
    section 360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title,
    of the device in class I or class II.
      (3)(A) In the case of a device which is described in paragraph
    (1)(A) and which is in class III - 
        (i) such device shall on the enactment date be considered a
      device with an approved application under section 360e of this
      title, and
        (ii) the requirements applicable to such device before the
      enactment date under section 355 of this title shall continue to
      apply to such device until changed by the Secretary as authorized
      by this chapter.

      (B) In the case of a device which is described in paragraph
    (1)(B) and which is in class III, an application for such device
    shall be considered as having been filed under section 360e of this
    title on the enactment date. The period in which the Secretary
    shall act on such application in accordance with section 360e(d)(1)
    of this title shall be one hundred and eighty days from the
    enactment date (or such greater period as the Secretary and the
    applicant may agree upon after the Secretary has made the finding
    required by section 360e(d)(1)(B)(i) of this title) less the number
    of days in the period beginning on the date an application for such
    device was filed under section 355 of this title and ending on the
    enactment date. After the expiration of such period such device is
    required, unless exempt under subsection (g) of this section, to
    have in effect an approved application under section 360e of this
    title.
      (C) A device which is described in paragraph (1)(C) and which is
    in class III shall be considered a new drug until the expiration of
    the ninety-day period beginning on the date of the promulgation of
    regulations under subsection (g) of this section. After the
    expiration of such period such device is required, unless exempt
    under subsection (g) of this section, to have in effect an approved
    application under section 360e of this title.
      (D)(i) Except as provided in clauses (ii) and (iii), a device
    which is described in subparagraph (D), (E), or (F) of paragraph
    (1) and which is in class III is required, unless exempt under
    subsection (g) of this section, to have on and after sixty days
    after the enactment date in effect an approved application under
    section 360e of this title.
      (ii) If - 
        (I) a petition is filed under paragraph (2) for a device
      described in subparagraph (D), (E), or (F) of paragraph (1), or
        (II) an application for premarket approval is filed under
      section 360e of this title for such a device,

    within the sixty-day period beginning on the enactment date (or
    within such greater period as the Secretary, after making the
    finding required under section 360e(d)(1)(B) of this title, and the
    petitioner or applicant may agree upon), the Secretary shall act on
    such petition or application in accordance with paragraph (2) or
    section 360e of this title except that the period within which the
    Secretary must act on the petition or application shall be within
    the one hundred and twenty-day period beginning on the date the
    petition or application is filed. If such a petition or application
    is filed within such sixty-day (or greater) period, clause (i) of
    this subparagraph shall not apply to such device before the
    expiration of such one hundred and twenty-day period, or if such
    petition is denied or such application is denied approval, before
    the date of such denial, whichever occurs first.
      (iii) In the case of a device which is described in subparagraph
    (E) of paragraph (1), which the Secretary in a notice published in
    the Federal Register after March 31, 1976, declared to be a new
    drug subject to section 355 of this title, and which is in class
    III - 
        (I) the device shall, after eighteen months after the enactment
      date, have in effect an approved application under section 360e
      of this title unless exempt under subsection (g) of this section,
      and
        (II) the Secretary may, during the period beginning one hundred
      and eighty days after the enactment date and ending eighteen
      months after such date, restrict the use of the device to
      investigational use by experts qualified by scientific training
      and experience to investigate the safety and effectiveness of
      such device, and to investigational use in accordance with the
      requirements applicable under regulations under subsection (g) of
      this section to investigational use of devices granted an
      exemption under such subsection.

    If the requirements under subsection (g) of this section are made
    applicable to the investigational use of such a device, they shall
    be made applicable in such a manner that the device shall be made
    reasonably available to physicians meeting appropriate
    qualifications prescribed by the Secretary.
      (4) Repealed. Pub. L. 105-115, title I, Sec. 125(b)(2)(E), Nov.
    21, 1997, 111 Stat. 2325.
      (5)(A) Before December 1, 1991, the Secretary shall by order
    require manufacturers of devices described in paragraph (1), which
    are subject to revision of classification under subparagraph (B),
    to submit to the Secretary a summary of and citation to any
    information known or otherwise available to the manufacturers
    respecting the devices, including adverse safety or effectiveness
    information which has not been submitted under section 360i of this
    title. The Secretary may require a manufacturer to submit the
    adverse safety or effectiveness data for which a summary and
    citation were submitted, if such data are available to the
    manufacturer.
      (B) Except as provided in subparagraph (C), after the issuance of
    an order under subparagraph (A) but before December 1, 1992, the
    Secretary shall publish a regulation in the Federal Register for
    each device which is classified in class III under paragraph (1)
    revising the classification of the device so that the device is
    classified into class I or class II, unless the regulation requires
    the device to remain in class III. In determining whether to revise
    the classification of a device or to require a device to remain in
    class III, the Secretary shall apply the criteria set forth in
    section 360c(a) of this title. Before the publication of a
    regulation requiring a device to remain in class III or revising
    its classification, the Secretary shall publish a proposed
    regulation respecting the classification of a device under this
    subparagraph and provide an opportunity for the submission of
    comments on any such regulation. No regulation under this
    subparagraph requiring a device to remain in class III or revising
    its classification may take effect before the expiration of 90 days
    from the date of the publication in the Federal Register of the
    proposed regulation.
      (C) The Secretary may by notice published in the Federal Register
    extend the period prescribed by subparagraph (B) for a device for
    an additional period not to exceed 1 year.
    (m) Humanitarian device exemption
      (1) To the extent consistent with the protection of the public
    health and safety and with ethical standards, it is the purpose of
    this subsection to encourage the discovery and use of devices
    intended to benefit patients in the treatment and diagnosis of
    diseases or conditions that affect fewer than 4,000 individuals in
    the United States.
      (2) The Secretary may grant a request for an exemption from the
    effectiveness requirements of sections 360d and 360e of this title
    for a device for which the Secretary finds that - 
        (A) the device is designed to treat or diagnose a disease or
      condition that affects fewer than 4,000 individuals in the United
      States,
        (B) the device would not be available to a person with a
      disease or condition referred to in subparagraph (A) unless the
      Secretary grants such an exemption and there is no comparable
      device, other than under this exemption, available to treat or
      diagnose such disease or condition, and
        (C) the device will not expose patients to an unreasonable or
      significant risk of illness or injury and the probable benefit to
      health from the use of the device outweighs the risk of injury or
      illness from its use, taking into account the probable risks and
      benefits of currently available devices or alternative forms of
      treatment.

    The request shall be in the form of an application submitted to the
    Secretary. Not later than 75 days after the date of the receipt of
    the application, the Secretary shall issue an order approving or
    denying the application.
      (3) No person granted an exemption under paragraph (2) with
    respect to a device may sell the device for an amount that exceeds
    the costs of research and development, fabrication, and
    distribution of the device.
      (4) Devices granted an exemption under paragraph (2) may only be
    used - 
        (A) in facilities that have established, in accordance with
      regulations of the Secretary, a local institutional review
      committee to supervise clinical testing of devices in the
      facilities, and
        (B) if, before the use of a device, an institutional review
      committee approves the use in the treatment or diagnosis of a
      disease or condition referred to in paragraph (2)(A), unless a
      physician determines in an emergency situation that approval from
      a local institutional review committee can not be obtained in
      time to prevent serious harm or death to a patient.

    In a case described in subparagraph (B) in which a physician uses a
    device without an approval from an institutional review committee,
    the physician shall, after the use of the device, notify the
    chairperson of the local institutional review committee of such
    use. Such notification shall include the identification of the
    patient involved, the date on which the device was used, and the
    reason for the use.
      (5) The Secretary may require a person granted an exemption under
    paragraph (2) to demonstrate continued compliance with the
    requirements of this subsection if the Secretary believes such
    demonstration to be necessary to protect the public health or if
    the Secretary has reason to believe that the criteria for the
    exemption are no longer met.
      (6) The Secretary may suspend or withdraw an exemption from the
    effectiveness requirements of sections 360d and 360e of this title
    for a humanitarian device only after providing notice and an
    opportunity for an informal hearing.
    (n) Regulation of contact lenses as devices
      (1) All contact lenses shall be deemed to be devices under
    section 321(h) of this title.
      (2) Paragraph (1) shall not be construed as bearing on or being
    relevant to the question of whether any product other than a
    contact lens is a device as defined by section 321(h) of this title
    or a drug as defined by section 321(g) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 520, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 565; amended Pub. L. 101-629, Secs. 3(b)(2),
    4(b)(2), 5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), Nov. 28, 1990,
    104 Stat. 4514, 4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102-
    571, title I, Sec. 107(10), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
    105-115, title I, Sec. 125(b)(2)(E), title II, Secs. 201(a), 203,
    216(a)(1), title IV, Sec. 410(a), Nov. 21, 1997, 111 Stat. 2325,
    2332, 2334, 2349, 2372; Pub. L. 109-96, Sec. 1, Nov. 9, 2005, 119
    Stat. 2119.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 14 of the Federal Advisory Committee Act, referred to in
    subsec. (f)(3), is section 14 of Pub. L. 92-463, which is set out
    in the Appendix to Title 5, Government Organization and Employees.

-COD-
                               CODIFICATION                           
      In subsec. (k), "section 3324(a) and (b) of title 31" substituted
    for reference to section 3648 of the Revised Statutes (31 U.S.C.
    529) on authority of Pub. L. 97-258, Sec. 4(b), Sept. 13, 1982, 96
    Stat. 1067, the first section of which enacted Title 31, Money and
    Finance.


-MISC1-
                                AMENDMENTS                            
      2005 - Subsec. (n). Pub. L. 109-96 added subsec. (n).
      1997 - Subsec. (f)(1)(B)(iii). Pub. L. 105-115, Sec. 410(a),
    added cl. (iii).
      Subsec. (g)(6), (7). Pub. L. 105-115, Sec. 201(a), added pars.
    (6) and (7).
      Subsec. (h)(4). Pub. L. 105-115, Sec. 216(a)(1), amended par. (4)
    generally. Prior to amendment, par. (4) related to premarket
    approval of devices.
      Subsec. (l). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out "or
    antibiotic drugs" after "new drugs" in heading.
      Subsec. (l)(4). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out
    par. (4) which read as follows: "Any device intended for human use
    which on the enactment date was subject to the requirements of
    section 357 of this title shall be subject to such requirements as
    follows:
        "(A) In the case of such a device which is classified into
      class I, such requirements shall apply to such device until the
      effective date of the regulation classifying the device into such
      class.
        "(B) In the case of such a device which is classified into
      class II, such requirements shall apply to such device until the
      effective date of a performance standard applicable to the device
      under section 360d of this title.
        "(C) In the case of such a device which is classified into
      class III, such requirements shall apply to such device until the
      date on which the device is required to have in effect an
      approved application under section 360e of this title."
      Subsec. (m)(2). Pub. L. 105-115, Sec. 203(1), inserted at end
    "The request shall be in the form of an application submitted to
    the Secretary. Not later than 75 days after the date of the receipt
    of the application, the Secretary shall issue an order approving or
    denying the application."
      Subsec. (m)(4). Pub. L. 105-115, Sec. 203(2)(B), inserted at end
    "In a case described in subparagraph (B) in which a physician uses
    a device without an approval from an institutional review
    committee, the physician shall, after the use of the device, notify
    the chairperson of the local institutional review committee of such
    use. Such notification shall include the identification of the
    patient involved, the date on which the device was used, and the
    reason for the use."
      Subsec. (m)(4)(B). Pub. L. 105-115, Sec. 203(2)(A), inserted
    before period at end ", unless a physician determines in an
    emergency situation that approval from a local institutional review
    committee can not be obtained in time to prevent serious harm or
    death to a patient".
      Subsec. (m)(5). Pub. L. 105-115, Sec. 203(3), amended par. (5)
    generally. Prior to amendment, par. (5) read as follows: "An
    exemption under paragraph (2) shall be for a term of 18 months and
    may only be initially granted in the 5-year period beginning on the
    date regulations under paragraph (6) take effect. The Secretary may
    extend such an exemption for a period of 18 months if the Secretary
    is able to make the findings set forth in paragraph (2) and if the
    applicant supplies information demonstrating compliance with
    paragraph (3). An exemption may be extended more than once and may
    be extended after the expiration of such 5-year period."
      Subsec. (m)(6). Pub. L. 105-115, Sec. 203(4), amended par. (6)
    generally. Prior to amendment, par. (6) read as follows: "Within
    one year of November 28, 1990, the Secretary shall issue
    regulations to implement this subsection."
      1992 - Subsec. (g)(2)(A). Pub. L. 102-571 substituted "379e" for
    "376".
      1990 - Subsec. (c). Pub. L. 101-629, Sec. 11(1), substituted
    "from class III to class II or class I" for "under section 360c of
    this title from class III to class II" and inserted "(1) in
    accordance with subsection (h) of this section, and (2)" after
    "except".
      Subsec. (f)(1)(A). Pub. L. 101-629, Sec. 18(e), inserted "pre-
    production design validation (including a process to assess the
    performance of a device but not including an evaluation of the
    safety or effectiveness of a device)," after "manufacture,".
      Subsec. (h)(3). Pub. L. 101-629, Sec. 11(2)(A), substituted
    "Except as provided in paragraph (4), any" for "Any".
      Subsec. (h)(4). Pub. L. 101-629, Sec. 11(2)(B), added par. (4).
      Subsec. (i). Pub. L. 101-629, Sec. 6(b)(2), substituted "section
    360d(b)(5)(B)" for "section 360d(g)(5)(B)".
      Subsec. (j). Pub. L. 101-629, Sec. 3(b)(2), substituted "Except
    as provided in section 360i(e) of this title, no" for "No".
      Subsec. (l)(2). Pub. L. 101-629, Sec. 18(f), struck out "and
    after affording the petitioner an opportunity for an informal
    hearing" after "under this paragraph".
      Pub. L. 101-629, Sec. 5(c)(2), substituted "The Secretary may
    initiate the reclassification of a device classified into class III
    under paragraph (1) of this subsection or the manufacturer" for
    "The manufacturer".
      Subsec. (l)(5). Pub. L. 101-629, Sec. 4(b)(2), added par. (5).
      Subsec. (m). Pub. L. 101-629, Sec. 14(a), added subsec. (m).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of Pub.
    L. 105-115 effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    a note under section 321 of this title.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 14(b) of Pub. L. 101-629 provided that: "Subsection (m)
    of section 520 of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360j(m)], as added by the amendment made by subsection (a),
    shall take effect on the effective date of the regulations issued
    by the Secretary under paragraph (6) of such subsection."

                   GUIDANCE REGARDING PEDIATRIC DEVICES               
      Pub. L. 107-250, title II, Sec. 213, Oct. 26, 2002, 116 Stat.
    1614, provided that: "Not later than 270 days after the date of the
    enactment of this Act [Oct. 26, 2002], the Secretary of Health and
    Human Services shall issue guidance on the following:
        "(1) The type of information necessary to provide reasonable
      assurance of the safety and effectiveness of medical devices
      intended for use in pediatric populations.
        "(2) Protections for pediatric subjects in clinical
      investigations of the safety or effectiveness of such devices."

                 REPORT ON HUMANITARIAN DEVICE EXEMPTIONS             
      Section 14(c) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, within 4 years after issuance of regulations under
    21 U.S.C. 360j(m)(6), to report to Congress on types of devices
    exempted, an evaluation of effects of such section, and a
    recommendation on extension of the section.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Sec. 360k                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360k. State and local requirements respecting devices

-STATUTE-
    (a) General rule
      Except as provided in subsection (b) of this section, no State or
    political subdivision of a State may establish or continue in
    effect with respect to a device intended for human use any
    requirement - 
        (1) which is different from, or in addition to, any requirement
      applicable under this chapter to the device, and
        (2) which relates to the safety or effectiveness of the device
      or to any other matter included in a requirement applicable to
      the device under this chapter.
    (b) Exempt requirements
      Upon application of a State or a political subdivision thereof,
    the Secretary may, by regulation promulgated after notice and
    opportunity for an oral hearing, exempt from subsection (a) of this
    section, under such conditions as may be prescribed in such
    regulation, a requirement of such State or political subdivision
    applicable to a device intended for human use if - 
        (1) the requirement is more stringent than a requirement under
      this chapter which would be applicable to the device if an
      exemption were not in effect under this subsection; or
        (2) the requirement - 
          (A) is required by compelling local conditions, and
          (B) compliance with the requirement would not cause the
        device to be in violation of any applicable requirement under
        this chapter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 521, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 574.)

-End-



-CITE-
    21 USC Sec. 360l                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360l. Postmarket surveillance

-STATUTE-
    (a) In general
      The Secretary may by order require a manufacturer to conduct
    postmarket surveillance for any device of the manufacturer which is
    a class II or class III device the failure of which would be
    reasonably likely to have serious adverse health consequences or
    which is intended to be - 
        (1) implanted in the human body for more than one year, or
        (2) a life sustaining or life supporting device used outside a
      device user facility.
    (b) Surveillance approval
      Each manufacturer required to conduct a surveillance of a device
    shall, within 30 days of receiving an order from the Secretary
    prescribing that the manufacturer is required under this section to
    conduct such surveillance, submit, for the approval of the
    Secretary, a plan for the required surveillance. The Secretary,
    within 60 days of the receipt of such plan, shall determine if the
    person designated to conduct the surveillance has appropriate
    qualifications and experience to undertake such surveillance and if
    the plan will result in the collection of useful data that can
    reveal unforeseen adverse events or other information necessary to
    protect the public health. The Secretary, in consultation with the
    manufacturer, may by order require a prospective surveillance
    period of up to 36 months. Any determination by the Secretary that
    a longer period is necessary shall be made by mutual agreement
    between the Secretary and the manufacturer or, if no agreement can
    be reached, after the completion of a dispute resolution process as
    described in section 360bbb-1 of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 522, as added Pub. L. 101-629, Sec.
    10, Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102-300, Sec.
    3(b), June 16, 1992, 106 Stat. 239; Pub. L. 105-115, title II, Sec.
    212, Nov. 21, 1997, 111 Stat. 2346.)


-MISC1-
                                AMENDMENTS                            
      1997 - Pub. L. 105-115 amended section generally, substituting
    present provisions for former provisions which related to required
    surveillance, discretionary surveillance, and surveillance
    approval.
      1992 - Subsec. (b). Pub. L. 102-300 substituted "(a)(1)" for
    "(a)", inserted comma after "commerce", and inserted after first
    sentence "Each manufacturer required to conduct a surveillance of a
    device under subsection (a)(2) of this section shall, within 30
    days after receiving notice that the manufacturer is required to
    conduct such surveillance, submit, for the approval of the
    Secretary, a protocol for the required surveillance."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 212 of Pub. L. 105-115 provided in part that the
    amendment made by that section is effective 90 days after Nov. 21,
    1997.

    STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE REGARDING
                           PEDIATRIC POPULATIONS
      Pub. L. 107-250, title II, Sec. 212, Oct. 26, 2002, 116 Stat.
    1614, as amended by Pub. L. 108-214, Sec. 2(d)(3)(C), Apr. 1, 2004,
    118 Stat. 577, provided that:
      "(a) In General. - The Secretary of Health and Human Services
    (referred to in this section as the 'Secretary') shall request the
    Institute of Medicine to enter into an agreement with the Secretary
    under which such Institute conducts a study for the purpose of
    determining whether the system under the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 301 et seq.] for the postmarket
    surveillance of medical devices provides adequate safeguards
    regarding the use of devices in pediatric populations.
      "(b) Certain Matters. - The Secretary shall ensure that
    determinations made in the study under subsection (a) include
    determinations of - 
        "(1) whether postmarket surveillance studies of implanted
      medical devices are of long enough duration to evaluate the
      impact of growth and development for the number of years that the
      child will have the implant, and whether the studies are adequate
      to evaluate how children's active lifestyles may affect the
      failure rate and longevity of the implant; and
        "(2) whether the postmarket surveillance by the Food and Drug
      Administration of medical devices used in pediatric populations
      is sufficient to provide adequate safeguards for such
      populations, taking into account the Secretary's monitoring of
      commitments made at the time of approval of medical devices and
      the Secretary's monitoring and use of adverse reaction reports,
      registries, and other postmarket surveillance activities.
      "(c) Report to Congress. - The Secretary shall ensure that, not
    later than four years after the date of the enactment of this Act
    [Oct. 26, 2002], a report describing the findings of the study
    under subsection (a) is submitted to the Congress. The report shall
    include any recommendations of the Secretary for administrative or
    legislative changes to the system of postmarket surveillance
    referred to in such subsection."

-End-



-CITE-
    21 USC Sec. 360m                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360m. Accredited persons

-STATUTE-
    (a) In general
      (1) Review and classification of devices
        Not later than 1 year after November 21, 1997, the Secretary
      shall, subject to paragraph (3), accredit persons for the purpose
      of reviewing reports submitted under section 360(k) of this title
      and making recommendations to the Secretary regarding the initial
      classification of devices under section 360c(f)(1) of this title.
      (2) Requirements regarding review
        (A) In general
          In making a recommendation to the Secretary under paragraph
        (1), an accredited person shall notify the Secretary in writing
        of the reasons for the recommendation.
        (B) Time period for review
          Not later than 30 days after the date on which the Secretary
        is notified under subparagraph (A) by an accredited person with
        respect to a recommendation of an initial classification of a
        device, the Secretary shall make a determination with respect
        to the initial classification.
        (C) Special rule
          The Secretary may change the initial classification under
        section 360c(f)(1) of this title that is recommended under
        paragraph (1) by an accredited person, and in such case shall
        provide to such person, and the person who submitted the report
        under section 360(k) of this title for the device, a statement
        explaining in detail the reasons for the change.
      (3) Certain devices
        (A) In general
          An accredited person may not be used to perform a review of -
        
            (i) a class III device;
            (ii) a class II device which is intended to be permanently
          implantable or life sustaining or life supporting; or
            (iii) a class II device which requires clinical data in the
          report submitted under section 360(k) of this title for the
          device, except that the number of class II devices to which
          the Secretary applies this clause for a year, less the number
          of such reports to which clauses (i) and (ii) apply, may not
          exceed 6 percent of the number that is equal to the total
          number of reports submitted to the Secretary under such
          section for such year less the number of such reports to
          which such clauses apply for such year.
        (B) Adjustment
          In determining for a year the ratio described in subparagraph
        (A)(iii), the Secretary shall not include in the numerator
        class III devices that the Secretary reclassified into class
        II, and the Secretary shall include in the denominator class II
        devices for which reports under section 360(k) of this title
        were not required to be submitted by reason of the operation of
        section 360(m) of this title.
    (b) Accreditation
      (1) Programs
        The Secretary shall provide for such accreditation through
      programs administered by the Food and Drug Administration, other
      government agencies, or by other qualified nongovernment
      organizations.
      (2) Accreditation
        (A) In general
          Not later than 180 days after November 21, 1997, the
        Secretary shall establish and publish in the Federal Register
        criteria to accredit or deny accreditation to persons who
        request to perform the duties specified in subsection (a) of
        this section. The Secretary shall respond to a request for
        accreditation within 60 days of the receipt of the request. The
        accreditation of such person shall specify the particular
        activities under subsection (a) of this section for which such
        person is accredited.
        (B) Withdrawal of accreditation
          The Secretary may suspend or withdraw accreditation of any
        person accredited under this paragraph, after providing notice
        and an opportunity for an informal hearing, when such person is
        substantially not in compliance with the requirements of this
        section or poses a threat to public health or fails to act in a
        manner that is consistent with the purposes of this section.
        (C) Performance auditing
          To ensure that persons accredited under this section will
        continue to meet the standards of accreditation, the Secretary
        shall - 
            (i) make onsite visits on a periodic basis to each
          accredited person to audit the performance of such person;
          and
            (ii) take such additional measures as the Secretary
          determines to be appropriate.
        (D) Annual report
          The Secretary shall include in the annual report required
        under section 393(g) of this title the names of all accredited
        persons and the particular activities under subsection (a) of
        this section for which each such person is accredited and the
        name of each accredited person whose accreditation has been
        withdrawn during the year.
      (3) Qualifications
        An accredited person shall, at a minimum, meet the following
      requirements:
          (A) Such person may not be an employee of the Federal
        Government.
          (B) Such person shall be an independent organization which is
        not owned or controlled by a manufacturer, supplier, or vendor
        of devices and which has no organizational, material, or
        financial affiliation with such a manufacturer, supplier, or
        vendor.
          (C) Such person shall be a legally constituted entity
        permitted to conduct the activities for which it seeks
        accreditation.
          (D) Such person shall not engage in the design, manufacture,
        promotion, or sale of devices.
          (E) The operations of such person shall be in accordance with
        generally accepted professional and ethical business practices
        and shall agree in writing that as a minimum it will - 
            (i) certify that reported information accurately reflects
          data reviewed;
            (ii) limit work to that for which competence and capacity
          are available;
            (iii) treat information received, records, reports, and
          recommendations as proprietary information;
            (iv) promptly respond and attempt to resolve complaints
          regarding its activities for which it is accredited; and
            (v) protect against the use, in carrying out subsection (a)
          of this section with respect to a device, of any officer or
          employee of the person who has a financial conflict of
          interest regarding the device, and annually make available to
          the public disclosures of the extent to which the person, and
          the officers and employees of the person, have maintained
          compliance with requirements under this clause relating to
          financial conflicts of interest.
      (4) Selection of accredited persons
        The Secretary shall provide each person who chooses to use an
      accredited person to receive a section 360(k) of this title
      report a panel of at least two or more accredited persons from
      which the regulated person may select one for a specific
      regulatory function.
      (5) Compensation of accredited persons
        Compensation for an accredited person shall be determined by
      agreement between the accredited person and the person who
      engages the services of the accredited person, and shall be paid
      by the person who engages such services.
    (c) Duration
      The authority provided by this section terminates October 1,
    2007.
    (d) Report
      Not later than January 10, 2007, the Secretary shall conduct a
    study based on the experience under the program under this section
    and submit to the Committee on Energy and Commerce of the House of
    Representatives, and the Committee on Health, Education, Labor, and
    Pensions of the Senate, a report describing the findings of the
    study. The objectives of the study shall include determining - 
        (1) the number of devices reviewed under this section;
        (2) the number of devices reviewed under this section that were
      ultimately cleared by the Secretary;
        (3) the number of devices reviewed under this section that were
      ultimately not cleared by the Secretary;
        (4) the average time period for a review under this section
      (including the time it takes for the Secretary to review a
      recommendation of an accredited person under subsection (a) of
      this section and determine the initial device classification);
        (5) the average time period identified in paragraph (4)
      compared to the average time period for review of devices solely
      by the Secretary pursuant to section 360(k) of this title;
        (6) if there is a difference in the average time period under
      paragraph (4) and the average time period under paragraph (5),
      the reasons for such difference;
        (7) whether the quality of reviews under this section for
      devices for which no guidance has been issued is qualitatively
      inferior to reviews by the Secretary for devices for which no
      guidance has been issued;
        (8) whether the quality of reviews under this section of
      devices for which no guidance has been issued is qualitatively
      inferior to reviews under this section of devices for which
      guidance has been issued;
        (9) whether this section has in any way jeopardized or improved
      the public health;
        (10) any impact of this section on resources available to the
      Secretary to review reports under section 360(k) of this title;
      and
        (11) any suggestions for continuation, modification (including
      contraction or expansion of device eligibility), or termination
      of this section that the Secretary determines to be appropriate.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 523, as added Pub. L. 105-115, title
    II, Sec. 210(a), Nov. 21, 1997, 111 Stat. 2342; amended Pub. L. 107-
    250, title II, Sec. 202, Oct. 26, 2002, 116 Stat. 1609.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (c). Pub. L. 107-250, Sec. 202(1), substituted
    "The authority provided by this section terminates October 1,
    2007." for "The authority provided by this section terminates - 
        "(1) 5 years after the date on which the Secretary notifies
      Congress that at least 2 persons accredited under subsection (b)
      of this section are available to review at least 60 percent of
      the submissions under section 360(k) of this title, or
        "(2) 4 years after the date on which the Secretary notifies
      Congress that the Secretary has made a determination described in
      paragraph (2)(B) of subsection (a) of this section for at least
      35 percent of the devices that are subject to review under
      paragraph (1) of such subsection,
    whichever occurs first."
      Subsec. (d). Pub. L. 107-250, Sec. 202(2), added subsec. (d).

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    a note under section 321 of this title.

                    REPORTS ON PROGRAM OF ACCREDITATION                
      Pub. L. 105-115, title II, Sec. 210(d), Nov. 21, 1997, 111 Stat.
    2345, provided that:
      "(1) Comptroller general. - 
        "(A) Implementation of program. - Not later than 5 years after
      the date of the enactment of this Act [Nov. 21, 1997], the
      Comptroller General of the United States shall submit to the
      Committee on Commerce [now Committee on Energy and Commerce] of
      the House of Representatives and the Committee on Labor and Human
      Resources [now Committee on Health, Education, Labor, and
      Pensions] of the Senate a report describing the extent to which
      the program of accreditation required by the amendment made by
      subsection (a) [enacting this section] has been implemented.
        "(B) Evaluation of program. - Not later than 6 months prior to
      the date on which, pursuant to subsection (c) of section 523 of
      the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(c)] (as
      added by subsection (a)), the authority provided under subsection
      (a) of such section will terminate, the Comptroller General shall
      submit to the Committee on Commerce [now Committee on Energy and
      Commerce] of the House of Representatives and the Committee on
      Labor and Human Resources [now Committee on Health, Education,
      Labor, and Pensions] of the Senate a report describing the use of
      accredited persons under such section 523, including an
      evaluation of the extent to which such use assisted the Secretary
      in carrying out the duties of the Secretary under such Act [21
      U.S.C. 301 et seq.] with respect to devices, and the extent to
      which such use promoted actions which are contrary to the
      purposes of such Act.
      "(2) Inclusion of certain devices within program. - Not later
    than 3 years after the date of the enactment of this Act [Nov. 21,
    1997], the Secretary of Health and Human Services shall submit to
    the Committee on Commerce of the House of Representatives and the
    Committee on Labor and Human Resources [now Committee on Health,
    Education, Labor, and Pensions] of the Senate a report providing a
    determination by the Secretary of whether, in the program of
    accreditation established pursuant to the amendment made by
    subsection (a), the limitation established in clause (iii) of
    section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act
    [21 U.S.C. 360m(a)(3)(A)] (relating to class II devices for which
    clinical data are required in reports under section 510(k) [21
    U.S.C. 360(k)]) should be removed."

-End-


-CITE-
    21 USC Part B - Drugs for Rare Diseases or Conditions       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
              PART B - DRUGS FOR RARE DISEASES OR CONDITIONS          

-End-



-CITE-
    21 USC Sec. 360aa                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360aa. Recommendations for investigations of drugs for rare
      diseases or conditions

-STATUTE-
    (a) Request by sponsor; response by Secretary
      The sponsor of a drug for a disease or condition which is rare in
    the States may request the Secretary to provide written
    recommendations for the non-clinical and clinical investigations
    which must be conducted with the drug before - 
        (1) it may be approved for such disease or condition under
      section 355 of this title, or
        (2) if the drug is a biological product, it may be licensed for
      such disease or condition under section 262 of title 42.

    If the Secretary has reason to believe that a drug for which a
    request is made under this section is a drug for a disease or
    condition which is rare in the States, the Secretary shall provide
    the person making the request written recommendations for the non-
    clinical and clinical investigations which the Secretary believes,
    on the basis of information available to the Secretary at the time
    of the request under this section, would be necessary for approval
    of such drug for such disease or condition under section 355 of
    this title or licensing of such drug for such disease or condition
    under section 262 of title 42.
    (b) Regulations
      The Secretary shall by regulation promulgate procedures for the
    implementation of subsection (a) of this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 525, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99-91, Sec.
    3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105-115, title I,
    Sec. 125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(G), struck
    out ", certification of such drug for such disease or condition
    under section 357 of this title," before "or licensing of such
    drug" in closing provisions.
      Subsec. (a)(1) to (3). Pub. L. 105-115, Sec. 125(b)(2)(F),
    inserted "or" at end of par. (1), redesignated par. (3) as (2), and
    struck out former par. (2), which read as follows: "if the drug is
    an antibiotic, it may be certified for such disease or condition
    under section 357 of this title, or".
      1985 - Subsec. (a). Pub. L. 99-91 struck out "or" at end of par.
    (1), inserted par. (2), redesignated former par. (2) as (3) and
    struck out "before" after "product,", and in last sentence inserted
    provisions relating to certification of such drug for disease or
    condition under section 357 of this title and substituted
    "licensing of such drug for such disease or condition under section
    262 of title 42" for "licensing under section 262 of title 42 for
    such disease or condition".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Section 8 of Pub. L. 99-91 provided that:
      "(a) General Rule. - Except as provided in subsection (b), this
    Act and the amendments made by this Act [amending this section,
    sections 360bb, 360cc, and 360ee of this title, and sections 295g-1
    and 6022 of Title 42, The Public Health and Welfare, and enacting
    provisions set out as notes under section 301 of this title and
    section 236 of Title 42] shall take effect October 1, 1985.
      "(b) Exception. - The amendments made by sections 2, 3, and 6(a)
    [amending this section and sections 360bb and 360cc of this title]
    shall take effect on the date of the enactment of this Act [Aug.
    15, 1985]. The amendment made by section 6(b) [amending section
    6022 of Title 42] shall take effect October 19, 1984. The
    amendments made by section 7 [amending section 295g-1 of Title 42]
    shall take effect October 1, 1984 and shall cease to be in effect
    after September 30, 1985."

                                   STUDY                               
      Pub. L. 100-290, Sec. 3(d), Apr. 18, 1988, 102 Stat. 91, directed
    Secretary of Health and Human Services to conduct a study to
    determine whether the application of subchapter B of chapter V of
    the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa et seq.
    (relating to drugs for rare diseases and conditions), and 26 U.S.C.
    28 (relating to tax credit) to medical devices or medical foods for
    rare diseases or conditions or to both was needed to encourage
    development of such devices and foods and report results of the
    study to Congress not later than one year after Apr. 18, 1988.

                          CONGRESSIONAL FINDINGS                      
      Section 1(b) of Pub. L. 97-414 provided that: "The Congress finds
    that - 
        "(1) there are many diseases and conditions, such as
      Huntington's disease, myoclonus, ALS (Lou Gehrig's disease),
      Tourette syndrome, and muscular dystrophy which affect such small
      numbers of individuals residing in the United States that the
      diseases and conditions are considered rare in the United States;
        "(2) adequate drugs for many of such diseases and conditions
      have not been developed;
        "(3) drugs for these diseases and conditions are commonly
      referred to as 'orphan drugs';
        "(4) because so few individuals are affected by any one rare
      disease or condition, a pharmaceutical company which develops an
      orphan drug may reasonably expect the drug to generate relatively
      small sales in comparison to the cost of developing the drug and
      consequently to incur a financial loss;
        "(5) there is reason to believe that some promising orphan
      drugs will not be developed unless changes are made in the
      applicable Federal laws to reduce the costs of developing such
      drugs and to provide financial incentives to develop such drugs;
      and
        "(6) it is in the public interest to provide such changes and
      incentives for the development of orphan drugs."

-End-



-CITE-
    21 USC Sec. 360bb                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360bb. Designation of drugs for rare diseases or conditions

-STATUTE-
    (a) Request by sponsor; preconditions; "rare disease or condition"
      defined
      (1) The manufacturer or the sponsor of a drug may request the
    Secretary to designate the drug as a drug for a rare disease or
    condition. A request for designation of a drug shall be made before
    the submission of an application under section 355(b) of this title
    for the drug, or the submission of an application for licensing of
    the drug under section 262 of title 42. If the Secretary finds that
    a drug for which a request is submitted under this subsection is
    being or will be investigated for a rare disease or condition and -
    
        (A) if an application for such drug is approved under section
      355 of this title, or
        (B) if a license for such drug is issued under section 262 of
      title 42,

    the approval, certification, or license would be for use for such
    disease or condition, the Secretary shall designate the drug as a
    drug for such disease or condition. A request for a designation of
    a drug under this subsection shall contain the consent of the
    applicant to notice being given by the Secretary under subsection
    (b) of this section respecting the designation of the drug.
      (2) For purposes of paragraph (1), the term "rare disease or
    condition" means any disease or condition which (A) affects less
    than 200,000 persons in the United States, or (B) affects more than
    200,000 in the United States and for which there is no reasonable
    expectation that the cost of developing and making available in the
    United States a drug for such disease or condition will be
    recovered from sales in the United States of such drug.
    Determinations under the preceding sentence with respect to any
    drug shall be made on the basis of the facts and circumstances as
    of the date the request for designation of the drug under this
    subsection is made.
    (b) Notification of discontinuance of drug or application as
      condition
      A designation of a drug under subsection (a) of this section
    shall be subject to the condition that - 
        (1) if an application was approved for the drug under section
      355(b) of this title or a license was issued for the drug under
      section 262 of title 42, the manufacturer of the drug will notify
      the Secretary of any discontinuance of the production of the drug
      at least one year before discontinuance, and
        (2) if an application has not been approved for the drug under
      section 355(b) of this title or a license has not been issued for
      the drug under section 262 of title 42 and if preclinical
      investigations or investigations under section 355(i) of this
      title are being conducted with the drug, the manufacturer or
      sponsor of the drug will notify the Secretary of any decision to
      discontinue active pursuit of approval of an application under
      section 355(b) of this title or approval of a license under
      section 262 of title 42.
    (c) Notice to public
      Notice respecting the designation of a drug under subsection (a)
    of this section shall be made available to the public.
    (d) Regulations
      The Secretary shall by regulation promulgate procedures for the
    implementation of subsection (a) of this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 526, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-551, Sec.
    4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec. 3(a)(2),
    Aug. 15, 1985, 99 Stat. 387; Pub. L. 100-290, Sec. 2, Apr. 18,
    1988, 102 Stat. 90; Pub. L. 105-115, title I, Sec. 125(b)(2)(H),
    (I), Nov. 21, 1997, 111 Stat. 2326.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 125(b)(2)(H), struck
    out "the submission of an application for certification of the drug
    under section 357 of this title," before "or the submission of an
    application for licensing of the drug" in introductory provisions,
    inserted "or" at end of subpar. (A), redesignated subpar. (C) as
    (B), and struck out former subpar. (B) which read as follows: "if a
    certification for such drug is issued under section 357 of this
    title, or".
      Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(I)(i), struck out
    ", a certificate was issued for the drug under section 357 of this
    title," before "or a license was issued".
      Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(I)(ii), struck
    out ", a certificate has not been issued for the drug under section
    357 of this title," before "or a license has not been issued" and
    ", approval of an application for certification under section 357
    of this title," before "or approval of a license".
      1988 - Subsec. (a)(1). Pub. L. 100-290, Sec. 2(a), inserted after
    first sentence "A request for designation of a drug shall be made
    before the submission of an application under section 355(b) of
    this title for the drug, the submission of an application for
    certification of the drug under section 357 of this title, or the
    submission of an application for licensing of the drug under
    section 262 of title 42."
      Subsecs. (b) to (d). Pub. L. 100-290, Sec. 2(b), added subsec.
    (b) and redesignated former subsecs. (b) and (c) as (c) and (d),
    respectively.
      1985 - Subsec. (a)(1). Pub. L. 99-91 struck out "or" at end of
    subpar. (A), struck out subpar. (B) and substituted subpars. (B)
    and (C), and inserted ", certification," after "approval".
      1984 - Subsec. (a)(2). Pub. L. 98-551 substituted "which (A)
    affects less than 200,000 persons in the United States, or (B)
    affects more than 200,000 in the United States and for which" for
    "which occurs so infrequently in the United States that".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section
    8(b) of Pub. L. 99-91, set out as a note under section 360aa of
    this title.

-End-



-CITE-
    21 USC Sec. 360cc                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360cc. Protection for drugs for rare diseases or conditions

-STATUTE-
    (a) Exclusive approval, certification, or license
      Except as provided in subsection (b) of this section, if the
    Secretary - 
        (1) approves an application filed pursuant to section 355 of
      this title, or
        (2) issues a license under section 262 of title 42

    for a drug designated under section 360bb of this title for a rare
    disease or condition, the Secretary may not approve another
    application under section 355 of this title or issue another
    license under section 262 of title 42 for such drug for such
    disease or condition for a person who is not the holder of such
    approved application or of such license until the expiration of
    seven years from the date of the approval of the approved
    application or the issuance of the license. Section 355(c)(2) of
    this title does not apply to the refusal to approve an application
    under the preceding sentence.
    (b) Exceptions
      If an application filed pursuant to section 355 of this title is
    approved for a drug designated under section 360bb of this title
    for a rare disease or condition or if a license is issued under
    section 262 of title 42 for such a drug, the Secretary may, during
    the seven-year period beginning on the date of the application
    approval or of the issuance of the license, approve another
    application under section 355 of this title or issue a license
    under section 262 of title 42, for such drug for such disease or
    condition for a person who is not the holder of such approved
    application or of such license if - 
        (1) the Secretary finds, after providing the holder notice and
      opportunity for the submission of views, that in such period the
      holder of the approved application or of the license cannot
      assure the availability of sufficient quantities of the drug to
      meet the needs of persons with the disease or condition for which
      the drug was designated; or
        (2) such holder provides the Secretary in writing the consent
      of such holder for the approval of other applications or the
      issuance of other licenses before the expiration of such seven-
      year period.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 527, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-417, title I,
    Sec. 102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99-91, Secs.
    2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103-80, Sec.
    3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, Sec.
    125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281,
    Sec. 4, Nov. 6, 2002, 116 Stat. 1993.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-281, in concluding provisions,
    struck out ", of such certification," after "such approved
    application" and ", the issuance of the certification," after
    "approval of the approved application".
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(J), struck
    out ", issue another certification under section 357 of this
    title," before "or issue another license" in closing provisions,
    inserted "or" at end of par. (1), redesignated par. (3) as (2), and
    struck out former par. (2) which read as follows: "issues a
    certification under section 357 of this title, or".
      Subsec. (b). Pub. L. 105-115, Sec. 125(b)(2)(K), in introductory
    provisions, struck out ", if a certification is issued under
    section 357 of this title for such a drug," after "rare disease or
    condition", ", of the issuance of the certification under section
    357 of this title," after "application approval", ", issue another
    certification under section 357 of this title," after "application
    under section 355 of this title", and ", of such certification,"
    after "approved application".
      Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ",
    of the certification," after "holder of the approved application".
      Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ",
    issuance of other certifications," after "approval of other
    applications".
      1993 - Subsec. (b). Pub. L. 103-80 struck out extraneous comma
    before "or issue a license under section 262" in introductory
    provisions and substituted "the" for "The" at beginning of par.
    (1).
      1985 - Pub. L. 99-91, Sec. 2(3), struck out "unpatented" before
    "drugs" in section catchline.
      Subsec. (a). Pub. L. 99-91, Secs. 2(1), 3(a)(3)(A)-(D), struck
    out "or" at end of par. (1), added par. (2), redesignated former
    par. (2) as (3), struck out "and for which a United States Letter
    of Patent may not be issued" after "rare disease or condition",
    inserted in first sentence ", issue another certification under
    section 357 of this title," after "section 355 of this title" the
    second time it appeared, inserted ", of such certification," after
    "holder of such approved application", and inserted ", the issuance
    of the certification," after "approval of the approved
    application".
      Subsec. (b). Pub. L. 99-91, Secs. 2(2), 3(a)(3)(E)-(K), struck
    out "and if a United States Letter of Patent may not be issued for
    the drug" after "such a drug", substituted ", if a certification is
    issued under section 357 of this title for such a drug, or if a
    license" for "or a license", inserted ", of the issuance of the
    certification under section 357 of this title," after "application
    approval", struck out ", if the drug is a biological product,"
    before "issue a license", inserted ", issue another certification
    under section 357 of this title," after "section 355 of this
    title", inserted ", of such certification," after "holder of such
    approved application", inserted ", of such certification," after
    "application" in par. (1), and inserted ", issuance of other
    certifications," after "other applications" in par. (2).
      1984 - Subsecs. (a), (b). Pub. L. 98-417 substituted "section
    355" for "section 355(b)" wherever appearing.

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section
    8(b) of Pub. L. 99-91, set out as a note under section 360aa of
    this title.

-End-



-CITE-
    21 USC Sec. 360dd                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360dd. Open protocols for investigations of drugs for rare
      diseases or conditions

-STATUTE-
      If a drug is designated under section 360bb of this title as a
    drug for a rare disease or condition and if notice of a claimed
    exemption under section 355(i) of this title or regulations issued
    thereunder is filed for such drug, the Secretary shall encourage
    the sponsor of such drug to design protocols for clinical
    investigations of the drug which may be conducted under the
    exemption to permit the addition to the investigations of persons
    with the disease or condition who need the drug to treat the
    disease or condition and who cannot be satisfactorily treated by
    available alternative drugs.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 528, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2051.)

-End-



-CITE-
    21 USC Sec. 360ee                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360ee. Grants and contracts for development of drugs for rare
      diseases and conditions

-STATUTE-
    (a) Authority of Secretary
      The Secretary may make grants to and enter into contracts with
    public and private entities and individuals to assist in (1)
    defraying the costs of qualified testing expenses incurred in
    connection with the development of drugs for rare diseases and
    conditions, (2) defraying the costs of developing medical devices
    for rare diseases or conditions, and (3) defraying the costs of
    developing medical foods for rare diseases or conditions.
    (b) Definitions
      For purposes of subsection (a) of this section:
        (1) The term "qualified testing" means - 
          (A) human clinical testing - 
            (i) which is carried out under an exemption for a drug for
          a rare disease or condition under section 355(i) of this
          title (or regulations issued under such section); and
            (ii) which occurs after the date such drug is designated
          under section 360bb of this title and before the date on
          which an application with respect to such drug is submitted
          under section 355(b) of this title or under section 262 of
          title 42; and

          (B) preclinical testing involving a drug for a rare disease
        or condition which occurs after the date such drug is
        designated under section 360bb of this title and before the
        date on which an application with respect to such drug is
        submitted under section 355(b) of this title or under section
        262 of title 42.

        (2) The term "rare disease or condition" means (1) in the case
      of a drug, any disease or condition which (A) affects less than
      200,000 persons in the United States, or (B) affects more than
      200,000 in the United States and for which there is no reasonable
      expectation that the cost of developing and making available in
      the United States a drug for such disease or condition will be
      recovered from sales in the United States of such drug, (2) in
      the case of a medical device, any disease or condition that
      occurs so infrequently in the United States that there is no
      reasonable expectation that a medical device for such disease or
      condition will be developed without assistance under subsection
      (a) of this section, and (3) in the case of a medical food, any
      disease or condition that occurs so infrequently in the United
      States that there is no reasonable expectation that a medical
      food for such disease or condition will be developed without
      assistance under subsection (a) of this section. Determinations
      under the preceding sentence with respect to any drug shall be
      made on the basis of the facts and circumstances as of the date
      the request for designation of the drug under section 360bb of
      this title is made.
        (3) The term "medical food" means a food which is formulated to
      be consumed or administered enterally under the supervision of a
      physician and which is intended for the specific dietary
      management of a disease or condition for which distinctive
      nutritional requirements, based on recognized scientific
      principles, are established by medical evaluation.
    (c) Authorization of appropriations
      For grants and contracts under subsection (a) of this section,
    there are authorized to be appropriated such sums as already have
    been appropriated for fiscal year 2002, and $25,000,000 for each of
    the fiscal years 2003 through 2006.

-SOURCE-
    (Pub. L. 97-414, Sec. 5, Jan. 4, 1983, 96 Stat. 2056; Pub. L. 98-
    551, Sec. 4(b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec.
    5, Aug. 15, 1985, 99 Stat. 391; Pub. L. 100-290, Sec. 3(a)-(c),
    Apr. 18, 1988, 102 Stat. 90, 91; Pub. L. 105-115, title I, Sec.
    125(b)(2)(N), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281, Sec.
    3, Nov. 6, 2002, 116 Stat. 1993.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Orphan Drug Act, and not as
    part of the Federal Food, Drug, and Cosmetic Act which comprises
    this chapter.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (c). Pub. L. 107-281 amended subsec. (c)
    generally. Prior to amendment, subsec. (c) read as follows: "For
    grants and contracts under subsection (a) of this section there are
    authorized to be appropriated $10,000,000 for fiscal year 1988,
    $12,000,000 for fiscal year 1989, $14,000,000 for fiscal year
    1990."
      1997 - Subsec. (b)(1)(A)(ii), (B). Pub. L. 105-115 struck out "or
    357" after "355(b)".
      1988 - Subsec. (a). Pub. L. 100-290, Sec. 3(a)(1), (b)(1),
    inserted "(1)" after "assist in" and added cls. (2) and (3).
      Subsec. (b)(2). Pub. L. 100-290, Sec. 3(a)(2), (b)(2), inserted
    "(1) in the case of a drug," after "means", added cls. (2) and (3),
    and substituted "under section 360bb of this title" for "under this
    subsection" in last sentence.
      Subsec. (b)(3). Pub. L. 100-290, Sec. 3(b)(3), added par. (3).
      Subsec. (c). Pub. L. 100-290, Sec. 3(c), amended subsec. (c)
    generally. Prior to amendment, subsec. (c) read as follows: "For
    grants and contracts under subsection (a) of this section there are
    authorized to be appropriated $4,000,000 for fiscal year 1986,
    $4,000,000 for fiscal year 1987, and $4,000,000 for fiscal year
    1988."
      1985 - Subsec. (a). Pub. L. 99-91, Sec. 5(a)(1), struck out
    "clinical" before "testing".
      Subsec. (b)(1). Pub. L. 99-91, Sec. 5(a)(2), substituted
    provisions defining "qualified testing" for provisions defining
    "qualified clinical testing".
      Subsec. (c). Pub. L. 99-91, Sec. 5(b), substituted provisions
    authorizing appropriations for fiscal years 1986 to 1988, for
    provisions authorizing appropriations for fiscal years 1983 and the
    two succeeding fiscal years.
      1984 - Subsec. (b)(2). Pub. L. 98-551 substituted "which (A)
    affects less than 200,000 persons in the United States, or (B)
    affects more than 200,000 in the United States and for which" for
    "which occurs so infrequently in the United States that".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-91 effective Oct. 1, 1985, see section
    8(a) of Pub. L. 99-91, set out as a note under section 360aa of
    this title.

                           FINDINGS AND PURPOSES                       
      Pub. L. 107-281, Sec. 2, Nov. 6, 2002, 116 Stat. 1992, provided
    that:
      "(a) Findings. - Congress makes the following findings:
        "(1) Rare diseases and disorders are those which affect small
      patient populations, typically populations smaller than 200,000
      individuals in the United States. Such diseases and conditions
      include Huntington's disease, amyotrophic lateral sclerosis (Lou
      Gehrig's disease), Tourette syndrome, Crohn's disease, cystic
      fibrosis, cystinosis, and Duchenne muscular dystrophy.
        "(2) For many years, the 25,000,000 Americans suffering from
      the over 6,000 rare diseases and disorders were denied access to
      effective medicines because prescription drug manufacturers could
      rarely make a profit from marketing drugs for such small groups
      of patients. The prescription drug industry did not adequately
      fund research into such treatments. Despite the urgent health
      need for these medicines, they came to be known as 'orphan drugs'
      because no companies would commercialize them.
        "(3) During the 1970s, an organization called the National
      Organization for Rare Disorders (NORD) was founded to provide
      services and to lobby on behalf of patients with rare diseases
      and disorders. NORD was instrumental in pressing Congress for
      legislation to encourage the development of orphan drugs.
        "(4) The Orphan Drug Act [see Short Title of 1983 Amendments
      note set out under section 301 of this title] created financial
      incentives for the research and production of such orphan drugs.
      New Federal programs at the National Institutes of Health and the
      Food and Drug Administration encouraged clinical research and
      commercial product development for products that target rare
      diseases. An Orphan Products Board was established to promote the
      development of drugs and devices for rare diseases or disorders.
        "(5) Before 1983, some 38 orphan drugs had been developed.
      Since the enactment of the Orphan Drug Act [Jan. 4, 1983], more
      than 220 new orphan drugs have been approved and marketed in the
      United States and more than 800 additional drugs are in the
      research pipeline.
        "(6) Despite the tremendous success of the Orphan Drug Act,
      rare diseases and disorders deserve greater emphasis in the
      national biomedical research enterprise.
        "(7) The Food and Drug Administration supports small clinical
      trials through Orphan Products Research Grants. Such grants
      embody successful partnerships of government and industry, and
      have led to the development of at least 23 drugs and four medical
      devices for rare diseases and disorders. Yet the appropriations
      in fiscal year 2001 for such grants were less than in fiscal year
      1995.
      "(b) Purposes. - The purpose of this Act [see Short Title of 2002
    Amendments note set out under section 301 of this title] is to
    increase the national investment in the development of diagnostics
    and treatments for patients with rare diseases and disorders."

-End-


-CITE-
    21 USC Part C - Electronic Product Radiation Control        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
               PART C - ELECTRONIC PRODUCT RADIATION CONTROL           

-COD-
                               CODIFICATION                           
      This part was classified to subpart 3 (Sec. 263c et seq.) of part
    F of subchapter II of chapter 6A of Title 42, The Public Health and
    Welfare, prior to its renumbering by Pub. L. 101-629, Sec.
    19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L. 103-
    80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat. 779.

-End-



-CITE-
    21 USC Sec. 360hh                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360hh. Definitions

-STATUTE-
      As used in this part - 
        (1) the term "electronic product radiation" means - 
          (A) any ionizing or non-ionizing electromagnetic or
        particulate radiation, or
          (B) any sonic, infrasonic, or ultrasonic wave, which is
        emitted from an electronic product as the result of the
        operation of an electronic circuit in such product;

        (2) the term "electronic product" means (A) any manufactured or
      assembled product which, when in operation, (i) contains or acts
      as part of an electronic circuit and (ii) emits (or in the
      absence of effective shielding or other controls would emit)
      electronic product radiation, or (B) any manufactured or
      assembled article which is intended for use as a component, part,
      or accessory of a product described in clause (A) and which when
      in operation emits (or in the absence of effective shielding or
      other controls would emit) such radiation;
        (3) the term "manufacturer" means any person engaged in the
      business of manufacturing, assembling, or importing of electronic
      products;
        (4) the term "commerce" means (A) commerce between any place in
      any State and any place outside thereof; and (B) commerce wholly
      within the District of Columbia; and
        (5) the term "State" includes the District of Columbia, the
      Commonwealth of Puerto Rico, the Northern Mariana Islands, the
      Virgin Islands, Guam, and American Samoa.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 531, formerly act July 1, 1944, ch.
    373, title III, Sec. 531, formerly Sec. 355, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L. 94-
    484, title IX, Sec. 905(b)(1), Oct. 12, 1976, 90 Stat. 2325;
    renumbered Sec. 531 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),
    (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.
    4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263c of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263c of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this part"
    for "this subpart" in introductory provisions.
      1976 - Par. (5). Pub. L. 94-484 defined "State" to include
    Northern Mariana Islands.

                                SHORT TITLE                            
      For short title of Pub. L. 90-602, which enacted provisions now
    comprising this part (Secs. 360hh to 360ss), as the "Radiation
    Control for Health and Safety Act of 1968", see section 1 of Pub.
    L. 90-602, set out as a Short Title of 1968 Amendments note under
    section 301 of this title.

                     TRANSFER OF SUBPART; CONSTRUCTION                 
      Section 19(c) of Pub. L. 101-629 provided that: "The transfer of
    subpart 3 of part F of title III of the Public Health Service Act
    [42 U.S.C. 263b et seq.] to the Federal Food, Drug, and Cosmetic
    Act [this chapter] does not change the application of the
    requirements of such subpart and such Act to electronic products
    which were in effect on the date of the enactment of this Act [Nov.
    28, 1990]."

-CROSS-
                DEFINITION OF "SECRETARY" AND "DEPARTMENT"            
      Section 3 of Pub. L. 90-602, as amended Pub. L. 96-88, title V,
    Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "As used
    in the amendments made by section 2 of this Act [enacting
    provisions now comprising sections 360hh to 360ss of this title],
    except when otherwise specified, the term 'Secretary' means the
    Secretary of Health and Human Services, and the term 'Department'
    means the Department of Health and Human Services."


-MISC2-
                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Section 4 of Pub. L. 90-602 provided that: "The amendments made
    by section 2 of this Act [enacting provisions now comprising
    sections 360hh to 360ss of this title] shall not be construed as
    superseding or limiting the functions, under any other provision of
    law, of any officer or agency of the United States."

-End-



-CITE-
    21 USC Sec. 360ii                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360ii. Program of control

-STATUTE-
    (a) Establishment
      The Secretary shall establish and carry out an electronic product
    radiation control program designed to protect the public health and
    safety from electronic product radiation. As a part of such
    program, he shall - 
        (1) pursuant to section 360kk of this title, develop and
      administer performance standards for electronic products;
        (2) plan, conduct, coordinate, and support research,
      development, training, and operational activities to minimize the
      emissions of and the exposure of people to, unnecessary
      electronic product radiation;
        (3) maintain liaison with and receive information from other
      Federal and State departments and agencies with related
      interests, professional organizations, industry, industry and
      labor associations, and other organizations on present and future
      potential electronic product radiation;
        (4) study and evaluate emissions of, and conditions of exposure
      to, electronic product radiation and intense magnetic fields;
        (5) develop, test, and evaluate the effectiveness of procedures
      and techniques for minimizing exposure to electronic product
      radiation; and
        (6) consult and maintain liaison with the Secretary of
      Commerce, the Secretary of Defense, the Secretary of Labor, the
      Atomic Energy Commission, and other appropriate Federal
      departments and agencies on (A) techniques, equipment, and
      programs for testing and evaluating electronic product radiation,
      and (B) the development of performance standards pursuant to
      section 360kk of this title to control such radiation emissions.
    (b) Powers of Secretary
      In carrying out the purposes of subsection (a) of this section,
    the Secretary is authorized to - 
        (1)(A) collect and make available, through publications and
      other appropriate means, the results of, and other information
      concerning, research and studies relating to the nature and
      extent of the hazards and control of electronic product
      radiation; and (B) make such recommendations relating to such
      hazards and control as he considers appropriate;
        (2) make grants to public and private agencies, organizations,
      and institutions, and to individuals for the purposes stated in
      paragraphs (2), (4), and (5) of subsection (a) of this section;
        (3) contract with public or private agencies, institutions, and
      organizations, and with individuals, without regard to section
      3324 of title 31 and section 5 of title 41; and
        (4) procure (by negotiation or otherwise) electronic products
      for research and testing purposes, and sell or otherwise dispose
      of such products.
    (c) Record keeping
      (1) Each recipient of assistance under this part pursuant to
    grants or contracts entered into under other than competitive
    bidding procedures shall keep such records as the Secretary shall
    prescribe, including records which fully disclose the amount and
    disposition by such recipient of the proceeds of such assistance,
    the total cost of the project or undertaking in connection with
    which such assistance is given or used, and the amount of that
    portion of the cost of the project or undertaking supplied by other
    sources, and such other records as will facilitate an effective
    audit.
      (2) The Secretary and the Comptroller General of the United
    States, or any of their duly authorized representatives, shall have
    access for the purpose of audit and examination to any books,
    documents, papers, and records of the recipients that are pertinent
    to the grants or contracts entered into under this part under other
    than competitive bidding procedures.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 532, formerly act July 1, 1944, ch.
    373, title III, Sec. 532, formerly Sec. 356, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered Sec. 532
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(A), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263d of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263d of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(1), (6). Pub. L. 101-629, Sec. 19(a)(2)(A)(i),
    substituted "section 360kk" for "section 263f".
      Subsec. (b)(3). Pub. L. 101-629, Sec. 19(a)(2)(A)(ii),
    substituted reference to section 3324 of title 31 for reference to
    section 3648 of the Revised Statutes (31 U.S.C. 529).
      Subsec. (c)(1), (2). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart".


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Atomic Energy Commission abolished and functions transferred by
    sections 5814 and 5841 of Title 42, The Public Health and Welfare.
    See also Transfer of Functions notes set out under those sections.


-MISC2-
                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law or any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360jj                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360jj. Studies by Secretary

-STATUTE-
    (a) Report to Congress
      The Secretary shall conduct the following studies, and shall make
    a report or reports of the results of such studies to the Congress
    on or before January 1, 1970, and from time to time thereafter as
    he may find necessary, together with such recommendations for
    legislation as he may deem appropriate:
      (1) A study of present State and Federal control of health
    hazards from electronic product radiation and other types of
    ionizing radiation, which study shall include, but not be limited
    to - 
        (A) control of health hazards from radioactive materials other
      than materials regulated under the Atomic Energy Act of 1954 [42
      U.S.C. 2011 et seq.];
        (B) any gaps and inconsistencies in present controls;
        (C) the need for controlling the sale of certain used
      electronic products, particularly antiquated X-ray equipment,
      without upgrading such products to meet the standards for new
      products or separate standards for used products;
        (D) measures to assure consistent and effective control of the
      aforementioned health hazards;
        (E) measures to strengthen radiological health programs of
      State governments; and
        (F) the feasibility of authorizing the Secretary to enter into
      arrangements with individual States or groups of States to define
      their respective functions and responsibilities for the control
      of electronic product radiation and other ionizing radiation;

      (2) A study to determine the necessity for the development of
    standards for the use of nonmedical electronic products for
    commercial and industrial purposes; and
      (3) A study of the development of practicable procedures for the
    detection and measurement of electronic product radiation which may
    be emitted from electronic products manufactured or imported prior
    to the effective date of any applicable standard established
    pursuant to this part.
    (b) Participation of other Federal agencies
      In carrying out these studies, the Secretary shall invite the
    participation of other Federal departments and agencies having
    related responsibilities and interests, State governments -
    particularly those of States which regulate radioactive materials
    under section 274 of the Atomic Energy Act of 1954, as amended [42
    U.S.C. 2021], and interested professional, labor, and industrial
    organizations. Upon request from congressional committees
    interested in these studies, the Secretary shall keep these
    committees currently informed as to the progress of the studies and
    shall permit the committees to send observers to meetings of the
    study groups.
    (c) Organization of studies and participation
      The Secretary or his designee shall organize the studies and the
    participation of the invited participants as he deems best. Any
    dissent from the findings and recommendations of the Secretary
    shall be included in the report if so requested by the dissenter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 533, formerly act July 1, 1944, ch.
    373, title III, Sec. 533, formerly Sec. 357, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered Sec. 533
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov. 28,
    1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13,
    1993, 107 Stat. 779.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A),
    is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch.
    1073, Sec. 1, 68 Stat. 921, and amended, which is classified
    generally to chapter 23 (Sec. 2011 et seq.) of Title 42, The Public
    Health and Welfare. For complete classification of this Act to the
    Code, see Short Title note set out under section 2011 of Title 42
    and Tables.

-COD-
                               CODIFICATION                           
      Section was classified to section 263e of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263e of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360kk                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360kk. Performance standards for electronic products

-STATUTE-
    (a) Promulgation of regulations
      (1) The Secretary shall by regulation prescribe performance
    standards for electronic products to control the emission of
    electronic product radiation from such products if he determines
    that such standards are necessary for the protection of the public
    health and safety. Such standards may include provisions for the
    testing of such products and the measurement of their electronic
    product radiation emissions, may require the attachment of warning
    signs and labels, and may require the provision of instructions for
    the installation, operation, and use of such products. Such
    standards may be prescribed from time to time whenever such
    determinations are made, but the first of such standards shall be
    prescribed prior to January 1, 1970. In the development of such
    standards, the Secretary shall consult with Federal and State
    departments and agencies having related responsibilities or
    interests and with appropriate professional organizations and
    interested persons, including representatives of industries and
    labor organizations which would be affected by such standards, and
    shall give consideration to - 
        (A) the latest available scientific and medical data in the
      field of electronic product radiation;
        (B) the standards currently recommended by (i) other Federal
      agencies having responsibilities relating to the control and
      measurement of electronic product radiation, and (ii) public or
      private groups having an expertise in the field of electronic
      product radiation;
        (C) the reasonableness and technical feasibility of such
      standards as applied to a particular electronic product;
        (D) the adaptability of such standards to the need for
      uniformity and reliability of testing and measuring procedures
      and equipment; and
        (E) in the case of a component, or accessory described in
      paragraph (2)(B) of section 360hh of this title, the performance
      of such article in the manufactured or assembled product for
      which it is designed.

      (2) The Secretary may prescribe different and individual
    performance standards, to the extent appropriate and feasible, for
    different electronic products so as to recognize their different
    operating characteristics and uses.
      (3) The performance standards prescribed under this section shall
    not apply to any electronic product which is intended solely for
    export if (A) such product and the outside of any shipping
    container used in the export of such product are labeled or tagged
    to show that such product is intended for export, and (B) such
    product meets all the applicable requirements of the country to
    which such product is intended for export.
      (4) The Secretary may by regulation amend or revoke any
    performance standard prescribed under this section.
      (5) The Secretary may exempt from the provisions of this section
    any electronic product intended for use by departments or agencies
    of the United States provided such department or agency has
    prescribed procurement specifications governing emissions of
    electronic product radiation and provided further that such product
    is of a type used solely or predominantly by departments or
    agencies of the United States.
    (b) Administrative procedure
      The provisions of subchapter II of chapter 5 of title 5 (relating
    to the administrative procedure for rulemaking), and of chapter 7
    of title 5 (relating to judicial review), shall apply with respect
    to any regulation prescribing, amending, or revoking any standard
    prescribed under this section.
    (c) Publication in Federal Register
      Each regulation prescribing, amending, or revoking a standard
    shall specify the date on which it shall take effect which, in the
    case of any regulation prescribing, or amending any standard, may
    not be sooner than one year or not later than two years after the
    date on which such regulation is issued, unless the Secretary
    finds, for good cause shown, that an earlier or later effective
    date is in the public interest and publishes in the Federal
    Register his reason for such finding, in which case such earlier or
    later date shall apply.
    (d) Judicial review
      (1) In a case of actual controversy as to the validity of any
    regulation issued under this section prescribing, amending, or
    revoking a performance standard, any person who will be adversely
    affected by such regulation when it is effective may at any time
    prior to the sixtieth day after such regulation is issued file a
    petition with the United States court of appeals for the circuit
    wherein such person resides or has his principal place of business,
    for a judicial review of such regulation. A copy of the petition
    shall be forthwith transmitted by the clerk of the court to the
    Secretary or other officer designated by him for that purpose. The
    Secretary thereupon shall file in the court the record of the
    proceedings on which the Secretary based the regulation, as
    provided in section 2112 of title 28.
      (2) If the petitioner applies to the court for leave to adduce
    additional evidence, and shows to the satisfaction of the court
    that such additional evidence is material and that there were
    reasonable grounds for the failure to adduce such evidence in the
    proceeding before the Secretary, the court may order such
    additional evidence (and evidence in rebuttal thereof) to be taken
    before the Secretary, and to be adduced upon the hearing, in such
    manner and upon such terms and conditions as to the court may seem
    proper. The Secretary may modify his findings, or make new
    findings, by reason of the additional evidence so taken, and he
    shall file such modified or new findings, and his recommendations,
    if any, for the modification or setting aside of his original
    regulation, with the return of such additional evidence.
      (3) Upon the filing of the petition referred to in paragraph (1)
    of this subsection, the court shall have jurisdiction to review the
    regulation in accordance with chapter 7 of title 5 and to grant
    appropriate relief as provided in such chapter.
      (4) The judgment of the court affirming or setting aside, in
    whole or in part, any such regulation of the Secretary shall be
    final, subject to review by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28.
      (5) Any action instituted under this subsection shall survive,
    notwithstanding any change in the person occupying the office of
    Secretary or any vacancy in such office.
      (6) The remedies provided for in this subsection shall be in
    addition to and not in substitution for any other remedies provided
    by law.
    (e) Availability of record
      A certified copy of the transcript of the record and
    administrative proceedings under this section shall be furnished by
    the Secretary to any interested party at his request, and payment
    of the costs thereof, and shall be admissible in any criminal,
    exclusion of imports, or other proceeding arising under or in
    respect of this part irrespective of whether proceedings with
    respect to the regulation have previously been initiated or become
    final under this section.
    (f) Technical Electronic Product Radiation Safety Standards
      Committee
      (1)(A) The Secretary shall establish a Technical Electronic
    Product Radiation Safety Standards Committee (hereafter in this
    part referred to as the "Committee") which he shall consult before
    prescribing any standard under this section. The Committee shall be
    appointed by the Secretary, after consultation with public and
    private agencies concerned with the technical aspect of electronic
    product radiation safety, and shall be composed of fifteen members
    each of whom shall be technically qualified by training and
    experience in one or more fields of science or engineering
    applicable to electronic product radiation safety, as follows:
        (i) Five members shall be selected from governmental agencies,
      including State and Federal Governments;
        (ii) Five members shall be selected from the affected
      industries after consultation with industry representatives; and
        (iii) Five members shall be selected from the general public,
      of which at least one shall be a representative of organized
      labor.

      (B) The Committee may propose electronic product radiation safety
    standards to the Secretary for his consideration. All proceedings
    of the Committee shall be recorded and the record of each such
    proceeding shall be available for public inspection.
      (2) Payments to members of the Committee who are not officers or
    employees of the United States pursuant to subsection (c) of
    section 210 of title 42 shall not render members of the Committee
    officers or employees of the United States for any purpose.
    (g) Review and evaluation
      The Secretary shall review and evaluate on a continuing basis
    testing programs carried out by industry to assure the adequacy of
    safeguards against hazardous electronic product radiation and to
    assure that electronic products comply with standards prescribed
    under this section.
    (h) Product certification
      Every manufacturer of an electronic product to which is
    applicable a standard in effect under this section shall furnish to
    the distributor or dealer at the time of delivery of such product,
    in the form of a label or tag permanently affixed to such product
    or in such manner as approved by the Secretary, the certification
    that such product conforms to all applicable standards under this
    section. Such certification shall be based upon a test, in
    accordance with such standard, of the individual article to which
    it is attached or upon a testing program which is in accord with
    good manufacturing practice and which has not been disapproved by
    the Secretary (in such manner as he shall prescribe by regulation)
    on the grounds that it does not assure the adequacy of safeguards
    against hazardous electronic product radiation or that it does not
    assure that electronic products comply with the standards
    prescribed under this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 534, formerly act July 1, 1944, ch.
    373, title III, Sec. 534, formerly Sec. 358, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91-
    515, title VI, Sec. 601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311;
    renumbered Sec. 534 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),
    (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-
    80, Secs. 3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263f of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80, Sec. 4(a)(2), amended directory language
    of Pub. L. 101-629, Sec. 19(a)(4), which renumbered section 263f of
    Title 42, The Public Health and Welfare, as this section.
      Subsec. (f)(2). Pub. L. 103-80, Sec. 3(w), made technical
    amendment to reference to section 210 of title 42 to reflect
    correction of corresponding provision of original act.
      1990 - Subsec. (a)(1)(E). Pub. L. 101-629, Sec. 19(a)(2)(B),
    substituted "section 360hh" for "section 263c".
      Subsecs. (e), (f)(1)(A). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart".
      1970 - Subsec. (f)(2). Pub. L. 91-515 struck out provisions
    related to payment of compensation and travel expenses of members
    of the Committee who are not officers or employees of the United
    States, and substituted "to members of the Committee who are not
    officers or employees of the United States pursuant to subsection
    (c) of section 210 of title 42" for "under this subsection".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360ll                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360ll. Notification of defects in and repair or replacement of
      electronic products

-STATUTE-
    (a) Notification; exemption
      (1) Every manufacturer of electronic products who discovers that
    an electronic product produced, assembled, or imported by him has a
    defect which relates to the safety of use of such product by reason
    of the emission of electronic product radiation, or that an
    electronic product produced, assembled, or imported by him on or
    after the effective date of an applicable standard prescribed
    pursuant to section 360kk of this title fails to comply with such
    standard, shall immediately notify the Secretary of such defect or
    failure to comply if such product has left the place of manufacture
    and shall (except as authorized by paragraph (2)) with reasonable
    promptness furnish notification of such defect or failure to the
    persons (where known to the manufacturer) specified in subsection
    (b) of this section.
      (2) If, in the opinion of such manufacturer, the defect or
    failure to comply is not such as to create a significant risk of
    injury, including genetic injury, to any person, he may, at the
    time of giving notice to the Secretary of such defect or failure to
    comply, apply to the Secretary for an exemption from the
    requirement of notice to the persons specified in subsection (b) of
    this section. If such application states reasonable grounds for
    such exemption, the Secretary shall afford such manufacturer an
    opportunity to present his views and evidence in support of the
    application, the burden of proof being on the manufacturer. If,
    after such presentation, the Secretary is satisfied that such
    defect or failure to comply is not such as to create a significant
    risk of injury, including genetic injury, to any person, he shall
    exempt such manufacturer from the requirement of notice to the
    persons specified in subsection (b) of this section and from the
    requirements of repair or replacement imposed by subsection (f) of
    this section.
    (b) Method of notification
      The notification (other than to the Secretary) required by
    paragraph (1) of subsection (a) of this section shall be
    accomplished - 
        (1) by certified mail to the first purchaser of such product
      for purposes other than resale, and to any subsequent transferee
      of such product; and
        (2) by certified mail or other more expeditious means to the
      dealers or distributors of such manufacturer to whom such product
      was delivered.
    (c) Requisite elements of notification
      The notifications required by paragraph (1) of subsection (a) of
    this section shall contain a clear description of such defect or
    failure to comply with an applicable standard, an evaluation of the
    hazard reasonably related to such defect or failure to comply, and
    a statement of the measures to be taken to repair such defect. In
    the case of a notification to a person referred to in subsection
    (b) of this section, the notification shall also advise the person
    of his rights under subsection (f) of this section.
    (d) Copies to Secretary of communications by manufacturers to
      dealers or distributors regarding defects
      Every manufacturer of electronic products shall furnish to the
    Secretary a true or representative copy of all notices, bulletins,
    and other communications to the dealers or distributors of such
    manufacturer or to purchasers (or subsequent transferees) of
    electronic products of such manufacturer regarding any such defect
    in such product or any such failure to comply with a standard
    applicable to such product. The Secretary shall disclose to the
    public so much of the information contained in such notice or other
    information obtained under section 360nn of this title as he deems
    will assist in carrying out the purposes of this part, but he shall
    not disclose any information which contains or relates to a trade
    secret or other matter referred to in section 1905 of title 18
    unless he determines that it is necessary to carry out the purposes
    of this part.
    (e) Notice from Secretary to manufacturer of defects or failure to
      comply with standards
      If through testing, inspection, investigation, or research
    carried out pursuant to this part, or examination of reports
    submitted pursuant to section 360nn of this title, or otherwise,
    the Secretary determines that any electronic product - 
        (1) does not comply with an applicable standard prescribed
      pursuant to section 360kk of this title; or
        (2) contains a defect which relates to the safety of use of
      such product by reason of the emission of electronic product
      radiation;

    he shall immediately notify the manufacturer of such product of
    such defect or failure to comply. The notice shall contain the
    findings of the Secretary and shall include all information upon
    which the findings are based. The Secretary shall afford such
    manufacturer an opportunity to present his views and evidence in
    support thereof, to establish that there is no failure of
    compliance or that the alleged defect does not exist or does not
    relate to safety of use of the product by reason of the emission of
    such radiation hazard. If after such presentation by the
    manufacturer the Secretary determines that such product does not
    comply with an applicable standard prescribed pursuant to section
    360kk of this title, or that it contains a defect which relates to
    the safety of use of such product by reason of the emission of
    electronic product radiation, the Secretary shall direct the
    manufacturer to furnish the notification specified in subsection
    (c) of this section to the persons specified in paragraphs (1) and
    (2) of subsection (b) of this section (where known to the
    manufacturer), unless the manufacturer has applied for an exemption
    from the requirement of such notification on the ground specified
    in paragraph (2) of subsection (a) of this section and the
    Secretary is satisfied that such noncompliance or defect is not
    such as to create a significant risk of injury, including genetic
    injury, to any person.
    (f) Correction of defects
      If any electronic product is found under subsection (a) or (e) of
    this section to fail to comply with an applicable standard
    prescribed under this part or to have a defect which relates to the
    safety of use of such product, and the notification specified in
    subsection (c) of this section is required to be furnished on
    account of such failure or defect, the manufacturer of such product
    shall (1) without charge, bring such product into conformity with
    such standard or remedy such defect and provide reimbursement for
    any expenses for transportation of such product incurred in
    connection with having such product brought into conformity or
    having such defect remedied, (2) replace such product with a like
    or equivalent product which complies with each applicable standard
    prescribed under this part and which has no defect relating to the
    safety of its use, or (3) make a refund of the cost of such
    product. The manufacturer shall take the action required by this
    subsection in such manner, and with respect to such persons, as the
    Secretary by regulations shall prescribe.
    (g) Effective date
      This section shall not apply to any electronic product that was
    manufactured before October 18, 1968.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 535, formerly act July 1, 1944, ch.
    373, title III, Sec. 535, formerly Sec. 359, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered Sec. 535
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263g of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263g of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(C)(i),
    substituted "section 360kk" for "section 263f".
      Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C)(ii),
    substituted "section 360nn" for "section 263i" and "this part" for
    "this subpart" in two places.
      Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C),
    substituted "this part" for "this subpart" and "section 360nn" for
    "section 263i" in introductory provisions and "section 360kk" for
    "section 263f" in par. (1) and concluding provisions.
      Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart" in two places.

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360mm                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360mm. Imports

-STATUTE-
    (a) Refusal of admission to noncomplying electronic products
      Any electronic product offered for importation into the United
    States which fails to comply with an applicable standard prescribed
    under this part, or to which is not affixed a certification in the
    form of a label or tag in conformity with section 360kk(h) of this
    title shall be refused admission into the United States. The
    Secretary of the Treasury shall deliver to the Secretary of Health
    and Human Services, upon the latter's request, samples of
    electronic products which are being imported or offered for import
    into the United States, giving notice thereof to the owner or
    consignee, who may have a hearing before the Secretary of Health
    and Human Services. If it appears from an examination of such
    samples or otherwise that any electronic product fails to comply
    with applicable standards prescribed pursuant to section 360kk of
    this title, then, unless subsection (b) of this section applies and
    is complied with, (1) such electronic product shall be refused
    admission, and (2) the Secretary of the Treasury shall cause the
    destruction of such electronic product unless such article is
    exported, under regulations prescribed by the Secretary of the
    Treasury, within 90 days after the date of notice of refusal of
    admission or within such additional time as may be permitted by
    such regulations.
    (b) Bond
      If it appears to the Secretary of Health and Human Services that
    any electronic product refused admission pursuant to subsection (a)
    of this section can be brought into compliance with applicable
    standards prescribed pursuant to section 360kk of this title, final
    determination as to admission of such electronic product may be
    deferred upon filing of timely written application by the owner or
    consignee and the execution by him of a good and sufficient bond
    providing for the payment of such liquidated damages in the event
    of default as the Secretary of Health and Human Services may by
    regulation prescribe. If such application is filed and such bond is
    executed the Secretary of Health and Human Services may, in
    accordance with rules prescribed by him, permit the applicant to
    perform such operations with respect to such electronic product as
    may be specified in the notice of permission.
    (c) Liability of owner or consignee for expenses connected with
      refusal of admission
      All expenses (including travel, per diem or subsistence, and
    salaries of officers or employees of the United States) in
    connection with the destruction provided for in subsection (a) of
    this section and the supervision of operations provided for in
    subsection (b) of this section, and all expenses in connection with
    the storage, cartage, or labor with respect to any electronic
    product refused admission pursuant to subsection (a) of this
    section, shall be paid by the owner or consignee, and, in event of
    default, shall constitute a lien against any future importations
    made by such owner or consignee.
    (d) Designation of agent for purposes of service
      It shall be the duty of every manufacturer offering an electronic
    product for importation into the United States to designate in
    writing an agent upon whom service of all administrative and
    judicial processes, notices, orders, decisions, and requirements
    may be made for and on behalf of said manufacturer, and to file
    such designation with the Secretary, which designation may from
    time to time be changed by like writing, similarly filed. Service
    of all administrative and judicial processes, notices, orders,
    decisions, and requirements may be made upon said manufacturer by
    service upon such designated agent at his office or usual place of
    residence with like effect as if made personally upon said
    manufacturer, and in default of such designation of such agent,
    service of process, notice, order, requirement, or decision in any
    proceeding before the Secretary or in any judicial proceeding for
    enforcement of this part or any standards prescribed pursuant to
    this part may be made by posting such process, notice, order,
    requirement, or decision in the Office of the Secretary or in a
    place designated by him by regulation.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 536, formerly act July 1, 1944, ch.
    373, title III, Sec. 536, formerly Sec. 360, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered Sec. 536
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102-300, Sec. 6(b)(1),
    June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Sec. 4(a)(2), Aug.
    13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263h of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263h of Title 42, The
    Public Health and Welfare, as this section.
      1992 - Subsecs. (a), (b). Pub. L. 102-300 substituted "Health and
    Human Services" for "Health, Education, and Welfare" wherever
    appearing.
      1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D),
    substituted "this part" for "this subpart", "section 360kk(h)" for
    "section 263f(h)", and "section 360kk" for "section 263f".
      Subsec. (b). Pub. L. 101-629, Sec. 19(a)(2)(D), substituted
    "section 360kk" for "section 263f".
      Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart" in two places.

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360nn                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360nn. Inspection, records, and reports

-STATUTE-
    (a) Inspection of premises
      If the Secretary finds for good cause that the methods, tests, or
    programs related to electronic product radiation safety in a
    particular factory, warehouse, or establishment in which electronic
    products are manufactured or held, may not be adequate or reliable,
    officers or employees duly designated by the Secretary, upon
    presenting appropriate credentials and a written notice to the
    owner, operator, or agent in charge, are thereafter authorized (1)
    to enter, at reasonable times, any area in such factory, warehouse,
    or establishment in which the manufacturer's tests (or testing
    programs) required by section 360kk(h) of this title are carried
    out, and (2) to inspect, at reasonable times and within reasonable
    limits and in a reasonable manner, the facilities and procedures
    within such area which are related to electronic product radiation
    safety. Each such inspection shall be commenced and completed with
    reasonable promptness. In addition to other grounds upon which good
    cause may be found for purposes of this subsection, good cause will
    be considered to exist in any case where the manufacturer has
    introduced into commerce any electronic product which does not
    comply with an applicable standard prescribed under this part and
    with respect to which no exemption from the notification
    requirements has been granted by the Secretary under section
    360ll(a)(2) or 360ll(e) of this title.
    (b) Record keeping
      Every manufacturer of electronic products shall establish and
    maintain such records (including testing records), make such
    reports, and provide such information, as the Secretary may
    reasonably require to enable him to determine whether such
    manufacturer has acted or is acting in compliance with this part
    and standards prescribed pursuant to this part and shall, upon
    request of an officer or employee duly designated by the Secretary,
    permit such officer or employee to inspect appropriate books,
    papers, records, and documents relevant to determining whether such
    manufacturer has acted or is acting in compliance with standards
    prescribed pursuant to this part.
    (c) Disclosure of technical data
      Every manufacturer of electronic products shall provide to the
    Secretary such performance data and other technical data related to
    safety as may be required to carry out the purposes of this part.
    The Secretary is authorized to require the manufacturer to give
    such notification of such performance and technical data at the
    time of original purchase to the ultimate purchaser of the
    electronic product, as he determines necessary to carry out the
    purposes of this part after consulting with the affected industry.
    (d) Public nature of reports
      Accident and investigation reports made under this part by any
    officer, employee, or agent of the Secretary shall be available for
    use in any civil, criminal, or other judicial proceeding arising
    out of such accident. Any such officer, employee, or agent may be
    required to testify in such proceedings as to the facts developed
    in such investigations. Any such report shall be made available to
    the public in a manner which need not identify individuals. All
    reports on research projects, demonstration projects, and other
    related activities shall be public information.
    (e) Trade secrets
      The Secretary or his representative shall not disclose any
    information reported to or otherwise obtained by him, pursuant to
    subsection (a) or (b) of this section, which concerns any
    information which contains or relates to a trade secret or other
    matter referred to in section 1905 of title 18, except that such
    information may be disclosed to other officers or employees of the
    Department and of other agencies concerned with carrying out this
    part or when relevant in any proceeding under this part. Nothing in
    this section shall authorize the withholding of information by the
    Secretary, or by any officers or employees under his control, from
    the duly authorized committees of the Congress.
    (f) Information required to identify and locate first purchasers of
      electronic products
      The Secretary may by regulation (1) require dealers and
    distributors of electronic products, to which there are applicable
    standards prescribed under this part and the retail prices of which
    is not less than $50, to furnish manufacturers of such products
    such information as may be necessary to identify and locate, for
    purposes of section 360ll of this title, the first purchasers of
    such products for purposes other than resale, and (2) require
    manufacturers to preserve such information. Any regulation
    establishing a requirement pursuant to clause (1) of the preceding
    sentence shall (A) authorize such dealers and distributors to
    elect, in lieu of immediately furnishing such information to the
    manufacturer, to hold and preserve such information until advised
    by the manufacturer or Secretary that such information is needed by
    the manufacturer for purposes of section 360ll of this title, and
    (B) provide that the dealer or distributor shall, upon making such
    election, give prompt notice of such election (together with
    information identifying the notifier and the product) to the
    manufacturer and shall, when advised by the manufacturer or
    Secretary, of the need therefor for the purposes of section 360ll
    of this title, immediately furnish the manufacturer with the
    required information. If a dealer or distributor discontinues the
    dealing in or distribution of electronic products, he shall turn
    the information over to the manufacturer. Any manufacturer
    receiving information pursuant to this subsection concerning first
    purchasers of products for purposes other than resale shall treat
    it as confidential and may use it only if necessary for the purpose
    of notifying persons pursuant to section 360ll(a) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 537, formerly act July 1, 1944, ch.
    373, title III, Sec. 537, formerly Sec. 360A, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered Sec. 537
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263i of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263i of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E),
    substituted "section 360kk(h)" for "section 263f(h)", "this part"
    for "this subpart", and "section 360ll(a)(2) or 360ll(e)" for
    "section 263g(a)(2) or 263g(e)".
      Subsecs. (b) to (e). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart" wherever appearing.
      Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E)(ii),
    substituted "this part" for "this subpart", "section 360ll" for
    "section 263g" in three places, and "section 360ll(a)" for "section
    263g(a)".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360oo                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360oo. Prohibited acts

-STATUTE-
      (a) It shall be unlawful - 
        (1) for any manufacturer to introduce, or to deliver for
      introduction, into commerce, or to import into the United States,
      any electronic product which does not comply with an applicable
      standard prescribed pursuant to section 360kk of this title;
        (2) for any person to fail to furnish any notification or other
      material or information required by section 360ll or 360nn of
      this title; or to fail to comply with the requirements of section
      360ll(f) of this title;
        (3) for any person to fail or to refuse to establish or
      maintain records required by this part or to permit access by the
      Secretary or any of his duly authorized representatives to, or
      the copying of, such records, or to permit entry or inspection,
      as required by or pursuant to section 360nn of this title;
        (4) for any person to fail or to refuse to make any report
      required pursuant to section 360nn(b) of this title or to furnish
      or preserve any information required pursuant to section 360nn(f)
      of this title; or
        (5) for any person (A) to fail to issue a certification as
      required by section 360kk(h) of this title, or (B) to issue such
      a certification when such certification is not based upon a test
      or testing program meeting the requirements of section 360kk(h)
      of this title or when the issuer, in the exercise of due care,
      would have reason to know that such certification is false or
      misleading in a material respect.

      (b) The Secretary may exempt any electronic product, or class
    thereof, from all or part of subsection (a) of this section, upon
    such conditions as he may find necessary to protect the public
    health or welfare, for the purpose of research, investigations,
    studies, demonstrations, or training, or for reasons of national
    security.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 538, formerly act July 1, 1944, ch.
    373, title III, Sec. 538, formerly Sec. 360B, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec. 538
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263j of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263j of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(F)(i),
    substituted "section 360kk" for "section 263f".
      Subsec. (a)(2). Pub. L. 101-629, Sec. 19(a)(2)(F)(ii), (iii),
    substituted "section 360ll or 360nn" for "section 263g or 263i" and
    "section 360ll(f)" for "section 263g(f)".
      Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F)(iii),
    substituted "this part" for "this subpart" and "section 360nn" for
    "section 263i".
      Subsec. (a)(4). Pub. L. 101-629, Sec. 19(a)(2)(F)(iii),
    substituted "section 360nn(b)" for "section 263i(b)" and "section
    360nn(f)" for "section 263i(f)".
      Subsec. (a)(5). Pub. L. 101-629, Sec. 19(a)(2)(F)(i), substituted
    "section 360kk(h)" for "section 263f(h)" in two places.

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360pp                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360pp. Enforcement

-STATUTE-
    (a) Jurisdiction of courts
      The district courts of the United States shall have jurisdiction,
    for cause shown, to restrain violations of section 360oo of this
    title and to restrain dealers and distributors of electronic
    products from selling or otherwise disposing of electronic products
    which do not conform to an applicable standard prescribed pursuant
    to section 360kk of this title except when such products are
    disposed of by returning them to the distributor or manufacturer
    from whom they were obtained. The district courts of the United
    States shall also have jurisdiction in accordance with section 1355
    of title 28 to enforce the provisions of subsection (b) of this
    section.
    (b) Penalties
      (1) Any person who violates section 360oo of this title shall be
    subject to a civil penalty of not more than $1,000. For purposes of
    this subsection, any such violation shall with respect to each
    electronic product involved, or with respect to each act or
    omission made unlawful by section 360oo of this title, constitute a
    separate violation, except that the maximum civil penalty imposed
    on any person under this subsection for any related series of
    violations shall not exceed $300,000.
      (2) Any such civil penalty may on application be remitted or
    mitigated by the Secretary. In determining the amount of such
    penalty, or whether it should be remitted or mitigated and in what
    amount, the appropriateness of such penalty to the size of the
    business of the person charged and the gravity of the violation
    shall be considered. The amount of such penalty, when finally
    determined, may be deducted from any sums owing by the United
    States to the person charged.
    (c) Venue; process
      Actions under subsections (a) and (b) of this section may be
    brought in the district court of the United States for the district
    wherein any act or omission or transaction constituting the
    violation occurred, or in such court for the district where the
    defendant is found or transacts business, and process in such cases
    may be served in any other district of which the defendant is an
    inhabitant or wherever the defendant may be found.
    (d) Warnings
      Nothing in this part shall be construed as requiring the
    Secretary to report for the institution of proceedings minor
    violations of this part whenever he believes that the public
    interest will be adequately served by a suitable written notice or
    warning.
    (e) Compliance with regulations
      Except as provided in the first sentence of section 360ss of this
    title, compliance with this part or any regulations issued
    thereunder shall not relieve any person from liability at common
    law or under statutory law.
    (f) Additional remedies
      The remedies provided for in this part shall be in addition to
    and not in substitution for any other remedies provided by law.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 539, formerly act July 1, 1944, ch.
    373, title III, Sec. 539, formerly Sec. 360C, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec. 539
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263k of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263k of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(2)(G)(i), (ii),
    substituted "section 360oo" for "section 263j" and "section 360kk"
    for "section 263f".
      Subsec. (b)(1). Pub. L. 101-629, Sec. 19(a)(2)(G)(ii),
    substituted "section 360oo" for "section 263j" in two places.
      Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart" in two places.
      Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G)(iii),
    substituted "section 360ss" for "section 263n" and "this part" for
    "this subpart".
      Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360qq                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360qq. Repealed.

-MISC1-
    Sec. 360qq. Repealed. Pub. L. 105-362, title VI, Sec. 601(a)(2)(A),
      Nov. 10, 1998, 112 Stat. 3285.
      Section, act June 25, 1938, ch. 675, Sec. 540, formerly act July
    1, 1944, ch. 373, title III, Sec. 540, formerly Sec. 360D, as added
    Pub. L. 90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1185; renumbered
    Sec. 540 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779, related to annual report on
    administration of electronic product radiation control program.

-End-



-CITE-
    21 USC Sec. 360rr                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360rr. Federal-State cooperation

-STATUTE-
      The Secretary is authorized (1) to accept from State and local
    authorities engaged in activities related to health or safety or
    consumer protection, on a reimbursable basis or otherwise, any
    assistance in the administration and enforcement of this part which
    he may request and which they may be able and willing to provide
    and, if so agreed, may pay in advance or otherwise for the
    reasonable cost of such assistance, and (2) he may, for the purpose
    of conducting examinations, investigations, and inspections,
    commission any officer or employee of any such authority as an
    officer of the Department.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 541, formerly act July 1, 1944, ch.
    373, title III, Sec. 541, formerly Sec. 360E, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec. 541
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov. 28,
    1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13,
    1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263m of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263m of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this part"
    for "this subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360ss                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360ss. State standards

-STATUTE-
      Whenever any standard prescribed pursuant to section 360kk of
    this title with respect to an aspect of performance of an
    electronic product is in effect, no State or political subdivision
    of a State shall have any authority either to establish, or to
    continue in effect, any standard which is applicable to the same
    aspect of performance of such product and which is not identical to
    the Federal standard. Nothing in this part shall be construed to
    prevent the Federal Government or the government of any State or
    political subdivision thereof from establishing a requirement with
    respect to emission of radiation from electronic products procured
    for its own use if such requirement imposes a more restrictive
    standard than that required to comply with the otherwise applicable
    Federal standard.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 542, formerly act July 1, 1944, ch.
    373, title III, Sec. 542, formerly Sec. 360F, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec. 542
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263n of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263n of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), substituted
    "section 360kk" for "section 263f" and "this part" for "this
    subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-


-CITE-
    21 USC Part D - Dissemination of Treatment Information      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
              PART D - DISSEMINATION OF TREATMENT INFORMATION          


-STATAMEND-
                            TERMINATION OF PART                        
      For termination of part by section 401(e) of Pub. L. 105-115, see
    Effective and Termination Dates note set out under section 360aaa
    of this title.

-End-



-CITE-
    21 USC Sec. 360aaa                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa. Requirements for dissemination of treatment
      information on drugs or devices

-STATUTE-
    (a) In general
      Notwithstanding sections 331(d), 352(f), and 355 of this title,
    and section 262 of title 42, a manufacturer may disseminate to - 
        (1) a health care practitioner;
        (2) a pharmacy benefit manager;
        (3) a health insurance issuer;
        (4) a group health plan; or
        (5) a Federal or State governmental agency;

    written information concerning the safety, effectiveness, or
    benefit of a use not described in the approved labeling of a drug
    or device if the manufacturer meets the requirements of subsection
    (b) of this section.
    (b) Specific requirements
      A manufacturer may disseminate information under subsection (a)
    of this section on a new use only if - 
        (1)(A) in the case of a drug, there is in effect for the drug
      an application filed under subsection (b) or (j) of section 355
      of this title or a biologics license issued under section 262 of
      title 42; or
        (B) in the case of a device, the device is being commercially
      distributed in accordance with a regulation under subsection (d)
      or (e) of section 360c of this title, an order under subsection
      (f) of such section, or the approval of an application under
      section 360e of this title;
        (2) the information meets the requirements of section 360aaa-1
      of this title;
        (3) the information to be disseminated is not derived from
      clinical research conducted by another manufacturer or if it was
      derived from research conducted by another manufacturer, the
      manufacturer disseminating the information has the permission of
      such other manufacturer to make the dissemination;
        (4) the manufacturer has, 60 days before such dissemination,
      submitted to the Secretary - 
          (A) a copy of the information to be disseminated; and
          (B) any clinical trial information the manufacturer has
        relating to the safety or effectiveness of the new use, any
        reports of clinical experience pertinent to the safety of the
        new use, and a summary of such information;

        (5) the manufacturer has complied with the requirements of
      section 360aaa-3 of this title (relating to a supplemental
      application for such use);
        (6) the manufacturer includes along with the information to be
      disseminated under this subsection - 
          (A) a prominently displayed statement that discloses - 
            (i) that the information concerns a use of a drug or device
          that has not been approved or cleared by the Food and Drug
          Administration;
            (ii) if applicable, that the information is being
          disseminated at the expense of the manufacturer;
            (iii) if applicable, the name of any authors of the
          information who are employees of, consultants to, or have
          received compensation from, the manufacturer, or who have a
          significant financial interest in the manufacturer;
            (iv) the official labeling for the drug or device and all
          updates with respect to the labeling;
            (v) if applicable, a statement that there are products or
          treatments that have been approved or cleared for the use
          that is the subject of the information being disseminated
          pursuant to subsection (a)(1) of this section; and
            (vi) the identification of any person that has provided
          funding for the conduct of a study relating to the new use of
          a drug or device for which such information is being
          disseminated; and

          (B) a bibliography of other articles from a scientific
        reference publication or scientific or medical journal that
        have been previously published about the use of the drug or
        device covered by the information disseminated (unless the
        information already includes such bibliography).
    (c) Additional information
      If the Secretary determines, after providing notice of such
    determination and an opportunity for a meeting with respect to such
    determination, that the information submitted by a manufacturer
    under subsection (b)(3)(B) of this section, with respect to the use
    of a drug or device for which the manufacturer intends to
    disseminate information, fails to provide data, analyses, or other
    written matter that is objective and balanced, the Secretary may
    require the manufacturer to disseminate - 
        (1) additional objective and scientifically sound information
      that pertains to the safety or effectiveness of the use and is
      necessary to provide objectivity and balance, including any
      information that the manufacturer has submitted to the Secretary
      or, where appropriate, a summary of such information or any other
      information that the Secretary has authority to make available to
      the public; and
        (2) an objective statement of the Secretary, based on data or
      other scientifically sound information available to the
      Secretary, that bears on the safety or effectiveness of the new
      use of the drug or device.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 551, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2356.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note below.


-MISC1-
                      EFFECTIVE AND TERMINATION DATES                  
      Section 401(d) of Pub. L. 105-115 provided that: "The amendments
    made by this section [enacting this part and amending section 331
    of this title] shall take effect 1 year after the date of enactment
    of this Act [Nov. 21, 1997], or upon the Secretary's issuance of
    final regulations pursuant to subsection (c) [section 401(c) of
    Pub. L. 105-115 set out below], whichever is sooner."
      Section 401(e) of Pub. L. 105-115 provided that: "The amendments
    made by this section [enacting this part and amending section 331
    of this title] cease to be effective September 30, 2006, or 7 years
    after the date on which the Secretary promulgates the regulations
    described in subsection (c) [section 401(c) of Pub. L. 105-115 set
    out below], whichever is later."

                                REGULATIONS                            
      Section 401(c) of Pub. L. 105-115 provided that: "Not later than
    1 year after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services shall promulgate regulations
    to implement the amendments made by this section [enacting this
    part and amending section 331 of this title]."

                            STUDIES AND REPORTS                        
      Pub. L. 105-115, title IV, Sec. 401(f), Nov. 21, 1997, 111 Stat.
    2364, provided that:
      "(1) General accounting office [now Government Accountability
    Office]. - 
        "(A) In general. - The Comptroller General of the United States
      shall conduct a study to determine the impact of subchapter D of
      chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
      360aaa et seq.], as added by this section, on the resources of
      the Department of Health and Human Services.
        "(B) Report. - Not later than January 1, 2002, the Comptroller
      General of the United States shall prepare and submit to the
      Committee on Labor and Human Resources [now Committee on Health,
      Education, Labor, and Pensions] of the Senate and the Committee
      on Commerce [now Committee on Energy and Commerce] of the House
      of Representatives a report of the results of the study.
      "(2) Department of health and human services. - 
        "(A) In general. - In order to assist Congress in determining
      whether the provisions of such subchapter should be extended
      beyond the termination date specified in subsection (e) [section
      401(e) of Pub. L. 105-115, set out above], the Secretary of
      Health and Human Services shall, in accordance with subparagraph
      (B), arrange for the conduct of a study of the scientific issues
      raised as a result of the enactment of such subchapter including
      issues relating to - 
          "(i) the effectiveness of such subchapter with respect to the
        provision of useful scientific information to health care
        practitioners;
          "(ii) the quality of the information being disseminated
        pursuant to the provisions of such subchapter;
          "(iii) the quality and usefulness of the information
        provided, in accordance with such subchapter, by the Secretary
        or by the manufacturer at the request of the Secretary; and
          "(iv) the impact of such subchapter on research in the area
        of new uses, indications, or dosages, particularly the impact
        on pediatric indications and rare diseases.
      "(3) Procedure for study. - 
        "(A) In general. - The Secretary shall request the Institute of
      Medicine of the National Academy of Sciences to conduct the study
      required by paragraph (2), and to prepare and submit the report
      required by subparagraph (B), under an arrangement by which the
      actual expenses incurred by the Institute of Medicine in
      conducting the study and preparing the report will be paid by the
      Secretary. If the Institute of Medicine is unwilling to conduct
      the study under such an arrangement, the Comptroller General of
      the United States shall conduct such study.
        "(B) Report. - Not later than September 30, 2005, the Institute
      of Medicine or the Comptroller General of the United States, as
      appropriate, shall prepare and submit to the Committee on Labor
      and Human Resources [now Committee on Health, Education, Labor,
      and Pensions] of the Senate, the Committee on Commerce [now
      Committee on Energy and Commerce] of the House of
      Representatives, and the Secretary a report of the results of the
      study required by paragraph (2). The Secretary, after the receipt
      of the report, shall make the report available to the public."

-End-



-CITE-
    21 USC Sec. 360aaa-1                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-1. Information authorized to be disseminated

-STATUTE-
    (a) Authorized information
      A manufacturer may disseminate information under section 360aaa
    of this title on a new use only if the information - 
        (1) is in the form of an unabridged - 
          (A) reprint or copy of an article, peer-reviewed by experts
        qualified by scientific training or experience to evaluate the
        safety or effectiveness of the drug or device involved, which
        was published in a scientific or medical journal (as defined in
        section 360aaa-5(5) of this title), which is about a clinical
        investigation with respect to the drug or device, and which
        would be considered to be scientifically sound by such experts;
        or
          (B) reference publication, described in subsection (b) of
        this section, that includes information about a clinical
        investigation with respect to the drug or device that would be
        considered to be scientifically sound by experts qualified by
        scientific training or experience to evaluate the safety or
        effectiveness of the drug or device that is the subject of such
        a clinical investigation; and

        (2) is not false or misleading and would not pose a significant
      risk to the public health.
    (b) Reference publication
      A reference publication referred to in subsection (a)(1)(B) of
    this section is a publication that - 
        (1) has not been written, edited, excerpted, or published
      specifically for, or at the request of, a manufacturer of a drug
      or device;
        (2) has not been edited or significantly influenced by such a
      manufacturer;
        (3) is not solely distributed through such a manufacturer but
      is generally available in bookstores or other distribution
      channels where medical textbooks are sold;
        (4) does not focus on any particular drug or device of a
      manufacturer that disseminates information under section 360aaa
      of this title and does not have a primary focus on new uses of
      drugs or devices that are marketed or under investigation by a
      manufacturer supporting the dissemination of information; and
        (5) presents materials that are not false or misleading.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 552, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2358.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-2                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-2. Establishment of list of articles and publications
      disseminated and list of providers that received articles and
      reference publications

-STATUTE-
    (a) In general
      A manufacturer may disseminate information under section 360aaa
    of this title on a new use only if the manufacturer prepares and
    submits to the Secretary biannually - 
        (1) a list containing the titles of the articles and reference
      publications relating to the new use of drugs or devices that
      were disseminated by the manufacturer to a person described in
      section 360aaa(a) of this title for the 6-month period preceding
      the date on which the manufacturer submits the list to the
      Secretary; and
        (2) a list that identifies the categories of providers (as
      described in section 360aaa(a) of this title) that received the
      articles and reference publications for the 6-month period
      described in paragraph (1).
    (b) Records
      A manufacturer that disseminates information under section 360aaa
    of this title shall keep records that may be used by the
    manufacturer when, pursuant to section 360aaa-4 of this title, such
    manufacturer is required to take corrective action and shall be
    made available to the Secretary, upon request, for purposes of
    ensuring or taking corrective action pursuant to such section. Such
    records, at the Secretary's discretion, may identify the recipient
    of information provided pursuant to section 360aaa of this title or
    the categories of such recipients.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 553, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-3                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-3. Requirement regarding submission of supplemental
      application for new use; exemption from requirement

-STATUTE-
    (a) In general
      A manufacturer may disseminate information under section 360aaa
    of this title on a new use only if - 
        (1)(A) the manufacturer has submitted to the Secretary a
      supplemental application for such use; or
        (B) the manufacturer meets the condition described in
      subsection (b) or (c) of this section (relating to a
      certification that the manufacturer will submit such an
      application); or
        (2) there is in effect for the manufacturer an exemption under
      subsection (d) of this section from the requirement of paragraph
      (1).
    (b) Certification on supplemental application; condition in case of
      completed studies
      For purposes of subsection (a)(1)(B) of this section, a
    manufacturer may disseminate information on a new use if the
    manufacturer has submitted to the Secretary an application
    containing a certification that - 
        (1) the studies needed for the submission of a supplemental
      application for the new use have been completed; and
        (2) the supplemental application will be submitted to the
      Secretary not later than 6 months after the date of the initial
      dissemination of information under section 360aaa of this title.
    (c) Certification on supplemental application; condition in case of
      planned studies
      (1) In general
        For purposes of subsection (a)(1)(B) of this section, a
      manufacturer may disseminate information on a new use if - 
          (A) the manufacturer has submitted to the Secretary an
        application containing - 
            (i) a proposed protocol and schedule for conducting the
          studies needed for the submission of a supplemental
          application for the new use; and
            (ii) a certification that the supplemental application will
          be submitted to the Secretary not later than 36 months after
          the date of the initial dissemination of information under
          section 360aaa of this title (or, as applicable, not later
          than such date as the Secretary may specify pursuant to an
          extension under paragraph (3)); and

          (B) the Secretary has determined that the proposed protocol
        is adequate and that the schedule for completing such studies
        is reasonable.
      (2) Progress reports on studies
        A manufacturer that submits to the Secretary an application
      under paragraph (1) shall submit to the Secretary periodic
      reports describing the status of the studies involved.
      (3) Extension of time regarding planned studies
        The period of 36 months authorized in paragraph (1)(A)(ii) for
      the completion of studies may be extended by the Secretary if - 
          (A) the Secretary determines that the studies needed to
        submit such an application cannot be completed and submitted
        within 36 months; or
          (B) the manufacturer involved submits to the Secretary a
        written request for the extension and the Secretary determines
        that the manufacturer has acted with due diligence to conduct
        the studies in a timely manner, except that an extension under
        this subparagraph may not be provided for more than 24
        additional months.
    (d) Exemption from requirement of supplemental application
      (1) In general
        For purposes of subsection (a)(2) of this section, a
      manufacturer may disseminate information on a new use if - 
          (A) the manufacturer has submitted to the Secretary an
        application for an exemption from meeting the requirement of
        subsection (a)(1) of this section; and
          (B)(i) the Secretary has approved the application in
        accordance with paragraph (2); or
          (ii) the application is deemed under paragraph (3)(A) to have
        been approved (unless such approval is terminated pursuant to
        paragraph (3)(B)).
      (2) Conditions for approval
        The Secretary may approve an application under paragraph (1)
      for an exemption if the Secretary makes a determination described
      in subparagraph (A) or (B), as follows:
          (A) The Secretary makes a determination that, for reasons
        defined by the Secretary, it would be economically prohibitive
        with respect to such drug or device for the manufacturer to
        incur the costs necessary for the submission of a supplemental
        application. In making such determination, the Secretary shall
        consider (in addition to any other considerations the Secretary
        finds appropriate) - 
            (i) the lack of the availability under law of any period
          during which the manufacturer would have exclusive marketing
          rights with respect to the new use involved; and
            (ii) the size of the population expected to benefit from
          approval of the supplemental application.

          (B) The Secretary makes a determination that, for reasons
        defined by the Secretary, it would be unethical to conduct the
        studies necessary for the supplemental application. In making
        such determination, the Secretary shall consider (in addition
        to any other considerations the Secretary finds appropriate)
        whether the new use involved is the standard of medical care
        for a health condition.
      (3) Time for consideration of application; deemed approval
        (A) In general
          The Secretary shall approve or deny an application under
        paragraph (1) for an exemption not later than 60 days after the
        receipt of the application. If the Secretary does not comply
        with the preceding sentence, the application is deemed to be
        approved.
        (B) Termination of deemed approval
          If pursuant to a deemed approval under subparagraph (A) a
        manufacturer disseminates written information under section
        360aaa of this title on a new use, the Secretary may at any
        time terminate such approval and under section 360aaa-4(b)(3)
        of this title order the manufacturer to cease disseminating the
        information.
    (e) Requirements regarding applications
      Applications under this section shall be submitted in the form
    and manner prescribed by the Secretary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 554, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-4                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-4. Corrective actions; cessation of dissemination

-STATUTE-
    (a) Postdissemination data regarding safety and effectiveness
      (1) Corrective actions
        With respect to data received by the Secretary after the
      dissemination of information under section 360aaa of this title
      by a manufacturer has begun (whether received pursuant to
      paragraph (2) or otherwise), if the Secretary determines that the
      data indicate that the new use involved may not be effective or
      may present a significant risk to public health, the Secretary
      shall, after consultation with the manufacturer, take such action
      regarding the dissemination of the information as the Secretary
      determines to be appropriate for the protection of the public
      health, which may include ordering that the manufacturer cease
      the dissemination of the information.
      (2) Responsibilities of manufacturers to submit data
        After a manufacturer disseminates information under section
      360aaa of this title, the manufacturer shall submit to the
      Secretary a notification of any additional knowledge of the
      manufacturer on clinical research or other data that relate to
      the safety or effectiveness of the new use involved. If the
      manufacturer is in possession of the data, the notification shall
      include the data. The Secretary shall by regulation establish the
      scope of the responsibilities of manufacturers under this
      paragraph, including such limits on the responsibilities as the
      Secretary determines to be appropriate.
    (b) Cessation of dissemination
      (1) Failure of manufacturer to comply with requirements
        The Secretary may order a manufacturer to cease the
      dissemination of information pursuant to section 360aaa of this
      title if the Secretary determines that the information being
      disseminated does not comply with the requirements established in
      this part. Such an order may be issued only after the Secretary
      has provided notice to the manufacturer of the intent of the
      Secretary to issue the order and (unless paragraph (2)(B)
      applies) has provided an opportunity for a meeting with respect
      to such intent. If the failure of the manufacturer constitutes a
      minor violation of this part, the Secretary shall delay issuing
      the order and provide to the manufacturer an opportunity to
      correct the violation.
      (2) Supplemental applications
        The Secretary may order a manufacturer to cease the
      dissemination of information pursuant to section 360aaa of this
      title if - 
          (A) in the case of a manufacturer that has submitted a
        supplemental application for a new use pursuant to section
        360aaa-3(a)(1) of this title, the Secretary determines that the
        supplemental application does not contain adequate information
        for approval of the new use for which the application was
        submitted;
          (B) in the case of a manufacturer that has submitted a
        certification under section 360aaa-3(b) of this title, the
        manufacturer has not, within the 6-month period involved,
        submitted the supplemental application referred to in the
        certification; or
          (C) in the case of a manufacturer that has submitted a
        certification under section 360aaa-3(c) of this title but has
        not yet submitted the supplemental application referred to in
        the certification, the Secretary determines, after an informal
        hearing, that the manufacturer is not acting with due diligence
        to complete the studies involved.
      (3) Termination of deemed approval of exemption regarding
        supplemental applications
        If under section 360aaa-3(d)(3) of this title the Secretary
      terminates a deemed approval of an exemption, the Secretary may
      order the manufacturer involved to cease disseminating the
      information. A manufacturer shall comply with an order under the
      preceding sentence not later than 60 days after the receipt of
      the order.
    (c) Corrective actions by manufacturers
      (1) In general
        In any case in which under this section the Secretary orders a
      manufacturer to cease disseminating information, the Secretary
      may order the manufacturer to take action to correct the
      information that has been disseminated, except as provided in
      paragraph (2).
      (2) Termination of deemed approval of exemption regarding
        supplemental applications
        In the case of an order under subsection (b)(3) of this section
      to cease disseminating information, the Secretary may not order
      the manufacturer involved to take action to correct the
      information that has been disseminated unless the Secretary
      determines that the new use described in the information would
      pose a significant risk to the public health.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 555, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2361.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-5                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-5. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "health care practitioner" means a physician, or
      other individual who is a provider of health care, who is
      licensed under the law of a State to prescribe drugs or devices.
        (2) The terms "health insurance issuer" and "group health plan"
      have the meaning given such terms under section 300gg-91 of title
      42.
        (3) The term "manufacturer" means a person who manufactures a
      drug or device, or who is licensed by such person to distribute
      or market the drug or device.
        (4) The term "new use" - 
          (A) with respect to a drug, means a use that is not included
        in the labeling of the approved drug; and
          (B) with respect to a device, means a use that is not
        included in the labeling for the approved or cleared device.

        (5) The term "scientific or medical journal" means a scientific
      or medical publication - 
          (A) that is published by an organization - 
            (i) that has an editorial board;
            (ii) that utilizes experts, who have demonstrated expertise
          in the subject of an article under review by the organization
          and who are independent of the organization, to review and
          objectively select, reject, or provide comments about
          proposed articles; and
            (iii) that has a publicly stated policy, to which the
          organization adheres, of full disclosure of any conflict of
          interest or biases for all authors or contributors involved
          with the journal or organization;

          (B) whose articles are peer-reviewed and published in
        accordance with the regular peer-review procedures of the
        organization;
          (C) that is generally recognized to be of national scope and
        reputation;
          (D) that is indexed in the Index Medicus of the National
        Library of Medicine of the National Institutes of Health; and
          (E) that is not in the form of a special supplement that has
        been funded in whole or in part by one or more manufacturers.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 556, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2362.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-6                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-6. Rules of construction

-STATUTE-
    (a) Unsolicited request
      Nothing in section 360aaa of this title shall be construed as
    prohibiting a manufacturer from disseminating information in
    response to an unsolicited request from a health care practitioner.
    (b) Dissemination of information on drugs or devices not evidence
      of intended use
      Notwithstanding subsection (a), (f), or (o) of section 352 of
    this title, or any other provision of law, the dissemination of
    information relating to a new use of a drug or device, in
    accordance with section 360aaa of this title, shall not be
    construed by the Secretary as evidence of a new intended use of the
    drug or device that is different from the intended use of the drug
    or device set forth in the official labeling of the drug or device.
    Such dissemination shall not be considered by the Secretary as
    labeling, adulteration, or misbranding of the drug or device.
    (c) Patent protection
      Nothing in section 360aaa of this title shall affect patent
    rights in any manner.
    (d) Authorization for dissemination of articles and fees for
      reprints of articles
      Nothing in section 360aaa of this title shall be construed as
    prohibiting an entity that publishes a scientific journal (as
    defined in section 360aaa-5(5) of this title) from requiring
    authorization from the entity to disseminate an article published
    by such entity or charging fees for the purchase of reprints of
    published articles from such entity.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 557, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2363.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-


-CITE-
    21 USC Part E - General Provisions Relating to Drugs and
                     Devices                               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
         PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES     

-End-



-CITE-
    21 USC Sec. 360bbb                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb. Expanded access to unapproved therapies and
      diagnostics

-STATUTE-
    (a) Emergency situations
      The Secretary may, under appropriate conditions determined by the
    Secretary, authorize the shipment of investigational drugs or
    investigational devices for the diagnosis, monitoring, or treatment
    of a serious disease or condition in emergency situations.
    (b) Individual patient access to investigational products intended
      for serious diseases
      Any person, acting through a physician licensed in accordance
    with State law, may request from a manufacturer or distributor, and
    any manufacturer or distributor may, after complying with the
    provisions of this subsection, provide to such physician an
    investigational drug or investigational device for the diagnosis,
    monitoring, or treatment of a serious disease or condition if - 
        (1) the licensed physician determines that the person has no
      comparable or satisfactory alternative therapy available to
      diagnose, monitor, or treat the disease or condition involved,
      and that the probable risk to the person from the investigational
      drug or investigational device is not greater than the probable
      risk from the disease or condition;
        (2) the Secretary determines that there is sufficient evidence
      of safety and effectiveness to support the use of the
      investigational drug or investigational device in the case
      described in paragraph (1);
        (3) the Secretary determines that provision of the
      investigational drug or investigational device will not interfere
      with the initiation, conduct, or completion of clinical
      investigations to support marketing approval; and
        (4) the sponsor, or clinical investigator, of the
      investigational drug or investigational device submits to the
      Secretary a clinical protocol consistent with the provisions of
      section 355(i) or 360j(g) of this title, including any
      regulations promulgated under section 355(i) or 360j(g) of this
      title, describing the use of the investigational drug or
      investigational device in a single patient or a small group of
      patients.
    (c) Treatment investigational new drug applications and treatment
      investigational device exemptions
      Upon submission by a sponsor or a physician of a protocol
    intended to provide widespread access to an investigational drug or
    investigational device for eligible patients (referred to in this
    subsection as an "expanded access protocol"), the Secretary shall
    permit such investigational drug or investigational device to be
    made available for expanded access under a treatment
    investigational new drug application or treatment investigational
    device exemption if the Secretary determines that - 
        (1) under the treatment investigational new drug application or
      treatment investigational device exemption, the investigational
      drug or investigational device is intended for use in the
      diagnosis, monitoring, or treatment of a serious or immediately
      life-threatening disease or condition;
        (2) there is no comparable or satisfactory alternative therapy
      available to diagnose, monitor, or treat that stage of disease or
      condition in the population of patients to which the
      investigational drug or investigational device is intended to be
      administered;
        (3)(A) the investigational drug or investigational device is
      under investigation in a controlled clinical trial for the use
      described in paragraph (1) under an investigational drug
      application in effect under section 355(i) of this title or
      investigational device exemption in effect under section 360j(g)
      of this title; or
        (B) all clinical trials necessary for approval of that use of
      the investigational drug or investigational device have been
      completed;
        (4) the sponsor of the controlled clinical trials is actively
      pursuing marketing approval of the investigational drug or
      investigational device for the use described in paragraph (1)
      with due diligence;
        (5) in the case of an investigational drug or investigational
      device described in paragraph (3)(A), the provision of the
      investigational drug or investigational device will not interfere
      with the enrollment of patients in ongoing clinical
      investigations under section 355(i) or 360j(g) of this title;
        (6) in the case of serious diseases, there is sufficient
      evidence of safety and effectiveness to support the use described
      in paragraph (1); and
        (7) in the case of immediately life-threatening diseases, the
      available scientific evidence, taken as a whole, provides a
      reasonable basis to conclude that the investigational drug or
      investigational device may be effective for its intended use and
      would not expose patients to an unreasonable and significant risk
      of illness or injury.

    A protocol submitted under this subsection shall be subject to the
    provisions of section 355(i) or 360j(g) of this title, including
    regulations promulgated under section 355(i) or 360j(g) of this
    title. The Secretary may inform national, State, and local medical
    associations and societies, voluntary health associations, and
    other appropriate persons about the availability of an
    investigational drug or investigational device under expanded
    access protocols submitted under this subsection. The information
    provided by the Secretary, in accordance with the preceding
    sentence, shall be the same type of information that is required by
    section 282(i)(3) of title 42.
    (d) Termination
      The Secretary may, at any time, with respect to a sponsor,
    physician, manufacturer, or distributor described in this section,
    terminate expanded access provided under this section for an
    investigational drug or investigational device if the requirements
    under this section are no longer met.
    (e) Definitions
      In this section, the terms "investigational drug",
    "investigational device", "treatment investigational new drug
    application", and "treatment investigational device exemption"
    shall have the meanings given the terms in regulations prescribed
    by the Secretary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 561, as added Pub. L. 105-115, title
    IV, Sec. 402, Nov. 21, 1997, 111 Stat. 2365; amended Pub. L. 109-
    482, title I, Sec. 102(f)(2), Jan. 15, 2007, 120 Stat. 3685.)


-MISC1-
                                AMENDMENTS                            
      2007 - Subsec. (c). Pub. L. 109-482 substituted "section
    282(i)(3)" for "section 282(j)(3)" in concluding provisions.

                     EFFECTIVE DATE OF 2007 AMENDMENT                 
      Amendment by Pub. L. 109-482 applicable only with respect to
    amounts appropriated for fiscal year 2007 or subsequent fiscal
    years, see section 109 of Pub. L. 109-482, set out as a note under
    section 281 of Title 42, The Public Health and Welfare.

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 360bbb-1                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-1. Dispute resolution

-STATUTE-
      If, regarding an obligation concerning drugs or devices under
    this Act or section 351 of the Public Health Service Act [42 U.S.C.
    262], there is a scientific controversy between the Secretary and a
    person who is a sponsor, applicant, or manufacturer and no specific
    provision of the Act involved, including a regulation promulgated
    under such Act, provides a right of review of the matter in
    controversy, the Secretary shall, by regulation, establish a
    procedure under which such sponsor, applicant, or manufacturer may
    request a review of such controversy, including a review by an
    appropriate scientific advisory panel described in section 355(n)
    of this title or an advisory committee described in section
    360e(g)(2)(B) of this title. Any such review shall take place in a
    timely manner. The Secretary shall promulgate such regulations
    within 1 year after November 21, 1997.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 562, as added Pub. L. 105-115, title
    IV, Sec. 404, Nov. 21, 1997, 111 Stat. 2368.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This Act, referred to in text, is the Federal Food, Drug, and
    Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to this chapter. For
    complete classification of this Act to the Code, see section 301 of
    this title and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 360bbb-2                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-2. Classification of products

-STATUTE-
    (a) Request
      A person who submits an application or submission (including a
    petition, notification, and any other similar form of request)
    under this chapter for a product, may submit a request to the
    Secretary respecting the classification of the product as a drug,
    biological product, device, or a combination product subject to
    section 353(g) of this title or respecting the component of the
    Food and Drug Administration that will regulate the product. In
    submitting the request, the person shall recommend a classification
    for the product, or a component to regulate the product, as
    appropriate.
    (b) Statement
      Not later than 60 days after the receipt of the request described
    in subsection (a) of this section, the Secretary shall determine
    the classification of the product under subsection (a) of this
    section, or the component of the Food and Drug Administration that
    will regulate the product, and shall provide to the person a
    written statement that identifies such classification or such
    component, and the reasons for such determination. The Secretary
    may not modify such statement except with the written consent of
    the person, or for public health reasons based on scientific
    evidence.
    (c) Inaction of Secretary
      If the Secretary does not provide the statement within the 60-day
    period described in subsection (b) of this section, the
    recommendation made by the person under subsection (a) of this
    section shall be considered to be a final determination by the
    Secretary of such classification of the product, or the component
    of the Food and Drug Administration that will regulate the product,
    as applicable, and may not be modified by the Secretary except with
    the written consent of the person, or for public health reasons
    based on scientific evidence.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 563, as added Pub. L. 105-115, title
    IV, Sec. 416, Nov. 21, 1997, 111 Stat. 2378.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 360bbb-3                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-3. Authorization for medical products for use in
      emergencies

-STATUTE-
    (a) In general
      (1) Emergency uses
        Notwithstanding sections 355, 360(k), and 360e of this title
      and section 262 of title 42, and subject to the provisions of
      this section, the Secretary may authorize the introduction into
      interstate commerce, during the effective period of a declaration
      under subsection (b) of this section, of a drug, device, or
      biological product intended for use in an actual or potential
      emergency (referred to in this section as an "emergency use").
      (2) Approval status of product
        An authorization under paragraph (1) may authorize an emergency
      use of a product that - 
          (A) is not approved, licensed, or cleared for commercial
        distribution under a provision of law referred to in such
        paragraph (referred to in this section as an "unapproved
        product"); or
          (B) is approved, licensed, or cleared under such a provision,
        but which use is not under such provision an approved,
        licensed, or cleared use of the product (referred to in this
        section as an "unapproved use of an approved product").
      (3) Relation to other uses
        An emergency use authorized under paragraph (1) for a product
      is in addition to any other use that is authorized for the
      product under a provision of law referred to in such paragraph.
      (4) Definitions
        For purposes of this section:
          (A) The term "biological product" has the meaning given such
        term in section 262 of title 42.
          (B) The term "emergency use" has the meaning indicated for
        such term in paragraph (1).
          (C) The term "product" means a drug, device, or biological
        product.
          (D) The term "unapproved product" has the meaning indicated
        for such term in paragraph (2)(A).
          (E) The term "unapproved use of an approved product" has the
        meaning indicated for such term in paragraph (2)(B).
    (b) Declaration of emergency
      (1) In general
        The Secretary may declare an emergency justifying the
      authorization under this subsection for a product on the basis of
      - 
          (A) a determination by the Secretary of Homeland Security
        that there is a domestic emergency, or a significant potential
        for a domestic emergency, involving a heightened risk of attack
        with a specified biological, chemical, radiological, or nuclear
        agent or agents;
          (B) a determination by the Secretary of Defense that there is
        a military emergency, or a significant potential for a military
        emergency, involving a heightened risk to United States
        military forces of attack with a specified biological,
        chemical, radiological, or nuclear agent or agents; or
          (C) a determination by the Secretary of a public health
        emergency under section 247d of title 42 that affects, or has a
        significant potential to affect, national security, and that
        involves a specified biological, chemical, radiological, or
        nuclear agent or agents, or a specified disease or condition
        that may be attributable to such agent or agents.
      (2) Termination of declaration
        (A) In general
          A declaration under this subsection shall terminate upon the
        earlier of - 
            (i) a determination by the Secretary, in consultation as
          appropriate with the Secretary of Homeland Security or the
          Secretary of Defense, that the circumstances described in
          paragraph (1) have ceased to exist; or
            (ii) the expiration of the one-year period beginning on the
          date on which the declaration is made.
        (B) Renewal
          Notwithstanding subparagraph (A), the Secretary may renew a
        declaration under this subsection, and this paragraph shall
        apply to any such renewal.
        (C) Disposition of product
          If an authorization under this section with respect to an
        unapproved product ceases to be effective as a result of a
        termination under subparagraph (A) of this paragraph, the
        Secretary shall consult with the manufacturer of such product
        with respect to the appropriate disposition of the product.
      (3) Advance notice of termination
        The Secretary shall provide advance notice that a declaration
      under this subsection will be terminated. The period of advance
      notice shall be a period reasonably determined to provide - 
          (A) in the case of an unapproved product, a sufficient period
        for disposition of the product, including the return of such
        product (except such quantities of product as are necessary to
        provide for continued use consistent with subsection (f)(2) of
        this section) to the manufacturer (in the case of a
        manufacturer that chooses to have such product returned); and
          (B) in the case of an unapproved use of an approved product,
        a sufficient period for the disposition of any labeling, or any
        information under subsection (e)(2)(B)(ii) of this section, as
        the case may be, that was provided with respect to the
        emergency use involved.
      (4) Publication
        The Secretary shall promptly publish in the Federal Register
      each declaration, determination, advance notice of termination,
      and renewal under this subsection.
    (c) Criteria for issuance of authorization
      The Secretary may issue an authorization under this section with
    respect to the emergency use of a product only if, after
    consultation with the Director of the National Institutes of Health
    and the Director of the Centers for Disease Control and Prevention
    (to the extent feasible and appropriate given the circumstances of
    the emergency involved), the Secretary concludes - 
        (1) that an agent specified in a declaration under subsection
      (b) of this section can cause a serious or life-threatening
      disease or condition;
        (2) that, based on the totality of scientific evidence
      available to the Secretary, including data from adequate and well-
      controlled clinical trials, if available, it is reasonable to
      believe that - 
          (A) the product may be effective in diagnosing, treating, or
        preventing - 
            (i) such disease or condition; or
            (ii) a serious or life-threatening disease or condition
          caused by a product authorized under this section, approved
          or cleared under this chapter, or licensed under section 262
          of title 42, for diagnosing, treating, or preventing such a
          disease or condition caused by such an agent; and

          (B) the known and potential benefits of the product, when
        used to diagnose, prevent, or treat such disease or condition,
        outweigh the known and potential risks of the product;

        (3) that there is no adequate, approved, and available
      alternative to the product for diagnosing, preventing, or
      treating such disease or condition; and
        (4) that such other criteria as the Secretary may by regulation
      prescribe are satisfied.
    (d) Scope of authorization
      An authorization of a product under this section shall state - 
        (1) each disease or condition that the product may be used to
      diagnose, prevent, or treat within the scope of the
      authorization;
        (2) the Secretary's conclusions, made under subsection
      (c)(2)(B) of this section, that the known and potential benefits
      of the product, when used to diagnose, prevent, or treat such
      disease or condition, outweigh the known and potential risks of
      the product; and
        (3) the Secretary's conclusions, made under subsection (c) of
      this section, concerning the safety and potential effectiveness
      of the product in diagnosing, preventing, or treating such
      diseases or conditions, including an assessment of the available
      scientific evidence.
    (e) Conditions of authorization
      (1) Unapproved product
        (A) Required conditions
          With respect to the emergency use of an unapproved product,
        the Secretary, to the extent practicable given the
        circumstances of the emergency, shall, for a person who carries
        out any activity for which the authorization is issued,
        establish such conditions on an authorization under this
        section as the Secretary finds necessary or appropriate to
        protect the public health, including the following:
            (i) Appropriate conditions designed to ensure that health
          care professionals administering the product are informed - 
              (I) that the Secretary has authorized the emergency use
            of the product;
              (II) of the significant known and potential benefits and
            risks of the emergency use of the product, and of the
            extent to which such benefits and risks are unknown; and
              (III) of the alternatives to the product that are
            available, and of their benefits and risks.

            (ii) Appropriate conditions designed to ensure that
          individuals to whom the product is administered are informed -
           
              (I) that the Secretary has authorized the emergency use
            of the product;
              (II) of the significant known and potential benefits and
            risks of such use, and of the extent to which such benefits
            and risks are unknown; and
              (III) of the option to accept or refuse administration of
            the product, of the consequences, if any, of refusing
            administration of the product, and of the alternatives to
            the product that are available and of their benefits and
            risks.

            (iii) Appropriate conditions for the monitoring and
          reporting of adverse events associated with the emergency use
          of the product.
            (iv) For manufacturers of the product, appropriate
          conditions concerning recordkeeping and reporting, including
          records access by the Secretary, with respect to the
          emergency use of the product.
        (B) Authority for additional conditions
          With respect to the emergency use of an unapproved product,
        the Secretary may, for a person who carries out any activity
        for which the authorization is issued, establish such
        conditions on an authorization under this section as the
        Secretary finds necessary or appropriate to protect the public
        health, including the following:
            (i) Appropriate conditions on which entities may distribute
          the product with respect to the emergency use of the product
          (including limitation to distribution by government
          entities), and on how distribution is to be performed.
            (ii) Appropriate conditions on who may administer the
          product with respect to the emergency use of the product, and
          on the categories of individuals to whom, and the
          circumstances under which, the product may be administered
          with respect to such use.
            (iii) Appropriate conditions with respect to the collection
          and analysis of information, during the period when the
          authorization is in effect, concerning the safety and
          effectiveness of the product with respect to the emergency
          use of such product.
            (iv) For persons other than manufacturers of the product,
          appropriate conditions concerning recordkeeping and
          reporting, including records access by the Secretary, with
          respect to the emergency use of the product.
      (2) Unapproved use
        With respect to the emergency use of a product that is an
      unapproved use of an approved product:
          (A) For a manufacturer of the product who carries out any
        activity for which the authorization is issued, the Secretary
        shall, to the extent practicable given the circumstances of the
        emergency, establish conditions described in clauses (i) and
        (ii) of paragraph (1)(A), and may establish conditions
        described in clauses (iii) and (iv) of such paragraph.
          (B)(i) If the authorization under this section regarding the
        emergency use authorizes a change in the labeling of the
        product, but the manufacturer of the product chooses not to
        make such change, such authorization may not authorize
        distributors of the product or any other person to alter or
        obscure the labeling provided by the manufacturer.
          (ii) In the circumstances described in clause (i), for a
        person who does not manufacture the product and who chooses to
        act under this clause, an authorization under this section
        regarding the emergency use shall, to the extent practicable
        given the circumstances of the emergency, authorize such person
        to provide appropriate information with respect to such product
        in addition to the labeling provided by the manufacturer,
        subject to compliance with clause (i). While the authorization
        under this section is effective, such additional information
        shall not be considered labeling for purposes of section 352 of
        this title.
          (C) The Secretary may establish with respect to the
        distribution and administration of the product for the
        unapproved use conditions no more restrictive than those
        established by the Secretary with respect to the distribution
        and administration of the product for the approved use.
      (3) Good manufacturing practice
        With respect to the emergency use of a product for which an
      authorization under this section is issued (whether an unapproved
      product or an unapproved use of an approved product), the
      Secretary may waive or limit, to the extent appropriate given the
      circumstances of the emergency, requirements regarding current
      good manufacturing practice otherwise applicable to the
      manufacture, processing, packing, or holding of products subject
      to regulation under this chapter, including such requirements
      established under section 351 of this title.
      (4) Advertising
        The Secretary may establish conditions on advertisements and
      other promotional descriptive printed matter that relate to the
      emergency use of a product for which an authorization under this
      section is issued (whether an unapproved product or an unapproved
      use of an approved product), including, as appropriate - 
          (A) with respect to drugs and biological products,
        requirements applicable to prescription drugs pursuant to
        section 352(n) of this title; or
          (B) with respect to devices, requirements applicable to
        restricted devices pursuant to section 352(r) of this title.
    (f) Duration of authorization
      (1) In general
        Except as provided in paragraph (2), an authorization under
      this section shall be effective until the earlier of the
      termination of the declaration under subsection (b) of this
      section or a revocation under subsection (g) of this section.
      (2) Continued use after end of effective period
        Notwithstanding the termination of the declaration under
      subsection (b) of this section or a revocation under subsection
      (g) of this section, an authorization shall continue to be
      effective to provide for continued use of an unapproved product
      with respect to a patient to whom it was administered during the
      period described by paragraph (1), to the extent found necessary
      by such patient's attending physician.
    (g) Revocation of authorization
      (1) Review
        The Secretary shall periodically review the circumstances and
      the appropriateness of an authorization under this section.
      (2) Revocation
        The Secretary may revoke an authorization under this section if
      the criteria under subsection (c) of this section for issuance of
      such authorization are no longer met or other circumstances make
      such revocation appropriate to protect the public health or
      safety.
    (h) Publication; confidential information
      (1) Publication
        The Secretary shall promptly publish in the Federal Register a
      notice of each authorization, and each termination or revocation
      of an authorization under this section, and an explanation of the
      reasons therefor (which may include a summary of data or
      information that has been submitted to the Secretary in an
      application under section 355(i) of this title or section 360j(g)
      of this title, even if such summary may indirectly reveal the
      existence of such application).
      (2) Confidential information
        Nothing in this section alters or amends section 1905 of title
      18 or section 552(b)(4) of title 5.
    (i) Actions committed to agency discretion
      Actions under the authority of this section by the Secretary, by
    the Secretary of Defense, or by the Secretary of Homeland Security
    are committed to agency discretion.
    (j) Rules of construction
      The following applies with respect to this section:
        (1) Nothing in this section impairs the authority of the
      President as Commander in Chief of the Armed Forces of the United
      States under article II, section 2 of the United States
      Constitution.
        (2) Nothing in this section impairs the authority of the
      Secretary of Defense with respect to the Department of Defense,
      including the armed forces, under other provisions of Federal
      law.
        (3) Nothing in this section (including any exercise of
      authority by a manufacturer under subsection (e)(2)) impairs the
      authority of the United States to use or manage quantities of a
      product that are owned or controlled by the United States
      (including quantities in the stockpile maintained under section
      247d-6b of title 42).
    (k) Relation to other provisions
      If a product is the subject of an authorization under this
    section, the use of such product within the scope of the
    authorization shall not be considered to constitute a clinical
    investigation for purposes of section 355(i) of this title, section
    360j(g) of this title, or any other provision of this chapter or
    section 262 of title 42.
    (l) Option to carry out authorized activities
      Nothing in this section provides the Secretary any authority to
    require any person to carry out any activity that becomes lawful
    pursuant to an authorization under this section, and no person is
    required to inform the Secretary that the person will not be
    carrying out such activity, except that a manufacturer of a sole-
    source unapproved product authorized for emergency use shall
    report to the Secretary within a reasonable period of time after
    the issuance by the Secretary of such authorization if such
    manufacturer does not intend to carry out any activity under the
    authorization. This section only has legal effect on a person who
    carries out an activity for which an authorization under this
    section is issued. This section does not modify or affect
    activities carried out pursuant to other provisions of this chapter
    or section 262 of title 42. Nothing in this subsection may be
    construed as restricting the Secretary from imposing conditions on
    persons who carry out any activity pursuant to an authorization
    under this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 564, as added Pub. L. 108-136, div.
    A, title XVI, Sec. 1603(a), Nov. 24, 2003, 117 Stat. 1684; amended
    Pub. L. 108-276, Sec. 4(a), July 21, 2004, 118 Stat. 853.)


-MISC1-
                                AMENDMENTS                            
      2004 - Pub. L. 108-276 amended section generally, substituting
    provisions of subsecs. (a) to (l) for similar former provisions,
    except for additional provisions in subsec. (b)(1) allowing
    Secretary to authorize use of medical products in actual or
    potential domestic and public health emergencies in addition to
    actual or potential military emergencies.

-End-



-CITE-
    21 USC Sec. 360bbb-4                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-4. Technical assistance

-STATUTE-
      The Secretary, in consultation with the Commissioner of Food and
    Drugs, shall establish within the Food and Drug Administration a
    team of experts on manufacturing and regulatory activities
    (including compliance with current Good Manufacturing Practice) to
    provide both off-site and on-site technical assistance to the
    manufacturers of qualified countermeasures (as defined in section
    247d-6a of title 42), security countermeasures (as defined in
    section 247d-6b of title 42), or vaccines, at the request of such a
    manufacturer and at the discretion of the Secretary, if the
    Secretary determines that a shortage or potential shortage may
    occur in the United States in the supply of such vaccines or
    countermeasures and that the provision of such assistance would be
    beneficial in helping alleviate or avert such shortage.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 565, as added Pub. L. 109-417, title
    IV, Sec. 404, Dec. 19, 2006, 120 Stat. 2875.)

-End-


-CITE-
    21 USC Part F - New Animal Drugs for Minor Use and Minor
                     Species                               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
         PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES     

-End-



-CITE-
    21 USC Sec. 360ccc                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
    Sec. 360ccc. Conditional approval of new animal drugs for minor use
      and minor species

-STATUTE-
    (a) Application requirements; contents; restrictions
      (1) Except as provided in paragraph (3) of this section,(!1) any
    person may file with the Secretary an application for conditional
    approval of a new animal drug intended for a minor use or a minor
    species. Such an application may not be a supplement to an
    application approved under section 360b of this title. Such
    application must comply in all respects with the provisions of
    section 360b of this title except sections 360b(a)(4), 360b(b)(2),
    360b(c)(1), 360b(c)(2), 360b(c)(3), 360b(d)(1), 360b(e), 360b(h),
    and 360b(n) of this title unless otherwise stated in this section,
    and any additional provisions of this section. New animal drugs are
    subject to application of the same safety standards that would be
    applied to such drugs under section 360b(d) of this title
    (including, for antimicrobial new animal drugs, with respect to
    antimicrobial resistance).

      (2) The applicant shall submit to the Secretary as part of an
    application for the conditional approval of a new animal drug - 
        (A) all information necessary to meet the requirements of
      section 360b(b)(1) of this title except section 360b(b)(1)(A) of
      this title;
        (B) full reports of investigations which have been made to show
      whether or not such drug is safe under section 360b(d) of this
      title (including, for an antimicrobial new animal drug, with
      respect to antimicrobial resistance) and there is a reasonable
      expectation of effectiveness for use;
        (C) data for establishing a conditional dose;
        (D) projections of expected need and the justification for that
      expectation based on the best information available;
        (E) information regarding the quantity of drug expected to be
      distributed on an annual basis to meet the expected need; and
        (F) a commitment that the applicant will conduct additional
      investigations to meet the requirements for the full
      demonstration of effectiveness under section 360b(d)(1)(E) of
      this title within 5 years.

      (3) A person may not file an application under paragraph (1) if -
    
        (A) the application seeks conditional approval of a new animal
      drug that is contained in, or is a product of, a transgenic
      animal.(!2)

        (B) the person has previously filed an application for
      conditional approval under paragraph (1) for the same drug in the
      same dosage form for the same intended use whether or not
      subsequently conditionally approved by the Secretary under
      subsection (b) of this section, or
        (C) the person obtained the application, or data or other
      information contained therein, directly or indirectly from the
      person who filed for conditional approval under paragraph (1) for
      the same drug in the same dosage form for the same intended use
      whether or not subsequently conditionally approved by the
      Secretary under subsection (b) of this section.
    (b) Order of approval or hearing
      Within 180 days after the filing of an application pursuant to
    subsection (a) of this section, or such additional period as may be
    agreed upon by the Secretary and the applicant, the Secretary shall
    either - 
        (1) issue an order, effective for one year, conditionally
      approving the application if the Secretary finds that none of the
      grounds for denying conditional approval, specified in subsection
      (c) of this section applies and publish a Federal Register notice
      of the conditional approval, or
        (2) give the applicant notice of an opportunity for an informal
      hearing on the question whether such application can be
      conditionally approved.
    (c) Order of approval or refusal after hearing
      If the Secretary finds, after giving the applicant notice and an
    opportunity for an informal hearing, that - 
        (1) any of the provisions of section 360b(d)(1)(A) through (D)
      or (F) through (I) of this title are applicable;
        (2) the information submitted to the Secretary as part of the
      application and any other information before the Secretary with
      respect to such drug, is insufficient to show that there is a
      reasonable expectation that the drug will have the effect it
      purports or is represented to have under the conditions of use
      prescribed, recommended, or suggested in the proposed labeling
      thereof; or
        (3) another person has received approval under section 360b of
      this title for the same drug in the same dosage form for the same
      intended use, and that person is able to assure the availability
      of sufficient quantities of the drug to meet the needs for which
      the drug is intended;

    the Secretary shall issue an order refusing to conditionally
    approve the application. If, after such notice and opportunity for
    an informal hearing, the Secretary finds that paragraphs (1)
    through (3) do not apply, the Secretary shall issue an order
    conditionally approving the application effective for one year and
    publish a Federal Register notice of the conditional approval. Any
    order issued under this subsection refusing to conditionally
    approve an application shall state the findings upon which it is
    based.
    (d) Effective period; renewal; refusal of renewal
      A conditional approval under this section is effective for a 1-
    year period and is thereafter renewable by the Secretary annually
    for up to 4 additional 1-year terms. A conditional approval shall
    be in effect for no more than 5 years from the date of approval
    under subsection (b)(1) or (c) of this section unless extended as
    provided for in subsection (h) of this section. The following shall
    also apply:
        (1) No later than 90 days from the end of the 1-year period for
      which the original or renewed conditional approval is effective,
      the applicant may submit a request to renew a conditional
      approval for an additional 1-year term.
        (2) A conditional approval shall be deemed renewed at the end
      of the 1-year period, or at the end of a 90-day extension that
      the Secretary may, at the Secretary's discretion, grant by letter
      in order to complete review of the renewal request, unless the
      Secretary determines before the expiration of the 1-year period
      or the 90-day extension that - 
          (A) the applicant failed to submit a timely renewal request;
          (B) the request fails to contain sufficient information to
        show that - 
            (i) the applicant is making sufficient progress toward
          meeting approval requirements under section 360b(d)(1)(E) of
          this title, and is likely to be able to fulfill those
          requirements and obtain an approval under section 360b of
          this title before the expiration of the 5-year maximum term
          of the conditional approval;
            (ii) the quantity of the drug that has been distributed is
          consistent with the conditionally approved intended use and
          conditions of use, unless there is adequate explanation that
          ensures that the drug is only used for its intended purpose;
          or
            (iii) the same drug in the same dosage form for the same
          intended use has not received approval under section 360b of
          this title, or if such a drug has been approved, that the
          holder of the approved application is unable to assure the
          availability of sufficient quantities of the drug to meet the
          needs for which the drug is intended; or

          (C) any of the provisions of section 360b(e)(1)(A) through
        (B) or (D) through (F) of this title are applicable.

        (3) If the Secretary determines before the end of the 1-year
      period or the 90-day extension, if granted, that a conditional
      approval should not be renewed, the Secretary shall issue an
      order refusing to renew the conditional approval, and such
      conditional approval shall be deemed withdrawn and no longer in
      effect. The Secretary shall thereafter provide an opportunity for
      an informal hearing to the applicant on the issue whether the
      conditional approval shall be reinstated.
    (e) Withdrawal of conditional approval
      (1) The Secretary shall issue an order withdrawing conditional
    approval of an application filed pursuant to subsection (a) of this
    section if the Secretary finds that another person has received
    approval under section 360b of this title for the same drug in the
    same dosage form for the same intended use and that person is able
    to assure the availability of sufficient quantities of the drug to
    meet the needs for which the drug is intended.
      (2) The Secretary shall, after due notice and opportunity for an
    informal hearing to the applicant, issue an order withdrawing
    conditional approval of an application filed pursuant to subsection
    (a) of this section if the Secretary finds that - 
        (A) any of the provisions of section 360b(e)(1)(A) through (B)
      or (D) through (F) of this title are applicable; or
        (B) on the basis of new information before the Secretary with
      respect to such drug, evaluated together with the evidence
      available to the Secretary when the application was conditionally
      approved, that there is not a reasonable expectation that such
      drug will have the effect it purports or is represented to have
      under the conditions of use prescribed, recommended, or suggested
      in the labeling thereof.

      (3) The Secretary may also, after due notice and opportunity for
    an informal hearing to the applicant, issue an order withdrawing
    conditional approval of an application filed pursuant to subsection
    (a) of this section if the Secretary finds that any of the
    provisions of section 360b(e)(2) of this title are applicable.
    (f) Labeling
      (1) The label and labeling of a new animal drug with a
    conditional approval under this section shall - 
        (A) bear the statement, "conditionally approved by FDA pending
      a full demonstration of effectiveness under application number";
      and
        (B) contain such other information as prescribed by the
      Secretary.

      (2) An intended use that is the subject of a conditional approval
    under this section shall not be included in the same product label
    with any intended use approved under section 360b of this title.
    (g) Amendment of application
      A conditionally approved new animal drug application may not be
    amended or supplemented to add indications for use.
    (h) Order of approval after conditional approval period termination
      180 days prior to the termination date established under
    subsection (d) of this section, an applicant shall have submitted
    all the information necessary to support a complete new animal drug
    application in accordance with section 360b(b)(1) of this title or
    the conditional approval issued under this section is no longer in
    effect. Following review of this information, the Secretary shall
    either - 
        (1) issue an order approving the application under section
      360b(c) of this title if the Secretary finds that none of the
      grounds for denying approval specified in section 360b(d)(1) of
      this title applies, or
        (2) give the applicant an opportunity for a hearing before the
      Secretary under section 360b(d) of this title on the question
      whether such application can be approved.

    Upon issuance of an order approving the application, product
    labeling and administrative records of approval shall be modified
    accordingly. If the Secretary has not issued an order under section
    360b(c) of this title approving such application prior to the
    termination date established under subsection (d) of this section,
    the conditional approval issued under this section is no longer in
    effect unless the Secretary grants an extension of an additional
    180-day period so that the Secretary can complete review of the
    application. The decision to grant an extension is committed to the
    discretion of the Secretary and not subject to judicial review.
    (i) Judicial review
      The decision of the Secretary under subsection (c), (d), or (e)
    of this section refusing or withdrawing conditional approval of an
    application shall constitute final agency action subject to
    judicial review.
    (j) Definition
      In this section and section 360ccc-1 of this title, the term
    "transgenic animal" means an animal whose genome contains a
    nucleotide sequence that has been intentionally modified in vitro,
    and the progeny of such an animal; Provided that the term
    "transgenic animal" does not include an animal of which the
    nucleotide sequence of the genome has been modified solely by
    selective breeding.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 571, as added Pub. L. 108-282, title
    I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 892.)


-MISC1-
                                 FINDINGS                             
      Pub. L. 108-282, title I, Sec. 102(a), Aug. 2, 2004, 118 Stat.
    891, provided that: "Congress makes the following findings:
        "(1) There is a severe shortage of approved new animal drugs
      for use in minor species.
        "(2) There is a severe shortage of approved new animal drugs
      for treating animal diseases and conditions that occur
      infrequently or in limited geographic areas.
        "(3) Because of the small market shares, low-profit margins
      involved, and capital investment required, it is generally not
      economically feasible for new animal drug applicants to pursue
      approvals for these species, diseases, and conditions.
        "(4) Because the populations for which such new animal drugs
      are intended may be small and conditions of animal management may
      vary widely, it is often difficult to design and conduct studies
      to establish drug safety and effectiveness under traditional new
      animal drug approval processes.
        "(5) It is in the public interest and in the interest of animal
      welfare to provide for special procedures to allow the lawful use
      and marketing of certain new animal drugs for minor species and
      minor uses that take into account these special circumstances and
      that ensure that such drugs do not endanger animal or public
      health.
        "(6) Exclusive marketing rights for clinical testing expenses
      have helped encourage the development of 'orphan' drugs for human
      use, and comparable incentives should encourage the development
      of new animal drugs for minor species and minor uses."

                                REGULATIONS                            
      Pub. L. 108-282, title I, Sec. 102(b)(6), Aug. 2, 2004, 118 Stat.
    905, provided that: "On the date of enactment of this Act [Aug. 2,
    2004], the Secretary of Health and Human Services shall implement
    sections 571 and 573 of the Federal Food, Drug, and Cosmetic Act
    [21 U.S.C. 360ccc, 360ccc-2] and subsequently publish implementing
    regulations. Not later than 12 months after the date of enactment
    of this Act, the Secretary shall issue proposed regulations to
    implement section 573 of the Federal Food, Drug, and Cosmetic Act
    (as added by this Act), and not later than 24 months after the date
    of enactment of this Act, the Secretary shall issue final
    regulations implementing section 573 of the Federal Food, Drug, and
    Cosmetic Act. Not later than 18 months after the date of enactment
    of this Act, the Secretary shall issue proposed regulations to
    implement section 572 of the Federal Food, Drug, and Cosmetic Act
    (as added by this Act) [21 U.S.C. 360ccc-1], and not later than 36
    months after the date of enactment of this Act, the Secretary shall
    issue final regulations implementing section 572 of the Federal
    Food, Drug, and Cosmetic Act. Not later than 30 months after the
    date of enactment of this Act, the Secretary shall issue proposed
    regulations to implement section 571 of the Federal Food, Drug, and
    Cosmetic Act (as added by this Act), and not later than 42 months
    after the date of enactment of this Act, the Secretary shall issue
    final regulations implementing section 571 of the Federal Food,
    Drug, and Cosmetic Act. These timeframes shall be extended by 12
    months for each fiscal year, in which the funds authorized to be
    appropriated under subsection (i) [no subsection (i) of section 102
    has been enacted] are not in fact appropriated."

-FOOTNOTE-
    (!1) So in original. Probably should be "this subsection,".

               

    (!2) So in original. The period probably should be a comma.


-End-



-CITE-
    21 USC Sec. 360ccc-1                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
    Sec. 360ccc-1. Index of legally marketed unapproved new animal
      drugs for minor species

-STATUTE-
    (a) Establishment and content
      (1) The Secretary shall establish an index limited to - 
        (A) new animal drugs intended for use in a minor species for
      which there is a reasonable certainty that the animal or edible
      products from the animal will not be consumed by humans or food-
      producing animals; and
        (B) new animal drugs intended for use only in a hatchery, tank,
      pond, or other similar contained man-made structure in an early,
      non-food life stage of a food-producing minor species, where
      safety for humans is demonstrated in accordance with the standard
      of section 360b(d) of this title (including, for an antimicrobial
      new animal drug, with respect to antimicrobial resistance).

      (2) The index shall not include a new animal drug that is
    contained in or a product of a transgenic animal.
    (b) Conferences
      Any person intending to file a request under this section shall
    be entitled to one or more conferences to discuss the requirements
    for indexing a new animal drug.
    (c) Request for determination of eligibility for inclusion in index
      (1) Any person may submit a request to the Secretary for a
    determination whether a new animal drug may be eligible for
    inclusion in the index. Such a request shall include - 
        (A) information regarding the need for the new animal drug, the
      species for which the new animal drug is intended, the proposed
      intended use and conditions of use, and anticipated annual
      distribution;
        (B) information to support the conclusion that the proposed use
      meets the conditions of subparagraph (A) or (B) of subsection
      (a)(1) of this section;
        (C) information regarding the components and composition of the
      new animal drug;
        (D) a description of the methods used in, and the facilities
      and controls used for, the manufacture, processing, and packing
      of such new animal drug;
        (E) an environmental assessment that meets the requirements of
      the National Environmental Policy Act of 1969 [42 U.S.C. 4321 et
      seq.], as amended, and as defined in 21 CFR Part 25, as it
      appears on August 2, 2004, and amended thereafter or information
      to support a categorical exclusion from the requirement to
      prepare an environmental assessment;
        (F) information sufficient to support the conclusion that the
      proposed use of the new animal drug is safe under section 360b(d)
      of this title with respect to individuals exposed to the new
      animal drug through its manufacture or use; and
        (G) such other information as the Secretary may deem necessary
      to make this eligibility determination.

      (2) Within 90 days after the submission of a request for a
    determination of eligibility for indexing based on subsection
    (a)(1)(A) of this section, or 180 days for a request submitted
    based on subsection (a)(1)(B) of this section, the Secretary shall
    grant or deny the request, and notify the person who requested such
    determination of the Secretary's decision. The Secretary shall
    grant the request if the Secretary finds that - 
        (A) the same drug in the same dosage form for the same intended
      use is not approved or conditionally approved;
        (B) the proposed use of the drug meets the conditions of
      subparagraph (A) or (B) of subsection (a)(1) of this section, as
      appropriate;
        (C) the person requesting the determination has established
      appropriate specifications for the manufacture and control of the
      new animal drug and has demonstrated an understanding of the
      requirements of current good manufacturing practices;
        (D) the new animal drug will not significantly affect the human
      environment; and
        (E) the new animal drug is safe with respect to individuals
      exposed to the new animal drug through its manufacture or use.

    If the Secretary denies the request, the Secretary shall thereafter
    provide due notice and an opportunity for an informal conference. A
    decision of the Secretary to deny an eligibility request following
    an informal conference shall constitute final agency action subject
    to judicial review.
    (d) Request for addition to index
      (1) With respect to a new animal drug for which the Secretary has
    made a determination of eligibility under subsection (c) of this
    section, the person who made such a request may ask that the
    Secretary add the new animal drug to the index established under
    subsection (a) of this section. The request for addition to the
    index shall include - 
        (A) a copy of the Secretary's determination of eligibility
      issued under subsection (c) of this section;
        (B) a written report that meets the requirements in subsection
      (d)(2) of this section;
        (C) a proposed index entry;
        (D) facsimile labeling;
        (E) anticipated annual distribution of the new animal drug;
        (F) a written commitment to manufacture the new animal drug and
      animal feeds bearing or containing such new animal drug according
      to current good manufacturing practices;
        (G) a written commitment to label, distribute, and promote the
      new animal drug only in accordance with the index entry;
        (H) upon specific request of the Secretary, information
      submitted to the expert panel described in paragraph (3); and
        (I) any additional requirements that the Secretary may
      prescribe by general regulation or specific order.

      (2) The report required in paragraph (1) shall - 
        (A) be authored by a qualified expert panel;
        (B) include an evaluation of all available target animal safety
      and effectiveness information, including anecdotal information;
        (C) state the expert panel's opinion regarding whether the
      benefits of using the new animal drug for the proposed use in a
      minor species outweigh its risks to the target animal, taking
      into account the harm being caused by the absence of an approved
      or conditionally approved new animal drug for the minor species
      in question;
        (D) include information from which labeling can be written; and
        (E) include a recommendation regarding whether the new animal
      drug should be limited to use under the professional supervision
      of a licensed veterinarian.

      (3) A qualified expert panel, as used in this section, is a panel
    that - 
        (A) is composed of experts qualified by scientific training and
      experience to evaluate the target animal safety and effectiveness
      of the new animal drug under consideration;
        (B) operates external to FDA; and
        (C) is not subject to the Federal Advisory Committee Act.

    The Secretary shall define the criteria for selection of a
    qualified expert panel and the procedures for the operation of the
    panel by regulation.
      (4) Within 180 days after the receipt of a request for listing a
    new animal drug in the index, the Secretary shall grant or deny the
    request. The Secretary shall grant the request if the request for
    indexing continues to meet the eligibility criteria in subsection
    (a) of this section and the Secretary finds, on the basis of the
    report of the qualified expert panel and other information
    available to the Secretary, that the benefits of using the new
    animal drug for the proposed use in a minor species outweigh its
    risks to the target animal, taking into account the harm caused by
    the absence of an approved or conditionally-approved new animal
    drug for the minor species in question. If the Secretary denies the
    request, the Secretary shall thereafter provide due notice and the
    opportunity for an informal conference. The decision of the
    Secretary following an informal conference shall constitute final
    agency action subject to judicial review.
    (e) Index contents; publication
      (1) The index established under subsection (a) of this section
    shall include the following information for each listed drug - 
        (A) the name and address of the person who holds the index
      listing;
        (B) the name of the drug and the intended use and conditions of
      use for which it is being indexed;
        (C) product labeling; and
        (D) conditions and any limitations that the Secretary deems
      necessary regarding use of the drug.

      (2) The Secretary shall publish the index, and revise it
    periodically.
      (3) The Secretary may establish by regulation a process for
    reporting changes in the conditions of manufacturing or labeling of
    indexed products.
    (f) Removal from index; suspended listing
      (1) If the Secretary finds, after due notice to the person who
    requested the index listing and an opportunity for an informal
    conference, that - 
        (A) the expert panel failed to meet the requirements as set
      forth by the Secretary by regulation;
        (B) on the basis of new information before the Secretary,
      evaluated together with the evidence available to the Secretary
      when the new animal drug was listed in the index, the benefits of
      using the new animal drug for the indexed use do not outweigh its
      risks to the target animal;
        (C) the conditions of subsection (c)(2) of this section are no
      longer satisfied;
        (D) the manufacture of the new animal drug is not in accordance
      with current good manufacturing practices;
        (E) the labeling, distribution, or promotion of the new animal
      drug is not in accordance with the index entry;
        (F) the conditions and limitations of use associated with the
      index listing have not been followed; or
        (G) the request for indexing contains any untrue statement of
      material fact,

    the Secretary shall remove the new animal drug from the index. The
    decision of the Secretary following an informal conference shall
    constitute final agency action subject to judicial review.
      (2) If the Secretary finds that there is a reasonable probability
    that the use of the drug would present a risk to the health of
    humans or other animals, the Secretary may - 
        (A) suspend the listing of such drug immediately;
        (B) give the person listed in the index prompt notice of the
      Secretary's action; and
        (C) afford that person the opportunity for an informal
      conference.

    The decision of the Secretary following an informal conference
    shall constitute final agency action subject to judicial review.
    (g) Regulations concerning exemptions for investigational use
      For purposes of indexing new animal drugs under this section, to
    the extent consistent with the public health, the Secretary shall
    promulgate regulations for exempting from the operation of section
    360b of this title minor species new animal drugs and animal feeds
    bearing or containing new animal drugs intended solely for
    investigational use by experts qualified by scientific training and
    experience to investigate the safety and effectiveness of minor
    species animal drugs. Such regulations may, at the discretion of
    the Secretary, among other conditions relating to the protection of
    the public health, provide for conditioning such exemption upon the
    establishment and maintenance of such records, and the making of
    such reports to the Secretary, by the manufacturer or the sponsor
    of the investigation of such article, of data (including but not
    limited to analytical reports by investigators) obtained as a
    result of such investigational use of such article, as the
    Secretary finds will enable the Secretary to evaluate the safety
    and effectiveness of such article in the event of the filing of a
    request for an index listing pursuant to this section.
    (h) Labeling contents
      The labeling of a new animal drug that is the subject of an index
    listing shall state, prominently and conspicuously - 
        (1) "Not approved by fda. - Legally marketed as an FDA indexed
      product. Extra-label use is prohibited.";
        (2) except in the case of new animal drugs indexed for use in
      an early life stage of a food-producing animal, "This product is
      not to be used in animals intended for use as food for humans or
      other animals."; and
        (3) such other information as may be prescribed by the
      Secretary in the index listing.
    (i) Records and reports
      (1) In the case of any new animal drug for which an index listing
    pursuant to subsection (a) of this section is in effect, the person
    who has an index listing shall establish and maintain such records,
    and make such reports to the Secretary, of data relating to
    experience, and other data or information, received or otherwise
    obtained by such person with respect to such drug, or with respect
    to animal feeds bearing or containing such drug, as the Secretary
    may by general regulation, or by order with respect to such
    listing, prescribe on the basis of a finding that such records and
    reports are necessary in order to enable the Secretary to
    determine, or facilitate a determination, whether there is or may
    be ground for invoking subsection (f) of this section. Such
    regulation or order shall provide, where the Secretary deems it to
    be appropriate, for the examination, upon request, by the persons
    to whom such regulation or order is applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this subsection to maintain
    records, and every person in charge or custody thereof, shall, upon
    request of an officer or employee designated by the Secretary,
    permit such officer or employee at all reasonable times to have
    access to and copy and verify such records.
    (j) Public disclosure of safety and effectiveness data
      (1) Safety and effectiveness data and information which has been
    submitted in support of a request for a new animal drug to be
    indexed under this section and which has not been previously
    disclosed to the public shall be made available to the public, upon
    request, unless extraordinary circumstances are shown - 
        (A) if no work is being or will be undertaken to have the drug
      indexed in accordance with the request,
        (B) if the Secretary has determined that such drug cannot be
      indexed and all legal appeals have been exhausted,
        (C) if the indexing of such drug is terminated and all legal
      appeals have been exhausted, or
        (D) if the Secretary has determined that such drug is not a new
      animal drug.

      (2) Any request for data and information pursuant to paragraph
    (1) shall include a verified statement by the person making the
    request that any data or information received under such paragraph
    shall not be disclosed by such person to any other person - 
        (A) for the purpose of, or as part of a plan, scheme, or device
      for, obtaining the right to make, use, or market, or making,
      using, or marketing, outside the United States, the drug
      identified in the request for indexing; and
        (B) without obtaining from any person to whom the data and
      information are disclosed an identical verified statement, a copy
      of which is to be provided by such person to the Secretary, which
      meets the requirements of this paragraph.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 572, as added Pub. L. 108-282, title
    I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 896.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The National Environmental Policy Act of 1969, referred to in
    subsec. (c)(1)(E), is Pub. L. 91-190, Jan. 1, 1970, 83 Stat. 852,
    as amended, which is classified generally to chapter 55 (Sec. 4321
    et seq.) of Title 42, The Public Health and Welfare. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 4321 of Title 42 and Tables.
      The Federal Advisory Committee Act, referred to in subsec.
    (d)(3)(C), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as
    amended, which is set out in the Appendix to Title 5, Government
    Organization and Employees.

-End-



-CITE-
    21 USC Sec. 360ccc-2                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
    Sec. 360ccc-2. Designated new animal drugs for minor use or minor
      species

-STATUTE-
    (a) Designation
      (1) The manufacturer or the sponsor of a new animal drug for a
    minor use or use in a minor species may request that the Secretary
    declare that drug a "designated new animal drug". A request for
    designation of a new animal drug shall be made before the
    submission of an application under section 360b(b) of this title or
    section 360ccc of this title for the new animal drug.
      (2) The Secretary may declare a new animal drug a "designated new
    animal drug" if - 
        (A) it is intended for a minor use or use in a minor species;
      and
        (B) the same drug in the same dosage form for the same intended
      use is not approved under section 360b or 360ccc of this title or
      designated under this section at the time the request is made.

      (3) Regarding the termination of a designation - 
        (A) the sponsor of a new animal drug shall notify the Secretary
      of any decision to discontinue active pursuit of approval under
      section 360b or 360ccc of this title of an application for a
      designated new animal drug. The Secretary shall terminate the
      designation upon such notification;
        (B) the Secretary may also terminate designation if the
      Secretary independently determines that the sponsor is not
      actively pursuing approval under section 360b or 360ccc of this
      title with due diligence;
        (C) the sponsor of an approved designated new animal drug shall
      notify the Secretary of any discontinuance of the manufacture of
      such new animal drug at least one year before discontinuance. The
      Secretary shall terminate the designation upon such notification;
      and
        (D) the designation shall terminate upon the expiration of any
      applicable exclusivity period under subsection (c) of this
      section.

      (4) Notice respecting the designation or termination of
    designation of a new animal drug shall be made available to the
    public.
    (b) Grants and contracts for development of designated new animal
      drugs
      (1) The Secretary may make grants to and enter into contracts
    with public and private entities and individuals to assist in
    defraying the costs of qualified safety and effectiveness testing
    expenses and manufacturing expenses incurred in connection with the
    development of designated new animal drugs.
      (2) For purposes of paragraph (1) of this section - 
        (A) The term "qualified safety and effectiveness testing" means
      testing - 
          (i) which occurs after the date such new animal drug is
        designated under this section and before the date on which an
        application with respect to such drug is submitted under
        section 360b of this title; and
          (ii) which is carried out under an investigational exemption
        under section 360b(j) of this title.

        (B) The term "manufacturing expenses" means expenses incurred
      in developing processes and procedures associated with
      manufacture of the designated new animal drug which occur after
      the new animal drug is designated under this section and before
      the date on which an application with respect to such new animal
      drug is submitted under section 360b or 360ccc of this title.
    (c) Exclusivity for designated new animal drugs
      (1) Except as provided in subsection (c)(2) of this section, if
    the Secretary approves or conditionally approves an application for
    a designated new animal drug, the Secretary may not approve or
    conditionally approve another application submitted for such new
    animal drug with the same intended use as the designated new animal
    drug for another applicant before the expiration of seven years
    from the date of approval or conditional approval of the
    application.
      (2) If an application filed pursuant to section 360b of this
    title or section 360ccc of this title is approved for a designated
    new animal drug, the Secretary may, during the 7-year exclusivity
    period beginning on the date of the application approval or
    conditional approval, approve or conditionally approve another
    application under section 360b of this title or section 360ccc of
    this title for such drug for such minor use or minor species for
    another applicant if - 
        (A) the Secretary finds, after providing the holder of such an
      approved application notice and opportunity for the submission of
      views, that in the granted exclusivity period the holder of the
      approved application cannot assure the availability of sufficient
      quantities of the drug to meet the needs for which the drug was
      designated; or
        (B) such holder provides written consent to the Secretary for
      the approval or conditional approval of other applications before
      the expiration of such exclusivity period.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 573, as added Pub. L. 108-282, title
    I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 900.)

-End-


-CITE-
    21 USC SUBCHAPTER VI - COSMETICS                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
                         SUBCHAPTER VI - COSMETICS                     

-End-



-CITE-
    21 USC Sec. 361                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 361. Adulterated cosmetics

-STATUTE-
      A cosmetic shall be deemed to be adulterated - 
      (a) If it bears or contains any poisonous or deleterious
    substance which may render it injurious to users under the
    conditions of use prescribed in the labeling thereof, or under such
    conditions of use as are customary or usual, except that this
    provision shall not apply to coal-tar hair dye, the label of which
    bears the following legend conspicuously displayed thereon:
    "Caution - This product contains ingredients which may cause skin
    irritation on certain individuals and a preliminary test according
    to accompanying directions should first be made. This product must
    not be used for dyeing the eyelashes or eyebrows; to do so may
    cause blindness.", and the labeling of which bears adequate
    directions for such preliminary testing. For the purposes of this
    paragraph and paragraph (e) the term "hair dye" shall not include
    eyelash dyes or eyebrow dyes.
      (b) If it consists in whole or in part of any filthy, putrid, or
    decomposed substance.
      (c) If it has been prepared, packed, or held under insanitary
    conditions whereby it may have become contaminated with filth, or
    whereby it may have been rendered injurious to health.
      (d) If its container is composed, in whole or in part, of any
    poisonous or deleterious substance which may render the contents
    injurious to health.
      (e) If it is not a hair dye and it is, or it bears or contains, a
    color additive which is unsafe within the meaning of section
    379e(a) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 601, 52 Stat. 1054; Pub. L. 86-618,
    title I, Sec. 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102-
    571, title I, Sec. 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
    103-80, Sec. 3(x), Aug. 13, 1993, 107 Stat. 778.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a). Pub. L. 103-80 substituted "usual, except
    that this" for "usual: Provided, That this".
      1992 - Par. (e). Pub. L. 102-571 substituted "379e(a)" for
    "376(a)".
      1960 - Par. (e). Pub. L. 86-618 substituted "and it is, or it
    bears or contains, a color additive which is unsafe within the
    meaning of section 376(a) of this title" for "and it bears or
    contains a coal-tar color other than one from a batch that has been
    certified in accordance with regulations as provided by section 364
    of this title".

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
    53 Stat. 853, set out as an Effective Date; Postponement in Certain
    Cases note under section 301 of this title.

                              EFFECTIVE DATE                          
      Section effective twelve months after June 25, 1938, except par.
    (a), which, with certain exceptions, became effective on June 25,
    1938, see section 902(a) of act June 25, 1938, set out as a note
    under section 301 of this title.

-End-



-CITE-
    21 USC Sec. 362                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 362. Misbranded cosmetics

-STATUTE-
      A cosmetic shall be deemed to be misbranded - 
      (a) If its labeling is false or misleading in any particular.
      (b) If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count: Provided,
    That under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
      (c) If any word, statement, or other information required by or
    under authority of this chapter to appear on the label or labeling
    is not prominently placed thereon with such conspicuousness (as
    compared with other words, statements, designs, or devices, in the
    labeling) and in such terms as to render it likely to be read and
    understood by the ordinary individual under customary conditions of
    purchase and use.
      (d) If its container is so made, formed, or filled as to be
    misleading.
      (e) If it is a color additive, unless its packaging and labeling
    are in conformity with such packaging and labeling requirements,
    applicable to such color additive, as may be contained in
    regulations issued under section 379e of this title. This paragraph
    shall not apply to packages of color additives which, with respect
    to their use for cosmetics, are marketed and intended for use only
    in or on hair dyes (as defined in the last sentence of section
    361(a) of this title).
      (f) If its packaging or labeling is in violation of an applicable
    regulation issued pursuant to section 1472 or 1473 of title 15.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 602, 52 Stat. 1054; Pub. L. 86-618,
    title I, Sec. 102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L. 91-
    601, Sec. 6(f), formerly Sec. 7(f), Dec. 30, 1970, 84 Stat. 1673,
    renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
    95 Stat. 716; Pub. L. 102-571, title I, Sec. 107(12), Oct. 29,
    1992, 106 Stat. 4499.)


-MISC1-
                                AMENDMENTS                            
      1992 - Par. (e). Pub. L. 102-571 substituted "379e" for "376".
      1970 - Par. (f). Pub. L. 91-601 added par. (f).
      1960 - Par. (e). Pub. L. 86-618 added par. (e).

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (b) effective Jan. 1, 1940, and such subsection effective
    July 1, 1940, as provided by regulations for certain lithographed
    labeling and containers bearing certain labeling, see act June 23,
    1939, ch. 242, 53 Stat. 853, set out as an Effective Date;
    Postponement in Certain Cases note under section 301 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 363                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 363. Regulations making exemptions

-STATUTE-
      The Secretary shall promulgate regulations exempting from any
    labeling requirement of this chapter cosmetics which are, in
    accordance with the practice of the trade, to be processed,
    labeled, or repacked in substantial quantities at establishments
    other than those where originally processed or packed, on condition
    that such cosmetics are not adulterated or misbranded under the
    provisions of this chapter upon removal from such processing,
    labeling, or repacking establishment.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 603, 52 Stat. 1054.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 364                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 364. Repealed.

-MISC1-
    Sec. 364. Repealed. Pub. L. 86-618, title I, Sec. 103(a)(3), July
      12, 1960, 74 Stat. 398.
      Section, act June 25, 1938, ch. 675, Sec. 604, 52 Stat. 1055,
    directed Secretary to promulgate regulations for listing of coal-
    tar colors for cosmetics. See section 379e of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective July 12, 1960, subject to the provisions of
    section 203 of Pub. L. 86-618, see section 202 of Pub. L. 86-618,
    set out as an Effective Date of 1960 Amendment note under section
    379e of this title.

-End-


-CITE-
    21 USC SUBCHAPTER VII - GENERAL AUTHORITY                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY

-HEAD-
                    SUBCHAPTER VII - GENERAL AUTHORITY                

-End-


-CITE-
    21 USC Part A - General Administrative Provisions           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
                PART A - GENERAL ADMINISTRATIVE PROVISIONS            

-End-



-CITE-
    21 USC Sec. 371                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 371. Regulations and hearings

-STATUTE-
    (a) Authority to promulgate regulations
      The authority to promulgate regulations for the efficient
    enforcement of this chapter, except as otherwise provided in this
    section, is vested in the Secretary.
    (b) Regulations for imports and exports
      The Secretary of the Treasury and the Secretary of Health and
    Human Services shall jointly prescribe regulations for the
    efficient enforcement of the provisions of section 381 of this
    title, except as otherwise provided therein. Such regulations shall
    be promulgated in such manner and take effect at such time, after
    due notice, as the Secretary of Health and Human Services shall
    determine.
    (c) Conduct of hearings
      Hearings authorized or required by this chapter shall be
    conducted by the Secretary or such officer or employee as he may
    designate for the purpose.
    (d) Effectiveness of definitions and standards of identity
      The definitions and standards of identity promulgated in
    accordance with the provisions of this chapter shall be effective
    for the purposes of the enforcement of this chapter,
    notwithstanding such definitions and standards as may be contained
    in other laws of the United States and regulations promulgated
    thereunder.
    (e) Procedure for establishment
      (1) Any action for the issuance, amendment, or repeal of any
    regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or
    (h) of this title, and any action for the amendment or repeal of
    any definition and standard of identity under section 341 of this
    title for any dairy product (including products regulated under
    parts 131, 133 and 135 of title 21, Code of Federal Regulations)
    shall be begun by a proposal made (A) by the Secretary on his own
    initiative, or (B) by petition of any interested person, showing
    reasonable grounds therefor, filed with the Secretary. The
    Secretary shall publish such proposal and shall afford all
    interested persons an opportunity to present their views thereon,
    orally or in writing. As soon as practicable thereafter, the
    Secretary shall by order act upon such proposal and shall make such
    order public. Except as provided in paragraph (2), the order shall
    become effective at such time as may be specified therein, but not
    prior to the day following the last day on which objections may be
    filed under such paragraph.
      (2) On or before the thirtieth day after the date on which an
    order entered under paragraph (1) is made public, any person who
    will be adversely affected by such order if placed in effect may
    file objections thereto with the Secretary, specifying with
    particularity the provisions of the order deemed objectionable,
    stating the grounds therefor, and requesting a public hearing upon
    such objections. Until final action upon such objections is taken
    by the Secretary under paragraph (3), the filing of such objections
    shall operate to stay the effectiveness of those provisions of the
    order to which the objections are made. As soon as practicable
    after the time for filing objections has expired the Secretary
    shall publish a notice in the Federal Register specifying those
    parts of the order which have been stayed by the filing of
    objections and, if no objections have been filed, stating that
    fact.
      (3) As soon as practicable after such request for a public
    hearing, the Secretary, after due notice, shall hold such a public
    hearing for the purpose of receiving evidence relevant and material
    to the issues raised by such objections. At the hearing, any
    interested person may be heard in person or by representative. As
    soon as practicable after completion of the hearing, the Secretary
    shall by order act upon such objections and make such order public.
    Such order shall be based only on substantial evidence of record at
    such hearing and shall set forth, as part of the order, detailed
    findings of fact on which the order is based. The Secretary shall
    specify in the order the date on which it shall take effect, except
    that it shall not be made to take effect prior to the ninetieth day
    after its publication unless the Secretary finds that emergency
    conditions exist necessitating an earlier effective date, in which
    event the Secretary shall specify in the order his findings as to
    such conditions.
    (f) Review of order
      (1) In a case of actual controversy as to the validity of any
    order under subsection (e) of this section, any person who will be
    adversely affected by such order if placed in effect may at any
    time prior to the ninetieth day after such order is issued file a
    petition with the United States court of appeals for the circuit
    wherein such person resides or has his principal place of business,
    for a judicial review of such order. A copy of the petition shall
    be forthwith transmitted by the clerk of the court to the Secretary
    or other officer designated by him for that purpose. The Secretary
    thereupon shall file in the court the record of the proceedings on
    which the Secretary based his order, as provided in section 2112 of
    title 28.
      (2) If the petitioner applies to the court for leave to adduce
    additional evidence, and shows to the satisfaction of the court
    that such additional evidence is material and that there were
    reasonable grounds for the failure to adduce such evidence in the
    proceeding before the Secretary, the court may order such
    additional evidence (and evidence in rebuttal thereof) to be taken
    before the Secretary, and to be adduced upon the hearing, in such
    manner and upon such terms and conditions as to the court may seem
    proper. The Secretary may modify his findings as to the facts, or
    make new findings, by reason of the additional evidence so taken,
    and he shall file such modified or new findings, and his
    recommendation, if any, for the modification or setting aside of
    his original order, with the return of such additional evidence.
      (3) Upon the filing of the petition referred to in paragraph (1)
    of this subsection, the court shall have jurisdiction to affirm the
    order, or to set it aside in whole or in part, temporarily or
    permanently. If the order of the Secretary refuses to issue, amend,
    or repeal a regulation and such order is not in accordance with law
    the court shall by its judgment order the Secretary to take action,
    with respect to such regulation, in accordance with law. The
    findings of the Secretary as to the facts, if supported by
    substantial evidence, shall be conclusive.
      (4) The judgment of the court affirming or setting aside, in
    whole or in part, any such order of the Secretary shall be final,
    subject to review by the Supreme Court of the United States upon
    certiorari or certification as provided in section 1254 of title
    28.
      (5) Any action instituted under this subsection shall survive
    notwithstanding any change in the person occupying the office of
    Secretary or any vacancy in such office.
      (6) The remedies provided for in this subsection shall be in
    addition to and not in substitution for any other remedies provided
    by law.
    (g) Copies of records of hearings
      A certified copy of the transcript of the record and proceedings
    under subsection (e) of this section shall be furnished by the
    Secretary to any interested party at his request, and payment of
    the costs thereof, and shall be admissible in any criminal, libel
    for condemnation, exclusion of imports, or other proceeding arising
    under or in respect to this chapter, irrespective of whether
    proceedings with respect to the order have previously been
    instituted or become final under subsection (f) of this section.
    (h) Guidance documents
      (1)(A) The Secretary shall develop guidance documents with public
    participation and ensure that information identifying the existence
    of such documents and the documents themselves are made available
    to the public both in written form and, as feasible, through
    electronic means. Such documents shall not create or confer any
    rights for or on any person, although they present the views of the
    Secretary on matters under the jurisdiction of the Food and Drug
    Administration.
      (B) Although guidance documents shall not be binding on the
    Secretary, the Secretary shall ensure that employees of the Food
    and Drug Administration do not deviate from such guidances without
    appropriate justification and supervisory concurrence. The
    Secretary shall provide training to employees in how to develop and
    use guidance documents and shall monitor the development and
    issuance of such documents.
      (C) For guidance documents that set forth initial interpretations
    of a statute or regulation, changes in interpretation or policy
    that are of more than a minor nature, complex scientific issues, or
    highly controversial issues, the Secretary shall ensure public
    participation prior to implementation of guidance documents, unless
    the Secretary determines that such prior public participation is
    not feasible or appropriate. In such cases, the Secretary shall
    provide for public comment upon implementation and take such
    comment into account.
      (D) For guidance documents that set forth existing practices or
    minor changes in policy, the Secretary shall provide for public
    comment upon implementation.
      (2) In developing guidance documents, the Secretary shall ensure
    uniform nomenclature for such documents and uniform internal
    procedures for approval of such documents. The Secretary shall
    ensure that guidance documents and revisions of such documents are
    properly dated and indicate the nonbinding nature of the documents.
    The Secretary shall periodically review all guidance documents and,
    where appropriate, revise such documents.
      (3) The Secretary, acting through the Commissioner, shall
    maintain electronically and update and publish periodically in the
    Federal Register a list of guidance documents. All such documents
    shall be made available to the public.
      (4) The Secretary shall ensure that an effective appeals
    mechanism is in place to address complaints that the Food and Drug
    Administration is not developing and using guidance documents in
    accordance with this subsection.
      (5) Not later than July 1, 2000, the Secretary after evaluating
    the effectiveness of the Good Guidance Practices document,
    published in the Federal Register at 62 Fed. Reg. 8961, shall
    promulgate a regulation consistent with this subsection specifying
    the policies and procedures of the Food and Drug Administration for
    the development, issuance, and use of guidance documents.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 701, 52 Stat. 1055; June 25, 1948,
    ch. 646, Sec. 32, 62 Stat. 991; Apr. 15, 1954, ch. 143, Sec. 2, 68
    Stat. 55; Aug. 1, 1956, ch. 861, Sec. 2, 70 Stat. 919; Pub. L. 85-
    791, Sec. 21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86-618, title
    I, Sec. 103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101-535,
    Sec. 8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102-300, Sec.
    6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Secs. 3(y),
    (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103-396,
    Sec. 3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105-115, title
    IV, Sec. 405, Nov. 21, 1997, 111 Stat. 2368.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (h). Pub. L. 105-115 added subsec. (h).
      1994 - Subsec. (e)(1). Pub. L. 103-396 which directed the
    amendment of par. (1) by striking out "or maple syrup (regulated
    under section 168.140 of title 21, Code of Federal Regulations).",
    was executed by striking out "or maple sirup (regulated under
    section 168.140 of title 21, Code of Federal Regulations)" before
    "shall be begun by a proposal", to reflect the probable intent of
    Congress.
      1993 - Subsec. (b). Pub. L. 103-80, Sec. 3(dd)(1), substituted
    "Health and Human Services" for "Agriculture" in two places.
      Subsec. (e)(1). Pub. L. 103-80, Sec. 4(c), made technical
    correction to directory language of Pub. L. 101-535, Sec. 8. See
    1990 Amendment note below.
      Pub. L. 103-80, Sec. 3(y)(1), struck out period after second
    reference to "Regulations)".
      Subsec. (f)(4). Pub. L. 103-80, Sec. 3(y)(2), substituted
    reference to section 1254 of title 28 for "sections 239 and 240 of
    the Judicial Code, as amended".
      1992 - Subsec. (b). Pub. L. 102-300, which directed the
    substitution of "Health and Human Services" for "Health, Education,
    and Welfare", could not be executed because such words did not
    appear in the original statutory text. See 1993 Amendment note
    above and Transfer of Functions note below.
      1990 - Subsec. (e)(1). Pub. L. 101-535, Sec. 8, as amended by
    Pub. L. 103-80, Sec. 4(c), substituted "Any action for the
    issuance, amendment, or repeal of any regulation under section
    343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and
    any action for the amendment or repeal of any definition and
    standard of identity under section 341 of this title for any dairy
    product (including products regulated under parts 131, 133 and 135
    of title 21, Code of Federal Regulations) or maple sirup (regulated
    under section 168.140 of title 21, Code of Federal Regulations)"
    for "Any action for the issuance, amendment, or repeal of any
    regulation under section 341, 343(j), 344(a), 346, 351(b), or
    352(d) or (h) of this title".
      1960 - Subsec. (e). Pub. L. 86-618 substituted "section 341,
    343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for
    "section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h),
    354 or 364 of this title".
      1958 - Subsec. (f)(1). Pub. L. 85-791, Sec. 21(a), substituted
    provisions requiring transmission of a copy of the petition by
    clerk to Secretary, and filing of the record by Secretary, for
    provisions which permitted service of summons and petition any
    place in United States and required Secretary to certify and file
    transcript of the proceedings and record upon service.
      Subsec. (f)(3). Pub. L. 85-791, Sec. 21(b), inserted "Upon the
    filing of the petition referred to in paragraph (1) of this
    subsection".
      1956 - Subsec. (e). Act Aug. 1, 1956, simplified procedures
    governing prescribing of regulations under certain provisions of
    this chapter.
      1954 - Subsec. (e). Act Apr. 15, 1954, struck out reference to
    section 341 of this title, before "343(j)", such section 341 now
    containing its own provisions with respect to hearings regarding
    the establishment of food standards.

-CHANGE-
                              CHANGE OF NAME                          
      Circuit Court of Appeals of the United States changed to United
    States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.


-MISC2-
                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter the
    authority of the Secretary of Health and Human Services and the
    Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21
    U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
    451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
    et seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

                             SAVINGS PROVISION                         
      Savings clause of act Aug. 1, 1956, see note set out under
    section 341 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC3-
        APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS    
      Section 403 of Pub. L. 105-115 provided that:
      "(a) Standards. - Not later than 180 days after the date of
    enactment of this Act [Nov. 21, 1997], the Secretary of Health and
    Human Services shall publish in the Federal Register standards for
    the prompt review of supplemental applications submitted for
    approved articles under the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service
    Act (42 U.S.C. 262).
      "(b) Guidance to Industry. - Not later than 180 days after the
    date of enactment of this Act [Nov. 21, 1997], the Secretary shall
    issue final guidances to clarify the requirements for, and
    facilitate the submission of data to support, the approval of
    supplemental applications for the approved articles described in
    subsection (a). The guidances shall - 
        "(1) clarify circumstances in which published matter may be the
      basis for approval of a supplemental application;
        "(2) specify data requirements that will avoid duplication of
      previously submitted data by recognizing the availability of data
      previously submitted in support of an original application; and
        "(3) define supplemental applications that are eligible for
      priority review.
      "(c) Responsibilities of Centers. - The Secretary shall designate
    an individual in each center within the Food and Drug
    Administration (except the Center for Food Safety and Applied
    Nutrition) to be responsible for - 
        "(1) encouraging the prompt review of supplemental applications
      for approved articles; and
        "(2) working with sponsors to facilitate the development and
      submission of data to support supplemental applications.
      "(d) Collaboration. - The Secretary shall implement programs and
    policies that will foster collaboration between the Food and Drug
    Administration, the National Institutes of Health, professional
    medical and scientific societies, and other persons, to identify
    published and unpublished studies that may support a supplemental
    application, and to encourage sponsors to make supplemental
    applications or conduct further research in support of a
    supplemental application based, in whole or in part, on such
    studies."

    HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS
      Provisions of this chapter in effect prior to Apr. 15, 1954, as
    applicable with respect to hearings begun prior to such date under
    subsection (e) of this section, regarding food standards, see
    Savings Provisions note set out under section 341 of this title.

-End-



-CITE-
    21 USC Sec. 372                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 372. Examinations and investigations

-STATUTE-
    (a) Authority to conduct
      (1) The Secretary is authorized to conduct examinations and
    investigations for the purposes of this chapter through officers
    and employees of the Department or through any health, food, or
    drug officer or employee of any State, Territory, or political
    subdivision thereof, duly commissioned by the Secretary as an
    officer of the Department.
      (2)(A) In addition to the authority established in paragraph (1),
    the Secretary, pursuant to a memorandum of understanding between
    the Secretary and the head of another Federal department or agency,
    is authorized to conduct examinations and investigations for the
    purposes of this chapter through the officers and employees of such
    other department or agency, subject to subparagraph (B). Such a
    memorandum shall include provisions to ensure adequate training of
    such officers and employees to conduct the examinations and
    investigations. The memorandum of understanding shall contain
    provisions regarding reimbursement. Such provisions may, at the
    sole discretion of the head of the other department or agency,
    require reimbursement, in whole or in part, from the Secretary for
    the examinations or investigations performed under this section by
    the officers or employees of the other department or agency.
      (B) A memorandum of understanding under subparagraph (A) between
    the Secretary and another Federal department or agency is effective
    only in the case of examinations or inspections at facilities or
    other locations that are jointly regulated by the Secretary and
    such department or agency.
      (C) For any fiscal year in which the Secretary and the head of
    another Federal department or agency carries out one or more
    examinations or inspections under a memorandum of understanding
    under subparagraph (A), the Secretary and the head of such
    department or agency shall with respect to their respective
    departments or agencies submit to the committees of jurisdiction
    (authorizing and appropriating) in the House of Representatives and
    the Senate a report that provides, for such year - 
        (i) the number of officers or employees that carried out one or
      more programs, projects, or activities under such memorandum;
        (ii) the number of additional articles that were inspected or
      examined as a result of such memorandum; and
        (iii) the number of additional examinations or investigations
      that were carried out pursuant to such memorandum.

      (3) In the case of food packed in the Commonwealth of Puerto Rico
    or a Territory the Secretary shall attempt to make inspection of
    such food at the first point of entry within the United States
    when, in his opinion and with due regard to the enforcement of all
    the provisions of this chapter, the facilities at his disposal will
    permit of such inspection.
      (4) For the purposes of this subsection, the term "United States"
    means the States and the District of Columbia.
    (b) Availability to owner of part of analysis samples
      Where a sample of a food, drug, or cosmetic is collected for
    analysis under this chapter the Secretary shall, upon request,
    provide a part of such official sample for examination or analysis
    by any person named on the label of the article, or the owner
    thereof, or his attorney or agent; except that the Secretary is
    authorized, by regulations, to make such reasonable exceptions
    from, and impose such reasonable terms and conditions relating to,
    the operation of this subsection as he finds necessary for the
    proper administration of the provisions of this chapter.
    (c) Records of other departments and agencies
      For purposes of enforcement of this chapter, records of any
    department or independent establishment in the executive branch of
    the Government shall be open to inspection by any official of the
    Department duly authorized by the Secretary to make such
    inspection.
    (d) Information on patents for drugs
      The Secretary is authorized and directed, upon request from the
    Under Secretary of Commerce for Intellectual Property and Director
    of the United States Patent and Trademark Office, to furnish full
    and complete information with respect to such questions relating to
    drugs as the Director may submit concerning any patent application.
    The Secretary is further authorized, upon receipt of any such
    request, to conduct or cause to be conducted, such research as may
    be required.
    (e) Powers of enforcement personnel
      Any officer or employee of the Department designated by the
    Secretary to conduct examinations, investigations, or inspections
    under this chapter relating to counterfeit drugs may, when so
    authorized by the Secretary - 
        (1) carry firearms;
        (2) execute and serve search warrants and arrest warrants;
        (3) execute seizure by process issued pursuant to libel under
      section 334 of this title;
        (4) make arrests without warrant for offenses under this
      chapter with respect to such drugs if the offense is committed in
      his presence or, in the case of a felony, if he has probable
      cause to believe that the person so arrested has committed, or is
      committing, such offense; and
        (5) make, prior to the institution of libel proceedings under
      section 334(a)(2) of this title, seizures of drugs or containers
      or of equipment, punches, dies, plates, stones, labeling, or
      other things, if they are, or he has reasonable grounds to
      believe that they are, subject to seizure and condemnation under
      such section 334(a)(2). In the event of seizure pursuant to this
      paragraph (5), libel proceedings under section 334(a)(2) of this
      title shall be instituted promptly and the property seized be
      placed under the jurisdiction of the court.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 702, 52 Stat. 1056; Pub. L. 87-781,
    title III, Secs. 307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L.
    89-74, Sec. 8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91-513,
    title II, Sec. 701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102-
    300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
    Sec. 3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106-113, div.
    B, Sec. 1000(a)(9) [title IV, Sec. 4732(b)(12)], Nov. 29, 1999, 113
    Stat. 1536, 1501A-584; Pub. L. 107-188, title III, Sec. 314, June
    12, 2002, 116 Stat. 674.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-188 inserted "(1)" before "The
    Secretary is authorized to conduct", added par. (2), inserted "(3)"
    before "In the case of food packed", and substituted "(4) For the
    purposes of this subsection," for "For the purposes of this
    subsection".
      1999 - Subsec. (d). Pub. L. 106-113, in first sentence,
    substituted "Under Secretary of Commerce for Intellectual Property
    and Director of the United States Patent and Trademark Office" for
    "Commissioner of Patents" and "Director" for "Commissioner".
      1993 - Subsec. (c). Pub. L. 103-80 struck out "of Agriculture"
    after "Department".
      1992 - Subsec. (c). Pub. L. 102-300, which directed the amendment
    of subsec. (c) by striking out "of Health, Education, and Welfare",
    could not be executed because such words did not appear in the
    original statutory text. See 1993 Amendment note above and Transfer
    of Functions note below.
      1970 - Subsec. (e). Pub. L. 91-513 struck out reference to
    depressant or stimulant drugs.
      1965 - Subsec. (e). Pub. L. 89-74 added subsec. (e).
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 307(b), inserted "the
    Commonwealth of Puerto Rico or" before "a Territory the Secretary".
      Subsec. (d). Pub. L. 87-781, Sec. 308, added subsec. (d).

                     EFFECTIVE DATE OF 1999 AMENDMENT                 
      Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
    1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
    113, set out as a note under section 1 of Title 35, Patents.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective July 15, 1965, see section
    11 of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for any violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be
    continued and brought to final determination in accord with laws
    and regulations in effect prior to Oct. 27, 1970, see section 702
    of Pub. L. 91-513, set out as a note under section 321 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see note set out under
    section 41 of this title.

-End-



-CITE-
    21 USC Sec. 372a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 372a. Transferred

-COD-
                               CODIFICATION                           
      Section, act June 25, 1938, ch. 675, Sec. 702A, formerly June 30,
    1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712, 48 Stat.
    1204, and amended, which related to examination of sea food, was
    renumbered section 706 of act June 25, 1938, by Pub. L. 102-571,
    title I, Sec. 106(3), Oct. 29, 1992, 106 Stat. 4498, and
    transferred to section 376 of this title.

-End-



-CITE-
    21 USC Sec. 373                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 373. Records

-STATUTE-
    (a) In general
      For the purpose of enforcing the provisions of this chapter,
    carriers engaged in interstate commerce, and persons receiving
    food, drugs, devices, or cosmetics in interstate commerce or
    holding such articles so received, shall, upon the request of an
    officer or employee duly designated by the Secretary, permit such
    officer or employee, at reasonable times, to have access to and to
    copy all records showing the movement in interstate commerce of any
    food, drug, device, or cosmetic, or the holding thereof during or
    after such movement, and the quantity, shipper, and consignee
    thereof; and it shall be unlawful for any such carrier or person to
    fail to permit such access to and copying of any such record so
    requested when such request is accompanied by a statement in
    writing specifying the nature or kind of food, drug, device, or
    cosmetic to which such request relates, except that evidence
    obtained under this section, or any evidence which is directly or
    indirectly derived from such evidence, shall not be used in a
    criminal prosecution of the person from whom obtained, and except
    that carriers shall not be subject to the other provisions of this
    chapter by reason of their receipt, carriage, holding, or delivery
    of food, drugs, devices, or cosmetics in the usual course of
    business as carriers, except as provided in subsection (b) of this
    section.
    (b) Food transportation records
      A shipper, carrier by motor vehicle or rail vehicle, receiver, or
    other person subject to section 350e of this title shall, on
    request of an officer or employee designated by the Secretary,
    permit the officer or employee, at reasonable times, to have access
    to and to copy all records that the Secretary requires to be kept
    under section 350e(c)(1)(E) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 703, 52 Stat. 1057; Pub. L. 91-452,
    title II, Sec. 230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103-80,
    Sec. 3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109-59, title VII,
    Sec. 7202(c), Aug. 10, 2005, 119 Stat. 1913.)


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-59 struck out "of interstate shipment" after
    "Records" in section catchline, designated existing provisions as
    subsec. (a), inserted subsec. heading, substituted "carriers,
    except as provided in subsection (b) of this section" for
    "carriers" before period at end, and added subsec. (b).
      1993 - Pub. L. 103-80 substituted ", except that" for ":
    Provided, That" and ", and except that" for ": Provided further,
    That".
      1970 - Pub. L. 91-452 inserted ", or any evidence which is
    directly or indirectly derived from such evidence," after "under
    this section".

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
    7204 of Pub. L. 109-59, set out as a note under section 331 of this
    title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-452 effective on sixtieth day following
    Oct. 15, 1970, and not to affect any immunity to which any
    individual is entitled under this section by reason of any
    testimony given before sixtieth day following Oct. 15, 1970, see
    section 260 of Pub. L. 91-452, set out as an Effective Date;
    Savings Provision note under section 6001 of Title 18, Crimes and
    Criminal Procedure.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 374                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 374. Inspection

-STATUTE-
    (a) Right of agents to enter; scope of inspection; notice;
      promptness; exclusions
      (1) For purposes of enforcement of this chapter, officers or
    employees duly designated by the Secretary, upon presenting
    appropriate credentials and a written notice to the owner,
    operator, or agent in charge, are authorized (A) to enter, at
    reasonable times, any factory, warehouse, or establishment in which
    food, drugs, devices, or cosmetics are manufactured, processed,
    packed, or held, for introduction into interstate commerce or after
    such introduction, or to enter any vehicle being used to transport
    or hold such food, drugs, devices, or cosmetics in interstate
    commerce; and (B) to inspect, at reasonable times and within
    reasonable limits and in a reasonable manner, such factory,
    warehouse, establishment, or vehicle and all pertinent equipment,
    finished and unfinished materials, containers, and labeling
    therein. In the case of any person (excluding farms and
    restaurants) who manufactures, processes, packs, transports,
    distributes, holds, or imports foods, the inspection shall extend
    to all records and other information described in section 350c of
    this title when the Secretary has a reasonable belief that an
    article of food is adulterated and presents a threat of serious
    adverse health consequences or death to humans or animals, subject
    to the limitations established in section 350c(d) of this title. In
    the case of any factory, warehouse, establishment, or consulting
    laboratory in which prescription drugs, nonprescription drugs
    intended for human use, or restricted devices are manufactured,
    processed, packed, or held, the inspection shall extend to all
    things therein (including records, files, papers, processes,
    controls, and facilities) bearing on whether prescription drugs,
    nonprescription drugs intended for human use, or restricted devices
    which are adulterated or misbranded within the meaning of this
    chapter, or which may not be manufactured, introduced into
    interstate commerce, or sold, or offered for sale by reason of any
    provision of this chapter, have been or are being manufactured,
    processed, packed, transported, or held in any such place, or
    otherwise bearing on violation of this chapter. No inspection
    authorized by the preceding sentence or by paragraph (3) shall
    extend to financial data, sales data other than shipment data,
    pricing data, personnel data (other than data as to qualification
    of technical and professional personnel performing functions
    subject to this chapter), and research data (other than data
    relating to new drugs, antibiotic drugs, and devices and subject to
    reporting and inspection under regulations lawfully issued pursuant
    to section 355(i) or (k) (!1) section 360i, or 360j(g) of this
    title, and data relating to other drugs or devices which in the
    case of a new drug would be subject to reporting or inspection
    under lawful regulations issued pursuant to section 355(j) of this
    title). A separate notice shall be given for each such inspection,
    but a notice shall not be required for each entry made during the
    period covered by the inspection. Each such inspection shall be
    commenced and completed with reasonable promptness.

      (2) The provisions of the third sentence of paragraph (1) shall
    not apply to - 
        (A) pharmacies which maintain establishments in conformance
      with any applicable local laws regulating the practice of
      pharmacy and medicine and which are regularly engaged in
      dispensing prescription drugs or devices, upon prescriptions of
      practitioners licensed to administer such drugs or devices to
      patients under the care of such practitioners in the course of
      their professional practice, and which do not, either through a
      subsidiary or otherwise, manufacture, prepare, propagate,
      compound, or process drugs or devices for sale other than in the
      regular course of their business of dispensing or selling drugs
      or devices at retail;
        (B) practitioners licensed by law to prescribe or administer
      drugs, or prescribe or use devices, as the case may be, and who
      manufacture, prepare, propagate, compound, or process drugs, or
      manufacture or process devices, solely for use in the course of
      their professional practice;
        (C) persons who manufacture, prepare, propagate, compound, or
      process drugs or manufacture or process devices, solely for use
      in research, teaching, or chemical analysis and not for sale;
        (D) such other classes of persons as the Secretary may by
      regulation exempt from the application of this section upon a
      finding that inspection as applied to such classes of persons in
      accordance with this section is not necessary for the protection
      of the public health.

      (3) An officer or employee making an inspection under paragraph
    (1) for purposes of enforcing the requirements of section 350a of
    this title applicable to infant formulas shall be permitted, at all
    reasonable times, to have access to and to copy and verify any
    records - 
        (A) bearing on whether the infant formula manufactured or held
      in the facility inspected meets the requirements of section 350a
      of this title, or
        (B) required to be maintained under section 350a of this title.
    (b) Written report to owner; copy to Secretary
      Upon completion of any such inspection of a factory, warehouse,
    consulting laboratory, or other establishment, and prior to leaving
    the premises, the officer or employee making the inspection shall
    give to the owner, operator, or agent in charge a report in writing
    setting forth any conditions or practices observed by him which, in
    his judgment, indicate that any food, drug, device, or cosmetic in
    such establishment (1) consists in whole or in part of any filthy,
    putrid, or decomposed substance, or (2) has been prepared, packed,
    or held under insanitary conditions whereby it may have become
    contaminated with filth, or whereby it may have been rendered
    injurious to health. A copy of such report shall be sent promptly
    to the Secretary.
    (c) Receipt for samples taken
      If the officer or employee making any such inspection of a
    factory, warehouse, or other establishment has obtained any sample
    in the course of the inspection, upon completion of the inspection
    and prior to leaving the premises he shall give to the owner,
    operator, or agent in charge a receipt describing the samples
    obtained.
    (d) Analysis of samples furnished owner
      Whenever in the course of any such inspection of a factory or
    other establishment where food is manufactured, processed, or
    packed, the officer or employee making the inspection obtains a
    sample of any such food, and an analysis is made of such sample for
    the purpose of ascertaining whether such food consists in whole or
    in part of any filthy, putrid, or decomposed substance, or is
    otherwise unfit for food, a copy of the results of such analysis
    shall be furnished promptly to the owner, operator, or agent in
    charge.
    (e) Accessibility of records
      Every person required under section 360i or 360j(g) of this title
    to maintain records and every person who is in charge or custody of
    such records shall, upon request of an officer or employee
    designated by the Secretary, permit such officer or employee at all
    reasonable times to have access to, and to copy and verify, such
    records.
    (f) Recordkeeping
      (1) An accredited person described in paragraph (3) shall
    maintain records documenting the training qualifications of the
    person and the employees of the person, the procedures used by the
    person for handling confidential information, the compensation
    arrangements made by the person, and the procedures used by the
    person to identify and avoid conflicts of interest. Upon the
    request of an officer or employee designated by the Secretary, the
    person shall permit the officer or employee, at all reasonable
    times, to have access to, to copy, and to verify, the records.
      (2) Within 15 days after the receipt of a written request from
    the Secretary to an accredited person described in paragraph (3)
    for copies of records described in paragraph (1), the person shall
    produce the copies of the records at the place designated by the
    Secretary.
      (3) For purposes of paragraphs (1) and (2), an accredited person
    described in this paragraph is a person who - 
        (A) is accredited under subsection (g) of this section; or
        (B) is accredited under section 360m of this title.
    (g) Inspections by accredited persons
      (1) Not later than one year after October 26, 2002, the Secretary
    shall, subject to the provisions of this subsection, accredit
    persons for the purpose of conducting inspections of establishments
    that manufacture, prepare, propagate, compound, or process class II
    or class III devices, which inspections are required under section
    360(h) of this title or are inspections of such establishments
    required to register under section 360(i) of this title. The owner
    or operator of such an establishment that is eligible under
    paragraph (6) may, from the list published under paragraph (4),
    select an accredited person to conduct such inspections.
      (2) Not later than 180 days after October 26, 2002, the Secretary
    shall publish in the Federal Register criteria to accredit or deny
    accreditation to persons who request to perform the duties
    specified in paragraph (1). Thereafter, the Secretary shall inform
    those requesting accreditation, within 60 days after the receipt of
    such request, whether the request for accreditation is adequate for
    review, and the Secretary shall promptly act on the request for
    accreditation. Any resulting accreditation shall state that such
    person is accredited to conduct inspections at device
    establishments identified in paragraph (1). The accreditation of
    such person shall specify the particular activities under this
    subsection for which such person is accredited. In the first year
    following the publication in the Federal Register of criteria to
    accredit or deny accreditation to persons who request to perform
    the duties specified in paragraph (1), the Secretary shall accredit
    no more than 15 persons who request to perform duties specified in
    paragraph (1).
      (3) An accredited person shall, at a minimum, meet the following
    requirements:
        (A) Such person may not be an employee of the Federal
      Government.
        (B) Such person shall be an independent organization which is
      not owned or controlled by a manufacturer, supplier, or vendor of
      articles regulated under this chapter and which has no
      organizational, material, or financial affiliation (including a
      consultative affiliation) with such a manufacturer, supplier, or
      vendor.
        (C) Such person shall be a legally constituted entity permitted
      to conduct the activities for which it seeks accreditation.
        (D) Such person shall not engage in the design, manufacture,
      promotion, or sale of articles regulated under this chapter.
        (E) The operations of such person shall be in accordance with
      generally accepted professional and ethical business practices,
      and such person shall agree in writing that at a minimum the
      person will - 
          (i) certify that reported information accurately reflects
        data reviewed, inspection observations made, other matters that
        relate to or may influence compliance with this chapter, and
        recommendations made during an inspection or at an inspection's
        closing meeting;
          (ii) limit work to that for which competence and capacity are
        available;
          (iii) treat information received, records, reports, and
        recommendations as confidential commercial or financial
        information or trade secret information, except such
        information may be made available to the Secretary;
          (iv) promptly respond and attempt to resolve complaints
        regarding its activities for which it is accredited; and
          (v) protect against the use, in carrying out paragraph (1),
        of any officer or employee of the accredited person who has a
        financial conflict of interest regarding any product regulated
        under this chapter, and annually make available to the public
        disclosures of the extent to which the accredited person, and
        the officers and employees of the person, have maintained
        compliance with requirements under this clause relating to
        financial conflicts of interest.

      (4) The Secretary shall publish on the Internet site of the Food
    and Drug Administration a list of persons who are accredited under
    paragraph (2). Such list shall be updated to ensure that the
    identity of each accredited person, and the particular activities
    for which the person is accredited, is known to the public. The
    updating of such list shall be no later than one month after the
    accreditation of a person under this subsection or the suspension
    or withdrawal of accreditation, or the modification of the
    particular activities for which the person is accredited.
      (5)(A) To ensure that persons accredited under this subsection
    continue to meet the standards of accreditation, the Secretary
    shall (i) audit the performance of such persons on a periodic basis
    through the review of inspection reports and inspections by persons
    designated by the Secretary to evaluate the compliance status of a
    device establishment and the performance of accredited persons, and
    (ii) take such additional measures as the Secretary determines to
    be appropriate.
      (B) The Secretary may withdraw accreditation of any person
    accredited under paragraph (2), after providing notice and an
    opportunity for an informal hearing, when such person is
    substantially not in compliance with the standards of
    accreditation, poses a threat to public health, fails to act in a
    manner that is consistent with the purposes of this subsection, or
    where the Secretary determines that there is a financial conflict
    of interest in the relationship between the accredited person and
    the owner or operator of a device establishment that the accredited
    person has inspected under this subsection. The Secretary may
    suspend the accreditation of such person during the pendency of the
    process under the preceding sentence.
      (6)(A) Subject to subparagraphs (B) and (C), a device
    establishment is eligible for inspections by persons accredited
    under paragraph (2) if the following conditions are met:
        (i) The Secretary classified the results of the most recent
      inspection described in paragraph (1) as "no action indicated" or
      "voluntary action indicated".
        (ii) With respect to inspections to be conducted by an
      accredited person during a 2-year period - 
          (I) the owner or operator of the establishment submits to the
        Secretary a notice requesting clearance to use an accredited
        person to conduct the inspection, and the Secretary provides
        such clearance; and
          (II) such notice identifies the accredited person whom the
        establishment has selected to conduct the inspection, and the
        Secretary agrees to the selected accredited person.

        (iii) With respect to the devices that are manufactured,
      prepared, propagated, compounded, or processed by the
      establishment, at least one of such devices is marketed in the
      United States, and 1 or both of the following additional
      conditions are met:
          (I) At least one of such devices is marketed, or is intended
        to be marketed, in one or more foreign countries, one of which
        countries certifies, accredits, or otherwise recognizes the
        person (accredited under paragraph (2) and identified under
        clause (ii)(II)) as a person authorized to conduct such
        inspections of device establishments.
          (II) The owner or operator of the establishment submits to
        the Secretary a statement that the law of a country in which
        such a device is marketed, or is intended to be marketed,
        recognizes an inspection of the establishment by the Secretary
        or by a person accredited under paragraph (2), and not later
        than 30 days after receiving such statement, the Secretary
        informs the owner or operator of the establishment that the
        owner or operator may submit a notice requesting clearance
        under clause (ii).

        (iv)(I) In the case of an inspection to be conducted pursuant
      to section 360(h) of this title, persons accredited under
      paragraph (2) did not conduct inspections of the establishment
      during the previous 4 years, except that the establishment may
      petition the Secretary for a waiver of such condition. Such a
      waiver may be granted only if the petition states a commercial
      reason for the waiver; the Secretary determines that the public
      health would be served by granting the waiver; and the Secretary
      has conducted an inspection of the establishment during the four-
      year period preceding the date on which the notice under clause
      (ii) is submitted to the Secretary. Such a waiver is deemed to be
      granted only if the Secretary has not determined that the public
      health would not be served by granting the waiver; and the owner
      or operator of the device establishment has requested in writing,
      not later than 18 months following the most recent inspection of
      such establishment by a person accredited under paragraph (2),
      that the Secretary inspect the establishment and the Secretary
      has not conducted an inspection within 30 months after the most
      recent inspection. With respect to such a waiver that is granted
      or deemed to be granted, no additional such waiver may be granted
      or deemed to be granted until after the Secretary has conducted
      an inspection of the establishment.
        (II) In the case of an inspection to be conducted of a device
      establishment required to register pursuant to section 360(i) of
      this title, the Secretary periodically conducts inspections of
      the establishment.

      (B)(i) The Secretary shall respond to a notice under subparagraph
    (A) from a device establishment not later than 30 days after the
    Secretary receives the notice. Through such response, the Secretary
    shall (I) provide clearance under such subparagraph, and agree to
    the selection of an accredited person, or (II) make a request under
    clause (ii). If the Secretary fails to respond to the notice within
    such 30-day period, the establishment is deemed to have such
    clearance, and to have the agreement of the Secretary for such
    selection.
      (ii) The request referred to in clause (i)(II) is - 
        (I) a request to the device establishment involved to submit to
      the Secretary compliance data in accordance with clause (iii); or
        (II) a request to the establishment, or to the accredited
      person identified in the notice under subparagraph (A), for
      information concerning the relationship between the establishment
      and such accredited person, including information about the
      number of inspections of the establishment, or other
      establishments owned or operated by the owner or operator of the
      establishment, that have been conducted by the accredited person.

    The Secretary may make both such requests.
      (iii) The compliance data to be submitted by a device
    establishment under clause (ii) are data describing whether the
    quality controls of the establishment have been sufficient for
    ensuring consistent compliance with current good manufacturing
    practice within the meaning of section 351(h) of this title and
    with other applicable provisions of this chapter. Such data shall
    include complete reports of inspectional findings regarding good
    manufacturing practice or other quality control audits that, during
    the preceding two-year period, were conducted at the establishment
    by persons other than the owner or operator of the establishment,
    together with all other relevant compliance data the Secretary
    deems necessary. Data under the preceding sentence shall
    demonstrate to the Secretary whether the establishment has
    facilitated consistent compliance by promptly correcting any
    compliance problems identified in such inspections.
      (iv)(I) Not later than 60 days after receiving compliance data
    under clause (iii) from a device establishment, the Secretary shall
    provide or deny clearance under subparagraph (A). The Secretary may
    deny clearance if the Secretary determines that the establishment
    has failed to demonstrate consistent compliance for purposes of
    clause (iii). The Secretary shall provide to the establishment a
    statement of such reasons for such determination. If the Secretary
    fails to provide such statement to the establishment within such 60-
    day period, the establishment is deemed to have such clearance.
      (II) If, during the two-year period following clearance under
    subparagraph (A), the Secretary determines that the device
    establishment is substantially not in compliance with this chapter,
    the Secretary may, after notice and a written response, notify the
    establishment that the eligibility of the establishment for the
    inspections by accredited persons has been suspended.
      (v)(I) A request to an accredited person under clause (ii)(II)
    may not seek any information that is not required to be maintained
    by such person in records under subsection (f)(1) of this section.
    Not later than 60 days after receiving the information sought by
    the request, the Secretary shall agree to, or reject, the selection
    of such person by the device establishment involved. The Secretary
    may reject the selection if the Secretary provides to the
    establishment a statement of the reasons for such rejection.
    Reasons for the rejection may include that the establishment or the
    accredited person, as the case may be, has failed to fully respond
    to the request, or that the Secretary has concerns regarding the
    relationship between the establishment and such accredited person.
    If within such 60-day period the Secretary fails to agree to or
    reject the selection in accordance with this subclause, the
    Secretary is deemed to have agreed to the selection.
      (II) If the Secretary rejects the selection of an accredited
    person by a device establishment, the establishment may make an
    additional selection of an accredited person by submitting to the
    Secretary a notice that identifies the additional selection.
    Clauses (i) and (ii), and subclause (I) of this clause, apply to
    the selection of an accredited person through a notice under the
    preceding sentence in the same manner and to the same extent as
    such provisions apply to a selection of an accredited person
    through a notice under subparagraph (A).
      (vi) In the case of a device establishment that under clause (iv)
    is denied clearance under subparagraph (A), or whose selection of
    an accredited person is rejected under clause (v), the Secretary
    shall designate a person to review the findings of the Secretary
    under such clause if, during the 30-day period beginning on the
    date on which the establishment receives the findings, the
    establishment requests the review. The review shall commence not
    later than 30 days after the establishment requests the review,
    unless the Secretary and the establishment otherwise agree.
      (C)(i) In the case of a device establishment for which the
    Secretary classified the results of the most recent inspection of
    the establishment by a person accredited under paragraph (2) as
    "official action indicated", the establishment, if otherwise
    eligible under subparagraph (A), is eligible for further
    inspections by persons accredited under such paragraph if (I) the
    Secretary issues a written statement to the owner or operator of
    the establishment that the violations leading to such
    classification have been resolved, and (II) the Secretary, either
    upon the Secretary's own initiative or a petition of the owner or
    operator of the establishment, notifies the establishment that it
    has clearance to use an accredited person for the inspections. The
    Secretary shall respond to such petition within 30 days after the
    receipt of the petition.
      (ii) If the Secretary denies a petition under clause (i), the
    device establishment involved may, after the expiration of one year
    after such denial, again petition the Secretary for a determination
    of eligibility for inspection by persons accredited by the
    Secretary under paragraph (2). If the Secretary denies such
    petition, the Secretary shall provide the establishment with such
    reasons for such denial within 60 days after the denial. If, as of
    the expiration of 48 months after the receipt of the first
    petition, the establishment has not been inspected by the
    Secretary, the establishment is eligible for further inspections by
    accredited persons.
      (7)(A) Persons accredited under paragraph (2) to conduct
    inspections shall record in writing their inspection observations
    and shall present the observations to the device establishment's
    designated representative and describe each observation.
    Additionally, such accredited person shall prepare an inspection
    report (including for inspections classified as "no action
    indicated") in a form and manner consistent with such reports
    prepared by employees and officials designated by the Secretary to
    conduct inspections.
      (B) At a minimum, an inspection report under subparagraph (A)
    shall identify the persons responsible for good manufacturing
    practice compliance at the inspected device establishment, the
    dates of the inspection, the scope of the inspection, and shall
    describe in detail each observation identified by the accredited
    person, identify other matters that relate to or may influence
    compliance with this chapter, and describe any recommendations
    during the inspection or at the inspection's closing meeting.
      (C) An inspection report under subparagraph (A) shall be sent to
    the Secretary and to the designated representative of the inspected
    device establishment at the same time, but under no circumstances
    later than three weeks after the last day of the inspection. The
    report to the Secretary shall be accompanied by all written
    inspection observations previously provided to the designated
    representative of the establishment.
      (D) Any statement or representation made by an employee or agent
    of a device establishment to a person accredited under paragraph
    (2) to conduct inspections shall be subject to section 1001 of
    title 18.
      (E) If at any time during an inspection by an accredited person
    the accredited person discovers a condition that could cause or
    contribute to an unreasonable risk to the public health, the
    accredited person shall immediately notify the Secretary of the
    identification of the device establishment subject to inspection
    and such condition.
      (8) Compensation for an accredited person shall be determined by
    agreement between the accredited person and the person who engages
    the services of the accredited person, and shall be paid by the
    person who engages such services.
      (9) Nothing in this subsection affects the authority of the
    Secretary to inspect any device establishment pursuant to this
    chapter.
      (10)(A) For fiscal year 2005 and each subsequent fiscal year, no
    device establishment may be inspected during the fiscal year
    involved by a person accredited under paragraph (2) if - 
        (i) of the amounts appropriated for salaries and expenses of
      the Food and Drug Administration for the preceding fiscal year
      (referred to in this subparagraph as the "first prior fiscal
      year"), the amount obligated by the Secretary for inspections of
      device establishments by the Secretary was less than the adjusted
      base amount applicable to such first prior fiscal year; and
        (ii) of the amounts appropriated for salaries and expenses of
      the Food and Drug Administration for the fiscal year preceding
      the first prior fiscal year (referred to in this subparagraph as
      the "second prior fiscal year"), the amount obligated by the
      Secretary for inspections of device establishments by the
      Secretary was less than the adjusted base amount applicable to
      such second prior fiscal year.

      (B)(i) Subject to clause (ii), the Comptroller General of the
    United States shall determine the amount that was obligated by the
    Secretary for fiscal year 2002 for compliance activities of the
    Food and Drug Administration with respect to devices (referred to
    in this subparagraph as the "compliance budget"), and of such
    amount, the amount that was obligated for inspections by the
    Secretary of device establishments (referred to in this
    subparagraph as the "inspection budget").
      (ii) For purposes of determinations under clause (i), the
    Comptroller General shall not include in the compliance budget or
    the inspection budget any amounts obligated for inspections of
    device establishments conducted as part of the process of reviewing
    applications under section 360e of this title.
      (iii) Not later than March 31, 2003, the Comptroller General
    shall complete the determinations required in this subparagraph and
    submit to the Secretary and the Congress a report describing the
    findings made through such determinations.
      (C) For purposes of this paragraph:
        (i) The term "base amount" means the inspection budget
      determined under subparagraph (B) for fiscal year 2002.
        (ii) The term "adjusted base amount", in the case of
      applicability to fiscal year 2003, means an amount equal to the
      base amount increased by 5 percent.
        (iii) The term "adjusted base amount", with respect to
      applicability to fiscal year 2004 or any subsequent fiscal year,
      means the adjusted based amount applicable to the preceding year
      increased by 5 percent.

      (11) The authority provided by this subsection terminates on
    October 1, 2012.
      (12) No later than four years after October 26, 2002, the
    Comptroller General shall report to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on
    Health, Education, Labor and Pensions of the Senate - 
        (A) the number of inspections conducted by accredited persons
      pursuant to this subsection and the number of inspections
      conducted by Federal employees pursuant to section 360(h) of this
      title and of device establishments required to register under
      section 360(i) of this title;
        (B) the number of persons who sought accreditation under this
      subsection, as well as the number of persons who were accredited
      under this subsection;
        (C) the reasons why persons who sought accreditation, but were
      denied accreditation, were denied;
        (D) the number of audits conducted by the Secretary of
      accredited persons, the quality of inspections conducted by
      accredited persons, whether accredited persons are meeting their
      obligations under this chapter, and whether the number of audits
      conducted is sufficient to permit these assessments;
        (E) whether this subsection is achieving the goal of ensuring
      more information about device establishment compliance is being
      presented to the Secretary, and whether that information is of a
      quality consistent with information obtained by the Secretary
      pursuant to inspections conducted by Federal employees;
        (F) whether this subsection is advancing efforts to allow
      device establishments to rely upon third-party inspections for
      purposes of compliance with the laws of foreign governments; and
        (G) whether the Congress should continue, modify, or terminate
      the program under this subsection.

      (13) The Secretary shall include in the annual report required
    under section 393(g) of this title the names of all accredited
    persons and the particular activities under this subsection for
    which each such person is accredited and the name of each
    accredited person whose accreditation has been withdrawn during the
    year.
      (14) Notwithstanding any provision of this subsection, this
    subsection does not have any legal effect on any agreement
    described in section 383(b) of this title between the Secretary and
    a foreign country.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 704, 52 Stat. 1057; Aug. 7, 1953, ch.
    350, Sec. 1, 67 Stat. 476; Pub. L. 87-781, title II, Sec. 201(a),
    (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, Sec. 6, May
    28, 1976, 90 Stat. 581; Pub. L. 96-359, Sec. 4, Sept. 26, 1980, 94
    Stat. 1193; Pub. L. 103-80, Sec. 3(aa), Aug. 13, 1993, 107 Stat.
    778; Pub. L. 105-115, title I, Sec. 125(b)(2)(L), title II, Sec.
    210(b), title IV, Sec. 412(b), Nov. 21, 1997, 111 Stat. 2326, 2344,
    2375; Pub. L. 107-188, title III, Sec. 306(b), June 12, 2002, 116
    Stat. 670; Pub. L. 107-250, title II, Sec. 201(a), (b), Oct. 26,
    2002, 116 Stat. 1602, 1609; Pub. L. 108-214, Sec. 2(b)(1), Apr. 1,
    2004, 118 Stat. 573.)


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (g)(1). Pub. L. 108-214, Sec. 2(b)(1)(A), in first
    sentence, substituted "conducting inspections of establishments
    that manufacture, prepare, propagate, compound, or process class II
    or class III devices, which inspections are required under section
    360(h) of this title or are inspections of such establishments
    required to register under section 360(i) of this title." for
    "conducting inspections of establishments that manufacture,
    prepare, propagate, compound, or process class II or class III
    devices that are required in section 360(h) of this title, or
    inspections of such establishments required to register pursuant to
    section 360(i) of this title."
      Subsec. (g)(5)(B). Pub. L. 108-214, Sec. 2(b)(1)(B), in first
    sentence, substituted "poses a threat to public health, fails to
    act in a manner that is consistent with the purposes of this
    subsection, or where the Secretary determines that there is a
    financial conflict of interest in the relationship between the
    accredited person and the owner or operator of a device
    establishment that the accredited person has inspected under this
    subsection." for "or poses a threat to public health or fails to
    act in a manner that is consistent with the purposes of this
    subsection."
      Subsec. (g)(6)(A)(i). Pub. L. 108-214, Sec. 2(b)(1)(C)(i),
    substituted "described in paragraph (1)" for "of the establishment
    pursuant to subsection (h) or (i) of section 360 of this title".
      Subsec. (g)(6)(A)(ii). Pub. L. 108-214, Sec. 2(b)(1)(C)(ii)(I),
    substituted "inspections" for "each inspection" and inserted
    "during a 2-year period" after "person" in introductory provisions.
      Subsec. (g)(6)(A)(ii)(I). Pub. L. 108-214, Sec.
    2(b)(1)(C)(ii)(II), substituted "an accredited person" for "such a
    person".
      Subsec. (g)(6)(A)(iii). Pub. L. 108-214, Sec. 2(b)(1)(C)(iii)(I),
    substituted "and 1 or both of the following additional conditions
    are met:" for "and the following additional conditions are met:" in
    introductory provisions.
      Subsec. (g)(6)(A)(iii)(I). Pub. L. 108-214, Sec.
    2(b)(1)(C)(iii)(II), substituted "(accredited under paragraph (2)
    and identified under clause (ii)(II)) as a person authorized to
    conduct such inspections of device establishments." for "accredited
    under paragraph (2) and identified under subclause (II) of this
    clause."
      Subsec. (g)(6)(A)(iii)(II). Pub. L. 108-214, Sec.
    2(b)(1)(C)(iii)(III), inserted "or by a person accredited under
    paragraph (2)" after "by the Secretary".
      Subsec. (g)(6)(A)(iv)(I). Pub. L. 108-214, Sec. 2(b)(1)(C)(iv),
    in first sentence, inserted "section" after "pursuant to" and
    substituted "inspections of the establishment during the previous 4
    years" for "the two immediately preceding inspections of the
    establishment", in third sentence, struck out "the petition states
    a commercial reason for the waiver;" after "granted only if" and
    inserted "not" after "the Secretary has not determined that the
    public health would", and, in last sentence, substituted "granted
    or deemed to be granted until" for "granted until".
      Subsec. (g)(6)(A)(iv)(II). Pub. L. 108-214, Sec. 2(b)(1)(C)(v),
    inserted "of a device establishment required to register" after "to
    be conducted" and "section" after "pursuant to".
      Subsec. (g)(6)(B)(iii). Pub. L. 108-214, Sec. 2(b)(1)(D), in
    first sentence, substituted "and with other" for ", and data
    otherwise describing whether the establishment has consistently
    been in compliance with sections 351 and 352 of this title and
    other" and, in second sentence, substituted "inspectional findings"
    for "inspections" and inserted "relevant" after "together with all
    other".
      Subsec. (g)(6)(B)(iv). Pub. L. 108-214, Sec. 2(b)(1)(E),
    designated existing provisions as subcl. (I) and added subcl. (II).
      Subsec. (g)(6)(C)(ii). Pub. L. 108-214, Sec. 2(b)(1)(F), struck
    out "in accordance with section 360(h) of this title, or has not
    during such period been inspected pursuant to section 360(i) of
    this title, as applicable" after "inspected by the Secretary".
      Subsec. (g)(10)(B)(iii). Pub. L. 108-214, Sec. 2(b)(1)(G),
    substituted "a report" for "a reporting".
      Subsec. (g)(12)(A). Pub. L. 108-214, Sec. 2(b)(1)(H)(i), added
    subpar. (A) and struck out former subpar. (A) which read as
    follows: "the number of inspections pursuant to subsections (h) and
    (i) of section 360 of this title conducted by accredited persons
    and the number of inspections pursuant to such subsections
    conducted by Federal employees;".
      Subsec. (g)(12)(E). Pub. L. 108-214, Sec. 2(b)(1)(H)(ii),
    substituted "obtained by the Secretary pursuant to inspections
    conducted by Federal employees;" for "obtained by the Secretary
    pursuant to subsection (h) or (i) of section 360 of this title;".
      2002 - Subsec. (a)(1). Pub. L. 107-188, Sec. 306(b)(1), inserted
    after first sentence "In the case of any person (excluding farms
    and restaurants) who manufactures, processes, packs, transports,
    distributes, holds, or imports foods, the inspection shall extend
    to all records and other information described in section 350c of
    this title when the Secretary has a reasonable belief that an
    article of food is adulterated and presents a threat of serious
    adverse health consequences or death to humans or animals, subject
    to the limitations established in section 350c(d) of this title."
      Subsec. (a)(2). Pub. L. 107-188, Sec. 306(b)(2), substituted
    "third sentence" for "second sentence" in introductory provisions.
      Subsec. (f)(1). Pub. L. 107-250, Sec. 201(b)(1), in first
    sentence, substituted "An accredited person described in paragraph
    (3) shall maintain records" for "A person accredited under section
    360m of this title to review reports made under section 360(k) of
    this title and make recommendations of initial classifications of
    devices to the Secretary shall maintain records".
      Subsec. (f)(2). Pub. L. 107-250, Sec. 201(b)(2), substituted "an
    accredited person described in paragraph (3)" for "a person
    accredited under section 360m of this title".
      Subsec. (f)(3). Pub. L. 107-250, Sec. 201(b)(3), added par. (3).
      Subsec. (g). Pub. L. 107-250, Sec. 201(a), added subsec. (g).
      1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 412(b), substituted
    "prescription drugs, nonprescription drugs intended for human use,"
    for "prescription drugs" in two places.
      Pub. L. 105-115, Sec. 125(b)(2)(L), struck out ", section 357(d)
    or (g)," before "section 360i".
      Subsec. (f). Pub. L. 105-115, Sec. 210(b), added subsec. (f).
      1993 - Subsec. (a)(1). Pub. L. 103-80 substituted a comma for
    semicolon after "finished and unfinished materials" and "section
    355(i) or (k)" for "section 355(i) or (j)".
      1980 - Subsec. (a)(1). Pub. L. 96-359, Sec. 4(1), (2),
    restructured first five sentences of former subsec. (a) as par. (1)
    and, as so restructured, inserted reference to paragraph (3) and
    substituted "(A)" and "(B)" for "(1)" and "(2)", respectively.
      Subsec. (a)(2). Pub. L. 96-359, Sec. 4(3), redesignated sixth
    sentence of former subsec. (a) as par. (2) and, as so redesignated,
    substituted reference to second sentence of paragraph (1) for
    reference to former second sentence of this subsection, and "(A)",
    "(B)", "(C)", and "(D)", for "(1)", "(2)", "(3)", and "(4)",
    respectively.
      Subsec. (a)(3). Pub. L. 96-359, Sec. 4(4), added par. (3).
      1976 - Subsec. (a). Pub. L. 94-295, Sec. 6(a)-(c), expanded
    existing provisions to encompass medical devices by inserting
    references to factories, warehouses, establishments, and consulting
    laboratories in which restricted devices are manufactured,
    processed, packed, or held, inspections relating to devices,
    reporting and inspection regulations issued pursuant to sections
    360i and 360j(g) of this title, and the manufacture and processing
    of devices.
      Subsec. (e). Pub. L. 94-295, Sec. 6(d), added subsec. (e).
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 201(a), extended the
    inspection, where prescription drugs are manufactured, processed,
    packed, or held, to all things bearing on whether adulterated or
    misbranded drugs, or any which may not be manufactured, introduced
    in interstate commerce, or sold or offered for sale under any
    provision of this chapter, have been or are being manufactured,
    processed, packed, transported or held in any such place, or
    otherwise bearing on violation of this chapter, but excluded from
    such inspection, data concerning finance, sales other than
    shipment, pricing, personnel other than qualifications of technical
    and professional personnel, research other than relating to new
    drugs subject to reporting, provided that provisions of second
    sentence of this subsection shall be inapplicable to pharmacies,
    practitioners and other persons enumerated in pars. (1) to (4), and
    struck out "are held" before "after such introduction".
      Subsec. (b). Pub. L. 87-781, Sec. 201(b), inserted "consulting
    laboratory" after "warehouse".
      1953 - Act Aug. 7, 1953, designated existing provisions as
    subsec. (a) and amended them by substituting provisions permitting
    entry and inspection upon presentation of appropriate credentials
    and a written notice to the owner, operator, or agent in charge for
    provisions which authorized entry and inspection only after making
    a request and obtaining permission from the owner, operator, or
    custodian, and inserting provisions requiring a separate written
    notice for each inspection but not for each entry made during the
    period covered by the inspection, and directing that the inspection
    shall be conducted within reasonable limits, in a reasonable manner
    and completed with reasonable promptness, and added subsecs. (b) to
    (d).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 210(b) and 412(b) of Pub. L. 105-115
    effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    203 of Pub. L. 87-781, set out as a note under section 332 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
             AUTHORITY OF SECRETARY PRIOR TO OCTOBER 10, 1962         
      Section 201(d) of Pub. L. 87-781 provided that: "Nothing in the
    amendments made by subsections (a) and (b) of this section
    [amending this section] shall be construed to negate or derogate
    from any authority of the Secretary existing prior to the enactment
    of this Act [Oct. 10, 1962]."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 374a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 374a. Inspections relating to food allergens

-STATUTE-
      The Secretary of Health and Human Services shall conduct
    inspections consistent with the authority under section 374 of this
    title of facilities in which foods are manufactured, processed,
    packed, or held - 
        (1) to ensure that the entities operating the facilities comply
      with practices to reduce or eliminate cross-contact of a food
      with residues of major food allergens that are not intentional
      ingredients of the food; and
        (2) to ensure that major food allergens are properly labeled on
      foods.

-SOURCE-
    (Pub. L. 108-282, title II, Sec. 205, Aug. 2, 2004, 118 Stat. 909.)

-COD-
                               CODIFICATION                           
      Section was enacted as a part of the Food Allergen Labeling and
    Consumer Protection Act of 2004, and not as part of the Federal
    Food, Drug, and Cosmetic Act which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 375                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 375. Publicity

-STATUTE-
    (a) Reports
      The Secretary shall cause to be published from time to time
    reports summarizing all judgments, decrees, and court orders which
    have been rendered under this chapter, including the nature of the
    charge and the disposition thereof.
    (b) Information regarding certain goods
      The Secretary may also cause to be disseminated information
    regarding food, drugs, devices, or cosmetics in situations
    involving, in the opinion of the Secretary, imminent danger to
    health or gross deception of the consumer. Nothing in this section
    shall be construed to prohibit the Secretary from collecting,
    reporting, and illustrating the results of the investigations of
    the Department.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 705, 52 Stat. 1057.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 376                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 376. Examination of sea food on request of packer; marking
      food with results; fees; penalties

-STATUTE-
      The Secretary, upon application of any packer of any sea food for
    shipment or sale within the jurisdiction of this chapter, may, at
    his discretion, designate inspectors to examine and inspect such
    food and the production, packing, and labeling thereof. If on such
    examination and inspection compliance is found with the provisions
    of this chapter and regulations promulgated thereunder, the
    applicant shall be authorized or required to mark the food as
    provided by regulation to show such compliance. Services under this
    section shall be rendered only upon payment by the applicant of
    fees fixed by regulation in such amounts as may be necessary to
    provide, equip, and maintain an adequate and efficient inspection
    service. Receipts from such fees shall be covered into the Treasury
    and shall be available to the Secretary for expenditures incurred
    in carrying out the purposes of this section, including
    expenditures for salaries of additional inspectors when necessary
    to supplement the number of inspectors for whose salaries Congress
    has appropriated. The Secretary is authorized to promulgate
    regulations governing the sanitary and other conditions under which
    the service herein provided shall be granted and maintained, and
    for otherwise carrying out the purposes of this section. Any person
    who forges, counterfeits, simulates, or falsely represents, or
    without proper authority uses any mark, stamp, tag, label, or other
    identification devices authorized or required by the provisions of
    this section or regulations thereunder, shall be guilty of a
    misdemeanor, and shall on conviction thereof be subject to
    imprisonment for not more than one year or a fine of not less than
    $1,000 nor more than $5,000, or both such imprisonment and fine.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 706, formerly Sec. 702A, formerly
    June 30, 1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712,
    48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June
    25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059; renumbered Sec. 702A
    of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat.
    500; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
    renumbered Sec. 706, Pub. L. 102-571, title I, Sec. 106(3), Oct.
    29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(dd)(2), Aug. 13,
    1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 372a of this title
    prior to renumbering by Pub. L. 102-571.
      Section, which formerly was not a part of the Federal Food, Drug,
    and Cosmetic Act, originally was classified to section 14a of this
    title. Section 902(a) of act June 25, 1938, set out as an Effective
    Date note under section 301 of this title, provided that the
    section should remain in force and effect and be applicable to the
    provisions of this chapter. Act July 12, 1943, renumbered this
    section as 702A of the Federal Food, Drug, and Cosmetic Act.


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 376, act June 25, 1938, ch. 675, Sec. 706, 52
    Stat. 1058, as amended, which related to listing and certification
    of color additives for foods, drugs, devices, and cosmetics, was
    renumbered section 721 of act June 25, 1938, by Pub. L. 102-571,
    title I, Sec. 106(4), Oct. 29, 1992, 106 Stat. 4498, and
    transferred to section 379e of this title.

                                AMENDMENTS                            
      1993 - Pub. L. 103-80 struck out "of Agriculture" after
    "Secretary" in two places.
      1992 - Pub. L. 102-300, which directed the amendment of the
    section by striking out "of Health, Education, and Welfare"
    wherever appearing, could not be executed because such words did
    not appear in the original statutory text. See 1993 Amendment note
    above and Transfer of Functions note below.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 377                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 377. Revision of United States Pharmacopoeia; development of
      analysis and mechanical and physical tests

-STATUTE-
      The Secretary, in carrying into effect the provisions of this
    chapter, is authorized on and after July 12, 1943, to cooperate
    with associations and scientific societies in the revision of the
    United States Pharmacopoeia and in the development of methods of
    analysis and mechanical and physical tests necessary to carry out
    the work of the Food and Drug Administration.

-SOURCE-
    (July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan
    No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Labor-Federal Security
    Appropriation Act, 1944, and not as part of the Federal Food, Drug,
    and Cosmetic Act which comprises this chapter.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 378                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 378. Advertising of foods

-STATUTE-
    (a) Determination of misbranding; notification of Federal Trade
      Commission by Secretary; contents
      (1) Except as provided in subsection (c) of this section, before
    the Secretary may initiate any action under subchapter III of this
    chapter - 
        (A) with respect to any food which the Secretary determines is
      misbranded under section 343(a)(2) of this title because of its
      advertising, or
        (B) with respect to a food's advertising which the Secretary
      determines causes the food to be so misbranded,

    the Secretary shall, in accordance with paragraph (2), notify in
    writing the Federal Trade Commission of the action the Secretary
    proposes to take respecting such food or advertising.
      (2) The notice required by paragraph (1) shall - 
        (A) contain (i) a description of the action the Secretary
      proposes to take and of the advertising which the Secretary has
      determined causes a food to be misbranded, (ii) a statement of
      the reasons for the Secretary's determination that such
      advertising has caused such food to be misbranded, and
        (B) be accompanied by the records, documents, and other written
      materials which the Secretary determines supports his
      determination that such food is misbranded because of such
      advertising.
    (b) Action by Federal Trade Commission precluding action by
      Secretary; exception
      (1) If the Secretary notifies the Federal Trade Commission under
    subsection (a) of this section of action proposed to be taken under
    subchapter III of this chapter with respect to a food or food
    advertising and the Commission notifies the Secretary in writing,
    within the 30-day period beginning on the date of the receipt of
    such notice, that - 
        (A) it has initiated under the Federal Trade Commission Act [15
      U.S.C. 41 et seq.] an investigation of such advertising to
      determine if it is prohibited by such Act or any order or rule
      under such Act,
        (B) it has commenced (or intends to commence) a civil action
      under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with
      respect to such advertising or the Attorney General has commenced
      (or intends to commence) a civil action under section 5 [15
      U.S.C. 45] with respect to such advertising,
        (C) it has issued and served (or intends to issue and serve) a
      complaint under section 5(b) of such Act [15 U.S.C. 45(b)]
      respecting such advertising, or
        (D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it
      has made a certification to the Attorney General respecting such
      advertising,

    the Secretary may not, except as provided by paragraph (2),
    initiate the action described in the Secretary's notice to the
    Federal Trade Commission.
      (2) If, before the expiration of the 60-day period beginning on
    the date the Secretary receives a notice described in paragraph (1)
    from the Federal Trade Commission in response to a notice of the
    Secretary under subsection (a) of this section - 
        (A) the Commission or the Attorney General does not commence a
      civil action described in subparagraph (B) of paragraph (1) of
      this subsection respecting the advertising described in the
      Secretary's notice,
        (B) the Commission does not issue and serve a complaint
      described in subparagraph (C) of such paragraph respecting such
      advertising, or
        (C) the Commission does not (as described in subparagraph (D)
      of such paragraph) make a certification to the Attorney General
      respecting such advertising, or, if the Commission does make such
      a certification to the Attorney General respecting such
      advertising, the Attorney General, before the expiration of such
      period, does not cause appropriate criminal proceedings to be
      brought against such advertising,

    the Secretary may, after the expiration of such period, initiate
    the action described in the notice to the Commission pursuant to
    subsection (a) of this section. The Commission shall promptly
    notify the Secretary of the commencement by the Commission of such
    a civil action, the issuance and service by it of such a complaint,
    or the causing by the Attorney General of criminal proceedings to
    be brought against such advertising.
    (c) Secretary's determination of imminent hazard to health as
      suspending applicability of provisions
      The requirements of subsections (a) and (b) of this section do
    not apply with respect to action under subchapter III of this
    chapter with respect to any food or food advertising if the
    Secretary determines that such action is required to eliminate an
    imminent hazard to health.
    (d) Coordination of action by Secretary with Federal Trade
      Commission
      For the purpose of avoiding unnecessary duplication, the
    Secretary shall coordinate any action taken under subchapter III of
    this chapter because of advertising which the Secretary determines
    causes a food to be misbranded with any action of the Federal Trade
    Commission under the Federal Trade Commission Act [15 U.S.C. 41 et
    seq.] with respect to such advertising.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 707, as added Pub. L. 94-278, title
    V, Sec. 502(b), Apr. 22, 1976, 90 Stat. 412.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Trade Commission Act, referred to in subsecs. (b) and
    (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, as amended,
    which is classified generally to subchapter I (Sec. 41 et seq.) of
    chapter 2 of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see section 58 of Title 15
    and Tables.

-End-



-CITE-
    21 USC Sec. 379                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379. Confidential information

-STATUTE-
      The Secretary may provide any information which is exempt from
    disclosure pursuant to subsection (a) of section 552 of title 5 by
    reason of subsection (b)(4) of such section to a person other than
    an officer or employee of the Department if the Secretary
    determines such other person requires the information in connection
    with an activity which is undertaken under contract with the
    Secretary, which relates to the administration of this chapter, and
    with respect to which the Secretary (or an officer or employee of
    the Department) is not prohibited from using such information. The
    Secretary shall require as a condition to the provision of
    information under this section that the person receiving it take
    such security precautions respecting the information as the
    Secretary may by regulation prescribe.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 708, as added Pub. L. 94-295, Sec. 8,
    May 28, 1976, 90 Stat. 582.)

-End-



-CITE-
    21 USC Sec. 379a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379a. Presumption of existence of jurisdiction

-STATUTE-
      In any action to enforce the requirements of this chapter
    respecting a device, food, drug, or cosmetic the connection with
    interstate commerce required for jurisdiction in such action shall
    be presumed to exist.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 709, as added Pub. L. 94-295, Sec. 8,
    May 28, 1976, 90 Stat. 583; amended Pub. L. 105-115, title IV, Sec.
    419, Nov. 21, 1997, 111 Stat. 2379.)


-MISC1-
                                AMENDMENTS                            
      1997 - Pub. L. 105-115 substituted "a device, food, drug, or
    cosmetic" for "a device".

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 379b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379b. Consolidated administrative and laboratory facility

-STATUTE-
    (a) Authority
      The Secretary, in consultation with the Administrator of the
    General Services Administration, shall enter into contracts for the
    design, construction, and operation of a consolidated Food and Drug
    Administration administrative and laboratory facility.
    (b) Awarding of contract
      The Secretary shall solicit contract proposals under subsection
    (a) of this section from interested parties. In awarding contracts
    under such subsection, the Secretary shall review such proposals
    and give priority to those alternatives that are the most cost
    effective for the Federal Government and that allow for the use of
    donated land, federally owned property, or lease-purchase
    arrangements. A contract under this subsection shall not be entered
    into unless such contract results in a net cost savings to the
    Federal Government over the duration of the contract, as compared
    to the Government purchase price including borrowing by the
    Secretary of the Treasury.
    (c) Donations
      In carrying out this section, the Secretary shall have the power,
    in connection with real property, buildings, and facilities, to
    accept on behalf of the Food and Drug Administration gifts or
    donations of services or property, real or personal, as the
    Secretary determines to be necessary.
    (d) Authorization of appropriations
      There are authorized to be appropriated to carry out this section
    $100,000,000 for fiscal year 1991, and such sums as may be
    necessary for each of the subsequent fiscal years, to remain
    available until expended.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 710, as added Pub. L. 101-635, title
    I, Sec. 101, Nov. 28, 1990, 104 Stat. 4583.)

-End-



-CITE-
    21 USC Sec. 379c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379c. Transferred

-COD-
                               CODIFICATION                           
      Section, act June 25, 1938, ch. 675, Sec. 711, as added Nov. 28,
    1990, Pub. L. 101-635, title II, Sec. 201, 104 Stat. 4584, which
    related to recovery and retention of fees for freedom of
    information requests, was renumbered section 731 of act June 25,
    1938, by Pub. L. 102-571, title I, Sec. 106(6), Oct. 29, 1992, 106
    Stat. 4499, and transferred to section 379f of this title.

-End-



-CITE-
    21 USC Sec. 379d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379d. Automation of Food and Drug Administration

-STATUTE-
    (a) In general
      The Secretary, acting through the Commissioner of Food and Drugs,
    shall automate appropriate activities of the Food and Drug
    Administration to ensure timely review of activities regulated
    under this chapter.
    (b) Authorization of appropriations
      There are authorized to be appropriated each fiscal year such
    sums as are necessary to carry out this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 711, formerly Sec. 712, as added Pub.
    L. 101-635, title IV, Sec. 401, Nov. 28, 1990, 104 Stat. 4585;
    renumbered Sec. 711, Pub. L. 102-571, title I, Sec. 106(3), Oct.
    29, 1992, 106 Stat. 4498.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 711 of act June 25, 1938, was renumbered section
    731 by Pub. L. 102-571 and is classified to section 379f of this
    title.

-End-


-CITE-
    21 USC Part B - Colors                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part B - Colors

-HEAD-
                              PART B - COLORS                          

-End-



-CITE-
    21 USC Sec. 379e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part B - Colors

-HEAD-
    Sec. 379e. Listing and certification of color additives for foods,
      drugs, devices, and cosmetics

-STATUTE-
    (a) Unsafe color additives
      A color additive shall, with respect to any particular use (for
    which it is being used or intended to be used or is represented as
    suitable) in or on food or drugs or devices or cosmetics, be deemed
    unsafe for the purposes of the application of section 342(c),
    351(a)(4), or 361(e) of this title, as the case may be, unless - 
        (1)(A) there is in effect, and such additive and such use are
      in conformity with, a regulation issued under subsection (b) of
      this section listing such additive for such use, including any
      provision of such regulation prescribing the conditions under
      which such additive may be safely used, and (B) such additive
      either (i) is from a batch certified, in accordance with
      regulations issued pursuant to subsection (c) of this section,
      for such use, or (ii) has, with respect to such use, been
      exempted by the Secretary from the requirement of certification;
      or
        (2) such additive and such use thereof conform to the terms of
      an exemption which is in effect pursuant to subsection (f) of
      this section.

    While there are in effect regulations under subsections (b) and (c)
    of this section relating to a color additive or an exemption
    pursuant to subsection (f) of this section with respect to such
    additive, an article shall not, by reason of bearing or containing
    such additive in all respects in accordance with such regulations
    or such exemption, be considered adulterated within the meaning of
    clause (1) of section 342(a) of this title if such article is a
    food, or within the meaning of section 361(a) of this title if such
    article is a cosmetic other than a hair dye (as defined in the last
    sentence of section 361(a) of this title). A color additive for use
    in or on a device shall be subject to this section only if the
    color additive comes in direct contact with the body of man or
    other animals for a significant period of time. The Secretary may
    by regulation designate the uses of color additives in or on
    devices which are subject to this section.
    (b) Listing of colors; regulations; issuance, amendment or repeal;
      referral to advisory committee; report and recommendations;
      appointment and compensation of advisory committee
      (1) The Secretary shall, by regulation, provide for separately
    listing color additives for use in or on food, color additives for
    use in or on drugs, or devices, and color additives for use in or
    on cosmetics, if and to the extent that such additives are suitable
    and safe for any such use when employed in accordance with such
    regulations.
      (2)(A) Such regulations may list any color additive for use
    generally in or on food, or in or on drugs or devices, or in or on
    cosmetics, if the Secretary finds that such additive is suitable
    and may safely be employed for such general use.
      (B) If the data before the Secretary do not establish that the
    additive satisfies the requirements for listing such additive on
    the applicable list pursuant to subparagraph (A) of this paragraph,
    or if the proposal is for listing such additive for a more limited
    use or uses, such regulations may list such additive only for any
    more limited use or uses for which it is suitable and may safely be
    employed.
      (3) Such regulations shall, to the extent deemed necessary by the
    Secretary to assure the safety of the use or uses for which a
    particular color additive is listed, prescribe the conditions under
    which such additive may be safely employed for such use or uses
    (including, but not limited to, specifications, hereafter in this
    section referred to as tolerance limitations, as to the maximum
    quantity or quantities which may be used or permitted to remain in
    or on the article or articles in or on which it is used;
    specifications as to the manner in which such additive may be added
    to or used in or on such article or articles; and directions or
    other labeling or packaging requirements for such additive).
      (4) The Secretary shall not list a color additive under this
    section for a proposed use unless the data before him establish
    that such use, under the conditions of use specified in the
    regulations, will be safe: Provided, however, That a color additive
    shall be deemed to be suitable and safe for the purpose of listing
    under this subsection for use generally in or on food, while there
    is in effect a published finding of the Secretary declaring such
    substance exempt from the term "food additive" because of its being
    generally recognized by qualified experts as safe for its intended
    use, as provided in section 321(s) of this title.
      (5)(A) In determining, for the purposes of this section, whether
    a proposed use of a color additive is safe, the Secretary shall
    consider, among other relevant factors - 
        (i) the probable consumption of, or other relevant exposure
      from, the additive and of any substance formed in or on food,
      drugs or devices, or cosmetics because of the use of the
      additive;
        (ii) the cumulative effect, if any, of such additive in the
      diet of man or animals, taking into account the same or any
      chemically or pharmacologically related substance or substances
      in such diet;
        (iii) safety factors which, in the opinion of experts qualified
      by scientific training and experience to evaluate the safety of
      color additives for the use or uses for which the additive is
      proposed to be listed, are generally recognized as appropriate
      for the use of animal experimentation data; and
        (iv) the availability of any needed practicable methods of
      analysis for determining the identity and quantity of (I) the
      pure dye and all intermediates and other impurities contained in
      such color additive, (II) such additive in or on any article of
      food, drug or device, or cosmetic, and (III) any substance formed
      in or on such article because of the use of such additive.

      (B) A color additive (i) shall be deemed unsafe, and shall not be
    listed, for any use which will or may result in ingestion of all or
    part of such additive, if the additive is found by the Secretary to
    induce cancer when ingested by man or animal, or if it is found by
    the Secretary, after tests which are appropriate for the evaluation
    of the safety of additives for use in food, to induce cancer in man
    or animal, and (ii) shall be deemed unsafe, and shall not be
    listed, for any use which will not result in ingestion of any part
    of such additive, if, after tests which are appropriate for the
    evaluation of the safety of additives for such use, or after other
    relevant exposure of man or animal to such additive, it is found by
    the Secretary to induce cancer in man or animal: Provided, That
    clause (i) of this subparagraph (B) shall not apply with respect to
    the use of a color additive as an ingredient of feed for animals
    which are raised for food production, if the Secretary finds that,
    under the conditions of use and feeding specified in proposed
    labeling and reasonably certain to be followed in practice, such
    additive will not adversely affect the animals for which such feed
    is intended, and that no residue of the additive will be found (by
    methods of examination prescribed or approved by the Secretary by
    regulations, which regulations shall not be subject to subsection
    (d) of this section) in any edible portion of such animals after
    slaughter or in any food yielded by or derived from the living
    animal.
      (C)(i) In any proceeding for the issuance, amendment, or repeal
    of a regulation listing a color additive, whether commenced by a
    proposal of the Secretary on his own initiative or by a proposal
    contained in a petition, the petitioner, or any other person who
    will be adversely affected by such proposal or by the Secretary's
    order issued in accordance with paragraph (1) of section 371(e) of
    this title if placed in effect, may request, within the time
    specified in this subparagraph, that the petition or order thereon,
    or the Secretary's proposal, be referred to an advisory committee
    for a report and recommendations with respect to any matter arising
    under subparagraph (B) of this paragraph, which is involved in such
    proposal or order and which requires the exercise of scientific
    judgment. Upon such request, or if the Secretary within such time
    deems such a referral necessary, the Secretary shall forthwith
    appoint an advisory committee under subparagraph (D) of this
    paragraph and shall refer to it, together with all the data before
    him, such matter arising under subparagraph (B) for study thereof
    and for a report and recommendations on such matter. A person who
    has filed a petition or who has requested the referral of a matter
    to an advisory committee pursuant to this subparagraph (C), as well
    as representatives of the Department, shall have the right to
    consult with such advisory committee in connection with the matter
    referred to it. The request for referral under this subparagraph,
    or the Secretary's referral on his own initiative, may be made at
    any time before, or within thirty days after, publication of an
    order of the Secretary acting upon the petition or proposal.
      (ii) Within sixty days after the date of such referral, or within
    an additional thirty days if the committee deems such additional
    time necessary, the committee shall, after independent study of the
    data furnished to it by the Secretary and other data before it,
    certify to the Secretary a report and recommendations, together
    with all underlying data and a statement of the reasons or basis
    for the recommendations. A copy of the foregoing shall be promptly
    supplied by the Secretary to any person who has filed a petition,
    or who has requested such referral to the advisory committee.
    Within thirty days after such certification, and after giving due
    consideration to all data then before him, including such report,
    recommendations, underlying data, and statement, and to any prior
    order issued by him in connection with such matter, the Secretary
    shall by order confirm or modify any order theretofore issued or,
    if no such prior order has been issued, shall by order act upon the
    petition or other proposal.
      (iii) Where - 
        (I) by reason of subparagraph (B) of this paragraph, the
      Secretary has initiated a proposal to remove from listing a color
      additive previously listed pursuant to this section; and
        (II) a request has been made for referral of such proposal to
      an advisory committee;

    the Secretary may not act by order on such proposal until the
    advisory committee has made a report and recommendations to him
    under clause (ii) of this subparagraph and he has considered such
    recommendations, unless the Secretary finds that emergency
    conditions exist necessitating the issuance of an order
    notwithstanding this clause.
      (D) The advisory committee referred to in subparagraph (C) of
    this paragraph shall be composed of experts selected by the
    National Academy of Sciences, qualified in the subject matter
    referred to the committee and of adequately diversified
    professional background, except that in the event of the inability
    or refusal of the National Academy of Sciences to act, the
    Secretary shall select the members of the committee. The size of
    the committee shall be determined by the Secretary. Members of any
    advisory committee established under this chapter, while attending
    conferences or meetings of their committees or otherwise serving at
    the request of the Secretary, shall be entitled to receive
    compensation at rates to be fixed by the Secretary but at rates not
    exceeding the daily equivalent of the rate specified at the time of
    such service for grade GS-18 of the General Schedule, including
    traveltime; and while away from their homes or regular places of
    business they may be allowed travel expenses, including per diem in
    lieu of subsistence, as authorized by section 5703 of title 5 for
    persons in the Government service employed intermittently. The
    members shall not be subject to any other provisions of law
    regarding the appointment and compensation of employees of the
    United States. The Secretary shall furnish the committee with
    adequate clerical and other assistance, and shall by rules and
    regulations prescribe the procedure to be followed by the
    committee.
      (6) The Secretary shall not list a color additive under this
    subsection for a proposed use if the data before him show that such
    proposed use would promote deception of the consumer in violation
    of this chapter or would otherwise result in misbranding or
    adulteration within the meaning of this chapter.
      (7) If, in the judgment of the Secretary, a tolerance limitation
    is required in order to assure that a proposed use of a color
    additive will be safe, the Secretary - 
        (A) shall not list the additive for such use if he finds that
      the data before him do not establish that such additive, if used
      within a safe tolerance limitation, would achieve the intended
      physical or other technical effect; and
        (B) shall not fix such tolerance limitation at a level higher
      than he finds to be reasonably required to accomplish the
      intended physical or other technical effect.

      (8) If, having regard to the aggregate quantity of color additive
    likely to be consumed in the diet or to be applied to the human
    body, the Secretary finds that the data before him fail to show
    that it would be safe and otherwise permissible to list a color
    additive (or pharmacologically related color additives) for all the
    uses proposed therefor and at the levels of concentration proposed,
    the Secretary shall, in determining for which use or uses such
    additive (or such related additives) shall be or remain listed, or
    how the aggregate allowable safe tolerance for such additive or
    additives shall be allocated by him among the uses under
    consideration, take into account, among other relevant factors (and
    subject to the paramount criterion of safety), (A) the relative
    marketability of the articles involved as affected by the proposed
    uses of the color additive (or of such related additives) in or on
    such articles, and the relative dependence of the industries
    concerned on such uses; (B) the relative aggregate amounts of such
    color additive which he estimates would be consumed in the diet or
    applied to the human body by reason of the various uses and levels
    of concentration proposed; and (C) the availability, if any, of
    other color additives suitable and safe for one or more of the uses
    proposed.
    (c) Certification of colors
      The Secretary shall further, by regulation, provide (1) for the
    certification, with safe diluents or without diluents, of batches
    of color additives listed pursuant to subsection (b) of this
    section and conforming to the requirements for such additives
    established by regulations under such subsection and this
    subsection, and (2) for exemption from the requirement of
    certification in the case of any such additive, or any listing or
    use thereof, for which he finds such requirement not to be
    necessary in the interest of the protection of the public health:
    Provided, That, with respect to any use in or on food for which a
    listed color additive is deemed to be safe by reason of the proviso
    to paragraph (4) of subsection (b), the requirement of
    certification shall be deemed not to be necessary in the interest
    of public health protection.
    (d) Procedure for issuance, amendment, or repeal of regulations
      The provisions of section 371(e), (f), and (g) of this title
    shall, subject to the provisions of subparagraph (C) of subsection
    (b)(5) of this section, apply to and in all respects govern
    proceedings for the issuance, amendment, or repeal of regulations
    under subsection (b) or (c) of this section (including judicial
    review of the Secretary's action in such proceedings) and the
    admissibility of transcripts of the record of such proceedings in
    other proceedings, except that - 
        (1) if the proceeding is commenced by the filing of a petition,
      notice of the proposal made by the petition shall be published in
      general terms by the Secretary within thirty days after such
      filing, and the Secretary's order (required by paragraph (1) of
      section 371(e) of this title) acting upon such proposal shall, in
      the absence of prior referral (or request for referral) to an
      advisory committee, be issued within ninety days after the date
      of such filing, except that the Secretary may (prior to such
      ninetieth day), by written notice to the petitioner, extend such
      ninety-day period to such time (not more than one hundred and
      eighty days after the date of filing of the petition) as the
      Secretary deems necessary to enable him to study and investigate
      the petition;
        (2) any report, recommendations, underlying data, and reasons
      certified to the Secretary by an advisory committee appointed
      pursuant to subparagraph (D) of subsection (b)(5) of this
      section, shall be made a part of the record of any hearing if
      relevant and material, subject to the provisions of section
      556(d) of title 5. The advisory committee shall designate a
      member to appear and testify at any such hearing with respect to
      the report and recommendations of such committee upon request of
      the Secretary, the petitioner, or the officer conducting the
      hearing, but this shall not preclude any other member of the
      advisory committee from appearing and testifying at such hearing;
        (3) the Secretary's order after public hearing (acting upon
      objections filed to an order made prior to hearing) shall be
      subject to the requirements of section 348(f)(2) of this title;
      and
        (4) the scope of judicial review of such order shall be in
      accordance with the fourth sentence of paragraph (2), and with
      the provisions of paragraph (3), of section 348(g) of this title.
    (e) Fees
      The admitting to listing and certification of color additives, in
    accordance with regulations prescribed under this chapter, shall be
    performed only upon payment of such fees, which shall be specified
    in such regulations, as may be necessary to provide, maintain, and
    equip an adequate service for such purposes.
    (f) Exemptions
      The Secretary shall by regulations (issued without regard to
    subsection (d) of this section) provide for exempting from the
    requirements of this section any color additive or any specific
    type of use thereof, and any article of food, drug, or device, or
    cosmetic bearing or containing such additive, intended solely for
    investigational use by qualified experts when in his opinion such
    exemption is consistent with the public health.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 721, formerly Sec. 706, 52 Stat.
    1058; Pub. L. 86-618, title I, Sec. 103(b), July 12, 1960, 74 Stat.
    399; Pub. L. 87-781, title I, Sec. 104(f)(2), Oct. 10, 1962, 76
    Stat. 785; Pub. L. 91-515, title VI, Sec. 601(d)(2), Oct. 30, 1970,
    84 Stat. 1311; Pub. L. 94-295, Sec. 9(a), May 28, 1976, 90 Stat.
    583; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
    renumbered Sec. 721, Pub. L. 102-571, title I, Sec. 106(4), Oct.
    29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(bb), Aug. 13,
    1993, 107 Stat. 778.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 376 of this title
    prior to renumbering by Pub. L. 102-571.
      In subsec. (d)(2), "section 556(d) of title 5" substituted for
    "section 7(c) of the Administrative Procedure Act (5 U.S.C., sec.
    1006(c))" on authority of Pub. L. 89-554, Sec. 7(b), Sept. 6, 1966,
    80 Stat. 631, the first section of which enacted Title 5,
    Government Organization and Employees.


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (b)(5)(D). Pub. L. 103-80 substituted "section
    5703" for "section 5703(b)".
      1992 - Subsec. (b)(5)(C)(i). Pub. L. 102-300 struck out "of
    Health, Education, and Welfare" after "representatives of the
    Department".
      1976 - Subsec. (a). Pub. L. 94-295, Sec. 9(a)(2), (3), inserted
    reference to devices and inserted provisions directing that color
    additives for use in or on devices be subject to this section only
    if the color additives come in direct contact with the body of man
    or other animals for a significant period of time and authorizing
    the Secretary to designate by regulation the uses of color
    additives in or on devices which are subject to this section.
      Subsec. (b). Pub. L. 94-295, Sec. 9(a)(1), (2), substituted "drug
    or device" for "drug" and "drugs or devices" for "drugs" wherever
    appearing.
      Subsec. (f). Pub. L. 94-295, Sec. 9(a)(1), substituted "drug or
    device" for "drug".
      1970 - Subsec. (b)(5)(D). Pub. L. 91-515 substituted provisions
    authorizing members of an advisory committee to receive
    compensation at rates fixed by the Secretary, with a specific
    maximum amount, and travel expenses, including per diem in lieu of
    subsistence, as authorized by section 5703(b) of Title 5, for
    provisions authorizing such members to receive as compensation a
    reasonable per diem for time actually spent on committee work, and
    necessary traveling and subsistence expenses while serving away
    from their places of residence.
      1962 - Subsec. (b)(5)(B). Pub. L. 87-781 provided that clause (i)
    of this subparagraph shall not apply to a color additive in feed of
    animals raised for food production, if under the conditions of use
    specified in proposed labeling, and which conditions are reasonably
    certain to be followed in practice, such additive will not
    adversely affect the animals and no residue will be found in any
    edible portion of such animal after slaughter or in any food from
    the living animal.
      1960 - Pub. L. 86-618 amended section generally. Prior to
    amendment, section read as follows: "The admitting to listing and
    certification of coal-tar colors, in accordance with regulations
    prescribed under this chapter, shall be performed only upon payment
    of such fees, which shall be specified in such regulations, as may
    be necessary to provide, maintain, and equip an adequate service
    for such purposes."

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.

      EFFECTIVE DATE OF 1960 AMENDMENT, TRANSITIONAL PROVISIONS, AND
                           EFFECT ON OTHER LAWS
      Title II of Pub. L. 86-618 provided that:
      "Sec. 201. [Definitions.] As used in this title, the term 'basic
    Act' means the Federal Food, Drug, and Cosmetic Act [this chapter];
    the term 'enactment date' means the date of enactment of this Act
    [July 12, 1960]; and other terms, insofar as also used in the basic
    Act (whether before or after enactment of this Act) shall have the
    same meaning as they have, or had when in effect, under the basic
    Act.
      "Sec. 202. [Effective Date.] This Act [amending this section and
    sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371
    of this title and repealing sections 354 and 364 of this title]
    shall, subject to the provisions of section 203, take effect on the
    enactment date [July 12, 1960].
      "Sec. 203. [Provisional Listings of Commercially Established
    Colors.] (a)(1) The purpose of this section is to make possible, on
    an interim basis for a reasonable period, through provisional
    listings, the use of commercially established color additives to
    the extent consistent with the public health, pending the
    completion of the scientific investigations needed as a basis for
    making determinations as to listing of such additives under the
    basic Act as amended by this Act. A provisional listing (including
    a deemed provisional listing) of a color additive under this
    section for any use shall, unless sooner terminated or expiring
    under the provisions of this section, expire (A) on the closing
    date (as defined in paragraph (2) of this subsection) or (B) on the
    effective date of a listing of such additive for such use under
    section 706 [now 721] of the basic Act, [this section], whichever
    date first occurs.
      "(2) For the purposes of this section, the term 'closing date'
    means (A) the last day of the two and one-half year period
    beginning on the enactment date [July 12, 1960] or (B), with
    respect to a particular provisional listing (or deemed provisional
    listing) of a color additive or use thereof, such later closing
    date as the Secretary may from time to time establish pursuant to
    the authority of this paragraph. The Secretary may by regulation,
    upon application of an interested person or on his own initiative,
    from time to time postpone the original closing date with respect
    to a provisional listing (or deemed provisional listing) under this
    section of a specified color additive, or of a specified use or
    uses of such additive, for such period or periods as he finds
    necessary to carry out the purpose of this section, if in the
    Secretary's judgment such action is consistent with the objective
    of carrying to completion in good faith, as soon as reasonably
    practicable, the scientific investigations necessary for making a
    determination as to listing such additive, or such specified use or
    uses thereof, under section 706 [now 721] of the basic Act [this
    section]. The Secretary may terminate a postponement of the closing
    date at any time if he finds that such postponement should not have
    been granted, or that by reason of a change in circumstances the
    basis for such postponement no longer exists, or that there has
    been a failure to comply with a requirement for submission of
    progress reports or with other conditions attached to such
    postponement.
      "(b) Subject to the other provisions of this section - 
        "(1) any color additive which, on the day preceding the
      enactment date [July 12, 1960], was listed and certifiable for
      any use or uses under section 406(b), 504, or 604 [section
      346(b), 354, or 364 of this title], or under the third proviso of
      section 402(c) [section 342(c) of this title], of the basic Act,
      and of which a batch or batches had been certified for such use
      or uses prior to the enactment date [July 12, 1960], and
        "(2) any color additive which was commercially used or sold
      prior to the enactment date [July 12, 1960] for any use or uses
      in or on any food, drug, or cosmetic, and which either, (A), on
      the day preceding the enactment date [July 12, 1960], was not a
      material within the purview of any of the provisions of the basic
      Act enumerated in paragraph (1) of this subsection, or (B) is the
      color additive known as synthetic beta-carotene,
    shall, beginning on the enactment date [July 12, 1960], be deemed
    to be provisionally listed under this section as a color additive
    for such use or uses.
      "(c) Upon request of any person, the Secretary, by regulations
    issued under subsection (d), shall without delay, if on the basis
    of the data before him he deems such action consistent with the
    protection of the public health, provisionally list a material as a
    color additive for any use for which it was listed, and for which a
    batch or batches of such material had been certified, under section
    406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364
    of this title] prior to the enactment date [July 12, 1960],
    although such color was no longer listed and certifiable for such
    use under such sections on the day preceding the enactment date.
    Such provisional listing shall take effect on the date of
    publication.
      "(d)(1) The Secretary shall, by regulations issued or amended
    from time to time under this section - 
        "(A) insofar as practicable promulgate and keep current a list
      or lists of the color additives, and of the particular uses
      thereof, which he finds are deemed provisionally listed under
      subsection (b), and the presence of a color additive on such a
      list with respect to a particular use shall, in any proceeding
      under the basic Act, be conclusive evidence that such provisional
      listing is in effect;
        "(B) provide for the provisional listing of the color additives
      and particular uses thereof specified in subsection (c);
        "(C) provide, with respect to particular uses for which color
      additives are or are deemed to be provisionally listed, such
      temporary tolerance limitations (including such limitations at
      zero level) and other conditions of use and labeling or packaging
      requirements, if any, as in his judgment are necessary to protect
      the public health pending listing under section 706 [now 721] of
      the basic Act [this section];
        "(D) provide for the certification of batches of such color
      additives (with or without diluents) for the uses for which they
      are so listed or deemed to be listed under this section, except
      that such an additive which is a color additive deemed
      provisionally listed under subsection (b)(2) of this section
      shall be deemed exempt from the requirement of such certification
      while not subject to a tolerance limitation; and
        "(E) provide for the termination of a provisional listing (or
      deemed provisional listing) of a color additive or particular use
      thereof forthwith whenever in his judgment such action is
      necessary to protect the public health.
      "(2)(A) Except as provided in subparagraph (C) of this paragraph,
    regulations under this section shall, from time to time, be issued,
    amended, or repealed by the Secretary without regard to the
    requirements of the basic Act [subsec. (e) of this section], but
    for the purposes of the application of section 706(e) [now 721(e)]
    of the basic Act (relating to fees) and of determining the
    availability of appropriations of fees (and of advance deposits to
    cover fees), proceedings, regulations, and certifications under
    this section shall be deemed to be proceedings, regulations, and
    certifications under such section 706 [now 721, this section].
    Regulations providing for fees (and advance deposits to cover
    fees), which on the day preceding the enactment date [July 12,
    1960] were in effect pursuant to section 706 [now 721] of the basic
    Act [this section], shall be deemed to be regulations under such
    section 706 [now 721, this section] as amended by this Act, and
    appropriations of fees (and advance deposits) available for the
    purposes specified in such section 706 [now 721] as in effect prior
    to the enactment date [July 12, 1960] shall be available for the
    purposes specified in such section 706 [now 721, this section] as
    so amended.
      "(B) If the Secretary, by regulation - 
        "(i) has terminated a provisional listing (or deemed
      provisional listing) of a color additive or particular use
      thereof pursuant to paragraph (1)(E) of this subsection; or
        "(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of
      this subsection, initially established or rendered more
      restrictive a tolerance limitation or other restriction or
      requirement with respect to a provisional listing (or deemed
      provisional listing) which listing had become effective prior to
      such action,
    any person adversely affected by such action may, prior to the
    expiration of the period specified in clause (A) of subsection
    (a)(2) of this section, file with the Secretary a petition for
    amendment of such regulation so as to revoke or modify such action
    of the Secretary, but the filing of such petition shall not operate
    to stay or suspend the effectiveness of such action. Such petition
    shall, in accordance with regulations, set forth the proposed
    amendment and shall contain data (or refer to data which are before
    the Secretary or of which he will take official notice), which show
    that the revocation or modification proposed is consistent with the
    protection of the public health. The Secretary shall, after
    publishing such proposal and affording all interested persons an
    opportunity to present their views thereon orally or in writing,
    act upon such proposal by published order.
      "(C) Any person adversely affected by an order entered under
    subparagraph (B) of this paragraph may, within thirty days after
    its publication, file objections thereto with the Secretary,
    specifying with particularity the provisions of the order deemed
    objectionable, stating reasonable grounds for such objections, and
    requesting a public hearing upon such objections. The Secretary
    shall hold a public hearing on such objections and shall, on the
    basis of the evidence adduced at such hearing, act on such
    objections by published order. Such order may reinstate a
    terminated provisional listing, or increase or dispense with a
    previously established temporary tolerance limitation, or make less
    restrictive any other limitation established by him under paragraph
    (1) or (3) of this subsection, only if in his judgment the evidence
    so adduced shows that such action will be consistent with the
    protection of the public health. An order entered under this
    subparagraph shall be subject to judicial review in accordance with
    section 701(f) of the basic Act [section 371(f) of this title]
    except that the findings and order of the Secretary shall be
    sustained only if based upon a fair evaluation of the entire record
    at such hearing. No stay or suspension of such order shall be
    ordered by the court pending conclusion of such judicial review.
      "(D) On and after the enactment date [July 12, 1960],
    regulations, provisional listings, and certifications (or
    exemptions from certification) in effect under this section shall,
    for the purpose of determining whether an article is adulterated or
    misbranded within the meaning of the basic Act by reason of its
    being, bearing, or containing a color additive, have the same
    effect as would regulations, listings, and certifications (or
    exemptions from certification) under section 706 [now 721] of the
    basic Act [this section]. A regulation, provisional listing or
    termination thereof, tolerance limitation, or certification or
    exemption therefrom, under this section shall not be the basis for
    any presumption or inference in any proceeding under section 706(b)
    or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of
    this section].
      "(3) For the purpose of enabling the Secretary to carry out his
    functions under paragraphs (1)(A) and (C) of this subsection with
    respect to color additives deemed provisionally listed, he shall,
    as soon as practicable after enactment of this Act [July 12, 1960],
    afford by public notice a reasonable opportunity to interested
    persons to submit data relevant thereto. If the data so submitted
    or otherwise before him do not, in his judgment, establish a
    reliable basis for including such a color additive or particular
    use or uses thereof in a list or lists promulgated under paragraph
    (1)(A), or for determining the prevailing level or levels of use
    thereof prior to the enactment date [July 12, 1960] with a view to
    prescribing a temporary tolerance or tolerances for such use or
    uses under paragraph (1)(C), the Secretary shall establish a
    temporary tolerance limitation at zero level for such use or uses
    until such time as he finds that it would not be inconsistent with
    the protection of the public health to increase or dispense with
    such temporary tolerance limitation.
      "Sec. 204. [Effect on Meat Inspection and Poultry Products
    Inspection Acts.] Nothing in this Act [amending this section and
    sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371
    of this title and repealing sections 354 and 364 of this title]
    shall be construed to exempt any meat or meat food product, poultry
    or poultry product, or any person from any requirement imposed by
    or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat.
    1260, as amended or extended (21 U.S.C. 71 and the following) [see
    section 601 et seq. of this title] or the Poultry Products
    Inspection Act (21 U.S.C. 451 and the following)."

                       EFFECTIVE DATE; ACCELERATION                   
      This section was made "immediately effective" by act May 2, 1939,
    ch. 107, title I, Sec. 1, 53 Stat. 631.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-


-CITE-
    21 USC Part C - Fees                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees

-HEAD-
                               PART C - FEES                           

-End-


-CITE-
    21 USC subpart 1 - freedom of information fees              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 1 - freedom of information fees

-HEAD-
                  SUBPART 1 - FREEDOM OF INFORMATION FEES              

-End-



-CITE-
    21 USC Sec. 379f                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 1 - freedom of information fees

-HEAD-
    Sec. 379f. Recovery and retention of fees for freedom of
      information requests

-STATUTE-
    (a) In general
      The Secretary, acting through the Commissioner of Food and Drugs,
    may - 
        (1) set and charge fees, in accordance with section
      552(a)(4)(A) of title 5, to recover all reasonable costs incurred
      in processing requests made under section 552 of title 5 for
      records obtained or created under this chapter or any other
      Federal law for which responsibility for administration has been
      delegated to the Commissioner by the Secretary;
        (2) retain all fees charged for such requests; and
        (3) establish an accounting system and procedures to control
      receipts and expenditures of fees received under this section.
    (b) Use of fees
      The Secretary and the Commissioner of Food and Drugs shall not
    use fees received under this section for any purpose other than
    funding the processing of requests described in subsection (a)(1)
    of this section. Such fees shall not be used to reduce the amount
    of funds made to carry out other provisions of this chapter.
    (c) Waiver of fees
      Nothing in this section shall supersede the right of a requester
    to obtain a waiver of fees pursuant to section 552(a)(4)(A) of
    title 5.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 731, formerly Sec. 711, as added Pub.
    L. 101-635, title II, Sec. 201, Nov. 28, 1990, 104 Stat. 4584;
    renumbered Sec. 731, Pub. L. 102-571, title I, Sec. 106(6), Oct.
    29, 1992, 106 Stat. 4499.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 379c of this title
    prior to renumbering by Pub. L. 102-571.

-End-


-CITE-
    21 USC subpart 2 - fees relating to drugs                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 2 - fees relating to drugs

-HEAD-
                    SUBPART 2 - FEES RELATING TO DRUGS                


-STATAMEND-
                          TERMINATION OF SUBPART                      
      For termination of subpart by section 105 of Pub. L. 102-571, see
    Termination Date note set out under section 379g of this title.

-End-



-CITE-
    21 USC Sec. 379g                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 2 - fees relating to drugs

-HEAD-
    Sec. 379g. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "human drug application" means an application for -
       
          (A) approval of a new drug submitted under section 355(b)(1)
        of this title,
          (B) approval of a new drug submitted under section 355(b)(2)
        of this title after September 30, 1992, which requests approval
        of - 
            (i) a molecular entity which is an active ingredient
          (including any salt or ester of an active ingredient), or
            (ii) an indication for a use,

        that had not been approved under an application submitted under
        section 355(b) of this title, or
          (C) licensure of a biological product under section 262 of
        title 42.

      Such term does not include a supplement to such an application,
      does not include an application with respect to whole blood or a
      blood component for transfusion, does not include an application
      with respect to a bovine blood product for topical application
      licensed before September 1, 1992, an allergenic extract product,
      or an in vitro diagnostic biologic product licensed under section
      262 of title 42, does not include an application with respect to
      a large volume parenteral drug product approved before September
      1, 1992, does not include an application for a licensure of a
      biological product for further manufacturing use only, and does
      not include an application or supplement submitted by a State or
      Federal Government entity for a drug that is not distributed
      commercially. Such term does include an application for
      licensure, as described in subparagraph (C), of a large volume
      biological product intended for single dose injection for
      intravenous use or infusion.
        (2) The term "supplement" means a request to the Secretary to
      approve a change in a human drug application which has been
      approved.
        (3) The term "prescription drug product" means a specific
      strength or potency of a drug in final dosage form - 
          (A) for which a human drug application has been approved,
          (B) which may be dispensed only under prescription pursuant
        to section 353(b) of this title, and
          (C) which is on the list of products described in section
        355(j)(7)(A) of this title or is on a list created and
        maintained by the Secretary of products approved under human
        drug applications under section 262 of title 42.

      Such term does not include whole blood or a blood component for
      transfusion, does not include a bovine blood product for topical
      application licensed before September 1, 1992, an allergenic
      extract product, or an in vitro diagnostic biologic product
      licensed under section 262 of title 42. Such term does not
      include a biological product that is licensed for further
      manufacturing use only, and does not include a drug that is not
      distributed commercially and is the subject of an application or
      supplement submitted by a State or Federal Government entity.
      Such term does include a large volume biological product intended
      for single dose injection for intravenous use or infusion.
        (4) The term "final dosage form" means, with respect to a
      prescription drug product, a finished dosage form which is
      approved for administration to a patient without substantial
      further manufacturing.
        (5) The term "prescription drug establishment" means a foreign
      or domestic place of business which is at one general physical
      location consisting of one or more buildings all of which are
      within five miles of each other and at which one or more
      prescription drug products are manufactured in final dosage form.
      For purposes of this paragraph, the term "manufactured" does not
      include packaging.
        (6) The term "process for the review of human drug
      applications" means the following activities of the Secretary
      with respect to the review of human drug applications and
      supplements:
          (A) The activities necessary for the review of human drug
        applications and supplements.
          (B) The issuance of action letters which approve human drug
        applications or which set forth in detail the specific
        deficiencies in such applications and, where appropriate, the
        actions necessary to place such applications in condition for
        approval.
          (C) The inspection of prescription drug establishments and
        other facilities undertaken as part of the Secretary's review
        of pending human drug applications and supplements.
          (D) Activities necessary for the review of applications for
        licensure of establishments subject to section 262 of title 42
        and for the release of lots of biologics under such section.
          (E) Monitoring of research conducted in connection with the
        review of human drug applications.
          (F) In the case of drugs approved after October 1, 2002,
        under human drug applications or supplements: collecting,
        developing, and reviewing safety information on the drugs,
        including adverse event reports, during a period of time after
        approval of such applications or supplements, not to exceed
        three years.

        (7) The term "costs of resources allocated for the process for
      the review of human drug applications" means the expenses
      incurred in connection with the process for the review of human
      drug applications for - 
          (A) officers and employees of the Food and Drug
        Administration, contractors of the Food and Drug
        Administration, advisory committees, and costs related to such
        officers, employees, and committees and to contracts with such
        contractors,
          (B) management of information, and the acquisition,
        maintenance, and repair of computer resources,
          (C) leasing, maintenance, renovation, and repair of
        facilities and acquisition, maintenance, and repair of
        fixtures, furniture, scientific equipment, and other necessary
        materials and supplies, and
          (D) collecting fees under section 379h of this title and
        accounting for resources allocated for the review of human drug
        applications and supplements.

        (8) The term "adjustment factor" applicable to a fiscal year is
      the Consumer Price Index for all urban consumers (all items;
      United States city average) for April of the preceding fiscal
      year divided by such Index for April 1997.
        (9) The term "affiliate" means a business entity that has a
      relationship with a second business entity if, directly or
      indirectly - 
          (A) one business entity controls, or has the power to
        control, the other business entity; or
          (B) a third party controls, or has power to control, both of
        the business entities.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 735, as added Pub. L. 102-571, title
    I, Sec. 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105-
    115, title I, Secs. 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat.
    2298, 2326; Pub. L. 107-188, title V, Sec. 503, June 12, 2002, 116
    Stat. 688.)


-STATAMEND-
                           AMENDMENT OF SECTION                       
      For termination of amendment by section 509 of Pub. L. 107-188,
    see Effective and Termination Dates of 2002 Amendments note below.
      For termination of amendment by section 107 of Pub. L. 105-115,
    see Effective and Termination Dates of 1997 Amendment note below.

                          TERMINATION OF SECTION                      
      For termination of section by section 105 of Pub. L. 102-571, see
    Termination Date note below.


-MISC1-
                                AMENDMENTS                            
      2002 - Par. (1). Pub. L. 107-188, Secs. 503(1), 509, temporarily
    substituted "licensure, as described in subparagraph (C)" for
    "licensure, as described in subparagraph (D)" in concluding
    provisions. See Effective and Termination Dates of 2002 Amendment
    note below.
      Par. (3). Pub. L. 107-188, Secs. 503(2)(D), 509, which directed
    the temporary amendment of concluding provisions of par. (3) by
    striking "section 262 of title 42" and all that follows through
    "biological product" and inserting "section 262 of title 42. Such
    term does not include a biological product", was executed by
    striking language ending with "biological product" the first time
    appearing, thereby making the substitution for "section 262 of
    title 42, does not include a large volume parenteral drug product
    approved before September 1, 1992, does not include a biological
    product", to reflect the probable intent of Congress. See Effective
    and Termination Dates of 2002 Amendment note below.
      Par. (3)(C). Pub. L. 107-188, Secs. 503(2)(A)-(C), 509,
    temporarily added subpar. (C). See Effective and Termination Dates
    of 2002 Amendment note below.
      Par. (6)(F). Pub. L. 107-188, Secs. 503(3), 509, temporarily
    added subpar. (F). See Effective and Termination Dates of 2002
    Amendment note below.
      Par. (8). Pub. L. 107-188, Secs. 503(4), 509, temporarily struck
    out designations of subpars. (A) and (B) and text of subpar. (B)
    and concluding provisions, substituting definition of "adjustment
    factor" as the Consumer Price Index for definition of Index as the
    lower of the Consumer Price Index or the total of discretionary
    budget authority provided for programs in the domestic category for
    the immediately preceding fiscal year divided by such budget
    authority for fiscal year 1997. See Effective and Termination Dates
    of 2002 Amendment note below.
      1997 - Par. (1). Pub. L. 105-115, Secs. 102(1), 107, in closing
    provisions, temporarily struck out "and" before "does not include
    an application" and substituted "September 1, 1992, does not
    include an application for a licensure of a biological product for
    further manufacturing use only, and does not include an application
    or supplement submitted by a State or Federal Government entity for
    a drug that is not distributed commercially. Such term does include
    an application for licensure, as described in subparagraph (D), of
    a large volume biological product intended for single dose
    injection for intravenous use or infusion" for "September 1, 1992"
    before period at end. See Effective and Termination Dates of 1997
    Amendment note below.
      Par. (1)(B) to (D). Pub. L. 105-115, Sec. 125(b)(2)(M), inserted
    "or" at end of subpar. (B), redesignated subpar. (D) as (C), and
    struck out former subpar. (C) which read as follows: "initial
    certification or initial approval of an antibiotic drug under
    section 357 of this title, or".
      Par. (3). Pub. L. 105-115, Secs. 102(2), 107, in closing
    provisions, temporarily struck out "and" before "does not include a
    large volume parenteral drug" and substituted "September 1, 1992,
    does not include a biological product that is licensed for further
    manufacturing use only, and does not include a drug that is not
    distributed commercially and is the subject of an application or
    supplement submitted by a State or Federal Government entity. Such
    term does include a large volume biological product intended for
    single dose injection for intravenous use or infusion" for
    "September 1, 1992" before period at end. See Effective and
    Termination Dates of 1997 Amendment note below.
      Par. (4). Pub. L. 105-115, Secs. 102(3), 107, temporarily
    substituted "without substantial further manufacturing" for
    "without further manufacturing". See Effective and Termination
    Dates of 1997 Amendment note below.
      Par. (5). Pub. L. 105-115, Secs. 102(4), 107, temporarily amended
    first sentence generally. Prior to amendment, first sentence read
    as follows: "The term 'prescription drug establishment' means a
    foreign or domestic place of business which is - 
        "(A) at one general physical location consisting of one or more
      buildings all of which are within 5 miles of each other, at which
      one or more prescription drug products are manufactured in final
      dosage form, and
        "(B) under the management of a person that is listed as the
      applicant in a human drug application for a prescription drug
      product with respect to at least one such product."
    See Effective and Termination Dates of 1997 Amendment note below.
      Par. (7)(A). Pub. L. 105-115, Secs. 102(5), 107, temporarily
    substituted "contractors of the Food and Drug Administration," for
    "employees under contract with the Food and Drug Administration who
    work in facilities owned or leased for the Food and Drug
    Administration," and "and committees and to contracts with such
    contractors," for "and committees,". See Effective and Termination
    Dates of 1997 Amendment note below.
      Par. (8)(A). Pub. L. 105-115, Secs. 102(6)(A), 107, temporarily
    substituted "April of the preceding fiscal year" for "August of the
    preceding fiscal year" and "April 1997" for "August 1992". See
    Effective and Termination Dates of 1997 Amendment note below.
      Par. (8)(B). Pub. L. 105-115, Secs. 102(6)(B), 107, temporarily
    substituted "section 254(c)" for "section 254(d)", "fiscal year
    1997" for "fiscal year 1992", and "105th Congress, 1st Session" for
    "102d Congress, 2d Session". See Effective and Termination Dates of
    1997 Amendment note below.
      Par. (9). Pub. L. 105-115, Secs. 102(7), 107, temporarily added
    par. (9). See Effective and Termination Dates of 1997 Amendment
    note below.

             EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT         
      Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section
    508 of Pub. L. 107-188, set out as an Effective Date of 2002
    Amendment note under section 356b of this title.
      Pub. L. 107-188, title V, Sec. 509, June 12, 2002, 116 Stat. 694,
    provided that: "The amendments made by sections 503 and 504
    [amending this section and section 379h of this title] cease to be
    effective October 1, 2007, and section 505 [enacting provisions set
    out as a note below] ceases to be effective 120 days after such
    date."

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Section 106 of title I of Pub. L. 105-115 provided that: "The
    amendments made by this subtitle [subtitle A (Secs. 101-107) of
    title I of Pub. L. 105-115, amending this section and section 379h
    of this title] shall take effect October 1, 1997."
      Section 107 of Pub. L. 105-115 provided that: "The amendments
    made by sections 102 and 103 [amending this section and section
    379h of this title] cease to be effective October 1, 2002, and
    section 104 [enacting provisions formerly set out as a note below]
    ceases to be effective 120 days after such date."

                             TERMINATION DATE                         
      Section 105 of Pub. L. 102-571 provided that: "The amendments
    made by section 103 [enacting this subpart] shall not be in effect
    after October 1, 1997 and section 104 [enacting provisions set out
    as a note below] shall not be in effect after 120 days after such
    date."

                             SAVINGS PROVISION                         
      Pub. L. 107-188, title V, Sec. 507, June 12, 2002, 116 Stat. 694,
    provided that: "Notwithstanding section 107 of the Food and Drug
    Administration Modernization Act of 1997 [section 107 of Pub. L.
    105-115, set out as an Effective and Termination Dates of 1997
    Amendment note above], and notwithstanding the amendments made by
    this subtitle [subtitle A (Secs. 501-509) of title V of Pub. L. 107-
    188, amending this section and sections 356b and 379h of this
    title], part 2 of subchapter C of chapter VII of the Federal Food,
    Drug, and Cosmetic Act [this subpart], as in effect on the day
    before the date of the enactment of this Act [June 12, 2002],
    continues to be in effect with respect to human drug applications
    and supplements (as defined in such part as of such day) that, on
    or after October 1, 1997, but before October 1, 2002, were accepted
    by the Food and Drug Administration for filing and with respect to
    assessing and collecting any fee required by such Act for a fiscal
    year prior to fiscal year 2003."
      Section 105 of Pub. L. 105-115 provided that: "Notwithstanding
    section 105 of the Prescription Drug User Fee Act of 1992 [section
    105 of Pub. L. 102-571, set out above], the Secretary shall retain
    the authority to assess and collect any fee required by part 2 of
    subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
    Act [this subpart] for a human drug application or supplement
    accepted for filing prior to October 1, 1997, and to assess and
    collect any product or establishment fee required by such Act for a
    fiscal year prior to fiscal year 1998."

                        ACCOUNTABILITY AND REPORTS                    
      Pub. L. 107-188, title V, Sec. 505, June 12, 2002, 116 Stat. 692,
    provided that:
      "(a) Public Accountability. - 
        "(1) Consultation. - In developing recommendations to the
      Congress for the goals and plans for meeting the goals for the
      process for the review of human drug applications for the fiscal
      years after fiscal year 2007, and for the reauthorization of
      sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 379g, 379h], the Secretary of Health and Human
      Services (referred to in this section as the 'Secretary') shall
      consult with the Committee on Energy and Commerce of the House of
      Representatives, the Committee on Health, Education, Labor, and
      Pensions of the Senate, appropriate scientific and academic
      experts, health care professionals, representatives of patient
      and consumer advocacy groups, and the regulated industry.
        "(2) Recommendations. - The Secretary shall publish in the
      Federal Register recommendations under paragraph (1), after
      negotiations with the regulated industry; shall present such
      recommendations to the congressional committees specified in such
      paragraph; shall hold a meeting at which the public may present
      its views on such recommendations; and shall provide for a period
      of 30 days for the public to provide written comments on such
      recommendations.
      "(b) Performance Report. - Beginning with fiscal year 2003, not
    later than 60 days after the end of each fiscal year during which
    fees are collected under part 2 of subchapter C of chapter VII of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.),
    the Secretary of Health and Human Services shall prepare and submit
    to the President, the Committee on Energy and Commerce of the House
    of Representatives, and the Committee on Health, Education, Labor,
    and Pensions of the Senate a report concerning the progress of the
    Food and Drug Administration in achieving the goals identified in
    the letters described in section 502(4) [section 502(4) of Pub. L.
    107-188, set out below] during such fiscal year and the future
    plans of the Food and Drug Administration for meeting the goals.
      "(c) Fiscal Report. - Beginning with fiscal year 2003, not later
    than 120 days after the end of each fiscal year during which fees
    are collected under the part described in subsection (b), the
    Secretary of Health and Human Services shall prepare and submit to
    the Committee on Energy and Commerce of the House of
    Representatives, and the Committee on Health, Education, Labor, and
    Pensions of the Senate, a report on the implementation of the
    authority for such fees during such fiscal year and the use, by the
    Food and Drug Administration, of the fees collected during such
    fiscal year for which the report is made."
      [Section 505 of Pub. L. 107-188, set out above, ceases to be
    effective 120 days after Oct. 1, 2007, see Effective and
    Termination Dates of 2002 Amendment note above.]

         CONGRESSIONAL FINDINGS CONCERNING FEES RELATING TO DRUGS     
      Pub. L. 107-188, title V, Sec. 502, June 12, 2002, 116 Stat. 687,
    provided that: "The Congress finds that - 
        "(1) prompt approval of safe and effective new drugs and other
      therapies is critical to the improvement of the public health so
      that patients may enjoy the benefits provided by these therapies
      to treat and prevent illness and disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for the review of human drug applications and the assurance of
      drug safety;
        "(3) the provisions added by the Prescription Drug User Fee Act
      of 1992 [see section 101(a) of Pub. L. 102-571, set out as a
      Short Title of 1992 Amendment note under section 301 of this
      title], as amended by the Food and Drug Administration
      Modernization Act of 1997 [see Short Title of 1997 Amendment note
      set out under section 301 of this title], have been successful in
      substantially reducing review times for human drug applications
      and should be - 
          "(A) reauthorized for an additional 5 years, with certain
        technical improvements; and
          "(B) carried out by the Food and Drug Administration with new
        commitments to implement more ambitious and comprehensive
        improvements in regulatory processes of the Food and Drug
        Administration, including - 
            "(i) strengthening and improving the review and monitoring
          of drug safety;
            "(ii) considering greater interaction between the agency
          and sponsors during the review of drugs and biologics
          intended to treat serious diseases and life-threatening
          diseases; and
            "(iii) developing principles for improving first-cycle
          reviews; and
        "(4) the fees authorized by amendments made in this subtitle
      [subtitle A (Secs. 501-509) of title V of Pub. L. 107-188,
      amending this section and sections 356b and 379h of this title]
      will be dedicated towards expediting the drug development process
      and the process for the review of human drug applications as set
      forth in the goals identified for purposes of part 2 of
      subchapter C of chapter VII of the Federal Food, Drug, and
      Cosmetic Act [this subpart], in the letters from the Secretary of
      Health and Human Services to the chairman of the Committee on
      Energy and Commerce of the House of Representatives and the
      chairman of the Committee on Health, Education, Labor and
      Pensions of the Senate, as set forth in the Congressional
      Record."
      Pub. L. 105-115, title I, Sec. 101, Nov. 21, 1997, 111 Stat.
    2298, provided that: "Congress finds that - 
        "(1) prompt approval of safe and effective new drugs and other
      therapies is critical to the improvement of the public health so
      that patients may enjoy the benefits provided by these therapies
      to treat and prevent illness and disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for review of human drug applications;
        "(3) the provisions added by the Prescription Drug User Fee Act
      of 1992 [see section 101(a) of Pub. L. 102-571, set out as a
      Short Title of 1992 Amendment note under section 301 of this
      title] have been successful in substantially reducing review
      times for human drug applications and should be - 
          "(A) reauthorized for an additional 5 years, with certain
        technical improvements; and
          "(B) carried out by the Food and Drug Administration with new
        commitments to implement more ambitious and comprehensive
        improvements in regulatory processes of the Food and Drug
        Administration; and
        "(4) the fees authorized by amendments made in this subtitle
      [subtitle A (Secs. 101-107) of title I of Pub. L. 105-115,
      amending this section and section 379h of this title] will be
      dedicated toward expediting the drug development process and the
      review of human drug applications as set forth in the goals
      identified, for purposes of part 2 of subchapter C of chapter VII
      of the Federal Food, Drug, and Cosmetic Act [this subpart], in
      the letters from the Secretary of Health and Human Services to
      the chairman of the Committee on Commerce of the House of
      Representatives and the chairman of the Committee on Labor and
      Human Resources [now Committee on Health, Education, Labor, and
      Pensions] of the Senate, as set forth in the Congressional
      Record."

                              ANNUAL REPORTS                          
      Pub. L. 105-115, title I, Sec. 104, Nov. 21, 1997, 111 Stat.
    2304, which directed the Secretary of Health and Human Services to
    prepare and submit to Committee on Commerce of the House of
    Representatives and the Committee on Labor and Human Resources of
    the Senate, within 60 days after the end of each fiscal year during
    which fees are collected under this subpart, a report stating the
    Food and Drug Administration's progress in achieving the goals
    identified in the letters described in section 101(4) of Pub. L.
    105-115, set out above, during such fiscal year and the
    Administration's future plans for meeting the goals, and within 120
    days after the end of each fiscal year during which fees are
    collected, to prepare and submit a report on the implementation of
    the authority for such fees during such fiscal year and on the use
    the Administration made of the fees collected during such fiscal
    year, ceased to be effective 120 days after Oct. 1, 2002. See
    section 107 of Pub. L. 105-115, set out as an Effective and
    Termination Dates of 1997 Amendment note above.

       CONGRESSIONAL FINDINGS CONCERNING PRESCRIPTION DRUG USER FEES   
      Section 102 of title I of Pub. L. 102-571 provided that: "The
    Congress finds that - 
        "(1) prompt approval of safe and effective new drugs is
      critical to the improvement of the public health so that patients
      may enjoy the benefits provided by these therapies to treat and
      prevent illness and disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for review of human drug applications; and
        "(3) the fees authorized by this title [see Short Title of 1992
      Amendment note, set out under section 301 of this title] will be
      dedicated toward expediting the review of human drug applications
      as set forth in the goals identified in the letters of September
      14, 1992, and September 21, 1992, from the Commissioner of Food
      and Drugs to the Chairman of the Energy and Commerce Committee of
      the House of Representatives and the Chairman of the Labor and
      Human Resources Committee of the Senate, as set forth at 138
      Cong. Rec. H9099-H9100 (daily ed. September 22, 1992)."

                              ANNUAL REPORTS                          
      Pub. L. 102-571, title I, Sec. 104, Oct. 29, 1992, 106 Stat.
    4498, which provided that the Secretary of Health and Human
    Services submit to Committee on Energy and Commerce of the House of
    Representatives and Committee on Labor and Human Resources of the
    Senate, within 60 days after the end of each fiscal year during
    which fees were collected under this subpart, a report stating the
    Food and Drug Administration's progress in achieving the goals
    identified in section 102(3) of Pub. L. 102-571, set out as a note
    above, during such fiscal year and that agency's future plans for
    meeting such goals, and within 120 days after the end of each
    fiscal year during which such fees were collected, a report on the
    implementation of the authority for such fees during such fiscal
    year and on the use the Food and Drug Administration made of the
    fees collected during such fiscal year, ceased to be in effect 120
    days after Oct. 1, 1997. See Termination Date note above.

                        ANIMAL DRUG USER FEE STUDY                    
      Section 108 of Pub. L. 102-571 directed Secretary, in
    consultation with manufacturers of animal drug products and other
    interested persons, to undertake study to evaluate whether, and
    under what conditions, to impose user fees to supplement
    appropriated funds in order to improve process of reviewing
    applications (including abbreviated and supplemental applications)
    for new animal drugs under section 360b of this title, and further
    provided for submission of study to Congress no later than Jan. 4,
    1994.

-End-



-CITE-
    21 USC Sec. 379h                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 2 - fees relating to drugs

-HEAD-
    Sec. 379h. Authority to assess and use drug fees

-STATUTE-
    (a) Types of fees
      Beginning in fiscal year 2003, the Secretary shall assess and
    collect fees in accordance with this section as follows:
      (1) Human drug application and supplement fee
        (A) In general
          Each person that submits, on or after September 1, 1992, a
        human drug application or a supplement shall be subject to a
        fee as follows:
            (i) A fee established under subsection (c)(4) of this
          section for a human drug application for which clinical data
          (other than bioavailability or bioequivalence studies) with
          respect to safety or effectiveness are required for approval.
            (ii) A fee established under subsection (c)(4) of this
          section for a human drug application for which clinical data
          with respect to safety or effectiveness are not required or a
          supplement for which clinical data (other than
          bioavailability or bioequivalence studies) with respect to
          safety or effectiveness are required. Such fee shall be half
          of the amount of the fee established under clause (i).
        (B) Payment
          The fee required by subparagraph (A) shall be due upon
        submission of the application or supplement.
        (C) Exception for previously filed application or supplement
          If a human drug application or supplement was submitted by a
        person that paid the fee for such application or supplement,
        was accepted for filing, and was not approved or was withdrawn
        (without a waiver), the submission of a human drug application
        or a supplement for the same product by the same person (or the
        person's licensee, assignee, or successor) shall not be subject
        to a fee under subparagraph (A).
        (D) Refund of fee if application refused for filing
          The Secretary shall refund 75 percent of the fee paid under
        subparagraph (B) for any application or supplement which is
        refused for filing.
        (E) Exception for designated orphan drug or indication
          A human drug application for a prescription drug product that
        has been designated as a drug for a rare disease or condition
        pursuant to section 360bb of this title shall not be subject to
        a fee under subparagraph (A), unless the human drug application
        includes an indication for other than a rare disease or
        condition. A supplement proposing to include a new indication
        for a rare disease or condition in a human drug application
        shall not be subject to a fee under subparagraph (A), if the
        drug has been designated pursuant to section 360bb of this
        title as a drug for a rare disease or condition with regard to
        the indication proposed in such supplement.
        (F) Refund of fee if application withdrawn
          If an application or supplement is withdrawn after the
        application or supplement was filed, the Secretary may refund
        the fee or a portion of the fee if no substantial work was
        performed on the application or supplement after the
        application or supplement was filed. The Secretary shall have
        the sole discretion to refund a fee or a portion of the fee
        under this subparagraph. A determination by the Secretary
        concerning a refund under this paragraph shall not be
        reviewable.
      (2) Prescription drug establishment fee
        (A) In general
          Except as provided in subparagraph (B), each person that - 
            (i) is named as the applicant in a human drug application;
          and
            (ii) after September 1, 1992, had pending before the
          Secretary a human drug application or supplement,

        shall be assessed an annual fee established under subsection
        (c)(4) of this section for each prescription drug establishment
        listed in its approved human drug application as an
        establishment that manufactures the prescription drug product
        named in the application. The annual establishment fee shall be
        assessed in each fiscal year in which the prescription drug
        product named in the application is assessed a fee under
        paragraph (3) unless the prescription drug establishment listed
        in the application does not engage in the manufacture of the
        prescription drug product during the fiscal year. The
        establishment fee shall be payable on or before October 1 of
        each year. Each such establishment shall be assessed only one
        fee per establishment, notwithstanding the number of
        prescription drug products manufactured at the establishment.
        In the event an establishment is listed in a human drug
        application by more than one applicant, the establishment fee
        for the fiscal year shall be divided equally and assessed among
        the applicants whose prescription drug products are
        manufactured by the establishment during the fiscal year and
        assessed product fees under paragraph (3).
        (B) Exception
          If, during the fiscal year, an applicant initiates or causes
        to be initiated the manufacture of a prescription drug product
        at an establishment listed in its human drug application - 
            (i) that did not manufacture the product in the previous
          fiscal year; and
            (ii) for which the full establishment fee has been assessed
          in the fiscal year at a time before manufacture of the
          prescription drug product was begun;

        the applicant will not be assessed a share of the establishment
        fee for the fiscal year in which the manufacture of the product
        began.
      (3) Prescription drug product fee
        (A) In general
          Except as provided in subparagraph (B), each person who is
        named as the applicant in a human drug application, and who,
        after September 1, 1992, had pending before the Secretary a
        human drug application or supplement, shall pay for each such
        prescription drug product the annual fee established under
        subsection (c)(4) of this section. Such fee shall be payable on
        or before October 1 of each year. Such fee shall be paid only
        once for each product for a fiscal year in which the fee is
        payable.
        (B) Exception
          A prescription drug product shall not be assessed a fee under
        subparagraph (A) if such product is identified on the list
        compiled under section 355(j)(7)(A) of this title with a
        potency described in terms of per 100 mL, or if such product is
        the same product as another product approved under an
        application filed under section 355(b) or 355(j) of this title,
        under an abbreviated application filed under section 357 of
        this title (as in effect on the day before November 21, 1997),
        or under an abbreviated new drug application pursuant to
        regulations in effect prior to the implementation of the Drug
        Price Competition and Patent Term Restoration Act of 1984.
    (b) Fee revenue amounts
      Except as provided in subsections (c), (d), (f), and (g) of this
    section, fees under subsection (a) of this section shall be
    established to generate the following revenue amounts:


    Type of Fee Revenue: Application/Supplement
      Fiscal Year 2003: $74,300,000
      Fiscal Year 2004: $77,000,000
      Fiscal Year 2005: $84,000,000
      Fiscal Year 2006: $86,434,000
      Fiscal Year 2007: $86,434,000
    Type of Fee Revenue: Establishment
      Fiscal Year 2003: $74,300,000
      Fiscal Year 2004: $77,000,000
      Fiscal Year 2005: $84,000,000
      Fiscal Year 2006: $86,433,000
      Fiscal Year 2007: $86,433,000
    Type of Fee Revenue: Product
      Fiscal Year 2003: $74,300,000
      Fiscal Year 2004: $77,000,000
      Fiscal Year 2005: $84,000,000
      Fiscal Year 2006: $86,433,000
      Fiscal Year 2007: $86,433,000
    Type of Fee Revenue: Total Fee Revenue
      Fiscal Year 2003: $222,900,000
      Fiscal Year 2004: $231,000,000
      Fiscal Year 2005: $252,000,000
      Fiscal Year 2006: $259,300,000
      Fiscal Year 2007: $259,300,000
    --------------------------------------------------------------------

    If, after June 12, 2002, legislation is enacted requiring the
    Secretary to fund additional costs of the retirement of Federal
    personnel, fee revenue amounts shall be increased in each year by
    the amount necessary to fully fund the portion of such additional
    costs that are attributable to the process for the review of human
    drug applications.
    (c) Adjustments
      (1) Inflation adjustment
        The revenues established in subsection (b) of this section
      shall be adjusted by the Secretary by notice, published in the
      Federal Register, for a fiscal year to reflect the greater of - 
          (A) the total percentage change that occurred in the Consumer
        Price Index for all urban consumers (all items; U.S. city
        average) for the 12 month period ending June 30 preceding the
        fiscal year for which fees are being established, or
          (B) the total percentage change for the previous fiscal year
        in basic pay under the General Schedule in accordance with
        section 5332 of title 5, as adjusted by any locality-based
        comparability payment pursuant to section 5304 of such title
        for Federal employees stationed in the District of Columbia.

      The adjustment made each fiscal year by this subsection will be
      added on a compounded basis to the sum of all adjustments made
      each fiscal year after fiscal year 2003 under this subsection.
      (2) Workload adjustment
        Beginning with fiscal year 2004, after the fee revenues
      established in subsection (b) of this section are adjusted for a
      fiscal year for inflation in accordance with paragraph (1), the
      fee revenues shall be adjusted further for such fiscal year to
      reflect changes in the workload of the Secretary for the process
      for the review of human drug applications. With respect to such
      adjustment:
          (A) The adjustment shall be determined by the Secretary based
        on a weighted average of the change in the total number of
        human drug applications, commercial investigational new drug
        applications, efficacy supplements, and manufacturing
        supplements submitted to the Secretary. The Secretary shall
        publish in the Federal Register the fee revenues and fees
        resulting from the adjustment and the supporting methodologies.
          (B) Under no circumstances shall the adjustment result in fee
        revenues for a fiscal year that are less than the fee revenues
        for the fiscal year established in subsection (b) of this
        section, as adjusted for inflation under paragraph (1).
      (3) Final year adjustment
        For fiscal year 2007, the Secretary may, in addition to
      adjustments under paragraphs (1) and (2), further increase the
      fee revenues and fees established in subsection (b) of this
      section if such an adjustment is necessary to provide for not
      more than three months of operating reserves of carryover user
      fees for the process for the review of human drug applications
      for the first three months of fiscal year 2008. If such an
      adjustment is necessary, the rationale for the amount of the
      increase shall be contained in the annual notice establishing fee
      revenues and fees for fiscal year 2007. If the Secretary has
      carryover balances for such process in excess of three months of
      such operating reserves, the adjustment under this paragraph
      shall not be made.
      (4) Annual fee setting
        The Secretary shall, 60 days before the start of each fiscal
      year that begins after September 30, 2002, establish, for the
      next fiscal year, application, product, and establishment fees
      under subsection (a) of this section, based on the revenue
      amounts established under subsection (b) of this section and the
      adjustments provided under this subsection.
      (5) Limit
        The total amount of fees charged, as adjusted under this
      subsection, for a fiscal year may not exceed the total costs for
      such fiscal year for the resources allocated for the process for
      the review of human drug applications.
    (d) Fee waiver or reduction
      (1) In general
        The Secretary shall grant a waiver from or a reduction of one
      or more fees assessed under subsection (a) of this section where
      the Secretary finds that - 
          (A) such waiver or reduction is necessary to protect the
        public health,
          (B) the assessment of the fee would present a significant
        barrier to innovation because of limited resources available to
        such person or other circumstances,
          (C) the fees to be paid by such person will exceed the
        anticipated present and future costs incurred by the Secretary
        in conducting the process for the review of human drug
        applications for such person, or
          (D) the applicant involved is a small business submitting its
        first human drug application to the Secretary for review.
      (2) Use of standard costs
        In making the finding in paragraph (1)(C), the Secretary may
      use standard costs.
      (3) Rules relating to small businesses
        (A) "Small business" defined
          In paragraph (1)(D), the term "small business" means an
        entity that has fewer than 500 employees, including employees
        of affiliates.
        (B) Waiver of application fee
          The Secretary shall waive under paragraph (1)(D) the
        application fee for the first human drug application that a
        small business or its affiliate submits to the Secretary for
        review. After a small business or its affiliate is granted such
        a waiver, the small business or its affiliate shall pay - 
            (i) application fees for all subsequent human drug
          applications submitted to the Secretary for review in the
          same manner as an entity that does not qualify as a small
          business; and
            (ii) all supplement fees for all supplements to human drug
          applications submitted to the Secretary for review in the
          same manner as an entity that does not qualify as a small
          business.
    (e) Effect of failure to pay fees
      A human drug application or supplement submitted by a person
    subject to fees under subsection (a) of this section shall be
    considered incomplete and shall not be accepted for filing by the
    Secretary until all fees owed by such person have been paid.
    (f) Limitations
      (1) In general
        Fees under subsection (a) of this section shall be refunded for
      a fiscal year beginning after fiscal year 1997 unless
      appropriations for salaries and expenses of the Food and Drug
      Administration for such fiscal year (excluding the amount of fees
      appropriated for such fiscal year) are equal to or greater than
      the amount of appropriations for the salaries and expenses of the
      Food and Drug Administration for the fiscal year 1997 (excluding
      the amount of fees appropriated for such fiscal year) multiplied
      by the adjustment factor applicable to the fiscal year involved.
      (2) Authority
        If the Secretary does not assess fees under subsection (a) of
      this section during any portion of a fiscal year because of
      paragraph (1) and if at a later date in such fiscal year the
      Secretary may assess such fees, the Secretary may assess and
      collect such fees, without any modification in the rate, for
      human drug applications and supplements, prescription drug
      establishments, and prescription drug products at any time in
      such fiscal year notwithstanding the provisions of subsection (a)
      of this section relating to the date fees are to be paid.
    (g) Crediting and availability of fees
      (1) In general
        Fees authorized under subsection (a) of this section shall be
      collected and available for obligation only to the extent and in
      the amount provided in advance in appropriations Acts. Such fees
      are authorized to remain available until expended. Such sums as
      may be necessary may be transferred from the Food and Drug
      Administration salaries and expenses appropriation account
      without fiscal year limitation to such appropriation account for
      salaries and expenses with such fiscal year limitation. The sums
      transferred shall be available solely for the process for the
      review of human drug applications.
      (2) Collections and appropriation acts
        (A) In general
          The fees authorized by this section - 
            (i) shall be retained in each fiscal year in an amount not
          to exceed the amount specified in appropriation Acts, or
          otherwise made available for obligation, for such fiscal
          year, and
            (ii) shall only be collected and available to defray
          increases in the costs of the resources allocated for the
          process for the review of human drug applications (including
          increases in such costs for an additional number of full-time
          equivalent positions in the Department of Health and Human
          Services to be engaged in such process) over such costs,
          excluding costs paid from fees collected under this section,
          for fiscal year 1997 multiplied by the adjustment factor.
        (B) Compliance
          The Secretary shall be considered to have met the
        requirements of subparagraph (A)(ii) in any fiscal year if the
        costs funded by appropriations and allocated for the process
        for the review of human drug applications - 
            (i) are not more than 3 percent below the level specified
          in subparagraph (A)(ii); or
            (ii)(I) are more than 3 percent below the level specified
          in subparagraph (A)(ii), and fees assessed for the fiscal
          year following the subsequent fiscal year are decreased by
          the amount in excess of 3 percent by which such costs fell
          below the level specified in such subparagraph; and
            (II) such costs are not more than 5 percent below the level
          specified in such subparagraph.
      (3) Authorization of appropriations
        There are authorized to be appropriated for fees under this
      section - 
          (A) $222,900,000 for fiscal year 2003;
          (B) $231,000,000 for fiscal year 2004;
          (C) $252,000,000 for fiscal year 2005;
          (D) $259,300,000 for fiscal year 2006; and
          (E) $259,300,000 for fiscal year 2007;

      as adjusted to reflect adjustments in the total fee revenues made
      under this section and changes in the total amounts collected by
      application, supplement, establishment, and product fees.
      (4) Offset
        Any amount of fees collected for a fiscal year under this
      section that exceeds the amount of fees specified in
      appropriation Acts for such fiscal year shall be credited to the
      appropriation account of the Food and Drug Administration as
      provided in paragraph (1), and shall be subtracted from the
      amount of fees that would otherwise be authorized to be collected
      under this section pursuant to appropriation Acts for a
      subsequent fiscal year.
    (h) Collection of unpaid fees
      In any case where the Secretary does not receive payment of a fee
    assessed under subsection (a) of this section within 30 days after
    it is due, such fee shall be treated as a claim of the United
    States Government subject to subchapter II of chapter 37 of title
    31.
    (i) Written requests for waivers, reductions, and refunds
      To qualify for consideration for a waiver or reduction under
    subsection (d) of this section, or for a refund of any fee
    collected in accordance with subsection (a) of this section, a
    person shall submit to the Secretary a written request for such
    waiver, reduction, or refund not later than 180 days after such fee
    is due.
    (j) Construction
      This section may not be construed to require that the number of
    full-time equivalent positions in the Department of Health and
    Human Services, for officers, employers, and advisory committees
    not engaged in the process of the review of human drug
    applications, be reduced to offset the number of officers,
    employees, and advisory committees so engaged.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 736, as added Pub. L. 102-571, title
    I, Sec. 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105-
    115, title I, Sec. 103(a)-(g), Nov. 21, 1997, 111 Stat. 2299-2304;
    Pub. L. 107-109, Sec. 5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L.
    107-188, title V, Sec. 504, June 12, 2002, 116 Stat. 689.)


-STATAMEND-
                           AMENDMENT OF SECTION                       
      For termination of amendment by section 509 of Pub. L. 107-188,
    see Effective and Termination Dates of 2002 Amendments note below.
      For termination of amendment by section 107 of Pub. L. 105-115,
    see Effective and Termination Dates of 1997 Amendment note below.

                          TERMINATION OF SECTION                      
      For termination of section by section 105 of Pub. L. 102-571, see
    Termination Date note below.

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 357 of this title, referred to in subsec. (a)(3)(B), was
    repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
    1997, 111 Stat. 2325.
      The Drug Price Competition and Patent Term Restoration Act of
    1984, referred to in subsec. (a)(3)(B), is Pub. L. 98-417, Sept.
    24, 1984, 98 Stat. 1585. For complete classification of this Act to
    the Code, see Short Title of 1984 Amendment note set out under
    section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-188, Secs. 504(a)(1), 509,
    temporarily substituted "fiscal year 2003" for "fiscal year 1998"
    in introductory provisions. See Effective and Termination Dates of
    2002 Amendment note below.
      Subsec. (a)(1)(A)(i). Pub. L. 107-188, Secs. 504(a)(2)(A), 509,
    temporarily substituted "under subsection (c)(4)" for "in
    subsection (b)". See Effective and Termination Dates of 2002
    Amendment note below.
      Subsec. (a)(1)(A)(ii). Pub. L. 107-188, Secs. 504(a)(2), 509,
    temporarily substituted "under subsection (c)(4)" for "in
    subsection (b)" and inserted "Such fee shall be half of the amount
    of the fee established under clause (i)." at end. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (a)(1)(F), (G). Pub. L. 107-109 redesignated subpar. (G)
    as (F) and struck out heading and text of former subpar. (F). Text
    read as follows: "A supplement to a human drug application
    proposing to include a new indication for use in pediatric
    populations shall not be assessed a fee under subparagraph (A)."
      Subsec. (a)(2)(A). Pub. L. 107-188, Secs. 504(a)(3), 509, in
    concluding provisions, temporarily substituted "under subsection
    (c)(4)" for "in subsection (b)" and "payable on or before October
    1" for "payable on or before January 31". See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (a)(3)(A). Pub. L. 107-188, Secs. 504(a)(4)(A), 509,
    temporarily amended heading and text of subpar. (A) generally.
    Prior to amendment, text read as follows: "Except as provided in
    subparagraph (B), each person - 
        "(i) who is named as the applicant in a human drug application
      for a prescription drug product which has been submitted for
      listing under section 360 of this title, and
        "(ii) who, after September 1, 1992, had pending before the
      Secretary a human drug application or supplement,
    shall pay for each such prescription drug product the annual fee
    established in subsection (b) of this section. Such fee shall be
    payable for the fiscal year in which the product is first submitted
    for listing under section 360 of this title, or is submitted for
    relisting under section 360 of this title if the product has been
    withdrawn from listing and relisted. After such fee is paid for
    that fiscal year, such fee shall be payable on or before January 31
    of each year. Such fee shall be paid only once for each product for
    a fiscal year in which the fee is payable." See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (a)(3)(B). Pub. L. 107-188, Secs. 504(a)(4)(B), 509,
    temporarily substituted "A prescription drug product shall not be
    assessed a fee under subparagraph (A) if such product is identified
    on the list compiled under section 355(j)(7)(A) of this title with
    a potency described in terms of per 100 mL, or if such product is
    the same product as another product approved under an application
    filed under section 355(b)" for "The listing of a prescription drug
    product under section 360 of this title shall not require the
    person who listed such product to pay the fee prescribed by
    subparagraph (A) if such product is the same product as a product
    approved under an application filed under section 355(b)(2)". See
    Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (b). Pub. L. 107-188, Secs. 504(b), 509, temporarily
    amended heading and text of subsec. (b) generally, substituting
    "Fee revenue amounts" for "Fee amounts" in heading and substituting
    fee schedules for fiscal years 2003 to 2007 for fee provisions
    relating to fiscal years 1998 to 2002. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (c)(1). Pub. L. 107-188, Secs. 504(c)(1)(A), (D), 509,
    temporarily substituted "revenues" for "fees and total fee
    revenues" in introductory provisions and "fiscal year 2003" for
    "fiscal year 1997" in concluding provisions. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (c)(1)(A). Pub. L. 107-188, Secs. 504(c)(1)(B), 509,
    temporarily struck out "during the preceding fiscal year" before
    "in the Consumer Price Index" and substituted "for the 12 month
    period ending June 30 preceding the fiscal year for which fees are
    being established, or" for ", or". See Effective and Termination
    Dates of 2002 Amendment note below.
      Subsec. (c)(1)(B). Pub. L. 107-188, Secs. 504(c)(1)(C), 509,
    temporarily substituted "for the previous fiscal year" for "for
    such fiscal year". See Effective and Termination Dates of 2002
    Amendment note below.
      Subsec. (c)(2) to (5). Pub. L. 107-188, Secs. 504(c)(2)-(4), 509,
    temporarily added pars. (2) and (3), redesignated former pars. (2)
    and (3) as (4) and (5), respectively, and amended heading and text
    of par. (4) generally. Prior to amendment, text of par. (4) read as
    follows: "Subject to the amount appropriated for a fiscal year
    under subsection (g) of this section, the Secretary shall, within
    60 days after the end of each fiscal year beginning after September
    30, 1997, adjust the establishment and product fees described in
    subsection (b) of this section for the fiscal year in which the
    adjustment occurs so that the revenues collected from each of the
    categories of fees described in paragraphs (2) and (3) of
    subsection (b) of this section shall be set to be equal to the
    revenues collected from the category of application and supplement
    fees described in paragraph (1) of subsection (b) of this section."
    See Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (d)(1)(C) to (E). Pub. L. 107-188, Secs. 504(d)(1), 509,
    temporarily inserted "or" at end of subpar. (C), redesignated
    subpar. (E) as (D), and struck out former subpar. (D) which read as
    follows: "assessment of the fee for an application or a supplement
    filed under section 355(b)(1) of this title pertaining to a drug
    containing an active ingredient would be inequitable because an
    application for a product containing the same active ingredient
    filed by another person under section 355(b)(2) of this title could
    not be assessed fees under subsection (a)(1) of this section, or".
    See Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (d)(3)(A), (B). Pub. L. 107-188, Secs. 504(d)(2), 509,
    temporarily substituted "paragraph (1)(D)" for "paragraph (1)(E)".
    See Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (f). Pub. L. 107-188, Secs. 504(e)(1), 509, temporarily
    substituted "Limitations" for "Assessment of fees" in heading. See
    Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (f)(1). Pub. L. 107-188, Secs. 504(e)(2), 509,
    temporarily substituted "In general" for "Limitation" in heading
    and "Fees under subsection (a) of this section shall be refunded
    for a fiscal year beginning" for "Fees may not be assessed under
    subsection (a) of this section for a fiscal year beginning" in
    text. See Effective and Termination Dates of 2002 Amendment note
    below.
      Subsec. (g)(1). Pub. L. 107-188, Secs. 504(f)(1), 509, which
    directed the temporary amendment of par. (1) by striking "Fees
    collected for a fiscal year" and all that follows through "fiscal
    year limitation." and inserting "Fees authorized under subsection
    (a) of this section shall be collected and available for obligation
    only to the extent and in the amount provided in advance in
    appropriations Acts. Such fees are authorized to remain available
    until expended.", was executed by striking language ending with
    "fiscal year limitation." the first time appearing, thereby making
    the substitution for "Fees collected for a fiscal year pursuant to
    subsection (a) of this section shall be credited to the
    appropriation account for salaries and expenses of the Food and
    Drug Administration and shall be available in accordance with
    appropriation Acts until expended without fiscal year limitation.",
    to reflect the probable intent of Congress. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (g)(2). Pub. L. 107-188, Secs. 504(f)(2), 509,
    temporarily amended par. (2) by designating existing provisions as
    subpar. (A), inserting subpar. (A) heading, adding subpar. (B),
    redesignating former subpars. (A) and (B) as cls. (i) and (ii),
    respectively, of subpar. (A), substituting "shall be retained in
    each fiscal year in an amount not to exceed the amount specified"
    for "shall be collected in each fiscal year in an amount equal to
    the amount specified" in cl. (i), and realigning margin of cl.
    (ii). See Effective and Termination Dates of 2002 Amendment note
    below.
      Subsec. (g)(3)(A) to (E). Pub. L. 107-188, Secs. 504(f)(3), 509,
    temporarily added subpars. (A) to (E) and struck out former
    subpars. (A) to (E) which read as follows:
      "(A) $106,800,000 for fiscal year 1998;
      "(B) $109,200,000 for fiscal year 1999;
      "(C) $109,200,000 for fiscal year 2000;
      "(D) $114,000,000 for fiscal year 2001; and
      "(E) $110,100,000 for fiscal year 2002,".
    See Effective and Termination Dates of 2002 Amendment note below.
      1997 - Subsec. (a). Pub. L. 105-115, Secs. 103(a)(1), 107,
    temporarily substituted "Beginning in fiscal year 1998" for
    "Beginning in fiscal year 1993" in introductory provisions. See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (a)(1)(B). Pub. L. 105-115, Secs. 103(a)(2)(A), 107,
    temporarily amended heading and text of subpar. (B) generally.
    Prior to amendment, text read as follows:
      "(i) First payment. - 50 percent of the fee required by
    subparagraph (A) shall be due upon submission of the application or
    supplement.
      "(ii) Final payment. - The remaining 50 percent of the fee
    required by subparagraph (A) shall be due upon - 
        "(I) the expiration of 30 days from the date the Secretary
      sends to the applicant a letter designated by the Secretary as an
      action letter described in section 379g(6)(B) of this title, or
        "(II) the withdrawal of the application or supplement after it
      is filed unless the Secretary waives the fee or a portion of the
      fee because no substantial work was performed on such application
      or supplement after it was filed.
    The designation under subclause (I) or the waiver under subclause
    (II) shall be solely in the discretion of the Secretary and shall
    not be reviewable." See Effective and Termination Dates of 1997
    Amendment note below.
      Subsec. (a)(1)(D). Pub. L. 105-115, Secs. 103(a)(2)(B), 107,
    temporarily substituted "refused" for "not accepted" in heading and
    "75 percent" for "50 percent", "subparagraph (B)" for "subparagraph
    (B)(i)", and "refused" for "not accepted" in text. See Effective
    and Termination Dates of 1997 Amendment note below.
      Subsec. (a)(1)(E) to (G). Pub. L. 105-115, Secs. 103(a)(2)(C),
    107, temporarily added subpars. (E) to (G). See Effective and
    Termination Dates of 1997 Amendment note below.
      Subsec. (a)(2). Pub. L. 105-115, Secs. 103(a)(3), 107,
    temporarily reenacted heading without change and amended text
    generally. Prior to amendment, text read as follows: "Each person
    that - 
        "(A) owns a prescription drug establishment, at which is
      manufactured at least 1 prescription drug product which is not
      the, or not the same as a, product approved under an application
      filed under section 355(b)(2) or 355(j) of this title, and
        "(B) after September 1, 1992, had pending before the Secretary
      a human drug application or supplement,
    shall be subject to the annual fee established in subsection (b) of
    this section for each such establishment, payable on or before
    January 31 of each year." See Effective and Termination Dates of
    1997 Amendment note below.
      Subsec. (a)(3)(A). Pub. L. 105-115, Secs. 103(a)(4)(A), 107,
    temporarily substituted, in cl. (i), "has been submitted for
    listing" for "is listed" and, in closing provisions, "Such fee
    shall be payable for the fiscal year in which the product is first
    submitted for listing under section 360 of this title, or is
    submitted for relisting under section 360 of this title if the
    product has been withdrawn from listing and relisted. After such
    fee is paid for that fiscal year, such fee shall be payable on or
    before January 31 of each year. Such fee shall be paid only once
    for each product for a fiscal year in which the fee is payable."
    for "Such fee shall be payable at the time of the first such
    listing of such product in each calendar year. Such fee shall be
    paid only once each year for each listed prescription drug product
    irrespective of the number of times such product is listed under
    section 360 of this title." See Effective and Termination Dates of
    1997 Amendment note below.
      Subsec. (a)(3)(B). Pub. L. 105-115, Secs. 103(a)(4)(B), 107,
    temporarily substituted "355(j) of this title, under an abbreviated
    application filed under section 357 of this title (as in effect on
    the day before November 21, 1997), or under an abbreviated new drug
    application pursuant to regulations in effect prior to the
    implementation of the Drug Price Competition and Patent Term
    Restoration Act of 1984." for "355(j) of this title.". See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (b). Pub. L. 105-115, Secs. 103(b), 107, temporarily
    amended subsec. (b) generally. Prior to amendment, subsec. (b)
    related to fee amounts, including a schedule of fees in par. (1)
    and fee exceptions for certain small businesses in par. (2). See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (c). Pub. L. 105-115, Secs. 103(c)(1), 107, temporarily
    substituted "Adjustments" for "Increases and adjustments" in
    heading. See Effective and Termination Dates of 1997 Amendment note
    below.
      Subsec. (c)(1). Pub. L. 105-115, Secs. 103(c)(2), 107,
    temporarily substituted "Inflation adjustment" for "Revenue
    increase" in heading, "The fees and total fee revenues established
    in subsection (b) of this section shall be adjusted by the
    Secretary" for "The total fee revenues established by the schedule
    in subsection (b)(1) of this section shall be increased by the
    Secretary" in introductory provisions, and "change" for "increase"
    after "total percentage" in subpars. (A) and (B), and inserted at
    end "The adjustment made each fiscal year by this subsection will
    be added on a compounded basis to the sum of all adjustments made
    each fiscal year after fiscal year 1997 under this subsection." See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (c)(2). Pub. L. 105-115, Secs. 103(c)(3), 107,
    temporarily substituted "September 30, 1997, adjust the
    establishment and product fees described in subsection (b) of this
    section for the fiscal year in which the adjustment occurs so that
    the revenues collected from each of the categories of fees
    described in paragraphs (2) and (3) of subsection (b) of this
    section shall be set to be equal to the revenues collected from the
    category of application and supplement fees described in paragraph
    (1) of subsection (b) of this section." for "October 1, 1992,
    adjust the fees established by the schedule in subsection (b)(1) of
    this section for the following fiscal year to achieve the total fee
    revenues, as may be increased under paragraph (1). Such fees shall
    be adjusted under this paragraph to maintain the proportions
    established in such schedule." See Effective and Termination Dates
    of 1997 Amendment note below.
      Subsec. (c)(3). Pub. L. 105-115, Secs. 103(c)(4), 107,
    temporarily substituted "this subsection" for "paragraph (2)". See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (d). Pub. L. 105-115, Secs. 103(d), 107, temporarily
    struck out introductory provisions which read "The Secretary shall
    grant a waiver from or a reduction of 1 or more fees under
    subsection (a) of this section where the Secretary finds that - "
    and closing provisions which read "In making the finding in
    paragraph (3), the Secretary may use standard costs.", inserted
    designation, heading, and introductory provisions of par. (1),
    redesignated former pars. (1) to (4) as subpars. (A) to (D),
    respectively, of par. (1), and added pars. (1)(E), (2), and (3).
    See Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (f)(1). Pub. L. 105-115, Secs. 103(e), 107, temporarily
    substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal
    year 1997 (excluding the amount of fees appropriated for such
    fiscal year)" for "fiscal year 1992". See Effective and Termination
    Dates of 1997 Amendment note below.
      Subsec. (g)(1). Pub. L. 105-115, Secs. 103(f)(1), 107,
    temporarily inserted at end "Such sums as may be necessary may be
    transferred from the Food and Drug Administration salaries and
    expenses appropriation account without fiscal year limitation to
    such appropriation account for salaries and expenses with such
    fiscal year limitation. The sums transferred shall be available
    solely for the process for the review of human drug applications."
    See Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (g)(2)(A). Pub. L. 105-115, Secs. 103(f)(2)(A), 107,
    temporarily substituted "Acts, or otherwise made available for
    obligation," for "Acts". See Effective and Termination Dates of
    1997 Amendment note below.
      Subsec. (g)(2)(B). Pub. L. 105-115, Secs. 103(f)(2)(B), 107,
    temporarily substituted "over such costs, excluding costs paid from
    fees collected under this section, for fiscal year 1997" for "over
    such costs for fiscal year 1992". See Effective and Termination
    Dates of 1997 Amendment note below.
      Subsec. (g)(3), (4). Pub. L. 105-115, Secs. 103(f)(3), 107,
    temporarily added pars. (3) and (4) and struck out heading and text
    of former par. (3). Text read as follows: "There are authorized to
    be appropriated for fees under this section - 
        "(A) $36,000,000 for fiscal year 1993,
        "(B) $54,000,000 for fiscal year 1994,
        "(C) $75,000,000 for fiscal year 1995,
        "(D) $78,000,000 for fiscal year 1996, and
        "(E) $84,000,000 for fiscal year 1997,
    as adjusted to reflect increases in the total fee revenues made
    under subsection (c)(1) of this section." See Effective and
    Termination Dates of 1997 Amendment note below.
      Subsecs. (i), (j). Pub. L. 105-115, Secs. 103(g), 107,
    temporarily added subsec. (i) and redesignated former subsec. (i)
    as (j). See Effective and Termination Dates of 1997 Amendment note
    below.

             EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT         
      Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section
    508 of Pub. L. 107-188, set out as an Effective Date of 2002
    Amendment note under section 356b of this title.
      Amendment by Pub. L. 107-188 to cease to be effective Oct. 1,
    2007, see section 509 of Pub. L. 107-188, set out as a note under
    section 379g of this title.

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Amendment by Pub. L. 105-115 effective Oct. 1, 1997, and ceases
    to be effective Oct. 1, 2002, see sections 106 and 107 of Pub. L.
    105-115, set out as notes under section 379g of this title.

                             TERMINATION DATE                         
      Section not in effect after Oct. 1, 1997, see section 105 of Pub.
    L. 102-571, set out as a note under section 379g of this title.

                   SPECIAL RULE FOR WAIVERS AND REFUNDS               
      Section 103(h) of Pub. L. 105-115 provided that: "Any requests
    for waivers or refunds for fees assessed under section 736 of the
    Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the
    date of enactment of this Act [Nov. 21, 1997] shall be submitted in
    writing to the Secretary of Health and Human Services within 1 year
    after the date of enactment of this Act. Any requests for waivers
    or refunds pertaining to a fee for a human drug application or
    supplement accepted for filing prior to October 1, 1997 or to a
    product or establishment fee required by such Act for a fiscal year
    prior to fiscal year 1998, shall be evaluated according to the
    terms of the Prescription Drug User Fee Act of 1992 [see section
    101(a) of Pub. L. 102-571, set out as a Short Title of 1992
    Amendment note under section 301 of this title] (as in effect on
    September 30, 1997) and part 2 of subchapter C of chapter VII of
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.]
    (as in effect on September 30, 1997). The term "person" in such
    Acts shall continue to include an affiliate thereof."

-End-


-CITE-
    21 USC subpart 3 - fees relating to devices                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 3 - fees relating to devices

-HEAD-
                   SUBPART 3 - FEES RELATING TO DEVICES               


-STATAMEND-
                          TERMINATION OF SUBPART                      
      For termination of subpart by section 107 of Pub. L. 107-250, see
    Effective and Termination Dates note set out under section 379i of
    this title.

-End-



-CITE-
    21 USC Sec. 379i                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 3 - fees relating to devices

-HEAD-
    Sec. 379i. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "premarket application" means - 
          (A) an application for approval of a device submitted under
        section 360e(c) of this title or section 262 of title 42; or
          (B) a product development protocol described in section
        360e(f) of this title.

      Such term does not include a supplement, a premarket report, or a
      premarket notification submission.
        (2) The term "premarket report" means a report submitted under
      section 360e(c)(2) of this title.
        (3) The term "premarket notification submission" means a report
      submitted under section 360(k) of this title.
        (4)(A) The term "supplement", with respect to a panel-track
      supplement, a 180-day supplement, a real-time supplement, or an
      efficacy supplement, means a request to the Secretary to approve
      a change in a device for which - 
          (i) an application or report has been approved under section
        360e(d) of this title, or an application has been approved
        under section 262 of title 42; or
          (ii) a notice of completion has become effective under
        section 360e(f) of this title.

        (B) The term "panel-track supplement" means a supplement to an
      approved premarket application or premarket report under section
      360e of this title that requests a significant change in design
      or performance of the device, or a new indication for use of the
      device, and for which substantial clinical data are necessary to
      provide a reasonable assurance of safety and effectiveness.
        (C) The term "180-day supplement" means a supplement to an
      approved premarket application or premarket report under section
      360e of this title that is not a panel-track supplement and
      requests a significant change in components, materials, design,
      specification, software, color additives, or labeling.
        (D) The term "real-time supplement" means a supplement to an
      approved premarket application or premarket report under section
      360e of this title that requests a minor change to the device,
      such as a minor change to the design of the device, software,
      sterilization, or labeling, and for which the applicant has
      requested and the agency has granted a meeting or similar forum
      to jointly review and determine the status of the supplement.
        (E) The term "efficacy supplement" means a supplement to an
      approved premarket application under section 262 of title 42 that
      requires substantive clinical data.
        (5) The term "process for the review of device applications"
      means the following activities of the Secretary with respect to
      the review of premarket applications, premarket reports,
      supplements, and premarket notification submissions:
          (A) The activities necessary for the review of premarket
        applications, premarket reports, supplements, and premarket
        notification submissions.
          (B) The issuance of action letters that allow the marketing
        of devices or which set forth in detail the specific
        deficiencies in such applications, reports, supplements, or
        submissions and, where appropriate, the actions necessary to
        place them in condition for approval.
          (C) The inspection of manufacturing establishments and other
        facilities undertaken as part of the Secretary's review of
        pending premarket applications, premarket reports, and
        supplements.
          (D) Monitoring of research conducted in connection with the
        review of such applications, reports, supplements, and
        submissions.
          (E) Review of device applications subject to section 262 of
        title 42 for an investigational new drug application under
        section 355(i) of this title or for an investigational device
        exemption under section 360j(g) of this title and activities
        conducted in anticipation of the submission of such
        applications under section 355(i) or 360j(g) of this title.
          (F) The development of guidance, policy documents, or
        regulations to improve the process for the review of premarket
        applications, premarket reports, supplements, and premarket
        notification submissions.
          (G) The development of voluntary test methods, consensus
        standards, or mandatory performance standards under section
        360d of this title in connection with the review of such
        applications, reports, supplements, or submissions and related
        activities.
          (H) The provision of technical assistance to device
        manufacturers in connection with the submission of such
        applications, reports, supplements, or submissions.
          (I) Any activity undertaken under section 360c or 360e(i) of
        this title in connection with the initial classification or
        reclassification of a device or under section 360e(b) of this
        title in connection with any requirement for approval of a
        device.
          (J) Evaluation of postmarket studies required as a condition
        of an approval of a premarket application or premarket report
        under section 360e of this title or a premarket application
        under section 262 of title 42.
          (K) Compiling, developing, and reviewing information on
        relevant devices to identify safety and effectiveness issues
        for devices subject to premarket applications, premarket
        reports, supplements, or premarket notification submissions.

        (6) The term "costs of resources allocated for the process for
      the review of device applications" means the expenses incurred in
      connection with the process for the review of device applications
      for - 
          (A) officers and employees of the Food and Drug
        Administration, contractors of the Food and Drug
        Administration, advisory committees, and costs related to such
        officers, employees, and committees and to contracts with such
        contractors;
          (B) management of information, and the acquisition,
        maintenance, and repair of computer resources;
          (C) leasing, maintenance, renovation, and repair of
        facilities and acquisition, maintenance, and repair of
        fixtures, furniture, scientific equipment, and other necessary
        materials and supplies; and
          (D) collecting fees and accounting for resources allocated
        for the review of premarket applications, premarket reports,
        supplements, and submissions.

        (7) The term "adjustment factor" applicable to a fiscal year is
      the Consumer Price Index for all urban consumers (all items;
      United States city average) for April of the preceding fiscal
      year divided by such Index for April 2002.
        (8) The term "affiliate" means a business entity that has a
      relationship with a second business entity (whether domestic or
      international) if, directly or indirectly - 
          (A) one business entity controls, or has the power to
        control, the other business entity; or
          (B) a third party controls, or has power to control, both of
        the business entities.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 737, as added Pub. L. 107-250, title
    I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108-
    214, Sec. 2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 107 of Pub. L. 107-250, see
    Effective and Termination Dates note set out below.


-MISC1-
                                AMENDMENTS                            
      2004 - Pub. L. 108-214, Sec. 2(d)(3)(A), made technical
    correction to directory language of Pub. L. 107-250, Sec. 102(a),
    which enacted this section.
      Par. (4)(B). Pub. L. 108-214, Sec. 2(a)(1)(A), substituted "and
    for which substantial clinical data are necessary to provide a
    reasonable assurance of safety and effectiveness" for "and for
    which clinical data are generally necessary to provide a reasonable
    assurance of safety and effectiveness".
      Par. (4)(D). Pub. L. 108-214, Sec. 2(a)(1)(B), struck out
    "manufacturing," after "software,".
      Par. (5)(J). Pub. L. 108-214, Sec. 2(a)(1)(C), substituted "a
    premarket application or premarket report under section 360e of
    this title or a premarket application under section 262 of title
    42." for "a premarket application under section 360e of this title
    or section 262 of title 42."
      Par. (8). Pub. L. 108-214, Sec. 2(a)(1)(D), substituted "The term
    'affiliate' means a business entity that has a relationship with a
    second business entity (whether domestic or international)" for
    "The term 'affiliate' means a business entity that has a
    relationship with a second business entity".

                      EFFECTIVE AND TERMINATION DATES                  
      Pub. L. 107-250, title I, Sec. 106, Oct. 26, 2002, 116 Stat.
    1602, provided that: "The amendments made by this title [enacting
    this subpart] shall take effect on the date of the enactment of
    this Act [Oct. 26, 2002], except that fees shall be assessed for
    all premarket applications, premarket reports, supplements, and
    premarket notification submissions received on or after October 1,
    2002, regardless of the date of enactment."
      Pub. L. 107-250, title I, Sec. 107, Oct. 26, 2002, 116 Stat.
    1602, provided that: "The amendments made by this title [enacting
    this subpart] cease to be effective October 1, 2007, except that
    section 103 [set out as a note below] with respect to annual
    reports ceases to be effective January 31, 2008."

                                 FINDINGS                             
      Pub. L. 107-250, title I, Sec. 101, Oct. 26, 2002, 116 Stat.
    1589, provided that: "The Congress finds that - 
        "(1) prompt approval and clearance of safe and effective
      devices is critical to the improvement of the public health so
      that patients may enjoy the benefits of devices to diagnose,
      treat, and prevent disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for the review of devices and the assurance of device safety and
      effectiveness so that statutorily mandated deadlines may be met;
      and
        "(3) the fees authorized by this title [enacting this subpart
      and provisions set out as notes under this section and section
      379j of this title] will be dedicated to meeting the goals
      identified in the letters from the Secretary of Health and Human
      Services to the Committee on Energy and Commerce of the House of
      Representatives and the Committee on Health, Education, Labor,
      and Pensions of the Senate, as set forth in the Congressional
      Record."

                              ANNUAL REPORTS                          
      Pub. L. 107-250, title I, Sec. 103, Oct. 26, 2002, 116 Stat.
    1600, as amended by Pub. L. 109-43, Sec. 2(b), Aug. 1, 2005, 119
    Stat. 441, provided that:
      "(a) In General. - Beginning with fiscal year 2003, the Secretary
    shall prepare and submit to the Committee on Energy and Commerce of
    the House of Representatives and the Committee on Health,
    Education, Labor and Pensions of the Senate a report concerning - 
        "(1) the progress of the Food and Drug Administration in
      achieving the goals identified in the letters described in
      section 101(3) [set out as a note above] during such fiscal year
      and the future plans of the Food and Drug Administration for
      meeting the goals, not later than 60 days after the end of each
      fiscal year during which fees are collected under this part
      [title I of Pub. L. 107-250 does not contain parts]; and
        "(2) the implementation of the authority for such fees during
      such fiscal year, and the use, by the Food and Drug
      Administration, of the fees collected during such fiscal year,
      not later than 120 days after the end of each fiscal year during
      which fees are collected under the medical device user-fee
      program established under the amendment made by section 102
      [enacting this subpart].
      "(b) Additional Information. - For fiscal years 2006 and 2007,
    the report described under subsection (a)(2) shall include - 
        "(1) information on the number of different types of
      applications and notifications, and the total amount of fees paid
      for each such type of application or notification, from
      businesses with gross receipts or sales from $0 to $100,000,000,
      with such businesses categorized in $10,000,000 intervals; and
        "(2) a certification by the Secretary that the amounts
      appropriated for salaries and expenses of the Food and Drug
      Administration for such fiscal year and obligated by the
      Secretary for the performance of any function relating to devices
      that is not for the process for the review of device
      applications, as defined in paragraph (5) of section 737 of the
      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not
      less than such amounts for fiscal year 2002 multiplied by the
      adjustment factor, as defined in paragraph (7) of such section
      737."
      [Section 103 of Pub. L. 107-250, set out above, ceases to be
    effective Jan. 31, 2008, see Effective and Termination Dates note
    above.]

                                   STUDY                               
      Pub. L. 107-250, title I, Sec. 104(b), Oct. 26, 2002, 116 Stat.
    1601, directed the Secretary of Health and Human Services to
    conduct a study for the purpose of making certain determinations
    regarding the medical device user-fee program established under the
    amendment made by section 102 of Pub. L. 107-250 and to submit a
    report to Congress by Jan. 10, 2007.

                               CONSULTATION                           
      Pub. L. 107-250, title I, Sec. 105, Oct. 26, 2002, 116 Stat.
    1601, provided that:
      "(a) In General. - In developing recommendations to the Congress
    for the goals and plans for meeting the goals for the process for
    the review of medical device applications for fiscal years after
    fiscal year 2007, and for the reauthorization of sections 737 and
    738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i,
    379j], the Secretary of Health and Human Services (referred to in
    this section as the 'Secretary') shall consult with the Committee
    on Energy and Commerce of the House of Representatives, the
    Committee on Health, Education, Labor, and Pensions of the Senate,
    appropriate scientific and academic experts, health care
    professionals, representatives of patient and consumer advocacy
    groups, and the regulated industry.
      "(b) Recommendations. - The Secretary shall publish in the
    Federal Register recommendations under subsection (a), after
    negotiations with the regulated industry; shall present such
    recommendations to the congressional committees specified in such
    paragraph; shall hold a meeting at which the public may present its
    views on such recommendations; and shall provide for a period of 30
    days for the public to provide written comments on such
    recommendations."

-End-



-CITE-
    21 USC Sec. 379j                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 3 - fees relating to devices

-HEAD-
    Sec. 379j. Authority to assess and use device fees

-STATUTE-
    (a) Types of fees
      (1) In general
        Beginning on October 26, 2002, the Secretary shall assess and
      collect fees in accordance with this section.
      (2) Premarket application, premarket report, supplement, and
        submission fee
        (A) In general
          Except as provided in subparagraph (B) and subsections (d)
        and (e) of this section, each person who submits any of the
        following, on or after October 1, 2002, shall be subject to a
        fee established under subsection (c)(1) of this section for the
        fiscal year involved in accordance with the following:
            (i) A premarket application.
            (ii) For a premarket report, a fee equal to the fee that
          applies under clause (i).
            (iii) For a panel track supplement, a fee equal to the fee
          that applies under clause (i).
            (iv) For a 180-day supplement, a fee equal to 21.5 percent
          of the fee that applies under clause (i).
            (v) For a real-time supplement, a fee equal to 7.2 percent
          of the fee that applies under clause (i).
            (vi) For an efficacy supplement, a fee equal to the fee
          that applies under clause (i).
            (vii) For a premarket notification submission, a fee equal
          to 1.42 percent of the fee that applies under clause (i),
          subject to any adjustment under subsection (e)(2)(C)(ii) of
          this section.
        (B) Exceptions
          (i) Humanitarian device exemption
            An application under section 360j(m) of this title is not
          subject to any fee under subparagraph (A).
          (ii) Further manufacturing use
            No fee shall be required under subparagraph (A) for the
          submission of a premarket application under section 262 of
          title 42 for a product licensed for further manufacturing use
          only.
          (iii) State or Federal Government sponsors
            No fee shall be required under subparagraph (A) for a
          premarket application, premarket report, supplement, or
          premarket notification submission submitted by a State or
          Federal Government entity unless the device involved is to be
          distributed commercially.
          (iv) Premarket notifications by third parties
            No fee shall be required under subparagraph (A) for a
          premarket notification submission reviewed by an accredited
          person pursuant to section 360m of this title.
          (v) Pediatric conditions of use
            (I) In general
              No fee shall be required under subparagraph (A) for a
            premarket application, premarket report, or premarket
            notification submission if the proposed conditions of use
            for the device involved are solely for a pediatric
            population. No fee shall be required under such
            subparagraph for a supplement if the sole purpose of the
            supplement is to propose conditions of use for a pediatric
            population.
            (II) Subsequent proposal of adult conditions of use
              In the case of a person who submits a premarket
            application or premarket report for which, under subclause
            (I), a fee under subparagraph (A) is not required, any
            supplement to such application that proposes conditions of
            use for any adult population is subject to the fee that
            applies under such subparagraph for a premarket
            application.
        (C) Payment
          The fee required by subparagraph (A) shall be due upon
        submission of the premarket application, premarket report,
        supplement, or premarket notification submission except that
        invoices for applications submitted between October 1, 2002,
        and October 26, 2002, shall be payable on October 30, 2002.
        Applicants submitting portions of applications pursuant to
        section 360e(c)(3) (!1) of this title shall pay such fees upon
        submission of the first portion of such applications. The fees
        credited to fiscal year 2003 under this section shall include
        all fees payable from October 1, 2002, through September 30,
        2003.

        (D) Refunds
          (i) Application refused for filing
            The Secretary shall refund 75 percent of the fee paid under
          subparagraph (A) for any application, report, or supplement
          that is refused for filing.
          (ii) Application withdrawn before filing
            The Secretary shall refund 75 percent of the fee paid under
          subparagraph (A) for any application, report, or supplement
          that is withdrawn prior to the filing decision of the
          Secretary.
          (iii) Application withdrawn before first action
            After receipt of a request for a refund of the fee paid
          under subparagraph (A) for a premarket application, premarket
          report, or supplement that is withdrawn after filing but
          before a first action, the Secretary may return some or all
          of the fee. The amount of refund, if any, shall be based on
          the level of effort already expended on the review of such
          application, report, or supplement. The Secretary shall have
          sole discretion to refund a fee or portion of the fee under
          this subparagraph. A determination by the Secretary
          concerning a refund under this paragraph shall not be
          reviewable.
    (b) Fee revenue amounts
      Except as provided in subsections (c), (d), (e), (g), and (h) of
    this section, the fees under subsection (a) of this section shall
    be established to generate the following revenue amounts:
    $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004;
    and $29,785,000 in fiscal year 2005. If legislation is enacted
    after October 26, 2002, requiring the Secretary to fund additional
    costs of the retirement of Federal personnel, fee revenue amounts
    under this subsection shall be increased in each year by the amount
    necessary to fully fund the portion of such additional costs that
    are attributable to the process for the review of device
    applications.
    (c) Annual fee setting
      (1) In general
        The Secretary shall, 60 days before the start of each fiscal
      year after September 30, 2002, publish in the Federal Register
      fees under subsection (a) of this section. The fees established
      for fiscal year 2006 shall be based on a premarket application
      fee of $259,600, and the fees established for fiscal year 2007
      shall be based on a premarket application fee of $281,600.
      (2) Limit
        The total amount of fees charged, as adjusted under this
      subsection, for a fiscal year may not exceed the total costs for
      such fiscal year for the resources allocated for the process for
      the review of device applications.
      (3) Supplement
        (A) In general
          For fiscal years 2006 and 2007, the Secretary may use
        unobligated carryover balances from fees collected in previous
        fiscal years to ensure that sufficient fee revenues are
        available in that fiscal year, so long as the Secretary
        maintains unobligated carryover balances of not less than 1
        month of operating reserves for the first month of fiscal year
        2008.
        (B) Notice to Congress
          Not later than 14 days before the Secretary anticipates the
        use of funds described in subparagraph (A), the Secretary shall
        provide notice to the Committee on Health, Education, Labor,
        and Pensions and the Committee on Appropriations of the Senate
        and the Committee on Energy and Commerce and the Committee on
        Appropriations of the House of Representatives.
    (d) Small businesses; fee waiver and fee reduction regarding
      premarket approval fees
      (1) In general
        The Secretary shall grant a waiver of the fee required under
      subsection (a) of this section for one premarket application, or
      one premarket report, where the Secretary finds that the
      applicant involved is a small business submitting its first
      premarket application to the Secretary, or its first premarket
      report, respectively, for review. For the purposes of this
      paragraph, the term "small business" means an entity that
      reported $30,000,000 or less of gross receipts or sales in its
      most recent Federal income tax return for a taxable year,
      including such returns of all of its affiliates, partners, and
      parent firms. In addition, for subsequent premarket applications,
      premarket reports, and supplements where the Secretary finds that
      the applicant involved is a small business, the fees specified in
      clauses (i) through (vi) of subsection (a)(2)(A) of this section
      may be paid at a reduced rate in accordance with paragraph
      (2)(C).
      (2) Rules relating to premarket approval fees
        (A) Definition
            For purposes of this paragraph, the term "small business"
          means an entity that reported $100,000,000 or less of gross
          receipts or sales in its most recent Federal income tax
          return for a taxable year, including such returns of all of
          its affiliates, partners, and parent firms.
        (B) Evidence of qualification
          An applicant shall pay the higher fees established by the
        Secretary each year unless the applicant submits evidence that
        it qualifies for a waiver of the fee or the lower fee rate. The
        applicant shall support its claim that it meets the definition
        under subparagraph (A) by submission of a copy of its most
        recent Federal income tax return for a taxable year, and a copy
        of such returns of its affiliates, partners, and parent firms,
        which show an amount of gross sales or receipts that is less
        than the maximum established in subparagraph (A). The
        applicant, and each of such affiliates, partners, and parent
        firms, shall certify that the information provided is a true
        and accurate copy of the actual tax forms they submitted to the
        Internal Revenue Service. If no tax forms are submitted for
        affiliates, partners, or parent firms, the applicant shall
        certify that the applicant has no affiliates, partners, or
        parent firms, respectively.
        (C) Reduced fees
          Where the Secretary finds that the applicant involved meets
        the definition under subparagraph (A), the fees established
        under subsection (c)(1) of this section may be paid at a
        reduced rate of 38 percent of the fee established under such
        subsection for a premarket application, a premarket report, or
        a supplement.
        (D) Request for fee waiver or reduction
          An applicant seeking a fee waiver or reduction under this
        subsection shall submit supporting information to the Secretary
        at least 60 days before the fee is required pursuant to
        subsection (a) of this section. The decision of the Secretary
        regarding whether an entity qualifies for such a waiver or
        reduction is not reviewable.
    (e) Small businesses; fee reduction regarding premarket
      notification submissions
      (1) In general
        For fiscal year 2004 and each subsequent fiscal year, where the
      Secretary finds that the applicant involved is a small business,
      the fee specified in subsection (a)(2)(A)(vii) of this section
      may be paid at a reduced rate in accordance with paragraph
      (2)(C).
      (2) Rules relating to premarket notification submissions
        (A) Definition
          For purposes of this subsection, the term "small business"
        means an entity that reported $100,000,000 or less of gross
        receipts or sales in its most recent Federal income tax return
        for a taxable year, including such returns of all of its
        affiliates, partners, and parent firms.
        (B) Evidence of qualification
          An applicant shall pay the higher fees established by the
        Secretary each year unless the applicant submits evidence that
        it qualifies for the lower fee rate. The applicant shall
        support its claim that it meets the definition under
        subparagraph (A) by submission of a copy of its most recent
        Federal income tax return for a taxable year, and a copy of
        such returns of its affiliates, partners, and parent firms,
        which show an amount of gross sales or receipts that is less
        than the maximum established in subparagraph (A). The
        applicant, and each of such affiliates, partners, and parent
        firms, shall certify that the information provided is a true
        and accurate copy of the actual tax forms they submitted to the
        Internal Revenue Service. If no tax forms are submitted for
        affiliates, partners, or parent firms, the applicant shall
        certify that the applicant has no affiliates, partners, or
        parent firms, respectively.
        (C) Reduced fees
          (i) In general
            For fiscal year 2004 and each subsequent fiscal year, where
          the Secretary finds that the applicant involved meets the
          definition under subparagraph (A), the fee for a premarket
          notification submission may be paid at 80 percent of the fee
          that applies under subsection (a)(2)(A)(vii) of this section,
          as adjusted under clause (ii) and as established under
          subsection (c)(1) of this section.
          (ii) Adjustment per fee revenue amount
            For fiscal year 2004 and each subsequent fiscal year, the
          Secretary, in setting the revenue amount under subsection
          (c)(1) of this section for premarket notification
          submissions, shall determine the revenue amount that would
          apply if all such submissions for the fiscal year involved
          paid a fee equal to 1.42 percent of the amount that applies
          under subsection (a)(2)(A)(i) of this section for premarket
          applications, and shall adjust the fee under subsection
          (a)(2)(A)(vii) of this section for premarket notification
          submissions such that the reduced fees collected under clause
          (i) of this subparagraph, when added to fees for such
          submissions that are not paid at the reduced rate, will equal
          such revenue amount for the fiscal year.
        (D) Request for reduction
          An applicant seeking a fee reduction under this subsection
        shall submit supporting information to the Secretary at least
        60 days before the fee is required pursuant to subsection (a)
        of this section. The decision of the Secretary regarding
        whether an entity qualifies for such a reduction is not
        reviewable.
    (f) Effect of failure to pay fees
      A premarket application, premarket report, supplement, or
    premarket notification submission submitted by a person subject to
    fees under subsection (a) of this section shall be considered
    incomplete and shall not be accepted by the Secretary until all
    fees owed by such person have been paid.
    (g) Conditions
      (1) Performance goals through fiscal year 2005; termination of
        program after fiscal year 2005
        With respect to the amount that, under the salaries and
      expenses account of the Food and Drug Administration, is
      appropriated for a fiscal year for devices and radiological
      products:
          (A)(i) For each of the fiscal years 2003 and 2004, the
        Secretary is expected to meet all of the goals identified for
        the fiscal year involved in any letter referred to in section
        101(3) of the Medical Device User Fee and Modernization Act of
        2002 (referred to in this paragraph as "performance goals") if
        the amount so appropriated for such fiscal year, excluding the
        amount of fees appropriated for such fiscal year, is equal to
        or greater than $205,720,000 multiplied by the adjustment
        factor applicable to the fiscal year.
          (ii) For each of the fiscal years 2003 and 2004, if the
        amount so appropriated for the fiscal year involved, excluding
        the amount of fees appropriated for such fiscal year, is less
        than the amount that applies under clause (i) for such fiscal
        year, the following applies:
            (I) The Secretary is expected to meet such goals to the
          extent practicable, taking into account the amounts that are
          available to the Secretary for such purpose, whether from
          fees under subsection (a) of this section or otherwise.
            (II) The Comptroller General of the United States shall
          submit to the Congress a report describing whether and to
          what extent the Secretary is meeting the performance goals
          identified for such fiscal year, and whether the Secretary
          will be able to meet all performance goals identified for
          fiscal year 2005. A report under the preceding sentence shall
          be submitted to the Congress not later than July 1 of the
          fiscal year with which the report is concerned.

          (B)(i) For fiscal year 2005, the Secretary is expected to
        meet all of the performance goals identified for the fiscal
        year if the amount so appropriated for such fiscal year,
        excluding the amount of fees appropriated for such fiscal year,
        is equal to or greater than $205,720,000 multiplied by the
        adjustment factor applicable to the fiscal year.
          (ii) For fiscal year 2005, if the amount so appropriated for
        such fiscal year, excluding the amount of fees appropriated for
        such fiscal year, is more than 1 percent less than the amount
        that applies under clause (i), the following applies:
            (I) The Secretary is expected to meet such goals to the
          extent practicable, taking into account the amounts that are
          available to the Secretary for such purpose, whether from
          fees under subsection (a) of this section or otherwise.
            (II) The Comptroller General of the United States shall
          submit to the Congress a report describing whether and to
          what extent the Secretary is meeting the performance goals
          identified for such fiscal year, and whether the Secretary
          will be able to meet all performance goals identified for
          fiscal year 2006. The report under the preceding sentence
          shall be submitted to the Congress not later than July 1,
          2005.

          (C) For fiscal year 2006, fees may not be assessed under
        subsection (a) of this section for the fiscal year, and the
        Secretary is not expected to meet any performance goals
        identified for the fiscal year, if the total of the amounts so
        appropriated for fiscal years 2005 and 2006, excluding the
        amount of fees appropriated for such fiscal years, is more than
        1 percent less than the sum of - 
            (i) $205,720,000 multiplied by the adjustment factor
          applicable to fiscal year 2006; and
            (ii) an amount equal to the amount that applies for
          purposes of subparagraph (B)(i).

          (D) For fiscal year 2007, fees may not be assessed under
        subsection (a) of this section for the fiscal year, and the
        Secretary is not expected to meet any performance goals
        identified for the fiscal year, if - 
            (i) the amount so appropriated for the fiscal year,
          excluding the amount of fees appropriated for the fiscal
          year, is more than 1 percent less than $205,720,000
          multiplied by the adjustment factor applicable to fiscal year
          2007; or
            (ii) pursuant to subparagraph (C), fees were not assessed
          under subsection (a) of this section for fiscal year 2006.
      (2) Authority
        If the Secretary does not assess fees under subsection (a) of
      this section during any portion of a fiscal year because of
      subparagraph (C) or (D) of paragraph (1) and if at a later date
      in such fiscal year the Secretary may assess such fees, the
      Secretary may assess and collect such fees, without any
      modification in the rate for premarket applications, supplements,
      premarket reports, and premarket notification submissions, and at
      any time in such fiscal year, notwithstanding the provisions of
      subsection (a) of this section relating to the date fees are to
      be paid.
    (h) Crediting and availability of fees
      (1) In general
        Fees authorized under subsection (a) of this section shall be
      collected and available for obligation only to the extent and in
      the amount provided in advance in appropriation Acts. Such fees
      are authorized to be appropriated to remain available until
      expended. Such sums as may be necessary may be transferred from
      the Food and Drug Administration salaries and expenses
      appropriation account without fiscal year limitation to such
      appropriation account for salaries and expenses with such fiscal
      year limitation. The sums transferred shall be available solely
      for the process for the review of device applications.
      (2) Collections and appropriation acts
        (A) In general
          The fees authorized by this section - 
            (i) shall be retained in each fiscal year in an amount not
          to exceed the amount specified in appropriation Acts, or
          otherwise made available for obligation, for such fiscal
          year, and
            (ii) shall only be collected and available to defray
          increases in the costs of the resources allocated for the
          process for the review of device applications (including
          increases in such costs for an additional number of full-time
          equivalent positions in the Department of Health and Human
          Services to be engaged in such process) over such costs,
          excluding costs paid from fees collected under this section,
          for fiscal year 2002 multiplied by the adjustment factor.
        (B) Compliance
          (i) In general
            The Secretary shall be considered to have met the
          requirements of subparagraph (A)(ii) in any fiscal year if
          the costs funded by appropriations and allocated for the
          process for the review of device applications - 
              (I) are not more than 3 percent below the level specified
            in subparagraph (A)(ii); or
              (II)(aa) are more than 3 percent below the level
            specified in subparagraph (A)(ii), and fees assessed for a
            subsequent fiscal year are decreased by the amount in
            excess of 3 percent by which such costs fell below the
            level specified in such subparagraph; and
              (bb) such costs are not more than 5 percent below the
            level specified in such subparagraph.
          (ii) More than 5 percent
            To the extent such costs are more than 5 percent below the
          specified level in subparagraph (A)(ii), fees may not be
          collected under this section for that fiscal year.
      (3) Authorization of appropriations
        There are authorized to be appropriated for fees under this
      section - 
          (A) $25,125,000 for fiscal year 2003;
          (B) $27,255,000 for fiscal year 2004;
          (C) $29,785,000 for fiscal year 2005; and
          (D) such sums as may be necessary for each of fiscal years
        2006 and 2007.(!2)


      as adjusted to reflect adjustments in the total fee revenues made
      under this section and changes in the total amounts collected by
      application fees.
      (4) Offset
        Any amount of fees collected for a fiscal year under this
      section that exceeds the amount of fees specified in
      appropriation Acts for such fiscal year shall be credited to the
      appropriation account of the Food and Drug Administration as
      provided in paragraph (1), and shall be subtracted from the
      amount of fees that would otherwise be authorized to be collected
      under this section pursuant to appropriation Acts for a
      subsequent fiscal year.
    (i) Collection of unpaid fees
      In any case where the Secretary does not receive payment of a fee
    assessed under subsection (a) of this section within 30 days after
    it is due, such fee shall be treated as a claim of the United
    States Government subject to subchapter II of chapter 37 of title
    31.
    (j) Written requests for refunds
      To qualify for consideration for a refund under subsection
    (a)(2)(D) of this section, a person shall submit to the Secretary a
    written request for such refund not later than 180 days after such
    fee is due.
    (k) Construction
      This section may not be construed to require that the number of
    full-time equivalent positions in the Department of Health and
    Human Services, for officers, employees, and advisory committees
    not engaged in the process of the review of device applications, be
    reduced to offset the number of officers, employees, and advisory
    committees so engaged.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 738, as added Pub. L. 107-250, title
    I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108-
    214, Sec. 2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat.
    572, 576, 577; Pub. L. 109-43, Sec. 2(a), Aug. 1, 2005, 119 Stat.
    439.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 107 of Pub. L. 107-250, see
    Effective and Termination Dates note set out under section 379i of
    this title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 360e(c)(3) of this title, referred to in subsec.
    (a)(2)(C), which related to submission of portions of applications,
    was redesignated section 360e(c)(4) of this title by Pub. L. 108-
    214, Sec. 2(d)(1)(A)(i), Apr. 1, 2004, 118 Stat. 576.
      Section 101(3) of the Medical Device User Fee and Modernization
    Act of 2002, referred to in subsec. (g)(1)(A)(i), is section 101(3)
    of Pub. L. 107-250, which is set out as a note under section 379i
    of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Subsec. (a)(2)(A). Pub. L. 109-43, Sec. 2(a)(7),
    substituted "subsection (c)(1)" for "subsection (c)(5)".
      Subsec. (b). Pub. L. 109-43, Sec. 2(a)(1), inserted "and" after
    "2004;" and substituted "2005" for "2005; $32,615,000 in fiscal
    year 2006, and $35,000,000 in fiscal year 2007".
      Subsec. (c). Pub. L. 109-43, Sec. 2(a)(2)(A), substituted "Annual
    fee setting" for "Adjustments" in heading.
      Subsec. (c)(1). Pub. L. 109-43, Sec. 2(a)(2)(B)-(D), redesignated
    par. (5) as (1), substituted "In general" for "Annual fee setting"
    in heading, "publish in the Federal Register fees under subsection
    (a) of this section. The fees" for "establish, for the next fiscal
    year, and publish in the Federal Register, fees under subsection
    (a) of this section, based on the revenue amounts established under
    subsection (b) of this section and the adjustment provided under
    this subsection and subsection (e)(2)(C)(ii) of this section,
    except that the fees", "2006" for "2003", and "$259,600, and the
    fees established for fiscal year 2007 shall be based on a premarket
    application fee of $281,600." for "$154,000." in text, and struck
    out former par. (1) which required an annual inflation adjustment
    of the revenues established in subsec. (b).
      Subsec. (c)(2). Pub. L. 109-43, Sec. 2(a)(2)(B), (C),
    redesignated par. (6) as (2) and struck out former par. (2) which
    required an annual adjustment of the fee revenues established in
    subsec. (b) to reflect changes in the workload of the Secretary for
    the process for the review of device applications.
      Subsec. (c)(3). Pub. L. 109-43, Sec. 2(a)(2)(B), (E), added par.
    (3) and struck out former par. (3) which required an annual
    compensating adjustment of the fee revenues established in subsec.
    (b).
      Subsec. (c)(4). Pub. L. 109-43, Sec. 2(a)(2)(B), struck out par.
    (4) which provided for a fiscal year 2007 adjustment of the fee
    revenues established in subsec. (b) to provide for operating
    reserves of carryover user fees.
      Subsec. (c)(5), (6). Pub. L. 109-43, Sec. 2(a)(2)(C),
    redesignated pars. (5) and (6) as (1) and (2), respectively.
      Subsec. (d)(1). Pub. L. 109-43, Sec. 2(a)(3)(A), inserted after
    first sentence "For the purposes of this paragraph, the term 'small
    business' means an entity that reported $30,000,000 or less of
    gross receipts or sales in its most recent Federal income tax
    return for a taxable year, including such returns of all of its
    affiliates, partners, and parent firms."
      Subsec. (d)(2)(A). Pub. L. 109-43, Sec. 2(a)(3)(B), struck out
    cl. (i) designation and heading before "For purposes", substituted
    "paragraph," for "subsection," and "$100,000,000" for
    "$30,000,000", and struck out heading and text of clause (ii). Text
    read as follows: "The Secretary may adjust the $30,000,000
    threshold established in clause (i) if the Secretary has evidence
    from actual experience that this threshold results in a reduction
    in revenues from premarket applications, premarket reports, and
    supplements that is 16 percent or more than would occur without
    small business exemptions and lower fee rates. To adjust this
    threshold, the Secretary shall publish a notice in the Federal
    Register setting out the rationale for the adjustment, and the new
    threshold."
      Subsec. (d)(2)(C). Pub. L. 109-43, Sec. 2(a)(7), substituted
    "subsection (c)(1)" for "subsection (c)(5)".
      Subsec. (e)(2)(A). Pub. L. 109-43, Sec. 2(a)(4), substituted
    "$100,000,000" for "$30,000,000".
      Subsec. (e)(2)(C). Pub. L. 109-43, Sec. 2(a)(7), substituted
    "subsection (c)(1)" for "subsection (c)(5)" in cls. (i) and (ii).
      Subsec. (g)(1)(B)(i). Pub. L. 109-43, Sec. 2(a)(5)(A)(i), added
    cl. (i) and struck out former cl. (i) which read as follows: "For
    fiscal year 2005, the Secretary is expected to meet all of the
    performance goals identified for the fiscal year if the total of
    the amounts so appropriated for fiscal years 2003 through 2005,
    excluding the amount of fees appropriated for such fiscal years, is
    equal to or greater than the sum of - 
        "(I) $205,720,000 multiplied by the adjustment factor
      applicable to fiscal year 2003;
        "(II) $205,720,000 multiplied by the adjustment factor
      applicable to fiscal year 2004; and
        "(III) $205,720,000 multiplied by the adjustment factor
      applicable to fiscal year 2005."
      Subsec. (g)(1)(B)(ii). Pub. L. 109-43, Sec. 2(a)(5)(A)(ii), added
    introductory provisions and struck out former introductory
    provisions which read as follows: "For fiscal year 2005, if the
    total of the amounts so appropriated for fiscal years 2003 through
    2005, excluding the amount of fees appropriated for such fiscal
    years, is less than the sum that applies under clause (i) for
    fiscal year 2005, the following applies:".
      Subsec. (g)(1)(C). Pub. L. 109-43, Sec. 2(a)(5)(B)(i),
    substituted "2005 and" for "2003 through" and inserted "more than 1
    percent" after "years, is".
      Subsec. (g)(1)(C)(ii). Pub. L. 109-43, Sec. 2(a)(5)(B)(ii),
    substituted "amount that applies" for "sum that applies".
      Subsec. (g)(1)(D)(i). Pub. L. 109-43, Sec. 2(a)(5)(C), inserted
    "more than 1 percent" after "year, is".
      Subsec. (h)(3)(D), (E). Pub. L. 109-43, Sec. 2(a)(6), added
    subpar. (D) and struck out former subpars. (D) and (E) which read
    as follows:
      "(D) $32,615,000 for fiscal year 2006; and
      "(E) $35,000,000 for fiscal year 2007,".
      2004 - Pub. L. 108-214, Sec. 2(d)(3)(A), made technical
    correction to directory language of Pub. L. 107-250, Sec. 102(a),
    which enacted this section.
      Subsec. (a). Pub. L. 108-214, Sec. 2(d)(2)(A), designated
    introductory provisions of subsec. (a) as par. (1), inserted
    heading, substituted "this section." for "this section as
    follows:", and redesignated former par. (1) as (2).
      Subsec. (a)(1)(A). Pub. L. 108-214, Sec. 2(a)(2)(A)(i),
    substituted, in introductory provisions, "subsections (d) and (e)"
    for "subsection (d)", in cl. (iv), "clause (i)" for "clause (i),
    subject to any adjustment under subsection (c)(3) of this section",
    and, in cl. (vii), "clause (i), subject to any adjustment under
    subsection (e)(2)(C)(ii)" for "clause (i), subject to any
    adjustment under subsection (c)(3) of this section and any
    adjustment under subsection (e)(2)(C)(ii)".
      Subsec. (a)(1)(D)(i), (ii). Pub. L. 108-214, Sec. 2(a)(2)(A)(ii),
    substituted "application, report," for "application".
      Subsec. (d)(1). Pub. L. 108-214, Sec. 2(d)(2)(B)(i), substituted
    "subsection (a)(2)(A)" for "subsection (a)(1)(A)" in last sentence.
      Subsec. (d)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(B), substituted
    "firms, which show" for "firms. which show" in second sentence.
      Subsec. (e)(1). Pub. L. 108-214, Sec. 2(a)(2)(C)(i),
    (d)(2)(B)(ii), substituted "For fiscal year 2004 and each
    subsequent fiscal year, where" for "Where" and "subsection
    (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)".
      Subsec. (e)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(C)(ii)(I),
    substituted "firms, which show" for "firms. which show".
      Subsec. (e)(2)(C). Pub. L. 108-214, Sec. 2(a)(2)(C)(ii)(II),
    (d)(2)(B)(iii), substituted "For fiscal year 2004 and each
    subsequent fiscal year, where" for "Where" in cl. (i), "subsection
    (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)" in cls. (i) and
    (ii), and "subsection (a)(2)(A)(i)" for "subsection (a)(1)(A)(i)"
    in cl. (ii).
      Subsec. (f). Pub. L. 108-214, Sec. 2(a)(2)(D), struck out "for
    filing" after "accepted".
      Subsec. (h)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(E), designated
    existing provisions as cl. (i), inserted heading, redesignated
    former cls. (i) and (ii) as subcls. (I) and (II), respectively, of
    cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as
    items (aa) and (bb), respectively, of cl. (i)(II), and added cl.
    (ii).
      Subsec. (j). Pub. L. 108-214, Sec. 2(d)(2)(B)(iv), substituted
    "subsection (a)(2)(D)" for "subsection (a)(1)(D)".

                      EFFECTIVE AND TERMINATION DATES                  
      Section effective Oct. 26, 2002, except for certain premarket
    fees, and ceases to be effective Oct. 1, 2007, see sections 106 and
    107 of Pub. L. 107-250, set out as notes under section 379i of this
    title.

      FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PREMARKET REPORTS  
      Pub. L. 107-250, title I, Sec. 102(b), Oct. 26, 2002, 116 Stat.
    1600, as amended by Pub. L. 108-214, Sec. 2(d)(2)(C), (3)(B), Apr.
    1, 2004, 118 Stat. 577, provided that: "A person submitting a
    premarket report to the Secretary of Health and Human Services is
    exempt from the fee under section 738(a)(2)(A)(ii) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 379j(a)(2)(A)(ii)] (as
    added by subsection (a) of this section) if - 
        "(1) the premarket report is the first such report submitted to
      the Secretary by the person; and
        "(2) before October 1, 2002, the person submitted a premarket
      application to the Secretary for the same device as the device
      for which the person is submitting the premarket report."

-FOOTNOTE-
    (!1) See References in Text note below.

               

    (!2) So in original. The period probably should be a comma.


-End-


-CITE-
    21 USC subpart 4 - fees relating to animal drugs            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 4 - fees relating to animal drugs

-HEAD-
                 SUBPART 4 - FEES RELATING TO ANIMAL DRUGS             


-STATAMEND-
                          TERMINATION OF SUBPART                      
      For termination of subpart by section 5 of Pub. L. 108-130, see
    Termination Date note set out under section 379j-11 of this title.

-End-



-CITE-
    21 USC Sec. 379j-11                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 4 - fees relating to animal drugs

-HEAD-
    Sec. 379j-11. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "animal drug application" means an application for
      approval of any new animal drug submitted under section
      360b(b)(1) of this title. Such term does not include either a new
      animal drug application submitted under section 360b(b)(2) of
      this title or a supplemental animal drug application.
        (2) The term "supplemental animal drug application" means - 
          (A) a request to the Secretary to approve a change in an
        animal drug application which has been approved; or
          (B) a request to the Secretary to approve a change to an
        application approved under section 360b(c)(2) of this title for
        which data with respect to safety or effectiveness are
        required.

        (3) The term "animal drug product" means each specific strength
      or potency of a particular active ingredient or ingredients in
      final dosage form marketed by a particular manufacturer or
      distributor, which is uniquely identified by the labeler code and
      product code portions of the national drug code, and for which an
      animal drug application or a supplemental animal drug application
      has been approved.
        (4) The term "animal drug establishment" means a foreign or
      domestic place of business which is at one general physical
      location consisting of one or more buildings all of which are
      within 5 miles of each other, at which one or more animal drug
      products are manufactured in final dosage form.
        (5) The term "investigational animal drug submission" means - 
          (A) the filing of a claim for an investigational exemption
        under section 360b(j) of this title for a new animal drug
        intended to be the subject of an animal drug application or a
        supplemental animal drug application, or
          (B) the submission of information for the purpose of enabling
        the Secretary to evaluate the safety or effectiveness of an
        animal drug application or supplemental animal drug application
        in the event of their filing.

        (6) The term "animal drug sponsor" means either an applicant
      named in an animal drug application, except for an approved
      application for which all subject products have been removed from
      listing under section 360 of this title, or a person who has
      submitted an investigational animal drug submission that has not
      been terminated or otherwise rendered inactive by the Secretary.
        (7) The term "final dosage form" means, with respect to an
      animal drug product, a finished dosage form which is approved for
      administration to an animal without substantial further
      manufacturing. Such term includes animal drug products intended
      for mixing in animal feeds.
        (8) The term "process for the review of animal drug
      applications" means the following activities of the Secretary
      with respect to the review of animal drug applications,
      supplemental animal drug applications, and investigational animal
      drug submissions:
          (A) The activities necessary for the review of animal drug
        applications, supplemental animal drug applications, and
        investigational animal drug submissions.
          (B) The issuance of action letters which approve animal drug
        applications or supplemental animal drug applications or which
        set forth in detail the specific deficiencies in animal drug
        applications, supplemental animal drug applications, or
        investigational animal drug submissions and, where appropriate,
        the actions necessary to place such applications, supplements
        or submissions in condition for approval.
          (C) The inspection of animal drug establishments and other
        facilities undertaken as part of the Secretary's review of
        pending animal drug applications, supplemental animal drug
        applications, and investigational animal drug submissions.
          (D) Monitoring of research conducted in connection with the
        review of animal drug applications, supplemental animal drug
        applications, and investigational animal drug submissions.
          (E) The development of regulations and policy related to the
        review of animal drug applications, supplemental animal drug
        applications, and investigational animal drug submissions.
          (F) Development of standards for products subject to review.
          (G) Meetings between the agency and the animal drug sponsor.
          (H) Review of advertising and labeling prior to approval of
        an animal drug application or supplemental animal drug
        application, but not such activities after an animal drug has
        been approved.

        (9) The term "costs of resources allocated for the process for
      the review of animal drug applications" means the expenses
      incurred in connection with the process for the review of animal
      drug applications for - 
          (A) officers and employees of the Food and Drug
        Administration, contractors of the Food and Drug
        Administration, advisory committees consulted with respect to
        the review of specific animal drug applications, supplemental
        animal drug applications, or investigational animal drug
        submissions, and costs related to such officers, employees,
        committees, and contractors, including costs for travel,
        education, and recruitment and other personnel activities,
          (B) management of information, and the acquisition,
        maintenance, and repair of computer resources,
          (C) leasing, maintenance, renovation, and repair of
        facilities and acquisition, maintenance, and repair of
        fixtures, furniture, scientific equipment, and other necessary
        materials and supplies, and
          (D) collecting fees under section 379j-12 of this title and
        accounting for resources allocated for the review of animal
        drug applications, supplemental animal drug applications, and
        investigational animal drug submissions.

        (10) The term "adjustment factor" applicable to a fiscal year
      refers to the formula set forth in section 379g(8) of this title
      with the base or comparator year being 2003.
        (11) The term "affiliate" refers to the definition set forth in
      section 379g(9) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 739, as added Pub. L. 108-130, Sec.
    3, Nov. 18, 2003, 117 Stat. 1361.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 5 of Pub. L. 108-130, see
    Termination Date note below.


-MISC1-
                             TERMINATION DATE                         
      Pub. L. 108-130, Sec. 5, Nov. 18, 2003, 117 Stat. 1371, provided
    that: "The amendments made by section 3 [enacting this subpart]
    shall not be in effect after October 1, 2008, and section 4
    [enacting provisions set out as a note below] shall not be in
    effect after 120 days after such date."

                                 FINDINGS                             
      Pub. L. 108-130, Sec. 2, Nov. 18, 2003, 117 Stat. 1361, provided
    that: "Congress finds as follows:
        "(1) Prompt approval of safe and effective new animal drugs is
      critical to the improvement of animal health and the public
      health.
        "(2) Animal health and the public health will be served by
      making additional funds available for the purpose of augmenting
      the resources of the Food and Drug Administration that are
      devoted to the process for review of new animal drug
      applications.
        "(3) The fees authorized by this Act [enacting this subpart and
      provisions set out as notes under this section and section 301 of
      this title] will be dedicated toward expediting the animal drug
      development process and the review of new and supplemental animal
      drug applications and investigational animal drug submissions as
      set forth in the goals identified, for purposes of part 4 of
      subchapter C of chapter VII of the Federal Food, Drug, and
      Cosmetic Act [this subpart], in the letters from the Secretary of
      Health and Human Services to the Chairman of the Committee on
      Energy and Commerce of the House of Representatives and the
      Chairman of the Committee on Health, Education, Labor, and
      Pensions of the Senate as set forth in the Congressional Record."

                        ACCOUNTABILITY AND REPORTS                    
      Pub. L. 108-130, Sec. 4, Nov. 18, 2003, 117 Stat. 1370, provided
    that:
      "(a) Public Accountability. - 
        "(1) Consultation. - In developing recommendations to Congress
      for the goals and plans for meeting the goals for the process for
      the review of animal drug applications for the fiscal years after
      fiscal year 2008, and for the reauthorization of sections 739 and
      740 of the Federal Food, Drug, and Cosmetic Act (as added by
      section 3) [42 U.S.C. 379j-11, 379j-12], the Secretary of Health
      and Human Services (referred to in this section as the
      'Secretary') shall consult with the Committee on Energy and
      Commerce of the House of Representatives, the Committee on
      Health, Education, Labor, and Pensions of the Senate, appropriate
      scientific and academic experts, veterinary professionals,
      representatives of consumer advocacy groups, and the regulated
      industry.
        "(2) Recommendations. - The Secretary shall - 
          "(A) publish in the Federal Register recommendations under
        paragraph (1), after negotiations with the regulated industry;
          "(B) present the recommendations to the Committees referred
        to in that paragraph;
          "(C) hold a meeting at which the public may comment on the
        recommendations; and
          "(D) provide for a period of 30 days for the public to
        provide written comments on the recommendations.
      "(b) Performance Reports. - Beginning with fiscal year 2004, not
    later than 60 days after the end of each fiscal year during which
    fees are collected under part 4 of subchapter C of chapter VII of
    the Federal Food, Drug, and Cosmetic Act [this subpart], the
    Secretary shall prepare and submit to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on
    Health, Education, Labor, and Pensions of the Senate a report
    concerning the progress of the Food and Drug Administration in
    achieving the goals identified in the letters described in section
    2(3) of this Act [set out as a note above] toward expediting the
    animal drug development process and the review of the new and
    supplemental animal drug applications and investigational animal
    drug submissions during such fiscal year, the future plans of the
    Food and Drug Administration for meeting the goals, the review
    times for abbreviated new animal drug applications, and the
    administrative procedures adopted by the Food and Drug
    Administration to ensure that review times for abbreviated new
    animal drug applications are not increased from their current level
    due to activities under the user fee program.
      "(c) Fiscal Report. - Beginning with fiscal year 2004, not later
    than 120 days after the end of each fiscal year during which fees
    are collected under the part described in subsection (b), the
    Secretary shall prepare and submit to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on
    Health, Education, Labor, and Pensions of the Senate a report on
    the implementation of the authority for such fees during such
    fiscal year and the use, by the Food and Drug Administration, of
    the fees collected during such fiscal year for which the report is
    made."

-End-



-CITE-
    21 USC Sec. 379j-12                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 4 - fees relating to animal drugs

-HEAD-
    Sec. 379j-12. Authority to assess and use animal drug fees

-STATUTE-
    (a) Types of fees
      Beginning in fiscal year 2004, the Secretary shall assess and
    collect fees in accordance with this section as follows:
      (1) Animal drug application and supplement fee
        (A) In general
          Each person that submits, on or after September 1, 2003, an
        animal drug application or a supplemental animal drug
        application shall be subject to a fee as follows:
            (i) A fee established in subsection (b) of this section for
          an animal drug application; and
            (ii) A fee established in subsection (b) of this section
          for a supplemental animal drug application for which safety
          or effectiveness data are required, in an amount that is
          equal to 50 percent of the amount of the fee under clause
          (i).
        (B) Payment
          The fee required by subparagraph (A) shall be due upon
        submission of the animal drug application or supplemental
        animal drug application.
        (C) Exception for previously filed application or supplement
          If an animal drug application or a supplemental animal drug
        application was submitted by a person that paid the fee for
        such application or supplement, was accepted for filing, and
        was not approved or was withdrawn (without a waiver or refund),
        the submission of an animal drug application or a supplemental
        animal drug application for the same product by the same person
        (or the person's licensee, assignee, or successor) shall not be
        subject to a fee under subparagraph (A).
        (D) Refund of fee if application refused for filing
          The Secretary shall refund 75 percent of the fee paid under
        subparagraph (B) for any animal drug application or
        supplemental animal drug application which is refused for
        filing.
        (E) Refund of fee if application withdrawn
          If an animal drug application or a supplemental animal drug
        application is withdrawn after the application or supplement
        was filed, the Secretary may refund the fee or portion of the
        fee paid under subparagraph (B) if no substantial work was
        performed on the application or supplement after the
        application or supplement was filed. The Secretary shall have
        the sole discretion to refund the fee under this paragraph. A
        determination by the Secretary concerning a refund under this
        paragraph shall not be reviewable.
      (2) Animal drug product fee
        Each person - 
          (A) who is named as the applicant in an animal drug
        application or supplemental animal drug application for an
        animal drug product which has been submitted for listing under
        section 360 of this title, and
          (B) who, after September 1, 2003, had pending before the
        Secretary an animal drug application or supplemental animal
        drug application;

      shall pay for each such animal drug product the annual fee
      established in subsection (b) of this section. Such fee shall be
      payable for the fiscal year in which the animal drug product is
      first submitted for listing under section 360 of this title, or
      is submitted for relisting under section 360 of this title if the
      animal drug product has been withdrawn from listing and relisted.
      After such fee is paid for that fiscal year, such fee shall be
      payable on or before January 31 of each year. Such fee shall be
      paid only once for each animal drug product for a fiscal year in
      which the fee is payable.
      (3) Animal drug establishment fee
        Each person - 
          (A) who owns or operates, directly or through an affiliate,
        an animal drug establishment, and
          (B) who is named as the applicant in an animal drug
        application or supplemental animal drug application for an
        animal drug product which has been submitted for listing under
        section 360 of this title, and
          (C) who, after September 1, 2003, had pending before the
        Secretary an animal drug application or supplemental animal
        drug application,

      shall be assessed an annual fee established in subsection (b) of
      this section for each animal drug establishment listed in its
      approved animal drug application as an establishment that
      manufactures the animal drug product named in the application.
      The annual establishment fee shall be assessed in each fiscal
      year in which the animal drug product named in the application is
      assessed a fee under paragraph (2) unless the animal drug
      establishment listed in the application does not engage in the
      manufacture of the animal drug product during the fiscal year.
      The fee shall be paid on or before January 31 of each year. The
      establishment shall be assessed only one fee per fiscal year
      under this section: Provided, however, that where a single
      establishment manufactures both animal drug products and
      prescription drug products, as defined in section 379g(3) of this
      title, such establishment shall be assessed both the animal drug
      establishment fee and the prescription drug establishment fee, as
      set forth in section 379h(a)(2) of this title, within a single
      fiscal year.
      (4) Animal drug sponsor fee
        Each person - 
          (A) who meets the definition of an animal drug sponsor within
        a fiscal year; and
          (B) who, after September 1, 2003, had pending before the
        Secretary an animal drug application, a supplemental animal
        drug application, or an investigational animal drug submission,

      shall be assessed an annual fee established under subsection (b)
      of this section. The fee shall be paid on or before January 31 of
      each year. Each animal drug sponsor shall pay only one such fee
      each fiscal year.
    (b) Fee amounts
      Except as provided in subsection (a)(1) of this section and
    subsections (c), (d), (f), and (g) of this section, the fees
    required under subsection (a) of this section shall be established
    to generate fee revenue amounts as follows:
      (1) Total fee revenues for application and supplement fees
        The total fee revenues to be collected in animal drug
      application fees under subsection (a)(1)(A)(i) of this section
      and supplemental animal drug application fees under subsection
      (a)(1)(A)(ii) of this section shall be $1,250,000 in fiscal year
      2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal
      years 2006, 2007, and 2008.
      (2) Total fee revenues for product fees
        The total fee revenues to be collected in product fees under
      subsection (a)(2) of this section shall be $1,250,000 in fiscal
      year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
      fiscal years 2006, 2007, and 2008.
      (3) Total fee revenues for establishment fees
        The total fee revenues to be collected in establishment fees
      under subsection (a)(3) of this section shall be $1,250,000 in
      fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000
      in fiscal years 2006, 2007, and 2008.
      (4) Total fee revenues for sponsor fees
        The total fee revenues to be collected in sponsor fees under
      subsection (a)(4) of this section shall be $1,250,000 in fiscal
      year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
      fiscal years 2006, 2007, and 2008.
    (c) Adjustments
      (1) Inflation adjustment
        The revenues established in subsection (b) of this section
      shall be adjusted by the Secretary by notice, published in the
      Federal Register, for a fiscal year to reflect the greater of - 
          (A) the total percentage change that occurred in the Consumer
        Price Index for all urban consumers (all items; United States
        city average) for the 12-month period ending June 30 preceding
        the fiscal year for which fees are being established; or
          (B) the total percentage change for the previous fiscal year
        in basic pay under the General Schedule in accordance with
        section 5332 of title 5, as adjusted by any locality-based
        comparability payment pursuant to section 5304 of such title
        for Federal employees stationed in the District of Columbia.

      The adjustment made each fiscal year by this subsection will be
      added on a compounded basis to the sum of all adjustments made
      each fiscal year after fiscal year 2004 under this subsection.
      (2) Workload adjustment
        After the fee revenues are adjusted for inflation in accordance
      with paragraph (1), the fee revenues shall be further adjusted
      each fiscal year after fiscal year 2004 to reflect changes in
      review workload. With respect to such adjustment:
          (A) This adjustment shall be determined by the Secretary
        based on a weighted average of the change in the total number
        of animal drug applications, supplemental animal drug
        applications for which data with respect to safety or
        effectiveness are required, manufacturing supplemental animal
        drug applications, investigational animal drug study
        submissions, and investigational animal drug protocol
        submissions submitted to the Secretary. The Secretary shall
        publish in the Federal Register the fees resulting from this
        adjustment and the supporting methodologies.
          (B) Under no circumstances shall this workload adjustment
        result in fee revenues for a fiscal year that are less than the
        fee revenues for that fiscal year established in subsection (b)
        of this section, as adjusted for inflation under paragraph (1).
      (3) Final year adjustment
        For fiscal year 2008, the Secretary may further increase the
      fees to provide for up to 3 months of operating reserves of
      carryover user fees for the process for the review of animal drug
      applications for the first 3 months of fiscal year 2009. If the
      Food and Drug Administration has carryover balances for the
      process for the review of animal drug applications in excess of 3
      months of such operating reserves, then this adjustment will not
      be made. If this adjustment is necessary, then the rationale for
      the amount of the increase shall be contained in the annual
      notice setting fees for fiscal year 2008.
      (4) Annual fee setting
        The Secretary shall establish, 60 days before the start of each
      fiscal year beginning after September 30, 2003, for that fiscal
      year, animal drug application fees, supplemental animal drug
      application fees, animal drug sponsor fees, animal drug
      establishment fees, and animal drug product fees based on the
      revenue amounts established under subsection (b) of this section
      and the adjustments provided under this subsection.
      (5) Limit
        The total amount of fees charged, as adjusted under this
      subsection, for a fiscal year may not exceed the total costs for
      such fiscal year for the resources allocated for the process for
      the review of animal drug applications.
    (d) Fee waiver or reduction
      (1) In general
        The Secretary shall grant a waiver from or a reduction of 1 or
      more fees assessed under subsection (a) of this section where the
      Secretary finds that - 
          (A) the assessment of the fee would present a significant
        barrier to innovation because of limited resources available to
        such person or other circumstances,
          (B) the fees to be paid by such person will exceed the
        anticipated present and future costs incurred by the Secretary
        in conducting the process for the review of animal drug
        applications for such person,
          (C) the animal drug application or supplemental animal drug
        application is intended solely to provide for use of the animal
        drug in - 
            (i) a Type B medicated feed (as defined in section
          558.3(b)(3) of title 21, Code of Federal Regulations (or any
          successor regulation)) intended for use in the manufacture of
          Type C free-choice medicated feeds, or
            (ii) a Type C free-choice medicated feed (as defined in
          section 558.3(b)(4) of title 21, Code of Federal Regulations
          (or any successor regulation)),

          (D) the animal drug application or supplemental animal drug
        application is intended solely to provide for a minor use or
        minor species indication, or
          (E) the sponsor involved is a small business submitting its
        first animal drug application to the Secretary for review.
      (2) Use of standard costs
        In making the finding in paragraph (1)(B), the Secretary may
      use standard costs.
      (3) Rules for small businesses
        (A) Definition
          In paragraph (1)(E), the term "small business" means an
        entity that has fewer than 500 employees, including employees
        of affiliates.
        (B) Waiver of application fee
          The Secretary shall waive under paragraph (1)(E) the
        application fee for the first animal drug application that a
        small business or its affiliate submits to the Secretary for
        review. After a small business or its affiliate is granted such
        a waiver, the small business or its affiliate shall pay
        application fees for all subsequent animal drug applications
        and supplemental animal drug applications for which safety or
        effectiveness data are required in the same manner as an entity
        that does not qualify as a small business.
        (C) Certification
          The Secretary shall require any person who applies for a
        waiver under paragraph (1)(E) to certify their qualification
        for the waiver. The Secretary shall periodically publish in the
        Federal Register a list of persons making such certifications.
    (e) Effect of failure to pay fees
      An animal drug application or supplemental animal drug
    application submitted by a person subject to fees under subsection
    (a) of this section shall be considered incomplete and shall not be
    accepted for filing by the Secretary until all fees owed by such
    person have been paid. An investigational animal drug submission
    under section 379j-11(5)(B) of this title that is submitted by a
    person subject to fees under subsection (a) of this section shall
    be considered incomplete and shall not be accepted for review by
    the Secretary until all fees owed by such person have been paid.
    The Secretary may discontinue review of any animal drug
    application, supplemental animal drug application or
    investigational animal drug submission from a person if such person
    has not submitted for payment all fees owed under this section by
    30 days after the date upon which they are due.
    (f) Assessment of fees
      (1) Limitation
        Fees may not be assessed under subsection (a) of this section
      for a fiscal year beginning after fiscal year 2003 unless
      appropriations for salaries and expenses of the Food and Drug
      Administration for such fiscal year (excluding the amount of fees
      appropriated for such fiscal year) are equal to or greater than
      the amount of appropriations for the salaries and expenses of the
      Food and Drug Administration for the fiscal year 2003 (excluding
      the amount of fees appropriated for such fiscal year) multiplied
      by the adjustment factor applicable to the fiscal year involved.
      (2) Authority
        If the Secretary does not assess fees under subsection (a) of
      this section during any portion of a fiscal year because of
      paragraph (1) and if at a later date in such fiscal year the
      Secretary may assess such fees, the Secretary may assess and
      collect such fees, without any modification in the rate, for
      animal drug applications, supplemental animal drug applications,
      investigational animal drug submissions, animal drug sponsors,
      animal drug establishments and animal drug products at any time
      in such fiscal year notwithstanding the provisions of subsection
      (a) of this section relating to the date fees are to be paid.
    (g) Crediting and availability of fees
      (1) In general
        Fees authorized under subsection (a) of this section shall be
      collected and available for obligation only to the extent and in
      the amount provided in advance in appropriations Acts. Such fees
      are authorized to be appropriated to remain available until
      expended. Such sums as may be necessary may be transferred from
      the Food and Drug Administration salaries and expenses
      appropriation account without fiscal year limitation to such
      appropriation account for salary and expenses with such fiscal
      year limitation. The sums transferred shall be available solely
      for the process for the review of animal drug applications.
      (2) Collections and appropriation acts
        (A) In general
          The fees authorized by this section - 
            (i) shall be retained in each fiscal year in an amount not
          to exceed the amount specified in appropriation Acts, or
          otherwise made available for obligation for such fiscal year,
          and
            (ii) shall only be collected and available to defray
          increases in the costs of the resources allocated for the
          process for the review of animal drug applications (including
          increases in such costs for an additional number of full-time
          equivalent positions in the Department of Health and Human
          Services to be engaged in such process) over such costs,
          excluding costs paid from fees collected under this section,
          for fiscal year 2003 multiplied by the adjustment factor.
        (B) Compliance
          The Secretary shall be considered to have met the
        requirements of subparagraph (A)(ii) in any fiscal year if the
        costs funded by appropriations and allocated for the process
        for the review of animal drug applications - 
            (i) are not more than 3 percent below the level specified
          in subparagraph (A)(ii); or
            (ii)(I) are more than 3 percent below the level specified
          in subparagraph (A)(ii), and fees assessed for the fiscal
          year following the subsequent fiscal year are decreased by
          the amount in excess of 3 percent by which such costs fell
          below the level specified in subparagraph (A)(ii); and
            (II) such costs are not more than 5 percent below the level
          specified in subparagraph (A)(ii).
      (3) Authorization of appropriations
        There are authorized to be appropriated for fees under this
      section - 
          (A) $5,000,000 for fiscal year 2004;
          (B) $8,000,000 for fiscal year 2005;
          (C) $10,000,000 for fiscal year 2006;
          (D) $10,000,000 for fiscal year 2007; and
          (E) $10,000,000 for fiscal year 2008;

      as adjusted to reflect adjustments in the total fee revenues made
      under this section and changes in the total amounts collected by
      animal drug application fees, supplemental animal drug
      application fees, animal drug sponsor fees, animal drug
      establishment fees, and animal drug product fees.
      (4) Offset
        Any amount of fees collected for a fiscal year under this
      section that exceeds the amount of fees specified in
      appropriations Acts for such fiscal year shall be credited to the
      appropriation account of the Food and Drug Administration as
      provided in paragraph (1), and shall be subtracted from the
      amount of fees that would otherwise be authorized to be collected
      under this section pursuant to appropriation Acts for a
      subsequent fiscal year.
    (h) Collection of unpaid fees
      In any case where the Secretary does not receive payment of a fee
    assessed under subsection (a) of this section within 30 days after
    it is due, such fee shall be treated as a claim of the United
    States Government subject to subchapter II of chapter 37 of title
    31.
    (i) Written requests for waivers, reductions, and refunds
      To qualify for consideration for a waiver or reduction under
    subsection (d) of this section, or for a refund of any fee
    collected in accordance with subsection (a) of this section, a
    person shall submit to the Secretary a written request for such
    waiver, reduction, or refund not later than 180 days after such fee
    is due.
    (j) Construction
      This section may not be construed to require that the number of
    full-time equivalent positions in the Department of Health and
    Human Services, for officers, employees, and advisory committees
    not engaged in the process of the review of animal drug
    applications, be reduced to offset the number of officers,
    employees, and advisory committees so engaged.
    (k) Abbreviated new animal drug applications
      The Secretary shall - 
        (1) to the extent practicable, segregate the review of
      abbreviated new animal drug applications from the process for the
      review of animal drug applications, and
        (2) adopt other administrative procedures to ensure that review
      times of abbreviated new animal drug applications do not increase
      from their current level due to activities under the user fee
      program.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 740, as added Pub. L. 108-130, Sec.
    3, Nov. 18, 2003, 117 Stat. 1363.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 5 of Pub. L. 108-130, see
    Termination Date note below.


-MISC1-
                             TERMINATION DATE                         
      Section not effective after Oct. 1, 2008, see section 5 of Pub.
    L. 108-130, set out as a note under section 379j-11 of this title.

-End-


-CITE-
    21 USC Part D - Information and Education                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part D - Information and Education

-HEAD-
                    PART D - INFORMATION AND EDUCATION                

-End-



-CITE-
    21 USC Sec. 379k                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part D - Information and Education

-HEAD-
    Sec. 379k. Information system

-STATUTE-
      The Secretary shall establish and maintain an information system
    to track the status and progress of each application or submission
    (including a petition, notification, or other similar form of
    request) submitted to the Food and Drug Administration requesting
    agency action.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 741, as added Pub. L. 105-115, title
    IV, Sec. 407(a), Nov. 21, 1997, 111 Stat. 2370.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

                        REPORT ON STATUS OF SYSTEM                    
      Section 407(b) of Pub. L. 105-115 provided that not later than 1
    year after Nov. 21, 1997, Secretary of Health and Human Services
    was to submit report to Congress on status of system to be
    established under this section, including projected costs of system
    and concerns about confidentiality.

-End-



-CITE-
    21 USC Sec. 379l                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part D - Information and Education

-HEAD-
    Sec. 379l. Education

-STATUTE-
    (a) In general
      The Secretary shall conduct training and education programs for
    the employees of the Food and Drug Administration relating to the
    regulatory responsibilities and policies established by this
    chapter, including programs for - 
        (1) scientific training;
        (2) training to improve the skill of officers and employees
      authorized to conduct inspections under section 374 of this
      title;
        (3) training to achieve product specialization in such
      inspections; and
        (4) training in administrative process and procedure and
      integrity issues.
    (b) Intramural fellowships and other training programs
      The Secretary, acting through the Commissioner, may, through
    fellowships and other training programs, conduct and support
    intramural research training for predoctoral and postdoctoral
    scientists and physicians.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 742, as added Pub. L. 105-115, title
    IV, Sec. 408(a), Nov. 21, 1997, 111 Stat. 2371.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part E - Environmental Impact Review                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part E - Environmental Impact Review

-HEAD-
                   PART E - ENVIRONMENTAL IMPACT REVIEW               

-End-



-CITE-
    21 USC Sec. 379o                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part E - Environmental Impact Review

-HEAD-
    Sec. 379o. Environmental impact

-STATUTE-
      Notwithstanding any other provision of law, an environmental
    impact statement prepared in accordance with the regulations
    published in part 25 of title 21, Code of Federal Regulations (as
    in effect on August 31, 1997) in connection with an action carried
    out under (or a recommendation or report relating to) this chapter,
    shall be considered to meet the requirements for a detailed
    statement under section 4332(2)(C) of title 42.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 746, as added Pub. L. 105-115, title
    IV, Sec. 411, Nov. 21, 1997, 111 Stat. 2373.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part F - National Uniformity for Nonprescription
                     Drugs and Preemption for Labeling
                     or Packaging of Cosmetics             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part F - National Uniformity for Nonprescription Drugs and
              Preemption for Labeling or Packaging of Cosmetics

-HEAD-
        PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
             PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS

-End-



-CITE-
    21 USC Sec. 379r                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part F - National Uniformity for Nonprescription Drugs and
              Preemption for Labeling or Packaging of Cosmetics

-HEAD-
    Sec. 379r. National uniformity for nonprescription drugs

-STATUTE-
    (a) In general
      Except as provided in subsection (b), (c)(1), (d), (e), or (f) of
    this section, no State or political subdivision of a State may
    establish or continue in effect any requirement - 
        (1) that relates to the regulation of a drug that is not
      subject to the requirements of section 353(b)(1) or 353(f)(1)(A)
      of this title; and
        (2) that is different from or in addition to, or that is
      otherwise not identical with, a requirement under this chapter,
      the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
      seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
      seq.).
    (b) Exemption
      (1) In general
        Upon application of a State or political subdivision thereof,
      the Secretary may by regulation, after notice and opportunity for
      written and oral presentation of views, exempt from subsection
      (a) of this section, under such conditions as may be prescribed
      in such regulation, a State or political subdivision requirement
      that - 
          (A) protects an important public interest that would
        otherwise be unprotected, including the health and safety of
        children;
          (B) would not cause any drug to be in violation of any
        applicable requirement or prohibition under Federal law; and
          (C) would not unduly burden interstate commerce.
      (2) Timely action
        The Secretary shall make a decision on the exemption of a State
      or political subdivision requirement under paragraph (1) not
      later than 120 days after receiving the application of the State
      or political subdivision under paragraph (1).
    (c) Scope
      (1) In general
        This section shall not apply to - 
          (A) any State or political subdivision requirement that
        relates to the practice of pharmacy; or
          (B) any State or political subdivision requirement that a
        drug be dispensed only upon the prescription of a practitioner
        licensed by law to administer such drug.
      (2) Safety or effectiveness
        For purposes of subsection (a) of this section, a requirement
      that relates to the regulation of a drug shall be deemed to
      include any requirement relating to public information or any
      other form of public communication relating to a warning of any
      kind for a drug.
    (d) Exceptions
      (1) In general
        In the case of a drug described in subsection (a)(1) of this
      section that is not the subject of an application approved under
      section 355 of this title or section 357 of this title (as in
      effect on the day before November 21, 1997) or a final regulation
      promulgated by the Secretary establishing conditions under which
      the drug is generally recognized as safe and effective and not
      misbranded, subsection (a) of this section shall apply only with
      respect to a requirement of a State or political subdivision of a
      State that relates to the same subject as, but is different from
      or in addition to, or that is otherwise not identical with - 
          (A) a regulation in effect with respect to the drug pursuant
        to a statute described in subsection (a)(2) of this section; or
          (B) any other requirement in effect with respect to the drug
        pursuant to an amendment to such a statute made on or after
        November 21, 1997.
      (2) State initiatives
        This section shall not apply to a State requirement adopted by
      a State public initiative or referendum enacted prior to
      September 1, 1997.
    (e) No effect on product liability law
      Nothing in this section shall be construed to modify or otherwise
    affect any action or the liability of any person under the product
    liability law of any State.
    (f) State enforcement authority
      Nothing in this section shall prevent a State or political
    subdivision thereof from enforcing, under any relevant civil or
    other enforcement authority, a requirement that is identical to a
    requirement of this chapter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 751, as added Pub. L. 105-115, title
    IV, Sec. 412(a), Nov. 21, 1997, 111 Stat. 2373.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Poison Prevention Packaging Act of 1970, referred to in
    subsec. (a)(2), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as
    amended, which is classified principally to chapter 39A (Sec. 1471
    et seq.) of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 1471 of Title 15 and Tables.
      The Fair Packaging and Labeling Act, referred to in subsec.
    (a)(2), is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended,
    which is classified generally to chapter 39 (Sec. 1451 et seq.) of
    Title 15, Commerce and Trade. For complete classification of this
    Act to the Code, see Short Title note set out under section 1451 of
    Title 15 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 379s                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part F - National Uniformity for Nonprescription Drugs and
              Preemption for Labeling or Packaging of Cosmetics

-HEAD-
    Sec. 379s. Preemption for labeling or packaging of cosmetics

-STATUTE-
    (a) In general
      Except as provided in subsection (b), (d), or (e) of this
    section, no State or political subdivision of a State may establish
    or continue in effect any requirement for labeling or packaging of
    a cosmetic that is different from or in addition to, or that is
    otherwise not identical with, a requirement specifically applicable
    to a particular cosmetic or class of cosmetics under this chapter,
    the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
    seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
    seq.).
    (b) Exemption
      Upon application of a State or political subdivision thereof, the
    Secretary may by regulation, after notice and opportunity for
    written and oral presentation of views, exempt from subsection (a)
    of this section, under such conditions as may be prescribed in such
    regulation, a State or political subdivision requirement for
    labeling or packaging that - 
        (1) protects an important public interest that would otherwise
      be unprotected;
        (2) would not cause a cosmetic to be in violation of any
      applicable requirement or prohibition under Federal law; and
        (3) would not unduly burden interstate commerce.
    (c) Scope
      For purposes of subsection (a) of this section, a reference to a
    State requirement that relates to the packaging or labeling of a
    cosmetic means any specific requirement relating to the same aspect
    of such cosmetic as a requirement specifically applicable to that
    particular cosmetic or class of cosmetics under this chapter for
    packaging or labeling, including any State requirement relating to
    public information or any other form of public communication.
    (d) No effect on product liability law
      Nothing in this section shall be construed to modify or otherwise
    affect any action or the liability of any person under the product
    liability law of any State.
    (e) State initiative
      This section shall not apply to a State requirement adopted by a
    State public initiative or referendum enacted prior to September 1,
    1997.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 752, as added Pub. L. 105-115, title
    IV, Sec. 412(d), Nov. 21, 1997, 111 Stat. 2376.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Poison Prevention Packaging Act of 1970, referred to in
    subsec. (a), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as
    amended, which is classified principally to chapter 39A (Sec. 1471
    et seq.) of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 1471 of Title 15 and Tables.
      The Fair Packaging and Labeling Act, referred to in subsec. (a),
    is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
    is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
    15, Commerce and Trade. For complete classification of this Act to
    the Code, see Short Title note set out under section 1451 of Title
    15 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part G - Safety Reports                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part G - Safety Reports

-HEAD-
                          PART G - SAFETY REPORTS                      

-End-



-CITE-
    21 USC Sec. 379v                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part G - Safety Reports

-HEAD-
    Sec. 379v. Safety report disclaimers

-STATUTE-
      With respect to any entity that submits or is required to submit
    a safety report or other information in connection with the safety
    of a product (including a product that is a food, drug, device,
    dietary supplement, or cosmetic) under this chapter (and any
    release by the Secretary of that report or information), such
    report or information shall not be construed to reflect necessarily
    a conclusion by the entity or the Secretary that the report or
    information constitutes an admission that the product involved
    malfunctioned, caused or contributed to an adverse experience, or
    otherwise caused or contributed to a death, serious injury, or
    serious illness. Such an entity need not admit, and may deny, that
    the report or information submitted by the entity constitutes an
    admission that the product involved malfunctioned, caused or
    contributed to an adverse experience, or caused or contributed to a
    death, serious injury, or serious illness.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 756, as added Pub. L. 105-115, title
    IV, Sec. 420, Nov. 21, 1997, 111 Stat. 2379.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part H - Serious Adverse Event Reports               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part H - Serious Adverse Event Reports

-HEAD-
                  PART H - SERIOUS ADVERSE EVENT REPORTS              

-End-



-CITE-
    21 USC Sec. 379aa                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part H - Serious Adverse Event Reports

-HEAD-
    Sec. 379aa. Serious adverse event reporting for nonprescription
      drugs

-STATUTE-
    (a) Definitions
      In this section:
      (1) Adverse event
        The term "adverse event" means any health-related event
      associated with the use of a nonprescription drug that is
      adverse, including - 
          (A) an event occurring from an overdose of the drug, whether
        accidental or intentional;
          (B) an event occurring from abuse of the drug;
          (C) an event occurring from withdrawal from the drug; and
          (D) any failure of expected pharmacological action of the
        drug.
      (2) Nonprescription drug
        The term "nonprescription drug" means a drug that is - 
          (A) not subject to section 353(b) of this title; and
          (B) not subject to approval in an application submitted under
        section 355 of this title.
      (3) Serious adverse event
        The term "serious adverse event" is an adverse event that - 
          (A) results in - 
            (i) death;
            (ii) a life-threatening experience;
            (iii) inpatient hospitalization;
            (iv) a persistent or significant disability or incapacity;
          or
            (v) a congenital anomaly or birth defect; or

          (B) requires, based on reasonable medical judgment, a medical
        or surgical intervention to prevent an outcome described under
        subparagraph (A).
      (4) Serious adverse event report
        The term "serious adverse event report" means a report that is
      required to be submitted to the Secretary under subsection (b).
    (b) Reporting requirement
      (1) In general
        The manufacturer, packer, or distributor whose name (pursuant
      to section 352(b)(1) of this title) appears on the label of a
      nonprescription drug marketed in the United States (referred to
      in this section as the "responsible person") shall submit to the
      Secretary any report received of a serious adverse event
      associated with such drug when used in the United States,
      accompanied by a copy of the label on or within the retail
      package of such drug.
      (2) Retailer
        A retailer whose name appears on the label described in
      paragraph (1) as a distributor may, by agreement, authorize the
      manufacturer or packer of the nonprescription drug to submit the
      required reports for such drugs to the Secretary so long as the
      retailer directs to the manufacturer or packer all adverse events
      associated with such drug that are reported to the retailer
      through the address or telephone number described in section
      352(x) of this title.
    (c) Submission of reports
      (1) Timing of reports
        The responsible person shall submit to the Secretary a serious
      adverse event report no later than 15 business days after the
      report is received through the address or phone number described
      in section 352(x) of this title.
      (2) New medical information
        The responsible person shall submit to the Secretary any new
      medical information, related to a submitted serious adverse event
      report that is received by the responsible person within 1 year
      of the initial report, no later than 15 business days after the
      new information is received by the responsible person.
      (3) Consolidation of reports
        The Secretary shall develop systems to ensure that duplicate
      reports of, and new medical information related to, a serious
      adverse event shall be consolidated into a single report.
      (4) Exemption
        The Secretary, after providing notice and an opportunity for
      comment from interested parties, may establish an exemption to
      the requirements under paragraphs (1) and (2) if the Secretary
      determines that such exemption would have no adverse effect on
      public health.
    (d) Contents of reports
      Each serious adverse event report under this section shall be
    submitted to the Secretary using the MedWatch form, which may be
    modified by the Secretary for nonprescription drugs, and may be
    accompanied by additional information.
    (e) Maintenance and inspection of records
      (1) Maintenance
        The responsible person shall maintain records related to each
      report of an adverse event received by the responsible person for
      a period of 6 years.
      (2) Records inspection
        (A) In general
          The responsible person shall permit an authorized person to
        have access to records required to be maintained under this
        section, during an inspection pursuant to section 374 of this
        title.
        (B) Authorized person
          For purposes of this paragraph, the term "authorized person"
        means an officer or employee of the Department of Health and
        Human Services who has - 
            (i) appropriate credentials, as determined by the
          Secretary; and
            (ii) been duly designated by the Secretary to have access
          to the records required under this section.
    (f) Protected information
      A serious adverse event report submitted to the Secretary under
    this section, including any new medical information submitted under
    subsection (c)(2), or an adverse event report voluntarily submitted
    to the Secretary shall be considered to be - 
        (1) a safety report under section 379v of this title and may be
      accompanied by a statement, which shall be a part of any report
      that is released for public disclosure, that denies that the
      report or the records constitute an admission that the product
      involved caused or contributed to the adverse event; and
        (2) a record about an individual under section 552a of title 5
      (commonly referred to as the "Privacy Act of 1974") and a medical
      or similar file the disclosure of which would constitute a
      violation of section 552 of such title 5 (commonly referred to as
      the "Freedom of Information Act"), and shall not be publicly
      disclosed unless all personally identifiable information is
      redacted.
    (g) Rule of construction
      The submission of any adverse event report in compliance with
    this section shall not be construed as an admission that the
    nonprescription drug involved caused or contributed to the adverse
    event.
    (h) Preemption
      (1) In general
        No State or local government shall establish or continue in
      effect any law, regulation, order, or other requirement, related
      to a mandatory system for adverse event reports for
      nonprescription drugs, that is different from, in addition to, or
      otherwise not identical to, this section.
      (2) Effect of section
        (A) In general
          Nothing in this section shall affect the authority of the
        Secretary to provide adverse event reports and information to
        any health, food, or drug officer or employee of any State,
        territory, or political subdivision of a State or territory,
        under a memorandum of understanding between the Secretary and
        such State, territory, or political subdivision.
        (B) Personally-identifiable information
          Notwithstanding any other provision of law, personally-
        identifiable information in adverse event reports provided by
        the Secretary to any health, food, or drug officer or employee
        of any State, territory, or political subdivision of a State or
        territory, shall not - 
            (i) be made publicly available pursuant to any State or
          other law requiring disclosure of information or records; or
            (ii) otherwise be disclosed or distributed to any party
          without the written consent of the Secretary and the person
          submitting such information to the Secretary.
        (C) Use of safety reports
          Nothing in this section shall permit a State, territory, or
        political subdivision of a State or territory, to use any
        safety report received from the Secretary in a manner
        inconsistent with subsection (g) or section 379v of this title.
    (i) Authorization of appropriations
      There are authorized to be appropriated to carry out this section
    such sums as may be necessary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 760, as added Pub. L. 109-462, Sec.
    2(a), Dec. 22, 2006, 120 Stat. 3469.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 1 year after Dec. 22, 2006, see section 2(e)(1)
    of Pub. L. 109-462, set out as an Effective Date of 2006 Amendment
    note under section 352 of this title.

                               MODIFICATIONS                           
      Pub. L. 109-462, Sec. 2(b), Dec. 22, 2006, 120 Stat. 3472,
    provided that: "The Secretary of Health and Human Services may
    modify requirements under the amendments made by this section
    [enacting this section and amending sections 331 and 352 of this
    title] in accordance with section 553 of title 5, United States
    Code, to maintain consistency with international harmonization
    efforts over time."

                                 GUIDANCE                             
      Pub. L. 109-462, Sec. 2(e)(3), Dec. 22, 2006, 120 Stat. 3472,
    provided that: "Not later than 270 days after the date of enactment
    of this Act [Dec. 22, 2006], the Secretary of Health and Human
    Services shall issue guidance on the minimum data elements that
    should be included in a serious adverse event report described
    under the amendments made by this Act [see Short Title of 2006
    Amendment note set out under section 301 of this title]."
      Pub. L. 109-462, Sec. 3(d)(3), Dec. 22, 2006, 120 Stat. 3475,
    enacted provisions substantially identical to those enacted by Pub.
    L. 109-462, Sec. 2(b), set out above.

-End-



-CITE-
    21 USC Sec. 379aa-1                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part H - Serious Adverse Event Reports

-HEAD-
    Sec. 379aa-1. Serious adverse event reporting for dietary
      supplements

-STATUTE-
    (a) Definitions
      In this section:
      (1) Adverse event
        The term "adverse event" means any health-related event
      associated with the use of a dietary supplement that is adverse.
      (2) Serious adverse event
        The term "serious adverse event" is an adverse event that - 
          (A) results in - 
            (i) death;
            (ii) a life-threatening experience;
            (iii) inpatient hospitalization;
            (iv) a persistent or significant disability or incapacity;
          or
            (v) a congenital anomaly or birth defect; or

          (B) requires, based on reasonable medical judgment, a medical
        or surgical intervention to prevent an outcome described under
        subparagraph (A).
      (3) Serious adverse event report
        The term "serious adverse event report" means a report that is
      required to be submitted to the Secretary under subsection (b).
    (b) Reporting requirement
      (1) In general
        The manufacturer, packer, or distributor of a dietary
      supplement whose name (pursuant to section 343(e)(1) of this
      title) appears on the label of a dietary supplement marketed in
      the United States (referred to in this section as the
      "responsible person") shall submit to the Secretary any report
      received of a serious adverse event associated with such dietary
      supplement when used in the United States, accompanied by a copy
      of the label on or within the retail packaging of such dietary
      supplement.
      (2) Retailer
        A retailer whose name appears on the label described in
      paragraph (1) as a distributor may, by agreement, authorize the
      manufacturer or packer of the dietary supplement to submit the
      required reports for such dietary supplements to the Secretary so
      long as the retailer directs to the manufacturer or packer all
      adverse events associated with such dietary supplement that are
      reported to the retailer through the address or telephone number
      described in section 343(y) of this title.
    (c) Submission of reports
      (1) Timing of reports
        The responsible person shall submit to the Secretary a serious
      adverse event report no later than 15 business days after the
      report is received through the address or phone number described
      in section 343(y) of this title.
      (2) New medical information
        The responsible person shall submit to the Secretary any new
      medical information, related to a submitted serious adverse event
      report that is received by the responsible person within 1 year
      of the initial report, no later than 15 business days after the
      new information is received by the responsible person.
      (3) Consolidation of reports
        The Secretary shall develop systems to ensure that duplicate
      reports of, and new medical information related to, a serious
      adverse event shall be consolidated into a single report.
      (4) Exemption
        The Secretary, after providing notice and an opportunity for
      comment from interested parties, may establish an exemption to
      the requirements under paragraphs (1) and (2) if the Secretary
      determines that such exemption would have no adverse effect on
      public health.
    (d) Contents of reports
      Each serious adverse event report under this section shall be
    submitted to the Secretary using the MedWatch form, which may be
    modified by the Secretary for dietary supplements, and may be
    accompanied by additional information.
    (e) Maintenance and inspection of records
      (1) Maintenance
        The responsible person shall maintain records related to each
      report of an adverse event received by the responsible person for
      a period of 6 years.
      (2) Records inspection
        (A) In general
          The responsible person shall permit an authorized person to
        have access to records required to be maintained under this
        section during an inspection pursuant to section 374 of this
        title.
        (B) Authorized person
          For purposes of this paragraph, the term "authorized person"
        means an officer or employee of the Department of Health and
        Human Services, who has - 
            (i) appropriate credentials, as determined by the
          Secretary; and
            (ii) been duly designated by the Secretary to have access
          to the records required under this section.
    (f) Protected information
      A serious adverse event report submitted to the Secretary under
    this section, including any new medical information submitted under
    subsection (c)(2), or an adverse event report voluntarily submitted
    to the Secretary shall be considered to be - 
        (1) a safety report under section 379v of this title and may be
      accompanied by a statement, which shall be a part of any report
      that is released for public disclosure, that denies that the
      report or the records constitute an admission that the product
      involved caused or contributed to the adverse event; and
        (2) a record about an individual under section 552a of title 5
      (commonly referred to as the "Privacy Act of 1974") and a medical
      or similar file the disclosure of which would constitute a
      violation of section 552 of such title 5 (commonly referred to as
      the "Freedom of Information Act"), and shall not be publicly
      disclosed unless all personally identifiable information is
      redacted.
    (g) Rule of construction
      The submission of any adverse event report in compliance with
    this section shall not be construed as an admission that the
    dietary supplement involved caused or contributed to the adverse
    event.
    (h) Preemption
      (1) In general
        No State or local government shall establish or continue in
      effect any law, regulation, order, or other requirement, related
      to a mandatory system for adverse event reports for dietary
      supplements, that is different from, in addition to, or otherwise
      not identical to, this section.
      (2) Effect of section
        (A) In general
          Nothing in this section shall affect the authority of the
        Secretary to provide adverse event reports and information to
        any health, food, or drug officer or employee of any State,
        territory, or political subdivision of a State or territory,
        under a memorandum of understanding between the Secretary and
        such State, territory, or political subdivision.
        (B) Personally-identifiable information
          Notwithstanding any other provision of law, personally-
        identifiable information in adverse event reports provided by
        the Secretary to any health, food, or drug officer or employee
        of any State, territory, or political subdivision of a State or
        territory, shall not - 
            (i) be made publicly available pursuant to any State or
          other law requiring disclosure of information or records; or
            (ii) otherwise be disclosed or distributed to any party
          without the written consent of the Secretary and the person
          submitting such information to the Secretary.
        (C) Use of safety reports
          Nothing in this section shall permit a State, territory, or
        political subdivision of a State or territory, to use any
        safety report received from the Secretary in a manner
        inconsistent with subsection (g) or section 379v of this title.
    (i) Authorization of appropriations
      There are authorized to be appropriated to carry out this section
    such sums as may be necessary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 761, as added Pub. L. 109-462, Sec.
    3(a), Dec. 22, 2006, 120 Stat. 3472.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 1 year after Dec. 22, 2006, see section 3(d)(1)
    of Pub. L. 109-462, set out as an Effective Date of 2006 Amendment
    note under section 343 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER VIII - IMPORTS AND EXPORTS                01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
                   SUBCHAPTER VIII - IMPORTS AND EXPORTS               

-End-



-CITE-
    21 USC Sec. 381                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 381. Imports and exports

-STATUTE-
    (a) Imports; list of registered foreign establishments; samples
      from unregistered foreign establishments; examination and refusal
      of admission
      The Secretary of the Treasury shall deliver to the Secretary of
    Health and Human Services, upon his request, samples of food,
    drugs, devices, and cosmetics which are being imported or offered
    for import into the United States, giving notice thereof to the
    owner or consignee, who may appear before the Secretary of Health
    and Human Services and have the right to introduce testimony. The
    Secretary of Health and Human Services shall furnish to the
    Secretary of the Treasury a list of establishments registered
    pursuant to subsection (i) of section 360 of this title and shall
    request that if any drugs and devices manufactured, prepared,
    propagated, compounded, or processed in an establishment not so
    registered are imported or offered for import into the United
    States, samples of such drugs and devices be delivered to the
    Secretary of Health and Human Services, with notice of such
    delivery to the owner or consignee, who may appear before the
    Secretary of Health and Human Services and have the right to
    introduce testimony. If it appears from the examination of such
    samples or otherwise that (1) such article has been manufactured,
    processed, or packed under insanitary conditions or, in the case of
    a device, the methods used in, or the facilities or controls used
    for, the manufacture, packing, storage, or installation of the
    device do not conform to the requirements of section 360j(f) of
    this title, or (2) such article is forbidden or restricted in sale
    in the country in which it was produced or from which it was
    exported, or (3) such article is adulterated, misbranded, or in
    violation of section 355 of this title, then such article shall be
    refused admission, except as provided in subsection (b) of this
    section. If such article is subject to a requirement under section
    379aa or 379aa-1 of this title and if the Secretary has credible
    evidence or information indicating that the responsible person (as
    defined in such section 379aa or 379aa-1 of this title) has not
    complied with a requirement of such section 379aa or 379aa-1 of
    this title with respect to any such article, or has not allowed
    access to records described in such section 379aa or 379aa-1 of
    this title, then such article shall be refused admission, except as
    provided in subsection (b) of this section. The Secretary of the
    Treasury shall cause the destruction of any such article refused
    admission unless such article is exported, under regulations
    prescribed by the Secretary of the Treasury, within ninety days of
    the date of notice of such refusal or within such additional time
    as may be permitted pursuant to such regulations. Clause (2) of the
    third sentence of this paragraph (!1) shall not be construed to
    prohibit the admission of narcotic drugs the importation of which
    is permitted under the Controlled Substances Import and Export Act
    [21 U.S.C. 951 et seq.].

    (b) Disposition of refused articles
      Pending decision as to the admission of an article being imported
    or offered for import, the Secretary of the Treasury may authorize
    delivery of such article to the owner or consignee upon the
    execution by him of a good and sufficient bond providing for the
    payment of such liquidated damages in the event of default as may
    be required pursuant to regulations of the Secretary of the
    Treasury. If it appears to the Secretary of Health and Human
    Services that (1) an article included within the provisions of
    clause (3) of subsection (a) of this section can, by relabeling or
    other action, be brought into compliance with this chapter or
    rendered other than a food, drug, device, or cosmetic, or (2) with
    respect to an article included within the provision of the fourth
    sentence of subsection (a), the responsible person (as defined in
    section 379aa or 379aa-1 of this title) can take action that would
    assure that the responsible person is in compliance with section
    379aa or 379aa-1 of this title, as the case may be, final
    determination as to admission of such article may be deferred and,
    upon filing of timely written application by the owner or consignee
    and the execution by him of a bond as provided in the preceding
    provisions of this subsection, the Secretary may, in accordance
    with regulations, authorize the applicant, or, with respect to
    clause (2), the responsible person, to perform such relabeling or
    other action specified in such authorization (including destruction
    or export of rejected articles or portions thereof, as may be
    specified in the Secretary's authorization). All such relabeling or
    other action pursuant to such authorization shall in accordance
    with regulations be under the supervision of an officer or employee
    of the Department of Health and Human Services designated by the
    Secretary, or an officer or employee of the Department of the
    Treasury designated by the Secretary of the Treasury.
    (c) Charges concerning refused articles
      All expenses (including travel, per diem or subsistence, and
    salaries of officers or employees of the United States) in
    connection with the destruction provided for in subsection (a) of
    this section and the supervision of the relabeling or other action
    authorized under the provisions of subsection (b) of this section,
    the amount of such expenses to be determined in accordance with
    regulations, and all expenses in connection with the storage,
    cartage, or labor with respect to any article refused admission
    under subsection (a) of this section, shall be paid by the owner or
    consignee and, in default of such payment, shall constitute a lien
    against any future importations made by such owner or consignee.
    (d) Reimportation
      (1) Except as provided in paragraph (2) and section 384 of this
    title, no drug subject to section 353(b) of this title or composed
    wholly or partly of insulin which is manufactured in a State and
    exported may be imported into the United States unless the drug is
    imported by the manufacturer of the drug.
      (2) The Secretary may authorize the importation of a drug the
    importation of which is prohibited by paragraph (1) if the drug is
    required for emergency medical care.
      (3)(A) Subject to subparagraph (B), no component of a drug, no
    component part or accessory of a device, or other article of device
    requiring further processing, which is ready or suitable for use
    for health-related purposes, and no article of a food additive,
    color additive, or dietary supplement, including a product in bulk
    form, shall be excluded from importation into the United States
    under subsection (a) of this section if each of the following
    conditions is met:
        (i) The importer of such article of a drug or device or
      importer of such article of a food additive, color additive, or
      dietary supplement submits to the Secretary, at the time of
      initial importation, a statement in accordance with the
      following:
          (I) Such statement provides that such article is intended to
        be further processed by the initial owner or consignee, or
        incorporated by the initial owner or consignee, into a drug,
        biological product, device, food, food additive, color
        additive, or dietary supplement that will be exported by the
        initial owner or consignee from the United States in accordance
        with subsection (e) of this section or section 382 of this
        title, or with section 262(h) of title 42.
          (II) The statement identifies the manufacturer of such
        article and each processor, packer, distributor, or other
        entity that had possession of the article in the chain of
        possession of the article from the manufacturer to such
        importer of the article.
          (III) The statement is accompanied by such certificates of
        analysis as are necessary to identify such article, unless the
        article is a device or is an article described in paragraph
        (4).

        (ii) At the time of initial importation and before the delivery
      of such article to the importer or the initial owner or
      consignee, such owner or consignee executes a good and sufficient
      bond providing for the payment of such liquidated damages in the
      event of default as may be required pursuant to regulations of
      the Secretary of the Treasury.
        (iii) Such article is used and exported by the initial owner or
      consignee in accordance with the intent described under clause
      (i)(I), except for any portions of the article that are
      destroyed.
        (iv) The initial owner or consignee maintains records on the
      use or destruction of such article or portions thereof, as the
      case may be, and submits to the Secretary any such records
      requested by the Secretary.
        (v) Upon request of the Secretary, the initial owner or
      consignee submits a report that provides an accounting of the
      exportation or destruction of such article or portions thereof,
      and the manner in which such owner or consignee complied with the
      requirements of this subparagraph.

      (B) Notwithstanding subparagraph (A), the Secretary may refuse
    admission to an article that otherwise would be imported into the
    United States under such subparagraph if the Secretary determines
    that there is credible evidence or information indicating that such
    article is not intended to be further processed by the initial
    owner or consignee, or incorporated by the initial owner or
    consignee, into a drug, biological product, device, food, food
    additive, color additive, or dietary supplement that will be
    exported by the initial owner or consignee from the United States
    in accordance with subsection (e) of this section or section 382 of
    this title, or with section 262(h) of title 42.
      (C) This section may not be construed as affecting the
    responsibility of the Secretary to ensure that articles imported
    into the United States under authority of subparagraph (A) meet
    each of the conditions established in such subparagraph for
    importation.
      (4) The importation into the United States of blood, blood
    components, source plasma, or source leukocytes or of a component,
    accessory, or part thereof is not permitted pursuant to paragraph
    (3) unless the importation complies with section 262(a) of title 42
    or the Secretary permits the importation under appropriate
    circumstances and conditions, as determined by the Secretary. The
    importation of tissue or a component or part of tissue is not
    permitted pursuant to paragraph (3) unless the importation complies
    with section 264 of title 42.
    (e) Exports
      (1) A food, drug, device, or cosmetic intended for export shall
    not be deemed to be adulterated or misbranded under this chapter if
    it - 
        (A) accords to the specifications of the foreign purchaser,
        (B) is not in conflict with the laws of the country to which it
      is intended for export,
        (C) is labeled on the outside of the shipping package that it
      is intended for export, and
        (D) is not sold or offered for sale in domestic commerce.

      (2) Paragraph (1) does not apply to any device - 
        (A) which does not comply with an applicable requirement of
      section 360d or 360e of this title,
        (B) which under section 360j(g) of this title is exempt from
      either such section, or
        (C) which is a banned device under section 360f of this title,

    unless, in addition to the requirements of paragraph (1), either
    (i) the Secretary has determined that the exportation of the device
    is not contrary to public health and safety and has the approval of
    the country to which it is intended for export or (ii) the device
    is eligible for export under section 382 of this title.
      (3) A new animal drug that requires approval under section 360b
    of this title shall not be exported pursuant to paragraph (1) if
    such drug has been banned in the United States.
      (4)(A) Any person who exports a drug, animal drug, or device may
    request that the Secretary - 
        (i) certify in writing that the exported drug, animal drug, or
      device meets the requirements of paragraph (1) or section 382 of
      this title; or
        (ii) certify in writing that the drug, animal drug, or device
      being exported meets the applicable requirements of this chapter
      upon a showing that the drug or device meets the applicable
      requirements of this chapter.

    The Secretary shall issue such a certification within 20 days of
    the receipt of a request for such certification.
      (B) If the Secretary issues a written export certification within
    the 20 days prescribed by subparagraph (A), a fee for such
    certification may be charged but shall not exceed $175 for each
    certification. Fees collected for a fiscal year pursuant to this
    subparagraph shall be credited to the appropriation account for
    salaries and expenses of the Food and Drug Administration and shall
    be available in accordance with appropriations Acts until expended
    without fiscal year limitation. Such fees shall be collected in
    each fiscal year in an amount equal to the amount specified in
    appropriations Acts for such fiscal year and shall only be
    collected and available for the costs of the Food and Drug
    Administration.
    (f) Labeling of exported drugs
      (1) If a drug (other than insulin, an antibiotic drug, an animal
    drug, or a drug exported under section 382 of this title) being
    exported in accordance with subsection (e) of this section is being
    exported to a country that has different or additional labeling
    requirements or conditions for use and such country requires the
    drug to be labeled in accordance with those requirements or uses,
    such drug may be labeled in accordance with such requirements and
    conditions for use in the country to which such drug is being
    exported if it also is labeled in accordance with the requirements
    of this chapter.
      (2) If, pursuant to paragraph (1), the labeling of an exported
    drug includes conditions for use that have not been approved under
    this chapter, the labeling must state that such conditions for use
    have not been approved under this chapter. A drug exported under
    section 382 of this title is exempt from this section.
    (g) Warning notice of importation in violation of chapter
      (1) With respect to a prescription drug being imported or offered
    for import into the United States, the Secretary, in the case of an
    individual who is not in the business of such importations, may not
    send a warning notice to the individual unless the following
    conditions are met:
        (A) The notice specifies, as applicable to the importation of
      the drug, that the Secretary has made a determination that - 
          (i) importation is in violation of subsection (a) of this
        section because the drug is or appears to be adulterated,
        misbranded, or in violation of section 355 of this title;
          (ii) importation is in violation of subsection (a) of this
        section because the drug is or appears to be forbidden or
        restricted in sale in the country in which it was produced or
        from which it was exported;
          (iii) importation is or appears to be in violation of
        subsection (d)(1) of this section; or
          (iv) importation otherwise is or appears to be in violation
        of Federal law.

        (B) The notice does not specify any provision described in
      subparagraph (A) that is not applicable to the importation of the
      drug.
        (C) The notice states the reasons underlying such determination
      by the Secretary, including a brief application to the principal
      facts involved of the provision of law described in subparagraph
      (A) that is the basis of the determination by the Secretary.

      (2) For purposes of this section, the term "warning notice", with
    respect to the importation of a drug, means a communication from
    the Secretary (written or otherwise) notifying a person, or clearly
    suggesting to the person, that importing the drug for personal use
    is, or appears to be, a violation of this chapter.
    (h) Protection against adulteration of food
      (1) The Secretary shall give high priority to increasing the
    number of inspections under this section for the purpose of
    enabling the Secretary to inspect food offered for import at ports
    of entry into the United States, with the greatest priority given
    to inspections to detect the intentional adulteration of food.
      (2) The Secretary shall give high priority to making necessary
    improvements to the information management systems of the Food and
    Drug Administration that contain information related to foods
    imported or offered for import into the United States for purposes
    of improving the ability of the Secretary to allocate resources,
    detect the intentional adulteration of food, and facilitate the
    importation of food that is in compliance with this chapter.
      (3) The Secretary shall improve linkages with other regulatory
    agencies of the Federal Government that share responsibility for
    food safety, and shall with respect to such safety improve linkages
    with the States and Indian tribes (as defined in section 450b(e) of
    title 25).
    (i) Testing for rapid detection of adulteration of food
      (1) For use in inspections of food under this section, the
    Secretary shall provide for research on the development of tests
    and sampling methodologies - 
        (A) whose purpose is to test food in order to rapidly detect
      the adulteration of the food, with the greatest priority given to
      detect the intentional adulteration of food; and
        (B) whose results offer significant improvements over the
      available technology in terms of accuracy, timing, or costs.

      (2) In providing for research under paragraph (1), the Secretary
    shall give priority to conducting research on the development of
    tests that are suitable for inspections of food at ports of entry
    into the United States.
      (3) In providing for research under paragraph (1), the Secretary
    shall as appropriate coordinate with the Director of the Centers
    for Disease Control and Prevention, the Director of the National
    Institutes of Health, the Administrator of the Environmental
    Protection Agency, and the Secretary of Agriculture.
      (4) The Secretary shall annually submit to the Committee on
    Energy and Commerce of the House of Representatives, and the
    Committee on Health, Education, Labor, and Pensions of the Senate,
    a report describing the progress made in research under paragraph
    (1), including progress regarding paragraph (2).
    (j) Temporary holds at ports of entry
      (1) If an officer or qualified employee of the Food and Drug
    Administration has credible evidence or information indicating that
    an article of food presents a threat of serious adverse health
    consequences or death to humans or animals, and such officer or
    qualified employee is unable to inspect, examine, or investigate
    such article upon the article being offered for import at a port of
    entry into the United States, the officer or qualified employee
    shall request the Secretary of Treasury to hold the food at the
    port of entry for a reasonable period of time, not to exceed 24
    hours, for the purpose of enabling the Secretary to inspect,
    examine, or investigate the article as appropriate.
      (2) The Secretary shall request the Secretary of Treasury to
    remove an article held pursuant to paragraph (1) to a secure
    facility, as appropriate. During the period of time that such
    article is so held, the article shall not be transferred by any
    person from the port of entry into the United States for the
    article, or from the secure facility to which the article has been
    removed, as the case may be. Subsection (b) of this section does
    not authorize the delivery of the article pursuant to the execution
    of a bond while the article is so held.
      (3) An officer or qualified employee of the Food and Drug
    Administration may make a request under paragraph (1) only if the
    Secretary or an official designated by the Secretary approves the
    request. An official may not be so designated unless the official
    is the director of the district under this chapter in which the
    article involved is located, or is an official senior to such
    director.
      (4) With respect to an article of food for which a request under
    paragraph (1) is made, the Secretary, promptly after the request is
    made, shall notify the State in which the port of entry involved is
    located that the request has been made, and as applicable, that
    such article is being held under this subsection.
    (k) Importation by debarred persons
      (1) If an article of food is being imported or offered for import
    into the United States, and the importer, owner, or consignee of
    the article is a person who has been debarred under section
    335a(b)(3) of this title, such article shall be held at the port of
    entry for the article, and may not be delivered to such person.
    Subsection (b) of this section does not authorize the delivery of
    the article pursuant to the execution of a bond while the article
    is so held. The article shall be removed to a secure facility, as
    appropriate. During the period of time that such article is so
    held, the article shall not be transferred by any person from the
    port of entry into the United States for the article, or from the
    secure facility to which the article has been removed, as the case
    may be.
      (2) An article of food held under paragraph (1) may be delivered
    to a person who is not a debarred person under section 335a(b)(3)
    of this title if such person affirmatively establishes, at the
    expense of the person, that the article complies with the
    requirements of this chapter, as determined by the Secretary.
    (l) Failure to register
      (1) (!2) If an article of food is being imported or offered for
    import into the United States, and such article is from a foreign
    facility for which a registration has not been submitted to the
    Secretary under section 350d of this title, such article shall be
    held at the port of entry for the article, and may not be delivered
    to the importer, owner, or consignee of the article, until the
    foreign facility is so registered. Subsection (b) of this section
    does not authorize the delivery of the article pursuant to the
    execution of a bond while the article is so held. The article shall
    be removed to a secure facility, as appropriate. During the period
    of time that such article is so held, the article shall not be
    transferred by any person from the port of entry into the United
    States for the article, or from the secure facility to which the
    article has been removed, as the case may be.

    (m) Prior notice of imported food shipments
      (1) In the case of an article of food that is being imported or
    offered for import into the United States, the Secretary, after
    consultation with the Secretary of the Treasury, shall by
    regulation require, for the purpose of enabling such article to be
    inspected at ports of entry into the United States, the submission
    to the Secretary of a notice providing the identity of each of the
    following: The article; the manufacturer and shipper of the
    article; if known within the specified period of time that notice
    is required to be provided, the grower of the article; the country
    from which the article originates; the country from which the
    article is shipped; and the anticipated port of entry for the
    article. An article of food imported or offered for import without
    submission of such notice in accordance with the requirements under
    this paragraph shall be refused admission into the United States.
    Nothing in this section may be construed as a limitation on the
    port of entry for an article of food.
      (2)(A) Regulations under paragraph (1) shall require that a
    notice under such paragraph be provided by a specified period of
    time in advance of the time of the importation of the article of
    food involved or the offering of the food for import, which period
    shall be no less than the minimum amount of time necessary for the
    Secretary to receive, review, and appropriately respond to such
    notification, but may not exceed five days. In determining the
    specified period of time required under this subparagraph, the
    Secretary may consider, but is not limited to consideration of, the
    effect on commerce of such period of time, the locations of the
    various ports of entry into the United States, the various modes of
    transportation, the types of food imported into the United States,
    and any other such consideration. Nothing in the preceding sentence
    may be construed as a limitation on the obligation of the Secretary
    to receive, review, and appropriately respond to any notice under
    paragraph (1).
      (B)(i) If an article of food is being imported or offered for
    import into the United States and a notice under paragraph (1) is
    not provided in advance in accordance with the requirements under
    paragraph (1), such article shall be held at the port of entry for
    the article, and may not be delivered to the importer, owner, or
    consignee of the article, until such notice is submitted to the
    Secretary, and the Secretary examines the notice and determines
    that the notice is in accordance with the requirements under
    paragraph (1). Subsection (b) of this section does not authorize
    the delivery of the article pursuant to the execution of a bond
    while the article is so held. The article shall be removed to a
    secure facility, as appropriate. During the period of time that
    such article is so held, the article shall not be transferred by
    any person from the port of entry into the United States for the
    article, or from the secure facility to which the article has been
    removed, as the case may be.
      (ii) In carrying out clause (i) with respect to an article of
    food, the Secretary shall determine whether there is in the
    possession of the Secretary any credible evidence or information
    indicating that such article presents a threat of serious adverse
    health consequences or death to humans or animals.
      (3)(A) This subsection may not be construed as limiting the
    authority of the Secretary to obtain information under any other
    provision of this chapter.
      (B) This subsection may not be construed as authorizing the
    Secretary to impose any requirements with respect to a food to the
    extent that it is within the exclusive jurisdiction of the
    Secretary of Agriculture pursuant to the Federal Meat Inspection
    Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
    (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
    U.S.C. 1031 et seq.).
    (n) Labeling of food refused admission
      (1) If a food has been refused admission under subsection (a) of
    this section, other than such a food that is required to be
    destroyed, the Secretary may require the owner or consignee of the
    food to affix to the container of the food a label that clearly and
    conspicuously bears the statement: "UNITED STATES: REFUSED ENTRY".
      (2) All expenses in connection with affixing a label under
    paragraph (1) shall be paid by the owner or consignee of the food
    involved, and in default of such payment, shall constitute a lien
    against future importations made by such owner or consignee.
      (3) A requirement under paragraph (1) remains in effect until the
    Secretary determines that the food involved has been brought into
    compliance with this chapter.
    (o) Registration statement
      If an article that is a drug or device is being imported or
    offered for import into the United States, and the importer, owner,
    or consignee of such article does not, at the time of offering the
    article for import, submit to the Secretary a statement that
    identifies the registration under section 360(i) of this title of
    each establishment that with respect to such article is required
    under such section to register with the Secretary, the article may
    be refused admission. If the article is refused admission for
    failure to submit such a statement, the article shall be held at
    the port of entry for the article, and may not be delivered to the
    importer, owner, or consignee of the article, until such a
    statement is submitted to the Secretary. Subsection (b) of this
    section does not authorize the delivery of the article pursuant to
    the execution of a bond while the article is so held. The article
    shall be removed to a secure facility, as appropriate. During the
    period of time that such article is so held, the article shall not
    be transferred by any person from the port of entry into the United
    States for the article, or from the secure facility to which the
    article has been removed, as the case may be.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 801, 52 Stat. 1058; Oct. 18, 1949,
    ch. 696, Secs. 1-3, 63 Stat. 882; Pub. L. 87-781, title III, Sec.
    306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90-399, Sec. 106, July
    13, 1968, 82 Stat. 353; Pub. L. 91-513, title II, Sec. 701(h), Oct.
    27, 1970, 84 Stat. 1282; Pub. L. 94-295, Secs. 3(f), 4(b)(3), May
    28, 1976, 90 Stat. 578, 580; Pub. L. 100-293, Sec. 3, Apr. 22,
    1988, 102 Stat. 96; Pub. L. 102-300, Sec. 6(b)(1), June 16, 1992,
    106 Stat. 240; Pub. L. 102-353, Sec. 5, Aug. 26, 1992, 106 Stat.
    943; Pub. L. 103-80, Sec. 3(cc), (dd)(1), Aug. 13, 1993, 107 Stat.
    778, 779; Pub. L. 104-134, title II, Sec. 2102(a)-(c), Apr. 26,
    1996, 110 Stat. 1321-313, 1321-314; Pub. L. 104-180, title VI, Sec.
    603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105-115,
    title I, Sec. 125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L.
    106-387, Sec. 1(a) [title VII, Secs. 745(c)(1), 746(c)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107-188, title
    III, Secs. 302(a)-(d), 303(c), 304(e), 305(c), 307(a), 308(a),
    321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667,
    668, 670, 672, 676; Pub. L. 109-462, Sec. 5(a), Dec. 22, 2006, 120
    Stat. 3475.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Controlled Substances Import and Export Act, referred to in
    subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84
    Stat. 1285, as amended, which is classified principally to
    subchapter II (Sec. 951 et seq.) of chapter 13 of this title. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 951 of this title and Tables.
      The Federal Meat Inspection Act, referred to in subsec.
    (m)(3)(B), is titles I to IV of act Mar. 4, 1907, ch. 2907, as
    added Pub. L. 90-201, Dec. 15, 1967, 81 Stat. 584, and amended,
    which are classified generally to subchapters I to IV (Sec. 601 et
    seq.) of chapter 12 of this title. For complete classification of
    this Act to the Code, see Short Title note set out under section
    601 of this title and Tables.
      The Poultry Products Inspection Act, referred to in subsec.
    (m)(3)(B), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as
    amended, which is classified generally to chapter 10 (Sec. 451 et
    seq.) of this title. For complete classification of this Act to the
    Code, see Short Title note set out under section 451 of this title
    and Tables.
      The Egg Products Inspection Act, referred to in subsec.
    (m)(3)(B), is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
    amended, which is classified generally to chapter 15 (Sec. 1031 et
    seq.) of this title. For complete classification of this Act to the
    Code, see Short Title note set out under section 1031 of this title
    and Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a). Pub. L. 109-462, Sec. 5(a)(1), inserted after
    third sentence "If such article is subject to a requirement under
    section 379aa or 379aa-1 of this title and if the Secretary has
    credible evidence or information indicating that the responsible
    person (as defined in such section 379aa or 379aa-1 of this title)
    has not complied with a requirement of such section 379aa or 379aa-
    1 of this title with respect to any such article, or has not
    allowed access to records described in such section 379aa or 379aa-
    1 of this title, then such article shall be refused admission,
    except as provided in subsection (b) of this section."
      Subsec. (b). Pub. L. 109-462, Sec. 5(a)(2), in second sentence,
    inserted "(1)" before "an article included", "or (2) with respect
    to an article included within the provision of the fourth sentence
    of subsection (a), the responsible person (as defined in section
    379aa or 379aa-1 of this title) can take action that would assure
    that the responsible person is in compliance with section 379aa or
    379aa-1 of this title, as the case may be," before "final
    determination", and ", or, with respect to clause (2), the
    responsible person," before "to perform".
      2002 - Subsec. (d)(3). Pub. L. 107-188, Sec. 322(a), amended par.
    (3) generally. Prior to amendment, par. (3) read as follows: "No
    component of a drug, no component part or accessory of a device, or
    other article of device requiring further processing, which is
    ready or suitable for use for health-related purposes, and no food
    additive, color additive, or dietary supplement, including a
    product in bulk form, shall be excluded from importation into the
    United States under subsection (a) of this section if - 
        "(A) the importer of such article of a drug or device or
      importer of the food additive, color additive, or dietary
      supplement submits a statement to the Secretary, at the time of
      initial importation, that such article of a drug or device, food
      additive, color additive, or dietary supplement is intended to be
      further processed by the initial owner or consignee, or
      incorporated by the initial owner or consignee into a drug,
      biological product, device, food, food additive, color additive,
      or dietary supplement that will be exported by such owner or
      consignee from the United States in accordance with subsection
      (e) of this section or section 382 of this title or section
      262(h) of title 42;
        "(B) the initial owner or consignee responsible for such
      imported article maintains records that identify the use of such
      imported article and upon request of the Secretary submits a
      report that provides an accounting of the exportation or the
      disposition of the imported article, including portions that have
      been destroyed, and the manner in which such person complied with
      the requirements of this paragraph; and
        "(C) any imported component, part, article, or accessory of a
      drug or device and any food additive, color additive, or dietary
      supplement not incorporated or further processed as described in
      subparagraph (A) is destroyed or exported by the owner or
      consignee."
      Subsec. (h). Pub. L. 107-188, Sec. 302(a)-(c), added subsec. (h).
      Subsec. (i). Pub. L. 107-188, Sec. 302(d), added subsec. (i).
      Subsec. (j). Pub. L. 107-188, Sec. 303(c), added subsec. (j).
      Subsec. (k). Pub. L. 107-188, Sec. 304(e), added subsec. (k).
      Subsec. (l). Pub. L. 107-188, Sec. 305(c), added subsec. (l).
      Subsec. (m). Pub. L. 107-188, Sec. 307(a), added subsec. (m).
      Subsec. (n). Pub. L. 107-188, Sec. 308(a), added subsec. (n).
      Subsec. (o). Pub. L. 107-188, Sec. 321(b)(1), added subsec. (o).
      2000 - Subsec. (d)(1). Pub. L. 106-387, Sec. 1(a) [title VII,
    Sec. 745(c)(1)], inserted "and section 384 of this title" after
    "paragraph (2)".
      Subsec. (g). Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(c)],
    added subsec. (g).
      1997 - Subsec. (d)(1). Pub. L. 105-115 inserted "or composed
    wholly or partly of insulin" after "353(b) of this title".
      1996 - Subsec. (d)(3). Pub. L. 104-180, Sec. 603(a), substituted
    "accessory of a device, or other article of device requiring
    further processing, which is ready" for "accessory of a device
    which is ready" in introductory provisions, inserted "further
    processed by the initial owner or consignee, or" after "is intended
    to be" in subpar. (A), and inserted "article," after "part," and
    "or further processed" after "incorporated" in subpar. (C).
      Pub. L. 104-134, Sec. 2102(a)(1), added par. (3)
      Subsec. (d)(4). Pub. L. 104-134, Sec. 2102(a)(1), added par. (4).
      Subsec. (e)(1). Pub. L. 104-134, Sec. 2102(b)(1), struck out
    concluding provisions which read as follows: "This paragraph does
    not authorize the exportation of any new animal drug, or an animal
    feed bearing or containing a new animal drug, which is unsafe
    within the meaning of section 360b of this title."
      Subsec. (e)(2). Pub. L. 104-134, Sec. 2102(b)(2), in concluding
    provisions, substituted "either (i) the Secretary" for "the
    Secretary" and added cl. (ii).
      Subsec. (e)(3), (4). Pub. L. 104-134, Sec. 2102(b)(3), added
    pars. (3) and (4).
      Subsec. (f). Pub. L. 104-180, Sec. 603(b), inserted "(other than
    insulin, an antibiotic drug, an animal drug, or a drug exported
    under section 382 of this title)" after "If a drug" in par. (1) and
    "A drug exported under section 382 of this title is exempt from
    this section." at end of par. (2).
      Pub. L. 104-134, Sec. 2102(c), added subsec. (f).
      1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(dd)(1), substituted
    "Health and Human Services" for "Agriculture" after "Secretary of"
    in two places in first sentence.
      Subsec. (b). Pub. L. 103-80, Sec. 3(cc), substituted "Secretary
    of Health and Human Services" for "Administrator" after "If it
    appears to the", "Secretary" for "Administrator" after "provisions
    of this subsection, the", "Secretary's" for "Administrator's" after
    "as may be specified in the", "Department of Health and Human
    Services" for "Federal Security Agency", and "Secretary" for
    "Administrator" after "designated by the".
      1992 - Subsecs. (a), (b). Pub. L. 102-300, which directed the
    substitution of "Health and Human Services" for "Health, Education,
    and Welfare" wherever appearing, was executed in second sentence of
    subsec. (a), but could not be executed in first sentence of subsec.
    (a) or in subsec. (b) because such words did not appear. See 1993
    Amendment note above and Transfer of Functions note below.
      Subsec. (d)(1). Pub. L. 102-353 substituted "manufacturer of" for
    "person who manufactured".
      1988 - Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and
    redesignated former subsec. (d) as (e).
      1976 - Subsec. (a). Pub. L. 94-295, Secs. 3(f)(2), 4(b)(3),
    expanded provisions requiring the Secretary of Health, Education,
    and Welfare to request that the Secretary of the Treasury deliver
    to the Secretary of Health, Education, and Welfare items imported
    or offered for import into the United States that were
    manufactured, prepared, propagated, compounded, or processed in non-
    registered establishments by extending the provisions to include
    devices imported or offered for import, and, in cl. (1), inserted
    reference to devices which were manufactured, packed, stored, or
    installed using methods, facilities, or controls not conforming to
    the requirements of section 360j(f) of this title.
      Subsec. (d). Pub. L. 94-295, Sec. 3(f)(1), designated existing
    provisions as par. (1) and added par. (2).
      1970 - Subsec. (a). Pub. L. 91-513 substituted "Clause (2) of the
    third sentence of this paragraph" for "This paragraph" and "the
    Controlled Substances Import and Export Act" for "section 173 of
    this title" in last sentence.
      1968 - Subsec. (d). Pub. L. 90-399 provided that nothing in
    subsec. (d) shall authorize the exportation of any new animal drug,
    or an animal feed bearing or containing a new animal drug, which is
    unsafe within the meaning of section 360b of this title.
      1962 - Subsec. (a). Pub. L. 87-781 inserted provisions requiring
    the Secretary of Health, Education, and Welfare to furnish the
    Secretary of the Treasury a list of establishments registered under
    section 360(i) of this title, and to request that samples of any
    drugs from any establishments not so registered be delivered to the
    Secretary of Health, Education, and Welfare, with notice of
    delivery to the consignee who may appear before the Secretary to
    testify.
      1949 - Subsec. (a). Act Oct. 18, 1949, Sec. 1, inserted before
    period at end of second sentence ", except as provided in
    subsection (b) of this section. The Secretary of the Treasury shall
    cause the destruction of any such article refused admission unless
    such article is exported, under regulations prescribed by the
    Secretary of the Treasury within ninety days of the notice of such
    refusal or within such additional time as may be permitted pursuant
    to such regulations".
      Subsec. (b). Act Oct. 18, 1949, Sec. 2, provided for express
    statutory authority for the long-standing administrative practice
    of releasing imported articles that do not comply with the
    requirements of the law so that they may be relabeled or given
    appropriate treatment to bring them into compliance.
      Subsec. (c). Act Oct. 18, 1949, Sec. 3, charged all costs,
    including salaries and travel and subsistence expenses of officers
    and employees, against importers.

                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Pub. L. 109-462, Sec. 5(b), Dec. 22, 2006, 120 Stat. 3476,
    provided that: "The amendments made by this section [amending this
    section] shall take effect 1 year after the date of enactment of
    this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Amendment by section 321(b)(1) of Pub. L. 107-188 effective upon
    the expiration of the 180-day period beginning June 12, 2002, see
    section 321(c) of Pub. L. 107-188, set out as a note under section
    331 of this title.
      Amendment by section 322(a) of Pub. L. 107-188 effective upon the
    expiration of the 90-day period beginning June 12, 2002, see
    section 322(c) of Pub. L. 107-188, set out as a note under section
    331 of this title.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-293 effective upon expiration of 90 days
    after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
    as a note under section 353 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment of subsec. (d) by Pub. L. 90-399 effective on first day
    of thirteenth calendar month after July 13, 1968, see section
    108(a) of Pub. L. 90-399, set out as an Effective Date and
    Transitional Provisions note under section 360b of this title.

                                REGULATIONS                            
      Pub. L. 107-188, title III, Sec. 307(c), June 12, 2002, 116 Stat.
    672, provided that:
      "(1) In general. - Not later than 18 months after the date of the
    enactment of this Act [June 12, 2002], the Secretary of Health and
    Human Services shall promulgate proposed and final regulations for
    the requirement of providing notice in accordance with section
    801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    381(m)] (as added by subsection (a) of this section). Such
    requirement of notification takes effect - 
        "(A) upon the effective date of such final regulations; or
        "(B) upon the expiration of such 18-month period if the final
      regulations have not been made effective as of the expiration of
      such period, subject to compliance with the final regulations
      when the final regulations are made effective.
      "(2) Default; minimum period of advance notice. - If under
    paragraph (1) the requirement for providing notice in accordance
    with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 381(m)] takes effect without final regulations having been
    made effective, then for purposes of such requirement, the
    specified period of time that the notice is required to be made in
    advance of the time of the importation of the article of food
    involved or the offering of the food for import shall be not fewer
    than eight hours and not more than five days, which shall remain in
    effect until the final regulations are made effective."

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for violation of law or any civil seizure or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotic and Dangerous
    Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be
    continued and brought to final determination in accord with laws
    and regulations in effect prior to Oct. 27, 1970, see section 702
    of Pub. L. 91-513, set out as a note under section 321 of this
    title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188           
      Pub. L. 107-188, title III, Sec. 308(c), June 12, 2002, 116 Stat.
    673, provided that: "With respect to articles of food that are
    imported or offered for import into the United States, nothing in
    this section [amending this section and section 343 of this title]
    shall be construed to limit the authority of the Secretary of
    Health and Human Services or the Secretary of the Treasury to
    require the marking of refused articles of food under any other
    provision of law."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
               STUDY AND REPORT ON TRADE IN PHARMACEUTICALS           
      Pub. L. 108-173, title XI, Sec. 1123, Dec. 8, 2003, 117 Stat.
    2469, provided that: "The President's designees shall conduct a
    study and report on issues related to trade and pharmaceuticals."

                                 FINDINGS                             
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(b)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-40, provided that: "The Congress finds
    as follows:
        "(1) Patients and their families sometimes have reason to
      import into the United States drugs that have been approved by
      the Food and Drug Administration ('FDA').
        "(2) There have been circumstances in which - 
          "(A) an individual seeking to import such a drug has received
        a notice from FDA that importing the drug violates or may
        violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
        et seq.]; and
          "(B) the notice failed to inform the individual of the
        reasons underlying the decision to send the notice.
        "(3) FDA should not send a warning notice regarding the
      importation of a drug without providing to the individual
      involved a statement of the underlying reasons for the notice."

-FOOTNOTE-
    (!1) So in original. Probably should be "subsection".

    (!2) So in original. No par. (2) has been enacted.


-End-



-CITE-
    21 USC Sec. 382                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 382. Exports of certain unapproved products

-STATUTE-
    (a) Drugs or devices intended for human or animal use which require
      approval or licensing
      A drug or device - 
        (1) which, in the case of a drug - 
          (A)(i) requires approval by the Secretary under section 355
        of this title before such drug may be introduced or delivered
        for introduction into interstate commerce; or
          (ii) requires licensing by the Secretary under section 262 of
        title 42 or by the Secretary of Agriculture under the Act of
        March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus-Serum
        Toxin Act) before it may be introduced or delivered for
        introduction into interstate commerce;
          (B) does not have such approval or license; and
          (C) is not exempt from such sections or Act; and

        (2) which, in the case of a device - 
          (A) does not comply with an applicable requirement under
        section 360d or 360e of this title;
          (B) under section 360j(g) of this title is exempt from either
        such section; or
          (C) is a banned device under section 360f of this title, is
        adulterated, misbranded, and in violation of such sections or
        Act unless the export of the drug or device is, except as
        provided in subsection (f) of this section, authorized under
        subsection (b), (c), (d), or (e) of this section or section
        381(e)(2) of this title. If a drug or device described in
        paragraphs (1) and (2) may be exported under subsection (b) of
        this section and if an application for such drug or device
        under section 355 or 360e of this title or section 262 of title
        42 was disapproved, the Secretary shall notify the appropriate
        public health official of the country to which such drug will
        be exported of such disapproval.
    (b) List of eligible countries for export; criteria for addition to
      list; direct export; petition for exemption
      (1)(A) A drug or device described in subsection (a) of this
    section may be exported to any country, if the drug or device
    complies with the laws of that country and has valid marketing
    authorization by the appropriate authority - 
        (i) in Australia, Canada, Israel, Japan, New Zealand,
      Switzerland, or South Africa; or
        (ii) in the European Union or a country in the European
      Economic Area (the countries in the European Union and the
      European Free Trade Association) if the drug or device is
      marketed in that country or the drug or device is authorized for
      general marketing in the European Economic Area.

      (B) The Secretary may designate an additional country to be
    included in the list of countries described in clauses (i) and (ii)
    of subparagraph (A) if all of the following requirements are met in
    such country:
        (i) Statutory or regulatory requirements which require the
      review of drugs and devices for safety and effectiveness by an
      entity of the government of such country and which authorize the
      approval of only those drugs and devices which have been
      determined to be safe and effective by experts employed by or
      acting on behalf of such entity and qualified by scientific
      training and experience to evaluate the safety and effectiveness
      of drugs and devices on the basis of adequate and well-controlled
      investigations, including clinical investigations, conducted by
      experts qualified by scientific training and experience to
      evaluate the safety and effectiveness of drugs and devices.
        (ii) Statutory or regulatory requirements that the methods used
      in, and the facilities and controls used for - 
          (I) the manufacture, processing, and packing of drugs in the
        country are adequate to preserve their identity, quality,
        purity, and strength; and
          (II) the manufacture, preproduction design validation,
        packing, storage, and installation of a device are adequate to
        assure that the device will be safe and effective.

        (iii) Statutory or regulatory requirements for the reporting of
      adverse reactions to drugs and devices and procedures to withdraw
      approval and remove drugs and devices found not to be safe or
      effective.
        (iv) Statutory or regulatory requirements that the labeling and
      promotion of drugs and devices must be in accordance with the
      approval of the drug or device.
        (v) The valid marketing authorization system in such country or
      countries is equivalent to the systems in the countries described
      in clauses (i) and (ii) of subparagraph (A).

    The Secretary shall not delegate the authority granted under this
    subparagraph.
      (C) An appropriate country official, manufacturer, or exporter
    may request the Secretary to take action under subparagraph (B) to
    designate an additional country or countries to be added to the
    list of countries described in clauses (i) and (ii) of subparagraph
    (A) by submitting documentation to the Secretary in support of such
    designation. Any person other than a country requesting such
    designation shall include, along with the request, a letter from
    the country indicating the desire of such country to be designated.
      (2) A drug described in subsection (a) of this section may be
    directly exported to a country which is not listed in clause (i) or
    (ii) of paragraph (1)(A) if - 
        (A) the drug complies with the laws of that country and has
      valid marketing authorization by the responsible authority in
      that country; and
        (B) the Secretary determines that all of the following
      requirements are met in that country:
          (i) Statutory or regulatory requirements which require the
        review of drugs for safety and effectiveness by an entity of
        the government of such country and which authorize the approval
        of only those drugs which have been determined to be safe and
        effective by experts employed by or acting on behalf of such
        entity and qualified by scientific training and experience to
        evaluate the safety and effectiveness of drugs on the basis of
        adequate and well-controlled investigations, including clinical
        investigations, conducted by experts qualified by scientific
        training and experience to evaluate the safety and
        effectiveness of drugs.
          (ii) Statutory or regulatory requirements that the methods
        used in, and the facilities and controls used for the
        manufacture, processing, and packing of drugs in the country
        are adequate to preserve their identity, quality, purity, and
        strength.
          (iii) Statutory or regulatory requirements for the reporting
        of adverse reactions to drugs and procedures to withdraw
        approval and remove drugs found not to be safe or effective.
          (iv) Statutory or regulatory requirements that the labeling
        and promotion of drugs must be in accordance with the approval
        of the drug.

      (3) The exporter of a drug described in subsection (a) of this
    section which would not meet the conditions for approval under this
    chapter or conditions for approval of a country described in clause
    (i) or (ii) of paragraph (1)(A) may petition the Secretary for
    authorization to export such drug to a country which is not
    described in clause (i) or (ii) of paragraph (1)(A) or which is not
    described in paragraph (2). The Secretary shall permit such export
    if - 
        (A) the person exporting the drug - 
          (i) certifies that the drug would not meet the conditions for
        approval under this chapter or the conditions for approval of a
        country described in clause (i) or (ii) of paragraph (1)(A);
        and
          (ii) provides the Secretary with credible scientific
        evidence, acceptable to the Secretary, that the drug would be
        safe and effective under the conditions of use in the country
        to which it is being exported; and

        (B) the appropriate health authority in the country to which
      the drug is being exported - 
          (i) requests approval of the export of the drug to such
        country;
          (ii) certifies that the health authority understands that the
        drug is not approved under this chapter or in a country
        described in clause (i) or (ii) of paragraph (1)(A); and
          (iii) concurs that the scientific evidence provided pursuant
        to subparagraph (A) is credible scientific evidence that the
        drug would be reasonably safe and effective in such country.

    The Secretary shall take action on a request for export of a drug
    under this paragraph within 60 days of receiving such request.
    (c) Investigational use exemption
      A drug or device intended for investigational use in any country
    described in clause (i) or (ii) of subsection (b)(1)(A) of this
    section may be exported in accordance with the laws of that country
    and shall be exempt from regulation under section 355(i) or 360j(g)
    of this title.
    (d) Anticipation of market authorization
      A drug or device intended for formulation, filling, packaging,
    labeling, or further processing in anticipation of market
    authorization in any country described in clause (i) or (ii) of
    subsection (b)(1)(A) of this section may be exported for use in
    accordance with the laws of that country.
    (e) Diagnosis, prevention, or treatment of tropical disease
      (1) A drug or device which is used in the diagnosis, prevention,
    or treatment of a tropical disease or another disease not of
    significant prevalence in the United States and which does not
    otherwise qualify for export under this section shall, upon
    approval of an application, be permitted to be exported if the
    Secretary finds that the drug or device will not expose patients in
    such country to an unreasonable risk of illness or injury and the
    probable benefit to health from the use of the drug or device
    (under conditions of use prescribed, recommended, or suggested in
    the labeling or proposed labeling of the drug or device) outweighs
    the risk of injury or illness from its use, taking into account the
    probable risks and benefits of currently available drug or device
    treatment.
      (2) The holder of an approved application for the export of a
    drug or device under this subsection shall report to the Secretary -
     
        (A) the receipt of any credible information indicating that the
      drug or device is being or may have been exported from a country
      for which the Secretary made a finding under paragraph (1)(A) to
      a country for which the Secretary cannot make such a finding; and
        (B) the receipt of any information indicating adverse reactions
      to such drug.

      (3)(A) If the Secretary determines that - 
        (i) a drug or device for which an application is approved under
      paragraph (1) does not continue to meet the requirements of such
      paragraph; or
        (ii) the holder of an approved application under paragraph (1)
      has not made the report required by paragraph (2),

    the Secretary may, after providing the holder of the application an
    opportunity for an informal hearing, withdraw the approved
    application.
      (B) If the Secretary determines that the holder of an approved
    application under paragraph (1) or an importer is exporting a drug
    or device from the United States to an importer and such importer
    is exporting the drug or device to a country for which the
    Secretary cannot make a finding under paragraph (1) and such export
    presents an imminent hazard, the Secretary shall immediately
    prohibit the export of the drug or device to such importer, provide
    the person exporting the drug or device from the United States
    prompt notice of the prohibition, and afford such person an
    opportunity for an expedited hearing.
    (f) Prohibition of export of drug or device
      A drug or device may not be exported under this section - 
        (1) if the drug or device is not manufactured, processed,
      packaged, and held in substantial conformity with current good
      manufacturing practice requirements or does not meet
      international standards as certified by an international
      standards organization recognized by the Secretary;
        (2) if the drug or device is adulterated under clause (1),
      (2)(A), or (3) of section 351(a) or subsection (c) or (d) of
      section 351 of this title;
        (3) if the requirements of subparagraphs (A) through (D) of
      section 381(e)(1) of this title have not been met;
        (4)(A) if the drug or device is the subject of a notice by the
      Secretary or the Secretary of Agriculture of a determination that
      the probability of reimportation of the exported drug or device
      would present an imminent hazard to the public health and safety
      of the United States and the only means of limiting the hazard is
      to prohibit the export of the drug or device; or
        (B) if the drug or device presents an imminent hazard to the
      public health of the country to which the drug or device would be
      exported;
        (5) if the labeling of the drug or device is not - 
          (A) in accordance with the requirements and conditions for
        use in - 
            (i) the country in which the drug or device received valid
          marketing authorization under subsection (b) of this section;
          and
            (ii) the country to which the drug or device would be
          exported; and

          (B) in the language and units of measurement of the country
        to which the drug or device would be exported or in the
        language designated by such country; or

        (6) if the drug or device is not promoted in accordance with
      the labeling requirements set forth in paragraph (5).

    In making a finding under paragraph (4)(B), (5), or (6) the
    Secretary shall consult with the appropriate public health official
    in the affected country.
    (g) Notification of Secretary
      The exporter of a drug or device exported under subsection (b)(1)
    of this section shall provide a simple notification to the
    Secretary identifying the drug or device when the exporter first
    begins to export such drug or device to any country listed in
    clause (i) or (ii) of subsection (b)(1)(A) of this section. When an
    exporter of a drug or device first begins to export a drug or
    device to a country which is not listed in clause (i) or (ii) of
    subsection (b)(1)A) (!1) of this section, the exporter shall
    provide a simple notification to the Secretary identifying the drug
    or device and the country to which such drug or device is being
    exported. Any exporter of a drug or device shall maintain records
    of all drugs or devices exported and the countries to which they
    were exported.

    (h) References to Secretary and term "drug"
      For purposes of this section - 
        (1) a reference to the Secretary shall in the case of a
      biological product which is required to be licensed under the Act
      of March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832-833)
      (commonly known as the Virus-Serum Toxin Act) be considered to be
      a reference to the Secretary of Agriculture, and
        (2) the term "drug" includes drugs for human use as well as
      biologicals under section 262 of title 42 or the Act of March 4,
      1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin
      Act).
    (i) Exportation
      Insulin and antibiotic drugs may be exported without regard to
    the requirements in this section if the insulin and antibiotic
    drugs meet the requirements of section 381(e)(1) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 802, as added Pub. L. 99-660, title
    I, Sec. 102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104-
    134, title III, Sec. 2102(d)(1), Apr. 26, 1996, 110 Stat. 1321-
    315; Pub. L. 104-180, title VI, Sec. 603(c), Aug. 6, 1996, 110
    Stat. 1595; Pub. L. 105-115, title I, Sec. 125(c), Nov. 21, 1997,
    111 Stat. 2326.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of March 4, 1913 (known as the Virus-Serum Toxin Act),
    referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the
    eighth paragraph under the heading "Bureau of Animal Industry" of
    act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is
    classified generally to chapter 5 (Sec. 151 et seq.) of this title.
    For complete classification of this Act to the Code, see Short
    Title note set out under section 151 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (i). Pub. L. 105-115 added subsec. (i).
      1996 - Pub. L. 104-134 reenacted section catchline without change
    and amended text generally. Prior to amendment, text related to
    exports of certain unapproved products, including provisions
    relating to drugs intended for human or animal use which required
    approval or licensing, conditions for export, active pursuit of
    drug approval or licensing, application for export, contents,
    approval or disapproval, list of eligible countries for export, and
    criteria for list change, report to Secretary by holder of approved
    application, events requiring report, and annual report to
    Secretary on pursuit of approval of drug, export of drug under
    approved application prohibited under certain conditions,
    determination by Secretary of noncompliance, failure of active
    pursuit of drug approval, imminent hazard of drug to public health,
    or exportation of drug to noneligible country, notices, hearings,
    and prohibition on exportation of drug under certain circumstances,
    drugs used in prevention or treatment of tropical disease, and
    reference to Secretary and holder of application.
      Subsec. (f)(5). Pub. L. 104-180 substituted "if the labeling of
    the drug or device is not" for "if the drug or device is not
    labeled".

-FOOTNOTE-
    (!1) So in original. Probably should be subsection "(b)(1)(A)".


-End-



-CITE-
    21 USC Sec. 383                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 383. Office of International Relations

-STATUTE-
    (a) Establishment
      There is established in the Department of Health and Human
    Services an Office of International Relations.
    (b) Agreements with foreign countries
      In carrying out the functions of the office under subsection (a)
    of this section, the Secretary may enter into agreements with
    foreign countries to facilitate commerce in devices between the
    United States and such countries consistent with the requirements
    of this chapter. In such agreements, the Secretary shall encourage
    the mutual recognition of - 
        (1) good manufacturing practice regulations promulgated under
      section 360j(f) of this title, and
        (2) other regulations and testing protocols as the Secretary
      determines to be appropriate.
    (c) Harmonizing regulatory requirements
      (1) The Secretary shall support the Office of the United States
    Trade Representative, in consultation with the Secretary of
    Commerce, in meetings with representatives of other countries to
    discuss methods and approaches to reduce the burden of regulation
    and harmonize regulatory requirements if the Secretary determines
    that such harmonization continues consumer protections consistent
    with the purposes of this chapter.
      (2) The Secretary shall support the Office of the United States
    Trade Representative, in consultation with the Secretary of
    Commerce, in efforts to move toward the acceptance of mutual
    recognition agreements relating to the regulation of drugs,
    biological products, devices, foods, food additives, and color
    additives, and the regulation of good manufacturing practices,
    between the European Union and the United States.
      (3) The Secretary shall regularly participate in meetings with
    representatives of other foreign governments to discuss and reach
    agreement on methods and approaches to harmonize regulatory
    requirements.
      (4) The Secretary shall, not later than 180 days after November
    21, 1997, make public a plan that establishes a framework for
    achieving mutual recognition of good manufacturing practices
    inspections.
      (5) Paragraphs (1) through (4) shall not apply with respect to
    products defined in section 321(ff) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 803, as added Pub. L. 101-629, Sec.
    15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105-115,
    title IV, Sec. 410(b), Nov. 21, 1997, 111 Stat. 2373.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (c). Pub. L. 105-115 added subsec. (c).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

         REPORT ON ACTIVITIES OF OFFICE OF INTERNATIONAL RELATIONS     
      Section 15(b) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, not later than 2 years after Nov. 28, 1990, to
    prepare and submit to the appropriate committees of Congress a
    report on the activities of the Office of International Relations
    under 21 U.S.C. 383.

-End-



-CITE-
    21 USC Sec. 384                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 384. Importation of prescription drugs

-STATUTE-
    (a) Definitions
      In this section:
      (1) Importer
        The term "importer" means a pharmacist or wholesaler.
      (2) Pharmacist
        The term "pharmacist" means a person licensed by a State to
      practice pharmacy, including the dispensing and selling of
      prescription drugs.
      (3) Prescription drug
        The term "prescription drug" means a drug subject to section
      353(b) of this title, other than - 
          (A) a controlled substance (as defined in section 802 of this
        title);
          (B) a biological product (as defined in section 262 of title
        42);
          (C) an infused drug (including a peritoneal dialysis
        solution);
          (D) an intravenously injected drug;
          (E) a drug that is inhaled during surgery; or
          (F) a drug which is a parenteral drug, the importation of
        which pursuant to subsection (b) of this section is determined
        by the Secretary to pose a threat to the public health, in
        which case section 381(d)(1) of this title shall continue to
        apply.
      (4) Qualifying laboratory
        The term "qualifying laboratory" means a laboratory in the
      United States that has been approved by the Secretary for the
      purposes of this section.
      (5) Wholesaler
        (A) In general
          The term "wholesaler" means a person licensed as a wholesaler
        or distributor of prescription drugs in the United States under
        section 353(e)(2)(A) of this title.
        (B) Exclusion
          The term "wholesaler" does not include a person authorized to
        import drugs under section 381(d)(1) of this title.
    (b) Regulations
      The Secretary, after consultation with the United States Trade
    Representative and the Commissioner of Customs, shall promulgate
    regulations permitting pharmacists and wholesalers to import
    prescription drugs from Canada into the United States.
    (c) Limitation
      The regulations under subsection (b) of this section shall - 
        (1) require that safeguards be in place to ensure that each
      prescription drug imported under the regulations complies with
      section 355 of this title (including with respect to being safe
      and effective for the intended use of the prescription drug),
      with sections 351 and 352 of this title, and with other
      applicable requirements of this chapter;
        (2) require that an importer of a prescription drug under the
      regulations comply with subsections (d)(1) and (e) of this
      section; and
        (3) contain any additional provisions determined by the
      Secretary to be appropriate as a safeguard to protect the public
      health or as a means to facilitate the importation of
      prescription drugs.
    (d) Information and records
      (1) In general
        The regulations under subsection (b) of this section shall
      require an importer of a prescription drug under subsection (b)
      of this section to submit to the Secretary the following
      information and documentation:
          (A) The name and quantity of the active ingredient of the
        prescription drug.
          (B) A description of the dosage form of the prescription
        drug.
          (C) The date on which the prescription drug is shipped.
          (D) The quantity of the prescription drug that is shipped.
          (E) The point of origin and destination of the prescription
        drug.
          (F) The price paid by the importer for the prescription drug.
          (G) Documentation from the foreign seller specifying - 
            (i) the original source of the prescription drug; and
            (ii) the quantity of each lot of the prescription drug
          originally received by the seller from that source.

          (H) The lot or control number assigned to the prescription
        drug by the manufacturer of the prescription drug.
          (I) The name, address, telephone number, and professional
        license number (if any) of the importer.
          (J)(i) In the case of a prescription drug that is shipped
        directly from the first foreign recipient of the prescription
        drug from the manufacturer:
            (I) Documentation demonstrating that the prescription drug
          was received by the recipient from the manufacturer and
          subsequently shipped by the first foreign recipient to the
          importer.
            (II) Documentation of the quantity of each lot of the
          prescription drug received by the first foreign recipient
          demonstrating that the quantity being imported into the
          United States is not more than the quantity that was received
          by the first foreign recipient.
            (III)(aa) In the case of an initial imported shipment,
          documentation demonstrating that each batch of the
          prescription drug in the shipment was statistically sampled
          and tested for authenticity and degradation.
            (bb) In the case of any subsequent shipment, documentation
          demonstrating that a statistically valid sample of the
          shipment was tested for authenticity and degradation.

          (ii) In the case of a prescription drug that is not shipped
        directly from the first foreign recipient of the prescription
        drug from the manufacturer, documentation demonstrating that
        each batch in each shipment offered for importation into the
        United States was statistically sampled and tested for
        authenticity and degradation.
          (K) Certification from the importer or manufacturer of the
        prescription drug that the prescription drug - 
            (i) is approved for marketing in the United States and is
          not adulterated or misbranded; and
            (ii) meets all labeling requirements under this chapter.

          (L) Laboratory records, including complete data derived from
        all tests necessary to ensure that the prescription drug is in
        compliance with established specifications and standards.
          (M) Documentation demonstrating that the testing required by
        subparagraphs (J) and (L) was conducted at a qualifying
        laboratory.
          (N) Any other information that the Secretary determines is
        necessary to ensure the protection of the public health.
      (2) Maintenance by the Secretary
        The Secretary shall maintain information and documentation
      submitted under paragraph (1) for such period of time as the
      Secretary determines to be necessary.
    (e) Testing
      The regulations under subsection (b) of this section shall
    require - 
        (1) that testing described in subparagraphs (J) and (L) of
      subsection (d)(1) of this section be conducted by the importer or
      by the manufacturer of the prescription drug at a qualified
      laboratory;
        (2) if the tests are conducted by the importer - 
          (A) that information needed to - 
            (i) authenticate the prescription drug being tested; and
            (ii) confirm that the labeling of the prescription drug
          complies with labeling requirements under this chapter;

        be supplied by the manufacturer of the prescription drug to the
        pharmacist or wholesaler; and
          (B) that the information supplied under subparagraph (A) be
        kept in strict confidence and used only for purposes of testing
        or otherwise complying with this chapter; and

        (3) may include such additional provisions as the Secretary
      determines to be appropriate to provide for the protection of
      trade secrets and commercial or financial information that is
      privileged or confidential.
    (f) Registration of foreign sellers
      Any establishment within Canada engaged in the distribution of a
    prescription drug that is imported or offered for importation into
    the United States shall register with the Secretary the name and
    place of business of the establishment and the name of the United
    States agent for the establishment.
    (g) Suspension of importation
      The Secretary shall require that importations of a specific
    prescription drug or importations by a specific importer under
    subsection (b) of this section be immediately suspended on
    discovery of a pattern of importation of that specific prescription
    drug or by that specific importer of drugs that are counterfeit or
    in violation of any requirement under this section, until an
    investigation is completed and the Secretary determines that the
    public is adequately protected from counterfeit and violative
    prescription drugs being imported under subsection (b) of this
    section.
    (h) Approved labeling
      The manufacturer of a prescription drug shall provide an importer
    written authorization for the importer to use, at no cost, the
    approved labeling for the prescription drug.
    (i) Charitable contributions
      Notwithstanding any other provision of this section, section
    381(d)(1) of this title continues to apply to a prescription drug
    that is donated or otherwise supplied at no charge by the
    manufacturer of the drug to a charitable or humanitarian
    organization (including the United Nations and affiliates) or to a
    government of a foreign country.
    (j) Waiver authority for importation by individuals
      (1) Declarations
        Congress declares that in the enforcement against individuals
      of the prohibition of importation of prescription drugs and
      devices, the Secretary should - 
          (A) focus enforcement on cases in which the importation by an
        individual poses a significant threat to public health; and
          (B) exercise discretion to permit individuals to make such
        importations in circumstances in which - 
            (i) the importation is clearly for personal use; and
            (ii) the prescription drug or device imported does not
          appear to present an unreasonable risk to the individual.
      (2) Waiver authority
        (A) In general
          The Secretary may grant to individuals, by regulation or on a
        case-by-case basis, a waiver of the prohibition of importation
        of a prescription drug or device or class of prescription drugs
        or devices, under such conditions as the Secretary determines
        to be appropriate.
        (B) Guidance on case-by-case waivers
          The Secretary shall publish, and update as necessary,
        guidance that accurately describes circumstances in which the
        Secretary will consistently grant waivers on a case-by-case
        basis under subparagraph (A), so that individuals may know with
        the greatest practicable degree of certainty whether a
        particular importation for personal use will be permitted.
      (3) Drugs imported from Canada
        In particular, the Secretary shall by regulation grant
      individuals a waiver to permit individuals to import into the
      United States a prescription drug that - 
          (A) is imported from a licensed pharmacy for personal use by
        an individual, not for resale, in quantities that do not exceed
        a 90-day supply;
          (B) is accompanied by a copy of a valid prescription;
          (C) is imported from Canada, from a seller registered with
        the Secretary;
          (D) is a prescription drug approved by the Secretary under
        subchapter V of this chapter;
          (E) is in the form of a final finished dosage that was
        manufactured in an establishment registered under section 360
        of this title; and
          (F) is imported under such other conditions as the Secretary
        determines to be necessary to ensure public safety.
    (k) Construction
      Nothing in this section limits the authority of the Secretary
    relating to the importation of prescription drugs, other than with
    respect to section 381(d)(1) of this title as provided in this
    section.
    (l) Effectiveness of section
      (1) Commencement of program
        This section shall become effective only if the Secretary
      certifies to the Congress that the implementation of this section
      will - 
          (A) pose no additional risk to the public's health and
        safety; and
          (B) result in a significant reduction in the cost of covered
        products to the American consumer.
      (2) Termination of program
        (A) In general
          If, after the date that is 1 year after the effective date of
        the regulations under subsection (b) of this section and before
        the date that is 18 months after the effective date, the
        Secretary submits to Congress a certification that, in the
        opinion of the Secretary, based on substantial evidence
        obtained after the effective date, the benefits of
        implementation of this section do not outweigh any detriment of
        implementation of this section, this section shall cease to be
        effective as of the date that is 30 days after the date on
        which the Secretary submits the certification.
        (B) Procedure
          The Secretary shall not submit a certification under
        subparagraph (A) unless, after a hearing on the record under
        sections 556 and 557 of title 5, the Secretary - 
            (i)(I) determines that it is more likely than not that
          implementation of this section would result in an increase in
          the risk to the public health and safety;
            (II) identifies specifically, in qualitative and
          quantitative terms, the nature of the increased risk;
            (III) identifies specifically the causes of the increased
          risk; and
            (IV)(aa) considers whether any measures can be taken to
          avoid, reduce, or mitigate the increased risk; and
            (bb) if the Secretary determines that any measures
          described in item (aa) would require additional statutory
          authority, submits to Congress a report describing the
          legislation that would be required;
            (ii) identifies specifically, in qualitative and
          quantitative terms, the benefits that would result from
          implementation of this section (including the benefit of
          reductions in the cost of covered products to consumers in
          the United States, allowing consumers to procure needed
          medication that consumers might not otherwise be able to
          procure without foregoing other necessities of life); and
            (iii)(I) compares in specific terms the detriment
          identified under clause (i) with the benefits identified
          under clause (ii); and
            (II) determines that the benefits do not outweigh the
          detriment.
    (m) Authorization of appropriations
      There are authorized to be appropriated such sums as are
    necessary to carry out this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 804, as added Pub. L. 108-173, title
    XI, Sec. 1121(a), Dec. 8, 2003, 117 Stat. 2464.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 384, act June 25, 1938, ch. 675, Sec. 804, as
    added Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(c)(2)], Oct.
    28, 2000, 114 Stat. 1549, 1549A-36, related to importation of
    covered products, prior to repeal by Pub. L. 108-173, title XI,
    Sec. 1121(a), Dec. 8, 2003, 117 Stat. 2464.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions, personnel, assets, and liabilities of
    the United States Customs Service of the Department of the
    Treasury, including functions of the Secretary of the Treasury
    relating thereto, to the Secretary of Homeland Security, and for
    treatment of related references, see sections 203(1), 551(d),
    552(d), and 557 of Title 6, Domestic Security, and the Department
    of Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.


-MISC2-
                 STUDY AND REPORT ON IMPORTATION OF DRUGS             
      Pub. L. 108-173, title XI, Sec. 1122, Dec. 8, 2003, 117 Stat.
    2469, directed the Secretary of Health and Human Services to
    conduct a study on the importation of drugs into the United States
    pursuant to this section and to submit to Congress, not later than
    12 months after Dec. 8, 2003, a report providing the findings of
    such study.

-End-


-CITE-
    21 USC SUBCHAPTER IX - MISCELLANEOUS                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
                       SUBCHAPTER IX - MISCELLANEOUS                   

-End-



-CITE-
    21 USC Sec. 391                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 391. Separability clause

-STATUTE-
      If any provision of this chapter is declared unconstitutional, or
    the applicability thereof to any person or circumstances is held
    invalid, the constitutionality of the remainder of the chapter and
    the applicability thereof to other persons and circumstances shall
    not be affected thereby.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 901, 52 Stat. 1059.)

-End-



-CITE-
    21 USC Sec. 392                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 392. Exemption of meats and meat food products

-STATUTE-
    (a) Law determinative of exemption
      Meats and meat food products shall be exempt from the provisions
    of this chapter to the extent of the application or the extension
    thereto of the Meat Inspection Act, approved March 4, 1907, as
    amended [21 U.S.C. 601 et seq.].
    (b) Laws unaffected
      Nothing contained in this chapter shall be construed as in any
    way affecting, modifying, repealing, or superseding the provisions
    of section 351 of Public Health Service Act [42 U.S.C. 262]
    (relating to viruses, serums, toxins, and analogous products
    applicable to man); the virus, serum, toxin, and analogous products
    provisions, applicable to domestic animals, of the Act of Congress
    approved March 4, 1913 (37 Stat. 832-833) [21 U.S.C. 151 et seq.];
    the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26,
    ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et
    seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141
    et seq.].

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 902(b), (c), 52 Stat. 1059; Pub. L.
    90-399, Sec. 107, July 13, 1968, 82 Stat. 353.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Meat Inspection Act, approved March 4, 1907, as amended,
    referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I
    to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which
    are classified generally to subchapters I to IV (Sec. 601 et seq.)
    of chapter 12 of this title. For complete classification of this
    Act to the Code, see Short Title note set out under section 601 of
    this title and Tables.
      Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4,
    1913, ch. 145, 37 Stat. 828, as amended. The provisions of such act
    referred to relating to viruses, etc., applicable to domestic
    animals, are contained in the eighth paragraph under the heading
    "Bureau of Animal Industry", 37 Stat. 832, as amended, popularly
    known as the Virus-Serum-Toxin Act, which is classified generally
    to chapter 5 (Sec. 151 et seq.) of this title. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 151 of this title and Tables.
      The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title
    26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch.
    337, 29 Stat. 253, as amended, which had been classified to chapter
    10 (Sec. 1000 et seq.) of Title 26, Internal Revenue, and included
    as chapter 17 (Sec. 2350 et seq.) of Title 26, Internal Revenue
    Code of 1939. Such chapter 17 was covered by section 4831 et seq.
    of Title 26, Internal Revenue Code, prior to the repeal of section
    4831 et seq. of Title 26 by Pub. L. 93-490, Sec. 3(a)(1), Oct. 26,
    1974, 88 Stat. 1466.
      The Filled Milk Act of March 4, 1923, referred to in subsec. (b),
    is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, as amended, which is
    classified generally to chapter 3 (Sec. 61 et seq.) of this title.
    For complete classification of this Act to the Code, see Short
    Title note set out under section 61 of this title and Tables.
      The Import Milk Act of February 15, 1927, referred to in subsec.
    (b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, as amended,
    which is classified generally to subchapter IV (Sec. 141 et seq.)
    of chapter 4 of this title. For complete classification of this Act
    to the Code, see Short Title note set out under section 141 of this
    title and Tables.

-COD-
                               CODIFICATION                           
      Subsecs. (a) and (b) of this section comprise respectively
    subsecs. (b) and (c) of section 902 of act June 25, 1938. Subsecs.
    (a) and (d) of section 902 of act June 25, 1938, which prescribed
    the effective date of this chapter and made appropriations
    available, are set out as notes under section 301 of this title and
    this section, respectively.


-MISC1-
                                AMENDMENTS                            
      1968 - Subsec. (b). Pub. L. 90-399 substituted "section 262 of
    title 42 (relating to viruses, serums, toxins, and analogous
    products applicable to man)" for "the virus serum, and toxin Act of
    July 1, 1902" and inserted reference to "the virus, serum, toxin,
    and analogous products provisions, applicable to domestic animals,
    of the Act of Congress approved March 4, 1913".

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

                      AVAILABILITY OF APPROPRIATIONS                  
      Section 902(d) of act June 25, 1938, provided that: "In order to
    carry out the provisions of this Act which take effect [see section
    902(a) of act June 25, 1938, set out as an Effective Date note
    under section 301 of this title] prior to the repeal of the Food
    and Drugs Act of June 30, 1906, as amended [sections 1 to 15 of
    this title], appropriations available for the enforcement of such
    Act of June 30, 1906, are also authorized to be made available to
    carry out such provisions."

-End-



-CITE-
    21 USC Sec. 393                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 393. Food and Drug Administration

-STATUTE-
    (a) In general
      There is established in the Department of Health and Human
    Services the Food and Drug Administration (hereinafter in this
    section referred to as the "Administration").
    (b) Mission
      The Administration shall - 
        (1) promote the public health by promptly and efficiently
      reviewing clinical research and taking appropriate action on the
      marketing of regulated products in a timely manner;
        (2) with respect to such products, protect the public health by
      ensuring that - 
          (A) foods are safe, wholesome, sanitary, and properly
        labeled;
          (B) human and veterinary drugs are safe and effective;
          (C) there is reasonable assurance of the safety and
        effectiveness of devices intended for human use;
          (D) cosmetics are safe and properly labeled; and
          (E) public health and safety are protected from electronic
        product radiation;

        (3) participate through appropriate processes with
      representatives of other countries to reduce the burden of
      regulation, harmonize regulatory requirements, and achieve
      appropriate reciprocal arrangements; and
        (4) as determined to be appropriate by the Secretary, carry out
      paragraphs (1) through (3) in consultation with experts in
      science, medicine, and public health, and in cooperation with
      consumers, users, manufacturers, importers, packers,
      distributors, and retailers of regulated products.
    (c) Interagency collaboration
      The Secretary shall implement programs and policies that will
    foster collaboration between the Administration, the National
    Institutes of Health, and other science-based Federal agencies, to
    enhance the scientific and technical expertise available to the
    Secretary in the conduct of the duties of the Secretary with
    respect to the development, clinical investigation, evaluation, and
    postmarket monitoring of emerging medical therapies, including
    complementary therapies, and advances in nutrition and food
    science.
    (d) Commissioner
      (1) Appointment
        There shall be in the Administration a Commissioner of Food and
      Drugs (hereinafter in this section referred to as the
      "Commissioner") who shall be appointed by the President by and
      with the advice and consent of the Senate.
      (2) General powers
        The Secretary, through the Commissioner, shall be responsible
      for executing this chapter and for - 
          (A) providing overall direction to the Food and Drug
        Administration and establishing and implementing general
        policies respecting the management and operation of programs
        and activities of the Food and Drug Administration;
          (B) coordinating and overseeing the operation of all
        administrative entities within the Administration;
          (C) research relating to foods, drugs, cosmetics, and devices
        in carrying out this chapter;
          (D) conducting educational and public information programs
        relating to the responsibilities of the Food and Drug
        Administration; and
          (E) performing such other functions as the Secretary may
        prescribe.
    (e) Technical and scientific review groups
      The Secretary through the Commissioner of Food and Drugs may,
    without regard to the provisions of title 5 governing appointments
    in the competitive service and without regard to the provisions of
    chapter 51 and subchapter III of chapter 53 of such title relating
    to classification and General Schedule pay rates, establish such
    technical and scientific review groups as are needed to carry out
    the functions of the Administration, including functions under this
    chapter, and appoint and pay the members of such groups, except
    that officers and employees of the United States shall not receive
    additional compensation for service as members of such groups.
    (f) Agency plan for statutory compliance
      (1) In general
        Not later than 1 year after November 21, 1997, the Secretary,
      after consultation with appropriate scientific and academic
      experts, health care professionals, representatives of patient
      and consumer advocacy groups, and the regulated industry, shall
      develop and publish in the Federal Register a plan bringing the
      Secretary into compliance with each of the obligations of the
      Secretary under this chapter. The Secretary shall review the plan
      biannually and shall revise the plan as necessary, in
      consultation with such persons.
      (2) Objectives of agency plan
        The plan required by paragraph (1) shall establish objectives
      and mechanisms to achieve such objectives, including objectives
      related to - 
          (A) maximizing the availability and clarity of information
        about the process for review of applications and submissions
        (including petitions, notifications, and any other similar
        forms of request) made under this chapter;
          (B) maximizing the availability and clarity of information
        for consumers and patients concerning new products;
          (C) implementing inspection and postmarket monitoring
        provisions of this chapter;
          (D) ensuring access to the scientific and technical expertise
        needed by the Secretary to meet obligations described in
        paragraph (1);
          (E) establishing mechanisms, by July 1, 1999, for meeting the
        time periods specified in this chapter for the review of all
        applications and submissions described in subparagraph (A) and
        submitted after November 21, 1997; and
          (F) eliminating backlogs in the review of applications and
        submissions described in subparagraph (A), by January 1, 2000.
    (g) Annual report
      The Secretary shall annually prepare and publish in the Federal
    Register and solicit public comment on a report that - 
        (1) provides detailed statistical information on the
      performance of the Secretary under the plan described in
      subsection (f) of this section;
        (2) compares such performance of the Secretary with the
      objectives of the plan and with the statutory obligations of the
      Secretary; and
        (3) identifies any regulatory policy that has a significant
      negative impact on compliance with any objective of the plan or
      any statutory obligation and sets forth any proposed revision to
      any such regulatory policy.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 903, as added Pub. L. 100-607, title
    V, Sec. 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100-
    690, title II, Sec. 2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L.
    105-115, title IV, Secs. 406, 414, Nov. 21, 1997, 111 Stat. 2369,
    2377.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The provisions of title 5 governing appointments in the
    competitive service, referred to in subsec. (e), are classified
    generally to section 3301 et seq. of Title 5, Government
    Organization and Employees.

-COD-
                               CODIFICATION                           
      Another section 903 of the Federal Food, Drug, and Cosmetic Act
    was renumbered section 904 and is classified to section 394 of this
    title.


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (b). Pub. L. 105-115, Sec. 406(a)(2), added
    subsec. (b). Former subsec. (b) redesignated (d).
      Subsec. (c). Pub. L. 105-115, Sec. 414, added subsec. (c). Former
    subsec. (c) redesignated (e).
      Subsecs. (d), (e). Pub. L. 105-115, Sec. 406(a)(1), redesignated
    subsecs. (b) and (c) as (d) and (e), respectively.
      Subsecs. (f), (g). Pub. L. 105-115, Sec. 406(b), added subsecs.
    (f) and (g).
      1988 - Subsec. (b)(2). Pub. L. 100-690 substituted "shall be
    responsible for executing this chapter and" for "shall be
    responsible".

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                              EFFECTIVE DATE                          
      Section 503(c) of title V of Pub. L. 100-607 provided that:
      "(1) Except as provided in paragraph (2), the amendments made by
    this title [enacting this section and amending sections 5315 and
    5316 of Title 5, Government Organization and Employees] shall take
    effect on the date of enactment of this Act [Nov. 4, 1988].
      "(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic
    Act [21 U.S.C. 393(b)(1)] (as added by subsection (a) of this
    section) shall apply to the appointments of Commissioners of Food
    and Drugs made after the date of enactment of this Act."

       OFFICE OF MINOR USE AND MINOR SPECIES ANIMAL DRUG DEVELOPMENT   
      Pub. L. 108-282, title I, Sec. 102(b)(7), Aug. 2, 2004, 118 Stat.
    905, provided that: "The Secretary of Health and Human Services
    shall establish within the Center for Veterinary Medicine (of the
    Food and Drug Administration), an Office of Minor Use and Minor
    Species Animal Drug Development that reports directly to the
    Director of the Center for Veterinary Medicine. This office shall
    be responsible for overseeing the development and legal marketing
    of new animal drugs for minor uses and minor species. There is
    authorized to be appropriated to carry out this subsection
    $1,200,000 for fiscal year 2004 and such sums as may be necessary
    for each fiscal year thereafter."

                    REGULATIONS FOR SUNSCREEN PRODUCTS                
      Section 129 of Pub. L. 105-115 provided that: "Not later than 18
    months after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services shall issue regulations for
    over-the-counter sunscreen products for the prevention or treatment
    of sunburn."

             FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD         
      Section 413 of Pub. L. 105-115 provided that:
      "(a) List and Analysis. - The Secretary of Health and Human
    Services shall, acting through the Food and Drug Administration - 
        "(1) compile a list of drugs and foods that contain
      intentionally introduced mercury compounds, and
        "(2) provide a quantitative and qualitative analysis of the
      mercury compounds in the list under paragraph (1).
    The Secretary shall compile the list required by paragraph (1)
    within 2 years after the date of enactment of the Food and Drug
    Administration Modernization Act of 1997 [Nov. 21, 1997] and shall
    provide the analysis required by paragraph (2) within 2 years after
    such date of enactment.
      "(b) Study. - The Secretary of Health and Human Services, acting
    through the Food and Drug Administration, shall conduct a study of
    the effect on humans of the use of mercury compounds in nasal
    sprays. Such study shall include data from other studies that have
    been made of such use.
      "(c) Study of Mercury Sales. - 
        "(1) Study. - The Secretary of Health and Human Services,
      acting through the Food and Drug Administration and subject to
      appropriations, shall conduct, or shall contract with the
      Institute of Medicine of the National Academy of Sciences to
      conduct, a study of the effect on humans of the use of elemental,
      organic, or inorganic mercury when offered for sale as a drug or
      dietary supplement. Such study shall, among other things,
      evaluate - 
          "(A) the scope of mercury use as a drug or dietary
        supplement; and
          "(B) the adverse effects on health of children and other
        sensitive populations resulting from exposure to, or ingestion
        or inhalation of, mercury when so used.
      In conducting such study, the Secretary shall consult with the
      Administrator of the Environmental Protection Agency, the Chair
      of the Consumer Product Safety Commission, and the Administrator
      of the Agency for Toxic Substances and Disease Registry, and, to
      the extent the Secretary believes necessary or appropriate, with
      any other Federal or private entity.
        "(2) Regulations. - If, in the opinion of the Secretary, the
      use of elemental, organic, or inorganic mercury offered for sale
      as a drug or dietary supplement poses a threat to human health,
      the Secretary shall promulgate regulations restricting the sale
      of mercury intended for such use. At a minimum, such regulations
      shall be designed to protect the health of children and other
      sensitive populations from adverse effects resulting from
      exposure to, or ingestion or inhalation of, mercury. Such
      regulations, to the extent feasible, should not unnecessarily
      interfere with the availability of mercury for use in religious
      ceremonies."

                        MANAGEMENT ACTIVITIES STUDY                    
      Pub. L. 102-571, title II, Sec. 205, Oct. 29, 1992, 106 Stat.
    4502, directed Comptroller General to conduct a study of management
    of activities of the Food and Drug Administration that are related
    to dietary supplements of vitamins, minerals, herbs, or other
    similar nutritional substances and submit an interim report to
    Congress, not later than 6 months after Oct. 29, 1992, with a final
    report to be submitted not later than 12 months after Oct. 29,
    1992.

                          CONGRESSIONAL FINDINGS                      
      Section 502 of Pub. L. 100-607 provided that: "Congress finds
    that - 
        "(1) the public health has been effectively protected by the
      presence of the Food and Drug Administration during the last
      eighty years;
        "(2) the presence and importance of the Food and Drug
      Administration must be guaranteed; and
        "(3) the independence and integrity of the Food and Drug
      Administration need to be enhanced in order to ensure the
      continuing protection of the public health."

-End-



-CITE-
    21 USC Sec. 393a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 393a. Office of Pediatric Therapeutics

-STATUTE-
    (a) Establishment
      The Secretary of Health and Human Services shall establish an
    Office of Pediatric Therapeutics within the Food and Drug
    Administration.
    (b) Duties
      The Office of Pediatric Therapeutics shall be responsible for
    coordination and facilitation of all activities of the Food and
    Drug Administration that may have any effect on a pediatric
    population or the practice of pediatrics or may in any other way
    involve pediatric issues.
    (c) Staff
      The staff of the Office of Pediatric Therapeutics shall
    coordinate with employees of the Department of Health and Human
    Services who exercise responsibilities relating to pediatric
    therapeutics and shall include - 
        (1) one or more additional individuals with expertise
      concerning ethical issues presented by the conduct of clinical
      research in the pediatric population; and
        (2) one or more additional individuals with expertise in
      pediatrics as may be necessary to perform the activities
      described in subsection (b) of this section.

-SOURCE-
    (Pub. L. 107-109, Sec. 6, Jan. 4, 2002, 115 Stat. 1414.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Best Pharmaceuticals for
    Children Act, and not as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 394                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 394. Scientific review groups

-STATUTE-
      Without regard to the provisions of title 5 governing
    appointments in the competitive service and without regard to the
    provisions of chapter 51 and subchapter III of chapter 53 of such
    title relating to classification and General Schedule pay rates,
    the Commissioner of Food and Drugs may - 
        (1) establish such technical and scientific review groups as
      are needed to carry out the functions of the Food and Drug
      Administration (including functions prescribed under this
      chapter); and
        (2) appoint and pay the members of such groups, except that
      officers and employees of the United States shall not receive
      additional compensation for service as members of such groups.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 904, formerly Sec. 903, as added Pub.
    L. 101-635, title III, Sec. 301, Nov. 28, 1990, 104 Stat. 4584;
    renumbered Sec. 904, Pub. L. 103-43, title XX, Sec. 2006(1), June
    10, 1993, 107 Stat. 209.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The provisions of title 5 governing appointments in the
    competitive service, referred to in text, are classified generally
    to section 3301 et seq. of Title 5, Government Organization and
    Employees.

-End-



-CITE-
    21 USC Sec. 395                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 395. Loan repayment program

-STATUTE-
    (a) In general
      (1) Authority for program
        Subject to paragraph (2), the Secretary shall carry out a
      program of entering into contracts with appropriately qualified
      health professionals under which such health professionals agree
      to conduct research, as employees of the Food and Drug
      Administration, in consideration of the Federal Government
      agreeing to repay, for each year of such service, not more than
      $20,000 of the principal and interest of the educational loans of
      such health professionals.
      (2) Limitation
        The Secretary may not enter into an agreement with a health
      professional pursuant to paragraph (1) unless such professional -
      
          (A) has a substantial amount of educational loans relative to
        income; and
          (B) agrees to serve as an employee of the Food and Drug
        Administration for purposes of paragraph (1) for a period of
        not less than 3 years.
    (b) Applicability of certain provisions
      With respect to the National Health Service Corps Loan Repayment
    Program established in subpart III of part D of title III of the
    Public Health Service Act [42 U.S.C. 254l et seq.], the provisions
    of such subpart shall, except as inconsistent with subsection (a)
    of this section, apply to the program established in such
    subsection in the same manner and to the same extent as such
    provisions apply to the National Health Service Corps Loan
    Repayment Program.
    (c) Authorization of appropriations
      For the purpose of carrying out this section, there are
    authorized to be appropriated such sums as may be necessary for
    each of the fiscal years 1994 through 1996.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 905, as added Pub. L. 103-43, title
    XX, Sec. 2006(2), June 10, 1993, 107 Stat. 210.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Public Health Service Act, referred to in subsec. (b), is act
    July 1, 1944, ch. 373, 58 Stat. 682, as amended. Subpart III of
    part D of title III of the Act is classified generally to subpart
    III [Sec. 254l et seq.] of part D of subchapter II of chapter 6A of
    Title 42, The Public Health and Welfare. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 201 of Title 42 and Tables.

-End-



-CITE-
    21 USC Sec. 396                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 396. Practice of medicine

-STATUTE-
      Nothing in this chapter shall be construed to limit or interfere
    with the authority of a health care practitioner to prescribe or
    administer any legally marketed device to a patient for any
    condition or disease within a legitimate health care practitioner-
    patient relationship. This section shall not limit any existing
    authority of the Secretary to establish and enforce restrictions on
    the sale or distribution, or in the labeling, of a device that are
    part of a determination of substantial equivalence, established as
    a condition of approval, or promulgated through regulations.
    Further, this section shall not change any existing prohibition on
    the promotion of unapproved uses of legally marketed devices.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 906, as added Pub. L. 105-115, title
    II, Sec. 214, Nov. 21, 1997, 111 Stat. 2348.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 397                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 397. Contracts for expert review

-STATUTE-
    (a) In general
      (1) Authority
        The Secretary may enter into a contract with any organization
      or any individual (who is not an employee of the Department) with
      relevant expertise, to review and evaluate, for the purpose of
      making recommendations to the Secretary on, part or all of any
      application or submission (including a petition, notification,
      and any other similar form of request) made under this chapter
      for the approval or classification of an article or made under
      section 351(a) of the Public Health Service Act (42 U.S.C.
      262(a)) with respect to a biological product. Any such contract
      shall be subject to the requirements of section 379 of this title
      relating to the confidentiality of information.
      (2) Increased efficiency and expertise through contracts
        The Secretary may use the authority granted in paragraph (1)
      whenever the Secretary determines that use of a contract
      described in paragraph (1) will improve the timeliness of the
      review of an application or submission described in paragraph
      (1), unless using such authority would reduce the quality, or
      unduly increase the cost, of such review. The Secretary may use
      such authority whenever the Secretary determines that use of such
      a contract will improve the quality of the review of an
      application or submission described in paragraph (1), unless
      using such authority would unduly increase the cost of such
      review. Such improvement in timeliness or quality may include
      providing the Secretary increased scientific or technical
      expertise that is necessary to review or evaluate new therapies
      and technologies.
    (b) Review of expert review
      (1) In general
        Subject to paragraph (2), the official of the Food and Drug
      Administration responsible for any matter for which expert review
      is used pursuant to subsection (a) of this section shall review
      the recommendations of the organization or individual who
      conducted the expert review and shall make a final decision
      regarding the matter in a timely manner.
      (2) Limitation
        A final decision by the Secretary on any such application or
      submission shall be made within the applicable prescribed time
      period for review of the matter as set forth in this chapter or
      in the Public Health Service Act (42 U.S.C. 201 et seq.).

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 907, as added Pub. L. 105-115, title
    IV, Sec. 415, Nov. 21, 1997, 111 Stat. 2377.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Public Health Service Act, referred to in subsec. (b)(2), is
    act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is
    classified generally to chapter 6A (Sec. 201 et seq.) of Title 42,
    The Public Health and Welfare. For complete classification of this
    Act to the Code, see Short Title note set out under section 201 of
    Title 42 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 398                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 398. Notices to States regarding imported food

-STATUTE-
    (a) In general
      If the Secretary has credible evidence or information indicating
    that a shipment of imported food or portion thereof presents a
    threat of serious adverse health consequences or death to humans or
    animals, the Secretary shall provide notice regarding such threat
    to the States in which the food is held or will be held, and to the
    States in which the manufacturer, packer, or distributor of the
    food is located, to the extent that the Secretary has knowledge of
    which States are so involved. In providing notice to a State, the
    Secretary shall request the State to take such action as the State
    considers appropriate, if any, to protect the public health
    regarding the food involved.
    (b) Rule of construction
      Subsection (a) of this section may not be construed as limiting
    the authority of the Secretary with respect to food under any other
    provision of this chapter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 908, as added Pub. L. 107-188, title
    III, Sec. 310, June 12, 2002, 116 Stat. 673.)

-End-



-CITE-
    21 USC Sec. 399                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 399. Grants to States for inspections

-STATUTE-
    (a) In general
      The Secretary is authorized to make grants to States,
    territories, and Indian tribes (as defined in section 450b(e) of
    title 25) that undertake examinations, inspections, and
    investigations, and related activities under section 372 of this
    title. The funds provided under such grants shall only be available
    for the costs of conducting such examinations, inspections,
    investigations, and related activities.
    (b) Notices regarding adulterated imported food
      The Secretary may make grants to the States for the purpose of
    assisting the States with the costs of taking appropriate action to
    protect the public health in response to notification under section
    398 of this title, including planning and otherwise preparing to
    take such action.
    (c) Authorization of appropriations
      For the purpose of carrying out this section, there are
    authorized to be appropriated $10,000,000 for fiscal year 2002, and
    such sums as may be necessary for each of the fiscal years 2003
    through 2006.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 909, as added Pub. L. 107-188, title
    III, Sec. 311, June 12, 2002, 116 Stat. 673.)

-End-


-CITE-
    21 USC CHAPTER 10 - POULTRY AND POULTRY PRODUCTS
           INSPECTION                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
           CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION       

-MISC1-
    Sec.                                                     
    451.        Congressional statement of findings.                  
    452.        Congressional declaration of policy.                  
    453.        Definitions.                                          
    454.        Federal and State cooperation in development and
                 administration of State poultry product inspection
                 programs.                                            
    455.        Inspection in official establishments.                
    456.        Operation of premises, facilities and equipment.      
    457.        Labeling and container standards.                     
    458.        Prohibited acts.                                      
    459.        Compliance by all establishments.                     
    460.        Miscellaneous activities subject to regulation.       
    461.        Offenses and punishment.                              
    462.        Reporting of violations; notice; opportunity to
                 present views.                                       
    463.        Rules and regulations.                                
    464.        Exemptions.                                           
    465.        Limitations upon entry of poultry products and other
                 materials into official establishments.              
    466.        Imports.                                              
    467.        Inspection services.                                  
    467a.       Administrative detention; duration; pending judicial
                 proceedings; notification of government authorities;
                 release; removal of official marks.                  
    467b.       Seizure and condemnation.                             
    467c.       Federal court jurisdiction of enforcement and
                 injunction proceedings and other kinds of cases;
                 limitations; United States as plaintiff; subpenas.   
    467d.       Administration and enforcement; applicability of
                 penalty provisions; conduct of inquiries; power and
                 jurisdiction of courts.                              
    467e.       Non-Federal jurisdiction of federally regulated
                 matters; prohibition of additional or different
                 requirements for establishments with inspection
                 services and as to marking, labeling, packaging, and
                 ingredients; recordkeeping and related requirements;
                 concurrent jurisdiction over distribution for human
                 food purposes of adulterated or misbranded and
                 imported articles; other matters.                    
    467f.       Federal Food, Drug, and Cosmetic Act applications.    
    468.        Cost of inspection; overtime.                         
    469.        Authorization of appropriations.                      
    470.        Omitted.                                              
    471.        Safe Meat and Poultry Inspection Panel.               

-End-



-CITE-
    21 USC Sec. 451                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 451. Congressional statement of findings

-STATUTE-
      Poultry and poultry products are an important source of the
    Nation's total supply of food. They are consumed throughout the
    Nation and the major portion thereof moves in interstate or foreign
    commerce. It is essential in the public interest that the health
    and welfare of consumers be protected by assuring that poultry
    products distributed to them are wholesome, not adulterated, and
    properly marked, labeled, and packaged. Unwholesome, adulterated,
    or misbranded poultry products impair the effective regulation of
    poultry products in interstate or foreign commerce, are injurious
    to the public welfare, destroy markets for wholesome, not
    adulterated, and properly labeled and packaged poultry products,
    and result in sundry losses to poultry producers and processors of
    poultry and poultry products, as well as injury to consumers. It is
    hereby found that all articles and poultry which are regulated
    under this chapter are either in interstate or foreign commerce or
    substantially affect such commerce, and that regulation by the
    Secretary of Agriculture and cooperation by the States and other
    jurisdictions as contemplated by this chapter are appropriate to
    prevent and eliminate burdens upon such commerce, to effectively
    regulate such commerce, and to protect the health and welfare of
    consumers.

-SOURCE-
    (Pub. L. 85-172, Sec. 2, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90-
    492, Sec. 2, Aug. 18, 1968, 82 Stat. 791.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 inserted provisions stating it to be
    necessary that the health and welfare of consumers be protected by
    assuring that poultry products distributed to them are wholesome,
    not adulterated, and properly marked, labeled, and packaged,
    provisions that misbranded poultry products impair the effective
    regulation of poultry products and destroy markets for wholesome,
    not adulterated, and properly labeled and packaged poultry
    products, and result in sundry losses to poultry producers and
    processors of poultry and poultry products, as well as injury to
    consumers, and provisions that all articles and poultry which are
    regulated by this chapter are either in interstate or foreign
    commerce or substantially affect such commerce and that regulation
    by the Secretary of Agriculture and cooperation by the states and
    other jurisdictions as contemplated by this chapter are appropriate
    to serve the specified aims, and struck out provisions that all
    poultry and poultry products which have or are required to have
    inspection under this chapter are either in the current of
    interstate or foreign commerce or directly affect such commerce,
    provisions that that part entering directly into the current of
    interstate or foreign commerce cannot be effectively inspected and
    regulated without also inspecting and regulating all poultry and
    poultry products in the same establishment, and provisions
    authorizing the Secretary to designate major consuming areas.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Section 20 of Pub. L. 90-492 provided that: "This Act [see Short
    Title of 1968 Amendment note below] shall become effective upon
    enactment [Aug. 18, 1968] except as provided in paragraphs (a)
    through (c):
      "(a) The provisions of subparagraphs (a)(2)(A) and (a)(3) of
    section 9 of the Poultry Products Inspection Act, as amended by
    section 9 of this Act [section 458(a)(2)(A) and (a)(3) of this
    title], shall become effective upon the expiration of sixty days
    after enactment hereof [Aug. 18, 1968].
      "(b) Section 14 of this Act, amending section 15 of the Poultry
    Products Inspection Act [section 464 of this title], shall become
    effective upon the expiration of sixty days after enactment hereof
    [Aug. 18, 1968].
      "(c) Paragraph 11(d) of the Poultry Products Inspection Act, as
    added by section 11 of this Act [section 460(d) of this title],
    shall become effective upon the expiration of sixty days after
    enactment hereof [Aug. 18, 1968]."

                              EFFECTIVE DATE                          
      Section 29, formerly section 22, of Pub. L. 85-172, as renumbered
    by Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat. 805, provided
    that: "This Act [this chapter] shall take effect upon enactment
    [Aug. 28, 1957], except that no person shall be subject to the
    provisions of this Act [this chapter] prior to January 1, 1959,
    unless such person after January 1, 1958, applies for and receives
    inspection for poultry or poultry products in accordance with the
    provisions of this Act [this chapter] and pursuant to regulations
    promulgated by the Secretary hereunder, in any establishment
    processing poultry or poultry products in commerce or in a
    designated major consuming area. Any person who voluntarily applies
    for and receives such inspection after January 1, 1958, shall be
    subject, on and after the date he commences to receive such
    inspection, to all of the provisions and penalties provided for in
    this Act [this chapter] with respect to all poultry or poultry
    products handled in the establishment for which such said
    application for inspection is made."

                       SHORT TITLE OF 1968 AMENDMENT                   
      Section 1 of Pub. L. 90-492 provided: "That this Act [enacting
    sections 467a to 467f and 470 of this title, amending this section
    and sections 452 to 461, 463 to 465, and 467 of this title, and
    enacting provisions set out as notes under this section] may be
    cited as the 'Wholesome Poultry Products Act'."

                                SHORT TITLE                            
      Section 1 of Pub. L. 85-172 provided: "That this Act [enacting
    this chapter and provisions set out as notes under this section]
    may be cited as the 'Poultry Products Inspection Act'."

                               SEPARABILITY                           
      Section 19 of Pub. L. 90-492 provided that: "If any provisions of
    this Act or of the amendments made hereby [see Short Title of 1968
    Amendment note above] or the application thereof to any person or
    circumstances is held invalid, the validity of the remainder of the
    Act and the remaining amendments and of the application of such
    provision to other persons and circumstances shall not be affected
    thereby."
      Section 28, formerly section 21, of Pub. L. 85-172, as renumbered
    by Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat. 805, provided
    that: "If any provision of this Act [this chapter] or the
    application thereof to any person or circumstances is held invalid,
    the validity of the remainder of the Act and of the application of
    such provision to other persons and circumstances shall not be
    affected thereby."

                     FOOD ADDITIVES AMENDMENT OF 1958                 
      Pub. L. 85-929, Sec. 7, Sept. 6, 1958, 72 Stat. 1789, provided
    that: "Nothing in this Act [amending sections 321, 331, 342, 346,
    and 348 of this title and section 210 of Title 42, The Public
    Health and Welfare, and enacting provisions set out as notes under
    sections 321 and 342 of this title] shall be construed to exempt
    any meat or meat food product or any person from any requirement
    imposed by or pursuant to the Poultry Products Inspection Act (21
    U.S.C. 451 and the following) [this chapter] or the Meat Inspection
    Act of March 4, 1907, 34 Stat. 1260, as amended and extended (21
    U.S.C. 71 and the following) [see section 601 et seq. of this
    title]."

-End-



-CITE-
    21 USC Sec. 452                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 452. Congressional declaration of policy

-STATUTE-
      It is hereby declared to be the policy of the Congress to provide
    for the inspection of poultry and poultry products and otherwise
    regulate the processing and distribution of such articles as
    hereinafter prescribed to prevent the movement or sale in
    interstate or foreign commerce of, or the burdening of such
    commerce by, poultry products which are adulterated or misbranded.
    It is the intent of Congress that when poultry and poultry products
    are condemned because of disease, the reason for condemnation in
    such instances shall be supported by scientific fact, information,
    or criteria, and such condemnation under this chapter shall be
    achieved through uniform inspection standards and uniform
    applications thereof.

-SOURCE-
    (Pub. L. 85-172, Sec. 3, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90-
    492, Sec. 3, Aug. 18, 1968, 82 Stat. 792.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 inserted provisions declaring the policy of
    Congress to be to otherwise regulate the processing and
    distribution of poultry and poultry products as hereinafter
    prescribed so as to prevent the movement or sale in interstate
    commerce of, or the burdening of such commerce by poultry products
    which are adulterated or misbranded, and provisions that declared
    the policy of Congress to be that condemnation of diseased poultry
    and poultry products shall be achieved through uniform inspection
    standards and supported by scientific fact or criteria, and struck
    out provisions that declared the policy of Congress to be to
    provide for inspection by the inspection service to prevent the
    movement in interstate commerce or foreign commerce or in a
    designated major consuming area of poultry products which are
    unwholesome, adulterated, or otherwise unfit for human food.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 453                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 453. Definitions

-STATUTE-
      For purposes of this chapter - 
      (a) The term "commerce" means commerce between any State, any
    territory, or the District of Columbia, and any place outside
    thereof; or within any territory not organized with a legislative
    body, or the District of Columbia.
      (b) Except as otherwise provided in this chapter, the term
    "State" means any State of the United States and the Commonwealth
    of Puerto Rico.
      (c) The term "territory" means Guam, the Virgin Islands of the
    United States, American Samoa, and any other territory or
    possession of the United States, excluding the Canal Zone.
      (d) The term "United States" means the States, the District of
    Columbia, and the territories of the United States.
      (e) The term "poultry" means any domesticated bird, whether live
    or dead.
      (f) The term "poultry product" means any poultry carcass, or part
    thereof; or any product which is made wholly or in part from any
    poultry carcass or part thereof, excepting products which contain
    poultry ingredients only in a relatively small proportion or
    historically have not been considered by consumers as products of
    the poultry food industry, and which are exempted by the Secretary
    from definition as a poultry product under such conditions as the
    Secretary may prescribe to assure that the poultry ingredients in
    such products are not adulterated and that such products are not
    represented as poultry products.
      (g) The term "adulterated" shall apply to any poultry product
    under one or more of the following circumstances:
        (1) if it bears or contains any poisonous or deleterious
      substance which may render it injurious to health; but in case
      the substance is not an added substance, such article shall not
      be considered adulterated under this clause if the quantity of
      such substance in or on such article does not ordinarily render
      it injurious to health;
        (2)(A) if it bears or contains (by reason of administration of
      any substance to the live poultry or otherwise) any added
      poisonous or added deleterious substance (other than one which is
      (i) a pesticide chemical in or on a raw agricultural commodity;
      (ii) a food additive; or (iii) a color additive) which may, in
      the judgment of the Secretary, make such article unfit for human
      food;
        (B) if it is, in whole or in part, a raw agricultural commodity
      and such commodity bears or contains a pesticide chemical which
      is unsafe within the meaning of section 346a of this title;
        (C) if it bears or contains any food additive which is unsafe
      within the meaning of section 348 of this title;
        (D) if it bears or contains any color additive which is unsafe
      within the meaning of section 379e of this title: Provided, That
      an article which is not otherwise deemed adulterated under clause
      (B), (C), or (D) shall nevertheless be deemed adulterated if use
      of the pesticide chemical, food additive, or color additive in or
      on such article is prohibited by regulations of the Secretary in
      official establishments;
        (3) if it consists in whole or in part of any filthy, putrid,
      or decomposed substance or is for any other reason unsound,
      unhealthful, unwholesome, or otherwise unfit for human food;
        (4) if it has been prepared, packed, or held under insanitary
      conditions whereby it may have become contaminated with filth, or
      whereby it may have been rendered injurious to health;
        (5) if it is, in whole or in part, the product of any poultry
      which has died otherwise than by slaughter;
        (6) if its container is composed, in whole or in part, of any
      poisonous or deleterious substance which may render the contents
      injurious to health;
        (7) if it has been intentionally subjected to radiation, unless
      the use of the radiation was in conformity with a regulation or
      exemption in effect pursuant to section 348 of this title;
        (8) if any valuable constituent has been in whole or in part
      omitted or abstracted therefrom; or if any substance has been
      substituted, wholly or in part therefor; or if damage or
      inferiority has been concealed in any manner; or if any substance
      has been added thereto or mixed or packed therewith so as to
      increase its bulk or weight, or reduce its quality or strength,
      or make it appear better or of greater value than it is.

      (h) The term "misbranded" shall apply to any poultry product
    under one or more of the following circumstances:
        (1) if its labeling is false or misleading in any particular;
        (2) if it is offered for sale under the name of another food;
        (3) if it is an imitation of another food, unless its label
      bears, in type of uniform size and prominence, the word
      "imitation" and immediately thereafter, the name of the food
      imitated;
        (4) if its container is so made, formed, or filled as to be
      misleading;
        (5) unless it bears a label showing (A) the name and the place
      of business of the manufacturer, packer, or distributor; and (B)
      an accurate statement of the quantity of the product in terms of
      weight, measure, or numerical count: Provided, That under clause
      (B) of this subparagraph (5), reasonable variations may be
      permitted, and exemptions as to small packages or articles not in
      packages or other containers may be established by regulations
      prescribed by the Secretary;
        (6) if any word, statement, or other information required by or
      under authority of this chapter to appear on the label or other
      labeling is not prominently placed thereon with such
      conspicuousness (as compared with other words, statements,
      designs, or devices, in the labeling) and in such terms as to
      render it likely to be read and understood by the ordinary
      individual under customary conditions of purchase and use;
        (7) if it purports to be or is represented as a food for which
      a definition and standard of identity or composition has been
      prescribed by regulations of the Secretary under section 457 of
      this title unless (A) it conforms to such definition and
      standard, and (B) its label bears the name of the food specified
      in the definition and standard and, insofar as may be required by
      such regulations, the common names of optional ingredients (other
      than spices, flavoring, and coloring) present in such food;
        (8) if it purports to be or is represented as a food for which
      a standard or standards of fill of container have been prescribed
      by regulations of the Secretary under section 457 of this title,
      and it falls below the standard of fill of container applicable
      thereto, unless its label bears, in such manner and form as such
      regulations specify, a statement that it falls below such
      standard;
        (9) if it is not subject to the provisions of subparagraph (7),
      unless its label bears (A) the common or usual name of the food,
      if any there be, and (B) in case it is fabricated from two or
      more ingredients, the common or usual name of each such
      ingredient; except that spices, flavorings, and colorings may,
      when authorized by the Secretary, be designated as spices,
      flavorings, and colorings without naming each: Provided, That to
      the extent that compliance with the requirements of clause (B) of
      this subparagraph (9) is impracticable or results in deception or
      unfair competition, exemptions shall be established by
      regulations promulgated by the Secretary;
        (10) if it purports to be or is represented for special dietary
      uses unless its label bears such information concerning its
      vitamin, mineral, and other dietary properties as the Secretary,
      after consultation with the Secretary of Health and Human
      Services, determines to be, and by regulations prescribes as,
      necessary in order fully to inform purchasers as to its value for
      such uses;
        (11) if it bears or contains any artificial flavoring,
      artificial coloring, or chemical preservative unless it bears
      labeling stating that fact: Provided, That, to the extent that
      compliance with the requirements of this subparagraph (11) is
      impracticable, exemptions shall be established by regulations
      promulgated by the Secretary; or
        (12) if it fails to bear on its containers, and in the case of
      nonconsumer packaged carcasses (if the Secretary so requires)
      directly thereon, as the Secretary may by regulations prescribe,
      the official inspection legend and official establishment number
      of the establishment where the article was processed, and,
      unrestricted by any of the foregoing, such other information as
      the Secretary may require in such regulations to assure that it
      will not have false or misleading labeling and that the public
      will be informed of the manner of handling required to maintain
      the article in a wholesome condition.

      (i) The term "Secretary" means the Secretary of Agriculture or
    his delegate.
      (j) The term "person" means any individual, partnership,
    corporation, association, or other business unit.
      (k) The term "inspector" means: (1) an employee or official of
    the United States Government authorized by the Secretary to inspect
    poultry and poultry products under the authority of this chapter,
    or (2) any employee or official of the government of any State or
    territory or the District of Columbia authorized by the Secretary
    to inspect poultry and poultry products under authority of this
    chapter, under an agreement entered into between the Secretary and
    the appropriate State or other agency.
      (l) The term "official mark" means the official inspection legend
    or any other symbol prescribed by regulation of the Secretary to
    identify the status of any article or poultry under this chapter.
      (m) The term "official inspection legend" means any symbol
    prescribed by regulations of the Secretary showing that an article
    was inspected for wholesomeness in accordance with this chapter.
      (n) The term "official certificate" means any certificate
    prescribed by regulations of the Secretary for issuance by an
    inspector or other person performing official functions under this
    chapter.
      (o) The term "official device" means any device prescribed or
    authorized by the Secretary for use in applying any official mark.
      (p) The term "official establishment" means any establishment as
    determined by the Secretary at which inspection of the slaughter of
    poultry, or the processing of poultry products, is maintained under
    the authority of this chapter.
      (q) The term "inspection service" means the official Government
    service within the Department of Agriculture designated by the
    Secretary as having the responsibility for carrying out the
    provisions of this chapter.
      (r) The term "container" or "package" includes any box, can, tin,
    cloth, plastic, or other receptacle, wrapper, or cover.
      (s) The term "label" means a display of written, printed, or
    graphic matter upon any article or the immediate container (not
    including packaged liners) of any article; and the term "labeling"
    means all labels and other written, printed, or graphic matter (1)
    upon any article or any of its containers or wrappers, or (2)
    accompanying such article.
      (t) The term "shipping container" means any container used or
    intended for use in packaging the product packed in an immediate
    container.
      (u) The term "immediate container" includes any consumer package;
    or any other container in which poultry products, not consumer
    packaged, are packed.
      (v) The term "capable of use as human food" shall apply to any
    carcass, or part or product of a carcass, of any poultry, unless it
    is denatured or otherwise identified as required by regulations
    prescribed by the Secretary to deter its use as human food, or it
    is naturally inedible by humans.
      (w) The term "processed" means slaughtered, canned, salted,
    stuffed, rendered, boned, cut up, or otherwise manufactured or
    processed.
      (x) The term "Federal Food, Drug, and Cosmetic Act" means the Act
    so entitled, approved June 25, 1938 (52 Stat. 1040) [21 U.S.C. 301
    et seq.], and Acts amendatory thereof or supplementary thereto.
      (y) The terms "pesticide chemical", "food additive", "color
    additive", and "raw agricultural commodity" shall have the same
    meanings for purposes of this chapter as under the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
      (z) The term "poultry products broker" means any person engaged
    in the business of buying or selling poultry products on
    commission, or otherwise negotiating purchases or sales of such
    articles other than for his own account or as an employee of
    another person.
      (aa) The term "renderer" means any person engaged in the business
    of rendering carcasses, or parts or products of the carcasses, of
    poultry, except rendering conducted under inspection or exemption
    under this chapter.
      (bb) The term "animal food manufacturer" means any person engaged
    in the business of manufacturing or processing animal food derived
    wholly or in part from carcasses, or parts or products of the
    carcasses, of poultry.

-SOURCE-
    (Pub. L. 85-172, Sec. 4, Aug. 28, 1957, 71 Stat. 441; Pub. L. 87-
    498, June 25, 1962, 76 Stat. 110; Pub. L. 90-492, Sec. 4, Aug. 18,
    1968, 82 Stat. 792; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17,
    1979, 93 Stat. 695; Pub. L. 102-571, title I, Sec. 107(13), Oct.
    29, 1992, 106 Stat. 4499.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in pars.
    (x) and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      1992 - Subsec. (g)(2)(D). Pub. L. 102-571 substituted "379e" for
    "376".
      1968 - Pub. L. 90-492 inserted definitions of "State",
    "territory", "United States", "misbranded", "official mark",
    "official inspection legend", "official certificate", "official
    device", "capable of use as human food", "processed", "Federal
    Food, Drug, and Cosmetic Act", "pesticide chemical", "poultry
    products broker", "renderer", and "animal food manufacturer",
    revised definitions of "commerce", "poultry", "poultry product",
    "adulterated", "Secretary", "inspector", "container" or "package",
    "label", and "immediate container", reenacted without change
    definitions of "person", "official establishment", "inspection
    service", and "shipping container", and deleted definition of
    "wholesome", "unwholesome", and "official inspection mark".
      1962 - Par. (a). Pub. L. 87-498 struck out references to
    Territories or possessions, and inserted definition of "State".

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in par. (h)(10)
    pursuant to section 509(b) of Pub. L. 96-88, which is classified to
    section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 454                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 454. Federal and State cooperation in development and
      administration of State poultry product inspection programs

-STATUTE-
    (a) State laws; planning, technical and financial assistance;
      advisory committees
      It is the policy of the Congress to protect the consuming public
    from poultry products that are adulterated or misbranded and to
    assist in efforts by State and other government agencies to
    accomplish this objective. In furtherance of this policy - 
        (1) The Secretary is authorized, whenever he determines that it
      would effectuate the purposes of this chapter, to cooperate with
      the appropriate State agency in developing and administering a
      State poultry product inspection program in any State which has
      enacted a mandatory State poultry product inspection law that
      imposes ante mortem and post mortem inspection, reinspection and
      sanitation requirements that are at least equal to those under
      this chapter, with respect to all or certain classes of persons
      engaged in the State in slaughtering poultry or processing
      poultry products for use as human food solely for distribution
      within such State.
        (2) The Secretary is further authorized, whenever he determines
      that it would effectuate the purposes of this chapter, to
      cooperate with appropriate State agencies in developing and
      administering State programs under State laws containing
      authorities at least equal to those provided in section 460 of
      this title; and to cooperate with other agencies of the United
      States in carrying out any provisions of this chapter. In
      carrying out the provisions of this chapter, the Secretary may
      conduct such examinations, investigations, and inspections as he
      determines practicable through any officer or employee of any
      State or Territory or the District of Columbia commissioned by
      the Secretary for such purpose.
        (3) Cooperation with State agencies under this section may
      include furnishing to the appropriate State agency (i) advisory
      assistance in planning and otherwise developing an adequate State
      program under the State law; and (ii) technical and laboratory
      assistance and training (including necessary curricular and
      instructional materials and equipment), and financial and other
      aid for administration of such a program. The amount to be
      contributed to any State by the Secretary under this section from
      Federal funds for any year shall not exceed 50 per centum of the
      estimated total cost of the cooperative program; and the Federal
      funds shall be allocated among the States desiring to cooperate
      on an equitable basis. Such cooperation and payment shall be
      contingent at all times upon the administration of the State
      program in a manner which the Secretary, in consultation with the
      appropriate advisory committee appointed under subparagraph (4),
      deems adequate to effectuate the purposes of this section.
        (4) The Secretary may appoint advisory committees consisting of
      such representatives of appropriate State agencies as the
      Secretary and the State agencies may designate to consult with
      him concerning State and Federal programs with respect to poultry
      product inspection and other matters within the scope of this
      chapter, including evaluating State programs for purposes of this
      chapter, and obtaining better coordination and more uniformity
      among the State programs and between the Federal and State
      programs and adequate protection of consumers.
    (b) Appropriate State agency; performance of functions by
      subordinate governmental unit
      The appropriate State agency with which the Secretary may
    cooperate under this chapter shall be a single agency in the State
    which is primarily responsible for the coordination of the State
    programs having objectives similar to those under this chapter.
    When the State program includes performance of certain functions by
    a municipality or other subordinate governmental unit, such unit
    shall be deemed to be a part of the State agency for purposes of
    this section.
    (c) Intrastate activities; designation of State for regulation;
      publication of designation; exempted operations; termination of
      designation; review of operations in nondesignated States; annual
      report
      (1) If the Secretary has reason to believe, by thirty days prior
    to the expiration of two years after August 18, 1968, that a State
    has failed to develop or is not enforcing, with respect to all
    establishments within its jurisdiction (except those that would be
    exempted from Federal inspection under subparagraph (2) of this
    paragraph (c)) at which poultry are slaughtered, or poultry
    products are processed for use as human food, solely for
    distribution within such State, and the products of such
    establishments, requirements at least equal to those imposed under
    sections 451 to 453, 455 to 459, 461 to 467d of this title, he
    shall promptly notify the Governor of the State of this fact. If
    the Secretary determines, after consultation with the Governor of
    the State, or representative selected by him, that such
    requirements have not been developed and activated, he shall
    promptly after the expiration of such two-year period designate
    such State as one in which the provisions of said sections of this
    chapter shall apply to operations and transactions wholly within
    such State: Provided, That if the Secretary has reason to believe
    that the State will activate such requirements within one
    additional year, he may delay such designation for said period, and
    not designate the State, if he determines at the end of the year
    that the State then has such requirements in effective operation.
    The Secretary shall publish any such designation in the Federal
    Register and, upon the expiration of thirty days after such
    publication, the provisions of said sections of this chapter shall
    apply to operations and transactions and to persons engaged therein
    in the State to the same extent and in the same manner as if such
    operations and transactions were conducted in or for commerce.
    However, notwithstanding any other provision of this section, if
    the Secretary determines that any establishment within a State is
    producing adulterated poultry products for distribution within such
    State which would clearly endanger the public health he shall
    notify the Governor of the State and the appropriate advisory
    committee provided for by subparagraph (a)(4) of this section of
    such fact for effective action under State or local law. If the
    State does not take action to prevent such endangering of the
    public health within a reasonable time after such notice, as
    determined by the Secretary, in light of the risk to public health,
    the Secretary may forthwith designate any such establishment as
    subject to the provisions of said sections of this chapter, and
    thereupon the establishment and operator thereof shall be subject
    to such provisions as though engaged in commerce until such time as
    the Secretary determines that such State has developed and will
    enforce requirements at least equal to those imposed under said
    sections.
      (2) The provisions of this chapter requiring inspection of the
    slaughter of poultry and the processing of poultry products shall
    not apply to operations of types traditionally and usually
    conducted at retail stores and restaurants, when conducted at any
    retail store or restaurant or similar retail-type establishment for
    sale in normal retail quantities or service of such articles to
    consumers at such establishments if such establishments are subject
    to such inspection provisions only under this paragraph (c). For
    the purposes of this subparagraph, operations conducted at a
    restaurant central kitchen facility shall be considered as being
    conducted at a restaurant if the restaurant central kitchen
    prepares poultry products that are ready to eat when they leave
    such facility and are served in meals or as entrees only to
    customers at restaurants owned or operated by the same person
    owning or operating such facility: Provided, That such facility
    shall be subject to the provisions of section 460(b) of this title:
    Provided further, That the facility may be subject to the
    inspection requirements of this chapter for as long as the
    Secretary deems necessary, if the Secretary determines that the
    sanitary conditions or practices of the facility or the processing
    procedures or methods at the facility are such that any of its
    poultry products are rendered adulterated.
      (3) Whenever the Secretary determines that any State designated
    under this paragraph (c) has developed and will enforce State
    poultry products inspection requirements at least equal to those
    imposed under the aforesaid sections of this chapter, with respect
    to the operations and transactions within such State which are
    regulated under subparagraph (1) of this paragraph (c), he shall
    terminate the designation of such State under this paragraph (c),
    but this shall not preclude the subsequent redesignation of the
    State at any time upon thirty days' notice to the Governor and
    publication in the Federal Register in accordance with this
    paragraph, and any State may be designated upon such notice and
    publication, at any time after the period specified in this
    paragraph whether or not the State has theretofore been designated,
    upon the Secretary determining that it is not effectively enforcing
    requirements at least equal to those imposed under said sections.
      (4) The Secretary shall promptly upon August 18, 1968, and
    periodically thereafter, but at least annually, review the
    requirements, including the enforcement thereof, of the several
    States not designated under this paragraph (c), with respect to the
    slaughter, and the processing, storage, handling, and distribution
    of poultry products, and inspection of such operations, and
    annually report thereon to the Committee on Agriculture of the
    House of Representatives and the Committee on Agriculture,
    Nutrition, and Forestry of the Senate in the report required in
    section 470 (!1) of this title.

    (d) "State" defined
      As used in this section, the term "State" means any State
    (including the Commonwealth of Puerto Rico) or organized territory.

-SOURCE-
    (Pub. L. 85-172, Sec. 5, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90-
    492, Sec. 5, Aug. 18, 1968, 82 Stat. 796; Pub. L. 98-487, Sec. 2,
    Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103-437, Sec. 8(1), Nov. 2,
    1994, 108 Stat. 4588.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 470 of this title, referred to in subsec. (c)(4), was
    omitted from the Code.

-COD-
                               CODIFICATION                           
      In par. (c)(1), (4), "August 18, 1968" substituted for "enactment
    of the Wholesome Poultry Products Act".


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (c)(4). Pub. L. 103-437 substituted "Agriculture,
    Nutrition, and Forestry" for "Agriculture and Forestry".
      1984 - Par. (c)(2). Pub. L. 98-487 inserted provisions relating
    to operations conducted at a restaurant central kitchen facility.
      1968 - Pub. L. 90-492 substituted provisions authorizing the
    Secretary to cooperate with the appropriate state agency in the
    development and administration of state poultry product inspection
    programs in those states having mandatory poultry product
    inspection laws and those states having laws at least equal to the
    provisions of section 460 of this title, provisions authorizing
    planning, technical and financial assistance and the appointment of
    advisory committees, provisions designating the appropriate state
    agency with which the Secretary may cooperate, provisions
    authorizing the Secretary to designate states as subject to the
    regulatory provisions of this chapter when the requirements of the
    specified section have not been complied with or when the specified
    intrastate activities are present, provisions exempting from the
    requirements of this chapter operations of the types traditionally
    and usually conducted at retail stores and restaurants, provisions
    authorizing the Secretary to terminate the aforementioned
    designation of states as subject to the regulatory provisions of
    this chapter, and provisions authorizing the Secretary to review
    the operations in nondesignated states and make an annual report
    thereon, for provisions authorizing the Secretary, upon application
    by any appropriate state or local official or agency or by any
    appropriate local poultry industry group and after public hearing,
    to designate major consuming areas as subject to the regulatory
    provisions of this chapter where the Secretary finds that poultry
    or poultry products are handled or consumed in such volume as to
    affect, burden or obstruct the movement of inspected poultry
    products in interstate commerce.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 455                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 455. Inspection in official establishments

-STATUTE-
    (a) Ante mortem inspection
      For the purpose of preventing the entry into or flow or movement
    in commerce of, or the burdening of commerce by, any poultry
    product which is capable of use as human food and is adulterated,
    the Secretary shall, where and to the extent considered by him
    necessary, cause to be made by inspectors ante mortem inspection of
    poultry in each official establishment processing poultry or
    poultry products for commerce or otherwise subject to inspection
    under this chapter.
    (b) Post mortem inspection; quarantine, segregation, and
      reinspection
      The Secretary, whenever processing operations are being
    conducted, shall cause to be made by inspectors post mortem
    inspection of the carcass of each bird processed, and at any time
    such quarantine, segregation, and reinspection as he deems
    necessary of poultry and poultry products capable of use as human
    food in each official establishment processing such poultry or
    poultry products for commerce or otherwise subject to inspection
    under this chapter.
    (c) Condemnation; appeal; reprocessing
      All poultry carcasses and parts thereof and other poultry
    products found to be adulterated shall be condemned and shall, if
    no appeal be taken from such determination of condemnation, be
    destroyed for human food purposes under the supervision of an
    inspector: Provided, That carcasses, parts, and products, which may
    by reprocessing be made not adulterated, need not be so condemned
    and destroyed if so reprocessed under the supervision of an
    inspector and thereafter found to be not adulterated. If an appeal
    be taken from such determination, the carcasses, parts, or products
    shall be appropriately marked and segregated pending completion of
    an appeal inspection, which appeal shall be at the cost of the
    appellant if the Secretary determines that the appeal is frivolous.
    If the determination of condemnation is sustained the carcasses,
    parts, and products shall be destroyed for human food purposes
    under the supervision of an inspector.

-SOURCE-
    (Pub. L. 85-172, Sec. 6, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90-
    492, Sec. 6, Aug. 18, 1968, 82 Stat. 798.)


-MISC1-
                                AMENDMENTS                            
      1968 - Par. (a). Pub. L. 90-492, Sec. 6(a), substituted "of, or
    the burdening of commerce by, any poultry product which is capable
    of use as human food and is adulterated," for "or a designated
    major consuming area of any poultry product which is unwholesome or
    adulterated," "each official establishment" for "any official
    establishment", and "otherwise subject to inspection under this
    chapter" for "in, or for marketing in a designated city or area".
      Par. (b). Pub. L. 90-492, Sec. 6(b), substituted "segregation,
    and reinspection" for "segregation, reinspection", and "otherwise
    subject to inspection under this chapter" for "in, or for marketing
    in a designated city or area", and inserted "capable of use as
    human food" after "necessary of poultry and poultry products".
      Par. (c). Pub. L. 90-492, Sec. 6(c), inserted "other" before
    "poultry products", and substituted "to be adulterated" for "to be
    unwholesome or adulterated", "made not adulterated" for "made not
    unwholesome and not adulterated", and "to be not adulterated" for
    "to be not unwholesome and not adulterated".

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

    APPLICABILITY OF CHAPTER REQUIREMENTS TO BIRDS OF THE ORDER RATITAE
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 752], Oct. 28, 2000,
    114 Stat. 1549, 1549A-41, provided that: "Effective 180 days after
    the date of the enactment of this Act [Oct. 28, 2000] and
    continuing for the remainder of fiscal year 2001 and each
    subsequent fiscal year, establishments in the United States that
    slaughter or process birds of the order Ratitae, such as ostriches,
    emus and rheas, and squab, for distribution in commerce as human
    food shall be subject to the ante mortem and post mortem
    inspection, reinspection, and sanitation requirements of the
    Poultry Products Inspection Act (21 U.S.C. 451 et seq.) rather than
    the voluntary poultry inspection program of the Department of
    Agriculture under section 203 of the Agricultural Marketing Act of
    1946 (7 U.S.C. 1622)."

-End-



-CITE-
    21 USC Sec. 456                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 456. Operation of premises, facilities and equipment

-STATUTE-
    (a) Sanitary practices
      Each official establishment slaughtering poultry or processing
    poultry products for commerce or otherwise subject to inspection
    under this chapter shall have such premises, facilities, and
    equipment, and be operated in accordance with such sanitary
    practices, as are required by regulations promulgated by the
    Secretary for the purpose of preventing the entry into or flow or
    movement in commerce or burdensome effect upon commerce, of poultry
    products which are adulterated.
    (b) Refusal of inspection
      The Secretary shall refuse to render inspection to any
    establishment whose premises, facilities, or equipment, or the
    operation thereof, fail to meet the requirements of this section.

-SOURCE-
    (Pub. L. 85-172, Sec. 7, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90-
    492, Sec. 7, Aug. 18, 1968, 82 Stat. 799.)


-MISC1-
                                AMENDMENTS                            
      1968 - Par. (a). Pub. L. 90-492 substituted "otherwise subject to
    inspection under this chapter" for "in or for marketing in a
    designated major consuming area", "burdensome effect upon commerce"
    for "in a designated major consuming area", and "which are
    adulterated" for "which are unwholesome or adulterated".

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 457                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 457. Labeling and container standards

-STATUTE-
    (a) Requirements for shipping containers and immediate containers;
      nonconsumer packaged carcasses
      All poultry products inspected at any official establishment
    under the authority of this chapter and found to be not
    adulterated, shall at the time they leave the establishment bear,
    in distinctly legible form, on their shipping containers and
    immediate containers as the Secretary may require, the information
    required under paragraph (h) of section 453 of this title. In
    addition, the Secretary whenever he determines such action is
    practicable and necessary for the protection of the public, may
    require nonconsumer packaged carcasses at the time they leave the
    establishment to bear directly thereon in distinctly legible form
    any information required under such paragraph (h).
    (b) Labeling requirements; definitions and standards of identity or
      composition or articles and standards of fill of container;
      standards consistent with Federal Food, Drug, and Cosmetic Act;
      consistency between Federal and State standards
      The Secretary, whenever he determines such action is necessary
    for the protection of the public, may prescribe: (1) the styles and
    sizes of type to be used with respect to material required to be
    incorporated in labeling to avoid false or misleading labeling in
    marketing and labeling any articles or poultry subject to this
    chapter; (2) definitions and standards of identity or composition
    or articles subject to this chapter and standards of fill of
    container for such articles not inconsistent with any such
    standards established under the Federal Food, Drug, and Cosmetic
    Act [21 U.S.C. 301 et seq.], and there shall be consultation
    between the Secretary and the Secretary of Health and Human
    Services prior to the issuance of such standards under either Act
    relating to articles subject to this chapter to avoid inconsistency
    in such standards and possible impairment of the coordinated
    effective administration of this chapter and the Federal Food,
    Drug, and Cosmetic Act. There shall also be consultation between
    the Secretary and an appropriate advisory committee provided for in
    section 454 of this title, prior to the issuance of such standards
    under this chapter, to avoid, insofar as feasible, inconsistency
    between Federal and State standards.
    (c) Use of trade names; false or misleading marking or labeling;
      misleading form or size of container
      No article subject to this chapter shall be sold or offered for
    sale by any person in commerce, under any name or other marking or
    labeling which is false or misleading, or in any container of a
    misleading form or size, but established trade names and other
    marking and labeling and containers which are not false or
    misleading and which are approved by the Secretary are permitted.
    (d) Withholding use of false or misleading mark, label, or
      container size or form; modification; hearing; conclusiveness of
      determination; appeal
      If the Secretary has reason to believe that any marking or
    labeling or the size or form of any container in use or proposed
    for use with respect to any article subject to this chapter is
    false or misleading in any particular, he may direct that such use
    be withheld unless the marking, labeling, or container is modified
    in such manner as he may prescribe so that it will not be false or
    misleading. If the person using or proposing to use the marketing,
    labeling, or container does not accept the determination of the
    Secretary, such person may request a hearing, but the use of the
    marking, labeling, or container shall, if the Secretary so directs,
    be withheld pending hearing and final determination by the
    Secretary. Any such determination by the Secretary shall be
    conclusive unless, within thirty days after receipt of notice of
    such final determination, the person adversely affected thereby
    appeals to the United States Court of Appeals for the circuit in
    which such person has its principal place of business or to the
    United States Court of Appeals for the District of Columbia
    Circuit. The provisions of section 194 of title 7 shall be
    applicable to appeals taken under this section.

-SOURCE-
    (Pub. L. 85-172, Sec. 8, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90-
    492, Sec. 8, Aug. 18, 1968, 82 Stat. 799; Pub. L. 96-88, title V,
    Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in par.
    (b), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      1968 - Par. (a). Pub. L. 90-492 substituted provisions requiring
    shipping containers and immediate containers, as the Secretary may
    order, to bear the information required under section 453(h) of
    this title, and provisions, whenever the Secretary determines such
    action to be practicable and necessary, requiring nonconsumer
    packaged carcasses at the time they leave the official
    establishment to bear the information required under the
    aforementioned section, for provisions requiring shipping
    containers to bear the official mark and the approved plant number
    of the official establishment in which the contents were processed,
    provisions requiring immediate containers to bear the official
    inspection mark, the name of the product, a statement of
    ingredients, the net weight or other appropriate measure of the
    contents, the name and address of the processor, and the approved
    plant number of the official establishment in which the contents
    were processed, and provisions authorizing the Secretary to make
    reasonable variations and grant exemptions from the foregoing
    labeling requirements.
      Par. (b). Pub. L. 90-492 added par. (b). Provisions of former
    par. (b) were redesignated as pars. (c) and (d).
      Par. (c). Pub. L. 90-492 redesignated part of provisions of
    former par. (b) as (c) and made changes in phraseology.
      Par. (d). Pub. L. 90-492 redesignated part of provisions of
    former par. (b) as (d) and extended the authority of the Secretary
    to withhold from use products which have false or misleading
    markings or containers.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in par. (b) pursuant
    to section 509(b) of Pub. L. 96-88, which is classified to section
    3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 458                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 458. Prohibited acts

-STATUTE-
      (a) No person shall - 
        (1) slaughter any poultry or process any poultry products which
      are capable of use as human food at any establishment processing
      any such articles for commerce, except in compliance with the
      requirements of this chapter;
        (2) sell, transport, offer for sale or transportation, or
      receive for transportation, in commerce, (A) any poultry products
      which are capable of use as human food and are adulterated or
      misbranded at the time of such sale, transportation, offer for
      sale or transportation, or receipt for transportation; or (B) any
      poultry products required to be inspected under this chapter
      unless they have been so inspected and passed;
        (3) do, with respect to any poultry products which are capable
      of use as human food, any act while they are being transported in
      commerce or held for sale after such transportation, which is
      intended to cause or has the effect of causing such products to
      be adulterated or misbranded;
        (4) sell, transport, offer for sale or transportation, or
      receive for transportation, in commerce or from an official
      establishment, any slaughtered poultry from which the blood,
      feathers, feet, head, or viscera have not been removed in
      accordance with regulations promulgated by the Secretary, except
      as may be authorized by regulations of the Secretary;
        (5) use to his own advantage, or reveal other than to the
      authorized representatives of the United States Government or any
      State or other government in their official capacity, or as
      ordered by a court in any judicial proceedings, any information
      acquired under the authority of this chapter concerning any
      matter which is entitled to protection as a trade secret.

      (b) No brand manufacturer, printer, or other person shall cast,
    print, lithograph, or otherwise make any device containing any
    official mark or simulation thereof, or any label bearing any such
    mark or simulation, or any form of official certificate or
    simulation thereof, except as authorized by the Secretary.
      (c) No person shall - 
        (1) forge any official device, mark, or certificate;
        (2) without authorization from the Secretary use any official
      device, mark, or certificate, or simulation thereof, or alter,
      detach, deface, or destroy any official device, mark, or
      certificate;
        (3) contrary to the regulations prescribed by the Secretary,
      fail to use, or to detach, deface, or destroy any official
      device, mark, or certificate;
        (4) knowingly possess, without promptly notifying the Secretary
      or his representative, any official device or any counterfeit,
      simulated, forged, or improperly altered official certificate or
      any device or label or any carcass of any poultry, or part or
      product thereof, bearing any counterfeit, simulated, forged, or
      improperly altered official mark;
        (5) knowingly make any false statement in any shipper's
      certificate or other nonofficial or official certificate provided
      for in the regulations prescribed by the Secretary; or
        (6) knowingly represent that any article has been inspected and
      passed, or exempted, under this chapter when, in fact, it has
      respectively, not been so inspected and passed, or exempted.

-SOURCE-
    (Pub. L. 85-172, Sec. 9, Aug. 28, 1957, 71 Stat. 445; Pub. L. 90-
    492, Sec. 9, Aug. 18, 1968, 82 Stat. 800.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 made revisions in form and phraseology,
    added to the enumerated prohibited acts slaughtering poultry or
    processing any poultry products capable of use as human food,
    except in compliance with the requirements of this chapter, selling
    and transporting adulterated or misbranded poultry products or
    uninspected poultry products, adulterating or misbranding poultry
    products while they are being transported in commerce or held for
    sale after such transportation, treating carcasses not in
    accordance with regulations promulgated by the Secretary,
    possessing, without notifying the Secretary, any official device or
    any counterfeit, simulated, etc., official certificate, or any
    device or label bearing any counterfeit, simulated, etc., official
    mark, and making false representations and statements, and
    clarified application to brand manufacturers and printers of
    existing provisions prohibiting the counterfeiting of official
    marks, labels, or certificates.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, except that
    amendment of pars. (a)(2)(A) and (a)(3) effective upon the
    expiration of sixty days after Aug. 18, 1968, see section 20 of
    Pub. L. 90-492, set out as a note under section 451 of this title.

-End-



-CITE-
    21 USC Sec. 459                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 459. Compliance by all establishments

-STATUTE-
      No establishment processing poultry or poultry products for
    commerce otherwise subject to this chapter shall process any
    poultry or poultry product except in compliance with the
    requirements of this chapter.

-SOURCE-
    (Pub. L. 85-172, Sec. 10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-
    492, Sec. 10, Aug. 18, 1968, 82 Stat. 801.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 substituted "otherwise subject to this
    chapter" for "in or for marketing in a designated major consuming
    area".

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 460                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 460. Miscellaneous activities subject to regulation

-STATUTE-
    (a) Prohibition of inspection of articles not intended for use as
      human food; denaturation or other identification prior to
      distribution in commerce; inedible articles
      Inspection shall not be provided under this chapter at any
    establishment for the slaughter of poultry or the processing of any
    carcasses or parts or products of poultry, which are not intended
    for use as human food, but such articles shall, prior to their
    offer for sale or transportation in commerce, unless naturally
    inedible by humans, be denatured or otherwise identified as
    prescribed by regulations of the Secretary to deter their use for
    human food. No person shall buy, sell, transport, or offer for sale
    or transportation, or receive for transportation, in commerce, or
    import, any poultry carcasses or parts or products thereof which
    are not intended for use as human food unless they are denatured or
    otherwise identified as required by the regulations of the
    Secretary or are naturally inedible by humans.
    (b) Recordkeeping requirements; persons liable; scope of
      disclosure; access to places of business; examination of records,
      facilities, and inventories; copies; samples
      The following classes of persons shall, for such period of time
    as the Secretary may by regulations prescribe, not to exceed two
    years unless otherwise directed by the Secretary for good cause
    shown, keep such records as are properly necessary for the
    effective enforcement of this chapter in order to insure against
    adulterated or misbranded poultry products for the American
    consumer; and all persons subject to such requirements shall, at
    all reasonable times, upon notice by a duly authorized
    representative of the Secretary, afford such representative access
    to their places of business and opportunity to examine the
    facilities, inventory, and records thereof, to copy all such
    records, and to take reasonable samples of their inventory upon
    payment of the fair market value therefor - 
        (1) Any person that engages in the business of slaughtering any
      poultry or processing, freezing, packaging, or labeling any
      carcasses, or parts or products of carcasses, of any poultry, for
      commerce, for use as human food or animal food;
        (2) Any person that engages in the business of buying or
      selling (as poultry products brokers, wholesalers or otherwise),
      or transporting, in commerce, or storing in or for commerce, or
      importing, any carcasses, or parts or products of carcasses, of
      any poultry;
        (3) Any person that engages in business, in or for commerce, as
      a renderer, or engages in the business of buying, selling, or
      transporting, in commerce, or importing, any dead, dying,
      disabled, or diseased poultry or parts of the carcasses of any
      poultry that died otherwise than by slaughter.
    (c) Registration of business, name of person, and trade names
      No person shall engage in business, in or for commerce, as a
    poultry products broker, renderer, or animal food manufacturer, or
    engage in business in commerce as a wholesaler of any carcasses, or
    parts or products of the carcasses, of any poultry, whether
    intended for human food or other purposes, or engage in business as
    a public warehouseman storing any such articles in or for commerce,
    or engage in the business of buying, selling, or transporting in
    commerce, or importing, any dead, dying, disabled, or diseased
    poultry, or parts of the carcasses of any poultry that died
    otherwise than by slaughter, unless when required by regulations of
    the Secretary, he has registered with the Secretary his name, and
    the address of each place of business at which, and all trade names
    under which, he conducts such business.
    (d) Regulation of transactions, transportation, or importation of
      dead, dying, disabled or diseased poultry or carcasses to prevent
      use as human food
      No person engaged in the business of buying, selling, or
    transporting in commerce, or importing, dead, dying, disabled, or
    diseased poultry, or any parts of the carcasses of any poultry that
    died otherwise than by slaughter, shall buy, sell, transport, offer
    for sale or transportation, or receive for transportation, in
    commerce, or import, any dead, dying, disabled, or diseased poultry
    or parts of the carcasses of any poultry that died otherwise than
    by slaughter, unless such transaction, transportation or
    importation is made in accordance with such regulations as the
    Secretary may prescribe to assure that such poultry, or the
    unwholesome parts or products thereof, will be prevented from being
    used for human food.
    (e) Federal provisions applicable to State or Territorial business
      transactions of a local nature and not subject to local authority
      The authority conferred on the Secretary by paragraph (b), (c),
    or (d) of this section with respect to persons engaged in the
    specified kinds of business in or for commerce may be exercised
    with respect to persons engaged, in any State or organized
    territory, in such kinds of business but not in or for commerce,
    whenever the Secretary determines, after consultation with an
    appropriate advisory committee provided for in section 454 of this
    title, that the State or territory does not have at least equal
    authority under its laws or such authority is not exercised in a
    manner to effectuate the purposes of this chapter, including the
    State or territory providing for the Secretary or his
    representative being afforded access to such places of business and
    the facilities, inventories, and records thereof, and the taking of
    reasonable samples, where he determines necessary in carrying out
    his responsibilities under this chapter; and in such case the
    provisions of paragraph (b), (c), or (d) of this section,
    respectively, shall apply to such persons to the same extent and in
    the same manner as if they were engaged in such business in or for
    commerce and the transactions involved were in commerce.

-SOURCE-
    (Pub. L. 85-172, Sec. 11, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-
    492, Sec. 11, Aug. 18, 1968, 82 Stat. 801.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 designated existing provisions as par. (b),
    added pars. (a), and (c) to (e), and in par. (b), as so designated,
    extended the types of persons required to maintain records
    necessary for the enforcement of this chapter, required such
    persons to give representatives of the Secretary access to their
    places of business, and opportunity to examine records, facilities,
    and inventories and to copy records and take inventory samples upon
    payment.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, except that
    par. (d) effective upon the expiration of sixty days after Aug. 18,
    1968, see section 20 of Pub. L. 90-492, set out as a note under
    section 451 of this title.

-End-



-CITE-
    21 USC Sec. 461                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 461. Offenses and punishment

-STATUTE-
    (a) Violations; liability of agents, employees, and employers
      Any person who violates the provisions of section 458, 459, 460,
    463, or 466 of this title shall be fined not more than $1,000 or
    imprisoned not more than one year, or both; but if such violation
    involves intent to defraud, or any distribution or attempted
    distribution of an article that is adulterated (except as defined
    in section 453(g)(8) of this title), such person shall be fined not
    more than $10,000 or imprisoned not more than three years, or both.
    When construing or enforcing the provisions of said sections the
    act, omission, or failure of any person acting for or employed by
    any individual, partnership, corporation, or association within the
    scope of his employment or office shall in every case be deemed the
    act, omission, or failure of such individual, partnership,
    corporation, or association, as well as of such person.
    (b) Liability of carrier
      No carrier shall be subject to the penalties of this chapter,
    other than the penalties for violation of section 460 of this
    title, by reason of his receipt, carriage, holding, or delivery, in
    the usual course of business, as a carrier, of poultry or poultry
    products, owned by another person unless the carrier has knowledge,
    or is in possession of facts which would cause a reasonable person
    to believe that such poultry or poultry products were not inspected
    or marked in accordance with the provisions of this chapter or were
    otherwise not eligible for transportation under this chapter or
    unless the carrier refuses to furnish on request of a
    representative of the Secretary the name and address of the person
    from whom he received such poultry or poultry products, and copies
    of all documents, if any there be, pertaining to the delivery of
    the poultry or poultry products to such carrier.
    (c) Assaulting, resisting, or impeding certain persons; murder;
      punishments
      Any person who forcibly assaults, resists, opposes, impedes,
    intimidates, or interferes with any person while engaged in or on
    account of the performance of his official duties under this
    chapter shall be fined not more than $5,000 or imprisoned not more
    than three years, or both. Whoever, in the commission of any such
    acts, uses a deadly or dangerous weapon, shall be fined not more
    than $10,000 or imprisoned not more than ten years, or both.
    Whoever kills any person while engaged in or on account of the
    performance of his official duties under this chapter shall be
    punished as provided under sections 1111 and 1114 of title 18.

-SOURCE-
    (Pub. L. 85-172, Sec. 12, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-
    492, Sec. 12, Aug. 18, 1968, 82 Stat. 802.)


-MISC1-
                                AMENDMENTS                            
      1968 - Par. (a). Pub. L. 90-492, Sec. 12(a), inserted reference
    to violations of section 463 of this title, and substituted
    provisions that violators of the enumerated sections shall be fined
    not more than $1,000 or imprisoned not more than one year, or both,
    but that in cases involving intent to defraud, or any distribution
    or attempt to distribute adulterated articles, except as defined in
    section 453(g) of this title, the violators shall be fined not more
    than $10,000 or imprisoned not more than three years, or both, for
    provisions that violators shall be guilty of a misdemeanor and
    subject to imprisonment for not more than six months or a fine of
    not more than $3,000, or both, with increased fines and
    imprisonment for any subsequent violations.
      Par. (b). Pub. L. 90-492, Sec. 12(b), substituted "of poultry"
    for "of slaughtered poultry", "such poultry" for "such slaughtered
    poultry", and "otherwise not eligible" for "not otherwise
    eligible", and inserted provision that no carrier shall be subject
    to punishment unless the carrier refuses to furnish the name and
    address of the person from whom he received such poultry or poultry
    products, and copies of any documents pertaining to the delivery of
    the poultry or poultry products to such carrier.
      Par. (c). Pub. L. 90-492, Sec. 12(c), added par. (c).

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 462                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 462. Reporting of violations; notice; opportunity to present
      views

-STATUTE-
      Before any violation of this chapter is reported by the Secretary
    to any United States attorney for institution of a criminal
    proceeding, the person against whom such proceeding is contemplated
    shall be given reasonable notice of the alleged violation and
    opportunity to present his views orally or in writing with regard
    to such contemplated proceeding. Nothing in this chapter shall be
    construed as requiring the Secretary to report for criminal
    prosecution violations of this chapter whenever he believes that
    the public interest will be adequately served and compliance with
    the chapter obtained by a suitable written notice or warning.

-SOURCE-
    (Pub. L. 85-172, Sec. 13, Aug. 28, 1957, 71 Stat. 447.)

-End-



-CITE-
    21 USC Sec. 463                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 463. Rules and regulations

-STATUTE-
    (a) Storage and handling of poultry products; violation of
      regulations
      The Secretary may by regulations prescribe conditions under which
    poultry products capable of use as human food, shall be stored or
    otherwise handled by any person engaged in the business of buying,
    selling, freezing, storing, or transporting, in or for commerce, or
    importing, such articles, whenever the Secretary deems such action
    necessary to assure that such articles will not be adulterated or
    misbranded when delivered to the consumer. Violation of any such
    regulation is prohibited.
    (b) Other necessary rules and regulations
      The Secretary shall promulgate such other rules and regulations
    as are necessary to carry out the provisions of this chapter.
    (c) Oral presentation of views
      In applying the provisions of section 553(c) of title 5 to
    proposed rule making under this chapter, an opportunity for the
    oral presentation of views shall be accorded all interested
    persons.

-SOURCE-
    (Pub. L. 85-172, Sec. 14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90-
    492, Sec. 13, Aug. 18, 1968, 82 Stat. 803.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 designated existing provisions as par. (b),
    added pars. (a) and (c), and in par. (b), as so designated,
    substituted "such other rules" for "such rules".

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 464                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 464. Exemptions

-STATUTE-
    (a) Persons exempted
      The Secretary shall, by regulation and under such conditions as
    to sanitary standards, practices, and procedures as he may
    prescribe, exempt from specific provisions of this chapter - 
        (1) retail dealers with respect to poultry products sold
      directly to consumers in individual retail stores, if the only
      processing operation performed by such retail dealers is the
      cutting up of poultry products on the premises where such sales
      to consumers are made;
        (2) for such period of time as the Secretary determines that it
      would be impracticable to provide inspection and the exemption
      will aid in the effective administration of this chapter, any
      person engaged in the processing of poultry or poultry products
      for commerce and the poultry or poultry products processed by
      such person: Provided, however, That no such exemption shall
      continue in effect on and after January 1, 1970; and
        (3) persons slaughtering, processing, or otherwise handling
      poultry or poultry products which have been or are to be
      processed as required by recognized religious dietary laws, to
      the extent that the Secretary determines necessary to avoid
      conflict with such requirements while still effectuating the
      purposes of this chapter.
    (b) Territorial exemption
      The Secretary may, under such sanitary conditions as he may by
    regulations prescribe, exempt from the inspection requirements of
    this chapter the slaughter of poultry, and the processing of
    poultry products, by any person in any Territory not organized with
    a legislative body, solely for distribution within such Territory,
    when the Secretary determines that it is impracticable to provide
    such inspection within the limits of funds appropriated for
    administration of this chapter and that such exemption will aid in
    the effective administration of this chapter.
    (c) Personal slaughtering; custom slaughtering; name and address of
      the poultry producer or processor in lieu of other labeling
      requirements; small enterprises; slaughterers or processors of
      specified number of turkeys; poultry producers raising poultry on
      own farms
      (1) The Secretary shall, by regulation and under such conditions,
    including sanitary standards, practices, and procedures, as he may
    prescribe, exempt from specific provisions of this chapter - 
        (A) the slaughtering by any person of poultry of his own
      raising, and the processing by him and transportation in commerce
      of the poultry products exclusively for use by him and members of
      his household and his nonpaying guests and employees;
        (B) the custom slaughter by any person of poultry delivered by
      the owner thereof for such slaughter, and the processing by such
      slaughterer and transportation in commerce of the poultry
      products exclusively for use, in the household of such owner, by
      him and members of his household and his nonpaying guests and
      employees: Provided, That such custom slaughterer does not engage
      in the business of buying or selling any poultry products capable
      of use as human food;
        (C) the slaughtering and processing of poultry products in any
      State or Territory or the District of Columbia by any poultry
      producer on his own premises with respect to sound and healthy
      poultry raised on his premises and the distribution by any person
      solely within such jurisdiction of the poultry products derived
      from such operations, if, in lieu of other labeling requirements,
      such poultry products are identified with the name and address of
      such poultry producer, and if they are not otherwise misbranded,
      and are sound, clean, and fit for human food when so distributed;
      and
        (D) the slaughtering of sound and healthy poultry or the
      processing of poultry products of such poultry in any State or
      territory or the District of Columbia by any poultry producer or
      other person for distribution by him solely within such
      jurisdiction directly to household consumers, restaurants,
      hotels, and boarding houses, for use in their own dining rooms,
      or in the preparation of meals for sales direct to consumers, if,
      in lieu of other labeling requirements, such poultry products are
      identified with the name and address of the processor, and if
      they are not otherwise misbranded and are sound, clean, and fit
      for human food when distributed by such processor.

    The exemptions provided for in clauses (C) and (D) above shall not
    apply if the poultry producer or other person engages in the
    current calendar year in the business of buying or selling any
    poultry or poultry products other than as specified in such
    clauses.
      (2) In addition to the specific exemptions provided herein, the
    Secretary shall, when he determines that the protection of
    consumers from adulterated or misbranded poultry products will not
    be impaired by such action, provide by regulation, consistent with
    subparagraph (3), for the exemption of the operation and products
    of small enterprises (including poultry producers), not exempted
    under subparagraph (1), which are engaged in any State or Territory
    or the District of Columbia in slaughtering and/or cutting up
    poultry for distribution as carcasses or parts thereof solely for
    distribution within such jurisdiction, from such provisions of this
    chapter as he deems appropriate, while still protecting the public
    from adulterated or misbranded products, under such conditions,
    including sanitary requirements, as he shall prescribe to
    effectuate the purposes of this chapter.
      (3) No exemption under subparagraph (1)(C) or (D) or subparagraph
    (2) shall apply to any poultry producer or other person who, in the
    current calendar year - 
        (A) slaughters or processes the products of more than 20,000
      poultry; or
        (B) slaughters or processes the products of poultry at a
      facility used for slaughtering or processing of the products of
      poultry by any other poultry producer or person.

    Notwithstanding clause (B), the Secretary may grant such exemption
    to any poultry producer or other person if the Secretary
    determines, upon application of such poultry producer or other
    person, that granting such exemption will not impair effectuating
    the purposes of this chapter.
      (4) The provisions of this chapter shall not apply to poultry
    producers with respect to poultry of their own raising on their own
    farms if (i) such producers slaughter not more than 1,000 poultry
    during the calendar year for which this exemption is being
    determined; (ii) such poultry producers do not engage in buying or
    selling poultry products other than those produced from poultry
    raised on their own farms; and (iii) none of such poultry moves in
    commerce (as defined in section 453(a) of this title).
    (d) Pizzas containing poultry products
      (1) Under such terms and conditions as the Secretary shall
    prescribe through rules and regulations issued under this section
    that may be necessary to ensure food safety and protect public
    health such as special handling procedures, the Secretary shall
    exempt pizzas containing a poultry product from the inspection
    requirements of this chapter if - 
        (A) the poultry product components of the pizzas have been
      prepared, inspected, and passed in a cured or cooked form as
      ready-to-eat in compliance with the requirements of this chapter;
      and
        (B) the pizzas are to be served in public or private nonprofit
      institutions.

      (2) The Secretary may withdraw or modify any exemption under this
    subsection whenever the Secretary determines such action is
    necessary to ensure food safety and to protect public health. The
    Secretary may reinstate or further modify any exemption withdrawn
    or modified under this subsection.
    (e) Applicability of adulteration and misbranding provisions to
      articles exempted from inspection
      The adulteration and misbranding provisions of this chapter,
    other than the requirement of the inspection legend, shall apply to
    articles which are exempted from inspection under this section,
    except as otherwise specified under paragraphs (a) and (d).
    (f) Suspension or termination of exemption
      The Secretary may by order suspend or terminate any exemption
    under this section with respect to any person whenever he finds
    that such action will aid in effectuating the purposes of this
    chapter.

-SOURCE-
    (Pub. L. 85-172, Sec. 15, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90-
    492, Sec. 14, Aug. 18, 1968, 82 Stat. 803; Pub. L. 97-206, June
    30, 1982, 96 Stat. 136; Pub. L. 102-237, title X, Sec. 1016(b),
    Dec. 13, 1991, 105 Stat. 1903.)


-MISC1-
                                AMENDMENTS                            
      1991 - Subsecs. (d) to (f). Pub. L. 102-237 added subsec. (d),
    redesignated former subsec. (d) as (e) and substituted "(d)" for
    "(c)", and redesignated former subsec. (e) as (f).
      1982 - Par. (c)(3). Pub. L. 97-206, Sec. 1, substituted
    provisions that no exemption would be given to persons who during
    the current calendar year either slaughter or process the products
    of more than 20,000 poultry, or slaughter or process such poultry
    at a facility of another poultry producer or person, but that, in
    the latter case, the Secretary may grant the exemption upon
    application of such poultry producer or person if granting such
    exemption would not impair the purposes of this chapter, for
    provisions that an exemption would not be granted to those who
    slaughter or process the products of more than 5,000 turkeys or an
    equivalent number of poultry of all species in the current calendar
    year (four birds of other species being deemed equivalent of one
    turkey).
      Par. (c)(4)(i). Pub. L. 97-206, Sec. 2, substituted "1,000
    poultry during the calendar year for which this exemption is being
    determined" for "250 turkeys, or not more than an equivalent number
    of birds of all species during the calendar year for which this
    exemption is being determined (four birds of other species being
    deemed the equivalent of one turkey)".
      1968 - Par. (a). Pub. L. 90-492, Sec. 14(a), (b), redesignated
    subpars. (2) to (4) as (1) to (3), respectively, and in subpar.
    (2), as so redesignated, substituted "January 1, 1970" for "July 1,
    1960". Former subpar. (1), which exempted poultry producers with
    respect to poultry of their own raising on their own farms which
    they sold directly to household consumers, hotels, etc., for use in
    their own dining rooms or in the preparation of meals for sales
    direct to consumers only, provided that such producers did not
    engage in buying or selling poultry products other than those
    produced from poultry raised on their own farms, was struck out.
      Pars. (b) to (e). Pub. L. 90-492, Sec. 14(c), added pars. (b) to
    (d) and redesignated former par. (b) as (e).

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective upon the expiration of
    sixty days after Aug. 18, 1968, see section 20(b) of Pub. L. 90-
    492, set out as a note under section 451 of this title.

                                REGULATIONS                            
      Section 1016(c) of Pub. L. 102-237 provided that: "No later than
    August 1, 1992, the Secretary of Agriculture shall issue final
    rules, through prior notice and comment rulemaking procedures, to
    implement the exemption authorized by section 23(c) of the Federal
    Meat Inspection Act [21 U.S.C. 623(c)] (as added by subsection (a))
    and the exemption authorized by section 15(d) of the Poultry
    Products Inspection Act [21 U.S.C. 464(d)] (as added by subsection
    (b)). Prior to the issuance of the final rules, the Secretary shall
    hold at least one public hearing examining the public health and
    food safety issues raised by the granting of each of the
    exemptions."

    STUDIES CONCERNING GRANT OF FUTURE EXEMPTIONS FOR POULTRY AND MEAT
                               FOOD PRODUCTS
      Section 1016(d) of Pub. L. 102-237 directed Secretary of
    Agriculture in consultation with National Academy of Sciences to
    conduct a study on meat food and poultry products inspection
    exemptions under Federal Meat Inspection Act and Poultry Products
    Inspection Act and a study on an exemption from requirements of
    such Acts for certain wholesale meat outlets selling to hotels and
    other similar institutional users not later than 24 months after
    Dec. 13, 1991, and on completion of each study to provide the
    results to Committee on Agriculture of House of Representatives and
    Committee on Agriculture, Nutrition, and Forestry of Senate.

-End-



-CITE-
    21 USC Sec. 465                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 465. Limitations upon entry of poultry products and other
      materials into official establishments

-STATUTE-
      The Secretary may limit the entry of poultry products and other
    materials into any official establishment, under such conditions as
    he may prescribe to assure that allowing the entry of such articles
    into such inspected establishments will be consistent with the
    purposes of this chapter.

-SOURCE-
    (Pub. L. 85-172, Sec. 16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90-
    492, Sec. 15, Aug. 18, 1968, 82 Stat. 805.)


-MISC1-
                                AMENDMENTS                            
      1968 - Pub. L. 90-492 substituted provisions authorizing the
    Secretary to limit the entry of poultry products and other
    materials into any official establishment for provisions that any
    person distributing unwholesome or adulterated exempted poultry or
    poultry products intended for human consumption shall be guilty of
    a misdemeanor and subject to penalties upon conviction thereof.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 466                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 466. Imports

-STATUTE-
    (a) Compliance with standards and regulations; status after
      importation
      No slaughtered poultry, or parts or products thereof, of any kind
    shall be imported into the United States unless they are healthful,
    wholesome, fit for human food, not adulterated, and contain no dye,
    chemical, preservative, or ingredient which renders them
    unhealthful, unwholesome, adulterated, or unfit for human food and
    unless they also comply with the rules and regulations made by the
    Secretary of Agriculture to assure that imported poultry or poultry
    products comply with the standards provided for in this chapter.
    All imported, slaughtered poultry, or parts or products thereof,
    shall after entry into the United States in compliance with such
    rules and regulations be deemed and treated as domestic slaughtered
    poultry, or parts or products thereof, within the meaning and
    subject to the provisions of this chapter and the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and Acts amendatory
    of, supplemental to, or in substitution for such chapter and Act.
    (b) Rules and regulations; destruction and exportation of refused
      imports
      The Secretary of Agriculture is authorized to make rules and
    regulations to carry out the purposes of this section and in such
    rules and regulations the Secretary of Agriculture may prescribe
    the terms and conditions for the destruction of all slaughtered
    poultry, or parts or products thereof, offered for entry and
    refused admission into the United States unless such slaughtered
    poultry, or parts or products thereof, be exported by the consignee
    within the time fixed therefor in such rules and regulations.
    (c) Storage, cartage and labor charges for imports refused
      admission
      All charges for storage, cartage, and labor with respect to any
    product which is refused admission pursuant to this section shall
    be paid by the owner or consignee, and in default of such payment
    shall constitute a lien against any other products imported
    thereafter by or for such owner or consignee.
    (d) Domestic standards and processing facilities applicable;
      enforcement
      (1) Notwithstanding any other provision of law, all poultry, or
    parts or products of poultry, capable of use as human food offered
    for importation into the United States shall - 
        (A) be subject to inspection, sanitary, quality, species
      verification, and residue standards that achieve a level of
      sanitary protection equivalent to that achieved under United
      States standards; and
        (B) have been processed in facilities and under conditions that
      achieve a level of sanitary protection equivalent to that
      achieved under United States standards.

      (2)(A) The Secretary may treat as equivalent to a United States
    standard a standard of an exporting country described in paragraph
    (1) if the exporting country provides the Secretary with scientific
    evidence or other information, in accordance with risk assessment
    methodologies determined appropriate by the Secretary, to
    demonstrate that the standard of the exporting country achieves the
    level of sanitary protection achieved under the United States
    standard. For the purposes of this subsection, the term "sanitary
    protection" means protection to safeguard public health.
      (B) The Secretary may - 
        (i) determine, on a scientific basis, that the standard of the
      exporting country does not achieve the level of protection that
      the Secretary considers appropriate; and
        (ii) provide the basis for the determination in writing to the
      exporting country on request.

      (3) Any such imported poultry article that does not meet such
    standards shall not be permitted entry into the United States.
      (4) The Secretary shall enforce this subsection through - 
        (A) random inspections for such species verification and for
      residues; and
        (B) random sampling and testing of internal organs and fat of
      carcasses for residues at the point of slaughter by the exporting
      country, in accordance with methods approved by the Secretary.

-SOURCE-
    (Pub. L. 85-172, Sec. 17, Aug. 28, 1957, 71 Stat. 448; Pub. L. 99-
    198, title XVII, Sec. 1701(a), Dec. 23, 1985, 99 Stat. 1633; Pub.
    L. 103-182, title III, Sec. 361(e), Dec. 8, 1993, 107 Stat. 2123;
    Pub. L. 103-465, title IV, Sec. 431(k), Dec. 8, 1994, 108 Stat.
    4969.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (d)(1). Pub. L. 103-465, Sec. 431(k)(1), amended
    par. (1) generally. Prior to amendment, par. (1) read as follows:
    "Notwithstanding any other provision of law, except as provided in
    paragraph (2), all poultry, or parts or products thereof, capable
    of use as human food offered for importation into the United States
    shall - 
        "(A) be subject to the same inspection, sanitary, quality,
      species verification, and residue standards applied to products
      produced in the United States; and
        "(B) have been processed in facilities and under conditions
      that are the same as those under which similar products are
      processed in the United States."
      Subsec. (d)(2)(A). Pub. L. 103-465, Sec. 431(k)(2)(A), amended
    subpar. (A) generally. Prior to amendment, subpar. (A) read as
    follows: "Notwithstanding any other provision of law, all poultry,
    or parts or products of poultry, capable of use as human food
    offered for importation into the United States from Canada and
    Mexico shall - 
        "(i) comply with paragraph (1); or
        "(ii)(I) be subject to inspection, sanitary, quality, species
      verification, and residue standards that are equivalent to United
      States standards; and
        "(II) have been processed in facilities and under conditions
      that meet standards that are equivalent to United States
      standards."
      Subsec. (d)(2)(B), (C). Pub. L. 103-465, Sec. 431(k)(2)(B), (C),
    redesignated subpar. (C) as (B) and struck out former subpar. (B)
    which read as follows: "The Secretary may treat as equivalent to a
    United States standard a standard of Canada or Mexico described in
    subparagraph (A)(ii) if the exporting country provides the
    Secretary with scientific evidence or other information, in
    accordance with risk assessment methodologies agreed to by the
    Secretary and the exporting country, to demonstrate that the
    standard of the exporting country achieves the level of protection
    that the Secretary considers appropriate."
      1993 - Subsec. (d). Pub. L. 103-182, in par. (1), inserted
    "except as provided in paragraph (2)," before "all poultry" in
    introductory provisions, added par. (2), and redesignated former
    pars. (2) and (3) as (3) and (4), respectively.
      1985 - Par. (d). Pub. L. 99-198 added par. (d).

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by Pub. L. 103-465 effective, except as otherwise
    provided, on the date of entry into force of the World Trade
    Organization Agreement with respect to the United States [Jan. 1,
    1995], see section 451 of Pub. L. 103-465, set out as an Effective
    Date note under section 3601 of Title 19, Customs Duties.

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Section 1701(b) of Pub. L. 99-198 proved that: "The amendment
    made by this section [amending this section] shall become effective
    6 months after the date of enactment of this Act [Dec. 23, 1985]."

-End-



-CITE-
    21 USC Sec. 467                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467. Inspection services

-STATUTE-
    (a) Refusal or withdrawal; hearing; business unfitness based upon
      certain convictions; persons responsibly connected with the
      business
      The Secretary may (for such period, or indefinitely, as he deems
    necessary to effectuate the purposes of this chapter) refuse to
    provide, or withdraw, inspection service under this chapter with
    respect to any establishment if he determines, after opportunity
    for a hearing is accorded to the applicant for, or recipient of,
    such service, that such applicant or recipient is unfit to engage
    in any business requiring inspection upon this chapter because the
    applicant or recipient or anyone responsibly connected with the
    applicant or recipient, has been convicted, in any Federal or State
    court, within the previous ten years of (1) any felony or more than
    one misdemeanor under any law based upon the acquiring, handling,
    or distributing of adulterated, mislabeled, or deceptively packaged
    food or fraud in connection with transactions in food; or (2) any
    felony, involving fraud, bribery, extortion, or any other act or
    circumstances indicating a lack of the integrity needed for the
    conduct of operations affecting the public health. For the purpose
    of this paragraph a person shall be deemed to be responsibly
    connected with the business if he was a partner, officer, director,
    holder, or owner of 10 per centum or more of its voting stock or
    employee in a managerial or executive capacity.
    (b) Hearing to determine validity of withdrawal or refusal of
      inspection services; continuation of withdrawal or refusal
      Upon the withdrawal of inspection service from any official
    establishment for failure to destroy condemned poultry products as
    required under section 455 of this title, or other failure of an
    official establishment to comply with the requirements as to
    premises, facilities, or equipment, or the operation thereof, as
    provided in section 456 of this title, or the refusal of inspection
    service to any applicant therefor because of failure to comply with
    any requirements under section 456 of this title, the applicant
    for, or recipient of, the service shall, upon request, be afforded
    opportunity for a hearing with respect to the merits or validity of
    such action; but such withdrawal or refusal shall continue in
    effect unless otherwise ordered by the Secretary.
    (c) Finality and conclusiveness of determination; judicial review;
      record
      The determination and order of the Secretary when made after
    opportunity for hearing, with respect to withdrawal or refusal of
    inspection service under this chapter shall be final and conclusive
    unless the affected applicant for, or recipient of, inspection
    service files application for judicial review within thirty days
    after the effective date of such order in the United States Court
    of Appeals as provided in section 457 of this title. Judicial
    review of any such order shall be upon the record upon which the
    determination and order are based. The provisions of section 194 of
    title 7 shall be applicable to appeals taken under this section.

-SOURCE-
    (Pub. L. 85-172, Sec. 18, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90-
    492, Sec. 16, Aug. 18, 1968, 82 Stat. 805.)


-MISC1-
                                AMENDMENTS                            
      1968 - Par. (a). Pub. L. 90-492 substituted provisions
    authorizing the Secretary to refuse or withdraw inspection services
    subsequent to a hearing determining that the applicant or recipient
    is unfit to engage in any business requiring inspection under this
    chapter based upon the specified considerations, for provisions
    granting the Secretary exclusive jurisdiction within the scope of
    this chapter and exempting poultry and poultry products from the
    provisions of the Federal Food, Drug, and Cosmetic Act, as amended,
    to the extent of the application or the extension thereof of the
    provisions of this chapter.
      Par. (b). Pub. L. 90-492 substituted provisions granting a
    hearing, upon request by the applicant or recipient, to determine
    the merits and validity of the withdrawal or refusal of inspection
    services and continuing such withdrawal or refusal in effect,
    unless otherwise ordered by the Secretary, for provisions
    authorizing the Secretary to cooperate with other branches of
    government and with State agencies and to conduct examinations,
    investigations, and inspections through any officer or employee of
    a State commissioned by the Secretary for such purpose.
      Par. (c). Pub. L. 90-492 added par. (c).

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
    20 of Pub. L. 90-492, set out as a note under section 451 of this
    title.

-End-



-CITE-
    21 USC Sec. 467a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467a. Administrative detention; duration; pending judicial
      proceedings; notification of government authorities; release;
      removal of official marks

-STATUTE-
      Whenever any poultry product, or any product exempted from the
    definition of a poultry product, or any dead, dying, disabled, or
    diseased poultry is found by any authorized representative of the
    Secretary upon any premises where it is held for purposes of, or
    during or after distribution in, commerce or otherwise subject to
    this chapter, and there is reason to believe that any such article
    is adulterated or misbranded and is capable of use as human food,
    or that it has not been inspected, in violation of the provisions
    of this chapter or of any other Federal law or the laws of any
    State or Territory, or the District of Columbia, or that it has
    been or is intended to be, distributed in violation of any such
    provisions, it may be detained by such representative for a period
    not to exceed twenty days, pending action under section 467b of
    this title or notification of any Federal, State, or other
    governmental authorities having jurisdiction over such article or
    poultry, and shall not be moved by any person, from the place at
    which it is located when so detained, until released by such
    representative. All official marks may be required by such
    representative to be removed from such article or poultry before it
    is released unless it appears to the satisfaction of the Secretary
    that the article or poultry is eligible to retain such marks.

-SOURCE-
    (Pub. L. 85-172, Sec. 19, as added Pub. L. 90-492, Sec. 17, Aug.
    18, 1968, 82 Stat. 805.)

-End-



-CITE-
    21 USC Sec. 467b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467b. Seizure and condemnation

-STATUTE-
    (a) Proceedings in rem; libel of information; jurisdiction;
      disposal by destruction or sale; proceeds into the Treasury;
      sales restrictions; bonds; court costs and fees, storage, and
      other expenses against claimants; jury trial; United States as
      plaintiff
      (1) Any poultry product, or any dead, dying, disabled, or
    diseased poultry, that is being transported in commerce or
    otherwise subject to this chapter, or is held for sale in the
    United States after such transportation, and that (A) is or has
    been processed, sold, transported, or otherwise distributed or
    offered or received for distribution in violation of this chapter,
    or (B) is capable of use as human food and is adulterated or
    misbranded, or (C) in any other way is in violation of this
    chapter, shall be liable to be proceeded against and seized and
    condemned, at any time, on a libel of information in any United
    States district court or other proper court as provided in section
    467c of this title within the jurisdiction of which the article or
    poultry is found.
      (2) If the article or poultry is condemned it shall, after entry
    of the decree, (A) be distributed in accordance with paragraph (5),
    or (B) be disposed of by destruction or sale as the court may
    direct and the proceeds, if sold, less the court costs and fees,
    and storage and other proper expenses, shall be paid into the
    Treasury of the United States, but the article or poultry shall not
    be sold contrary to the provisions of this chapter, or the laws of
    the jurisdiction in which it is sold: Provided, That upon the
    execution and delivery of a good and sufficient bond conditioned
    that the article or poultry shall not be sold or otherwise disposed
    of contrary to the provisions of this chapter, or the laws of the
    jurisdiction in which disposal is made, the court may direct that
    such article or poultry be delivered to the owner thereof subject
    to such supervision by authorized representatives of the Secretary
    as is necessary to insure compliance with the applicable laws.
      (3) When a decree of condemnation is entered against the article
    or poultry and it is released under bond, or destroyed, court costs
    and fees, and storage and other proper expenses shall be awarded
    against the person, if any, intervening as claimant of the article
    or poultry.
      (4) The proceedings in such libel cases shall conform, as nearly
    as may be, to the proceedings in admiralty, except that either
    party may demand trial by jury of any issue of fact joined in any
    case, and all such proceedings shall be at the suit of and in the
    name of the United States.
      (5)(A) An article that is condemned under paragraph (1) may as
    the court may direct, after entry of the decree, be distributed
    without charge to nonprofit, private entities or to Federal, State,
    or local government entities engaged in the distribution of food
    without charge to individuals, if such article - 
        (i) is capable of use as a human food;
        (ii) has been inspected under this chapter and found to be
      wholesome and not to be adulterated within the meaning of
      paragraphs (1) through (7) of section 453(g) of this title and a
      determination is made at the time of the entry of the decree that
      such article is wholesome and not so adulterated; and
        (iii) is plainly marked "Not for Sale" on such article or its
      container.

      (B) The United States may not be held legally responsible for any
    article that is distributed under subparagraph (A) to a nonprofit,
    private entity or to a Federal, State, or local government entity,
    if such article - 
        (i) was found after inspection under this chapter to be
      wholesome and not adulterated within the meaning of paragraphs
      (1) through (7) of section 453(g) of this title and a
      determination was made at the time of the entry of the decree
      that such article was wholesome and not so adulterated; and
        (ii) was plainly marked "Not for Sale" on such article or its
      container.

      (C) The person from whom such article was seized and condemned
    may not be held legally responsible for such article, if such
    article - 
        (i) was found after inspection under this chapter to be
      wholesome and not adulterated within the meaning of paragraphs
      (1) through (7) of section 453(g) of this title and a
      determination was made at the time of entry of the decree that
      such article was wholesome and not so adulterated; and
        (ii) was plainly marked "Not for Sale" on such article or its
      container.
    (b) Condemnation or seizure under other provisions unaffected
      The provisions of this section shall in no way derogate from
    authority for condemnation or seizure conferred by other provisions
    of this chapter, or other laws.

-SOURCE-
    (Pub. L. 85-172, Sec. 20, as added Pub. L. 90-492, Sec. 17, Aug.
    18, 1968, 82 Stat. 806; amended Pub. L. 101-205, Sec. 2, Dec. 7,
    1989, 103 Stat. 1830.)


-MISC1-
                                AMENDMENTS                            
      1989 - Subsec. (a). Pub. L. 101-205 designated first sentence as
    par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C),
    respectively, designated second sentence as par. (2) and inserted
    "(A) be distributed in accordance with paragraph (5), or (B)" after
    "entry of the decree,", designated third and fourth sentences as
    pars. (3) and (4), respectively, and added par. (5).

-End-



-CITE-
    21 USC Sec. 467c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467c. Federal court jurisdiction of enforcement and injunction
      proceedings and other kinds of cases; limitations; United States
      as plaintiff; subpenas

-STATUTE-
      The United States district courts, the District Court of Guam,
    the District Court of the Virgin Islands, the highest court of
    American Samoa, and the United States courts of the other
    territories, are vested with jurisdiction specifically to enforce,
    and to prevent and restrain violations of, this chapter, and shall
    have jurisdiction in all other kinds of cases arising under this
    chapter, except as provided in section 457(d) or 467 of this title.
    All proceedings for the enforcement or to restrain violations of
    this chapter shall be by and in the name of the United States.
    Subpenas for witnesses who are required to attend a court of the
    United States, in any district, may run into any other district in
    any such proceeding.

-SOURCE-
    (Pub. L. 85-172, Sec. 21, as added Pub. L. 90-492, Sec. 17, Aug.
    18, 1968, 82 Stat. 806.)

-End-



-CITE-
    21 USC Sec. 467d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467d. Administration and enforcement; applicability of penalty
      provisions; conduct of inquiries; power and jurisdiction of
      courts

-STATUTE-
      For the efficient administration and enforcement of this chapter,
    the provision (including penalties) of sections 46, 48, 49 and 50
    of title 15 (except paragraphs (c) through (h) of section 46 and
    the last paragraph of section 49 (!1) of title 15), and the
    provisions of section 409(l) (!1) of title 47, are made applicable
    to the jurisdiction, powers, and duties of the Secretary in
    administering and enforcing the provisions of this chapter and to
    any person with respect to whom such authority is exercised. The
    Secretary, in person or by such agents as he may designate, may
    prosecute any inquiry necessary to his duties under this chapter in
    any part of the United States, and the powers conferred by said
    sections 49 and 50 of title 15 on the district courts of the United
    States may be exercised for the purposes of this chapter by any
    court designated in section 467c of this title.


-SOURCE-
    (Pub. L. 85-172, Sec. 22, as added Pub. L. 90-492, Sec. 17, Aug.
    18, 1968, 82 Stat. 807.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The last paragraph of section 49 of title 15, and the provisions
    of section 409(l) of title 47, referred to in text, which related
    to immunity of witnesses, were repealed by sections 211 and 242,
    respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
    929, 930. For provisions relating to immunity of witnesses, see
    section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 467e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467e. Non-Federal jurisdiction of federally regulated matters;
      prohibition of additional or different requirements for
      establishments with inspection services and as to marking,
      labeling, packaging, and ingredients; recordkeeping and related
      requirements; concurrent jurisdiction over distribution for human
      food purposes of adulterated or misbranded and imported articles;
      other matters

-STATUTE-
      Requirements within the scope of this chapter with respect to
    premises, facilities and operations of any official establishment
    which are in addition to, or different than those made under this
    chapter may not be imposed by any State or Territory or the
    District of Columbia, except that any such jurisdiction may impose
    recordkeeping and other requirements within the scope of paragraph
    (b) of section 460 of this title, if consistent therewith, with
    respect to any such establishment. Marking, labeling, packaging, or
    ingredient requirements (or storage or handling requirements found
    by the Secretary to unduly interfere with the free flow of poultry
    products in commerce) in addition to, or different than, those made
    under this chapter may not be imposed by any State or Territory or
    the District of Columbia with respect to articles prepared at any
    official establishment in accordance with the requirements under
    this chapter, but any State or Territory or the District of
    Columbia may, consistent with the requirements under this chapter
    exercise concurrent jurisdiction with the Secretary over articles
    required to be inspected under this chapter for the purpose of
    preventing the distribution for human food purposes of any such
    articles which are adulterated or misbranded and are outside of
    such an establishment, or, in the case of imported articles which
    are not at such an establishment, after their entry into the United
    States. This chapter shall not preclude any State or Territory or
    the District of Columbia from making requirement or taking other
    action, consistent with this chapter, with respect to any other
    matters regulated under this chapter.

-SOURCE-
    (Pub. L. 85-172, Sec. 23, as added Pub. L. 90-492, Sec. 17, Aug.
    18, 1968, 82 Stat. 807.)

-End-



-CITE-
    21 USC Sec. 467f                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 467f. Federal Food, Drug, and Cosmetic Act applications

-STATUTE-
    (a) Exemptions; authorities under food, drug, and cosmetic
      provisions unaffected
      Poultry and poultry products shall be exempt from the provisions
    of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
    to the extent of the application or extension thereto of the
    provisions of this chapter, except that the provisions of this
    chapter shall not derogate from any authority conferred by the
    Federal Food, Drug, and Cosmetic Act prior to August 18, 1968.
    (b) Enforcement proceedings; detainer authority of representatives
      of Secretary of Health and Human Services
      The detainer authority conferred by section 467a of this title
    shall apply to any authorized representative of the Secretary of
    Health and Human Services for purposes of the enforcement of the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with
    respect to any poultry carcass, or part or product thereof, that is
    outside any official establishment, and for such purposes the first
    reference to the Secretary in section 467a of this title shall be
    deemed to refer to the Secretary of Health and Human Services.

-SOURCE-
    (Pub. L. 85-172, Sec. 24, as added Pub. L. 90-492, Sec. 17, Aug.
    18, 1968, 82 Stat. 807; amended Pub. L. 96-88, title V, Sec.
    509(b), Oct. 17, 1979, 93 Stat. 695.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in text, is
    act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
    classified generally to chapter 9 (Sec. 301 et seq.) of this title.
    For complete classification of this Act to the Code, see section
    301 of this title and Tables.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in par. (b) pursuant
    to section 509(b) of Pub. L. 96-88, which is classified to section
    3508(b) of Title 20, Education.

-End-



-CITE-
    21 USC Sec. 468                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 468. Cost of inspection; overtime

-STATUTE-
      The cost of inspection rendered under the requirements of this
    chapter, shall be borne by the United States, except the cost of
    overtime and holiday pay paid pursuant to the (!1) section 2219a of
    title 7.


-SOURCE-
    (Pub. L. 85-172, Sec. 25, formerly Sec. 19, Aug. 28, 1957, 71 Stat.
    448, renumbered Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat.
    805; Pub. L. 107-171, title X, Sec. 10703(c)(1), May 13, 2002, 116
    Stat. 517.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 2219a of title 7, referred to in text, was in the
    original "section 10703 of the Farm Security and Rural Investment
    Act of 2002", meaning section 10703 of Pub. L. 107-171, which
    enacted section 2219a of Title 7, Agriculture, amended this
    section, section 695 of this title, and section 5549 of Title 5,
    Government Organization and Employees, and repealed section 394 of
    Title 7.


-MISC1-
                                AMENDMENTS                            
      2002 - Pub. L. 107-171 substituted "except the cost of overtime
    and holiday pay paid pursuant to the section 2219a of title 7." for
    "except that the cost of overtime and holiday work performed in
    establishments subject to the provisions of this chapter at such
    rates as the Secretary may determine shall be borne by such
    establishments. Sums received by the Secretary in reimbursement for
    sums paid out by him for such premium pay work shall be available
    without fiscal year limitation to carry out the purposes of this
    section."

-FOOTNOTE-
    (!1) So in original. The word "the" probably should not appear.


-End-



-CITE-
    21 USC Sec. 469                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 469. Authorization of appropriations

-STATUTE-
      There is authorized to be appropriated such sums as are necessary
    to carry out the provisions of this chapter.

-SOURCE-
    (Pub. L. 85-172, Sec. 26, formerly Sec. 20, Aug. 28, 1957, 71 Stat.
    449, renumbered Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat.
    805.)

-End-



-CITE-
    21 USC Sec. 470                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 470. Omitted

-COD-
                               CODIFICATION                           
      Section, Pub. L. 85-172, Sec. 27, as added Pub. L. 90-492, Sec.
    17, Aug. 18, 1968, 82 Stat. 807; amended Pub. L. 103-437, Sec.
    8(1), Nov. 2, 1994, 108 Stat. 4588, which required the Secretary of
    Agriculture to report annually to the Committee on Agriculture of
    the House of Representatives and the Committee on Agriculture,
    Nutrition, and Forestry of the Senate on the slaughter of poultry
    and the processing and distribution of poultry parts and products,
    terminated, effective May 15, 2000, pursuant to section 3003 of
    Pub. L. 104-66, as amended, set out as a note under section 1113 of
    Title 31, Money and Finance. See, also, page 46 of House Document
    No. 103-7.

-End-



-CITE-
    21 USC Sec. 471                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION

-HEAD-
    Sec. 471. Safe Meat and Poultry Inspection Panel

-STATUTE-
    (a) Review and evaluation
      The advisory panel known as the "Safe Meat and Poultry Inspection
    Panel" established by section 679a of this title shall review and
    evaluate, as the panel considers necessary, the adequacy,
    necessity, safety, cost-effectiveness, and scientific merit of - 
        (1) inspection procedures of, and work rules and worker
      relations involving Federal employees employed in, plants
      inspected under this chapter;
        (2) informal petitions or proposals for changes in inspection
      procedures, processes, and techniques of plants inspected under
      this chapter;
        (3) formal changes in poultry inspection regulations
      promulgated under this chapter, whether in notice, proposed, or
      final form; and
        (4) such other matters as may be referred to the panel by the
      Secretary regarding the quality or effectiveness of a safe and
      cost-effective poultry inspection system under this chapter.
    (b) Reports
      (1) In general
        The Safe Meat and Poultry Inspection Panel shall submit to the
      Secretary a report on the results of each review and evaluation
      carried out under paragraph (1), including such recommendations
      as the panel considers appropriate.
      (2) Reports on formal changes
        In the case of a report concerning a formal change in poultry
      inspection regulations, the report shall be made within the time
      limits prescribed for formal comments on such changes.

-SOURCE-
    (Pub. L. 85-172, Sec. 30, as added Pub. L. 104-127, title IX, Sec.
    918(a)(2), Apr. 4, 1996, 110 Stat. 1190.)

-End-


-CITE-
    21 USC CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS

-HEAD-
                CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS            

-End-



-CITE-
    21 USC Secs. 501 to 517                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS

-HEAD-
    Secs. 501 to 517. Repealed.

-MISC1-
    Secs. 501 to 517. Repealed. Pub. L. 91-513, title III, Sec.
      1101(a)(10), Oct. 27, 1970, 84 Stat. 1292.
      Sections, Pub. L. 86-429, Apr. 22, 1960, 74 Stat. 55, provided
    for licensing and control of the manufacture of all narcotic drugs
    and was known as the "Narcotic Manufacturing Act of 1960". Sections
    1 to 3 and 5 to 22 of said Pub. L. 86-429 were classified
    respectively to sections 501, 501 notes, and 502 to 517 of this
    title. Section 4 of Pub. L. 86-429 was classified to sections 4702,
    4731, and 4731 note of Title 26, Internal Revenue Code. See section
    801 et seq. of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
    set out as a note under section 951 of this title. For provisions
    postponing such effective date if the Attorney General postpones
    the effective date of section 826 of this title, see section
    1105(c) of Pub. L. 91-513, set out as an Effective Date note under
    section 951 of this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of repeal of these sections by section 1101
    of Pub. L. 91-513 not to be affected or abated by reason thereof,
    see section 1103 of Pub. L. 91-513, set out as a note under
    sections 171 to 174 of this title.

-End-


-CITE-
    21 USC CHAPTER 12 - MEAT INSPECTION                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION

-HEAD-
                       CHAPTER 12 - MEAT INSPECTION                   


-MISC1-
         SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND
                                MISBRANDING
    Sec.                                                     
    601.        Definitions.                                          
    602.        Congressional statement of findings.                  
    603.        Inspection of meat and meat food products.            
    604.        Post mortem examination of carcasses and marking or
                 labeling; destruction of carcasses condemned;
                 reinspection.                                        
    605.        Examination of carcasses brought into slaughtering or
                 packing establishments, and of meat food products
                 issued from and returned thereto; conditions for
                 entry.                                               
    606.        Inspectors of meat food products; marks of inspection;
                 destruction of condemned products; products for
                 export.                                              
    607.        Labeling, marking, and container requirements.        
    608.        Sanitary inspection and regulation of slaughtering and
                 packing establishments; rejection of adulterated meat
                 or meat food products.                               
    609.        Examination of animals and food products thereof,
                 slaughtered and prepared during nighttime.           
    610.        Prohibited acts.                                      
    611.        Devices, marks, labels, and certificates; simulations.
    612 to 614. Repealed.                                             
    615.        Inspection of carcasses, meat of which is intended for
                 export.                                              
    616.        Inspectors of carcasses, etc., meat of which is
                 intended for export; certificates of condition.      
    617.        Clearance prohibited to vessel carrying meat for
                 export without inspector's certificate.              
    618.        Delivery of inspectors' certificates, and of copies.  
    619.        Marking, labeling, or other identification to show
                 kinds of animals from which derived; separate
                 establishments for preparation and slaughtering
                 activities.                                          
    620.        Imports.                                              
    621.        Inspectors to make examinations provided for;
                 appointment; duties; regulations.                    
    622.        Bribery of or gifts to inspectors or other officers
                 and acceptance of gifts.                             
    623.        Exemptions from inspection requirements.              
    624.        Storage and handling regulations; violations;
                 exemption of establishments subject to non-Federal
                 jurisdiction.                                        

          SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES      
    641.        Prohibition of subchapter I inspection of articles not
                 intended for use as human food; denaturation or other
                 identification prior to distribution in commerce;
                 inedible articles.                                   
    642.        Recordkeeping requirements.                           
    643.        Registration of business, name of person, and trade
                 names.                                               
    644.        Regulation of transactions, transportation, or
                 importation of 4-D animals to prevent use as human
                 food.                                                
    645.        Federal provisions applicable to State or Territorial
                 business transactions of a local nature and not
                 subject to local authority.                          

              SUBCHAPTER III - FEDERAL AND STATE COOPERATION          
    661.        Federal and State cooperation.                        

                   SUBCHAPTER IV - AUXILIARY PROVISIONS               
    671.        Inspection services; refusal or withdrawal; hearing;
                 business unfitness based upon certain convictions;
                 other provisions for withdrawal of services
                 unaffected; responsible connection with business;
                 finality of Secretary's actions; judicial review;
                 record.                                              
    672.        Administrative detention; duration; pending judicial
                 proceedings; notification of governmental
                 authorities; release.                                
    673.        Seizure and condemnation.                             
    674.        Federal court jurisdiction of enforcement and
                 injunction proceedings and other kinds of cases;
                 limitations of section 607(e) of this title.         
    675.        Assaulting, resisting, or impeding certain persons;
                 murder; protection of such persons.                  
    676.        Violations.                                           
    677.        Other Federal laws applicable for administration and
                 enforcement of chapter; location of inquiries;
                 jurisdiction of Federal courts.                      
    678.        Non-Federal jurisdiction of federally regulated
                 matters; prohibition of additional or different
                 requirements for establishments with inspection
                 services and as to marking, labeling, packaging, and
                 ingredients; recordkeeping and related requirements;
                 concurrent jurisdiction over distribution for human
                 food purposes of adulterated or misbranded and
                 imported articles; other matters.                    
    679.        Application of Federal Food, Drug, and Cosmetic Act.  
    679a.       Safe Meat and Poultry Inspection Panel.               
    679b.       Pasteurization of meat and poultry.                   
    679c.       Expansion of Food Safety Inspection Service
                 activities.                                          
    680.        Authorization of appropriations.                      

                  SUBCHAPTER V - MISCELLANEOUS PROVISIONS              
    691.        Omitted.                                              
    692.        Inspection extended to reindeer.                      
    693.        Inspection of dairy products for export.              
    694.        Authorization of appropriations.                      
    695.        Payment of cost of meat-inspection service; exception.

-End-


-CITE-
    21 USC SUBCHAPTER I - INSPECTION REQUIREMENTS;
           ADULTERATION AND MISBRANDING                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
         SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND
                                MISBRANDING

-End-



-CITE-
    21 USC Sec. 601                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 601. Definitions

-STATUTE-
      As used in this chapter, except as otherwise specified, the
    following terms shall have the meanings stated below:
      (a) The term "Secretary" means the Secretary of Agriculture of
    the United States or his delegate.
      (b) The term "firm" means any partnership, association, or other
    unincorporated business organization.
      (c) The term "meat broker" means any person, firm, or corporation
    engaged in the business of buying or selling carcasses, parts of
    carcasses, meat, or meat food products of cattle, sheep, swine,
    goats, horses, mules, or other equines on commission, or otherwise
    negotiating purchases or sales of such articles other than for his
    own account or as an employee of another person, firm, or
    corporation.
      (d) The term "renderer" means any person, firm, or corporation
    engaged in the business of rendering carcasses or parts or products
    of the carcasses, of cattle, sheep, swine, goats, horses, mules, or
    other equines, except rendering conducted under inspection or
    exemption under this subchapter.
      (e) The term "animal food manufacturer" means any person, firm,
    or corporation engaged in the business of manufacturing or
    processing animal food derived wholly or in part from carcasses, or
    parts or products of the carcasses, of cattle, sheep, swine, goats,
    horses, mules, or other equines.
      (f) The term "State" means any State of the United States and the
    Commonwealth of Puerto Rico.
      (g) The term "Territory" means Guam, the Virgin Islands of the
    United States, American Samoa, and any other territory or
    possession of the United States, excluding the Canal Zone.
      (h) The term "commerce" means commerce between any State, any
    Territory, or the District of Columbia, and any place outside
    thereof; or within any Territory not organized with a legislative
    body, or the District of Columbia.
      (i) The term "United States" means the States, the District of
    Columbia, and the Territories of the United States.
      (j) The term "meat food product" means any product capable of use
    as human food which is made wholly or in part from any meat or
    other portion of the carcass of any cattle, sheep, swine, or goats,
    excepting products which contain meat or other portions of such
    carcasses only in a relatively small proportion or historically
    have not been considered by consumers as products of the meat food
    industry, and which are exempted from definition as a meat food
    product by the Secretary under such conditions as he may prescribe
    to assure that the meat or other portions of such carcasses
    contained in such product are not adulterated and that such
    products are not represented as meat food products. This term as
    applied to food products of equines shall have a meaning comparable
    to that provided in this paragraph with respect to cattle, sheep,
    swine, and goats.
      (k) The term "capable of use as human food" shall apply to any
    carcass, or part or product of a carcass, of any animal, unless it
    is denatured or otherwise identified as required by regulations
    prescribed by the Secretary to deter its use as human food, or it
    is naturally inedible by humans.
      (l) The term "prepared" means slaughtered, canned, salted,
    rendered, boned, cut up, or otherwise manufactured or processed.
      (m) The term "adulterated" shall apply to any carcass, part
    thereof, meat or meat food product under one or more of the
    following circumstances:
        (1) if it bears or contains any poisonous or deleterious
      substance which may render it injurious to health; but in case
      the substance is not an added substance, such article shall not
      be considered adulterated under this clause if the quantity of
      such substance in or on such article does not ordinarily render
      it injurious to health;
        (2)(A) if it bears or contains (by reason of administration of
      any substance to the live animal or otherwise) any added
      poisonous or added deleterious substance (other than one which is
      (i) a pesticide chemical in or on a raw agricultural commodity;
      (ii) a food additive; or (iii) a color additive) which may, in
      the judgment of the Secretary, make such article unfit for human
      food;
        (B) if it is, in whole or in part, a raw agricultural commodity
      and such commodity bears or contains a pesticide chemical which
      is unsafe within the meaning of section 346a of this title,
        (C) if it bears or contains any food additive which is unsafe
      within the meaning of section 348 of this title,
        (D) if it bears or contains any color additive which is unsafe
      within the meaning of section 379e of this title: Provided, That
      an article which is not adulterated under clause (B), (C), or (D)
      shall nevertheless be deemed adulterated if use of the pesticide
      chemical, food additive, or color additive in or on such article
      is prohibited by regulations of the Secretary in establishments
      at which inspection is maintained under this subchapter;
        (3) if it consists in whole or in part of any filthy, putrid,
      or decomposed substance or is for any other reason unsound,
      unhealthful, unwholesome, or otherwise unfit for human food;
        (4) if it has been prepared, packed, or held under insanitary
      conditions whereby it may have become contaminated with filth, or
      whereby it may have been rendered injurious to health;
        (5) if it is, in whole or in part, the product of an animal
      which has died otherwise than by slaughter;
        (6) if its container is composed, in whole or in part, of any
      poisonous or deleterious substance which may render the contents
      injurious to health;
        (7) if it has been intentionally subjected to radiation, unless
      the use of the radiation was in conformity with a regulation or
      exemption in effect pursuant to section 348 of this title;
        (8) if any valuable constituent has been in whole or in part
      omitted or abstracted therefrom; or if any substance has been
      substituted, wholly or in part therefor; or if damage or
      inferiority has been concealed in any manner; or if any substance
      has been added thereto or mixed or packed therewith so as to
      increase its bulk or weight, or reduce its quality or strength,
      or make it appear better or of greater value than it is; or
        (9) if it is margarine containing animal fat and any of the raw
      material used therein consisted in whole or in part of any
      filthy, putrid, or decomposed substance.

      (n) The term "misbranded" shall apply to any carcass, part
    thereof, meat or meat food product under one or more of the
    following circumstances:
        (1) if its labeling is false or misleading in any particular;
        (2) if it is offered for sale under the name of another food;
        (3) if it is an imitation of another food, unless its label
      bears, in type of uniform size and prominence, the word
      "imitation" and immediately thereafter, the name of the food
      imitated;
        (4) if its container is so made, formed, or filled as to be
      misleading;
        (5) if in a package or other container unless it bears a label
      showing (A) the name and place of business of the manufacturer,
      packer, or distributor; and (B) an accurate statement of the
      quantity of the contents in terms of weight, measure, or
      numerical count: Provided, That under clause (B) of this
      subparagraph (5), reasonable variations may be permitted, and
      exemptions as to small packages may be established, by
      regulations prescribed by the Secretary;
        (6) if any word, statement, or other information required by or
      under authority of this chapter to appear on the label or other
      labeling is not prominently placed thereon with such
      conspicuousness (as compared with other words, statements,
      designs, or devices, in the labeling) and in such terms as to
      render it likely to be read and understood by the ordinary
      individual under customary conditions of purchase and use;
        (7) if it purports to be or is represented as a food for which
      a definition and standard of identity or composition has been
      prescribed by regulations of the Secretary under section 607 of
      this title unless (A) it conforms to such definition and
      standard, and (B) its label bears the name of the food specified
      in the definition and standard and, insofar as may be required by
      such regulations, the common names of optional ingredients (other
      than spices, flavoring, and coloring) present in such food;
        (8) if it purports to be or is represented as a food for which
      a standard or standards of fill of container have been prescribed
      by regulations of the Secretary under section 607 of this title,
      and it falls below the standard of fill of container applicable
      thereto, unless its label bears, in such manner and form as such
      regulations specify, a statement that it falls below such
      standard;
        (9) if it is not subject to the provisions of subparagraph (7),
      unless its label bears (A) the common or usual name of the food,
      if any there be, and (B) in case it is fabricated from two or
      more ingredients, the common or usual name of each such
      ingredient; except that spices, flavorings, and colorings may,
      when authorized by the Secretary, be designated as spices,
      flavorings, and colorings without naming each: Provided, That to
      the extent that compliance with the requirements of clause (B) of
      this subparagraph (9) is impracticable, or results in deception
      or unfair competition, exemptions shall be established by
      regulations promulgated by the Secretary;
        (10) if it purports to be or is represented for special dietary
      uses, unless its label bears such information concerning its
      vitamin, mineral, and other dietary properties as the Secretary,
      after consultation with the Secretary of Health and Human
      Services, determines to be, and by regulations prescribes as,
      necessary in order fully to inform purchasers as to its value for
      such uses;
        (11) if it bears or contains any artificial flavoring,
      artificial coloring, or chemical preservative, unless it bears
      labeling stating that fact: Provided, That, to the extent that
      compliance with the requirements of this subparagraph (11) is
      impracticable, exemptions shall be established by regulations
      promulgated by the Secretary; or
        (12) if it fails to bear, directly thereon or on its container,
      as the Secretary may by regulations prescribe, the inspection
      legend and, unrestricted by any of the foregoing, such other
      information as the Secretary may require in such regulations to
      assure that it will not have false or misleading labeling and
      that the public will be informed of the manner of handling
      required to maintain the article in a wholesome condition.

      (o) The term "label" means a display of written, printed, or
    graphic matter upon the immediate container (not including package
    liners) of any article.
      (p) The term "labeling" means all labels and other written,
    printed, or graphic matter (1) upon any article or any of its
    containers or wrappers, or (2) accompanying such article.
      (q) The term "Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
    et seq.]" means the Act so entitled, approved June 25, 1938 (52
    Stat. 1040), and Acts amendatory thereof or supplementary thereto.
      (r) The terms "pesticide chemical," "food additive," "color
    additive," and "raw agricultural commodity" shall have the same
    meanings for purposes of this chapter as under the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
      (s) The term "official mark" means the official inspection legend
    or any other symbol prescribed by regulations of the Secretary to
    identify the status of any article or animal under this chapter.
      (t) The term "official inspection legend" means any symbol
    prescribed by regulations of the Secretary showing that an article
    was inspected and passed in accordance with this chapter.
      (u) The term "official certificate" means any certificate
    prescribed by regulations of the Secretary for issuance by an
    inspector or other person performing official functions under this
    chapter.
      (v) The term "official device" means any device prescribed or
    authorized by the Secretary for use in applying any official mark.
      (w) The term "amenable species" means - 
        (1) those species subject to the provisions of this chapter on
      the day before November 10, 2005; and
        (2) any additional species of livestock that the Secretary
      considers appropriate.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 1, as added Pub. L. 90-201,
    Sec. 2, Dec. 15, 1967, 81 Stat. 584; amended Pub. L. 96-88, title
    V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-571, title
    I, Sec. 107(14), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 109-97,
    title VII, Sec. 798[(a)](2), Nov. 10, 2005, 119 Stat. 2166.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in pars.
    (q) and (r), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      2005 - Par. (w). Pub. L. 109-97 added par. (w).
      1992 - Par. (m)(2)(D). Pub. L. 102-571 substituted "379e" for
    "376".

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in par. (n)(10)
    pursuant to section 509(b) of Pub. L. 96-88, which is classified to
    section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Pub. L. 109-97, title VII, Sec. 798(b), Nov. 10, 2005, 119 Stat.
    2166, provided that: "The amendments made by subsection (a)
    [amending this section and sections 603 to 605, 608, 609, 615, and
    617 to 621 of this title] shall take effect on the day after the
    effective date of section 794 of the Agriculture, Rural
    Development, Food and Drug Administration, and Related Agencies
    Appropriations Act, 2006 [section 794 of Pub. L. 109-97, 119 Stat.
    2164, effective 120 days after Nov. 10, 2005]."

                              EFFECTIVE DATE                          
      Section 20 of Pub. L. 90-201 provided that: "This Act [see Short
    Title note below] shall become effective upon enactment [Dec. 15,
    1967] except as provided in paragraphs (a) through (d):
      "(a) The provisions of paragraph (b)(1) and (c) of section 10 and
    the provisions of section 20 of the Federal Meat Inspection Act, as
    amended by sections 7 and 10 of this Act [sections 610 and 620 of
    this title], and the provisions of section 18 of this Act repealing
    paragraph (b) of section 306 of the Tariff Act of 1930 [section
    1306(b) of Title 19, Customs Duties], shall become effective upon
    the expiration of sixty days after enactment [Dec. 15, 1967],
    hereof.
      "(b) The provisions of title I of the Federal Meat Inspection
    Act, as amended by this Act [this subchapter], shall become
    effective with respect to equines (other than horses) and their
    carcasses and parts thereof, meat, and meat food products thereof
    upon the expiration of sixty days after enactment [Dec. 15, 1967]
    hereof.
      "(c) Section 11 of this Act, amending section 23, of the Federal
    Meat Inspection Act [section 623 of this title], shall become
    effective upon the expiration of sixty days after enactment hereof
    [Dec. 15, 1967].
      "(d) Section 204 of the Federal Meat Inspection Act, as added by
    section 14 of this Act [section 644 of this title], shall become
    effective upon the expiration of sixty days after enactment hereof
    [Dec. 15, 1967]."

                       SHORT TITLE OF 1986 AMENDMENT                   
      Pub. L. 99-641, title IV, Sec. 401, Nov. 10, 1986, 100 Stat.
    3567, provided that: "This title [amending sections 606, 609, 621,
    671, and 676 of this title and enacting provisions set out as notes
    under sections 606, 609, 621, 671, and 676 of this title] may be
    cited as the 'Processed Products Inspection Improvement Act of
    1986'."

                       SHORT TITLE OF 1978 AMENDMENT                   
      Pub. L. 95-445, Sec. 1, Oct. 10, 1978, 92 Stat. 1069, provided:
    "That this Act [amending sections 603, 610, and 620 of this title
    and sections 1902 and 1904 of Title 7, Agriculture, repealing
    sections 1903 and 1905 of Title 7, and enacting provisions set out
    as notes under this section and section 603 of this title] may be
    cited as the 'Humane Methods of Slaughter Act of 1978'."

                                SHORT TITLE                            
      Section 1 of Pub. L. 90-201 provided in part: "That this Act
    [enacting this section and sections 602, 624, 641 to 645, 661, 671
    to 680, and 691 of this title, amending sections 603 to 623 of this
    title, repealing section 96 of this title and section 1306(b) of
    Title 19, Customs Duties, and enacting provisions set out as notes
    under this section] may be cited as the 'Wholesome Meat Act'."
      Section 1 of Pub. L. 90-201 provided in part that the provisions
    of act Mar. 4, 1907, as amended, classified to subchapters I to IV
    of this chapter, are designated as the "Federal Meat Inspection
    Act".

                               SEPARABILITY                           
      Section 19 of Pub. L. 90-201 provided that: "If any provision of
    this Act or of the amendments made hereby [see Short Title note
    above] or the application thereof to any person or circumstances is
    held invalid, the validity of the remainder of the Act and the
    remaining amendments [see Short Title note above] and of the
    application of such provision to other persons and circumstances
    shall not be affected thereby."

-End-



-CITE-
    21 USC Sec. 602                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 602. Congressional statement of findings

-STATUTE-
      Meat and meat food products are an important source of the
    Nation's total supply of food. They are consumed throughout the
    Nation and the major portion thereof moves in interstate or foreign
    commerce. It is essential in the public interest that the health
    and welfare of consumers be protected by assuring that meat and
    meat food products distributed to them are wholesome, not
    adulterated, and properly marked, labeled, and packaged.
    Unwholesome, adulterated, or misbranded meat or meat food products
    impair the effective regulation of meat and meat food products in
    interstate or foreign commerce, are injurious to the public
    welfare, destroy markets for wholesome, not adulterated, and
    properly labeled and packaged meat and meat food products, and
    result in sundry losses to livestock producers and processors of
    meat and meat food products, as well as injury to consumers. The
    unwholesome, adulterated, mislabeled, or deceptively packaged
    articles can be sold at lower prices and compete unfairly with the
    wholesome, not adulterated, and properly labeled and packaged
    articles, to the detriment of consumers and the public generally.
    It is hereby found that all articles and animals which are
    regulated under this chapter are either in interstate or foreign
    commerce or substantially affect such commerce, and that regulation
    by the Secretary and cooperation by the States and other
    jurisdictions as contemplated by this chapter are appropriate to
    prevent and eliminate burdens upon such commerce, to effectively
    regulate such commerce, and to protect the health and welfare of
    consumers.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 2, as added Pub. L. 90-201,
    Sec. 2, Dec. 15, 1967, 81 Stat. 587.)

-End-



-CITE-
    21 USC Sec. 603                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 603. Inspection of meat and meat food products

-STATUTE-
    (a) Examination of animals before slaughtering; diseased animals
      slaughtered separately and carcasses examined
      For the purpose of preventing the use in commerce of meat and
    meat food products which are adulterated, the Secretary shall cause
    to be made, by inspectors appointed for that purpose, an
    examination and inspection of all amenable species before they
    shall be allowed to enter into any slaughtering, packing, meat-
    canning, rendering, or similar establishment, in which they are to
    be slaughtered and the meat and meat food products thereof are to
    be used in commerce; and all amenable species found on such
    inspection to show symptoms of disease shall be set apart and
    slaughtered separately from all other cattle, sheep, swine, goats,
    horses, mules, or other equines, and when so slaughtered the
    carcasses of said cattle, sheep, swine, goats, horses, mules, or
    other equines shall be subject to a careful examination and
    inspection, all as provided by the rules and regulations to be
    prescribed by the Secretary, as provided for in this subchapter.
    (b) Humane methods of slaughter
      For the purpose of preventing the inhumane slaughtering of
    livestock, the Secretary shall cause to be made, by inspectors
    appointed for that purpose, an examination and inspection of the
    method by which amenable species are slaughtered and handled in
    connection with slaughter in the slaughtering establishments
    inspected under this chapter. The Secretary may refuse to provide
    inspection to a new slaughtering establishment or may cause
    inspection to be temporarily suspended at a slaughtering
    establishment if the Secretary finds that any cattle, sheep, swine,
    goats, horses, mules, or other equines have been slaughtered or
    handled in connection with slaughter at such establishment by any
    method not in accordance with the Act of August 27, 1958 (72 Stat.
    862; 7 U.S.C. 1901-1906) until the establishment furnishes
    assurances satisfactory to the Secretary that all slaughtering and
    handling in connection with slaughter of livestock shall be in
    accordance with such a method.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 3, formerly 1st par., 34
    Stat. 1260; renumbered Sec. 3 and amended Pub. L. 90-201, Secs. 1,
    3, 12(a), (b), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 95-
    445, Sec. 2, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 109-97, title
    VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85-
    765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
    generally to chapter 48 (Sec. 1901 et seq.) of Title 7,
    Agriculture. For complete classification of this Act to the Code,
    see Tables.
      Sections 1903 and 1905 of Title 7, included within reference to
    Act of August 27, 1958, were repealed by Pub. L. 95-445, Sec. 5(b),
    Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7
    of Pub. L. 95-445, set out as an Effective Date of 1978 Amendment
    note below.

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 71 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines" wherever
    appearing.
      1978 - Pub. L. 95-445 designated existing provisions as subsec.
    (a) and added subsec. (b).
      1967 - Pub. L. 90-201, Secs. 3, 12(a), (b), struck out
    "interstate or foreign" before "commerce" in two places,
    substituted "Secretary shall" for "Secretary, at his discretion,
    may", and struck out "of Agriculture" after "Secretary", included
    horses, mules, and other equines, and horses, mules, or other
    equines in the list of animals, and substituted "adulterated" for
    "unsound, unhealthful, unwholesome, or otherwise unfit for human
    food", respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Section 7 of Pub. L. 95-445 provided that: "The provisions of
    this Act [see Short Title of 1978 Amendment note set out under
    section 601 of this title] shall become effective one year after
    the date of enactment [Oct. 10, 1978]. However, such provisions
    shall not apply to a person, firm, or corporation for such
    additional period of time, not to exceed eighteen months, as may be
    determined by the Secretary, if the Secretary, upon application,
    finds that compliance with the provisions of this Act on its
    effective date would cause undue hardship on such person, firm, or
    corporation."

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

                    RELIGIOUS FREEDOM; RITUAL SLAUGHTER                
      Section 6 of Pub. L. 95-445 provided that: "Nothing in this Act
    [see Short Title of 1978 Amendment note set out under section 601
    of this title] shall be construed to prohibit, abridge, or in any
    way hinder the religious freedom of any person or group.
    Notwithstanding any other provision of this Act, in order to
    protect freedom of religion, ritual slaughter and the handling or
    other preparation of livestock for ritual slaughter are exempted
    from the terms of this Act. For the purposes of this section the
    term 'ritual slaughter' means slaughter in accordance with section
    2(b) of the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C.
    1902(b))."

-End-



-CITE-
    21 USC Sec. 604                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 604. Post mortem examination of carcasses and marking or
      labeling; destruction of carcasses condemned; reinspection

-STATUTE-
      For the purposes hereinbefore set forth the Secretary shall cause
    to be made by inspectors appointed for that purpose a post mortem
    examination and inspection of the carcasses and parts thereof of
    all amenable species to be prepared at any slaughtering, meat-
    canning, salting, packing, rendering, or similar establishment in
    any State, Territory, or the District of Columbia as articles of
    commerce which are capable of use as human food; and the carcasses
    and parts thereof of all such animals found to be not adulterated
    shall be marked, stamped, tagged, or labeled as "Inspected and
    passed"; and said inspectors shall label, mark, stamp, or tag as
    "Inspected and condemned" all carcasses and parts thereof of
    animals found to be adulterated; and all carcasses and parts
    thereof thus inspected and condemned shall be destroyed for food
    purposes by the said establishment in the presence of an inspector,
    and the Secretary may remove inspectors from any such establishment
    which fails to so destroy any such condemned carcass or part
    thereof, and said inspectors, after said first inspection, shall,
    when they deem it necessary, reinspect said carcasses or parts
    thereof to determine whether since the first inspection the same
    have become adulterated, and if any carcass or any part thereof
    shall, upon examination and inspection subsequent to the first
    examination and inspection, be found to be adulterated, it shall be
    destroyed for food purposes by the said establishment in the
    presence of an inspector, and the Secretary may remove inspectors
    from any establishment which fails to so destroy any such condemned
    carcass or part thereof.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 4, formerly 2nd par., 34
    Stat. 1260; renumbered Sec. 4 and amended Pub. L. 90-201, Secs. 1,
    3, 4, 12(a)-(d), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-
    97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 72 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines".
      1967 - Pub. L. 90-201, Secs. 3, 4, 12(a)-(d), struck out
    "interstate or foreign" before "commerce" and "of Agriculture"
    after "Secretary" in three places; struck out "for human
    consumption" before "at any slaughtering" and "for transportation
    or sale" after "District of Columbia" and inserted "which are
    capable of use as human food" after "commerce"; included horses,
    mules, and other equines in the list of animals; substituted
    "adulterated" for "unsound, unhealthful, unwholesome, or otherwise
    unfit for human food" after " 'Inspected and condemned,' all
    carcasses and parts thereof of animals found to be" and before ",
    it shall be destroyed"; substituted "not adulterated" for "sound,
    healthful, wholesome, and fit for human food"; and substituted
    "adulterated" for "unsound, unhealthful, unwholesome, or in any way
    unfit for human food" before "and if any carcass", respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 605                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 605. Examination of carcasses brought into slaughtering or
      packing establishments, and of meat food products issued from and
      returned thereto; conditions for entry

-STATUTE-
      The foregoing provisions shall apply to all carcasses or parts of
    carcasses of amenable species or the meat or meat products thereof
    which may be brought into any slaughtering, meat-canning, salting,
    packing, rendering, or similar establishment, and such examination
    and inspection shall be had before the said carcasses or parts
    thereof shall be allowed to enter into any department wherein the
    same are to be treated and prepared for meat food products; and the
    foregoing provisions shall also apply to all such products, which,
    after having been issued from any slaughtering, meat-canning,
    salting, packing, rendering, or similar establishment, shall be
    returned to the same or to any similar establishment where such
    inspection is maintained. The Secretary may limit the entry of
    carcasses, parts of carcasses, meat and meat food products, and
    other materials into any establishment at which inspection under
    this subchapter is maintained, under such conditions as he may
    prescribe to assure that allowing the entry of such articles into
    such inspected establishments will be consistent with the purposes
    of this chapter.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 5, formerly 3rd par., 34
    Stat. 1261; renumbered Sec. 5 and amended Pub. L. 90-201, Secs. 1,
    5, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-97,
    title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 73 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines".
      1967 - Pub. L. 90-201, Secs. 5, 12(a), limited entry of articles
    into establishments under such prescribed conditions as would be
    consistent with the purpose of this chapter and included horses,
    mules, and other equines in the list of animals, respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 606                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 606. Inspectors of meat food products; marks of inspection;
      destruction of condemned products; products for export

-STATUTE-
      For the purposes hereinbefore set forth the Secretary shall cause
    to be made, by inspectors appointed for that purpose, an
    examination and inspection of all meat food products prepared for
    commerce in any slaughtering, meat-canning, salting, packing,
    rendering, or similar establishment, and for the purposes of any
    examination and inspection and inspectors shall have access at all
    times, by day or night, whether the establishment be operated or
    not, to every part of said establishment; and said inspectors shall
    mark, stamp, tag, or label as "Inspected and passed" all such
    products found to be not adulterated; and said inspectors shall
    label, mark, stamp, or tag as "Inspected and condemned" all such
    products found adulterated, and all such condemned meat food
    products shall be destroyed for food purposes, as hereinbefore
    provided, and the Secretary may remove inspectors from any
    establishment which fails to so destroy such condemned meat food
    products: Provided, That subject to the rules and regulations of
    the Secretary the provisions of this section in regard to
    preservatives shall not apply to meat food products for export to
    any foreign country and which are prepared or packed according to
    the specifications or directions of the foreign purchaser, when no
    substance is used in the preparation or packing thereof in conflict
    with the laws of the foreign country to which said article is to be
    exported; but if said article shall be in fact sold or offered for
    sale for domestic use or consumption then this proviso shall not
    exempt said article from the operation of all the other provisions
    of this chapter.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 6, formerly 4th par., 34
    Stat. 1261; renumbered Sec. 6 and amended Pub. L. 90-201, Secs. 1,
    3, 12(e), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99-641,
    title IV, Sec. 403(a), Nov. 10, 1986, 100 Stat. 3567.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 74 of this title.


-MISC1-
                                AMENDMENTS                            
      1986 - Pub. L. 99-641 temporarily added subsecs. (a) to (c) and
    struck out former undesignated provisions which read as follows:
    "For the purposes hereinbefore set forth the Secretary shall cause
    to be made, by inspectors appointed for that purpose, an
    examination and inspection of all meat food products prepared for
    commerce in any slaughtering, meat-canning, salting, packing,
    rendering, or similar establishment, and for the purposes of any
    examination and inspection and inspectors shall have access at all
    times, by day or night, whether the establishment be operated or
    not, to every part of said establishment; and said inspectors shall
    mark, stamp, tag, or label as 'Inspected and passed' all such
    products found to be not adulterated; and said inspectors shall
    label, mark, stamp, or tag as 'Inspected and condemned' all such
    products found adulterated, and all such condemned meat food
    products shall be destroyed for food purposes, as hereinbefore
    provided, and the Secretary may remove inspectors from any
    establishment which fails to so destroy such condemned meat food
    products: Provided, That", designated remaining provisions as
    subsec. (d), and inserted "Notwithstanding the preceding provisions
    of this section,". See Effective and Termination Dates of 1986
    Amendment note below.
      1967 - Pub. L. 90-201, Secs. 3, 12(e), struck out "interstate or
    foreign" before "commerce" and "of Agriculture" after "Secretary"
    in three places, and substituted "not adulterated" for "sound,
    healthful, and wholesome, and which contains no dyes, chemicals,
    preservatives, or ingredients which render such meat or meat food
    products unsound, unhealthful, unwholesome, or unfit for human
    food" and "adulterated" for "unsound, unhealthful, and unwholesome,
    or which contain dyes, chemicals, preservatives, or ingredients
    which render such meat or meat food products unsound, unhealthful,
    unwholesome, or unfit for human food," respectively.

             EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT         
      Section 403(a) of Pub. L. 99-641 provided in part that the
    amendment of this section by Pub. L. 99-641 is effective only
    during the 6-year period beginning Nov. 10, 1986.
      Section 408 of title IV of Pub. L. 99-641 provided that:
      "(a) General Effective Date. - Except as provided in subsection
    (b) of this section, this title and the amendments made by this
    title [amending sections 606, 609, 621, 671, and 676 of this title
    and enacting provisions set out as notes under sections 606, 609,
    621, 671, and 676 of this title] shall become effective on the date
    of the enactment of this Act [Nov. 10, 1986].
      "(b) Temporary Application of Existing Law. - Sections 6, 9, and
    21 of the Federal Meat Inspection Act (21 U.S.C. 606, 609, and
    621), as in effect immediately before the date of the enactment of
    this Act [Nov. 10, 1986], shall apply with respect to
    establishments until the Secretary of Agriculture first issues
    rules and regulations to implement the amendments made by section
    403(a) [amending this section]."

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

                             SAVINGS PROVISION                         
      Section 404 of Pub. L. 99-641 provided that: "The expiration date
    provisions of section 403 [enacting provisions set out as notes
    under this section and sections 609, 621, 671, and 676 of this
    title] shall not have the effect of releasing or extinguishing any
    penalty, forfeiture, or liability incurred under the Federal Meat
    Inspection Act (21 U.S.C. 601 et seq.), as amended by section 403
    [amending this section and sections 609, 621, 671, and 676 of this
    title], or under the rules or regulations issued under such Act."

     INSPECTION SERVICES FOR ESTABLISHMENTS NOT PARTICIPATING IN TOTAL
                       PLANT QUALITY-CONTROL PROGRAM
      Section 403(e) of Pub. L. 99-641 provided that: "The amendments
    made by this section [amending this section and sections 609, 621,
    671, and 676 of this title] shall not be construed to authorize the
    Secretary of Agriculture to refuse to provide inspection under the
    Federal Meat Inspection Act (21 U.S.C. 601 et seq.) at an
    establishment solely because such establishment does not
    participate in a total plant quality-control program."

       DETECTION OF RESIDUE IN LIVESTOCK AND PROGRAM FOR TRACING OF
                                 LIVESTOCK
      Section 405 of Pub. L. 99-641 provided that: "It is the sense of
    Congress that the Secretary of Agriculture should - 
        "(1) carry out a program to detect residues in livestock that
      are subject to inspection under title I of the Federal Meat
      Inspection Act (21 U.S.C. 601 et seq.); and
        "(2) evaluate the feasibility of, and develop, a program that
      would enable the Secretary to trace any particular livestock that
      are subject to inspection under title I of the Federal Meat
      Inspection Act, in order to identify the producer of such
      livestock."

                            REPORTS TO CONGRESS                        
      Pub. L. 99-641, title IV, Sec. 406, Nov. 10, 1986, 100 Stat.
    3571, which required the Secretary of Agriculture to submit an
    annual report to the Committee on Agriculture of the House of
    Representatives and the Committee on Agriculture, Nutrition, and
    Forestry of the Senate describing any action proposed or taken by
    the Secretary to implement amendments made by section 403 of Pub.
    L. 99-641 (amending this section and sections 609, 621, 671, and
    676 of this title), to carry out a program for detecting residues
    in livestock, or to develop a program for tracing particular
    livestock in order to identify the producer, and describing any
    personnel action proposed or taken by the Secretary as a result of
    amendments made by section 403 of Pub. L. 99-641 along with any
    effort made by the Secretary to minimize any adverse economic
    effect of the amendments on employees of the Department of
    Agriculture, terminated, effective May 15, 2000, pursuant to
    section 3003 of Pub. L. 104-66, as amended, set out as a note under
    section 1113 of Title 31, Money and Finance. See, also, page 46 of
    House Document No. 103-7.

             CONGRESSIONAL REEVALUATION OF INSPECTION PROGRAM         
      Section 407 of Pub. L. 99-641 provided that: "It is the sense of
    Congress that, not later than 6 years after the date of the
    enactment of this Act [Nov. 10, 1986], Congress shall - 
        "(1) evaluate the operation and effects of the amendments made
      by section 403 [amending this section and sections 609, 621, 671,
      and 676 of this title], for the purpose of determining whether to
      extend or modify the operation of such amendments; and
        "(2) enact such legislation as may be necessary to efficiently
      and effectively carry out the Federal Meat Inspection Act (21
      U.S.C. 601 et seq.)."

-End-



-CITE-
    21 USC Sec. 607                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 607. Labeling, marking, and container requirements

-STATUTE-
    (a) Labeling receptacles or coverings of meat or meat food products
      inspected and passed; supervision by inspectors
      When any meat or meat food product prepared for commerce which
    has been inspected as hereinbefore provided and marked "Inspected
    and passed" shall be placed or packed in any can, pot, tin, canvas,
    or other receptacle or covering in any establishment where
    inspection under the provisions of this chapter is maintained, the
    person, firm, or corporation preparing said product shall cause a
    label to be attached to said can, pot, tin, canvas, or other
    receptacle or covering, under the supervision of an inspector,
    which label shall state that the contents thereof have been
    "inspected and passed" under the provisions of this chapter; and no
    inspection and examination of meat or meat food products deposited
    or inclosed in cans, tins, pots, canvas, or other receptacle or
    covering in any establishment where inspection under the provisions
    of this chapter is maintained shall be deemed to be complete until
    such meat or meat food products have been sealed or inclosed in
    said can, tin, pot, canvas, or other receptacle or covering under
    the supervision of an inspector.
    (b) Information on articles or containers; legible form
      All carcasses, parts of carcasses, meat and meat food products
    inspected at any establishment under the authority of this
    subchapter and found to be not adulterated, shall at the time they
    leave the establishment bear, in distinctly legible form, directly
    thereon or on their containers, as the Secretary may require, the
    information required under paragraph (n) of section 601 of this
    title.
    (c) Labeling: type styles and sizes; definitions and standards of
      identity or composition; standards of fill of container;
      consistency of Federal and Federal-State standards
      The Secretary, whenever he determines such action is necessary
    for the protection of the public, may prescribe: (1) the styles and
    sizes of type to be used with respect to material required to be
    incorporated in labeling to avoid false or misleading labeling in
    marketing and labeling any articles or animals subject to this
    subchapter or subchapter II of this chapter; (2) definitions and
    standards of identity or composition for articles subject to this
    subchapter and standards of fill of container for such articles not
    inconsistent with any such standards established under the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and there
    shall be consultation between the Secretary and the Secretary of
    Health and Human Services prior to the issuance of such standards
    under either Act relating to articles subject to this chapter to
    avoid inconsistency in such standards and possible impairment of
    the coordinated effective administration of these Acts. There shall
    also be consultation between the Secretary and an appropriate
    advisory committee provided for in section 661 of this title, prior
    to the issuance of such standards under this chapter, to avoid,
    insofar as feasible, inconsistency between Federal and State
    standards.
    (d) Sales under false or misleading name, other marking or labeling
      or in containers of misleading form or size; trade names, and
      other marking, labeling, and containers approved by Secretary
      No article subject to this subchapter shall be sold or offered
    for sale by any person, firm, or corporation, in commerce, under
    any name or other marking or labeling which is false or misleading,
    or in any container of a misleading form or size, but established
    trade names and other marking and labeling and containers which are
    not false or misleading and which are approved by the Secretary are
    permitted.
    (e) Use withholding directive respecting false or misleading
      marking, labeling, or container; modification of false or
      misleading matter; hearing; withholding use pending proceedings;
      finality of Secretary's action; judicial review; application of
      section 194 of title 7
      If the Secretary has reason to believe that any marking or
    labeling or the size or form of any container in use or proposed
    for use with respect to any article subject to this subchapter is
    false or misleading in any particular, he may direct that such use
    be withheld unless the marking, labeling, or container is modified
    in such manner as he may prescribe so that it will not be false or
    misleading. If the person, firm, or corporation using or proposing
    to use the marking, labeling or container does not accept the
    determination of the Secretary, such person, firm, or corporation
    may request a hearing, but the use of the marking, labeling, or
    container shall, if the Secretary so directs, be withheld pending
    hearing and final determination by the Secretary. Any such
    determination by the Secretary shall be conclusive unless, within
    thirty days after receipt of notice of such final determination,
    the person, firm, or corporation adversely affected thereby appeals
    to the United States court of appeals for the circuit in which such
    person, firm, or corporation has its principal place of business or
    to the United States Court of Appeals for the District of Columbia
    Circuit. The provisions of section 194 of title 7 shall be
    applicable to appeals taken under this section.
    (f) Lamb and mutton
      The Secretary, consistent with United States international
    obligations, shall establish standards for the labeling of sheep
    carcasses, parts of sheep carcasses, sheepmeat, and sheepmeat food
    products.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 7, formerly 5th par., 34
    Stat. 1262; renumbered Sec. 7 and amended Pub. L. 90-201, Secs. 1,
    3(a), 6, Dec. 15, 1967, 81 Stat. 584, 588; Pub. L. 96-88, title V,
    Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 104-127, title
    II, Sec. 279, Apr. 4, 1996, 110 Stat. 979.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (c)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.
      Either Act and these Acts, referred to in subsec. (c)(2), mean
    the Federal Meat Inspection Act and the Federal Food, Drug, and
    Cosmetic Act. The Federal Meat Inspection Act is act Mar. 4, 1907,
    ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201,
    81 Stat. 584, and amended, which are classified generally to
    subchapters I to IV (Sec. 601 et seq.), respectively, of this
    chapter. For complete classification of this Act to the Code, see
    Short Title note under section 601 of this title and Tables.

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 75 of this title.


-MISC1-
                                AMENDMENTS                            
      1996 - Subsec. (f). Pub. L. 104-127 added subsec. (f).
      1967 - Subsec. (a). Pub. L. 90-201, Secs. 3(a), 6(a), (b), struck
    out "interstate or foreign" before "commerce" and provisions
    prohibiting sales of meat or meat food products in interstate or
    foreign commerce under any false or deceptive names and permitting
    trade names or names which are usual to such products and are not
    false and deceptive and are approved by the Secretary of
    Agriculture, now incorporated in subsec. (d), and designated
    remaining provisions as subsecs. (a), respectively.
      Subsecs. (b) to (e). Pub. L. 90-201, Sec. 6(c), added subsecs.
    (b) to (e).

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in subsec. (c)(2)
    pursuant to section 509(b) of Pub. L. 96-88, which is classified to
    section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 608                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 608. Sanitary inspection and regulation of slaughtering and
      packing establishments; rejection of adulterated meat or meat
      food products

-STATUTE-
      The Secretary shall cause to be made, by experts in sanitation or
    by other competent inspectors, such inspection of all slaughtering,
    meat canning, salting, packing, rendering, or similar
    establishments in which amenable species are slaughtered and the
    meat and meat food products thereof are prepared for commerce as
    may be necessary to inform himself concerning the sanitary
    conditions of the same, and to prescribe the rules and regulations
    of sanitation under which such establishments shall be maintained;
    and where the sanitary conditions of any such establishment are
    such that the meat or meat food products are rendered adulterated,
    he shall refuse to allow said meat or meat food products to be
    labeled, marked, stamped or tagged as "inspected and passed."

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 8, formerly 6th par., 34
    Stat. 1262; renumbered Sec. 8 and amended Pub. L. 90-201, Secs. 1,
    3, 12(a), (f), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-
    97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 76 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines".
      1967 - Pub. L. 90-201, Secs. 3, 12(a), (f), struck out
    "interstate or foreign" before "commerce" and "of Agriculture"
    after "Secretary", included horses, mules, and other equines in the
    list of animals, and substituted "adulterated" for "unclean,
    unsound, unhealthful, unwholesome, or otherwise unfit for human
    food", respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 609                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 609. Examination of animals and food products thereof,
      slaughtered and prepared during nighttime

-STATUTE-
      The Secretary shall cause an examination and inspection of all
    amenable species, and the food products thereof, slaughtered and
    prepared in the establishments hereinbefore described for the
    purposes of commerce to be made during the nighttime as well as
    during the daytime when the slaughtering of said amenable species,
    or the preparation of said food products is conducted during the
    nighttime.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 9, formerly 7th par., 34
    Stat. 1262; renumbered Sec. 9 and amended Pub. L. 90-201, Secs. 1,
    3, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99-641,
    title IV, Sec. 403(d)(1), Nov. 10, 1986, 100 Stat. 3570; Pub. L.
    109-97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat.
    2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 77 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines" in two
    places.
      1986 - Pub. L. 99-641 temporarily inserted ", except as provided
    in section 606 of this title," after first reference to "other
    equines, and". See Effective and Termination Dates of 1986
    Amendment note below.
      1967 - Pub. L. 90-201, Secs. 3, 12(a), struck out "interstate or
    foreign" before "commerce" and "of Agriculture" after "Secretary"
    and included horses, mules, and other equines in the list of
    animals, respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

             EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT         
      Section 403(d)(1) of Pub. L. 99-641 provided that the amendment
    made by that section is effective only during the 6-year period
    beginning Nov. 10, 1986.
      Amendment by Pub. L. 99-641 effective Nov. 10, 1986, except that
    this section as in effect immediately before Nov. 10, 1986, applies
    with respect to establishments until the Secretary of Agriculture
    first issues rules and regulations to implement the amendments made
    by section 403(a) of Pub. L. 99-641 to section 606 of this title,
    see section 408 of Pub. L. 99-641, set out as a note under section
    606 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

          CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641      
      For provisions relating to construction and effect of temporary
    amendments by section 403 of Pub. L. 99-641, see sections 403(e)
    and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
    Services for Establishments Not Participating in Total Plant
    Quality-Control Program" and "Savings Provision", respectively,
    under section 606 of this title.

-End-



-CITE-
    21 USC Sec. 610                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 610. Prohibited acts

-STATUTE-
      No person, firm, or corporation shall, with respect to any
    cattle, sheep, swine, goats, horses, mules, or other equines, or
    any carcasses, parts of carcasses, meat or meat food products of
    any such animals - 
      (a) Slaughtering animals or preparation of articles capable of
        use as human food
        slaughter any such animals or prepare any such articles which
      are capable of use as human food at any establishment preparing
      any such articles for commerce, except in compliance with the
      requirements of this chapter;
      (b) Humane methods of slaughter
        slaughter or handle in connection with slaughter any such
      animals in any manner not in accordance with the Act of August
      27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906);
      (c) Sales, transportation, and other transactions
        sell, transport, offer for sale or transportation, or receive
      for transportation, in commerce, (1) any such articles which (A)
      are capable of use as human food and (B) are adulterated or
      misbranded at the time of such sale, transportation, offer for
      sale or transportation, or receipt for transportation; or (2) any
      articles required to be inspected under this subchapter unless
      they have been so inspected and passed;
      (d) Adulteration or misbranding
        do, with respect to any such articles which are capable of use
      as human food, any act while they are being transported in
      commerce or held for sale after such transportation, which is
      intended to cause or has the effect of causing such articles to
      be adulterated or misbranded.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 10, formerly 8th par., 34
    Stat. 1262; renumbered Sec. 10 and amended Pub. L. 90-201, Secs. 1,
    7, Dec. 15, 1967, 81 Stat. 584, 589; Pub. L. 95-445, Sec. 3, Oct.
    10, 1978, 92 Stat. 1069.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85-
    765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
    generally to chapter 48 (Sec. 1901 et seq.) of Title 7,
    Agriculture. For complete classification of this Act to the Code,
    see Tables.
      Sections 1903 and 1905 of Title 7, included within reference to
    Act of August 27, 1958, were repealed by Pub. L. 95-445, Sec. 5(b),
    Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7
    of Pub. L. 95-445, set out as an Effective Date of 1978 Amendment
    note under section 603 of this title.

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 78 of this title.


-MISC1-
                                AMENDMENTS                            
      1978 - Subsecs. (b) to (d). Pub. L. 95-445 added subsec. (b) and
    redesignated former subsecs. (b) and (c) as (c) and (d),
    respectively.
      1967 - Pub. L. 90-201, Sec. 7, included the list of animals and
    prohibited, except in compliance with requirements of this chapter,
    slaughtering animals or preparation of articles capable of use as
    human food, sales, transportation, and other transactions, and acts
    of adulteration or misbranding, incorporating in subsec. (b)(2)
    existing prohibition on distributions in interstate or foreign
    commerce of noninspected articles.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-445 effective one year after Oct. 10,
    1978, and an additional eighteen month period thereafter in
    hardship cases, see section 7 of Pub. L. 95-445, set out as an
    Effective Date of 1978 Amendment note under section 603 of this
    title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    subsecs. (b)(1) and (c) of this section effective upon expiration
    of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90-
    201, set out as an Effective Date note under section 601 of this
    title.

-End-



-CITE-
    21 USC Sec. 611                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 611. Devices, marks, labels, and certificates; simulations

-STATUTE-
    (a) Devices to be made under authorization of Secretary
      No brand manufacturer, printer, or other person, firm, or
    corporation shall cast, print, lithograph, or otherwise make any
    device containing any official mark or simulation thereof, or any
    label bearing any such mark or simulation, or any form of official
    certificate or simulation thereof, except as authorized by the
    Secretary.
    (b) Other misconduct
      No person, firm, or corporation shall - 
        (1) forge any official device, mark, or certificate;
        (2) without authorization from the Secretary use any official
      device, mark, or certificate, or simulation thereof, or alter,
      detach, deface, or destroy any official device, mark, or
      certificate;
        (3) contrary to the regulations prescribed by the Secretary,
      fail to use, or to detach, deface, or destroy any official
      device, mark, or certificate;
        (4) knowingly possess, without promptly notifying the Secretary
      or his representative, any official device or any counterfeit,
      simulated, forged, or improperly altered official certificate or
      any device or label or any carcass of any animal, or part or
      product thereof, bearing any counterfeit, simulated, forged, or
      improperly altered official mark;
        (5) knowingly make any false statement in any shipper's
      certificate or other nonofficial or official certificate provided
      for in the regulations prescribed by the Secretary; or
        (6) knowingly represent that any article has been inspected and
      passed, or exempted, under this chapter when, in fact, it has,
      respectively, not been so inspected and passed, or exempted.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 11, formerly 9th par., 34
    Stat. 1263; renumbered Sec. 11 and amended Pub. L. 90-201, Secs. 1,
    8, Dec. 15, 1967, 81 Stat. 584, 589.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 79 of this title.


-MISC1-
                                AMENDMENTS                            
      1967 - Pub. L. 90-201, Sec. 8, clarified application to brand
    manufacturers and printers of existing prohibition against
    counterfeiting official marks, labels or certificates, the
    provisions with respect to forgery, unauthorized use or failure to
    use official marks, or similar items, and similar offenses, and
    existing prohibitions with respect to false statements in official
    or nonofficial certificates, and added restriction upon possession
    of official devices, or devices, labels, meat, or other articles
    bearing counterfeit official marks, counterfeit official
    certificates, or similar items, and prohibition against false
    representations.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Secs. 612 to 614                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Secs. 612 to 614. Repealed.

-MISC1-
    Secs. 612 to 614. Repealed. Pub. L. 107-171, title X, Sec.
      10418(a)(19), May 13, 2002, 116 Stat. 508.
      Section 612, act Mar. 4, 1907, ch. 2907, title I, Sec. 12,
    formerly 10th par., 34 Stat. 1263; renumbered Sec. 12 and amended
    Pub. L. 90-201, Secs. 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584,
    588, 592, related to inspection of animals for export. Section was
    formerly classified to section 80 of this title.
      Section 613, act Mar. 4, 1907, ch. 2907, title I, Sec. 13,
    formerly 11th par., 34 Stat. 1263; renumbered Sec. 13 and amended
    Pub. L. 90-201, Secs. 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584,
    588, 592, related to inspectors of animals for export and
    certificates of condition. Section was formerly classified to
    section 81 of this title.
      Section 614, act Mar. 4, 1907, ch. 2907, title I, Sec. 14,
    formerly 12th par., 34 Stat. 1263; renumbered Sec. 14 and amended
    Pub. L. 90-201, Secs. 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584,
    588, 592, prohibited clearance to vessel carrying animals for
    export without inspector's certificate. Section was formerly
    classified to section 82 of this title.

-End-



-CITE-
    21 USC Sec. 615                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 615. Inspection of carcasses, meat of which is intended for
      export

-STATUTE-
      The Secretary shall also cause to be made a careful inspection of
    the carcasses and parts thereof of all amenable species, the meat
    of which, fresh, salted, canned, corned, packed, cured, or
    otherwise prepared, is intended and offered for export to any
    foreign country, at such times and places and in such manner as he
    may deem proper.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 15, formerly 13th par., 34
    Stat. 1263; renumbered Sec. 15 and amended Pub. L. 90-201, Secs. 1,
    3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-97,
    title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 83 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines".
      1967 - Pub. L. 90-201, Secs. 3(b), 12(a), struck out "of
    Agriculture" after "Secretary" and included horses, mules, and
    other equines in the list of animals, respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 616                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 616. Inspectors of carcasses, etc., meat of which is intended
      for export; certificates of condition

-STATUTE-
      For the purpose of section 615 of this title the Secretary may
    appoint inspectors who shall be authorized to give an official
    certificate stating the condition in which said cattle, sheep,
    swine, goats, horses, mules, or other equines, and the meat
    thereof, are found.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 16, formerly 14th par., 34
    Stat. 1263; renumbered Sec. 16 and amended Pub. L. 90-201, Secs. 1,
    3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 84 of this title.


-MISC1-
                                AMENDMENTS                            
      1967 - Pub. L. 90-201, Secs. 3(b), 12(a), struck out "of
    Agriculture" after "Secretary", and included horses, mules, or
    other equines in the list of animals.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 617                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 617. Clearance prohibited to vessel carrying meat for export
      without inspector's certificate

-STATUTE-
      No clearance shall be given to any vessel having on board any
    fresh, salted, canned, corned, or packed beef, mutton, pork, goat
    or equine meat for export to and sale in a foreign country from any
    port in the United States, until the owner or shipper thereof shall
    obtain from an inspector appointed under the provisions of this
    chapter a certificate that the said amenable species were sound and
    healthy at the time of inspection, and that their meat is sound and
    wholesome, unless the Secretary shall have waived the requirements
    of such certificate for the country to which said amenable species
    or meats are to be exported.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 17, formerly 15th par., 34
    Stat. 1263; renumbered Sec. 17 and amended Pub. L. 90-201, Secs. 1,
    3(b), 12(a), (g), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L.
    109-97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat.
    2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 85 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines" in two
    places.
      1967 - Pub. L. 90-201, Secs. 3(b), 12(a), (g), struck out "of
    Agriculture" after "Secretary", included horses, mules, and other
    equines in the list of animals, and substituted "goat or equine
    meat" for "or goat meat, being the meat of animals killed after
    March 4, 1907, or except as hereinbefore provided", respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 618                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 618. Delivery of inspectors' certificates, and of copies

-STATUTE-
      The inspectors provided for under this subchapter shall be
    authorized to give official certificates of the condition of the
    carcasses and products of amenable species; and one copy of every
    certificate granted under the provisions of this chapter shall be
    filed in the Department of Agriculture, another copy shall be
    delivered to the owner or shipper, and when the amenable species,
    or their carcasses and products are sent abroad, a third copy shall
    be delivered to the chief officer of the vessel on which the
    shipment shall be made.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 18, formerly 16th par., 34
    Stat. 1263; renumbered Sec. 18 and amended Pub. L. 90-201, Secs. 1,
    12(a), (h), Dec. 15, 1967, 81 Stat. 584, 592; Pub. L. 107-171,
    title X, Sec. 10418(b)(4), May 13, 2002, 116 Stat. 508; Pub. L. 109-
    97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-COD-
                               CODIFICATION                           
      "Provided for under this subchapter" was in the original
    "provided for herein".
      Section was formerly classified to section 86 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines" in two
    places.
      2002 - Pub. L. 107-171 substituted "of the carcasses and products
    of cattle, sheep, swine, goats, horses, mules, and other equines"
    for "of the cattle, sheep, swine, goats, horses, mules, and other
    equines, their carcasses and products as described in this
    subchapter".
      1967 - Pub. L. 90-201, Sec. 12(a), (h), included horses, mules,
    and other equines in the list of animals and struck out "sound and
    wholesome" before "conditions", respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 619                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 619. Marking, labeling, or other identification to show kinds
      of animals from which derived; separate establishments for
      preparation and slaughtering activities

-STATUTE-
      No person, firm, or corporation shall sell, transport, offer for
    sale or transportation, or receive for transportation, in commerce,
    any carcasses of species designated by regulations in effect on the
    day before November 10, 2005, or parts of such carcasses, or the
    meat or meat food products thereof, unless they are plainly and
    conspicuously marked or labeled or otherwise identified as required
    by regulations prescribed by the Secretary to show the kinds of
    animals from which they were derived. When required by the
    Secretary, with respect to establishments at which inspection is
    maintained under this subchapter, such animals and their carcasses,
    parts thereof, meat and meat food products shall be prepared in
    establishments separate from those in which other amenable species
    are slaughtered or their carcasses, parts thereof, meat or meat
    food products are prepared.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 19, formerly 17th par., 34
    Stat. 1264; renumbered Sec. 19 and amended Pub. L. 90-201, Secs. 1,
    9, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 109-97, title VII,
    Sec. 798[(a)](3), Nov. 10, 2005, 119 Stat. 2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 87 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "species designated by
    regulations in effect on the day before November 10, 2005," for
    "horses, mules, or other equines" and "other amenable species" for
    "cattle, sheep, swine, or goats".
      1967 - Pub. L. 90-201, Sec. 9, substituted provisions for
    marking, labeling, or other identification of kinds of animals
    whence the articles are derived and for separate establishments for
    preparation and slaughtering activities for prohibition against
    transportation or sale of meat or meat food products without
    complying with inspection provisions. See section 610(b) of this
    title.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L, 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration, of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 620                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 620. Imports

-STATUTE-
    (a) Adulteration or misbranding prohibition; compliance with
      inspection, building construction standards, and other
      provisions; humane methods of slaughter; treatment as domestic
      articles subject to this chapter and food, drug, and cosmetic
      provisions; marking and labeling; personal consumption exemption
      No carcasses, parts of carcasses, meat or meat food products of
    cattle, sheep, swine, goats, horses, mules, or other equines which
    are capable of use as human food, shall be imported into the United
    States if such articles are adulterated or misbranded and unless
    they comply with all the inspection, building, construction
    standards, and all other provisions of this chapter and regulations
    issued thereunder applicable to such articles in commerce within
    the United States. No such carcasses, parts of carcasses, meat or
    meat food products shall be imported into the United States unless
    the livestock from which they were produced was slaughtered and
    handled in connection with slaughter in accordance with the Act of
    August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906). All such
    imported articles shall, upon entry into the United States, be
    deemed and treated as domestic articles subject to the other
    provisions of this chapter and the Federal Food, Drug, and Cosmetic
    Act [21 U.S.C. 301 et seq.]: Provided, That they shall be marked
    and labeled as required by such regulations for imported articles:
    Provided further, That nothing in this section shall apply to any
    individual who purchases meat or meat products outside the United
    States for his own consumption except that the total amount of such
    meat or meat products shall not exceed fifty pounds.
    (b) Terms and conditions for destruction
      The Secretary may prescribe the terms and conditions for the
    destruction of all such articles which are imported contrary to
    this section, unless (1) they are exported by the consignee within
    the time fixed therefor by the Secretary, or (2) in the case of
    articles which are not in compliance with the chapter solely
    because of misbranding, such articles are brought into compliance
    with the chapter under supervision of authorized representatives of
    the Secretary.
    (c) Payment of storage, cartage, and labor charges by owner or
      consignee; liens
      All charges for storage, cartage, and labor with respect to any
    article which is imported contrary to this section shall be paid by
    the owner or consignee, and in default of such payment shall
    constitute a lien against such article and any other article
    thereafter imported under this chapter by or for such owner or
    consignee.
    (d) Prohibition
      The knowing importation of any article contrary to this section
    is prohibited.
    (e) Omitted
    (f) Inspection and other standards; applicability, enforcement,
      etc.; certifications
      Notwithstanding any other provision of law, all carcasses, parts
    of carcasses, meat, and meat food products of cattle, sheep, swine,
    goats, horses, mules, or other equines, capable of use as human
    food, offered for importation into the United States shall be
    subject to the inspection, sanitary, quality, species verification,
    and residue standards applied to products produced in the United
    States. Any such imported meat articles that do not meet such
    standards shall not be permitted entry in to the United States. The
    Secretary shall enforce this provision through (1) the imposition
    of random inspections for such species verification and for
    residues, and (2) random sampling and testing of internal organs
    and fat of the carcasses for residues at the point of slaughter by
    the exporting country in accordance with methods approved by the
    Secretary. Each foreign country from which such meat articles are
    offered for importation into the United States shall obtain a
    certification issued by the Secretary stating that the country
    maintains a program using reliable analytical methods to ensure
    compliance with the United States standards for residues in such
    meat articles. No such meat article shall be permitted entry into
    the United States from a country for which the Secretary has not
    issued such certification. The Secretary shall periodically review
    such certifications and shall revoke any certification if the
    Secretary determines that the country involved is not maintaining a
    program that uses reliable analytical methods to ensure compliance
    with United States standards for residues in such meat articles.
    The consideration of any application for a certification under this
    subsection and the review of any such certification, by the
    Secretary, shall include the inspection of individual
    establishments to ensure that the inspection program of the foreign
    country involved is meeting such United States standards.
    (g) Administration of animal drugs or antibiotics; terms and
      conditions; entry order violations
      The Secretary may prescribe terms and conditions under which
    amenable species that have been administered an animal drug or
    antibiotic banned for use in the United States may be imported for
    slaughter and human consumption. No person shall enter amenable
    species into the United States in violation of any order issued
    under this subsection by the Secretary.
    (h) Reciprocal meat inspection requirement
      (1) As used in this subsection:
        (A) The term "meat articles" means carcasses, meat and meat
      food products of cattle, sheep, swine, goats, horses, mules, or
      other equines, that are capable of use as human food.
        (B) The term "standards" means inspection, building
      construction, sanitary, quality, species verification, residue,
      and other standards that are applicable to meat articles.

      (2) On request of the Committee on Agriculture or the Committee
    on Ways and Means of the House of Representatives or the Committee
    on Agriculture, Nutrition, and Forestry or the Committee on Finance
    of the Senate, or at the initiative of the Secretary, the Secretary
    shall, as soon as practicable, determine whether a particular
    foreign country applies standards for the importation of meat
    articles from the United States that are not related to public
    health concerns about end-product quality that can be substantiated
    by reliable analytical methods.
      (3) If the Secretary determines that a foreign country applies
    standards described in paragraph (2) - 
        (A) the Secretary shall consult with the United States Trade
      Representative; and
        (B) within 30 days after the determination of the Secretary
      under paragraph (2), the Secretary and the United States Trade
      Representative shall recommend to the President whether action
      should be taken under paragraph (4).

      (4) Within 30 days after receiving a recommendation for action
    under paragraph (3), the President shall, if and for such time as
    the President considers appropriate, prohibit imports into the
    United States of any meat articles produced in such foreign country
    unless it is determined that the meat articles produced in that
    country meet the standards applicable to meat articles in commerce
    within the United States.
      (5) The action authorized under paragraph (4) may be used instead
    of, or in addition to, any other action taken under any other law.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 20, formerly 18th par., 34
    Stat. 1264; renumbered Sec. 20 and amended Pub. L. 90-201, Secs. 1,
    10, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 95-445, Sec. 4, Oct.
    10, 1978, 92 Stat. 1069; Pub. L. 97-98, title XI, Sec. 1122, Dec.
    22, 1981, 95 Stat. 1273; Pub. L. 99-198, title XVII, Sec. 1702,
    Dec. 23, 1985, 99 Stat. 1634; Pub. L. 100-418, title IV, Sec. 4604,
    Aug. 23, 1988, 102 Stat. 1408; Pub. L. 103-182, title III, Sec.
    361(f), Dec. 8, 1993, 107 Stat. 2124; Pub. L. 103-437, Sec. 8(2),
    Nov. 2, 1994, 108 Stat. 4588; Pub. L. 103-465, title IV, Sec.
    431(l), Dec. 8, 1994, 108 Stat. 4970; Pub. L. 109-97, title VII,
    Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of August 27, 1958, referred to in subsec. (a), is Pub. L. 85-
    765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
    generally to chapter 48 (Sec. 1901 et seq.) of Title 7,
    Agriculture. Sections 1903 and 1905 of Title 7, included within
    reference to Act of August 27, 1958, were repealed by Pub. L. 95-
    445, Sec. 5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set
    forth in section 7 of Pub. L. 95-445, set out as an Effective Date
    of 1978 Amendment note under section 603 of this title. For
    complete classification of this Act to the Code, see Tables.
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this act to the Code,
    see section 301 of this title and Tables.

-COD-
                               CODIFICATION                           
      Subsec. (e) of this section, which required the Secretary to
    submit to the Committee on Agriculture of the House of
    Representatives and the Committee on Agriculture, Nutrition, and
    Forestry of the Senate a comprehensive and detailed written annual
    report on the administration of this section, terminated, effective
    May 15, 2000, pursuant to section 3003 of Pub. L. 104-66, as
    amended, set out as a note under section 1113 of Title 31, Money
    and Finance. See, also, page 46 of House Document No. 103-7.
      Section was formerly classified to section 88 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Subsec. (g). Pub. L. 109-97 substituted "amenable species"
    for "cattle, sheep, swine, goats, horses, mules, and other equines"
    in two places.
      1994 - Subsec. (e). Pub. L. 103-437 substituted "Agriculture,
    Nutrition, and Forestry" for "Agriculture and Forestry" in
    introductory provisions.
      Subsec. (e)(1)(A), (B). Pub. L. 103-465, Sec. 431(l)(1), amended
    subpars. (A) and (B) generally. Prior to amendment, subpars. (A)
    and (B) read as follows:
      "(A) Subject to subparagraphs (B) and (C), a certification by the
    Secretary that foreign plants in Canada and Mexico that export
    carcasses or meat or meat products referred to in subsection (a) of
    this section have complied with paragraph (2) or with requirements
    that are equivalent to United States requirements with regard to
    all inspection and building construction standards, and all other
    provisions of this chapter and regulations issued under this
    chapter.
      "(B) Subject to subparagraph (C), the Secretary may treat as
    equivalent to a United States requirement a requirement described
    in subparagraph (A) if the exporting country provides the Secretary
    with scientific evidence or other information, in accordance with
    risk assessment methodologies agreed to by the Secretary and the
    exporting country, to demonstrate that the requirement or standard
    of the exporting country achieves the level of protection that the
    Secretary considers appropriate."
      Subsec. (e)(2) to (7). Pub. L. 103-465, Sec. 431(l)(2), (3),
    redesignated pars. (3) to (7) as (2) to (6), respectively, and
    struck out former par. (2) which read as follows: "A certification
    by the Secretary that, except as provided in paragraph (1), foreign
    plants that export carcasses or meat or meat products referred to
    in subsection (a) of this section have complied with requirements
    that are at least equal to all inspection and building construction
    standards and all other provisions of this chapter and regulations
    issued under this chapter."
      1993 - Subsec. (e). Pub. L. 103-182, Sec. 361(f)(1), substituted
    "not be limited to the following:" for "not be limited to - " in
    introductory provisions.
      Subsec. (e)(1) to (7). Pub. L. 103-182, Sec. 361(f)(2)-(7), added
    pars. (1) and (2), struck out former par. (1), redesignated pars.
    (2) to (6) as (3) to (7), respectively, substituted "The" for "the"
    at beginning of each par., substituted period for semicolon at end
    of pars. (3) to (5), and substituted period for "; and" at end of
    par. (6). Prior to amendment, former par. (1) read as follows: "a
    certification by the Secretary that foreign plants exporting
    carcasses or meat or meat products referred to in subsection (a) of
    this section have complied with requirements at least equal to all
    the inspection, building construction standards, and all other
    provisions of this chapter and regulations issued thereunder;".
      1988 - Subsec. (e)(6). Pub. L. 100-418, Sec. 4604(b), added par.
    (6).
      Subsec. (h). Pub. L. 100-418, Sec. 4604(a), added subsec. (h).
      1985 - Subsec. (f). Pub. L. 99-198, Sec. 1702(a), struck out
    provision which had made this subsection effective six months after
    Dec. 22, 1981, and inserted provisions requiring that each foreign
    country from which meat articles are offered for importation into
    the United States obtain a certification issued by the Secretary
    stating that the country maintains a program using reliable
    analytical methods to ensure compliance with the United States
    standards for residues in such meat articles, that no meat article
    be permitted entry into the United States from a country for which
    the Secretary has not issued such certification, that the Secretary
    periodically review such certifications and revoke any
    certification if the Secretary determines that the country involved
    is not maintaining a program that uses reliable analytical methods
    to ensure compliance with United States standards for residues in
    such meat articles, and that the consideration of any application
    for a certification under this subsection and the review of any
    such certification, by the Secretary, include the inspection of
    individual establishments to ensure that the inspection program of
    the foreign country involved is meeting such United States
    standards.
      Subsec. (g). Pub. L. 99-198, Sec. 1702(b), added subsec. (g).
      1981 - Subsec. (f). Pub. L. 97-98 added subsec. (f).
      1978 - Subsec. (a). Pub. L. 95-445 prohibited imports which do
    not comply with humane methods of slaughter.
      1967 - Pub. L. 90-201, Sec. 10, substituted imported articles
    provisions for penalty provisions deeming offenses as misdemeanors
    and punishable by fine of $10,000 or imprisonment for two years or
    both. See section 676(a) of this title.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by Pub. L. 103-465 effective, except as otherwise
    provided, on the date of entry into force of the World Trade
    Organization Agreement with respect to the United States [Jan. 1,
    1995], see section 451 of Pub. L. 103-465, set out as an Effective
    Date note under section 3601 of Title 19, Customs Duties.

                     EFFECTIVE DATE OF 1981 AMENDMENT                 
      Amendment by Pub. L. 97-98 effective Dec. 22, 1981, see section
    1801 of Pub. L. 97-98, set out as an Effective Date note under
    section 4301 of Title 7, Agriculture.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-445 effective one year after Oct. 10,
    1978, and an additional eighteen-month period thereafter in
    hardship cases, see section 7 of Pub. L. 95-445, set out as a note
    under section 603 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective upon expiration of sixty
    days after Dec. 15, 1967, see section 20(a) of Pub. L. 90-201, set
    out as an Effective Date note under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 621                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 621. Inspectors to make examinations provided for;
      appointment; duties; regulations

-STATUTE-
      The Secretary shall appoint from time to time inspectors to make
    examination and inspection of all amenable species, inspection of
    which is hereby provided for and of all carcasses and parts
    thereof, and of all meats and meat food products thereof, and of
    the sanitary conditions of all establishments in which such meat
    and meat food products hereinbefore described are prepared; and
    said inspectors shall refuse to stamp, mark, tag, or label any
    carcass or any part thereof, or meat food product therefrom,
    prepared in any establishment hereinbefore mentioned, until the
    same shall have actually been inspected and found to be not
    adulterated; and shall perform such other duties as are provided by
    this chapter and by the rules and regulations to be prescribed by
    said Secretary; and said Secretary shall, from time to time, make
    such rules and regulations as are necessary for the efficient
    execution of the provisions of this chapter, and all inspections
    and examinations made under this chapter, shall be such and made in
    such manner as described in the rules and regulations prescribed by
    said Secretary not inconsistent with provisions of this chapter.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 21, formerly 19th par., 34
    Stat. 1264; renumbered Sec. 21 and amended Pub. L. 90-201, Secs. 1,
    3(b), 12(a), (i), Dec. 15, 1967, 81 Stat. 584, 588, 592, 593; Pub.
    L. 99-641, title IV, Sec. 403(d)(2), Nov. 10, 1986, 100 Stat. 3570;
    Pub. L. 109-97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119
    Stat. 2166.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 89 of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
    sheep, swine, goats, horses, mules, and other equines".
      1986 - Pub. L. 99-641 temporarily substituted "thereof, and of
    meat food products" for "and meat food products", which
    substitution was made for the first such reference as the probable
    intent of Congress. See Effective and Termination Dates of 1986
    Amendment note below.
      1967 - Pub. L. 90-201, Secs. 3(b), 12(a), (i), struck out "of
    Agriculture" after "Secretary" in four places, included horses,
    mules, and other equines in the list of animals, and substituted
    "not adulterated" for "sound, healthful, wholesome, and fit for
    human food, and to contain no dyes, chemicals, preservatives, or
    ingredients which render such meat food product unsound,
    unhealthful, unwholesome, or unfit for human food; and to have been
    prepared under proper sanitary conditions, hereinbefore provided
    for", respectively.

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-97 effective the day after 120 days
    after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
    as a note under section 601 of this title.

             EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT         
      Section 403(d)(2) of Pub. L. 99-641 provided that the amendment
    made by that section is effective only during the 6-year period
    beginning on Nov. 10, 1986.
      Amendment by Pub. L. 99-641 effective Nov. 10, 1986, except that
    this section as in effect immediately before Nov. 10, 1986, applies
    with respect to establishments until the Secretary of Agriculture
    first issues rules and regulations to implement the amendments made
    by section 403(a) of Pub. L. 99-641 to section 606 of this title,
    see section 408 of Pub. L. 99-641, set out as a note under section
    606 of this title.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

          CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641      
      For provisions relating to construction and effect of temporary
    amendments by section 403 of Pub. L. 99-641, see sections 403(e)
    and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
    Services for Establishments Not Participating in Total Plant
    Quality-Control Program" and "Savings Provision", respectively,
    under section 606 of this title.

-End-



-CITE-
    21 USC Sec. 622                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 622. Bribery of or gifts to inspectors or other officers and
      acceptance of gifts

-STATUTE-
      Any person, firm, or corporation, or any agent or employee of any
    person, firm, or corporation, who shall give, pay, or offer,
    directly or indirectly, to any inspector, deputy inspector, chief
    inspector, or any other officer or employee of the United States
    authorized to perform any of the duties prescribed by this chapter
    or by the rules and regulations of the Secretary any money or other
    thing of value, with intent to influence said inspector, deputy
    inspector, chief inspector, or other officer or employee of the
    United States in the discharge of any duty provided for in this
    chapter, shall be deemed guilty of a felony, and, upon conviction
    thereof, shall be punished by a fine not less than $5,000 nor more
    than $10,000 and by imprisonment not less than one year nor more
    than three years; and any inspector, deputy inspector, chief
    inspector, or other officer or employee of the United States
    authorized to perform any of the duties prescribed by this chapter
    who shall accept any money, gift, or other thing of value from any
    person, firm, or corporation, or officers, agents, or employees
    thereof, given with intent to influence his official action, or who
    shall receive or accept from any person, firm, or corporation
    engaged in commerce any gift, money, or other thing of value, given
    with any purpose or intent whatsoever, shall be deemed guilty of a
    felony and shall, upon conviction thereof, be summarily discharged
    from office and shall be punished by a fine not less than $1,000
    nor more than $10,000 and by imprisonment not less than one year
    nor more than three years.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 22, formerly 20th par., 34
    Stat. 1264; renumbered Sec. 22 and amended Pub. L. 90-201, Secs. 1,
    3, Dec. 15, 1967, 81 Stat. 584, 588.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 90 of this title.


-MISC1-
                                AMENDMENTS                            
      1967 - Pub. L. 90-201, Sec. 3, struck out "interstate or foreign"
    before "commerce" and "of Agriculture" after "Secretary".

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
    with respect to equines (other than horses) and their carcasses and
    parts thereof, meat, and meat food products thereof, amendment
    effective upon expiration of sixty days after Dec. 15, 1967, see
    section 20(b) of Pub. L. 90-201, set out as an Effective Date note
    under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 623                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 623. Exemptions from inspection requirements

-STATUTE-
    (a) Personal slaughtering and custom slaughtering for personal,
      household, guest, and employee uses
      The provisions of this subchapter requiring inspection of the
    slaughter of animals and the preparation of the carcasses, parts
    thereof, meat and meat food products at establishments conducting
    such operations for commerce shall not apply to the slaughtering by
    any person of animals of his own raising, and the preparation by
    him and transportation in commerce of the carcasses, parts thereof,
    meat and meat food products of such animals exclusively for use by
    him and members of his household and his nonpaying guests and
    employees; nor to the custom slaughter by any person, firm, or
    corporation of cattle, sheep, swine or goats delivered by the owner
    thereof for such slaughter, and the preparation by such slaughterer
    and transportation in commerce of the carcasses, parts thereof,
    meat and meat food products of such animals, exclusively for use,
    in the household of such owner, by him and members of his household
    and his nonpaying guests and employees; nor to the custom
    preparation by any person, firm, or corporation of carcasses, parts
    thereof, meat or meat food products, derived from the slaughter by
    any person of cattle, sheep, swine, or goats of his own raising, or
    from game animals, delivered by the owner thereof for such custom
    preparation, and transportation in commerce of such custom prepared
    articles, exclusively for use in the household of such owner, by
    him and members of his household and his nonpaying guests and
    employees: Provided, That in cases where such person, firm, or
    corporation engages in such custom operations at an establishment
    at which inspection under this subchapter is maintained, the
    Secretary may exempt from such inspection at such establishment any
    animals slaughtered or any meat or meat food products otherwise
    prepared on such custom basis: Provided further, That custom
    operations at any establishment shall be exempt from inspection
    requirements as provided by this section only if the establishment
    complies with regulations which the Secretary is hereby authorized
    to promulgate to assure that any carcasses, parts thereof, meat or
    meat food products wherever handled on a custom basis, or any
    containers or packages containing such articles, are separated at
    all times from carcasses, parts thereof, meat or meat food products
    prepared for sale, and that all such articles prepared on a custom
    basis, or any containers or packages containing such articles, are
    plainly marked "Not for Sale" immediately after being prepared and
    kept so identified until delivered to the owner and that the
    establishment conducting the custom operation is maintained and
    operated in a sanitary manner.
    (b) Territorial exemption; refusal, withdrawal, or modification
      The Secretary may, under such sanitary conditions as he may by
    regulations prescribe, exempt from the inspection requirements of
    this subchapter the slaughter of animals, and the preparation of
    carcasses, parts thereof, meat and meat food products, by any
    person, firm, or corporation in any Territory not organized with a
    legislative body solely for distribution within such Territory when
    the Secretary determines that it is impracticable to provide such
    inspection within the limits of funds appropriated for
    administration of this chapter and that such exemption will
    otherwise facilitate enforcement of this chapter. The Secretary may
    refuse, withdraw, or modify any exemption under this subsection in
    his discretion whenever he determines such action is necessary to
    effectuate the purposes of this chapter.
    (c) Pizzas containing meat food products
      (1) Under such terms and conditions as the Secretary shall
    prescribe through rules and regulations issued under section 624 of
    this title that may be necessary to ensure food safety and protect
    public health such as special handling procedures, the Secretary
    shall exempt pizzas containing a meat food product from the
    inspection requirements of this chapter if - 
        (A) the meat food product components of the pizzas have been
      prepared, inspected, and passed in a cured or cooked form as
      ready-to-eat in compliance with the requirements of this chapter;
      and
        (B) the pizzas are to be served in public or private nonprofit
      institutions.

      (2) The Secretary may withdraw or modify any exemption under this
    subsection whenever the Secretary determines such action is
    necessary to ensure food safety and to protect public health. The
    Secretary may reinstate or further modify any exemption withdrawn
    or modified under this subsection.
    (d) Adulteration and misbranding provisions applicable to
      inspection-free articles
      The adulteration and misbranding provisions of this subchapter,
    other than the requirement of the inspection legend, shall apply to
    articles which are exempted from inspection or not required to be
    inspected under this section.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 23, formerly 21st, 22nd
    pars., 34 Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235;
    renumbered Sec. 23 and amended Pub. L. 90-201, Secs. 1, 11, Dec.
    15, 1967, 81 Stat. 584, 591; Pub. L. 91-342, July 18, 1970, 84
    Stat. 438; Pub. L. 102-237, title X, Sec. 1016(a), Dec. 13, 1991,
    105 Stat. 1902.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to sections 91 and 92 of this
    title.


-MISC1-
                                AMENDMENTS                            
      1991 - Subsecs. (c), (d). Pub. L. 102-237 added subsec. (c) and
    redesignated former subsec. (c) as (d).
      1970 - Subsec. (a). Pub. L. 91-342 changed proviso so as to
    permit custom slaughterers to conduct a separate inspected meat
    business, continued the exemption for owners to slaughter and
    process their own animals for their own use, authorized the
    Secretary to exempt custom slaughtering and processing performed by
    an inspected establishment, and required that custom slaughtered
    articles be clearly marked "not for sale".
      1967 - Pub. L. 90-201, Sec. 11, substituted provisions for
    personal, custom, and territorial slaughtering exemptions and for
    application of adulteration and misbranding provisions to
    inspection-free articles for farmer definition and retail butcher
    and retail dealer exemption provisions.
      1938 - Act June 29, 1948, amended section generally.

                     EFFECTIVE DATE OF 1967 AMENDMENT                 
      Amendment by Pub. L. 90-201 effective upon expiration of sixty
    days after Dec. 15, 1967, see section 20(c) of Pub. L. 90-201, set
    out as an Effective Date note under section 601 of this title.

                                REGULATIONS                            
      Secretary to issue final rules no later than Aug. 1, 1992, to
    implement exemption authorized by subsec. (c) of this section, see
    section 1016(c) of Pub. L. 102-237, set out as a note under section
    464 of this title.

-End-



-CITE-
    21 USC Sec. 624                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING

-HEAD-
    Sec. 624. Storage and handling regulations; violations; exemption
      of establishments subject to non-Federal jurisdiction

-STATUTE-
      The Secretary may by regulations prescribe conditions under which
    carcasses, parts of carcasses, meat, and meat food products of
    cattle, sheep, swine, goats, horses, mules, or other equines,
    capable of use as human food, shall be stored or otherwise handled
    by any person, firm, or corporation engaged in the business of
    buying, selling, freezing, storing, or transporting, in or for
    commerce, or importing, such articles, whenever the Secretary deems
    such action necessary to assure that such articles will not be
    adulterated or misbranded when delivered to the consumer. Violation
    of any such regulation is prohibited. However, such regulations
    shall not apply to the storage or handling of such articles at any
    retail store or other establishment in any State or organized
    Territory that would be subject to this section only because of
    purchases in commerce, if the storage and handling of such articles
    at such establishment is regulated under the laws of the State or
    Territory in which such establishment is located, in a manner which
    the Secretary, after consultation with the appropriate advisory
    committee provided for in section 661 of this title, determines is
    adequate to effectuate the purposes of this section.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title I, Sec. 24, as added Pub. L. 90-201,
    Sec. 13, Dec. 15, 1967, 81 Stat. 593.)

-End-


-CITE-
    21 USC SUBCHAPTER II - MEAT PROCESSORS AND RELATED
           INDUSTRIES                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES

-HEAD-
          SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES      

-End-



-CITE-
    21 USC Sec. 641                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES

-HEAD-
    Sec. 641. Prohibition of subchapter I inspection of articles not
      intended for use as human food; denaturation or other
      identification prior to distribution in commerce; inedible
      articles

-STATUTE-
      Inspection shall not be provided under subchapter I of this
    chapter at any establishment for the slaughter of cattle, sheep,
    swine, goats, horses, mules, or other equines, or the preparation
    of any carcasses or parts or products of such animals, which are
    not intended for use as human food, but such articles shall, prior
    to their offer for sale or transportation in commerce, unless
    naturally inedible by humans, be denatured or otherwise identified
    as prescribed by regulations of the Secretary to deter their use
    for human food. No person, firm, or corporation shall buy, sell,
    transport, or offer for sale or transportation, or receive for
    transportation, in commerce, or import, any carcasses, parts
    thereof, meat or meat food products of any such animals, which are
    not intended for use as human food unless they are denatured or
    otherwise identified as required by the regulations of the
    Secretary or are naturally inedible by humans.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title II, Sec. 201, as added Pub. L. 90-
    201, Sec. 14, Dec. 15, 1967, 81 Stat. 593.)


-MISC1-
                              EFFECTIVE DATE                          
      Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90-
    201, set out as a note under section 601 of this title.

-End-



-CITE-
    21 USC Sec. 642                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES

-HEAD-
    Sec. 642. Recordkeeping requirements

-STATUTE-
    (a) Classes of persons bound; scope of disclosure; access to places
      of business; examination of records, facilities, and inventories;
      copies; samples
      The following classes of persons, firms, and corporations shall
    keep such records as will fully and correctly disclose all
    transactions involved in their businesses; and all persons, firms,
    and corporations subject to such requirements shall, at all
    reasonable times upon notice by a duly authorized representative of
    the Secretary, afford such representative access to their places of
    business and opportunity to examine the facilities, inventory, and
    records thereof, to copy all such records, and to take reasonable
    samples of their inventory upon payment of the fair market value
    therefor - 
        (1) Any persons, firms, or corporations that engage, for
      commerce, in the business of slaughtering any cattle, sheep,
      swine, goats, horses, mules, or other equines, or preparing,
      freezing, packaging, or labeling any carcasses, or parts or
      products of carcasses, of any such animals, for use as human food
      or animal food;
        (2) Any persons, firms, or corporations that engage in the
      business of buying or selling (as meat brokers, wholesalers or
      otherwise), or transporting in commerce, or storing in or for
      commerce, or importing, any carcasses, or parts or products of
      carcasses, of any such animals;
        (3) Any persons, firms, or corporations that engage in
      business, in or for commerce, as renderers, or engage in the
      business of buying, selling, or transporting, in commerce, or
      importing, any dead, dying, disabled, or diseased cattle, sheep,
      swine, goats, horses, mules, or other equines, or parts of the
      carcasses of any such animals that died otherwise than by
      slaughter.
    (b) Period of maintenance
      Any record required to be maintained by this section shall be
    maintained for such period of time as the Secretary may by
    regulations prescribe.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title II, Sec. 202, as added Pub. L. 90-
    201, Sec. 14, Dec. 15, 1967, 81 Stat. 593.)

-End-



-CITE-
    21 USC Sec. 643                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES

-HEAD-
    Sec. 643. Registration of business, name of person, and trade names

-STATUTE-
      No person, firm, or corporation shall engage in business, in or
    for commerce, as a meat broker, renderer, or animal food
    manufacturer, or engage in business in commerce as a wholesaler of
    any carcasses, or parts or products of the carcasses, of any
    cattle, sheep, swine, goats, horses, mules, or other equines,
    whether intended for human food or other purposes, or engage in
    business as a public warehouseman storing any such articles in or
    for commerce, or engage in the business of buying, selling, or
    transporting in commerce, or importing, any dead, dying, disabled,
    or diseased animals of the specified kinds, or parts of the
    carcasses of any such animals that died otherwise than by
    slaughter, unless, when required by regulations of the Secretary,
    he has registered with the Secretary his name, and the address of
    each place of business at which, and all trade names under which,
    he conducts such business.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title II, Sec. 203, as added Pub. L. 90-
    201, Sec. 14, Dec. 15, 1967, 81 Stat. 594.)

-End-



-CITE-
    21 USC Sec. 644                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES

-HEAD-
    Sec. 644. Regulation of transactions, transportation, or
      importation of 4-D animals to prevent use as human food

-STATUTE-
      No person, firm, or corporation engaged in the business of
    buying, selling, or transporting in commerce, or importing, dead,
    dying, disabled, or diseased animals, or any parts of the carcasses
    of any animals that died otherwise than by slaughter, shall buy,
    sell, transport, offer for sale or transportation, or receive for
    transportation, in commerce, or import, any dead, dying, disabled,
    or diseased cattle, sheep, swine, goats, horses, mules or other
    equines, or parts of the carcasses of any such animals that died
    otherwise than by slaughter, unless such transaction,
    transportation or importation is made in accordance with such
    regulations as the Secretary may prescribe to assure that such
    animals, or the unwholesome parts or products thereof, will be
    prevented from being used for human food purposes.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title II, Sec. 204, as added Pub. L. 90-
    201, Sec. 14, Dec. 15, 1967, 81 Stat. 594.)

-End-



-CITE-
    21 USC Sec. 645                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES

-HEAD-
    Sec. 645. Federal provisions applicable to State or Territorial
      business transactions of a local nature and not subject to local
      authority

-STATUTE-
      The authority conferred on the Secretary by section 642, 643, or
    644 of this title with respect to persons, firms, and corporations
    engaged in the specified kinds of business in or for commerce may
    be exercised with respect to persons, firms, or corporations
    engaged, in any State or organized Territory, in such kinds of
    business but not in or for commerce, whenever the Secretary
    determines, after consultation with an appropriate advisory
    committee provided for in section 661 of this title, that the State
    or territory does not have at least equal authority under its laws
    or such authority is not exercised in a manner to effectuate the
    purposes of this chapter including the State providing for the
    Secretary or his representative being afforded access to such
    places of business and the facilities, inventories, and records
    thereof, and the taking of reasonable samples, where he determines
    necessary in carrying out his responsibilities under this chapter;
    and in such case the provisions of section 642, 643, or 644 of this
    title, respectively, shall apply to such persons, firms, and
    corporations to the same extent and in the same manner as if they
    were engaged in such business in or for commerce and the
    transactions involved were in commerce.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title II, Sec. 205, as added Pub. L. 90-
    201, Sec. 14, Dec. 15, 1967, 81 Stat. 594.)

-End-


-CITE-
    21 USC SUBCHAPTER III - FEDERAL AND STATE COOPERATION       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER III - FEDERAL AND STATE COOPERATION

-HEAD-
              SUBCHAPTER III - FEDERAL AND STATE COOPERATION          

-End-



-CITE-
    21 USC Sec. 661                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER III - FEDERAL AND STATE COOPERATION

-HEAD-
    Sec. 661. Federal and State cooperation

-STATUTE-
    (a) Congressional statement of policy
      It is the policy of the Congress to protect the consuming public
    from meat and meat food products that are adulterated or misbranded
    and to assist in efforts by State and other Government agencies to
    accomplish this objective. In furtherance of this policy - 
      (1) Development and administration of State meat inspection
        program equal to subchapter I ante and post mortem inspection,
        reinspection, and sanitation requirements
        The Secretary is authorized, whenever he determines that it
      would effectuate the purposes of this chapter, to cooperate with
      the appropriate State agency in developing and administering a
      State meat inspection program in any State which has enacted a
      State meat inspection law that imposes mandatory ante mortem and
      post mortem inspection, reinspection and sanitation requirements
      that are at least equal to those under subchapter I of this
      chapter, with respect to all or certain classes of persons
      engaged in the State in slaughtering cattle, sheep, swine, goats,
      or equines, or preparing the carcasses, parts thereof, meat or
      meat food products, of any such animals for use as human food
      solely for distribution within such State.
      (2) Development and administration of State program with
        authorities equal to subchapter II authorities; cooperation
        with Federal agencies
        The Secretary is further authorized, whenever he determines
      that it would effectuate the purposes of this chapter, to
      cooperate with appropriate State agencies in developing and
      administering State programs under State laws containing
      authorities at least equal to those provided in subchapter II of
      this chapter; and to cooperate with other agencies of the United
      States in carrying out any provisions of this chapter.
      (3) Scope of cooperation: advisory assistance, technical and
        laboratory assistance and training, and financial and other
        aid; limitation on amount; equitable allocation of Federal
        funds; adequacy of State program to obtain Federal cooperation
        and payments
        Cooperation with State agencies under this section may include
      furnishing to the appropriate State agency (i) advisory
      assistance in planning and otherwise developing an adequate State
      program under the State law; and (ii) technical and laboratory
      assistance and training (including necessary curricular and
      instructional materials and equipment), and financial and other
      aid for administration of such a program. The amount to be
      contributed to any State by the Secretary under this section from
      Federal funds for any year shall not exceed 50 per centum of the
      estimated total cost of the cooperative program; and the Federal
      funds shall be allocated among the States desiring to cooperate
      on an equitable basis. Such cooperation and payment shall be
      contingent at all times upon the administration of the State
      program in a manner which the Secretary, in consultation with the
      appropriate advisory committee appointed under paragraph (4),
      deems adequate to effectuate the purposes of this section.
      (4) Advisory committees
        The Secretary may appoint advisory committees consisting of
      such representatives of appropriate State agencies as the
      Secretary and the State agencies may designate to consult with
      him concerning State and Federal programs with respect to meat
      inspection and other matters within the scope of this chapter,
      including evaluating State programs for purposes of this chapter
      and obtaining better coordination and more uniformity among the
      State programs and between the Federal and State programs and
      adequate protection of consumers.
    (b) Single State agency; subordinate governmental unit as part of
      State agency
      The appropriate State agency with which the Secretary may
    cooperate under this chapter shall be a single agency in the State
    which is primarily responsible for the coordination of the State
    programs having objectives similar to those under this chapter.
    When the State program includes performance of certain functions by
    a municipality or other subordinate governmental unit, such unit
    shall be deemed to be a part of the State agency for purposes of
    this section.
    (c) State meat inspection requirements
    (1) Notice to Governor of nondevelopment or nonenforcement;
      designation of State as subject to subchapters I and IV; delay
      and revocation of designation; publication in Federal Register;
      notice of production of adulterated meat or meat food products;
      designation of State
      If the Secretary has reason to believe, by thirty days prior to
    the expiration of two years after December 15, 1967, that a State
    has failed to develop or is not enforcing, with respect to all
    establishments within its jurisdiction (except those that would be
    exempted from Federal inspection under subparagraph (2)) at which
    cattle, sheep, swine, goats, or equines are slaughtered, or their
    carcasses, or parts or products thereof, are prepared for use as
    human food, solely for distribution within such State, and the
    products of such establishments, requirements at least equal to
    those imposed under subchapter I and IV of this chapter, he shall
    promptly notify the Governor of the State of this fact. If the
    Secretary determines, after consultation with the Governor of the
    State, or representative selected by him, that such requirements
    have not been developed and activated, he shall promptly after the
    expiration of such two-year period designate such State as one in
    which the provisions of subchapters I and IV of this chapter shall
    apply to operations and transactions wholly within such State:
    Provided, That if the Secretary has reason to believe that the
    State will activate such requirements within one additional year,
    he may delay such designation for said period, and not designate
    the State, if he determines at the end of the year that the State
    then has such requirements in effective operation. The Secretary
    shall publish any such designation in the Federal Register and,
    upon the expiration of thirty days after such publication, the
    provisions of subchapters I and IV shall apply to operations and
    transactions and to persons, firms, and corporations engaged
    therein in the State to the same extent and in the same manner as
    if such operations and transactions were conducted in or for
    commerce. Thereafter, upon request of the Governor, the Secretary
    shall revoke such designation if the Secretary determines that such
    State has developed and will enforce requirements at least equal to
    those imposed under subchapter I and subchapter IV of this chapter:
    And provided further, That, notwithstanding any other provision of
    this section, if the Secretary determines that any establishment
    within a State is producing adulterated meat or meat food products
    for distribution within such State which would clearly endanger the
    public health he shall notify the Governor of the State and the
    appropriate Advisory Committee provided by section 661 of this
    title of such fact for effective action under State or local law.
    If the State does not take action to prevent such endangering of
    the public health within a reasonable time after such notice, as
    determined by the Secretary, in light of the risk to public health,
    the Secretary may forthwith designate any such establishment as
    subject to the provisions of subchapters I and IV of this chapter,
    and thereupon the establishment and operator thereof shall be
    subject to such provisions as though engaged in commerce until such
    time as the Secretary determines that such State has developed and
    will enforce requirements at least equal to those imposed under
    subchapter I and subchapter IV of this chapter.
    (2) Exemptions of retail stores, restaurants, and similar retail-
      type establishments; operations conducted at a restaurant
      central kitchen facility
      The provisions of this chapter requiring inspection of the
    slaughter of animals and the preparation of carcasses, parts
    thereof, meat and meat food products shall not apply to operations
    of types traditionally and usually conducted at retail stores and
    restaurants, when conducted at any retail store or restaurant or
    similar retail-type establishment for sale in normal retail
    quantities or service of such articles to consumers at such
    establishments if such establishments are subject to such
    inspection provisions only under this paragraph (c). For the
    purposes of this subparagraph, operations conducted at a restaurant
    central kitchen facility shall be considered as being conducted at
    a restaurant if the restaurant central kitchen prepares meat or
    meat food products that are ready to eat when they leave such
    facility and are served in meals or as entrees only to customers at
    restaurants owned or operated by the same person, firm, or
    corporation owning or operating such facility: Provided, That such
    facility shall be subject to the provisions of section 642 of this
    title: Provided further, That the facility may be subject to the
    inspection requirements under subchapter I of this chapter for as
    long as the Secretary deems necessary, if the Secretary determines
    that the sanitary conditions or practices of the facility or the
    processing procedures or methods at the facility are such that any
    of its meat or meat food products are rendered adulterated.
    (3) Termination of designation of State upon development and
      enforcement of minimum requirements; redesignation; designation
      for nonenforcement of minimum requirements: notice and
      publication in Federal Register
      Whenever the Secretary determines that any State designated under
    this paragraph (c) has developed and will enforce State meat
    inspection requirements at least equal to those imposed under
    subchapters I and IV of this chapter with respect to the operations
    and transactions within such State which are regulated under
    paragraph (1), he shall terminate the designation of such State
    under this paragraph (c), but this shall not preclude the
    subsequent redesignation of the State at any time upon thirty days
    notice to the Governor and publication in the Federal Register in
    accordance with this paragraph, and any State may be designated
    upon such notice and publication at any time after the period
    specified in this paragraph whether or not the State has
    theretofore been designated upon the Secretary determining that it
    is not effectively enforcing requirements at least equal to those
    imposed under subchapters I and IV of this chapter.
    (4) Periodic review; report to Congressional committees
      The Secretary shall promptly upon December 15, 1967, and
    periodically thereafter, but at least annually, review the
    requirements, including the enforcement thereof, of the several
    States not designated under this paragraph (c), with respect to the
    slaughter, and the preparation, storage, handling and distribution
    of carcasses, parts thereof, meat and meat food products, of such
    animals, and inspection of such operations and annually report
    thereon to the Committee on Agriculture of the House of
    Representatives and the Committee on Agriculture, Nutrition, and
    Forestry of the Senate in the report required under section 691
    (!1) of this title.

    (d) "State" defined
      As used in this section, the term "State" means any State
    (including the Commonwealth of Puerto Rico) or organized Territory.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title III Sec. 301, as added Pub. L. 90-
    201, Sec. 15, Dec. 15, 1967, 81 Stat. 595; amended Pub. L. 98-487,
    Sec. 1, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103-437, Sec. 8(2),
    Nov. 2, 1994, 108 Stat. 4588.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 691 of this title, referred to in subsec. (c)(4), was
    omitted from the Code.

-COD-
                               CODIFICATION                           
      In subsec. (c)(1), (4), "December 15, 1967" substituted for
    "enactment of the Wholesome Meat Act".


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (c)(4). Pub. L. 103-437 substituted "Agriculture,
    Nutrition, and Forestry" for "Agriculture and Forestry".
      1984 - Subsec. (c)(2). Pub. L. 98-487 inserted provisions
    relating to operations conducted at a restaurant central kitchen
    facility.

                              EFFECTIVE DATE                          
      Section effective Dec. 15, 1967, see section 20 of Pub. L. 90-
    201, set out as a note under section 601 of this title.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-


-CITE-
    21 USC SUBCHAPTER IV - AUXILIARY PROVISIONS                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
                   SUBCHAPTER IV - AUXILIARY PROVISIONS               

-End-



-CITE-
    21 USC Sec. 671                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 671. Inspection services; refusal or withdrawal; hearing;
      business unfitness based upon certain convictions; other
      provisions for withdrawal of services unaffected; responsible
      connection with business; finality of Secretary's actions;
      judicial review; record

-STATUTE-
      The Secretary may (for such period, or indefinitely, as he deems
    necessary to effectuate the purposes of this chapter) refuse to
    provide, or withdraw, inspection service under subchapter I of this
    chapter with respect to any establishment if he determines, after
    opportunity for a hearing is accorded to the applicant for, or
    recipient of, such service, that such applicant or recipient is
    unfit to engage in any business requiring inspection under
    subchapter I because the applicant or recipient, or anyone
    responsibly connected with the applicant or recipient, has been
    convicted, in any Federal or State court, of (1) any felony, or (2)
    more than one violation of any law, other than a felony, based upon
    the acquiring, handling, or distributing of unwholesome,
    mislabeled, or deceptively packaged food or upon fraud in
    connection with transactions in food. This section shall not affect
    in any way other provisions of this chapter for withdrawal of
    inspection services under subchapter I from establishments failing
    to maintain sanitary conditions or to destroy condemned carcasses,
    parts, meat or meat food products.
      For the purpose of this section a person shall be deemed to be
    responsibly connected with the business if he was a partner,
    officer, director, holder, or owner of 10 per centum or more of its
    voting stock or employee in a managerial or executive capacity.
      The determination and order of the Secretary with respect thereto
    under this section shall be final and conclusive unless the
    affected applicant for, or recipient of, inspection service files
    application for judicial review within thirty days after the
    effective date of such order in the appropriate court as provided
    in section 674 of this title. Judicial review of any such order
    shall be upon the record upon which the determination and order are
    based.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 401, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 597; amended Pub. L. 99-641,
    title IV, Sec. 403(b), Nov. 10, 1986, 100 Stat. 3568.)


-MISC1-
                                AMENDMENTS                            
      1986 - Subsec. (a). Pub. L. 99-641, Sec. 403(b)(1), (2)(B), (C),
    temporarily designated provisions which related to authority to
    refuse or withdraw inspection service as subsec. (a), struck out
    "any felony, or (2)" after "of (1)", and inserted "or (2) any
    felony" after "transactions in food". See Effective and Termination
    Dates of 1986 Amendment note below.
      Pub. L. 99-641, Sec. 403(b)(2)(A), which directed that subsec.
    (a) be amended by substituting "applicant for" for "applicant,
    for", could not be executed because "applicant, for" does not
    appear.
      Subsecs. (b) to (e). Pub. L. 99-641, Sec. 403(b)(6), temporarily
    added subsecs. (b) to (e). See Effective and Termination Dates of
    1986 Amendment note below.
      Subsec. (f). Pub. L. 99-641, Sec. 403(b)(3), temporarily
    designated provisions which related to other provisions for
    withdrawal of inspection services as subsec. (f). See Effective and
    Termination Dates of 1986 Amendment note below.
      Subsec. (g). Pub. L. 99-641, Sec. 403(b)(4), temporarily
    designated provisions which related to responsible connection with
    business as subsec. (g). See Effective and Termination Dates of
    1986 Amendment note below.
      Subsec. (h). Pub. L. 99-641, Sec. 403(b)(5), temporarily
    designated provisions which related to finality of determination by
    Secretary and to judicial review as subsec. (h), substituted
    "Except as provided in subsection (e)(2) of this section, the
    determination" for "The determination" and "subsection (e) of this
    section" for "this section". See Effective and Termination Dates of
    1986 Amendment note below.

             EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT         
      Section 403(b) of Pub. L. 99-641 provided that the amendment made
    by that section is effective only during the 6-year period
    beginning Nov. 10, 1986.

                              EFFECTIVE DATE                          
      Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90-
    201, set out as a note under section 601 of this title.

          CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641      
      For provisions relating to construction and effect of temporary
    amendments by section 403 of Pub. L. 99-641, see sections 403(e)
    and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
    Services for Establishments Not Participating in Total Plant
    Quality-Control Program" and "Savings Provision", respectively,
    under section 606 of this title.

-End-



-CITE-
    21 USC Sec. 672                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 672. Administrative detention; duration; pending judicial
      proceedings; notification of governmental authorities; release

-STATUTE-
      Whenever any carcass, part of a carcass, meat or meat food
    product of cattle, sheep, swine, goats, horses, mules, or other
    equines, or any product exempted from the definition of a meat food
    product, or any dead, dying, disabled, or diseased cattle, sheep,
    swine, goat, or equine is found by any authorized representative of
    the Secretary upon any premises where it is held for purposes of,
    or during or after distribution in, commerce or otherwise subject
    to subchapter I or II of this chapter, and there is reason to
    believe that any such article is adulterated or misbranded and is
    capable of use as human food, or that it has not been inspected, in
    violation of the provisions of subchapter I of this chapter or of
    any other Federal law or the laws of any State or Territory, or the
    District of Columbia, or that such article or animal has been or is
    intended to be, distributed in violation of any such provisions, it
    may be detained by such representative for a period not to exceed
    twenty days, pending action under section 673 of this title or
    notification of any Federal, State, or other governmental
    authorities having jurisdiction over such article or animal, and
    shall not be moved by any person, firm, or corporation from the
    place at which it is located when so detained, until released by
    such representative. All official marks may be required by such
    representative to be removed from such article or animal before it
    is released unless it appears to the satisfaction of the Secretary
    that the article or animal is eligible to retain such marks.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 402, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 598.)

-End-



-CITE-
    21 USC Sec. 673                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 673. Seizure and condemnation

-STATUTE-
    (a) Proceedings in rem; libel of information; jurisdiction;
      disposal by destruction or sale; proceeds into the Treasury;
      sales restrictions; bond; court costs and fees, storage, and
      other expenses against claimants; proceedings in admiralty; jury
      trial; United States as plaintiff
      (1) Any carcass, part of a carcass, meat or meat food product of
    cattle, sheep, swine, goats, horses, mules or other equines, or any
    dead, dying, disabled, or diseased cattle, sheep, swine, goat, or
    equine, that is being transported in commerce or otherwise subject
    to subchapter I or II of this chapter, or is held for sale in the
    United States after such transportation, and that (A) is or has
    been prepared, sold, transported, or otherwise distributed or
    offered or received for distribution in violation of this chapter,
    or (B) is capable of use as human food and is adulterated or
    misbranded, or (C) in any other way is in violation of this
    chapter, shall be liable to be proceeded against and seized and
    condemned, at any time, on a libel of information in any United
    States district court or other proper court as provided in section
    674 of this title within the jurisdiction of which the article or
    animal is found.
      (2) If the article or animal is condemned it shall, after entry
    of the decree, (A) be distributed in accordance with paragraph (5),
    or (B) be disposed of by destruction or sale as the court may
    direct and the proceeds, if sold, less the court costs and fees,
    and storage and other proper expenses, shall be paid into the
    Treasury of the United States, but the article or animal shall not
    be sold contrary to the provisions of this chapter, or the laws of
    the jurisdiction in which it is sold: Provided, That upon the
    execution and delivery of a good and sufficient bond conditioned
    that the article or animal shall not be sold or otherwise disposed
    of contrary to the provisions of this chapter, or the laws of the
    jurisdiction in which disposal is made, the court may direct that
    such article or animal be delivered to the owner thereof subject to
    such supervision by authorized representatives of the Secretary as
    is necessary to insure compliance with the applicable laws.
      (3) When a decree of condemnation is entered against the article
    or animal and it is released under bond, or destroyed, court costs
    and fees, and storage and other proper expenses shall be awarded
    against the person, if any, intervening as claimant of the article
    or animal.
      (4) The proceedings in such libel cases shall conform, as nearly
    as may be, to the proceedings in admiralty, except that either
    party may demand trial by jury of any issue of fact joined in any
    case, and all such proceedings shall be at the suit of and in the
    name of the United States.
      (5)(A) An article that is condemned under paragraph (1) may as
    the court may direct, after entry of the decree, be distributed
    without charge to nonprofit, private entities or to Federal, State,
    or local government entities engaged in the distribution of food
    without charge to individuals, if such article - 
        (i) has been inspected under this chapter and found to be
      wholesome and not to be adulterated within the meaning of
      paragraphs (1) through (7) and (9) of section 601(m) of this
      title and a determination is made at the time of the entry of the
      decree that such article is wholesome and not so adulterated; and
        (ii) is plainly marked "Not for Sale" on such article or its
      container.

      (B) The United States may not be held legally responsible for any
    article that is distributed under subparagraph (A) to a nonprofit,
    private entity or to a Federal, State, or local government entity,
    if such article - 
        (i) was found after inspection under this chapter to be
      wholesome and not adulterated within the meaning of paragraphs
      (1) through (7) and (9) of section 601(m) of this title and a
      determination was made at the time of the entry of the decree
      that such article was wholesome and not so adulterated; and
        (ii) was plainly marked "Not for Sale" on such article or its
      container.

      (C) The person from whom such article was seized and condemned
    may not be held legally responsible for such article, if such
    article - 
        (i) was found after inspection under this chapter to be
      wholesome and not adulterated within the meaning of paragraphs
      (1) through (7) and (9) of section 601(m) of this title and a
      determination was made at the time of the entry of the decree
      that such article was wholesome and not so adulterated; and
        (ii) was plainly marked "Not for Sale" on such article or its
      container.
    (b) Condemnation or seizure under other provisions unaffected
      The provisions of this section shall in no way derogate from
    authority for condemnation or seizure conferred by other provisions
    of this chapter, or other laws.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 403, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 598; amended Pub. L. 101-
    205, Sec. 1, Dec. 7, 1989, 103 Stat. 1829.)


-MISC1-
                                AMENDMENTS                            
      1989 - Subsec. (a). Pub. L. 101-205 designated first sentence as
    par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C),
    respectively, designated second sentence as par. (2) and inserted
    "(A) to be distributed in accordance with paragraph (5), or (B)"
    after "entry of the decree,", designated third and fourth sentences
    as pars. (3) and (4), respectively, and added par. (5).

-End-



-CITE-
    21 USC Sec. 674                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 674. Federal court jurisdiction of enforcement and injunction
      proceedings and other kinds of cases; limitations of section
      607(e) of this title

-STATUTE-
      The United States district courts, the District Court of Guam,
    the District Court of the Virgin Islands, the highest court of
    American Samoa, and the United States courts of the other
    Territories, are vested with jurisdiction specifically to enforce,
    and to prevent and restrain violations of, this chapter, and shall
    have jurisdiction in all other kinds of cases arising under this
    chapter, except as provided in section 607(e) of this title.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 404, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 599.)

-End-



-CITE-
    21 USC Sec. 675                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 675. Assaulting, resisting, or impeding certain persons;
      murder; protection of such persons

-STATUTE-
      Any person who forcibly assaults, resists, opposes, impedes,
    intimidates, or interferes with any person while engaged in or on
    account of the performance of his official duties under this
    chapter shall be fined not more than $5,000 or imprisoned not more
    than three years, or both. Whoever, in the commission of any such
    acts, uses a deadly or dangerous weapon, shall be fined not more
    than $10,000 or imprisoned not more than ten years, or both.
    Whoever kills any person while engaged in or on account of the
    performance of his official duties under this chapter shall be
    punished as provided under sections 1111 and 1114 of title 18.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 405, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 599.)

-End-



-CITE-
    21 USC Sec. 676                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 676. Violations

-STATUTE-
    (a) Misdemeanors; felonies: intent to defraud and distribution of
      adulterated articles; good faith
      Any person, firm, or corporation who violates any provision of
    this chapter for which no other criminal penalty is provided by
    this chapter shall upon conviction be subject to imprisonment for
    not more than one year, or a fine of not more than $1,000, or both
    such imprisonment and fine; but if such violation involves intent
    to defraud, or any distribution or attempted distribution of an
    article that is adulterated (except as defined in section 601(m)(8)
    of this title), such person, firm, or corporation shall be subject
    to imprisonment for not more than three years or a fine of not more
    than $10,000, or both: Provided, That no person, firm, or
    corporation, shall be subject to penalties under this section for
    receiving for transportation any article or animal in violation of
    this chapter if such receipt was made in good faith, unless such
    person, firm, or corporation refuses to furnish on request of a
    representative of the Secretary the name and address of the person
    from whom he received such article or animal, and copies of all
    documents, if any there be, pertaining to the delivery of the
    article or animal to him.
    (b) Minor violations; written notice of warning of criminal and
      civil proceedings
      Nothing in this chapter shall be construed as requiring the
    Secretary to report for prosecution or for the institution of libel
    or injunction proceedings, minor violations of this chapter
    whenever he believes that the public interest will be adequately
    served by a suitable written notice of warning.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 406, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 599; amended Pub. L. 99-641,
    title IV, Sec. 403(c), Nov. 10, 1986, 100 Stat. 3570.)


-MISC1-
                                AMENDMENTS                            
      1986 - Subsec. (b). Pub. L. 99-641, Sec. 403(c)(1), temporarily
    inserted provisions which related to factors required to be
    considered by Secretary in determining whether public interest is
    served by written notice of warning. See Effective and Termination
    Dates of 1986 Amendment note below.
      Subsec. (c). Pub. L. 99-641, Sec. 403(c)(2), temporarily added
    subsec. (c). See Effective and Termination Dates of 1986 Amendment
    note below.

             EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT         
      Section 403(c) of Pub. L. 99-641 provided that the amendment made
    by that section is effective only during the 6-year period
    beginning Nov. 10, 1986.

          CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641      
      For provisions relating to construction and effect of temporary
    amendments by section 403 of Pub. L. 99-641, see sections 403(e)
    and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
    Services for Establishments Not Participating in Total Plant
    Quality-Control Program" and "Savings Provision", respectively,
    under section 606 of this title.

-End-



-CITE-
    21 USC Sec. 677                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 677. Other Federal laws applicable for administration and
      enforcement of chapter; location of inquiries; jurisdiction of
      Federal courts

-STATUTE-
      For the efficient administration and enforcement of this chapter,
    the provisions (including penalties) of sections 46, 48, 49 and 50
    of title 15 (except paragraphs (c) through (h) of section 46 and
    the last paragraph of section 49 (!1) of title 15), and the
    provisions of section 409(l) (!1) of title 47; are made applicable
    to the jurisdiction, powers, and duties of the Secretary in
    administering and enforcing the provisions of this chapter and to
    any person, firm, or corporation with respect to whom such
    authority is exercised. The Secretary, in person or by such agents
    as he may designate, may prosecute any inquiry necessary to his
    duties under this chapter in any part of the United States, and the
    powers conferred by said sections 49 and 50 of title 15 on the
    district courts of the United States may be exercised for the
    purposes of this chapter by any court designated in section 674 of
    this title.


-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 407, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 599.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The last paragraph of section 49 of title 15, and the provisions
    of section 409(l) of title 47, referred to in text, which related
    to immunity of witnesses, were repealed by sections 211 and 242,
    respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
    929, 930. For provisions relating to immunity of witnesses, see
    section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 678                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 678. Non-Federal jurisdiction of federally regulated matters;
      prohibition of additional or different requirements for
      establishments with inspection services and as to marking,
      labeling, packaging, and ingredients; recordkeeping and related
      requirements; concurrent jurisdiction over distribution for human
      food purposes of adulterated or misbranded and imported articles;
      other matters

-STATUTE-
      Requirements within the scope of this chapter with respect to
    premises, facilities and operations of any establishment at which
    inspection is provided under subchapter I of this chapter, which
    are in addition to, or different than those made under this chapter
    may not be imposed by any State or Territory or the District of
    Columbia, except that any such jurisdiction may impose
    recordkeeping and other requirements within the scope of section
    642 of this title, if consistent therewith, with respect to any
    such establishment. Marking, labeling, packaging, or ingredient
    requirements in addition to, or different than, those made under
    this chapter may not be imposed by any State or Territory or the
    District of Columbia with respect to articles prepared at any
    establishment under inspection in accordance with the requirements
    under subchapter I of this chapter, but any State or Territory or
    the District of Columbia may, consistent with the requirements
    under this chapter, exercise concurrent jurisdiction with the
    Secretary over articles required to be inspected under said
    subchapter I, for the purpose of preventing the distribution for
    human food purposes of any such articles which are adulterated or
    misbranded and are outside of such an establishment, or, in the
    case of imported articles which are not at such an establishment,
    after their entry into the United States. This chapter shall not
    preclude any State or Territory or the District of Columbia from
    making requirement (!1) or taking other action, consistent with
    this chapter, with respect to any other matters regulated under
    this chapter.


-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 408, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 600.)

-FOOTNOTE-
    (!1) So in original. Probably should be "requirements".


-End-



-CITE-
    21 USC Sec. 679                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 679. Application of Federal Food, Drug, and Cosmetic Act

-STATUTE-
    (a) Authorities under food, drug, and cosmetic provisions
      unaffected
      Notwithstanding any other provisions of law, including section
    902(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    392(a)), the provisions of this chapter shall not derogate from any
    authority conferred by the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 301 et seq.] prior to December 15, 1967.
    (b) Enforcement proceedings; detainer authority of representatives
      of Secretary of Health and Human Services
      The detainer authority conferred by section 672 of this title
    shall apply to any authorized representative of the Secretary of
    Health and Human Services for purposes of the enforcement of the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with
    respect to any carcass, part thereof, meat, or meat food product of
    cattle, sheep, swine, goats, or equines that is outside any
    premises at which inspection is being maintained under this
    chapter, and for such purposes the first reference to the Secretary
    in section 672 of this title shall be deemed to refer to the
    Secretary of Health and Human Services.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 409, as added Pub. L. 90-
    201, Sec. 16, Dec. 15, 1967, 81 Stat. 600; amended Pub. L. 96-88,
    title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (b), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in subsec. (b)
    pursuant to section 509(b) of Pub. L. 96-88, which is classified to
    section 3508(b) of Title 20, Education.

-End-



-CITE-
    21 USC Sec. 679a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 679a. Safe Meat and Poultry Inspection Panel

-STATUTE-
    (a) Establishment
      There is established in the Department of Agriculture a permanent
    advisory panel to be known as the "Safe Meat and Poultry Inspection
    Panel" (referred to in this section as the "panel").
    (b) Duties
      (1) Review and evaluation
        The panel shall review and evaluate, as the panel considers
      necessary, the adequacy, necessity, safety, cost-effectiveness,
      and scientific merit of - 
          (A) inspection procedures of, and work rules and worker
        relations involving Federal employees employed in, plants
        inspected under this chapter;
          (B) informal petitions or proposals for changes in inspection
        procedures, processes, and techniques of plants inspected under
        this chapter;
          (C) formal changes in meat inspection regulations promulgated
        under this chapter, whether in notice, proposed, or final form;
        and
          (D) such other matters as may be referred to the panel by the
        Secretary regarding the quality or effectiveness of a safe and
        cost-effective meat inspection system under this chapter.
      (2) Reports
        (A) In general
          The panel shall submit to the Secretary a report on the
        results of each review and evaluation carried out under
        paragraph (1), including such recommendations as the panel
        considers appropriate.
        (B) Reports on formal changes
          In the case of a report concerning a formal change in meat
        inspection regulations, the report shall be made within the
        time limits prescribed for formal comments on such changes.
        (C) Publication in Federal Register
          Each report of the panel to the Secretary shall be published
        in the Federal Register.
    (c) Secretarial response
      Not later than 90 days after the publication of a panel report
    under subsection (b)(2)(C) of this section, the Secretary shall
    publish in the Federal Register any response required of the
    Secretary to the report.
    (d) Composition of panel
      The panel shall be composed of 7 members, not fewer than 5 of
    whom shall be from the food science, meat science, or poultry
    science profession, appointed to staggered terms not to exceed 3
    years by the Secretary from nominations received from the National
    Institutes of Health and the Federation of American Societies of
    Food Animal Science and based on the professional qualifications of
    the nominees.
    (e) Nominations
      (1) Initial panel
        In constituting the initial panel, the Secretary shall solicit
      6 nominees from the National Institutes of Health and 6 nominees
      from the Federation of American Societies of Food Animal Science
      for membership on the panel.
      (2) Vacancies
        Any subsequent vacancy on the panel shall be filled by the
      Secretary after soliciting 2 nominees from the National
      Institutes of Health and 2 nominees from the Federation of
      American Societies of Food Animal Science.
      (3) Requirements for nominees
        (A) In general
          Each nominee provided under paragraph (1) or (2) shall have a
        background in public health issues and a scientific expertise
        in food, meat, or poultry science or in veterinary science.
        (B) Submission of information
          The Secretary may require nominees to submit such information
        as the Secretary considers necessary prior to completing the
        selection process.
      (4) Additional nominees
        If any list of nominees provided under paragraph (1) or (2) is
      unsatisfactory to the Secretary, the Secretary may request the
      nominating entities to submit an additional list of nominees.
    (f) Travel expenses
      While away from the home or regular place of business of a member
    of the panel in the performance of services for the panel, the
    member shall be allowed travel expenses, including per diem in lieu
    of subsistence, at the same rate as a person employed
    intermittently in the Government service would be allowed under
    section 5703 of title 5.
    (g) Conflicts of interest
      The Secretary shall promulgate regulations regarding conflicts of
    interest with respect to the members of the panel.
    (h) Exemption
      The Federal Advisory Committee Act (5 U.S.C. App.) and title
    XVIII of the Food and Agriculture Act of 1977 (7 U.S.C. 2281 et
    seq.) shall not apply to the panel.
    (i) Funding
      From funds available to the Secretary to carry out this chapter
    and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
    the Secretary shall allocate such sums as may be necessary to carry
    out this section.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 410, as added Pub. L. 104-
    127, title IX, Sec. 918(a)(1)(B), Apr. 4, 1996, 110 Stat. 1188.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Advisory Committee Act, referred to in subsec. (h),
    is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is
    set out in the Appendix to Title 5, Government Organization and
    Employees.
      The Food and Agriculture Act of 1977, referred to in subsec. (h),
    is Pub. L. 95-113, Sept. 29, 1977, 91 Stat. 913, as amended. Title
    XVIII of the Act is classified generally to chapter 55A (Sec. 2281
    et seq.) of Title 7, Agriculture. For complete classification of
    this Act to the Code, see Short Title of 1977 Amendment note set
    out under section 1281 of Title 7 and Tables.
      The Poultry Products Inspection Act, referred to in subsec. (i),
    is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
    is classified generally to chapter 10 (Sec. 451 et seq.) of this
    title. For complete classification of this Act to the Code, see
    Short Title note set out under section 451 of this title and
    Tables.


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 410 of act Mar. 4, 1907, was renumbered section
    411, and is classified to section 680 of this title.

-End-



-CITE-
    21 USC Sec. 679b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 679b. Pasteurization of meat and poultry

-STATUTE-
    (1) In general
      Effective beginning not later than 30 days after May 13, 2002,
    the Secretary of Agriculture shall conduct an education program
    regarding the availability and safety of processes and treatments
    that eliminate or substantially reduce the level of pathogens on
    meat, meat food products, poultry, and poultry products.
    (2) Authorization of appropriations
      There is authorized to be appropriated such sums as are necessary
    to carry out this section.

-SOURCE-
    (Pub. L. 107-171, title X, Sec. 10808(a), May 13, 2002, 116 Stat.
    530.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Farm Security and Rural
    Investment Act of 2002, and not as part of the Federal Meat
    Inspection Act which is classified to subchapters I to IV of this
    chapter.

-End-



-CITE-
    21 USC Sec. 679c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 679c. Expansion of Food Safety Inspection Service activities

-STATUTE-
    (a) In general
      The Secretary of Agriculture may utilize existing authorities to
    give high priority to enhancing and expanding the capacity of the
    Food Safety Inspection Service to conduct activities to - 
        (1) enhance the ability of the Service to inspect and ensure
      the safety and wholesomeness of meat and poultry products;
        (2) improve the capacity of the Service to inspect
      international meat and meat products, poultry and poultry
      products, and egg products at points of origin and at ports of
      entry;
        (3) strengthen the ability of the Service to collaborate with
      relevant agencies within the Department of Agriculture and with
      other entities in the Federal Government, the States, and Indian
      tribes (as defined in section 450b(e) of title 25) through the
      sharing of information and technology; and
        (4) otherwise expand the capacity of the Service to protect
      against the threat of bioterrorism.
    (b) Authorization of appropriations
      There is authorized to be appropriated to carry out this section,
    $15,000,000 for fiscal year 2002, and such sums as may be necessary
    for each subsequent fiscal year.

-SOURCE-
    (Pub. L. 107-188, title III, Sec. 332, June 12, 2002, 116 Stat.
    679.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002, and not as part
    of the Federal Meat Inspection Act which is classified to
    subchapters I to IV of this chapter.

-End-



-CITE-
    21 USC Sec. 680                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER IV - AUXILIARY PROVISIONS

-HEAD-
    Sec. 680. Authorization of appropriations

-STATUTE-
      There are hereby authorized to be appropriated such sums as may
    be necessary to carry out the provisions of this chapter.

-SOURCE-
    (Mar. 4, 1907, ch. 2907, title IV, Sec. 411, formerly Sec. 410, as
    added Pub. L. 90-201, Sec. 16, Dec. 15, 1967, 81 Stat. 600;
    renumbered Sec. 411, Pub. L. 104-127, title IX, Sec. 918(a)(1)(A),
    Apr. 4, 1996, 110 Stat. 1188.)

-End-


-CITE-
    21 USC SUBCHAPTER V - MISCELLANEOUS PROVISIONS              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER V - MISCELLANEOUS PROVISIONS

-HEAD-
                  SUBCHAPTER V - MISCELLANEOUS PROVISIONS              

-End-



-CITE-
    21 USC Sec. 691                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER V - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 691. Omitted

-COD-
                               CODIFICATION                           
      Section, Pub. L. 90-201, Sec. 17, Dec. 15, 1967, 81 Stat. 600;
    Pub. L. 103-437, Sec. 8(3), Nov. 2, 1994, 108 Stat. 4588, which
    required the Secretary of Agriculture to report annually to the
    Committee on Agriculture of the House of Representatives and the
    Committee on Agriculture, Nutrition, and Forestry of the Senate on
    the slaughter of animals and the processing and distribution of
    carcasses and products, terminated, effective May 15, 2000,
    pursuant to section 3003 of Pub. L. 104-66, as amended, set out as
    a note under section 1113 of Title 31, Money and Finance. See,
    also, page 46 of House Document No. 103-7.

-End-



-CITE-
    21 USC Sec. 692                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER V - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 692. Inspection extended to reindeer

-STATUTE-
      The provisions of the meat inspection law may be extended to the
    inspection of reindeer.

-SOURCE-
    (June 30, 1914, ch. 131, 38 Stat. 420.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The meat inspection law, referred to in text, is classified
    generally to this chapter. At the time of enactment, such reference
    probably meant the Act of Mar. 4, 1907, ch. 2907, 34 Stat. 1260, as
    amended. That Act (formerly classified to section 71 et seq. of
    this title), was generally revised by Pub. L. 90-201, Dec. 15,
    1967, 81 Stat. 584, and is classified to this chapter. For complete
    classification of this Act to the Code, see Tables.

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Meat Inspection
    Act which is classified to subchapters I to IV of this chapter.
      Section was formerly classified to section 94 of this title.

-End-



-CITE-
    21 USC Sec. 693                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER V - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 693. Inspection of dairy products for export

-STATUTE-
      The act of March 3, 1891, as amended, for the inspection of live
    cattle and products thereof, shall be deemed to include dairy
    products intended for exportation to any foreign country, and the
    Secretary of Agriculture may apply, under rules and regulations to
    be prescribed by him, the provisions of said act for inspection and
    certification appropriate for ascertaining the purity and quality
    of such products, and may cause the same to be so marked, stamped,
    or labeled as to secure their identity and make known in the
    markets of foreign countries to which they may be sent from the
    United States their purity, quality, and grade; and all the
    provisions of said act relating to live cattle and products thereof
    for export shall apply to dairy products so inspected and
    certified.

-SOURCE-
    (May 23, 1908, ch. 192, 35 Stat. 254.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of March 3, 1891, referred to in text, is act Mar. 3, 1891,
    ch. 555, 26 Stat. 1089, which was superseded by act Mar. 4, 1907,
    ch. 2907, 34 Stat. 1260, as amended by act June 29, 1938, ch. 810,
    52 Stat. 1235 (formerly classified to section 71 et seq. of this
    title). Act Mar. 4, 1907, ch. 2907, was generally revised by Pub.
    L. 90-201, Dec. 15, 1967, 81 Stat. 584, and is classified to this
    chapter.

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Meat Inspection
    Act which is classified to subchapters I to IV of this chapter.
      Section was formerly classified to sections 94a and 132 of this
    title.

-End-



-CITE-
    21 USC Sec. 694                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER V - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 694. Authorization of appropriations

-STATUTE-
      Annual appropriations of the sum of $3,000,000 from the general
    fund of the Treasury are authorized for the expenses of the
    inspection of cattle, sheep, swine, and goats and the meat and meat
    food products thereof which enter into interstate or foreign
    commerce and for all expenses necessary to carry into effect the
    provisions of this Act relating to meat inspection, including rent
    and the employment of labor in Washington and elsewhere, for each
    year, and in addition there is authorized to be appropriated such
    other sums as may be necessary in the enforcement of the meat
    inspection laws.

-SOURCE-
    (June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756,
    Sec. 2, 48 Stat. 1225.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This Act, referred to in text, is act June 30, 1906, ch. 3913, 34
    Stat. 669, which made appropriations for the Department of
    Agriculture for the fiscal year ending June 30, 1907.

-COD-
                               CODIFICATION                           
      Section 2 of act June 26, 1934, which was classified to section
    725a of former Title 31, Money and Finance, repealed the permanent
    appropriation under the title "Meat inspection, Bureau of Animal
    Industry (fiscal year) (3-114)" effective July 1, 1935, provided
    that such portions of any Acts as make permanent appropriations to
    be expended under such account are amended so as to authorize, in
    lieu thereof, annual appropriations from the general fund of the
    Treasury in identical terms and in such amounts as now provided by
    the laws providing such permanent appropriations, and authorized,
    in addition thereto, the appropriation of "such other sums as may
    be necessary in the enforcement of the meat inspection laws." In
    the original, the parenthetical "(U.S.C., title 21, secs. 71 to 96,
    inclusive)" followed the phrase "meat inspection laws". The "meat
    inspection laws" are classified generally to this chapter.
      Section was not enacted as part of the Federal Meat Inspection
    Act which is classified to subchapters I to IV of this chapter.
      Section was formerly classified to section 95 of this title.

-End-



-CITE-
    21 USC Sec. 695                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 12 - MEAT INSPECTION
    SUBCHAPTER V - MISCELLANEOUS PROVISIONS

-HEAD-
    Sec. 695. Payment of cost of meat-inspection service; exception

-STATUTE-
      The cost of inspection rendered on and after July 1, 1948, under
    the requirements of laws relating to Federal inspection of meat and
    meat food products shall be borne by the United States except the
    cost of overtime and holiday pay paid pursuant to section 2219a of
    title 7.

-SOURCE-
    (June 5, 1948, ch. 423, 62 Stat. 344; Pub. L. 107-171, title X,
    Sec. 10703(c)(2), May 13, 2002, 116 Stat. 517.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 2219a of title 7, referred to in text, was in the
    original "section 10703 of the Farm Security and Rural Investment
    Act of 2002", meaning section 10703 of Pub. L. 107-171, which
    enacted section 2219a of Title 7, Agriculture, amended this
    section, section 468 of this title, and section 5549 of Title 5,
    Government Organization and Employees, and repealed section 394 of
    Title 7.

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Meat Inspection
    Act which is classified to subchapters I to IV of this chapter.


-MISC1-
                                AMENDMENTS                            
      2002 - Pub. L. 107-171 substituted "overtime and holiday pay paid
    pursuant to section 2219a of title 7." for "overtime pursuant to
    section 394 of title 7."
      Section was formerly classified to section 98 of this title.

-End-




-CITE-
    21 USC CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL

-HEAD-
              CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL          

-MISC1-
                  SUBCHAPTER I - CONTROL AND ENFORCEMENT              

                     PART A - INTRODUCTORY PROVISIONS                 
    Sec.                                                     
    801.        Congressional findings and declarations: controlled
                 substances.                                          
    801a.       Congressional findings and declarations: psychotropic
                 substances.                                          
    802.        Definitions.                                          
    803.        Repealed.                                             

          PART B - AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES      
    811.        Authority and criteria for classification of
                 substances.                                          
    812.        Schedules of controlled substances.                   
    813.        Treatment of controlled substance analogues.          
    814.        Removal of exemption of certain drugs.                

         PART C - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
                    DISPENSERS OF CONTROLLED SUBSTANCES
    821.        Rules and regulations.                                
    822.        Persons required to register.                         
    823.        Registration requirements.                            
    824.        Denial, revocation, or suspension of registration.    
    825.        Labeling and packaging.                               
    826.        Production quotas for controlled substances.          
    827.        Records and reports of registrants.                   
    828.        Order forms.                                          
    829.        Prescriptions.                                        
    830.        Regulation of listed chemicals and certain machines.  

                      PART D - OFFENSES AND PENALTIES                  
    841.        Prohibited acts A.                                    
    842.        Prohibited acts B.                                    
    843.        Prohibited acts C.                                    
    844.        Penalties for simple possession.                      
    844a.       Civil penalty for possession of small amounts of
                 certain controlled substances.                       
    845 to 845b. Transferred.                                         
    846.        Attempt and conspiracy.                               
    847.        Additional penalties.                                 
    848.        Continuing criminal enterprise.                       
    849.        Transportation safety offenses.                       
    850.        Information for sentencing.                           
    851.        Proceedings to establish prior convictions.           
    852.        Application of treaties and other international
                 agreements.                                          
    853.        Criminal forfeitures.                                 
    853a.       Transferred.                                          
    854.        Investment of illicit drug profits.                   
    855.        Alternative fine.                                     
    856.        Maintaining drug-involved premises.                   
    857.        Repealed.                                             
    858.        Endangering human life while illegally manufacturing
                 controlled substance.                                
    859.        Distribution to persons under age twenty-one.         
    860.        Distribution or manufacturing in or near schools and
                 colleges.                                            
    860a.       Consecutive sentence for manufacturing or
                 distributing, or possessing with intent to
                 manufacture or distribute, methamphetamine on
                 premises where children are present or reside.       
    861.        Employment or use of persons under 18 years of age in
                 drug operations.                                     
    862.        Denial of Federal benefits to drug traffickers and
                 possessors.                                          
    862a.       Denial of assistance and benefits for certain
                 drug-related convictions.                            
    862b.       Sanctioning for testing positive for controlled
                 substances.                                          
    863.        Drug paraphernalia.                                   
    864.        Anhydrous ammonia.                                    
    865.        Smuggling methamphetamine or methamphetamine precursor
                 chemicals into the United States while using
                 facilitated entry programs.                          

            PART E - ADMINISTRATIVE AND ENFORCEMENT PROVISIONS        
    871.        Attorney General.                                     
    871a.       Semiannual reports to Congress.                       
    872.        Education and research programs of Attorney General.  
    872a.       Public-private education program.                     
    873.        Cooperative arrangements.                             
    874.        Advisory committees.                                  
    875.        Administrative hearings.                              
    876.        Subpenas.                                             
    877.        Judicial review.                                      
    878.        Powers of enforcement personnel.                      
    879.        Search warrants.                                      
    880.        Administrative inspections and warrants.              
    881.        Forfeitures.                                          
    881-1, 881a. Transferred.                                         
    882.        Injunctions.                                          
    883.        Enforcement proceedings.                              
    884.        Immunity and privilege.                               
    885.        Burden of proof; liabilities.                         
    886.        Payments and advances.                                
    886a.       Diversion Control Fee Account.                        
    887.        Coordination and consolidation of post-seizure
                 administration.                                      
    888.        Repealed.                                             
    889.        Production control of controlled substances.          
    890.        Review of Federal sales of chemicals usable to
                 manufacture controlled substances.                   

                        PART F - GENERAL PROVISIONS                    
    901.        Severability.                                         
    902.        Savings provisions.                                   
    903.        Application of State law.                             
    904.        Payment of tort claims.                               

                     SUBCHAPTER II - IMPORT AND EXPORT                 
    951.        Definitions.                                          
    952.        Importation of controlled substances.                 
    953.        Exportation of controlled substances.                 
    954.        Transshipment and in-transit shipment of controlled
                 substances.                                          
    955.        Possession on board vessels, etc., arriving in or
                 departing from United States.                        
    955a to 955d. Transferred.                                        
    956.        Exemption authority.                                  
    957.        Persons required to register.                         
    958.        Registration requirements.                            
    959.        Possession, manufacture, or distribution of controlled
                 substance.                                           
    960.        Prohibited acts A.                                    
    960a.       Foreign terrorist organizations, terrorist persons and
                 groups.                                              
    961.        Prohibited acts B.                                    
    962.        Second or subsequent offenses.                        
    963.        Attempt and conspiracy.                               
    964.        Additional penalties.                                 
    965.        Applicability of part E of subchapter I.              
    966.        Authority of Secretary of the Treasury.               
    967.        Smuggling of controlled substances; investigations;
                 oaths; subpenas; witnesses; evidence; production of
                 records; territorial limits; fees and mileage of
                 witnesses.                                           
    968.        Service of subpena; proof of service.                 
    969.        Contempt proceedings.                                 
    970.        Criminal forfeitures.                                 
    971.        Notification, suspension of shipment, and penalties
                 with respect to importation and exportation of listed
                 chemicals.                                           

-End-


-CITE-
    21 USC SUBCHAPTER I - CONTROL AND ENFORCEMENT               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT

-HEAD-
                  SUBCHAPTER I - CONTROL AND ENFORCEMENT              

-End-


-CITE-
    21 USC Part A - Introductory Provisions                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part A - Introductory Provisions

-HEAD-
                     PART A - INTRODUCTORY PROVISIONS                 

-End-



-CITE-
    21 USC Sec. 801                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part A - Introductory Provisions

-HEAD-
    Sec. 801. Congressional findings and declarations: controlled
      substances

-STATUTE-
      The Congress makes the following findings and declarations:
      (1) Many of the drugs included within this subchapter have a
    useful and legitimate medical purpose and are necessary to maintain
    the health and general welfare of the American people.
      (2) The illegal importation, manufacture, distribution, and
    possession and improper use of controlled substances have a
    substantial and detrimental effect on the health and general
    welfare of the American people.
      (3) A major portion of the traffic in controlled substances flows
    through interstate and foreign commerce. Incidents of the traffic
    which are not an integral part of the interstate or foreign flow,
    such as manufacture, local distribution, and possession,
    nonetheless have a substantial and direct effect upon interstate
    commerce because - 
        (A) after manufacture, many controlled substances are
      transported in interstate commerce,
        (B) controlled substances distributed locally usually have been
      transported in interstate commerce immediately before their
      distribution, and
        (C) controlled substances possessed commonly flow through
      interstate commerce immediately prior to such possession.

      (4) Local distribution and possession of controlled substances
    contribute to swelling the interstate traffic in such substances.
      (5) Controlled substances manufactured and distributed intrastate
    cannot be differentiated from controlled substances manufactured
    and distributed interstate. Thus, it is not feasible to
    distinguish, in terms of controls, between controlled substances
    manufactured and distributed interstate and controlled substances
    manufactured and distributed intrastate.
      (6) Federal control of the intrastate incidents of the traffic in
    controlled substances is essential to the effective control of the
    interstate incidents of such traffic.
      (7) The United States is a party to the Single Convention on
    Narcotic Drugs, 1961, and other international conventions designed
    to establish effective control over international and domestic
    traffic in controlled substances.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 101, Oct. 27, 1970, 84 Stat. 1242.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in par. (1), was in the original
    "this title", meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84
    Stat. 1242, as amended, and is popularly known as the "Controlled
    Substances Act". For complete classification of title II to the
    Code, see second paragraph of Short Title note set out below and
    Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section 704 of title II of Pub. L. 91-513 provided that:
      "(a) Except as otherwise provided in this section, this title
    [see Short Title note below] shall become effective on the first
    day of the seventh calendar month that begins after the day
    immediately preceding the date of enactment [Oct. 27, 1970].
      "(b) Parts A, B, E, and F of this title [Parts A, B, E, and F of
    this subchapter], section 702 [set out as a note under section 321
    of this title], this section, and sections 705 through 709
    [sections 901 to 904 of this title and note set out below], shall
    become effective upon enactment [Oct. 27, 1970].
      "(c) Sections 305 (relating to labels and labeling) [section 825
    of this title], and 306 (relating to manufacturing quotas) [section
    826 of this title] shall become effective on the date specified in
    subsection (a) of this section, except that the Attorney General
    may by order published in the Federal Register postpone the
    effective date of either or both of these sections for such period
    as he may determine to be necessary for the efficient
    administration of this title [see Short Title note below]."

                       SHORT TITLE OF 2006 AMENDMENT                   
      Pub. L. 109-177, title VII, Sec. 701, Mar. 9, 2006, 120 Stat.
    256, provided that: "This title [see Tables for classification] may
    be cited as the 'Combat Methamphetamine Epidemic Act of 2005'."

                       SHORT TITLE OF 2005 AMENDMENT                   
      Pub. L. 109-57, Sec. 1(a), Aug. 2, 2005, 119 Stat. 592, provided
    that: "This Act [amending section 953 of this title] may be cited
    as the 'Controlled Substances Export Reform Act of 2005'."

                       SHORT TITLE OF 2004 AMENDMENT                   
      Pub. L. 108-358, Sec. 1, Oct. 22, 2004, 118 Stat. 1661, provided
    that: "This Act [enacting section 290bb-25f of Title 42, The Public
    Health and Welfare, amending sections 802 and 811 of this title,
    enacting provisions set out as notes under section 802 of this
    title and section 290aa-4 of Title 42 and listed in a table
    relating to sentencing guidelines set out as a note under section
    994 of Title 28, Judiciary and Judicial Procedure, and amending
    provisions set out as a note under section 802 of this title] may
    be cited as the 'Anabolic Steroid Control Act of 2004'."

                       SHORT TITLE OF 2003 AMENDMENT                   
      Pub. L. 108-21, title VI, Sec. 608(a), Apr. 30, 2003, 117 Stat.
    691, provided that: "This section [amending sections 843 and 856 of
    this title and enacting provisions listed in a table relating to
    sentencing guidelines set out as a note under section 994 of Title
    28, Judiciary and Judicial Procedure] may be cited as the 'Illicit
    Drug Anti-Proliferation Act of 2003'."

                      SHORT TITLE OF 2000 AMENDMENTS                  
      Pub. L. 106-310, div. B, title XXXV, Sec. 3501, Oct. 17, 2000,
    114 Stat. 1222, provided that: "This title [amending sections 823
    and 824 of this title] may be cited as the 'Drug Addiction
    Treatment Act of 2000'."
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3601, Oct. 17, 2000,
    114 Stat. 1227, provided that: "This title [enacting section 864 of
    this title and sections 290aa-5b and 290bb-9 of Title 42, The
    Public Health and Welfare, amending sections 802, 830, 853, 856,
    and 863 of this title, sections 3663 and 3663A of Title 18, Crimes
    and Criminal Procedure, section 524 of Title 28, Judiciary and
    Judicial Procedure, and sections 285o-2 and 3751 of Title 42, and
    enacting provisions set out as notes under this section and
    sections 802, 872, 873, 886, and 1706 of this title, sections 524
    and 994 of Title 28, and sections 201, 290aa-4, 290aa-5b and 3751
    of Title 42] may be cited as the 'Methamphetamine Anti-
    Proliferation Act of 2000'."
      Pub. L. 106-172, Sec. 1, Feb. 18, 2000, 114 Stat. 7, provided
    that: "This Act [amending sections 802, 827, 841 and 960 of this
    title and enacting provisions set out as notes under this section
    and section 812 of this title] may be cited as the 'Hillory J.
    Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000'."

                       SHORT TITLE OF 1998 AMENDMENT                   
      Pub. L. 105-277, div. C, title VIII, Sec. 801(a), Oct. 21, 1998,
    112 Stat. 2681-693, provided that: "This title [enacting section
    1713 of this title and section 2291-5 of Title 22, Foreign
    Relations and Intercourse, amending section 956 of this title, and
    enacting provisions set out as notes under sections 801 and 956 of
    this title and section 2291 of Title 22] may be cited as the
    'Western Hemisphere Drug Elimination Act'."
      Pub. L. 105-277, div. C, title VIII, subtitle G (Secs. 871, 872),
    Sec. 871, Oct. 21, 1998, 112 Stat. 2681-707, and Pub. L. 105-357,
    Sec. 1, Nov. 10, 1998, 112 Stat. 3271, provided that such subtitle
    and such Act, which amended section 956 of this title and enacted
    provisions set out as notes under section 956 of this title "may be
    cited as the 'Controlled Substances Trafficking Prohibition Act'."
      Pub. L. 105-277, div. E, Sec. 1, Oct. 21, 1998, 112 Stat. 2681-
    759, provided that: "This division [amending sections 841 and 960
    of this title and section 13705 of Title 42, The Public Health and
    Welfare] may be cited as the 'Methamphetamine Trafficking Penalty
    Enhancement Act of 1998'."

                      SHORT TITLE OF 1996 AMENDMENTS                  
      Pub. L. 104-305, Sec. 1, Oct. 13, 1996, 110 Stat. 3807, provided
    that: "This Act [amending sections 841, 844, 959, and 960 of this
    title and enacting provisions set out as notes under section 872 of
    this title and section 994 of Title 28, Judiciary and Judicial
    Procedure] may be cited as the 'Drug-Induced Rape Prevention and
    Punishment Act of 1996'."
      Pub. L. 104-237, Sec. 1(a), Oct. 3, 1996, 110 Stat. 3099,
    provided that: "This Act [enacting section 872a of this title,
    amending sections 802, 814, 830, 841 to 844, 853, 881, 959, and 960
    of this title and section 1607 of Title 19, Customs Duties, and
    enacting provisions set out as notes under this section and
    sections 802, 872, and 971 of this title, section 994 of Title 28,
    Judiciary and Judicial Procedure, and section 290aa-4 of Title 42,
    The Public Health and Welfare] may be cited as the 'Comprehensive
    Methamphetamine Control Act of 1996'."

                       SHORT TITLE OF 1994 AMENDMENT                   
      Pub. L. 103-322, title XVIII, Sec. 180201(a), Sept. 13, 1994, 108
    Stat. 2046, provided that: "This section [enacting section 849 of
    this title, amending section 841 of this title, and enacting
    provisions set out as a note under section 994 of Title 28,
    Judiciary and Judicial Procedure] may be cited as the 'Drug Free
    Truck Stop Act'."

                       SHORT TITLE OF 1993 AMENDMENT                   
      Pub. L. 103-200, Sec. 1, Dec. 17, 1993, 107 Stat. 2333, provided
    that: "This Act [enacting section 814 of this title, amending
    sections 802, 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of
    this title, and enacting provisions set out as a note under section
    802 of this title] may be cited as the 'Domestic Chemical Diversion
    Control Act of 1993'."

                       SHORT TITLE OF 1990 AMENDMENT                   
      Pub. L. 101-647, title XIX, Sec. 1901, Nov. 29, 1990, 104 Stat.
    4851, provided that: "This Act [probably means title XIX of Pub. L.
    101-647, which amended sections 333, 802, 812, and 844 of this
    title and section 290aa-6 of Title 42, The Public Health and
    Welfare, repealed section 333a of this title, and enacted
    provisions set out as notes under sections 802 and 829 of this
    title] may be cited as the 'Anabolic Steroids Control Act of
    1990'."

                       SHORT TITLE OF 1988 AMENDMENT                   
      Pub. L. 100-690, title VI, Sec. 6001, Nov. 18, 1988, 102 Stat.
    4312, provided that: "This title [see Tables for classification]
    may be cited as the 'Anti-Drug Abuse Amendments Act of 1988'."
      Pub. L. 100-690, title VI, Sec. 6051, Nov. 18, 1988, 102 Stat.
    4312, provided that: "This subtitle [subtitle A (Secs. 6051-6061)
    of title VI of Pub. L. 100-690, enacting section 971 of this title,
    amending sections 802, 830, 841 to 843, 872, 876, 881, 960, and 961
    of this title, and enacting provisions set out as notes under
    sections 802 and 971 of this title] may be cited as the 'Chemical
    Diversion and Trafficking Act of 1988'."
      Pub. L. 100-690, title VI, Sec. 6071, Nov. 18, 1988, 102 Stat.
    4320, provided that: "This subtitle [subtitle B (Secs. 6071-6080)
    of title VI of Pub. L. 100-690, enacting sections 881-1, 887, and
    1509 of this title, amending section 881 of this title, section
    1594 of Title 19, Customs Duties, section 524 of Title 28,
    Judiciary and Judicial Procedure, and section 782 of former Title
    49, Transportation, and enacting provisions set out as notes under
    section 881 of this title] may be cited as the 'Asset Forfeiture
    Amendments Act of 1988'."

                       SHORT TITLE OF 1986 AMENDMENT                   
      Pub. L. 99-570, Sec. 1, Oct. 27, 1986, 100 Stat. 3207, provided
    that: "This Act [see Tables for classification] may be cited as the
    'Anti-Drug Abuse Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1001, Oct. 27, 1986, 100 Stat. 3207-
    2, provided that: "This subtitle [subtitle A (Secs. 1001-1009) of
    title I of Pub. L. 99-570, amending sections 802, 841, 845, 845a,
    848, 881, 960, and 962 of this title, sections 3553 and 3583 of
    Title 18, Crimes and Criminal Procedure, rule 35 of the Federal
    Rules of Criminal Procedure, Title 18, Appendix, and section 994 of
    Title 28, Judiciary and Judicial Procedure, and enacting provisions
    set out as notes under section 841 of this title, sections 3553 and
    3583 of Title 18, and rule 35 of the Federal Rules of Criminal
    Procedure] may be cited as the 'Narcotics Penalties and Enforcement
    Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1051, Oct. 27, 1986, 100 Stat. 3207-
    8, provided that: "This subtitle [subtitle B (Secs. 1051, 1052) of
    title I of Pub. L. 99-570, amending section 844 of this title] may
    be cited as the 'Drug Possession Penalty Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1101, Oct. 27, 1986, 100 Stat. 3207-
    10, provided that: "This subtitle [subtitle C (Secs. 1101-1105) of
    title I of Pub. L. 99-570, enacting section 845b of this title and
    amending sections 841, 845, and 845a of this title] may be cited as
    the 'Juvenile Drug Trafficking Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1201, Oct. 27, 1986, 100 Stat. 3207-
    13, provided that: "This subtitle [subtitle E (Secs. 1201-1204) of
    title I of Pub. L. 99-570, enacting section 813 of this title and
    amending section 802 of this title] may be cited as the 'Controlled
    Substance Analogue Enforcement Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1251, Oct. 27, 1986, 100 Stat. 3207-
    14, provided that: "This subtitle [subtitle F (Secs. 1251-1253) of
    title I of Pub. L. 99-570, amending section 848 of this title] may
    be cited as the 'Continuing Drug Enterprises Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1301, Oct. 27, 1986, 100 Stat. 3207-
    15, provided that: "This subtitle [subtitle G (Secs. 1301, 1302)
    of title I of Pub. L. 99-570, amending section 960 of this title]
    may be cited as the 'Controlled Substances Import and Export
    Penalties Enhancement Act of 1986'."
      Pub. L. 99-570, title I, Sec. 1821, Oct. 27, 1986, 100 Stat. 3207-
    51, which provided that subtitle O (Secs. 1821-1823) of title I of
    Pub. L. 99-570, enacting section 857 of this title and provisions
    set out as a note under section 857 of this title, was to be cited
    as the "Mail Order Drug Paraphernalia Control Act", was repealed by
    Pub. L. 101-647, title XXIV, Sec. 2401(d), Nov. 29, 1990, 104 Stat.
    4859.
      Pub. L. 99-570, title I, Sec. 1991, Oct. 27, 1986, 100 Stat. 3207-
    59, provided that: "This subtitle [subtitle U (Secs. 1991, 1992)
    of title I of Pub. L. 99-570, amending section 881 of this title]
    may be cited as the 'Federal Drug Law Enforcement Agent Protection
    Act of 1986'."

                       SHORT TITLE OF 1984 AMENDMENT                   
      Pub. L. 98-473, title II, Sec. 501, Oct. 12, 1984, 98 Stat. 2068,
    provided that: "This chapter [chapter V (Secs. 501-525) of title II
    of Pub. L. 98-473, enacting section 845a of this title, amending
    sections 802, 811, 812, 822-824, 827, 841, 843, 845, 873, 881, 952,
    953, 957, 958, 960, and 962 of this title, and enacting provisions
    set out as a note under this section] may be cited as the
    'Controlled Substances Penalties Amendments Act of 1984'."
      Pub. L. 98-473, title II, Sec. 506(a), Oct. 12, 1984, 98 Stat.
    2070, provided that: "This part [part B of chapter V (Secs. 506-
    525) of title II of Pub. L. 98-473, amending sections 802, 811,
    812, 822-824, 827, 843, 873, 881, 952, 953, 957, and 958 of this
    title] may be cited as the 'Dangerous Drug Diversion Control Act of
    1984'."

                       SHORT TITLE OF 1978 AMENDMENT                   
      Pub. L. 95-633, Sec. 1, Nov. 10, 1978, 92 Stat. 3768, provided:
    "That this Act [enacting sections 801a, 830, and 852 of this title,
    amending sections 352, 802, 811, 812, 823, 827, 841 to 843, 872,
    881, 952, 953, and 965 of this title and section 242a of Title 42,
    The Public Health and Welfare, repealing section 830 of this title
    (effective Jan. 1, 1981), and enacting provisions set out as notes
    under sections 801a, 812, and 830 of this title] may be cited as
    the 'Psychotropic Substances Act of 1978'."

                       SHORT TITLE OF 1974 AMENDMENT                   
      Pub. L. 93-281, Sec. 1, May 14, 1974, 88 Stat. 124, provided:
    "That this Act [amending sections 802, 823, 824, and 827 of this
    title] may be cited as the 'Narcotic Addict Treatment Act of
    1974'."

                                SHORT TITLE                            
      Pub. L. 91-513, in the provisions preceding section 1 immediately
    following the enacting clause, provided: "That this Act [enacting
    this chapter and sections 257a, 2688l-1, 2688n-1, and 3509 of Title
    42, The Public Health and Welfare, amending sections 162, 198a,
    321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114,
    1952, and 4251 of Title 18, Crimes and Criminal Procedure, sections
    1584, 2078, 2079, and 2080 of Title 19, Customs Duties, sections
    4901, 4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and
    7655 of Title 26, Internal Revenue Code, section 2901 of Title 28,
    Judiciary and Judicial Procedure, section 304m of former Title 40,
    Public Buildings, Property, and Works, sections 201, 225a, 242,
    242a, 246, 257, 258, 259, 260, 261, 261a, 2688k, 2688l, 2688m,
    2688n, 2688o, 2688r, and 3411 of Title 42, The Public Health and
    Welfare, section 239a of former Title 46, Shipping, and section 787
    of Title 49, Appendix, Transportation, repealing sections 171 to
    174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, 360a, and
    501 to 517 of this title, sections 1401 to 1407 and 3616 of Title
    18, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to
    4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237,
    7238, and 7491 of Title 26, sections 529a and 529g of former Title
    31, Money and Finance, and section 1421m of Title 48, Territories
    and Insular Possessions, and enacting provisions set out as notes
    under this section and sections 171, 321, 822, 951, and 957 of this
    title] may be cited as the 'Comprehensive Drug Abuse Prevention and
    Control Act of 1970'."
      Section 100 of title II of Pub. L. 91-513 provided that: "This
    title [enacting this subchapter, repealing section 360a of this
    title, amending sections 321, 331, 333, 334, 360, 372, and 381 of
    this title, sections 1114 and 1952 of Title 18, Crimes and Criminal
    Procedure, and section 242 of Title 42, The Public Health and
    Welfare, and enacting provisions set out as notes under this
    section and sections 321 and 822 of this title] may be cited as the
    'Controlled Substances Act'."
      For short title and complete classification of title III of Pub.
    L. 91-513, which enacted subchapter II of this chapter, as the
    "Controlled Substances Import and Export Act", see section 1000 of
    Pub. L. 91-513, set out as a note under section 951 of this title.

                               SEVERABILITY                           
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3673, Oct. 17, 2000,
    114 Stat. 1246, provided that: "Any provision of this title [see
    Short Title of 2000 Amendments note above] held to be invalid or
    unenforceable by its terms, or as applied to any person or
    circumstance, shall be construed as to give the maximum effect
    permitted by law, unless such provision is held to be utterly
    invalid or unenforceable, in which event such provision shall be
    severed from this title and shall not affect the applicability of
    the remainder of this title, or of such provision, to other persons
    not similarly situated or to other, dissimilar circumstances."

              CONTINUATION OF ORDERS, RULES, AND REGULATIONS          
      Section 705 of title II of Pub. L. 91-513 provided that: "Any
    orders, rules, and regulations which have been promulgated under
    any law affected by this title [see Short Title note above] and
    which are in effect on the day preceding enactment of this title
    [Oct. 27, 1970] shall continue in effect until modified,
    superseded, or repealed."

          ANTI-DRUG MESSAGES ON FEDERAL GOVERNMENT INTERNET SITES      
      Pub. L. 106-391, title III, Sec. 320, Oct. 30, 2000, 114 Stat.
    1597, provided that: "Not later than 90 days after the date of the
    enactment of this Act [Oct. 30, 2000], the Administrator [of the
    National Aeronautics and Space Administration], in consultation
    with the Director of the Office of National Drug Control Policy,
    shall place anti-drug messages on Internet sites controlled by the
    National Aeronautics and Space Administration."
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3671, Oct. 17, 2000,
    114 Stat. 1245, provided that: "Not later than 90 days after the
    date of the enactment of this Act [Oct. 17, 2000], the head of each
    department, agency, and establishment of the Federal Government
    shall, in consultation with the Director of the Office of National
    Drug Control Policy, place antidrug messages on appropriate
    Internet websites controlled by such department, agency, or
    establishment which messages shall, where appropriate, contain an
    electronic hyperlink to the Internet website, if any, of the
    Office."

    PROTOCOLS FOR INVESTIGATIONS AND PROSECUTIONS RELATING TO DATE-RAPE
      DRUGS AND OTHER CONTROLLED SUBSTANCES; ANNUAL REPORT; NATIONAL
                            AWARENESS CAMPAIGN
      Pub. L. 106-172, Secs. 6, 7, Feb. 18, 2000, 114 Stat. 11,
    provided that:

      "SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS,
        FORENSIC FIELD TESTS, AND COORDINATION MECHANISM FOR
        INVESTIGATIONS AND PROSECUTIONS RELATING TO GAMMA
        HYDROXYBUTYRIC ACID, OTHER CONTROLLED SUBSTANCES, AND DESIGNER
        DRUGS.
      "(a) In General. - The Attorney General, in consultation with the
    Administrator of the Drug Enforcement Administration and the
    Director of the Federal Bureau of Investigation, shall - 
        "(1) develop - 
          "(A) model protocols for the collection of toxicology
        specimens and the taking of victim statements in connection
        with investigations into and prosecutions related to possible
        violations of the Controlled Substances Act [21 U.S.C. 801 et
        seq.] or other Federal or State laws that result in or
        contribute to rape, other crimes of violence, or other crimes
        involving abuse of gamma hydroxybutyric acid, other controlled
        substances, or so-called 'designer drugs'; and
          "(B) model training materials for law enforcement personnel
        involved in such investigations; and
        "(2) make such protocols and training materials available to
      Federal, State, and local personnel responsible for such
      investigations.
      "(b) Grant. - 
        "(1) In general. - The Attorney General shall make a grant, in
      such amount and to such public or private person or entity as the
      Attorney General considers appropriate, for the development of
      forensic field tests to assist law enforcement officials in
      detecting the presence of gamma hydroxybutyric acid and related
      substances.
        "(2) Authorization of appropriations. - There are authorized to
      be appropriated such sums as may be necessary to carry out this
      subsection.
      "(c) Report. - Not later than 180 days after the date of the
    enactment of this Act [Feb. 18, 2000], the Attorney General shall
    submit to the Committees on the Judiciary of the Senate and House
    of Representatives a report on current mechanisms for coordinating
    Federal, State, and local investigations into and prosecutions
    related to possible violations of the Controlled Substances Act [21
    U.S.C. 801 et seq.] or other Federal or State laws that result in
    or contribute to rape, other crimes of violence, or other crimes
    involving the abuse of gamma hydroxybutyric acid, other controlled
    substances, or so-called 'designer drugs'. The report shall also
    include recommendations for the improvement of such mechanisms.

      "SEC. 7. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL
        AWARENESS CAMPAIGN.
      "(a) Annual Report. - The Secretary of Health and Human Services
    (in this section referred to as the 'Secretary') shall periodically
    submit to Congress reports each of which provides an estimate of
    the number of incidents of the abuse of date-rape drugs (as defined
    in subsection (c)) that occurred during the most recent 1-year
    period for which data are available. The first such report shall be
    submitted not later than January 15, 2000, and subsequent reports
    shall be submitted annually thereafter.
      "(b) National Awareness Campaign. - 
        "(1) Development of plan; recommendations of advisory
      committee. - 
          "(A) In general. - The Secretary, in consultation with the
        Attorney General, shall develop a plan for carrying out a
        national campaign to educate individuals described in
        subparagraph (B) on the following:
            "(i) The dangers of date-rape drugs.
            "(ii) The applicability of the Controlled Substances Act
          [21 U.S.C. 801 et seq.] to such drugs, including penalties
          under such Act.
            "(iii) Recognizing the symptoms that indicate an individual
          may be a victim of such drugs, including symptoms with
          respect to sexual assault.
            "(iv) Appropriately responding when an individual has such
          symptoms.
          "(B) Intended population. - The individuals referred to in
        subparagraph (A) are young adults, youths, law enforcement
        personnel, educators, school nurses, counselors of rape
        victims, and emergency room personnel in hospitals.
          "(C) Advisory committee. - Not later than 180 days after the
        date of the enactment of this Act [Feb. 18, 2000], the
        Secretary shall establish an advisory committee to make
        recommendations to the Secretary regarding the plan under
        subparagraph (A). The committee shall be composed of
        individuals who collectively possess expertise on the effects
        of date-rape drugs and on detecting and controlling the drugs.
        "(2) Implementation of plan. - Not later than 180 days after
      the date on which the advisory committee under paragraph (1) is
      established, the Secretary, in consultation with the Attorney
      General, shall commence carrying out the national campaign under
      such paragraph in accordance with the plan developed under such
      paragraph. The campaign may be carried out directly by the
      Secretary and through grants and contracts.
        "(3) Evaluation by general accounting office [now Government
      Accountability Office]. - Not later than 2 years after the date
      on which the national campaign under paragraph (1) is commenced,
      the Comptroller General of the United States shall submit to
      Congress an evaluation of the effects with respect to date-rape
      drugs of the national campaign.
      "(c) Definition. - For purposes of this section, the term 'date-
    rape drugs' means gamma hydroxybutyric acid and its salts,
    isomers, and salts of isomers and such other drugs or substances as
    the Secretary, after consultation with the Attorney General,
    determines to be appropriate."

     CONGRESSIONAL FINDINGS REGARDING METHAMPHETAMINE MANUFACTURE AND
                                   ABUSE
      Pub. L. 104-237, Sec. 2, Oct. 3, 1996, 110 Stat. 3100, provided
    that: "The Congress finds the following:
        "(1) Methamphetamine is a very dangerous and harmful drug. It
      is highly addictive and is associated with permanent brain damage
      in long-term users.
        "(2) The abuse of methamphetamine has increased dramatically
      since 1990. This increased use has led to devastating effects on
      individuals and the community, including - 
          "(A) a dramatic increase in deaths associated with
        methamphetamine ingestion;
          "(B) an increase in the number of violent crimes associated
        with methamphetamine ingestion; and
          "(C) an increase in criminal activity associated with the
        illegal importation of methamphetamine and precursor compounds
        to support the growing appetite for this drug in the United
        States.
        "(3) Illegal methamphetamine manufacture and abuse presents an
      imminent public health threat that warrants aggressive law
      enforcement action, increased research on methamphetamine and
      other substance abuse, increased coordinated efforts to prevent
      methamphetamine abuse, and increased monitoring of the public
      health threat methamphetamine presents to the communities of the
      United States."

     SUPPORT FOR INTERNATIONAL EFFORTS TO CONTROL METHAMPHETAMINE AND
                                PRECURSORS
      Pub. L. 104-237, title I, Sec. 101, Oct. 3, 1996, 110 Stat. 3100,
    provided that: "The Attorney General, in consultation with the
    Secretary of State, shall coordinate international drug enforcement
    efforts to decrease the movement of methamphetamine and
    methamphetamine precursors into the United States."

                  INTERAGENCY METHAMPHETAMINE TASK FORCE              
      Pub. L. 104-237, title V, Sec. 501, Oct. 3, 1996, 110 Stat. 3111,
    provided that:
      "(a) Establishment. - There is established a 'Methamphetamine
    Interagency Task Force' (referred to as the 'interagency task
    force') which shall consist of the following members:
        "(1) The Attorney General, or a designee, who shall serve as
      chair.
        "(2) 2 representatives selected by the Attorney General.
        "(3) The Secretary of Education or a designee.
        "(4) The Secretary of Health and Human Services or a designee.
        "(5) 2 representatives of State and local law enforcement and
      regulatory agencies, to be selected by the Attorney General.
        "(6) 2 representatives selected by the Secretary of Health and
      Human Services.
        "(7) 5 nongovernmental experts in drug abuse prevention and
      treatment to be selected by the Attorney General.
      "(b) Responsibilities. - The interagency task force shall be
    responsible for designing, implementing, and evaluating the
    education and prevention and treatment practices and strategies of
    the Federal Government with respect to methamphetamine and other
    synthetic stimulants.
      "(c) Meetings. - The interagency task force shall meet at least
    once every 6 months.
      "(d) Funding. - The administrative expenses of the interagency
    task force shall be paid out of existing Department of Justice
    appropriations.
      "(e) FACA. - The Federal Advisory Committee Act (5 U.S.C. App. 2)
    [5 U.S.C. App.] shall apply to the interagency task force.
      "(f) Termination. - The interagency task force shall terminate 4
    years after the date of enactment of this Act [Oct. 3, 1996]."

                       SUSPICIOUS ORDERS TASK FORCE                   
      Pub. L. 104-237, title V, Sec. 504, Oct. 3, 1996, 110 Stat. 3112,
    provided that:
      "(a) In General. - The Attorney General shall establish a
    'Suspicious Orders Task Force' (the 'Task Force') which shall
    consist of - 
        "(1) appropriate personnel from the Drug Enforcement
      Administration (the 'DEA') and other Federal, State, and local
      law enforcement and regulatory agencies with the experience in
      investigating and prosecuting illegal transactions of listed
      chemicals and supplies; and
        "(2) representatives from the chemical and pharmaceutical
      industry.
      "(b) Responsibilities. - The Task Force shall be responsible for
    developing proposals to define suspicious orders of listed
    chemicals, and particularly to develop quantifiable parameters
    which can be used by registrants in determining if an order is a
    suspicious order which must be reported to DEA. The quantifiable
    parameters to be addressed will include frequency of orders,
    deviations from prior orders, and size of orders. The Task Force
    shall also recommend provisions as to what types of payment
    practices or unusual business practices shall constitute prima
    facie suspicious orders. In evaluating the proposals, the Task
    Force shall consider effectiveness, cost and feasibility for
    industry and government, and other relevant factors.
      "(c) Meetings. - The Task Force shall meet at least two times per
    year and at such other times as may be determined necessary by the
    Task Force.
      "(d) Report. - The Task Force shall present a report to the
    Attorney General on its proposals with regard to suspicious orders
    and the electronic reporting of suspicious orders within one year
    of the date of enactment of this Act [Oct. 3, 1996]. Copies of the
    report shall be forwarded to the Committees of the Senate and House
    of Representatives having jurisdiction over the regulation of
    listed chemical and controlled substances.
      "(e) Funding. - The administrative expenses of the Task Force
    shall be paid out of existing Department of Justice funds or
    appropriations.
      "(f) FACA. - The Federal Advisory Committee Act (5 U.S.C. App. 2)
    [5 U.S.C. App.] shall apply to the Task Force.
      "(g) Termination. - The Task Force shall terminate upon
    presentation of its report to the Attorney General, or two years
    after the date of enactment of this Act [Oct. 3, 1996], whichever
    is sooner."

           JOINT FEDERAL TASK FORCE ON ILLEGAL DRUG LABORATORIES       
      Pub. L. 100-690, title II, Sec. 2405, Nov. 18, 1988, 102 Stat.
    4231, provided that:
      "(a) Establishment of Task Force. - There is established the
    Joint Federal Task Force on Illegal Drug Laboratories (hereafter in
    this section referred to as the 'Task Force').
      "(b) Appointment and Membership of Task Force. - The members of
    the Task Force shall be appointed by the Administrators of the
    Environmental Protection Agency and the Drug Enforcement
    Administration (hereafter in this section referred to as the
    'Administrators'). The Task Force shall consist of at least 6 and
    not more than 20 members. Each Administrator shall appoint one-half
    of the members as follows: (1) the Administrator of the
    Environmental Protection Agency shall appoint members from among
    Emergency Response Technicians and other appropriate employees of
    the Agency; and (2) the Administrator of the Drug Enforcement
    Administration shall appoint members from among Special Agents
    assigned to field divisions and other appropriate employees of the
    Administration.
      "(c) Duties of Task Force. - The Task Force shall formulate,
    establish, and implement a program for the cleanup and disposal of
    hazardous waste produced by illegal drug laboratories. In
    formulating such program, the Task Force shall consider the
    following factors:
        "(1) The volume of hazardous waste produced by illegal drug
      laboratories.
        "(2) The cost of cleaning up and disposing of hazardous waste
      produced by illegal drug laboratories.
        "(3) The effectiveness of the various methods of cleaning up
      and disposing of hazardous waste produced by illegal drug
      laboratories.
        "(4) The coordination of the efforts of the Environmental
      Protection Agency and the Drug Enforcement Administration in
      cleaning up and disposing of hazardous waste produced by illegal
      drug laboratories.
        "(5) The dissemination of information to law enforcement
      agencies that have responsibility for enforcement of drug laws.
      "(d) Guidelines. - The Task Force shall recommend to the
    Administrators guidelines for cleanup of illegal drug laboratories
    to protect the public health and environment. Not later than 180
    days after the date of the enactment of this subtitle [Nov. 18,
    1988], the Administrators shall formulate and publish such
    guidelines.
      "(e) Demonstration Projects. - 
        "(1) The Attorney General shall make grants to, and enter into
      contracts with, State and local governments for demonstration
      projects to clean up and safely dispose of substances associated
      with illegal drug laboratories which may present a danger to
      public health or the environment.
        "(2) The Attorney General may not under this subsection make a
      grant or enter into a contract unless the applicant for such
      assistance agrees to comply with the guidelines issued pursuant
      to subsection (d).
        "(3) The Attorney General shall, through grant or contract,
      provide for independent evaluations of the activities carried out
      pursuant to this subsection and shall recommend appropriate
      legislation to the Congress.
      "(f) Funding. - Of the amounts made available to carry out the
    Controlled Substances Act [21 U.S.C. 801 et seq.] for fiscal year
    1989, not less than $5,000,000 shall be made available to carry out
    subsections (d) and (e).
      "(g) Reports. - After consultation with the Task Force, the
    Administrators shall - 
        "(1) transmit to the President and to each House of Congress
      not later than 270 days after the date of the enactment of this
      subtitle [Nov. 18, 1988] a report describing the program
      established by the Task Force under subsection (c) (including an
      analysis of the factors specified in paragraphs (1) through (5)
      of that subsection);
        "(2) periodically transmit to the President and to each House
      of Congress reports describing the implementation of the program
      established by the Task Force under subsection (c) (including an
      analysis of the factors specified in paragraphs (1) through (5)
      of that subsection) and the progress made in the cleanup and
      disposal of hazardous waste produced by illegal drug
      laboratories; and
        "(3) transmit to each House of Congress a report describing the
      findings made as a result of the evaluations referred to in
      subsection (e)(3)."

                       GREAT LAKES DRUG INTERDICTION                   
      Pub. L. 100-690, title VII, Sec. 7404, Nov. 18, 1988, 102 Stat.
    4484, provided that:
      "(a) Interagency Agreement. - The Secretary of Transportation and
    the Secretary of the Treasury shall enter into an agreement for the
    purpose of increasing the effectiveness of maritime drug
    interdiction activities of the Coast Guard and the Customs Service
    in the Great Lakes area.
      "(b) Negotiations With Canada on Drug Enforcement Cooperation. -
    The Secretary of State is encouraged to enter into negotiations
    with appropriate officials of the Government of Canada for the
    purpose of establishing an agreement between the United States and
    Canada which provides for increased cooperation and sharing of
    information between United States and Canadian law enforcement
    officials with respect to law enforcement efforts conducted on the
    Great Lakes between the United States and Canada."
      [For transfer of authorities, functions, personnel, and assets of
    the Coast Guard, including the authorities and functions of the
    Secretary of Transportation relating thereto, to the Department of
    Homeland Security, and for treatment of related references, see
    sections 468(b), 551(d), 552(d), and 557 of Title 6, Domestic
    Security, and the Department of Homeland Security Reorganization
    Plan of November 25, 2002, as modified, set out as a note under
    section 542 of Title 6.]
      [For transfer of functions, personnel, assets, and liabilities of
    the United States Customs Service of the Department of the
    Treasury, including functions of the Secretary of the Treasury
    relating thereto, to the Secretary of Homeland Security, and for
    treatment of related references, see sections 203(1), 551(d),
    552(d), and 557 of Title 6, Domestic Security, and the Department
    of Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.]

        GAO STUDY OF CAPABILITIES OF UNITED STATES TO CONTROL DRUG
                       SMUGGLING INTO UNITED STATES
      Pub. L. 100-180, div. A, title XII, Sec. 1241, Dec. 4, 1987, 101
    Stat. 1162, directed Comptroller General of the United States to
    conduct a comprehensive study regarding smuggling of illegal drugs
    into United States and current capabilities of United States to
    deter such smuggling, with special consideration given to issues
    involving use of military and National Guard units along with
    Customs Service in cooperative drug smuggling interdiction efforts,
    and to issue, not later than Apr. 30, 1988, and Mar. 31, 1989,
    reports to Congress outlining results of this study.

                        COMPLIANCE WITH BUDGET ACT                    
      Pub. L. 99-570, Sec. 3, Oct. 27, 1986, 100 Stat. 3207-1, provided
    that: "Notwithstanding any other provision of this Act [see Tables
    for classification], any spending authority and any credit
    authority provided under this Act shall be effective for any fiscal
    year only to such extent or in such amounts as are provided in
    appropriation Acts. For purposes of this Act, the term 'spending
    authority' has the meaning provided in section 401(c)(2) of the
    Congressional Budget Act of 1974 [2 U.S.C. 651(c)(2)] and the term
    'credit authority' has the meaning provided in section 3(10) of the
    Congresssional [sic] Budget Act of 1974 [2 U.S.C. 622(10)]."

                             DRUG INTERDICTION                         
      Pub. L. 99-570, title III, Secs. 3001-3003, 3301, Oct. 27, 1986,
    100 Stat. 3207-73, 3207-74, 3207-98, as amended by Pub. L. 104-66,
    title I, Sec. 1091(a), Dec. 21, 1995, 109 Stat. 722, provided that:

      "SEC. 3001. SHORT TITLE.
      "This title [enacting section 379 of Title 10, Armed Forces,
    sections 1590, 1628, 1629, and 2081 of Title 19, Customs Duties,
    and section 312a of Title 47, Telegraphs, Telephones, and
    Radiotelegraphs, amending section 959 of this title, sections 374
    and 911 of Title 10, sections 507, 1401, 1433, 1436, 1454, 1459,
    1497, 1509, 1584 to 1586, 1594 to 1595a, 1613, 1613b, 1619, and
    1622 of Title 19, section 5316 of Title 31, Money and Finance,
    section 12109 of Title 46, Shipping, sections 1901 to 1904 of Title
    46, Appendix, Shipping, and sections 1401, 1472, 1474, and 1509 of
    former Title 49, Transportation, repealing section 1460 of Title
    19, enacting provisions set out as notes under section 801 of this
    title, sections 371, 374, 525, and 9441 of Title 10, sections 1613b
    and 1654 of Title 19, section 403 of Title 23, Highways, section
    1901 of Title 46, Appendix, section 11344 of Title 49, and section
    1509 of former Title 49, and repealing provisions set out as a note
    under section 89 of Title 14, Coast Guard] may be cited as the
    'National Drug Interdiction Improvement Act of 1986'.

      "SEC. 3002. FINDINGS.
      "The Congress hereby finds that - 
        "(1) a balanced, coordinated, multifaceted strategy for
      combating the growing drug abuse and drug trafficking problem in
      the United States is essential in order to stop the flow and
      abuse of drugs within our borders;
        "(2) a balanced, coordinated, multifaceted strategy for
      combating the narcotics drug abuse and trafficking in the United
      States should include - 
          "(A) increased investigations of large networks of drug
        smuggler organizations;
          "(B) source country drug eradication;
          "(C) increased emphasis on stopping narcotics traffickers in
        countries through which drugs are transshipped;
          "(D) increased emphasis on drug education programs in the
        schools and workplace;
          "(E) increased Federal Government assistance to State and
        local agencies, civic groups, school systems, and officials in
        their efforts to combat the drug abuse and trafficking problem
        at the local level; and
          "(F) increased emphasis on the interdiction of drugs and drug
        smugglers at the borders of the United States, in the air, at
        sea, and on the land;
        "(3) funds to support the interdiction of narcotics smugglers
      who threaten the transport of drugs through the air, on the sea,
      and across the land borders of the United States should be
      emphasized in the Federal Government budget process to the same
      extent as the other elements of a comprehensive antidrug effort
      are emphasized;
        "(4) the Department of Defense and the use of its resources
      should be an integral part of a comprehensive, natonal [national]
      drug interdiction program;
        "(5) the Federal Government civilian agencies engaged in drug
      interdiction, particularly the United States Customs Service and
      the Coast Guard, currently lack the aircraft, ships, radar,
      command, control, communications, and intelligence (C3I) system,
      and manpower resources necessary to mount a comprehensive attack
      on the narcotics traffickers who threaten the United States;
        "(6) the civilian drug interdiction agencies of the United
      States are currently interdicting only a small percentage of the
      illegal, drug smuggler penetrations in the United States every
      year;
        "(7) the budgets for our civilian drug interdiction agencies,
      primarily the United States Customs Service and the Coast Guard,
      have not kept pace with those of the traditional investigative
      law enforcement agencies of the Department of Justice; and
        "(8) since the amendment of the Posse Comitatus Act (18 U.S.C.
      1385) in 1981, the Department of Defense has assisted in the
      effort to interdict drugs, but they can do more.

      "SEC. 3003. PURPOSES.
      "It is the purpose of this title - 
        "(1) to increase the level of funding and resources available
      to civilian drug interdiction agencies of the Federal Government;
        "(2) to increase the level of support from the Department of
      Defense as consistent with the Posse Comitatus Act [18 U.S.C.
      1385], for interdiction of the narcotics traffickers before such
      traffickers penetrate the borders of the United States; and
        "(3) to improve other drug interdiction programs of the Federal
      Government.

      "SEC. 3301. ESTABLISHMENT OF A UNITED STATES-BAHAMAS DRUG
        INTERDICTION TASK FORCE
      "(a) Authorization of Appropriations. - 
        "(1) Establishment of a united states-bahamas drug interdiction
      task force. - (A) There is authorized to be established a United
      States-Bahamas Drug Interdiction Task Force to be operated
      jointly by the United States Government and the Government of the
      Bahamas.
        "(B) The Secretary of State, the Commandant of the Coast Guard,
      the Commissioner of Customs, the Attorney General, and the head
      of the National Narcotics Border Interdiction System (NNBIS),
      shall upon enactment of this Act [Oct. 27, 1986], immediately
      commence negotiations with the Government of the Bahamas to enter
      into a detailed agreement for the establishment and operation of
      a new drug interdiction task force, including plans for (i) the
      joint operation and maintenance of any drug interdiction assets
      authorized for the task force in this section and section 3141
      [see 19 U.S.C. 2075], and (ii) any training and personnel
      enhancements authorized in this section and section 3141.
        "(2) Amounts authorized. - There are authorized to be
      appropriated, in addition to any other amounts authorized to be
      appropriated in this title [see section 3001 of Pub. L. 99-570
      set out above], $10,000,000 for the following:
          "(A) $9,000,000 for 3 drug interdiction pursuit helicopters
        for use primarily for operations of the United States-Bahamas
        Drug Interdiction Task Force established under this section;
        and
          "(B) $1,000,000 to enhance communications capabilities for
        the operation of a United States-Bahamas Drug Interdiction Task
        Force established under this section.
        "(3) Coast guard-bahamas drug interdiction docking facility. -
      (A) There is authorized to be appropriated for acquisition,
      construction, and improvements for the Coast Guard for fiscal
      year 1987, $5,000,000, to be used for initial design engineering,
      and other activities for construction of a drug interdiction
      docking facility in the Bahamas to facilitate Coast Guard and
      Bahamian drug interdiction operations in and through the Bahama
      Islands. Of the amounts authorized to be appropriated in this
      subsection, such sums as may be necessary shall be available for
      necessary communication and air support.
        "(B) The Commandant of the Coast Guard shall use such amounts
      appropriated pursuant to the authorization in this paragraph as
      may be necessary to establish a repair, maintenance, and boat
      lift facility to provide repair and maintenance services for both
      Coast Guard and Bahamian marine drug interdiction equipment,
      vessels, and related assets.
      "(b) Concurrence by Secretary of State. - Programs authorized by
    this section may be carried out only with the concurrence of the
    Secretary of State."

                INFORMATION ON DRUG ABUSE AT THE WORKPLACE            
      Pub. L. 99-570, title IV, Sec. 4303, Oct. 27, 1986, 100 Stat.
    3207-154, directed Secretary of Labor to collect such information
    as is available on the incidence of drug abuse in the workplace and
    efforts to assist workers, including counseling, rehabilitation and
    employee assistance programs, to conduct such additional research
    as is necessary to assess the impact and extent of drug abuse and
    remediation efforts, and submit the findings of such collection and
    research to Congress no later than two years from Oct. 27, 1986.

                         INTERAGENCY COORDINATION                     
      Pub. L. 99-570, title IV, Sec. 4304, Oct. 27, 1986, 100 Stat.
    3207-154, provided that:
      "(a) The Secretary of Education, the Secretary of Health and
    Human Services, and the Secretary of Labor shall each designate an
    officer or employee of the Departments of Education, Health and
    Human Services, and Labor, respectively, to coordinate interagency
    drug abuse prevention activities to prevent duplication of effort.
      "(b) Within one year after enactment of this Act [Oct. 27, 1986],
    a report shall be jointly submitted to the Congress by such
    Secretaries concerning the extent to which States and localities
    have been able to implement non-duplicative drug abuse prevention
    activities."

                      SUBSTANCE ABUSE COVERAGE STUDY                  
      Pub. L. 99-570, title VI, Sec. 6005, Oct. 27, 1986, 100 Stat.
    3207-160, as amended by Pub. L. 100-690, title II, Sec. 2058(c),
    Nov. 18, 1988, 102 Stat. 4214, directed Secretary of Health and
    Human Services to contract with Institute of Medicine of National
    Academy of Sciences to conduct a study of extent to which cost of
    drug abuse treatment is covered by private insurance, public
    programs, and other sources of payment, and adequacy of such
    coverage for the rehabilitation of drug abusers, and not later than
    18 months after execution of such contract to transmit to Congress
    a report of results of study, including recommendations of means to
    meet the needs identified in such study.

         HEALTH INSURANCE COVERAGE FOR DRUG AND ALCOHOL TREATMENT     
      Pub. L. 99-570, title VI, Sec. 6006, Oct. 27, 1986, 100 Stat.
    3207-160, provided that:
      "(a) Findings. - The Congress finds that - 
        "(1) drug and alcohol abuse are problems of grave concern and
      consequence in American society;
        "(2) over 500,000 individuals are known heroin addicts; 5
      million individuals use cocaine; and at least 7 million
      individuals regularly use prescription drugs, mostly addictive
      ones, without medical supervision;
        "(3) 10 million adults and 3 million children and adolescents
      abuse alcohol, and an additional 30 to 40 million people are
      adversely affected because of close family ties to alcoholics;
        "(4) the total cost of drug abuse to the Nation in 1983 was
      over $60,000,000,000; and
        "(5) the vast majority of health benefits plans provide only
      limited coverage for treatment of drug and alcohol addiction,
      which is a fact that can discourage the abuser from seeking
      treatment or, if the abuser does seek treatment, can cause the
      abuser to face significant out of pocket expenses for the
      treatment.
      "(b) Sense of Congress. - It is the sense of Congress that - 
        "(1) all employers providing health insurance policies should
      ensure that the policies provide adequate coverage for treatment
      of drug and alcohol addiction in recognition that the health
      consequences and costs for individuals and society can be as
      formidable as those resulting from other diseases and illnesses
      for which insurance coverage is much more adequate; and
        "(2) State insurance commissioners should encourage employers
      providing health benefits plans to ensure that the policies
      provide more adequate coverage for treatment of drug and alcohol
      addiction."

                  COMMISSION ON MARIHUANA AND DRUG ABUSE              
      Section 601 of Pub. L. 91-513, as amended by Pub. L. 92-13, May
    14, 1971, 85 Stat. 37, provided that:
      "(a) [Establishment; composition] There is established a
    commission to be known as the Commission on Marihuana and Drug
    Abuse (hereafter in this section referred to as the 'Commission').
    The Commission shall be composed of - 
        "(1) two Members of the Senate appointed by the President of
      the Senate;
        "(2) two Members of the House of Representatives appointed by
      the Speaker of the House of Representatives; and
        "(3) nine members appointed by the President of the United
      States.
    At no time shall more than one of the members appointed under
    paragraph (1), or more than one of the members appointed under
    paragraph (2), or more than five of the members appointed under
    paragraph (3) be members of the same political party.
      "(b) [Chairman; Vice Chairman; compensation of members; meetings]
    (1) The President shall designate one of the members of the
    Commission as Chairman and one as Vice Chairman. Seven members of
    the Commission shall constitute a quorum, but a lesser number may
    conduct hearings.
      "(2) Members of the Commission who are Members of Congress or
    full-time officers or employees of the United States shall serve
    without additional compensation but shall be reimbursed for travel,
    subsistence, and other necessary expenses incurred in the
    performance of the duties vested in the Commission. Members of the
    Commission from private life shall receive $100 per diem while
    engaged in the actual performance of the duties vested in the
    Commission, plus reimbursement for travel, subsistence, and other
    necessary expenses incurred in the performance of such duties.
      "(3) The Commission shall meet at the call of the Chairman or at
    the call of a majority of the members thereof.
      "(c) [Personnel; experts; information from departments and
    agencies] (1) The Commission shall have the power to appoint and
    fix the compensation of such personnel as it deems advisable,
    without regard to the provisions of title 5, United States Code,
    governing appointments in the competitive service, and the
    provisions of chapter 51 and subchapter III of chapter 53 of such
    title, relating to classification and General Schedule pay rates.
      "(2) The Commission may procure, in accordance with the
    provisions of section 3109 of title 5, United States Code, the
    temporary or intermittent services of experts or consultants.
    Persons so employed shall receive compensation at a rate to be
    fixed by the Commission, but not in excess of $75 per diem,
    including traveltime. While away from his home or regular place of
    business in the performance of services for the Commission, any
    such person may be allowed travel expenses, including per diem in
    lieu of subsistence, as authorized by section 5703(b) of title 5,
    United States Code, for persons in the Government service employed
    intermittently.
      "(3) The Commission may secure directly from any department or
    agency of the United States information necessary to enable it to
    carry out its duties under this section. Upon request of the
    Chairman of the Commission, such department or agency shall furnish
    such information to the Commission.
      "(d) [Marihuana study; report to the President and the Congress]
    (1) The Commission shall conduct a study of marihuana including,
    but not limited to, the following areas:
        "(A) the extent of use of marihuana in the United States to
      include its various sources of users, number of arrests, number
      of convictions, amount of marihuana seized, type of user, nature
      of use;
        "(B) an evaluation of the efficacy of existing marihuana laws;
        "(C) a study of the pharmacology of marihuana and its immediate
      and long-term effects, both physiological and psychological;
        "(D) the relationship of marihuana use to aggressive behavior
      and crime;
        "(E) the relationship between marihuana and the use of other
      drugs; and
        "(F) the international control of marihuana.
      "(2) Within one year after the date on which funds first become
    available to carry out this section, the Commission shall submit to
    the President and the Congress a comprehensive report on its study
    and investigation under this subsection which shall include its
    recommendations and such proposals for legislation and
    administrative action as may be necessary to carry out its
    recommendations.
      "(e) [Study and investigation of causes of drug abuse; report to
    the President and the Congress; termination of Commission] The
    Commission shall conduct a comprehensive study and investigation of
    the causes of drug abuse and their relative significance. The
    Commission shall submit to the President and the Congress such
    interim reports as it deems advisable and shall within two years
    after the date on which funds first become available to carry out
    this section submit to the President and the Congress a final
    report which shall contain a detailed statement of its findings and
    conclusions and also such recommendations for legislation and
    administrative actions as it deems appropriate. The Commission
    shall cease to exist sixty days after the final report is submitted
    under this subsection.
      "(f) [Limitation on expenditures] Total expenditures of the
    Commission shall not exceed $4,000,000."


-EXEC-
                         EXECUTIVE ORDER NO. 11599                     
      Ex. Ord. No. 11599, June 17, 1971, 36 F.R. 11793, which
    established the Special Action Office for Drug Abuse Prevention,
    was superseded. See Prior Provisions notes set out under section
    1111 of this title.

                         EXECUTIVE ORDER NO. 11641                     
      Ex. Ord. No. 11641, Jan. 28, 1972, 37 F.R. 2421, which
    established the Office for Drug Abuse Law Enforcement, was revoked
    by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.

                         EXECUTIVE ORDER NO. 11676                     
      Ex. Ord. No. 11676, July 27, 1972, 37 F.R. 15125, which
    established the Office of National Narcotics Intelligence, was
    revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out
    below.

                 EX. ORD. NO. 11727. DRUG LAW ENFORCEMENT             
      Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, provided:
      Reorganization Plan No. 2 of 1973 [set out in the Appendix to
    Title 5, Government Organization and Employees], which becomes
    effective on July 1, 1973, among other things establishes a Drug
    Enforcement Administration in the Department of Justice. In my
    message to the Congress transmitting that plan, I stated that all
    functions of the Office for Drug Abuse Law Enforcement (established
    pursuant to Executive Order No. 11641 of January 28, 1972) and the
    Office of National Narcotics Intelligence (established pursuant to
    Executive Order No. 11676 of July 27, 1972) would, together with
    other related functions, be merged in the new Drug Enforcement
    Administration.
      NOW, THEREFORE, by virtue of the authority vested in me by the
    Constitution and laws of the United States, including section 5317
    of title 5 of the United States Code, as amended, it is hereby
    ordered as follows:
      Section 1. The Attorney General, to the extent permitted by law,
    is authorized to coordinate all activities of executive branch
    departments and agencies which are directly related to the
    enforcement of laws respecting narcotics and dangerous drugs. Each
    department and agency of the Federal Government shall, upon request
    and to the extent permitted by law, assist the Attorney General in
    the performance of functions assigned to him pursuant to this
    order, and the Attorney General may, in carrying out those
    functions, utilize the services of any other agencies, Federal and
    State, as may be available and appropriate.
      Sec. 2. Executive Order No. 11641 of January 28, 1972, is revoked
    and the Attorney General shall provide for the reassignment of the
    functions of the Office for Drug Abuse Law Enforcement and for the
    abolishment of that Office.
      Sec. 3. Executive Order No. 11676 of July 27, 1972, is hereby
    revoked and the Attorney General shall provide for the reassignment
    of the functions of the Office of National Narcotics Intelligence
    and for the abolishment of that Office.
      Sec. 4. Section 1 of Executive Order No. 11708 of March 23, 1973,
    as amended [set out as a note under section 5317 of Title 5,
    Government Organization and Employees], placing certain positions
    in level IV of the Executive Schedule is hereby further amended by
    deleting - 
      (1) "(6) Director, Office for Drug Abuse Law Enforcement,
    Department of Justice."; and
      (2) "(7) Director, Office of National Narcotics Intelligence,
    Department of Justice."
      Sec. 5. The Attorney General shall provide for the winding up of
    the affairs of the two offices and for the reassignment of their
    functions.
      Sec. 6. This order shall be effective as of July 1, 1973.
                                                          Richard Nixon.

-End-



-CITE-
    21 USC Sec. 801a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part A - Introductory Provisions

-HEAD-
    Sec. 801a. Congressional findings and declarations: psychotropic
      substances

-STATUTE-
      The Congress makes the following findings and declarations:
        (1) The Congress has long recognized the danger involved in the
      manufacture, distribution, and use of certain psychotropic
      substances for nonscientific and nonmedical purposes, and has
      provided strong and effective legislation to control illicit
      trafficking and to regulate legitimate uses of psychotropic
      substances in this country. Abuse of psychotropic substances has
      become a phenomenon common to many countries, however, and is not
      confined to national borders. It is, therefore, essential that
      the United States cooperate with other nations in establishing
      effective controls over international traffic in such substances.
        (2) The United States has joined with other countries in
      executing an international treaty, entitled the Convention on
      Psychotropic Substances and signed at Vienna, Austria, on
      February 21, 1971, which is designed to establish suitable
      controls over the manufacture, distribution, transfer, and use of
      certain psychotropic substances. The Convention is not self-
      executing, and the obligations of the United States thereunder
      may only be performed pursuant to appropriate legislation. It is
      the intent of the Congress that the amendments made by this Act,
      together with existing law, will enable the United States to meet
      all of its obligations under the Convention and that no further
      legislation will be necessary for that purpose.
        (3) In implementing the Convention on Psychotropic Substances,
      the Congress intends that, consistent with the obligations of the
      United States under the Convention, control of psychotropic
      substances in the United States should be accomplished within the
      framework of the procedures and criteria for classification of
      substances provided in the Comprehensive Drug Abuse Prevention
      and Control Act of 1970 [21 U.S.C. 801 et seq.]. This will insure
      that (A) the availability of psychotropic substances to
      manufacturers, distributors, dispensers, and researchers for
      useful and legitimate medical and scientific purposes will not be
      unduly restricted; (B) nothing in the Convention will interfere
      with bona fide research activities; and (C) nothing in the
      Convention will interfere with ethical medical practice in this
      country as determined by the Secretary of Health and Human
      Services on the basis of a consensus of the views of the American
      medical and scientific community.

-SOURCE-
    (Pub. L. 95-633, title I, Sec. 101, Nov. 10, 1978, 92 Stat. 3768;
    Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This Act, referred to in par. (2), is Pub. L. 95-633, Nov. 10,
    1978, 92 Stat. 2768, as amended, known as the Psychotropic
    Substances Act of 1978, which enacted sections 801a, 830, and 852
    of this title, amended sections 352, 802, 811, 812, 823, 827, 841
    to 843, 872, 881, 952, 953, and 965 of this title and section 242a
    of Title 42, The Public Health and Welfare, repealed section 830 of
    this title effective Jan. 1, 1981, and enacted provisions set out
    as notes under sections 801, 801a, 812, and 830 of this title. For
    complete classification of this Act to the Code, see Short Title of
    1978 Amendment note set out under section 801 of this title and
    Tables.
      The Comprehensive Drug Abuse Prevention and Control Act of 1970,
    referred to in par. (3), is Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
    1236, as amended, which is classified principally to this chapter
    [Sec. 801 et seq.]. For complete classification of this Act to the
    Code, see Short Title note set out under section 801 of this title
    and Tables.

-COD-
                               CODIFICATION                           
      Section was enacted as a part of the Psychotropic Substances Act
    of 1978, and not as a part of the Controlled Substances Act which
    comprises this subchapter.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in par. (3) pursuant
    to section 509(b) of Pub. L. 96-88, which is classified to section
    3508(b) of Title 20, Education.


-MISC1-
                              EFFECTIVE DATE                          
      Section 112 of title I of Pub. L. 95-633 provided that: "This
    title [enacting this section and section 852 of this title,
    amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953
    of this title and section 242a of Title 42, The Public Health and
    Welfare, and enacting provisions set out as notes under sections
    801 and 812 of this title] and the amendments made by this title
    shall take effect on the date the Convention on Psychotropic
    Substances, signed at Vienna, Austria on February 21, 1971, enters
    into force in respect to the United States." [The Convention
    entered into force in respect to the United States on July 15,
    1980.]

-End-



-CITE-
    21 USC Sec. 802                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part A - Introductory Provisions

-HEAD-
    Sec. 802. Definitions

-STATUTE-
      As used in this subchapter:
      (1) The term "addict" means any individual who habitually uses
    any narcotic drug so as to endanger the public morals, health,
    safety, or welfare, or who is so far addicted to the use of
    narcotic drugs as to have lost the power of self-control with
    reference to his addiction.
      (2) The term "administer" refers to the direct application of a
    controlled substance to the body of a patient or research subject
    by - 
        (A) a practitioner (or, in his presence, by his authorized
      agent), or
        (B) the patient or research subject at the direction and in the
      presence of the practitioner,

    whether such application be by injection, inhalation, ingestion, or
    any other means.
      (3) The term "agent" means an authorized person who acts on
    behalf of or at the direction of a manufacturer, distributor, or
    dispenser; except that such term does not include a common or
    contract carrier, public warehouseman, or employee of the carrier
    or warehouseman, when acting in the usual and lawful course of the
    carrier's or warehouseman's business.
      (4) The term "Drug Enforcement Administration" means the Drug
    Enforcement Administration in the Department of Justice.
      (5) The term "control" means to add a drug or other substance, or
    immediate precursor, to a schedule under part B of this subchapter,
    whether by transfer from another schedule or otherwise.
      (6) The term "controlled substance" means a drug or other
    substance, or immediate precursor, included in schedule I, II, III,
    IV, or V of part B of this subchapter. The term does not include
    distilled spirits, wine, malt beverages, or tobacco, as those terms
    are defined or used in subtitle E of the Internal Revenue Code of
    1986.
      (7) The term "counterfeit substance" means a controlled substance
    which, or the container or labeling of which, without
    authorization, bears the trademark, trade name, or other
    identifying mark, imprint, number, or device, or any likeness
    thereof, of a manufacturer, distributor, or dispenser other than
    the person or persons who in fact manufactured, distributed, or
    dispensed such substance and which thereby falsely purports or is
    represented to be the product of, or to have been distributed by,
    such other manufacturer, distributor, or dispenser.
      (8) The terms "deliver" or "delivery" mean the actual,
    constructive, or attempted transfer of a controlled substance or a
    listed chemical, whether or not there exists an agency
    relationship.
      (9) The term "depressant or stimulant substance" means - 
        (A) a drug which contains any quantity of barbituric acid or
      any of the salts of barbituric acid; or
        (B) a drug which contains any quantity of (i) amphetamine or
      any of its optical isomers; (ii) any salt of amphetamine or any
      salt of an optical isomer of amphetamine; or (iii) any substance
      which the Attorney General, after investigation, has found to be,
      and by regulation designated as, habit forming because of its
      stimulant effect on the central nervous system; or
        (C) lysergic acid diethylamide; or
        (D) any drug which contains any quantity of a substance which
      the Attorney General, after investigation, has found to have, and
      by regulation designated as having, a potential for abuse because
      of its depressant or stimulant effect on the central nervous
      system or its hallucinogenic effect.

      (10) The term "dispense" means to deliver a controlled substance
    to an ultimate user or research subject by, or pursuant to the
    lawful order of, a practitioner, including the prescribing and
    administering of a controlled substance and the packaging, labeling
    or compounding necessary to prepare the substance for such
    delivery. The term "dispenser" means a practitioner who so delivers
    a controlled substance to an ultimate user or research subject.
      (11) The term "distribute" means to deliver (other than by
    administering or dispensing) a controlled substance or a listed
    chemical. The term "distributor" means a person who so delivers a
    controlled substance or a listed chemical.
      (12) The term "drug" has the meaning given that term by section
    321(g)(1) of this title.
      (13) The term "felony" means any Federal or State offense
    classified by applicable Federal or State law as a felony.
      (14) The term "isomer" means the optical isomer, except as used
    in schedule I(c) and schedule II(a)(4). As used in schedule I(c),
    the term "isomer" means any optical, positional, or geometric
    isomer. As used in schedule II(a)(4), the term "isomer" means any
    optical or geometric isomer.
      (15) The term "manufacture" means the production, preparation,
    propagation, compounding, or processing of a drug or other
    substance, either directly or indirectly or by extraction from
    substances of natural origin, or independently by means of chemical
    synthesis or by a combination of extraction and chemical synthesis,
    and includes any packaging or repackaging of such substance or
    labeling or relabeling of its container; except that such term does
    not include the preparation, compounding, packaging, or labeling of
    a drug or other substance in conformity with applicable State or
    local law by a practitioner as an incident to his administration or
    dispensing of such drug or substance in the course of his
    professional practice. The term "manufacturer" means a person who
    manufactures a drug or other substance.
      (16) The term "marihuana" means all parts of the plant Cannabis
    sativa L., whether growing or not; the seeds thereof; the resin
    extracted from any part of such plant; and every compound,
    manufacture, salt, derivative, mixture, or preparation of such
    plant, its seeds or resin. Such term does not include the mature
    stalks of such plant, fiber produced from such stalks, oil or cake
    made from the seeds of such plant, any other compound, manufacture,
    salt, derivative, mixture, or preparation of such mature stalks
    (except the resin extracted therefrom), fiber, oil, or cake, or the
    sterilized seed of such plant which is incapable of germination.
      (17) The term "narcotic drug" means any of the following whether
    produced directly or indirectly by extraction from substances of
    vegetable origin, or independently by means of chemical synthesis,
    or by a combination of extraction and chemical synthesis:
        (A) Opium, opiates, derivatives of opium and opiates, including
      their isomers, esters, ethers, salts, and salts of isomers,
      esters, and ethers, whenever the existence of such isomers,
      esters, ethers, and salts is possible within the specific
      chemical designation. Such term does not include the isoquinoline
      alkaloids of opium.
        (B) Poppy straw and concentrate of poppy straw.
        (C) Coca leaves, except coca leaves and extracts of coca leaves
      from which cocaine, ecgonine, and derivatives of ecgonine or
      their salts have been removed.
        (D) Cocaine, its salts, optical and geometric isomers, and
      salts of isomers.
        (E) Ecgonine, its derivatives, their salts, isomers, and salts
      of isomers.
        (F) Any compound, mixture, or preparation which contains any
      quantity of any of the substances referred to in subparagraphs
      (A) through (E).

      (18) The term "opiate" means any drug or other substance having
    an addiction-forming or addiction-sustaining liability similar to
    morphine or being capable of conversion into a drug having such
    addiction-forming or addiction-sustaining liability.
      (19) The term "opium poppy" means the plant of the species
    Papaver somniferum L., except the seed thereof.
      (20) The term "poppy straw" means all parts, except the seeds, of
    the opium poppy, after mowing.
      (21) The term "practitioner" means a physician, dentist,
    veterinarian, scientific investigator, pharmacy, hospital, or other
    person licensed, registered, or otherwise permitted, by the United
    States or the jurisdiction in which he practices or does research,
    to distribute, dispense, conduct research with respect to,
    administer, or use in teaching or chemical analysis, a controlled
    substance in the course of professional practice or research.
      (22) The term "production" includes the manufacture, planting,
    cultivation, growing, or harvesting of a controlled substance.
      (23) The term "immediate precursor" means a substance - 
        (A) which the Attorney General has found to be and by
      regulation designated as being the principal compound used, or
      produced primarily for use, in the manufacture of a controlled
      substance;
        (B) which is an immediate chemical intermediary used or likely
      to be used in the manufacture of such controlled substance; and
        (C) the control of which is necessary to prevent, curtail, or
      limit the manufacture of such controlled substance.

      (24) The term "Secretary", unless the context otherwise
    indicates, means the Secretary of Health and Human Services.
      (25) The term "serious bodily injury" means bodily injury which
    involves - 
        (A) a substantial risk of death;
        (B) protracted and obvious disfigurement; or
        (C) protracted loss or impairment of the function of a bodily
      member, organ, or mental faculty.

      (26) The term "State" means a State of the United States, the
    District of Columbia, and any commonwealth, territory, or
    possession of the United States.
      (27) The term "ultimate user" means a person who has lawfully
    obtained, and who possesses, a controlled substance for his own use
    or for the use of a member of his household or for an animal owned
    by him or by a member of his household.
      (28) The term "United States", when used in a geographic sense,
    means all places and waters, continental or insular, subject to the
    jurisdiction of the United States.
      (29) The term "maintenance treatment" means the dispensing, for a
    period in excess of twenty-one days, of a narcotic drug in the
    treatment of an individual for dependence upon heroin or other
    morphine-like drugs.
      (30) The term "detoxification treatment" means the dispensing,
    for a period not in excess of one hundred and eighty days, of a
    narcotic drug in decreasing doses to an individual in order to
    alleviate adverse physiological or psychological effects incident
    to withdrawal from the continuous or sustained use of a narcotic
    drug and as a method of bringing the individual to a narcotic drug-
    free state within such period.
      (31) The term "Convention on Psychotropic Substances" means the
    Convention on Psychotropic Substances signed at Vienna, Austria, on
    February 21, 1971; and the term "Single Convention on Narcotic
    Drugs" means the Single Convention on Narcotic Drugs signed at New
    York, New York, on March 30, 1961.
      (32)(A) Except as provided in subparagraph (C), the term
    "controlled substance analogue" means a substance - 
        (i) the chemical structure of which is substantially similar to
      the chemical structure of a controlled substance in schedule I or
      II;
        (ii) which has a stimulant, depressant, or hallucinogenic
      effect on the central nervous system that is substantially
      similar to or greater than the stimulant, depressant, or
      hallucinogenic effect on the central nervous system of a
      controlled substance in schedule I or II; or
        (iii) with respect to a particular person, which such person
      represents or intends to have a stimulant, depressant, or
      hallucinogenic effect on the central nervous system that is
      substantially similar to or greater than the stimulant,
      depressant, or hallucinogenic effect on the central nervous
      system of a controlled substance in schedule I or II.

      (B) The designation of gamma butyrolactone or any other chemical
    as a listed chemical pursuant to paragraph (34) or (35) does not
    preclude a finding pursuant to subparagraph (A) of this paragraph
    that the chemical is a controlled substance analogue.
      (C) Such term does not include - 
        (i) a controlled substance;
        (ii) any substance for which there is an approved new drug
      application;
        (iii) with respect to a particular person any substance, if an
      exemption is in effect for investigational use, for that person,
      under section 355 of this title to the extent conduct with
      respect to such substance is pursuant to such exemption; or
        (iv) any substance to the extent not intended for human
      consumption before such an exemption takes effect with respect to
      that substance.

      (33) The term "listed chemical" means any list I chemical or any
    list II chemical.
      (34) The term "list I chemical" means a chemical specified by
    regulation of the Attorney General as a chemical that is used in
    manufacturing a controlled substance in violation of this
    subchapter and is important to the manufacture of the controlled
    substances, and such term includes (until otherwise specified by
    regulation of the Attorney General, as considered appropriate by
    the Attorney General or upon petition to the Attorney General by
    any person) the following:
        (A) Anthranilic acid, its esters, and its salts.
        (B) Benzyl cyanide.
        (C) Ephedrine, its salts, optical isomers, and salts of optical
      isomers.
        (D) Ergonovine and its salts.
        (E) Ergotamine and its salts.
        (F) N-Acetylanthranilic acid, its esters, and its salts.
        (G) Norpseudoephedrine, its salts, optical isomers, and salts
      of optical isomers.
        (H) Phenylacetic acid, its esters, and its salts.
        (I) Phenylpropanolamine, its salts, optical isomers, and salts
      of optical isomers.
        (J) Piperidine and its salts.
        (K) Pseudoephedrine, its salts, optical isomers, and salts of
      optical isomers.
        (L) 3,4-Methylenedioxyphenyl-2-propanone.
        (M) Methylamine.
        (N) Ethylamine.
        (O) Propionic anhydride.
        (P) Isosafrole.
        (Q) Safrole.
        (R) Piperonal.
        (S) N-Methylephedrine.
        (T) N-methylpseudoephedrine.
        (U) Hydriodic acid.
        (V) Benzaldehyde.
        (W) Nitroethane.
        (X) Gamma butyrolactone.
        (Y) Any salt, optical isomer, or salt of an optical isomer of
      the chemicals listed in subparagraphs (M) through (U) of this
      paragraph.

      (35) The term "list II chemical" means a chemical (other than a
    list I chemical) specified by regulation of the Attorney General as
    a chemical that is used in manufacturing a controlled substance in
    violation of this subchapter, and such term includes (until
    otherwise specified by regulation of the Attorney General, as
    considered appropriate by the Attorney General or upon petition to
    the Attorney General by any person) the following chemicals:
        (A) Acetic anhydride.
        (B) Acetone.
        (C) Benzyl chloride.
        (D) Ethyl ether.
        (E) Repealed. Pub. L. 101-647, title XXIII, Sec. 2301(b), Nov.
      29, 1990, 104 Stat. 4858.
        (F) Potassium permanganate.
        (G) 2-Butanone (or Methyl Ethyl Ketone).
        (H) Toluene.
        (I) Iodine.
        (J) Hydrochloric gas.

      (36) The term "regular customer" means, with respect to a
    regulated person, a customer with whom the regulated person has an
    established business relationship that is reported to the Attorney
    General.
      (37) The term "regular importer" means, with respect to a listed
    chemical, a person that has an established record as an importer of
    that listed chemical that is reported to the Attorney General.
      (38) The term "regulated person" means a person who manufactures,
    distributes, imports, or exports a listed chemical, a tableting
    machine, or an encapsulating machine or who acts as a broker or
    trader for an international transaction involving a listed
    chemical, a tableting machine, or an encapsulating machine.
      (39) The term "regulated transaction" means - 
        (A) a distribution, receipt, sale, importation, or exportation
      of, or an international transaction involving shipment of, a
      listed chemical, or if the Attorney General establishes a
      threshold amount for a specific listed chemical, a threshold
      amount, including a cumulative threshold amount for multiple
      transactions (as determined by the Attorney General, in
      consultation with the chemical industry and taking into
      consideration the quantities normally used for lawful purposes),
      of a listed chemical, except that such term does not include - 
          (i) a domestic lawful distribution in the usual course of
        business between agents or employees of a single regulated
        person;
          (ii) a delivery of a listed chemical to or by a common or
        contract carrier for carriage in the lawful and usual course of
        the business of the common or contract carrier, or to or by a
        warehouseman for storage in the lawful and usual course of the
        business of the warehouseman, except that if the carriage or
        storage is in connection with the distribution, importation, or
        exportation of a listed chemical to a third person, this clause
        does not relieve a distributor, importer, or exporter from
        compliance with section 830 of this title;
          (iii) any category of transaction or any category of
        transaction for a specific listed chemical or chemicals
        specified by regulation of the Attorney General as excluded
        from this definition as unnecessary for enforcement of this
        subchapter or subchapter II of this chapter;
          (iv) any transaction in a listed chemical that is contained
        in a drug that may be marketed or distributed lawfully in the
        United States under the Federal Food, Drug, and Cosmetic Act
        [21 U.S.C. 301 et seq.], subject to clause (v), unless - 
            (I) the Attorney General has determined under section 814
          of this title that the drug or group of drugs is being
          diverted to obtain the listed chemical for use in the illicit
          production of a controlled substance; and
            (II) the quantity of the listed chemical contained in the
          drug included in the transaction or multiple transactions
          equals or exceeds the threshold established for that chemical
          by the Attorney General;

          (v) any transaction in a scheduled listed chemical product
        that is a sale at retail by a regulated seller or a distributor
        required to submit reports under section 830(b)(3) of this
        title; or
          (vi) any transaction in a chemical mixture which the Attorney
        General has by regulation designated as exempt from the
        application of this subchapter and subchapter II of this
        chapter based on a finding that the mixture is formulated in
        such a way that it cannot be easily used in the illicit
        production of a controlled substance and that the listed
        chemical or chemicals contained in the mixture cannot be
        readily recovered; and

        (B) a distribution, importation, or exportation of a tableting
      machine or encapsulating machine.

      (40) The term "chemical mixture" means a combination of two or
    more chemical substances, at least one of which is not a list I
    chemical or a list II chemical, except that such term does not
    include any combination of a list I chemical or a list II chemical
    with another chemical that is present solely as an impurity.
      (41)(A) The term "anabolic steroid" means any drug or hormonal
    substance, chemically and pharmacologically related to testosterone
    (other than estrogens, progestins, corticosteroids, and
    dehydroepiandrosterone), and includes - 
        (i) androstanediol - 
          (I) 3&beta;,17&beta;-dihydroxy-5&alpha;-androstane; and
          (II) 3&alpha;,17&beta;-dihydroxy-5&alpha;-androstane;

        (ii) androstanedione (5&alpha;-androstan-3,17-dione);
        (iii) androstenediol - 
          (I) 1-androstenediol (3&beta;,17&beta;-dihydroxy-5&alpha;-
        androst-1-ene);
          (II) 1-androstenediol (3&alpha;,17&beta;-dihydroxy-5&alpha;-
        androst-1-ene);
          (III) 4-androstenediol (3&beta;,17&beta;-dihydroxy-androst-4-
        ene); and
          (IV) 5-androstenediol (3&beta;,17&beta;-dihydroxy-androst-5-
        ene);

        (iv) androstenedione - 
          (I) 1-androstenedione ([5&alpha;]-androst-1-en-3,17-dione);
          (II) 4-androstenedione (androst-4-en-3,17-dione); and
          (III) 5-androstenedione (androst-5-en-3,17-dione);

        (v) bolasterone (7&alpha;,17&alpha;-dimethyl-17&beta;-
      hydroxyandrost-4-en-3-one);
        (vi) boldenone (17&beta;-hydroxyandrost-1,4,-diene-3-one);
        (vii) calusterone (7&beta;,17&alpha;-dimethyl-17&beta;-
      hydroxyandrost-4-en-3-one);
        (viii) clostebol (4-chloro-17&beta;-hydroxyandrost-4-en-3-one);
        (ix) dehydrochloromethyltestosterone (4-chloro-17&beta;-hydroxy-
      17&alpha;-methyl-androst-1,4-dien-3-one);
        (x) &Delta;1-dihydrotestosterone (a.k.a. "1-testosterone")
      (17&beta;-hydroxy-5&alpha;-androst-1-en-3-one);
        (xi) 4-dihydrotestosterone (17&beta;-hydroxy-androstan-3-one);
        (xii) drostanolone (17&beta;-hydroxy-2&alpha;-methyl-5&alpha;-
      androstan-3-one);
        (xiii) ethylestrenol (17&alpha;-ethyl-17&beta;-hydroxyestr-4-
      ene);
        (xiv) fluoxymesterone (9-fluoro-17&alpha;-methyl-
      11&beta;,17&beta;-dihydroxyandrost-4-en-3-one);
        (xv) formebolone (2-formyl-17&alpha;-methyl-11&alpha;,17&beta;-
      dihydroxyandrost-1,4-dien-3-one);
        (xvi) furazabol (17&alpha;-methyl-17&beta;-
      hydroxyandrostano[2,3-c]-furazan);
        (xvii) 13&beta;-ethyl-17&beta;-hydroxygon-4-en-3-one;
        (xviii) 4-hydroxytestosterone (4,17&beta;-dihydroxy-androst-4-
      en-3-one);
        (xix) 4-hydroxy-19-nortestosterone (4,17&beta;-dihydroxy-estr-4-
      en-3-one);
        (xx) mestanolone (17&alpha;-methyl-17&beta;-hydroxy-5&alpha;-
      androstan-3-one);
        (xxi) mesterolone (1&alpha;-methyl-17&beta;-hydroxy-[5&alpha;]-
      androstan-3-one);
        (xxii) methandienone (17&alpha;-methyl-17&beta;-hydroxyandrost-
      1,4-dien-3-one);
        (xxiii) methandriol (17&alpha;-methyl-3&beta;,17&beta;-
      dihydroxyandrost-5-ene);
        (xxiv) methenolone (1-methyl-17&beta;-hydroxy-5&alpha;-androst-
      1-en-3-one);
        (xxv) 17&alpha;-methyl-3&beta;, 17&beta;-dihydroxy-5&alpha;-
      androstane;
        (xxvi) 17&alpha;-methyl-3&alpha;,17&beta;-dihydroxy-5&alpha;-
      androstane;
        (xxvii) 17&alpha;-methyl-3&beta;,17&beta;-dihydroxyandrost-4-
      ene.
        (xxviii) 17&alpha;-methyl-4-hydroxynandrolone (17&alpha;-methyl-
      4-hydroxy-17&beta;-hydroxyestr-4-en-3-one);
        (xxix) methyldienolone (17&alpha;-methyl-17&beta;-hydroxyestra-
      4,9(10)-dien-3-one);
        (xxx) methyltrienolone (17&alpha;-methyl-17&beta;-hydroxyestra-
      4,9-11-trien-3-one);
        (xxxi) methyltestosterone (17&alpha;-methyl-17&beta;-
      hydroxyandrost-4-en-3-one);
        (xxxii) mibolerone (7&alpha;,17&alpha;-dimethyl-17&beta;-
      hydroxyestr-4-en-3-one);
        (xxxiii) 17&alpha;-methyl-&Delta;1-dihydrotestosterone
      (17&beta;-hydroxy-17&alpha;-methyl-5&alpha;-androst-1-en-3-one)
      (a.k.a. "17-&alpha;-methyl-1-testosterone");
        (xxxiv) nandrolone (17&beta;-hydroxyestr-4-en-3-one);
        (xxxv) norandrostenediol - 
          (I) 19-nor-4-androstenediol (3&beta;, 17&beta;-dihydroxyestr-
        4-ene);
          (II) 19-nor-4-androstenediol (3&alpha;, 17&beta;-
        dihydroxyestr-4-ene);
          (III) 19-nor-5-androstenediol (3&beta;, 17&beta;-
        dihydroxyestr-5-ene); and
          (IV) 19-nor-5-androstenediol (3&alpha;, 17&beta;-
        dihydroxyestr-5-ene);

        (xxxvi) norandrostenedione - 
          (I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and
          (II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;

        (xxxvii) norbolethone (13&beta;,17&alpha;-diethyl-17&beta;-
      hydroxygon-4-en-3-one);
        (xxxviii) norclostebol (4-chloro-17&beta;-hydroxyestr-4-en-3-
      one);
        (xxxix) norethandrolone (17&alpha;-ethyl-17&beta;-hydroxyestr-4-
      en-3-one);
        (xl) normethandrolone (17&alpha;-methyl-17&beta;-hydroxyestr-4-
      en-3-one);
        (xli) oxandrolone (17&alpha;-methyl-17&beta;-hydroxy-2-oxa-
      [5&alpha;]-androstan-3-one);
        (xlii) oxymesterone (17&alpha;-methyl-4,17&beta;-
      dihydroxyandrost-4-en-3-one);
        (xliii) oxymetholone (17&alpha;-methyl-2-hydroxymethylene-
      17&beta;-hydroxy-[5&alpha;]-androstan-3-one);
        (xliv) stanozolol (17&alpha;-methyl-17&beta;-hydroxy-[5&alpha;]-
      androst-2-eno[3,2-c]-pyrazole);
        (xlv) stenbolone (17&beta;-hydroxy-2-methyl-[5&alpha;]-androst-
      1-en-3-one);
        (xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-
      dien-17-oic acid lactone);
        (xlvii) testosterone (17&beta;-hydroxyandrost-4-en-3-one);
        (xlviii) tetrahydrogestrinone (13&beta;,17&alpha;-diethyl-
      17&beta;-hydroxygon-4,9,11-trien-3-one);
        (xlix) trenbolone (17&beta;-hydroxyestr-4,9,11-trien-3-one);
      and
        (xlx) (!1) any salt, ester, or ether of a drug or substance
      described in this paragraph.


    The substances excluded under this subparagraph may at any time be
    scheduled by the Attorney General in accordance with the authority
    and requirements of subsections (a) through (c) of section 811 of
    this title.
      (B)(i) Except as provided in clause (ii), such term does not
    include an anabolic steroid which is expressly intended for
    administration through implants to cattle or other nonhuman species
    and which has been approved by the Secretary of Health and Human
    Services for such administration.
      (ii) If any person prescribes, dispenses, or distributes such
    steroid for human use, such person shall be considered to have
    prescribed, dispensed, or distributed an anabolic steroid within
    the meaning of subparagraph (A).
      (42) The term "international transaction" means a transaction
    involving the shipment of a listed chemical across an international
    border (other than a United States border) in which a broker or
    trader located in the United States participates.
      (43) The terms "broker" and "trader" mean a person that assists
    in arranging an international transaction in a listed chemical by -
    
        (A) negotiating contracts;
        (B) serving as an agent or intermediary; or
        (C) bringing together a buyer and seller, a buyer and
      transporter, or a seller and transporter.

      (44) The term "felony drug offense" means an offense that is
    punishable by imprisonment for more than one year under any law of
    the United States or of a State or foreign country that prohibits
    or restricts conduct relating to narcotic drugs, marihuana,
    anabolic steroids, or depressant or stimulant substances.
      (45)(A) The term "scheduled listed chemical product" means,
    subject to subparagraph (B), a product that - 
        (i) contains ephedrine, pseudoephedrine, or
      phenylpropanolamine; and
        (ii) may be marketed or distributed lawfully in the United
      States under the Federal, Food, Drug, and Cosmetic Act [21 U.S.C.
      301 et seq.] as a nonprescription drug.

    Each reference in clause (i) to ephedrine, pseudoephedrine, or
    phenylpropanolamine includes each of the salts, optical isomers,
    and salts of optical isomers of such chemical.
      (B) Such term does not include a product described in
    subparagraph (A) if the product contains a chemical specified in
    such subparagraph that the Attorney General has under section
    811(a) of this title added to any of the schedules under section
    812(c) of this title. In the absence of such scheduling by the
    Attorney General, a chemical specified in such subparagraph may not
    be considered to be a controlled substance.
      (46) The term "regulated seller" means a retail distributor
    (including a pharmacy or a mobile retail vendor), except that such
    term does not include an employee or agent of such distributor.
      (47) The term "mobile retail vendor" means a person or entity
    that makes sales at retail from a stand that is intended to be
    temporary, or is capable of being moved from one location to
    another, whether the stand is located within or on the premises of
    a fixed facility (such as a kiosk at a shopping center or an
    airport) or whether the stand is located on unimproved real estate
    (such as a lot or field leased for retail purposes).
      (48) The term "at retail", with respect to the sale or purchase
    of a scheduled listed chemical product, means a sale or purchase
    for personal use, respectively.
      (49)(A) The term "retail distributor" means a grocery store,
    general merchandise store, drug store, or other entity or person
    whose activities as a distributor relating to ephedrine,
    pseudoephedrine, or phenylpropanolamine products are limited almost
    exclusively to sales for personal use, both in number of sales and
    volume of sales, either directly to walk-in customers or in face-to-
    face transactions by direct sales.
      (B) For purposes of this paragraph, entities are defined by
    reference to the Standard Industrial Classification (SIC) code, as
    follows:
        (i) A grocery store is an entity within SIC code 5411.
        (ii) A general merchandise store is an entity within SIC codes
      5300 through 5399 and 5499.
        (iii) A drug store is an entity within SIC code 5912.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 102, Oct. 27, 1970, 84 Stat. 1242;
    Pub. L. 93-281, Sec. 2, May 14, 1974, 88 Stat. 124; Pub. L. 95-633,
    title I, Sec. 102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96-88,
    title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-132,
    Sec. 16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98-473, title II,
    Sec. 507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98-509,
    title III, Sec. 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99-
    514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99-570, title
    I, Secs. 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207-6, 3207-
    13, 3207-56; Pub. L. 99-646, Sec. 83, Nov. 10, 1986, 100 Stat.
    3619; Pub. L. 100-690, title VI, Sec. 6054, Nov. 18, 1988, 102
    Stat. 4316; Pub. L. 101-647, title XIX, Sec. 1902(b), title XXIII,
    Sec. 2301, title XXXV, Sec. 3599I, Nov. 29, 1990, 104 Stat. 4852,
    4858, 4932; Pub. L. 103-200, Secs. 2(a), 7-9(a), Dec. 17, 1993, 107
    Stat. 2333, 2340; Pub. L. 103-322, title IX, Sec. 90105(d), title
    XXXIII, Sec. 330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat.
    1988, 2150; Pub. L. 104-237, title II, Secs. 204(a), 209, title IV,
    Sec. 401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107;
    Pub. L. 104-294, title VI, Secs. 604(b)(4), 607(j), Oct. 11, 1996,
    110 Stat. 3506, 3512; Pub. L. 105-115, title I, Sec. 126(c)(3),
    Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106-172, Secs. 3(c), 5(a),
    Feb. 18, 2000, 114 Stat. 9, 10; Pub. L. 106-310, div. B, title
    XXXVI, Sec. 3622(a), Oct. 17, 2000, 114 Stat. 1231; Pub. L. 107-
    273, div. B, title IV, Sec. 4002(c)(1), Nov. 2, 2002, 116 Stat.
    1808; Pub. L. 108-358, Sec. 2(a), Oct. 22, 2004, 118 Stat. 1661;
    Pub. L. 109-162, title XI, Sec. 1180, Jan. 5, 2006, 119 Stat. 3126;
    Pub. L. 109-177, title VII, Secs. 711(a)(1), (2)(A), 712(a)(1),
    Mar. 9, 2006, 120 Stat. 256, 257, 263.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, IV, and V, referred to in pars. (6), (14),
    and (32)(A), are set out in section 812(c) of this title.
      This subchapter, referred to in introductory provisions and in
    par. (39)(A)(iii), (vi), was in the original "this title", meaning
    title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
    amended, and is popularly known as the "Controlled Substances Act".
    For complete classification of title II to the Code, see second
    paragraph of Short Title note set out under section 801 of this
    title and Tables.
      Subchapter II of this chapter, referred to in par. (39)(A)(iii),
    (vi), was in the original "title III", meaning title III of Pub. L.
    91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
    subchapter II of this chapter. For classification of Part B,
    consisting of sections 1101 to 1105 of title III, see Tables.
      The Federal Food, Drug, and Cosmetic Act, referred to in pars.
    (39)(A)(iv) and (45)(A)(ii), is act June 25, 1938, ch. 675, 52
    Stat. 1040, as amended, which is classified generally to chapter 9
    (Sec. 301 et seq.) of this title. For complete classification of
    this Act to the Code, see section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (39)(A)(iv). Pub. L. 109-177, Sec. 712(a)(1)(A)(i),
    amended cl. (iv) generally. Prior to amendment, cl. (iv) related to
    transactions involving drugs containing ephedrine, pseudoephedrine,
    or phenylpropanolamine.
      Par. (39)(A)(v), (vi). Pub. L. 109-177, Sec. 712(a)(1)(A)(ii),
    (iii), added cl. (v) and redesignated former cl. (v) as (vi).
      Par. (41)(A)(xvii). Pub. L. 109-162, Sec. 1180(1), substituted
    "13&beta;-ethyl-17&beta;-hydroxygon-4-en-3-one;" for "13&beta;-
    ethyl-17&alpha;-hydroxygon-4-en-3-one;".
      Par. (41)(A)(xliv). Pub. L. 109-162, Sec. 1180(2), substituted
    "(17&alpha;-methyl-17&beta;-hydroxy-[5&alpha;]-androst-2-eno[3,2-c]-
    pyrazole);" for "(17&alpha;-methyl-17&alpha;-hydroxy-[5&alpha;]-
    androst-2-eno[3,2-c]-pyrazole);".
      Par. (45). Pub. L. 109-177, Secs. 711(a)(1)(B), 712(a)(1)(B),
    added par. (45) and struck out former par. (45) which defined
    "ordinary over-the-counter pseudoephedrine or phenylpropanolamine
    product".
      Pars. (46) to (48). Pub. L. 109-177, Secs. 711(a)(1)(B), added
    pars. (46) to (48). Former par. (46) redesignated (49).
      Par. (49). Pub. L. 109-177, Sec. 711(a)(1)(A), (2)(A),
    redesignated par. (46) as (49), substituted "ephedrine,
    pseudoephedrine, or" for "pseudoephedrine or" in subpar. (A),
    redesignated subpar. (C) as (B), and struck out former subpar. (B)
    which read as follows: "For purposes of this paragraph, sale for
    personal use means the sale of below-threshold quantities in a
    single transaction to an individual for legitimate medical use."
      2004 - Par. (41). Pub. L. 108-358, Sec. 2(a)(1), realigned
    margins, added subpar. (A), and struck out former subpar. (A) which
    defined "anabolic steroid".
      Par. (44). Pub. L. 108-358, Sec. 2(a)(2), inserted "anabolic
    steroids," after "marihuana,".
      2002 - Pars. (43), (44). Pub. L. 107-273 repealed Pub. L. 104-
    294, Secs. 604(b)(4), 607(j)(2). See 1996 Amendment note below.
      2000 - Par. (32)(A). Pub. L. 106-172, Sec. 5(a)(1), substituted
    "subparagraph (C)" for "subparagraph (B)" in introductory
    provisions.
      Par. (32)(B), (C). Pub. L. 106-172, Sec. 5(a)(2), (3), added
    subpar. (B) and redesignated former subpar. (B) as (C).
      Par. (34)(X), (Y). Pub. L. 106-172, Sec. 3(c), added subpar. (X)
    and redesignated former subpar. (X) as (Y).
      Par. (39)(A)(iv)(II). Pub. L. 106-310 substituted "9 grams" for
    "24 grams" in two places and inserted before semicolon at end "and
    sold in package sizes of not more than 3 grams of pseudoephedrine
    base or 3 grams of phenylpropanolamine base".
      1997 - Par. (9)(A). Pub. L. 105-115 redesignated cl. (i) as
    subpar. (A) and struck out cl. (ii) which read as follows: "any
    derivative of barbituric acid which has been designated by the
    Secretary as habit forming under section 352(d) of this title; or".
      1996 - Par. (26). Pub. L. 104-294, Sec. 607(j)(1), amended par.
    (26) generally. Prior to amendment, par. (26) read as follows: "The
    term 'State' means any State, territory, or possession of the
    United States, the District of Columbia, the Commonwealth of Puerto
    Rico, the Trust Territory of the Pacific Islands, and the Canal
    Zone."
      Par. (34)(P), (S), (U). Pub. L. 104-237, Sec. 209(1), substituted
    "Isosafrole" for "Insosafrole" in subpar. (P), "N-Methylephedrine"
    for "N-Methylepherdrine" in subpar. (S), and "Hydriodic acid" for
    "Hydriotic acid" in subpar. (U).
      Par. (35)(G). Pub. L. 104-237, Sec. 209(2), amended subpar. (G)
    generally, inserting "(or Methyl Ethyl Ketone)" before period at
    end.
      Par. (35)(I), (J). Pub. L. 104-237, Sec. 204(a), added subpars.
    (I) and (J).
      Par. (39)(A)(iv)(I)(aa). Pub. L. 104-237, Sec. 401(a)(1), (b)(1),
    substituted ", pseudoephedrine or its salts, optical isomers, or
    salts of optical isomers, or phenylpropanolamine or its salts,
    optical isomers, or salts of optical isomers unless otherwise
    provided by regulation of the Attorney General issued pursuant to
    section 814(e) of this title, except that any sale of ordinary over-
    the-counter pseudoephedrine or phenylpropanolamine products by
    retail distributors shall not be a regulated transaction (except as
    provided in section 401(d) of the Comprehensive Methamphetamine
    Control Act of 1996);" for "as the only active medicinal ingredient
    or contains ephedrine or its salts, optical isomers, or salts of
    optical isomers and therapeutically insignificant quantities of
    another active medicinal ingredient;".
      Par. (39)(A)(iv)(II). Pub. L. 104-237, Sec. 401(a)(2), (b)(2),
    inserted ", pseudoephedrine, phenylpropanolamine," after
    "ephedrine" and inserted before semicolon ", except that the
    threshold for any sale of products containing pseudoephedrine or
    phenylpropanolamine products by retail distributors or by
    distributors required to submit reports by section 830(b)(3) of
    this title shall be 24 grams of pseudoephedrine or 24 grams of
    phenylpropanolamine in a single transaction".
      Pars. (43), (44). Pub. L. 104-294, Secs. 604(b)(4), 607(j)(2),
    which provided for amendment to section identical to Pub. L. 104-
    237, Sec. 401(b)(3), below, were repealed by Pub. L. 107-273, Sec.
    4002(c)(1).
      Pub. L. 104-237, Sec. 401(b)(3), redesignated par. (43), relating
    to felony drug offense, as (44).
      Pars. (45), (46). Pub. L. 104-237, Sec. 401(b)(4), added pars.
    (45) and (46).
      1994 - Par. (34)(V), (W). Pub. L. 103-322, Sec. 330024(b),
    realigned margins and capitalized first letter.
      Par. (35). Pub. L. 103-322, Sec. 330024(d)(1), made technical
    correction to directory language of Pub. L. 103-200, Sec.
    2(a)(4)(B). See 1993 Amendment note below.
      Par. (39)(A)(iv)(II). Pub. L. 103-322, Sec. 330024(a),
    substituted "; or" for period at end.
      Par. (43). Pub. L. 103-322, Sec. 90105(d), added par. (43)
    defining "felony drug offense".
      1993 - Par. (33). Pub. L. 103-200, Sec. 2(a)(1), substituted "any
    list I chemical or any list II chemical" for "any listed precursor
    chemical or listed essential chemical".
      Par. (34). Pub. L. 103-200, Sec. 2(a)(2), substituted "list I
    chemical" for "listed precursor chemical" and "important to the
    manufacture" for "critical to the creation" in introductory
    provisions.
      Par. (34)(A), (F), (H). Pub. L. 103-200, Sec. 2(a)(3), inserted
    ", its esters," before "and".
      Par. (34)(O). Pub. L. 103-200, Sec. 8(1), (2), redesignated
    subpar. (P) as (O) and struck out former subpar. (O) which read as
    follows: "D-lysergic acid."
      Par. (34)(P) to (S). Pub. L. 103-200, Sec. 8(2), redesignated
    subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P)
    redesignated (O).
      Par. (34)(T). Pub. L. 103-200, Sec. 8(2), redesignated subpar.
    (V) as (T). Former subpar. (T) redesignated (S).
      Par. (34)(U). Pub. L. 103-200, Sec. 8(1), (2), redesignated
    subpar. (X) as (U) and struck out former subpar. (U) which read as
    follows: "N-ethylephedrine."
      Par. (34)(V). Pub. L. 103-200, Sec. 8(2), (4), added subpar. (V)
    and redesignated former subpar. (V) as (T).
      Par. (34)(W). Pub. L. 103-200, Sec. 8(1), (4), added subpar. (W)
    and struck out former subpar. (W) which read as follows: "N-
    ethylpseudoephedrine."
      Par. (34)(X). Pub. L. 103-200, Sec. 8(2), (3), redesignated
    subpar. (Y) as (X) and substituted "through (U)" for "through (X)".
      Par. (34)(Y). Pub. L. 103-200, Sec. 8(2), redesignated subpar.
    (Y) as (X).
      Par. (35). Pub. L. 103-200, Sec. 2(a)(4)(A), (C), substituted
    "list II chemical" for "listed essential chemical" and struck out
    "as a solvent, reagent, or catalyst" before "in manufacturing".
      Pub. L. 103-200, Sec. 2(a)(4)(B), as amended by Pub. L. 103-322,
    Sec. 330024(d)(1), inserted "(other than a list I chemical)" before
    "specified" the first time appearing.
      Par. (37). Pub. L. 103-200, Sec. 9(a), amended par. (37)
    generally. Prior to amendment, par. (37) read as follows: "The term
    'regular supplier' means, with respect to a regulated person, a
    supplier with whom the regulated person has an established business
    relationship that is reported to the Attorney General."
      Par. (38). Pub. L. 103-200, Sec. 2(a)(5), inserted before period
    at end "or who acts as a broker or trader for an international
    transaction involving a listed chemical, a tableting machine, or an
    encapsulating machine".
      Par. (39)(A). Pub. L. 103-200, Secs. 2(a)(6)(A), 7, in
    introductory provisions, substituted "importation, or exportation
    of, or an international transaction involving shipment of," for
    "importation or exportation of" and inserted "a listed chemical, or
    if the Attorney General establishes a threshold amount for a
    specific listed chemical," before "a threshold amount,".
      Par. (39)(A)(iii). Pub. L. 103-200, Sec. 2(a)(6)(B), inserted "or
    any category of transaction for a specific listed chemical or
    chemicals" after "transaction".
      Par. (39)(A)(iv). Pub. L. 103-200, Sec. 2(a)(6)(C), amended cl.
    (iv) generally. Prior to amendment, cl. (iv) read as follows: "any
    transaction in a listed chemical that is contained in a drug that
    may be marketed or distributed lawfully in the United States under
    the Federal Food, Drug, and Cosmetic Act; or".
      Par. (39)(A)(v). Pub. L. 103-200, Sec. 2(a)(6)(D), inserted
    before semicolon at end "which the Attorney General has by
    regulation designated as exempt from the application of this
    subchapter and subchapter II of this chapter based on a finding
    that the mixture is formulated in such a way that it cannot be
    easily used in the illicit production of a controlled substance and
    that the listed chemical or chemicals contained in the mixture
    cannot be readily recovered".
      Par. (40). Pub. L. 103-200, Sec. 2(a)(7), substituted "list I
    chemical or a list II chemical" for "listed precursor chemical or a
    listed essential chemical" in two places.
      Pars. (42), (43). Pub. L. 103-200, Sec. 2(a)(8), added pars. (42)
    and (43).
      1990 - Par. (32)(A). Pub. L. 101-647, Sec. 3599I, substituted
    "the stimulant" for "the stimulent" in cl. (ii) and "a stimulant"
    for "a stimulent" in cl. (iii).
      Par. (34)(M) to (Y). Pub. L. 101-647, Sec. 2301(a), added
    subpars. (M) to (Y).
      Par. (35)(E). Pub. L. 101-647, Sec. 2301(b), struck out subpar.
    (E) "Hydriodic acid."
      Par. (41). Pub. L. 101-647, Sec. 1902(b), added par. (41).
      1988 - Par. (8). Pub. L. 100-690, Sec. 6054(1), inserted "or a
    listed chemical" after "a controlled substance".
      Par. (11). Pub. L. 100-690, Sec. 6054(2), inserted "or a listed
    chemical" after "a controlled substance" in two places.
      Pars. (33) to (40). Pub. L. 100-690, Sec. 6054(3), added pars.
    (33) to (40).
      1986 - Par. (6). Pub. L. 99-514 substituted "Internal Revenue
    Code of 1986" for "Internal Revenue Code of 1954".
      Par. (14). Pub. L. 99-570, Sec. 1870, and Pub. L. 99-646 amended
    par. (14) identically, substituting "any optical" for "the optical"
    in second and third sentences.
      Par. (25). Pub. L. 99-570, Sec. 1003(b)(1), added par. (25).
    Former par. (25) redesignated (26).
      Pars. (26) to (31). Pub. L. 99-570, Sec. 1003(b)(2), redesignated
    pars. (25) to (30) as (26) to (31), respectively.
      Par. (32). Pub. L. 99-570, Sec. 1203, added par. (32).
      1984 - Pars. (14) to (16). Pub. L. 98-473, Sec. 507(a), added
    par. (14) and redesignated former pars. (14) to (16) as (15) to
    (17), respectively.
      Par. (17). Pub. L. 98-473, Sec. 507, redesignated former par.
    (16) as (17), and expanded and revised definition of "narcotic
    drug", including within term poppy straw, cocaine, and ecgonine.
    Former par. (17) redesignated (18).
      Pars. (18) to (28). Pub. L. 98-473, Sec. 507(a), redesignated
    former pars. (17) to (27) as (18) to (28), respectively.
      Par. (29). Pub. L. 98-509 which directed the substitution of "one
    hundred and eighty" for "twenty-one" in par. (28), was executed to
    par. (29) in view of the redesignation of par. (28) as par. (29) by
    Pub. L. 98-473.
      Pub. L. 98-473, Sec. 507(a), redesignated former par. (28) as
    (29). Former par. (29) redesignated (30).
      Par. (30). Pub. L. 98-473, Sec. 507(a), redesignated former par.
    (29) as (30).
      1979 - Par. (4). Pub. L. 96-132 substituted provisions defining
    "Drug Enforcement Administration" for provisions defining "Bureau
    of Narcotics and Dangerous Drugs".
      1978 - Par. (29). Pub. L. 95-633 added par. (29).
      1974 - Pars. (27), (28). Pub. L. 93-281 added pars. (27) and
    (28).

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in par. (24) pursuant
    to section 509(b) of Pub. L. 96-88, which is classified to section
    3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Pub. L. 108-358, Sec. 2(d), Oct. 22, 2004, 118 Stat. 1664,
    provided that: "The amendments made by this section [amending this
    section, section 811 of this title, and provisions set out as a
    note under this section] shall take effect 90 days after the date
    of enactment of this Act [Oct. 22, 2004]."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-273, div. B, title IV, Sec. 4002(c)(1), Nov. 2, 2002,
    116 Stat. 1808, provided that the amendment made by section
    4002(c)(1) is effective Oct. 11, 1996.

                     EFFECTIVE DATE OF 2000 AMENDMENT                 
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3622(b), Oct. 17,
    2000, 114 Stat. 1231, provided that: "The amendments made by
    subsection (a) [amending this section] shall take effect 1 year
    after the date of the enactment of this Act [Oct. 17, 2000]."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1996 AMENDMENTS                 
      Amendment by section 604(b)(4) of Pub. L. 104-294 effective Sept.
    13, 1994, see section 604(d) of Pub. L. 104-294, set out as a note
    under section 13 of Title 18, Crimes and Criminal Procedure.
      Section 401(g) of Pub. L. 104-237 provided that: "Notwithstanding
    any other provision of this Act [see section 1(a) of Pub. L. 104-
    237, set out as a Short Title of 1996 Amendments note under
    section 801 of this title], this section [amending this section and
    section 814 of this title and enacting provisions set out as a note
    below] shall not apply to the sale of any pseudoephedrine or
    phenylpropanolamine product prior to 12 months after the date of
    enactment of this Act [Oct. 3, 1996], except that, on application
    of a manufacturer of a particular pseudoephedrine or
    phenylpropanolamine drug product, the Attorney General may, in her
    sole discretion, extend such effective date up to an additional six
    months. Notwithstanding any other provision of law, the decision of
    the Attorney General on such an application shall not be subject to
    judicial review."

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 330024(f) of Pub. L. 103-322 provided that: "The
    amendments made by this section [amending this section and sections
    824, 960, and 971 of this title] shall take effect as of the date
    that is 120 days after the date of enactment of the Domestic
    Chemical Diversion Control Act of 1993 [Dec. 17, 1993]."

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Section 11 of Pub. L. 103-200 provided that: "This Act [enacting
    section 814 of this title, amending this section and sections 821
    to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and
    enacting provisions set out as a note under section 801 of this
    title] and the amendments made by this Act shall take effect on the
    date that is 120 days after the date of enactment of this Act [Dec.
    17, 1993]."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 1902(d) of Pub. L. 101-647 provided that: "This section
    [amending this section and section 812 of this title and enacting
    provisions set out as a note under section 829 of this title] and
    the amendment made by this section shall take effect 90 days after
    the date of enactment of this Act [Nov. 29, 1990]."

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Section 6061 of title VI of Pub. L. 100-690 provided that:
    "Except as otherwise provided in this subtitle, this subtitle
    [subtitle A (Secs. 6051-6061) of title VI of Pub. L. 100-690,
    enacting section 971 of this title, amending this section and
    sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this
    title, and enacting provisions set out as notes under this section
    and section 971 of this title] shall take effect 120 days after the
    enactment of this Act [Nov. 18, 1988]."

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

                                REGULATIONS                            
      Section 301(b) of Pub. L. 98-509 provided that: "The Secretary of
    Health and Human Services shall, within ninety days of the date of
    the enactment of this Act [Oct. 19, 1984], promulgate regulations
    for the administration of section 102(28) of the Controlled
    Substances Act [21 U.S.C. 802(29)] as amended by subsection (a) and
    shall include in the first report submitted under section 505(b)
    [503(b)] of the Public Health Service Act [former 42 U.S.C. 290aa-
    2(b)] after the expiration of such ninety days the findings of the
    Secretary with respect to the effect of the amendment made by
    subsection (a)."

       PRESERVATION OF STATE AUTHORITY TO REGULATE SCHEDULED LISTED
                                 CHEMICALS
      Pub. L. 109-177, title VII, Sec. 711(g), Mar. 9, 2006, 120 Stat.
    263, provided that: "This section [amending this section and
    sections 830, 841, 842, and 844 of this title and enacting
    provisions set out as notes under sections 830 and 844 of this
    title] and the amendments made by this section may not be construed
    as having any legal effect on section 708 of the Controlled
    Substances Act [21 U.S.C. 903] as applied to the regulation of
    scheduled listed chemicals (as defined in section 102(45) of such
    Act [21 U.S.C. 802(45)])."

     REPORT ON DIVERSION OF ORDINARY, OVER-THE-COUNTER PSEUDOEPHEDRINE
                     AND PHENYLPROPANOLAMINE PRODUCTS
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3642, Oct. 17, 2000,
    114 Stat. 1237, provided that:
      "(a) Study. - The Attorney General shall conduct a study of the
    use of ordinary, over-the-counter pseudoephedrine and
    phenylpropanolamine products in the clandestine production of
    illicit drugs. Sources of data for the study shall include the
    following:
        "(1) Information from Federal, State, and local clandestine
      laboratory seizures and related investigations identifying the
      source, type, or brand of drug products being utilized and how
      they were obtained for the illicit production of methamphetamine
      and amphetamine.
        "(2) Information submitted voluntarily from the pharmaceutical
      and retail industries involved in the manufacture, distribution,
      and sale of drug products containing ephedrine, pseudoephedrine,
      and phenylpropanolamine, including information on changes in the
      pattern, volume, or both, of sales of ordinary, over-the-counter
      pseudoephedrine and phenylpropanolamine products.
      "(b) Report. - 
        "(1) Requirement. - Not later than 1 year after the date of the
      enactment of this Act [Oct. 17, 2000], the Attorney General shall
      submit to Congress a report on the study conducted under
      subsection (a).
        "(2) Elements. - The report shall include - 
          "(A) the findings of the Attorney General as a result of the
        study; and
          "(B) such recommendations on the need to establish additional
        measures to prevent diversion of ordinary, over-the-counter
        pseudoephedrine and phenylpropanolamine (such as a threshold on
        ordinary, over-the-counter pseudoephedrine and
        phenylpropanolamine products) as the Attorney General considers
        appropriate.
        "(3) Matters considered. - In preparing the report, the
      Attorney General shall consider the comments and recommendations
      including the comments on the Attorney General's proposed
      findings and recommendations, of State and local law enforcement
      and regulatory officials and of representatives of the industry
      described in subsection (a)(2).
      "(c) Regulation of Retail Sales. - 
        "(1) In general. - Notwithstanding section 401(d) of the
      Comprehensive Methamphetamine Control Act of 1996 [Pub. L. 104-
      237] (21 U.S.C. 802 note) and subject to paragraph (2), the
      Attorney General shall establish by regulation a single-
      transaction limit of not less than 24 grams of ordinary, over-
      the-counter pseudoephedrine or phenylpropanolamine (as the case
      may be) for retail distributors, if the Attorney General finds,
      in the report under subsection (b), that - 
          "(A) there is a significant number of instances (as set forth
        in paragraph (3)(A) of such section 401(d) for purposes of such
        section) where ordinary, over-the-counter pseudoephedrine
        products, phenylpropanolamine products, or both such products
        that were purchased from retail distributors were widely used
        in the clandestine production of illicit drugs; and
          "(B) the best practical method of preventing such use is the
        establishment of single-transaction limits for retail
        distributors of either or both of such products.
        "(2) Due process. - The Attorney General shall establish the
      single-transaction limit under paragraph (1) only after notice,
      comment, and an informal hearing."

     REGULATION OF RETAIL SALES OF CERTAIN PRECURSOR CHEMICALS; EFFECT
               ON THRESHOLDS; COMBINATION EPHEDRINE PRODUCTS
      Pub. L. 104-237, title IV, Sec. 401(d)-(f), Oct. 3, 1996, 110
    Stat. 3108, which authorized the Attorney General to establish a
    single-transaction limit of 24 grams for pseudoephedrine,
    phenylpropanolamine, and combination ephedrine products for retail
    distributors, was repealed by Pub. L. 109-177, title VII, Sec.
    712(b), Mar. 9, 2006, 120 Stat. 264.

                EXEMPTION FOR SUBSTANCES IN PARAGRAPH (41)            
      Pub. L. 101-647, title XIX, Sec. 1903, Nov. 29, 1990, 104 Stat.
    4853, as amended by Pub. L. 108-358, Sec. 2(c), Oct. 22, 2004, 118
    Stat. 1663, provided that:
      "(a) Drugs for Treatment of Rare Diseases. - If the Attorney
    General finds that a drug listed in paragraph (41) of section 102
    of the Controlled Substances Act (as added by section 2 [1902] of
    this Act) is - 
        "(1) approved by the Food and Drug Administration as an
      accepted treatment for a rare disease or condition, as defined in
      section 526 of the Federal Food, Drug, and Cosmetic Act (21
      U.S.C. 360bb); and
        "(2) does not have a significant potential for abuse, the
      Attorney General may exempt such drug from any production
      regulations otherwise issued under the Controlled Substances Act
      as may be necessary to ensure adequate supplies of such drug for
      medical purposes.
      "(b) Date of Issuance of Regulations. - The Attorney General
    shall issue regulations implementing this section not later than 45
    days after the date of enactment of this Act [Nov. 29, 1990],
    except that the regulations required under section 3(a) [former
    1903(a)] shall be issued not later than 180 days after the date of
    enactment of this Act."

-FOOTNOTE-
    (!1) So in original. Probably should be "(l)".


-End-



-CITE-
    21 USC Sec. 803                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part A - Introductory Provisions

-HEAD-
    Sec. 803. Repealed.

-MISC1-
    Sec. 803. Repealed. Pub. L. 95-137, Sec. 1(b), Oct. 18, 1977, 91
      Stat. 1169.
      Section, Pub. L. 91-513, title II, Sec. 103, Oct. 27, 1970, 84
    Stat. 1245, authorized Bureau of Narcotics and Dangerous Drugs to
    add, during fiscal year 1971, 300 agents, together with necessary
    supporting personnel, and provided for appropriations of $6,000,000
    to carry out such addition.

-End-


-CITE-
    21 USC Part B - Authority To Control; Standards and
                     Schedules                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part B - Authority To Control; Standards and Schedules

-HEAD-
          PART B - AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES      

-End-



-CITE-
    21 USC Sec. 811                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part B - Authority To Control; Standards and Schedules

-HEAD-
    Sec. 811. Authority and criteria for classification of substances

-STATUTE-
    (a) Rules and regulations of Attorney General; hearing
      The Attorney General shall apply the provisions of this
    subchapter to the controlled substances listed in the schedules
    established by section 812 of this title and to any other drug or
    other substance added to such schedules under this subchapter.
    Except as provided in subsections (d) and (e) of this section, the
    Attorney General may by rule - 
        (1) add to such a schedule or transfer between such schedules
      any drug or other substance if he - 
          (A) finds that such drug or other substance has a potential
        for abuse, and
          (B) makes with respect to such drug or other substance the
        findings prescribed by subsection (b) of section 812 of this
        title for the schedule in which such drug is to be placed; or

        (2) remove any drug or other substance from the schedules if he
      finds that the drug or other substance does not meet the
      requirements for inclusion in any schedule.

    Rules of the Attorney General under this subsection shall be made
    on the record after opportunity for a hearing pursuant to the
    rulemaking procedures prescribed by subchapter II of chapter 5 of
    title 5. Proceedings for the issuance, amendment, or repeal of such
    rules may be initiated by the Attorney General (1) on his own
    motion, (2) at the request of the Secretary, or (3) on the petition
    of any interested party.
    (b) Evaluation of drugs and other substances
      The Attorney General shall, before initiating proceedings under
    subsection (a) of this section to control a drug or other substance
    or to remove a drug or other substance entirely from the schedules,
    and after gathering the necessary data, request from the Secretary
    a scientific and medical evaluation, and his recommendations, as to
    whether such drug or other substance should be so controlled or
    removed as a controlled substance. In making such evaluation and
    recommendations, the Secretary shall consider the factors listed in
    paragraphs (2), (3), (6), (7), and (8) of subsection (c) of this
    section and any scientific or medical considerations involved in
    paragraphs (1), (4), and (5) of such subsection. The
    recommendations of the Secretary shall include recommendations with
    respect to the appropriate schedule, if any, under which such drug
    or other substance should be listed. The evaluation and the
    recommendations of the Secretary shall be made in writing and
    submitted to the Attorney General within a reasonable time. The
    recommendations of the Secretary to the Attorney General shall be
    binding on the Attorney General as to such scientific and medical
    matters, and if the Secretary recommends that a drug or other
    substance not be controlled, the Attorney General shall not control
    the drug or other substance. If the Attorney General determines
    that these facts and all other relevant data constitute substantial
    evidence of potential for abuse such as to warrant control or
    substantial evidence that the drug or other substance should be
    removed entirely from the schedules, he shall initiate proceedings
    for control or removal, as the case may be, under subsection (a) of
    this section.
    (c) Factors determinative of control or removal from schedules
      In making any finding under subsection (a) of this section or
    under subsection (b) of section 812 of this title, the Attorney
    General shall consider the following factors with respect to each
    drug or other substance proposed to be controlled or removed from
    the schedules:
        (1) Its actual or relative potential for abuse.
        (2) Scientific evidence of its pharmacological effect, if
      known.
        (3) The state of current scientific knowledge regarding the
      drug or other substance.
        (4) Its history and current pattern of abuse.
        (5) The scope, duration, and significance of abuse.
        (6) What, if any, risk there is to the public health.
        (7) Its psychic or physiological dependence liability.
        (8) Whether the substance is an immediate precursor of a
      substance already controlled under this subchapter.
    (d) International treaties, conventions, and protocols requiring
      control; procedures respecting changes in drug schedules of
      Convention on Psychotropic Substances
      (1) If control is required by United States obligations under
    international treaties, conventions, or protocols in effect on
    October 27, 1970, the Attorney General shall issue an order
    controlling such drug under the schedule he deems most appropriate
    to carry out such obligations, without regard to the findings
    required by subsection (a) of this section or section 812(b) of
    this title and without regard to the procedures prescribed by
    subsections (a) and (b) of this section.
      (2)(A) Whenever the Secretary of State receives notification from
    the Secretary-General of the United Nations that information has
    been transmitted by or to the World Health Organization, pursuant
    to article 2 of the Convention on Psychotropic Substances, which
    may justify adding a drug or other substance to one of the
    schedules of the Convention, transferring a drug or substance from
    one schedule to another, or deleting it from the schedules, the
    Secretary of State shall immediately transmit the notice to the
    Secretary of Health and Human Services who shall publish it in the
    Federal Register and provide opportunity to interested persons to
    submit to him comments respecting the scientific and medical
    evaluations which he is to prepare respecting such drug or
    substance. The Secretary of Health and Human Services shall prepare
    for transmission through the Secretary of State to the World Health
    Organization such medical and scientific evaluations as may be
    appropriate regarding the possible action that could be proposed by
    the World Health Organization respecting the drug or substance with
    respect to which a notice was transmitted under this subparagraph.
      (B) Whenever the Secretary of State receives information that the
    Commission on Narcotic Drugs of the United Nations proposes to
    decide whether to add a drug or other substance to one of the
    schedules of the Convention, transfer a drug or substance from one
    schedule to another, or delete it from the schedules, the Secretary
    of State shall transmit timely notice to the Secretary of Health
    and Human Services of such information who shall publish a summary
    of such information in the Federal Register and provide opportunity
    to interested persons to submit to him comments respecting the
    recommendation which he is to furnish, pursuant to this
    subparagraph, respecting such proposal. The Secretary of Health and
    Human Services shall evaluate the proposal and furnish a
    recommendation to the Secretary of State which shall be binding on
    the representative of the United States in discussions and
    negotiations relating to the proposal.
      (3) When the United States receives notification of a scheduling
    decision pursuant to article 2 of the Convention on Psychotropic
    Substances that a drug or other substance has been added or
    transferred to a schedule specified in the notification or receives
    notification (referred to in this subsection as a "schedule
    notice") that existing legal controls applicable under this
    subchapter to a drug or substance and the controls required by the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] do not
    meet the requirements of the schedule of the Convention in which
    such drug or substance has been placed, the Secretary of Health and
    Human Services after consultation with the Attorney General, shall
    first determine whether existing legal controls under this
    subchapter applicable to the drug or substance and the controls
    required by the Federal Food, Drug, and Cosmetic Act, meet the
    requirements of the schedule specified in the notification or
    schedule notice and shall take the following action:
        (A) If such requirements are met by such existing controls but
      the Secretary of Health and Human Services nonetheless believes
      that more stringent controls should be applied to the drug or
      substance, the Secretary shall recommend to the Attorney General
      that he initiate proceedings for scheduling the drug or
      substance, pursuant to subsections (a) and (b) of this section,
      to apply to such controls.
        (B) If such requirements are not met by such existing controls
      and the Secretary of Health and Human Services concurs in the
      scheduling decision or schedule notice transmitted by the
      notification, the Secretary shall recommend to the Attorney
      General that he initiate proceedings for scheduling the drug or
      substance under the appropriate schedule pursuant to subsections
      (a) and (b) of this section.
        (C) If such requirements are not met by such existing controls
      and the Secretary of Health and Human Services does not concur in
      the scheduling decision or schedule notice transmitted by the
      notification, the Secretary shall - 
          (i) if he deems that additional controls are necessary to
        protect the public health and safety, recommend to the Attorney
        General that he initiate proceedings for scheduling the drug or
        substance pursuant to subsections (a) and (b) of this section,
        to apply such additional controls;
          (ii) request the Secretary of State to transmit a notice of
        qualified acceptance, within the period specified in the
        Convention, pursuant to paragraph 7 of article 2 of the
        Convention, to the Secretary-General of the United Nations;
          (iii) request the Secretary of State to transmit a notice of
        qualified acceptance as prescribed in clause (ii) and request
        the Secretary of State to ask for a review by the Economic and
        Social Council of the United Nations, in accordance with
        paragraph 8 of article 2 of the Convention, of the scheduling
        decision; or
          (iv) in the case of a schedule notice, request the Secretary
        of State to take appropriate action under the Convention to
        initiate proceedings to remove the drug or substance from the
        schedules under the Convention or to transfer the drug or
        substance to a schedule under the Convention different from the
        one specified in the schedule notice.

      (4)(A) If the Attorney General determines, after consultation
    with the Secretary of Health and Human Services, that proceedings
    initiated under recommendations made under paragraph (!1) (B) or
    (C)(i) of paragraph (3) will not be completed within the time
    period required by paragraph 7 of article 2 of the Convention, the
    Attorney General, after consultation with the Secretary and after
    providing interested persons opportunity to submit comments
    respecting the requirements of the temporary order to be issued
    under this sentence, shall issue a temporary order controlling the
    drug or substance under schedule IV or V, whichever is most
    appropriate to carry out the minimum United States obligations
    under paragraph 7 of article 2 of the Convention. As a part of such
    order, the Attorney General shall, after consultation with the
    Secretary, except such drug or substance from the application of
    any provision of part C of this subchapter which he finds is not
    required to carry out the United States obligations under paragraph
    7 of article 2 of the Convention. In the case of proceedings
    initiated under subparagraph (B) of paragraph (3), the Attorney
    General, concurrently with the issuance of such order, shall
    request the Secretary of State to transmit a notice of qualified
    acceptance to the Secretary-General of the United Nations pursuant
    to paragraph 7 of article 2 of the Convention. A temporary order
    issued under this subparagraph controlling a drug or other
    substance subject to proceedings initiated under subsections (a)
    and (b) of this section shall expire upon the effective date of the
    application to the drug or substance of the controls resulting from
    such proceedings.

      (B) After a notice of qualified acceptance of a scheduling
    decision with respect to a drug or other substance is transmitted
    to the Secretary-General of the United Nations in accordance with
    clause (ii) or (iii) of paragraph (3)(C) or after a request has
    been made under clause (iv) of such paragraph with respect to a
    drug or substance described in a schedule notice, the Attorney
    General, after consultation with the Secretary of Health and Human
    Services and after providing interested persons opportunity to
    submit comments respecting the requirements of the order to be
    issued under this sentence, shall issue an order controlling the
    drug or substance under schedule IV or V, whichever is most
    appropriate to carry out the minimum United States obligations
    under paragraph 7 of article 2 of the Convention in the case of a
    drug or substance for which a notice of qualified acceptance was
    transmitted or whichever the Attorney General determines is
    appropriate in the case of a drug or substance described in a
    schedule notice. As a part of such order, the Attorney General
    shall, after consultation with the Secretary, except such drug or
    substance from the application of any provision of part C of this
    subchapter which he finds is not required to carry out the United
    States obligations under paragraph 7 of article 2 of the
    Convention. If, as a result of a review under paragraph 8 of
    article 2 of the Convention of the scheduling decision with respect
    to which a notice of qualified acceptance was transmitted in
    accordance with clause (ii) or (iii) of paragraph (3)(C) - 
        (i) the decision is reversed, and
        (ii) the drug or substance subject to such decision is not
      required to be controlled under schedule IV or V to carry out the
      minimum United States obligations under paragraph 7 of article 2
      of the Convention,

    the order issued under this subparagraph with respect to such drug
    or substance shall expire upon receipt by the United States of the
    review decision. If, as a result of action taken pursuant to action
    initiated under a request transmitted under clause (iv) of
    paragraph (3)(C), the drug or substance with respect to which such
    action was taken is not required to be controlled under schedule IV
    or V, the order issued under this paragraph with respect to such
    drug or substance shall expire upon receipt by the United States of
    a notice of the action taken with respect to such drug or substance
    under the Convention.
      (C) An order issued under subparagraph (A) or (B) may be issued
    without regard to the findings required by subsection (a) of this
    section or by section 812(b) of this title and without regard to
    the procedures prescribed by subsection (a) or (b) of this section.
      (5) Nothing in the amendments made by the Psychotropic Substances
    Act of 1978 or the regulations or orders promulgated thereunder
    shall be construed to preclude requests by the Secretary of Health
    and Human Services or the Attorney General through the Secretary of
    State, pursuant to article 2 or other applicable provisions of the
    Convention, for review of scheduling decisions under such
    Convention, based on new or additional information.
    (e) Immediate precursors
      The Attorney General may, without regard to the findings required
    by subsection (a) of this section or section 812(b) of this title
    and without regard to the procedures prescribed by subsections (a)
    and (b) of this section, place an immediate precursor in the same
    schedule in which the controlled substance of which it is an
    immediate precursor is placed or in any other schedule with a
    higher numerical designation. If the Attorney General designates a
    substance as an immediate precursor and places it in a schedule,
    other substances shall not be placed in a schedule solely because
    they are its precursors.
    (f) Abuse potential
      If, at the time a new-drug application is submitted to the
    Secretary for any drug having a stimulant, depressant, or
    hallucinogenic effect on the central nervous system, it appears
    that such drug has an abuse potential, such information shall be
    forwarded by the Secretary to the Attorney General.
    (g) Exclusion of non-narcotic substances sold over the counter
      without a prescription; dextromethorphan; exemption of substances
      lacking abuse potential
      (1) The Attorney General shall by regulation exclude any non-
    narcotic drug which contains a controlled substance from the
    application of this subchapter and subchapter II of this chapter if
    such drug may, under the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 301 et seq.], be lawfully sold over the counter without a
    prescription.
      (2) Dextromethorphan shall not be deemed to be included in any
    schedule by reason of enactment of this subchapter unless
    controlled after October 27, 1970 pursuant to the foregoing
    provisions of this section.
      (3) The Attorney General may, by regulation, exempt any compound,
    mixture, or preparation containing a controlled substance from the
    application of all or any part of this subchapter if he finds such
    compound, mixture, or preparation meets the requirements of one of
    the following categories:
        (A) A mixture, or preparation containing a nonnarcotic
      controlled substance, which mixture or preparation is approved
      for prescription use, and which contains one or more other active
      ingredients which are not listed in any schedule and which are
      included therein in such combinations, quantity, proportion, or
      concentration as to vitiate the potential for abuse.
        (B) A compound, mixture, or preparation which contains any
      controlled substance, which is not for administration to a human
      being or animal, and which is packaged in such form or
      concentration, or with adulterants or denaturants, so that as
      packaged it does not present any significant potential for abuse.
        (C) Upon the recommendation of the Secretary of Health and
      Human Services, a compound, mixture, or preparation which
      contains any anabolic steroid, which is intended for
      administration to a human being or an animal, and which, because
      of its concentration, preparation, formulation or delivery
      system, does not present any significant potential for abuse.
    (h) Temporary scheduling to avoid imminent hazards to public safety
      (1) If the Attorney General finds that the scheduling of a
    substance in schedule I on a temporary basis is necessary to avoid
    an imminent hazard to the public safety, he may, by order and
    without regard to the requirements of subsection (b) of this
    section relating to the Secretary of Health and Human Services,
    schedule such substance in schedule I if the substance is not
    listed in any other schedule in section 812 of this title or if no
    exemption or approval is in effect for the substance under section
    505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355].
    Such an order may not be issued before the expiration of thirty
    days from - 
        (A) the date of the publication by the Attorney General of a
      notice in the Federal Register of the intention to issue such
      order and the grounds upon which such order is to be issued, and
        (B) the date the Attorney General has transmitted the notice
      required by paragraph (4).

      (2) The scheduling of a substance under this subsection shall
    expire at the end of one year from the date of the issuance of the
    order scheduling such substance, except that the Attorney General
    may, during the pendency of proceedings under subsection (a)(1) of
    this section with respect to the substance, extend the temporary
    scheduling for up to six months.
      (3) When issuing an order under paragraph (1), the Attorney
    General shall be required to consider, with respect to the finding
    of an imminent hazard to the public safety, only those factors set
    forth in paragraphs (4), (5), and (6) of subsection (c) of this
    section, including actual abuse, diversion from legitimate
    channels, and clandestine importation, manufacture, or
    distribution.
      (4) The Attorney General shall transmit notice of an order
    proposed to be issued under paragraph (1) to the Secretary of
    Health and Human Services. In issuing an order under paragraph (1),
    the Attorney General shall take into consideration any comments
    submitted by the Secretary in response to a notice transmitted
    pursuant to this paragraph.
      (5) An order issued under paragraph (1) with respect to a
    substance shall be vacated upon the conclusion of a subsequent
    rulemaking proceeding initiated under subsection (a) of this
    section with respect to such substance.
      (6) An order issued under paragraph (1) is not subject to
    judicial review.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 201, Oct. 27, 1970, 84 Stat. 1245;
    Pub. L. 95-633, title I, Sec. 102(a), Nov. 10, 1978, 92 Stat. 3769;
    Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695;
    Pub. L. 98-473, title II, Secs. 508, 509(a), Oct. 12, 1984, 98
    Stat. 2071, 2072; Pub. L. 108-358, Sec. 2(b), Oct. 22, 2004, 118
    Stat. 1663.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in subsecs. (a), (c)(8), (d)(3),
    (4)(A), (B), and (g)(2), (3), was in the original "this title",
    meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242,
    as amended, and is popularly known as the "Controlled Substances
    Act". For complete classification of title II to the Code, see
    second paragraph of Short Title note set out under section 801 of
    this title and Tables.
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (d)(3) and (g)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.
      Schedules I, IV, and V, referred to in subsecs. (d)(4)(A), (B),
    and (h)(1), are set out in section 812(c) of this title.
      The Psychotropic Substances Act of 1978, referred to in subsec.
    (d)(5), is Pub. L. 95-633, Nov. 10, 1978, 92 Stat. 3768, which
    enacted sections 801a, 830, and 852 of this title, amended sections
    352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and
    965 of this title and section 242a of Title 42, The Public Health
    and Welfare, repealed section 830 of this title effective Jan. 1,
    1981, and enacted provisions set out as notes under sections 801,
    801a, 812, and 830 of this title. For complete classification of
    this Act to the Code, see Short Title of 1978 Amendment note set
    out under section 801 of this title and Tables.
      This subchapter and subchapter II of this chapter, referred to in
    subsec. (g)(1), was in the original "titles II and III of the
    Comprehensive Drug Abuse Prevention and Control Act", which was
    translated as meaning titles II and III of the Comprehensive Drug
    Abuse Prevention and Control Act of 1970, Pub. L. 91-513, Oct. 27,
    1970, 84 Stat. 1242, 1285, as amended, to reflect the probable
    intent of Congress. Title II is classified principally to this
    subchapter and part A of title III comprises subchapter II of this
    chapter. For complete classification of this Act to the Code, see
    Short Title notes set out under section 801 of this title and
    Tables.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (g)(1). Pub. L. 108-358, Sec. 2(b)(1), substituted
    "drug which contains a controlled substance from the application of
    this subchapter and subchapter II of this chapter if such drug" for
    "substance from a schedule if such substance".
      Subsec. (g)(3)(C). Pub. L. 108-358, Sec. 2(b)(2), added subpar.
    (C).
      1984 - Subsec. (g)(3). Pub. L. 98-473, Sec. 509(a), added par.
    (3).
      Subsec. (h). Pub. L. 98-473, Sec. 508, added subsec. (h).
      1978 - Subsec. (d). Pub. L. 95-633 designated existing provisions
    as par. (1) and added pars. (2) to (5).

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in subsec. (d)(2),
    (3), (4)(A), (B), (5) pursuant to section 509(b) of Pub. L. 96-88
    which is classified to section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Amendment by Pub. L. 108-358 effective 90 days after Oct. 22,
    2004, see section 2(d) of Pub. L. 108-358, set out as a note under
    section 802 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

-FOOTNOTE-
    (!1) So in original. Probably should be "subparagraph".


-End-



-CITE-
    21 USC Sec. 812                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part B - Authority To Control; Standards and Schedules

-HEAD-
    Sec. 812. Schedules of controlled substances

-STATUTE-
    (a) Establishment
      There are established five schedules of controlled substances, to
    be known as schedules I, II, III, IV, and V. Such schedules shall
    initially consist of the substances listed in this section. The
    schedules established by this section shall be updated and
    republished on a semiannual basis during the two-year period
    beginning one year after October 27, 1970, and shall be updated and
    republished on an annual basis thereafter.
    (b) Placement on schedules; findings required
      Except where control is required by United States obligations
    under an international treaty, convention, or protocol, in effect
    on October 27, 1970, and except in the case of an immediate
    precursor, a drug or other substance may not be placed in any
    schedule unless the findings required for such schedule are made
    with respect to such drug or other substance. The findings required
    for each of the schedules are as follows:
      (1) Schedule I. - 
        (A) The drug or other substance has a high potential for abuse.
        (B) The drug or other substance has no currently accepted
      medical use in treatment in the United States.
        (C) There is a lack of accepted safety for use of the drug or
      other substance under medical supervision.

      (2) Schedule II. - 
        (A) The drug or other substance has a high potential for abuse.
        (B) The drug or other substance has a currently accepted
      medical use in treatment in the United States or a currently
      accepted medical use with severe restrictions.
        (C) Abuse of the drug or other substances may lead to severe
      psychological or physical dependence.

      (3) Schedule III. - 
        (A) The drug or other substance has a potential for abuse less
      than the drugs or other substances in schedules I and II.
        (B) The drug or other substance has a currently accepted
      medical use in treatment in the United States.
        (C) Abuse of the drug or other substance may lead to moderate
      or low physical dependence or high psychological dependence.

      (4) Schedule IV. - 
        (A) The drug or other substance has a low potential for abuse
      relative to the drugs or other substances in schedule III.
        (B) The drug or other substance has a currently accepted
      medical use in treatment in the United States.
        (C) Abuse of the drug or other substance may lead to limited
      physical dependence or psychological dependence relative to the
      drugs or other substances in schedule III.

      (5) Schedule V. - 
        (A) The drug or other substance has a low potential for abuse
      relative to the drugs or other substances in schedule IV.
        (B) The drug or other substance has a currently accepted
      medical use in treatment in the United States.
        (C) Abuse of the drug or other substance may lead to limited
      physical dependence or psychological dependence relative to the
      drugs or other substances in schedule IV.
    (c) Initial schedules of controlled substances
      Schedules I, II, III, IV, and V shall, unless and until amended
    (!1) pursuant to section 811 of this title, consist of the
    following drugs or other substances, by whatever official name,
    common or usual name, chemical name, or brand name designated:


                                SCHEDULE I                            
      (a) Unless specifically excepted or unless listed in another
    schedule, any of the following opiates, including their isomers,
    esters, ethers, salts, and salts of isomers, esters, and ethers,
    whenever the existence of such isomers, esters, ethers, and salts
    is possible within the specific chemical designation:
        (1) Acetylmethadol.
        (2) Allylprodine.
        (3) Alphacetylmathadol.(!2)

        (4) Alphameprodine.
        (5) Alphamethadol.
        (6) Benzethidine.
        (7) Betacetylmethadol.
        (8) Betameprodine.
        (9) Betamethadol.
        (10) Betaprodine.
        (11) Clonitazene.
        (12) Dextromoramide.
        (13) Dextrorphan.
        (14) Diampromide.
        (15) Diethylthiambutene.
        (16) Dimenoxadol.
        (17) Dimepheptanol.
        (18) Dimethylthiambutene.
        (19) Dioxaphetyl butyrate.
        (20) Dipipanone.
        (21) Ethylmethylthiambutene.
        (22) Etonitazene.
        (23) Etoxeridine.
        (24) Furethidine.
        (25) Hydroxypethidine.
        (26) Ketobemidone.
        (27) Levomoramide.
        (28) Levophenacylmorphan.
        (29) Morpheridine.
        (30) Noracymethadol.
        (31) Norlevorphanol.
        (32) Normethadone.
        (33) Norpipanone.
        (34) Phenadoxone.
        (35) Phenampromide.
        (36) Phenomorphan.
        (37) Phenoperidine.
        (38) Piritramide.
        (39) Propheptazine.
        (40) Properidine.
        (41) Racemoramide.
        (42) Trimeperidine.

      (b) Unless specifically excepted or unless listed in another
    schedule, any of the following opium derivatives, their salts,
    isomers, and salts of isomers whenever the existence of such salts,
    isomers, and salts of isomers is possible within the specific
    chemical designation:
        (1) Acetorphine.
        (2) Acetyldihydrocodeine.
        (3) Benzylmorphine.
        (4) Codeine methylbromide.
        (5) Codeine-N-Oxide.
        (6) Cyprenorphine.
        (7) Desomorphine.
        (8) Dihydromorphine.
        (9) Etorphine.
        (10) Heroin.
        (11) Hydromorphinol.
        (12) Methyldesorphine.
        (13) Methylhydromorphine.
        (14) Morphine methylbromide.
        (15) Morphine methylsulfonate.
        (16) Morphine-N-Oxide.
        (17) Myrophine.
        (18) Nicocodeine.
        (19) Nicomorphine.
        (20) Normorphine.
        (21) Pholcodine.
        (22) Thebacon.

      (c) Unless specifically excepted or unless listed in another
    schedule, any material, compound, mixture, or preparation, which
    contains any quantity of the following hallucinogenic substances,
    or which contains any of their salts, isomers, and salts of isomers
    whenever the existence of such salts, isomers, and salts of isomers
    is possible within the specific chemical designation:
        (1) 3,4-methylenedioxy amphetamine.
        (2) 5-methoxy-3,4-methylenedioxy amphetamine.
        (3) 3,4,5-trimethoxy amphetamine.
        (4) Bufotenine.
        (5) Diethyltryptamine.
        (6) Dimethyltryptamine.
        (7) 4-methyl-2,5-diamethoxyamphetamine.
        (8) Ibogaine.
        (9) Lysergic acid diethylamide.
        (10) Marihuana.
        (11) Mescaline.
        (12) Peyote.
        (13) N-ethyl-3-piperidyl benzilate.
        (14) N-methyl-3-piperidyl benzilate.
        (15) Psilocybin.
        (16) Psilocyn.
        (17) Tetrahydrocannabinols.
                                SCHEDULE II                            
      (a) Unless specifically excepted or unless listed in another
    schedule, any of the following substances whether produced directly
    or indirectly by extraction from substances of vegetable origin, or
    independently by means of chemical synthesis, or by a combination
    of extraction and chemical synthesis:
        (1) Opium and opiate, and any salt, compound, derivative, or
      preparation of opium or opiate.
        (2) Any salt, compound, derivative, or preparation thereof
      which is chemically equivalent or identical with any of the
      substances referred to in clause (1), except that these
      substances shall not include the isoquinoline alkaloids of opium.
        (3) Opium poppy and poppy straw.
        (4) coca (!3) leaves, except coca leaves and extracts of coca
      leaves from which cocaine, ecgonine, and derivatives of ecgonine
      or their salts have been removed; cocaine, its salts, optical and
      geometric isomers, and salts of isomers; ecgonine, its
      derivatives, their salts, isomers, and salts of isomers; or any
      compound, mixture, or preparation which contains any quantity of
      any of the substances referred to in this paragraph.


      (b) Unless specifically excepted or unless listed in another
    schedule, any of the following opiates, including their isomers,
    esters, ethers, salts, and salts of isomers, esters and ethers,
    whenever the existence of such isomers, esters, ethers, and salts
    is possible within the specific chemical designation:
        (1) Alphaprodine.
        (2) Anileridine.
        (3) Bezitramide.
        (4) Dihydrocodeine.
        (5) Diphenoxylate.
        (6) Fentanyl.
        (7) Isomethadone.
        (8) Levomethorphan.
        (9) Levorphanol.
        (10) Metazocine.
        (11) Methadone.
        (12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-
      diphenyl butane.
        (13) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-
      diphenylpropane-carboxylic acid.
        (14) Pethidine.
        (15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-
      phenylpiperidine.
        (16) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-
      carboxylate.
        (17) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-
      carboxylic acid.
        (18) Phenazocine.
        (19) Piminodine.
        (20) Racemethorphan.
        (21) Racemorphan.

      (c) Unless specifically excepted or unless listed in another
    schedule, any injectable liquid which contains any quantity of
    methamphetamine, including its salts, isomers, and salts of
    isomers.
                               SCHEDULE III                           
      (a) Unless specifically excepted or unless listed in another
    schedule, any material, compound, mixture, or preparation which
    contains any quantity of the following substances having a
    stimulant effect on the central nervous system:
        (1) Amphetamine, its salts, optical isomers, and salts of its
      optical isomers.
        (2) Phenmetrazine and its salts.
        (3) Any substance (except an injectable liquid) which contains
      any quantity of methamphetamine, including its salts, isomers,
      and salts of isomers.
        (4) Methylphenidate.

      (b) Unless specifically excepted or unless listed in another
    schedule, any material, compound, mixture, or preparation which
    contains any quantity of the following substances having a
    depressant effect on the central nervous system:
        (1) Any substance which contains any quantity of a derivative
      of barbituric acid, or any salt of a derivative of barbituric
      acid.
        (2) Chorhexadol.
        (3) Glutethimide.
        (4) Lysergic acid.
        (5) Lysergic acid amide.
        (6) Methyprylon.
        (7) Phencyclidine.
        (8) Sulfondiethylmethane.
        (9) Sulfonethylmethane.
        (10) Sulfonmethane.

      (c) Nalorphine.
      (d) Unless specifically excepted or unless listed in another
    schedule, any material, compound, mixture, or preparation
    containing limited quantities of any of the following narcotic
    drugs, or any salts thereof:
        (1) Not more than 1.8 grams of codeine per 100 milliliters or
      not more than 90 milligrams per dosage unit, with an equal or
      greater quantity of an isoquinoline alkaloid of opium.
        (2) Not more than 1.8 grams of codeine per 100 milliliters or
      not more than 90 milligrams per dosage unit, with one or more
      active, non-narcotic ingredients in recognized therapeutic
      amounts.
        (3) Not more than 300 milligrams of dihydrocodeinone per 100
      milliliters or not more than 15 milligrams per dosage unit, with
      a fourfold or greater quantity of an isoquinoline alkaloid of
      opium.
        (4) Not more than 300 milligrams of dihydrocodeinone per 100
      milliliters or not more than 15 milligrams per dosage unit, with
      one or more active, nonnarcotic ingredients in recognized
      therapeutic amounts.
        (5) Not more than 1.8 grams of dihydrocodeine per 100
      milliliters or not more than 90 milligrams per dosage unit, with
      one or more active, nonnarcotic ingredients in recognized
      therapeutic amounts.
        (6) Not more than 300 milligrams of ethylmorphine per 100
      milliliters or not more than 15 milligrams per dosage unit, with
      one or more active, nonnarcotic ingredients in recognized
      therapeutic amounts.
        (7) Not more than 500 milligrams of opium per 100 milliliters
      or per 100 grams, or not more than 25 milligrams per dosage unit,
      with one or more active, nonnarcotic ingredients in recognized
      therapeutic amounts.
        (8) Not more than 50 milligrams of morphine per 100 milliliters
      or per 100 grams with one or more active, nonnarcotic ingredients
      in recognized therapeutic amounts.

      (e) Anabolic steroids.
                                SCHEDULE IV                            
      (1) Barbital.
      (2) Chloral betaine.
      (3) Chloral hydrate.
      (4) Ethchlorvynol.
      (5) Ethinamate.
      (6) Methohexital.
      (7) Meprobamate.
      (8) Methylphenobarbital.
      (9) Paraldehyde.
      (10) Petrichloral.
      (11) Phenobarbital.
                                SCHEDULE V                            
      Any compound, mixture, or preparation containing any of the
    following limited quantities of narcotic drugs, which shall include
    one or more nonnarcotic active medicinal ingredients in sufficient
    proportion to confer upon the compound, mixture, or preparation
    valuable medicinal qualities other than those possessed by the
    narcotic drug alone:
        (1) Not more than 200 milligrams of codeine per 100 milliliters
      or per 100 grams.
        (2) Not more than 100 milligrams of dihydrocodeine per 100
      milliliters or per 100 grams.
        (3) Not more than 100 milligrams of ethylmorphine per 100
      milliliters or per 100 grams.
        (4) Not more than 2.5 milligrams of diphenoxylate and not less
      than 25 micrograms of atropine sulfate per dosage unit.
        (5) Not more than 100 milligrams of opium per 100 milliliters
      or per 100 grams.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 202, Oct. 27, 1970, 84 Stat. 1247;
    Pub. L. 95-633, title I, Sec. 103, Nov. 10, 1978, 92 Stat. 3772;
    Pub. L. 98-473, title II, Secs. 507(c), 509(b), Oct. 12, 1984, 98
    Stat. 2071, 2072; Pub. L. 99-570, title I, Sec. 1867, Oct. 27,
    1986, 100 Stat. 3207-55; Pub. L. 99-646, Sec. 84, Nov. 10, 1986,
    100 Stat. 3619; Pub. L. 101-647, title XIX, Sec. 1902(a), Nov. 29,
    1990, 104 Stat. 4851.)


-MISC1-
                                AMENDMENTS                            
      1990 - Subsec. (c). Pub. L. 101-647 added item (e) at end of
    schedule III.
      1986 - Subsec. (c). Pub. L. 99-646 amended schedule II(a)(4)
    generally. Prior to amendment, schedule II(a)(4) read as follows:
    "Coca leaves (except coca leaves and extracts of coca leaves from
    which cocaine, ecgonine, and derivatives of ecgonine or their salts
    have been removed); cocaine, its salts, optical and geometric
    isomers, and salts of isomers; and ecgonine, its derivatives, their
    salts, isomers, and salts of isomers."
      Pub. L. 99-570 amended schedule II(a)(4) generally. Prior to
    amendment, schedule II(a)(4) read as follows: "Coca leaves and any
    salt, compound, derivative, or preparation of coca leaves
    (including cocaine and ecgonine and their salts, isomers,
    derivatives, and salts of isomers and derivatives), and any salt,
    compound, derivative, or preparation thereof which is chemically
    equivalent or identical with any of these substances, except that
    the substances shall not include decocainized coca leaves or
    extraction of coca leaves, which extractions do not contain cocaine
    or ecgonine."
      1984 - Subsec. (c). Pub. L. 98-473, Sec. 507(c), in schedule
    II(a)(4) added applicability to cocaine and ecgonine and their
    salts, isomers, etc.
      Subsec. (d). Pub. L. 98-473, Sec. 509(b), struck out subsec. (d)
    which related to authority of Attorney General to except stimulants
    or depressants containing active medicinal ingredients.
      1978 - Subsec. (d)(3). Pub. L. 95-633 added cl. (3).

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-647 effective 90 days after Nov. 29,
    1990, see section 1902(d) of Pub. L. 101-647, set out as a note
    under section 802 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

     CONGRESSIONAL FINDING; EMERGENCY SCHEDULING OF GHB IN CONTROLLED
                              SUBSTANCES ACT
      Pub. L. 106-172, Secs. 2, 3(a), Feb. 18, 2000, 114 Stat. 7, 8,
    provided that:

      "SEC. 2. FINDINGS.
      "Congress finds as follows:
        "(1) Gamma hydroxybutyric acid (also called G, Liquid X, Liquid
      Ecstasy, Grievous Bodily Harm, Georgia Home Boy, Scoop) has
      become a significant and growing problem in law enforcement. At
      least 20 States have scheduled such drug in their drug laws and
      law enforcement officials have been experiencing an increased
      presence of the drug in driving under the influence, sexual
      assault, and overdose cases especially at night clubs and
      parties.
        "(2) A behavioral depressant and a hypnotic, gamma
      hydroxybutyric acid ('GHB') is being used in conjunction with
      alcohol and other drugs with detrimental effects in an increasing
      number of cases. It is difficult to isolate the impact of such
      drug's ingestion since it is so typically taken with an ever-
      changing array of other drugs and especially alcohol which
      potentiates its impact.
        "(3) GHB takes the same path as alcohol, processes via alcohol
      dehydrogenase, and its symptoms at high levels of intake and as
      impact builds are comparable to alcohol ingestion/intoxication.
      Thus, aggression and violence can be expected in some individuals
      who use such drug.
        "(4) If taken for human consumption, common industrial
      chemicals such as gamma butyrolactone and 1.4-butanediol are
      swiftly converted by the body into GHB. Illicit use of these and
      other GHB analogues and precursor chemicals is a significant and
      growing law enforcement problem.
        "(5) A human pharmaceutical formulation of gamma hydroxybutyric
      acid is being developed as a treatment for cataplexy, a serious
      and debilitating disease. Cataplexy, which causes sudden and
      total loss of muscle control, affects about 65 percent of the
      estimated 180,000 Americans with narcolepsy, a sleep disorder.
      People with cataplexy often are unable to work, drive a car, hold
      their children or live a normal life.
        "(6) Abuse of illicit GHB is an imminent hazard to public
      safety that requires immediate regulatory action under the
      Controlled Substances Act (21 U.S.C. 801 et seq.).

      "SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND
        LISTING OF GAMMA BUTYROLACTONE AS LIST I CHEMICAL.
      "(a) Emergency Scheduling of GHB. - 
        "(1) In general. - The Congress finds that the abuse of illicit
      gamma hydroxybutyric acid is an imminent hazard to the public
      safety. Accordingly, the Attorney General, notwithstanding
      sections 201(a), 201(b), 201(c), and 202 of the Controlled
      Substances Act [21 U.S.C. 811(a)-(c), 812], shall issue, not
      later than 60 days after the date of the enactment of this Act
      [Feb. 18, 2000], a final order that schedules such drug (together
      with its salts, isomers, and salts of isomers) in the same
      schedule under section 202(c) of the Controlled Substances Act as
      would apply to a scheduling of a substance by the Attorney
      General under section 201(h)(1) of such Act (relating to imminent
      hazards to the public safety), except as follows:
          "(A) For purposes of any requirements that relate to the
        physical security of registered manufacturers and registered
        distributors, the final order shall treat such drug, when the
        drug is manufactured, distributed, or possessed in accordance
        with an exemption under section 505(i) of the Federal Food,
        Drug, and Cosmetic Act [21 U.S.C. 355(i)] (whether the
        exemption involved is authorized before, on, or after the date
        of the enactment of this Act [Feb. 18, 2000]), as being in the
        same schedule as that recommended by the Secretary of Health
        and Human Services for the drug when the drug is the subject of
        an authorized investigational new drug application (relating to
        such section 505(i)). The recommendation referred to in the
        preceding sentence is contained in the first paragraph of the
        letter transmitted on May 19, 1999, by such Secretary (acting
        through the Assistant Secretary for Health) to the Attorney
        General (acting through the Deputy Administrator of the Drug
        Enforcement Administration), which letter was in response to
        the letter transmitted by the Attorney General (acting through
        such Deputy Administrator) on September 16, 1997. In publishing
        the final order in the Federal Register, the Attorney General
        shall publish a copy of the letter that was transmitted by the
        Secretary of Health and Human Services.
          "(B) In the case of gamma hydroxybutyric acid that is
        contained in a drug product for which an application is
        approved under section 505 of the Federal Food, Drug, and
        Cosmetic Act [21 U.S.C. 355] (whether the application involved
        is approved before, on, or after the date of the enactment of
        this Act [Feb. 18, 2000]), the final order shall schedule such
        drug in the same schedule as that recommended by the Secretary
        of Health and Human Services for authorized formulations of the
        drug. The recommendation referred to in the preceding sentence
        is contained in the last sentence of the fourth paragraph of
        the letter referred to in subparagraph (A) with respect to May
        19, 1999.
        "(2) Failure to issue order. - If the final order is not issued
      within the period specified in paragraph (1), gamma
      hydroxybutyric acid (together with its salts, isomers, and salts
      of isomers) is deemed to be scheduled under section 202(c) of the
      Controlled Substances Act [21 U.S.C. 812(c)] in accordance with
      the policies described in paragraph (1), as if the Attorney
      General had issued a final order in accordance with such
      paragraph."

        PLACEMENT OF PIPRADROL AND SPA IN SCHEDULE IV TO CARRY OUT
          OBLIGATION UNDER CONVENTION ON PSYCHOTROPIC SUBSTANCES
      Section 102(c) of Pub. L. 95-633 provided that: "For the purpose
    of carrying out the minimum United States obligations under
    paragraph 7 of article 2 of the Convention on Psychotropic
    Substances, signed at Vienna, Austria, on February 21, 1971, with
    respect to pipradrol and SPA (also known as (-)-1-dimethylamino-1,2-
    diphenylethane), the Attorney General shall by order, made without
    regard to sections 201 and 202 of the Controlled Substances Act
    [this section and section 811 of this title], place such drugs in
    schedule IV of such Act [see subsec. (c) of this section]."
      Provision of section 102(c) of Pub. L. 95-633, set out above,
    effective on the date the Convention on Psychotropic Substances
    enters into force in the United States [July 15, 1980], see section
    112 of Pub. L. 95-633, set out as an Effective Date note under
    section 801a of this title.

-FOOTNOTE-
    (!1) Revised schedules are published in the Code of Federal
         Regulations, Part 1308 of Title 21, Food and Drugs.

               

    (!2) So in original. Probably should be "Alphacetylmethadol."

    (!3) So in original. Probably should be capitalized.


-End-



-CITE-
    21 USC Sec. 813                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part B - Authority To Control; Standards and Schedules

-HEAD-
    Sec. 813. Treatment of controlled substance analogues

-STATUTE-
      A controlled substance analogue shall, to the extent intended for
    human consumption, be treated, for the purposes of any Federal law
    as a controlled substance in schedule I.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 203, as added Pub. L. 99-570, title
    I, Sec. 1202, Oct. 27, 1986, 100 Stat. 3207-13; amended Pub. L. 100-
    690, title VI, Sec. 6470(c), Nov. 18, 1988, 102 Stat. 4378.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedule I, referred to in text, is set out in section 812(c) of
    this title.


-MISC1-
                                AMENDMENTS                            
      1988 - Pub. L. 100-690 substituted "any Federal law" for "this
    subchapter and subchapter II of this chapter".

-End-



-CITE-
    21 USC Sec. 814                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part B - Authority To Control; Standards and Schedules

-HEAD-
    Sec. 814. Removal of exemption of certain drugs

-STATUTE-
    (a) Removal of exemption
      The Attorney General shall by regulation remove from exemption
    under section 802(39)(A)(iv) of this title a drug or group of drugs
    that the Attorney General finds is being diverted to obtain a
    listed chemical for use in the illicit production of a controlled
    substance.
    (b) Factors to be considered
      In removing a drug or group of drugs from exemption under
    subsection (a) of this section, the Attorney General shall
    consider, with respect to a drug or group of drugs that is proposed
    to be removed from exemption - 
        (1) the scope, duration, and significance of the diversion;
        (2) whether the drug or group of drugs is formulated in such a
      way that it cannot be easily used in the illicit production of a
      controlled substance; and
        (3) whether the listed chemical can be readily recovered from
      the drug or group of drugs.
    (c) Specificity of designation
      The Attorney General shall limit the designation of a drug or a
    group of drugs removed from exemption under subsection (a) of this
    section to the most particularly identifiable type of drug or group
    of drugs for which evidence of diversion exists unless there is
    evidence, based on the pattern of diversion and other relevant
    factors, that the diversion will not be limited to that particular
    drug or group of drugs.
    (d) Reinstatement of exemption with respect to particular drug
      products
      (1) Reinstatement
        On application by a manufacturer of a particular drug product
      that has been removed from exemption under subsection (a) of this
      section, the Attorney General shall by regulation reinstate the
      exemption with respect to that particular drug product if the
      Attorney General determines that the particular drug product is
      manufactured and distributed in a manner that prevents diversion.
      (2) Factors to be considered
        In deciding whether to reinstate the exemption with respect to
      a particular drug product under paragraph (1), the Attorney
      General shall consider - 
          (A) the package sizes and manner of packaging of the drug
        product;
          (B) the manner of distribution and advertising of the drug
        product;
          (C) evidence of diversion of the drug product;
          (D) any actions taken by the manufacturer to prevent
        diversion of the drug product; and
          (E) such other factors as are relevant to and consistent with
        the public health and safety, including the factors described
        in subsection (b) of this section as applied to the drug
        product.
      (3) Status pending application for reinstatement
        A transaction involving a particular drug product that is the
      subject of a bona fide pending application for reinstatement of
      exemption filed with the Attorney General not later than 60 days
      after a regulation removing the exemption is issued pursuant to
      subsection (a) of this section shall not be considered to be a
      regulated transaction if the transaction occurs during the
      pendency of the application and, if the Attorney General denies
      the application, during the period of 60 days following the date
      on which the Attorney General denies the application, unless - 
          (A) the Attorney General has evidence that, applying the
        factors described in subsection (b) of this section to the drug
        product, the drug product is being diverted; and
          (B) the Attorney General so notifies the applicant.
      (4) Amendment and modification
        A regulation reinstating an exemption under paragraph (1) may
      be modified or revoked with respect to a particular drug product
      upon a finding that - 
          (A) applying the factors described in subsection (b) of this
        section to the drug product, the drug product is being
        diverted; or
          (B) there is a significant change in the data that led to the
        issuance of the regulation.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 204, as added Pub. L. 103-200, Sec.
    2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104-237,
    title IV, Sec. 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109-
    177, title VII, Sec. 712(a)(2), Mar. 9, 2006, 120 Stat. 263.)


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (e). Pub. L. 109-177 struck out subsec. (e). Text
    read as follows: "Pursuant to subsection (d)(1) of this section,
    the Attorney General shall by regulation reinstate the exemption
    with respect to a particular ephedrine, pseudoephedrine, or
    phenylpropanolamine drug product if the Attorney General determines
    that the drug product is manufactured and distributed in a manner
    that prevents diversion. In making this determination the Attorney
    General shall consider the factors listed in subsection (d)(2) of
    this section. Any regulation issued pursuant to this subsection may
    be amended or revoked based on the factors listed in subsection
    (d)(4) of this section."
      1996 - Subsec. (e). Pub. L. 104-237 added subsec. (e).

                     EFFECTIVE DATE OF 1996 AMENDMENT                 
      Amendment by Pub. L. 104-237 not applicable to sale of any
    pseudoephedrine or phenylpropanolamine product prior to 12 months
    after Oct. 3, 1996, except that, on application of manufacturer of
    particular drug product, Attorney General may exercise sole and
    judicially unreviewable discretion to extend such effective date up
    to additional 6 months, see section 401(g) of Pub. L. 104-237, set
    out as a note under section 802 of this title.

                              EFFECTIVE DATE                          
      Section effective on date that is 120 days after Dec. 17, 1993,
    see section 11 of Pub. L. 103-200, set out as an Effective Date of
    1993 Amendment note under section 802 of this title.

-End-


-CITE-
    21 USC Part C - Registration of Manufacturers,
                     Distributors, and Dispensers of
                     Controlled Substances                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
         PART C - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
                    DISPENSERS OF CONTROLLED SUBSTANCES

-End-



-CITE-
    21 USC Sec. 821                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 821. Rules and regulations

-STATUTE-
      The Attorney General is authorized to promulgate rules and
    regulations and to charge reasonable fees relating to the
    registration and control of the manufacture, distribution, and
    dispensing of controlled substances and to listed chemicals.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 301, Oct. 27, 1970, 84 Stat. 1253;
    Pub. L. 103-200, Sec. 3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L.
    108-447, div. B, title VI, Sec. 633(b), Dec. 8, 2004, 118 Stat.
    2922.)


-MISC1-
                                AMENDMENTS                            
      2004 - Pub. L. 108-447 substituted "listed chemicals" for "the
    registration and control of regulated persons and of regulated
    transactions".
      1993 - Pub. L. 103-200 inserted before period at end "and to the
    registration and control of regulated persons and of regulated
    transactions".

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

-End-



-CITE-
    21 USC Sec. 822                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 822. Persons required to register

-STATUTE-
    (a) Period of registration
      (1) Every person who manufactures or distributes any controlled
    substance or list I chemical, or who proposes to engage in the
    manufacture or distribution of any controlled substance or list I
    chemical, shall obtain annually a registration issued by the
    Attorney General in accordance with the rules and regulations
    promulgated by him.
      (2) Every person who dispenses, or who proposes to dispense, any
    controlled substance, shall obtain from the Attorney General a
    registration issued in accordance with the rules and regulations
    promulgated by him. The Attorney General shall, by regulation,
    determine the period of such registrations. In no event, however,
    shall such registrations be issued for less than one year nor for
    more than three years.
    (b) Authorized activities
      Persons registered by the Attorney General under this subchapter
    to manufacture, distribute, or dispense controlled substances or
    list I chemicals are authorized to possess, manufacture,
    distribute, or dispense such substances or chemicals (including any
    such activity in the conduct of research) to the extent authorized
    by their registration and in conformity with the other provisions
    of this subchapter.
    (c) Exceptions
      The following persons shall not be required to register and may
    lawfully possess any controlled substance or list I chemical under
    this subchapter:
        (1) An agent or employee of any registered manufacturer,
      distributor, or dispenser of any controlled substance or list I
      chemical if such agent or employee is acting in the usual course
      of his business or employment.
        (2) A common or contract carrier or warehouseman, or an
      employee thereof, whose possession of the controlled substance or
      list I chemical is in the usual course of his business or
      employment.
        (3) An ultimate user who possesses such substance for a purpose
      specified in section 802(25) (!1) of this title.

    (d) Waiver
      The Attorney General may, by regulation, waive the requirement
    for registration of certain manufacturers, distributors, or
    dispensers if he finds it consistent with the public health and
    safety.
    (e) Separate registration
      A separate registration shall be required at each principal place
    of business or professional practice where the applicant
    manufactures, distributes, or dispenses controlled substances or
    list I chemicals.
    (f) Inspection
      The Attorney General is authorized to inspect the establishment
    of a registrant or applicant for registration in accordance with
    the rules and regulations promulgated by him.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 302, Oct. 27, 1970, 84 Stat. 1253;
    Pub. L. 98-473, title II, Sec. 510, Oct. 12, 1984, 98 Stat. 2072;
    Pub. L. 103-200, Sec. 3(b), Dec. 17, 1993, 107 Stat. 2336.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in subsecs. (b) and (c), was in the
    original "this title", meaning title II of Pub. L. 91-513, Oct. 27,
    1970, 84 Stat. 1242, as amended, and is popularly known as the
    "Controlled Substances Act". For complete classification of title
    II to the Code, see second paragraph of Short Title note set out
    under section 801 of this title and Tables.
      Section 802(25) of this title, referred to in subsec. (c)(3), was
    redesignated section 802(26) of this title by Pub. L. 98-473, title
    II, Sec. 507(a), Oct. 12, 1984, 98 Stat. 2071, and was further
    redesignated section 802(27) of this title by Pub. L. 99-570, title
    I, Sec. 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207-6.


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 3(b)(1), inserted
    "or list I chemical" after "controlled substance" in two places.
      Subsec. (b). Pub. L. 103-200, Sec. 3(b)(2), inserted "or list I
    chemicals" after "controlled substances" and "or chemicals" after
    "such substances".
      Subsec. (c). Pub. L. 103-200, Sec. 3(b)(3), inserted "or list I
    chemical" after "controlled substance" wherever appearing.
      Subsec. (e). Pub. L. 103-200, Sec. 3(b)(4), inserted "or list I
    chemicals" after "controlled substances".
      1984 - Subsec. (a). Pub. L. 98-473 designated existing provisions
    as par. (1), struck out provisions relating to dispensing
    controlled substances, and added par. (2).

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                         PROVISIONAL REGISTRATION                     
      Section 703 of Pub. L. 91-513, as amended by Pub. L. 99-514, Sec.
    2, Oct. 22, 1986, 100 Stat. 2095, provided that:
      "(a)(1) Any person who - 
        "(A) is engaged in manufacturing, distributing, or dispensing
      any controlled substance on the day before the effective date of
      section 302 [this section], and
        "(B) is registered on such day under section 510 of the Federal
      Food, Drug, and Cosmetic Act [section 360 of this title] or under
      section 4722 of the Internal Revenue Code of 1986 [formerly
      I.R.C. 1954, section 4722 of Title 26],
    shall, with respect to each establishment for which such
    registration is in effect under any such section, be deemed to have
    a provisional registration under section 303 [section 823 of this
    title] for the manufacture, distribution, or dispensing (as the
    case may be) of controlled substances.
      "(2) During the period his provisional registration is in effect
    under this section, the registration number assigned such person
    under such section 510 [section 360 of this title] or under such
    section 4722 [section 4722 of Title 26] (as the case may be) shall
    be his registration number for purposes of section 303 of this
    title [section 823 of this title].
      "(b) The provisions of section 304 [section 824 of this title],
    relating to suspension and revocation of registration, shall apply
    to a provisional registration under this section.
      "(c) Unless sooner suspended or revoked under subsection (b), a
    provisional registration of a person under subsection (a)(1) of
    this section shall be in effect until - 
        "(1) the date on which such person has registered with the
      Attorney General under section 303 [section 823 of this title] or
      has had his registration denied under such section, or
        "(2) such date as may be prescribed by the Attorney General for
      registration of manufacturers, distributors, or dispensers, as
      the case may be,
    whichever occurs first."

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 823                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 823. Registration requirements

-STATUTE-
    (a) Manufacturers of controlled substances in schedule I or II
      The Attorney General shall register an applicant to manufacture
    controlled substances in schedule I or II if he determines that
    such registration is consistent with the public interest and with
    United States obligations under international treaties,
    conventions, or protocols in effect on May 1, 1971. In determining
    the public interest, the following factors shall be considered:
        (1) maintenance of effective controls against diversion of
      particular controlled substances and any controlled substance in
      schedule I or II compounded therefrom into other than legitimate
      medical, scientific, research, or industrial channels, by
      limiting the importation and bulk manufacture of such controlled
      substances to a number of establishments which can produce an
      adequate and uninterrupted supply of these substances under
      adequately competitive conditions for legitimate medical,
      scientific, research, and industrial purposes;
        (2) compliance with applicable State and local law;
        (3) promotion of technical advances in the art of manufacturing
      these substances and the development of new substances;
        (4) prior conviction record of applicant under Federal and
      State laws relating to the manufacture, distribution, or
      dispensing of such substances;
        (5) past experience in the manufacture of controlled
      substances, and the existence in the establishment of effective
      control against diversion; and
        (6) such other factors as may be relevant to and consistent
      with the public health and safety.
    (b) Distributors of controlled substances in schedule I or II
      The Attorney General shall register an applicant to distribute a
    controlled substance in schedule I or II unless he determines that
    the issuance of such registration is inconsistent with the public
    interest. In determining the public interest, the following factors
    shall be considered:
        (1) maintenance of effective control against diversion of
      particular controlled substances into other than legitimate
      medical, scientific, and industrial channels;
        (2) compliance with applicable State and local law;
        (3) prior conviction record of applicant under Federal or State
      laws relating to the manufacture, distribution, or dispensing of
      such substances;
        (4) past experience in the distribution of controlled
      substances; and
        (5) such other factors as may be relevant to and consistent
      with the public health and safety.
    (c) Limits of authorized activities
      Registration granted under subsections (a) and (b) of this
    section shall not entitle a registrant to (1) manufacture or
    distribute controlled substances in schedule I or II other than
    those specified in the registration, or (2) manufacture any
    quantity of those controlled substances in excess of the quota
    assigned pursuant to section 826 of this title.
    (d) Manufacturers of controlled substances in schedule III, IV, or
      V
      The Attorney General shall register an applicant to manufacture
    controlled substances in schedule III, IV, or V, unless he
    determines that the issuance of such registration is inconsistent
    with the public interest. In determining the public interest, the
    following factors shall be considered:
        (1) maintenance of effective controls against diversion of
      particular controlled substances and any controlled substance in
      schedule III, IV, or V compounded therefrom into other than
      legitimate medical, scientific, or industrial channels;
        (2) compliance with applicable State and local law;
        (3) promotion of technical advances in the art of manufacturing
      these substances and the development of new substances;
        (4) prior conviction record of applicant under Federal or State
      laws relating to the manufacture, distribution, or dispensing of
      such substances;
        (5) past experience in the manufacture, distribution, and
      dispensing of controlled substances, and the existence in the
      establishment of effective controls against diversion; and
        (6) such other factors as may be relevant to and consistent
      with the public health and safety.
    (e) Distributors of controlled substances in schedule III, IV, or V
      The Attorney General shall register an applicant to distribute
    controlled substances in schedule III, IV, or V, unless he
    determines that the issuance of such registration is inconsistent
    with the public interest. In determining the public interest, the
    following factors shall be considered:
        (1) maintenance of effective controls against diversion of
      particular controlled substances into other than legitimate
      medical, scientific, and industrial channels;
        (2) compliance with applicable State and local law;
        (3) prior conviction record of applicant under Federal or State
      laws relating to the manufacture, distribution, or dispensing of
      such substances;
        (4) past experience in the distribution of controlled
      substances; and
        (5) such other factors as may be relevant to and consistent
      with the public health and safety.
    (f) Research by practitioners; pharmacies; research applications;
      construction of Article 7 of the Convention on Psychotropic
      Substances
      The Attorney General shall register practitioners (including
    pharmacies, as distinguished from pharmacists) to dispense, or
    conduct research with, controlled substances in schedule II, III,
    IV, or V, if the applicant is authorized to dispense, or conduct
    research with respect to, controlled substances under the laws of
    the State in which he practices. The Attorney General may deny an
    application for such registration if he determines that the
    issuance of such registration would be inconsistent with the public
    interest. In determining the public interest, the following factors
    shall be considered:
        (1) The recommendation of the appropriate State licensing board
      or professional disciplinary authority.
        (2) The applicant's experience in dispensing, or conducting
      research with respect to controlled substances.
        (3) The applicant's conviction record under Federal or State
      laws relating to the manufacture, distribution, or dispensing of
      controlled substances.
        (4) Compliance with applicable State, Federal, or local laws
      relating to controlled substances.
        (5) Such other conduct which may threaten the public health and
      safety.

    Separate registration under this part for practitioners engaging in
    research with controlled substances in schedule II, III, IV, or V,
    who are already registered under this part in another capacity,
    shall not be required. Registration applications by practitioners
    wishing to conduct research with controlled substances in schedule
    I shall be referred to the Secretary, who shall determine the
    qualifications and competency of each practitioner requesting
    registration, as well as the merits of the research protocol. The
    Secretary, in determining the merits of each research protocol,
    shall consult with the Attorney General as to effective procedures
    to adequately safeguard against diversion of such controlled
    substances from legitimate medical or scientific use. Registration
    for the purpose of bona fide research with controlled substances in
    schedule I by a practitioner deemed qualified by the Secretary may
    be denied by the Attorney General only on a ground specified in
    section 824(a) of this title. Article 7 of the Convention on
    Psychotropic Substances shall not be construed to prohibit, or
    impose additional restrictions upon, research involving drugs or
    other substances scheduled under the convention which is conducted
    in conformity with this subsection and other applicable provisions
    of this subchapter.
    (g) Practitioners dispensing narcotic drugs for narcotic treatment;
      annual registration; separate registration; qualifications;
      waiver
      (1) Except as provided in paragraph (2), practitioners who
    dispense narcotic drugs to individuals for maintenance treatment or
    detoxification treatment shall obtain annually a separate
    registration for that purpose. The Attorney General shall register
    an applicant to dispense narcotic drugs to individuals for
    maintenance treatment or detoxification treatment (or both)
        (A) if the applicant is a practitioner who is determined by the
      Secretary to be qualified (under standards established by the
      Secretary) to engage in the treatment with respect to which
      registration is sought;
        (B) if the Attorney General determines that the applicant will
      comply with standards established by the Attorney General
      respecting (i) security of stocks of narcotic drugs for such
      treatment, and (ii) the maintenance of records (in accordance
      with section 827 of this title) on such drugs; and
        (C) if the Secretary determines that the applicant will comply
      with standards established by the Secretary (after consultation
      with the Attorney General) respecting the quantities of narcotic
      drugs which may be provided for unsupervised use by individuals
      in such treatment.

      (2)(A) Subject to subparagraphs (D) and (J), the requirements of
    paragraph (1) are waived in the case of the dispensing (including
    the prescribing), by a practitioner, of narcotic drugs in schedule
    III, IV, or V or combinations of such drugs if the practitioner
    meets the conditions specified in subparagraph (B) and the narcotic
    drugs or combinations of such drugs meet the conditions specified
    in subparagraph (C).
      (B) For purposes of subparagraph (A), the conditions specified in
    this subparagraph with respect to a practitioner are that, before
    the initial dispensing of narcotic drugs in schedule III, IV, or V
    or combinations of such drugs to patients for maintenance or
    detoxification treatment, the practitioner submit to the Secretary
    a notification of the intent of the practitioner to begin
    dispensing the drugs or combinations for such purpose, and that the
    notification contain the following certifications by the
    practitioner:
        (i) The practitioner is a qualifying physician (as defined in
      subparagraph (G)).
        (ii) With respect to patients to whom the practitioner will
      provide such drugs or combinations of drugs, the practitioner has
      the capacity to refer the patients for appropriate counseling and
      other appropriate ancillary services.
        (iii) The total number of such patients of the practitioner at
      any one time will not exceed the applicable number. For purposes
      of this clause, the applicable number is 30, unless, not sooner
      than 1 year after the date on which the practitioner submitted
      the initial notification, the practitioner submits a second
      notification to the Secretary of the need and intent of the
      practitioner to treat up to 100 patients. A second notification
      under this clause shall contain the certifications required by
      clauses (i) and (ii) of this subparagraph. The Secretary may by
      regulation change such total number.

      (C) For purposes of subparagraph (A), the conditions specified in
    this subparagraph with respect to narcotic drugs in schedule III,
    IV, or V or combinations of such drugs are as follows:
        (i) The drugs or combinations of drugs have, under the Federal
      Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or section
      262 of title 42, been approved for use in maintenance or
      detoxification treatment.
        (ii) The drugs or combinations of drugs have not been the
      subject of an adverse determination. For purposes of this clause,
      an adverse determination is a determination published in the
      Federal Register and made by the Secretary, after consultation
      with the Attorney General, that the use of the drugs or
      combinations of drugs for maintenance or detoxification treatment
      requires additional standards respecting the qualifications of
      practitioners to provide such treatment, or requires standards
      respecting the quantities of the drugs that may be provided for
      unsupervised use.

      (D)(i) A waiver under subparagraph (A) with respect to a
    practitioner is not in effect unless (in addition to conditions
    under subparagraphs (B) and (C)) the following conditions are met:
        (I) The notification under subparagraph (B) is in writing and
      states the name of the practitioner.
        (II) The notification identifies the registration issued for
      the practitioner pursuant to subsection (f) of this section.
        (III) If the practitioner is a member of a group practice, the
      notification states the names of the other practitioners in the
      practice and identifies the registrations issued for the other
      practitioners pursuant to subsection (f) of this section.

      (ii) Upon receiving a notification under subparagraph (B), the
    Attorney General shall assign the practitioner involved an
    identification number under this paragraph for inclusion with the
    registration issued for the practitioner pursuant to subsection (f)
    of this section. The identification number so assigned shall be
    appropriate to preserve the confidentiality of patients for whom
    the practitioner has dispensed narcotic drugs under a waiver under
    subparagraph (A).
      (iii) Not later than 45 days after the date on which the
    Secretary receives a notification under subparagraph (B), the
    Secretary shall make a determination of whether the practitioner
    involved meets all requirements for a waiver under subparagraph
    (B). If the Secretary fails to make such determination by the end
    of the such 45-day period, the Attorney General shall assign the
    physician an identification number described in clause (ii) at the
    end of such period.
      (E)(i) If a practitioner is not registered under paragraph (1)
    and, in violation of the conditions specified in subparagraphs (B)
    through (D), dispenses narcotic drugs in schedule III, IV, or V or
    combinations of such drugs for maintenance treatment or
    detoxification treatment, the Attorney General may, for purposes of
    section 824(a)(4) of this title, consider the practitioner to have
    committed an act that renders the registration of the practitioner
    pursuant to subsection (f) of this section to be inconsistent with
    the public interest.
      (ii)(I) Upon the expiration of 45 days from the date on which the
    Secretary receives a notification under subparagraph (B), a
    practitioner who in good faith submits a notification under
    subparagraph (B) and reasonably believes that the conditions
    specified in subparagraphs (B) through (D) have been met shall, in
    dispensing narcotic drugs in schedule III, IV, or V or combinations
    of such drugs for maintenance treatment or detoxification
    treatment, be considered to have a waiver under subparagraph (A)
    until notified otherwise by the Secretary, except that such a
    practitioner may commence to prescribe or dispense such narcotic
    drugs for such purposes prior to the expiration of such 45-day
    period if it facilitates the treatment of an individual patient and
    both the Secretary and the Attorney General are notified by the
    practitioner of the intent to commence prescribing or dispensing
    such narcotic drugs.
      (II) For purposes of subclause (I), the publication in the
    Federal Register of an adverse determination by the Secretary
    pursuant to subparagraph (C)(ii) shall (with respect to the
    narcotic drug or combination involved) be considered to be a
    notification provided by the Secretary to practitioners, effective
    upon the expiration of the 30-day period beginning on the date on
    which the adverse determination is so published.
      (F)(i) With respect to the dispensing of narcotic drugs in
    schedule III, IV, or V or combinations of such drugs to patients
    for maintenance or detoxification treatment, a practitioner may, in
    his or her discretion, dispense such drugs or combinations for such
    treatment under a registration under paragraph (1) or a waiver
    under subparagraph (A) (subject to meeting the applicable
    conditions).
      (ii) This paragraph may not be construed as having any legal
    effect on the conditions for obtaining a registration under
    paragraph (1), including with respect to the number of patients who
    may be served under such a registration.
      (G) For purposes of this paragraph:
        (i) The term "group practice" has the meaning given such term
      in section 1395nn(h)(4) of title 42.
        (ii) The term "qualifying physician" means a physician who is
      licensed under State law and who meets one or more of the
      following conditions:
          (I) The physician holds a subspecialty board certification in
        addiction psychiatry from the American Board of Medical
        Specialties.
          (II) The physician holds an addiction certification from the
        American Society of Addiction Medicine.
          (III) The physician holds a subspecialty board certification
        in addiction medicine from the American Osteopathic
        Association.
          (IV) The physician has, with respect to the treatment and
        management of opiate-dependent patients, completed not less
        than eight hours of training (through classroom situations,
        seminars at professional society meetings, electronic
        communications, or otherwise) that is provided by the American
        Society of Addiction Medicine, the American Academy of
        Addiction Psychiatry, the American Medical Association, the
        American Osteopathic Association, the American Psychiatric
        Association, or any other organization that the Secretary
        determines is appropriate for purposes of this subclause.
          (V) The physician has participated as an investigator in one
        or more clinical trials leading to the approval of a narcotic
        drug in schedule III, IV, or V for maintenance or
        detoxification treatment, as demonstrated by a statement
        submitted to the Secretary by the sponsor of such approved
        drug.
          (VI) The physician has such other training or experience as
        the State medical licensing board (of the State in which the
        physician will provide maintenance or detoxification treatment)
        considers to demonstrate the ability of the physician to treat
        and manage opiate-dependent patients.
          (VII) The physician has such other training or experience as
        the Secretary considers to demonstrate the ability of the
        physician to treat and manage opiate-dependent patients. Any
        criteria of the Secretary under this subclause shall be
        established by regulation. Any such criteria are effective only
        for 3 years after the date on which the criteria are
        promulgated, but may be extended for such additional discrete 3-
        year periods as the Secretary considers appropriate for
        purposes of this subclause. Such an extension of criteria may
        only be effectuated through a statement published in the
        Federal Register by the Secretary during the 30-day period
        preceding the end of the 3-year period involved.

      (H)(i) In consultation with the Administrator of the Drug
    Enforcement Administration, the Administrator of the Substance
    Abuse and Mental Health Services Administration, the Director of
    the National Institute on Drug Abuse, and the Commissioner of Food
    and Drugs, the Secretary shall issue regulations (through notice
    and comment rulemaking) or issue practice guidelines to address the
    following:
        (I) Approval of additional credentialing bodies and the
      responsibilities of additional credentialing bodies.
        (II) Additional exemptions from the requirements of this
      paragraph and any regulations under this paragraph.

    Nothing in such regulations or practice guidelines may authorize
    any Federal official or employee to exercise supervision or control
    over the practice of medicine or the manner in which medical
    services are provided.
      (ii) Not later than 120 days after October 17, 2000, the
    Secretary shall issue a treatment improvement protocol containing
    best practice guidelines for the treatment and maintenance of
    opiate-dependent patients. The Secretary shall develop the protocol
    in consultation with the Director of the National Institute on Drug
    Abuse, the Administrator of the Drug Enforcement Administration,
    the Commissioner of Food and Drugs, the Administrator of the
    Substance Abuse and Mental Health Services Administration and other
    substance abuse disorder professionals. The protocol shall be
    guided by science.
      (I) During the 3-year period beginning on the date of approval by
    the Food and Drug Administration of a drug in schedule III, IV, or
    V, a State may not preclude a practitioner from dispensing or
    prescribing such drug, or combination of such drugs, to patients
    for maintenance or detoxification treatment in accordance with this
    paragraph unless, before the expiration of that 3-year period, the
    State enacts a law prohibiting a practitioner from dispensing such
    drugs or combinations of drug.(!1)

      (J)(i) This paragraph takes effect the date referred to in
    subparagraph (I), and remains in effect thereafter.
      (ii) For purposes relating to clause (iii), the Secretary and the
    Attorney General may, during the 3-year period beginning on
    December 29, 2006, make determinations in accordance with the
    following:
        (I) The Secretary may make a determination of whether
      treatments provided under waivers under subparagraph (A) have
      been effective forms of maintenance treatment and detoxification
      treatment in clinical settings; may make a determination of
      whether such waivers have significantly increased (relative to
      the beginning of such period) the availability of maintenance
      treatment and detoxification treatment; and may make a
      determination of whether such waivers have adverse consequences
      for the public health.
        (II) The Attorney General may make a determination of the
      extent to which there have been violations of the numerical
      limitations established under subparagraph (B) for the number of
      individuals to whom a practitioner may provide treatment; may
      make a determination of whether waivers under subparagraph (A)
      have increased (relative to the beginning of such period) the
      extent to which narcotic drugs in schedule III, IV, or V or
      combinations of such drugs are being dispensed or possessed in
      violation of this chapter; and may make a determination of
      whether such waivers have adverse consequences for the public
      health.

      (iii) If, before the expiration of the period specified in clause
    (ii), the Secretary or the Attorney General publishes in the
    Federal Register a decision, made on the basis of determinations
    under such clause, that subparagraph (B)(iii) should be applied by
    limiting the total number of patients a practitioner may treat to
    30, then the provisions in such subparagraph (B)(iii) permitting
    more than 30 patients shall not apply, effective 60 days after the
    date on which the decision is so published. The Secretary shall in
    making any such decision consult with the Attorney General, and
    shall in publishing the decision in the Federal Register include
    any comments received from the Attorney General for inclusion in
    the publication. The Attorney General shall in making any such
    decision consult with the Secretary, and shall in publishing the
    decision in the Federal Register include any comments received from
    the Secretary for inclusion in the publication.
    (h) Applicants for distribution of list I chemicals
      The Attorney General shall register an applicant to distribute a
    list I chemical unless the Attorney General determines that
    registration of the applicant is inconsistent with the public
    interest. Registration under this subsection shall not be required
    for the distribution of a drug product that is exempted under
    clause (iv) or (v) of section 802(39)(A) of this title. In
    determining the public interest for the purposes of this
    subsection, the Attorney General shall consider - 
        (1) maintenance by the applicant of effective controls against
      diversion of listed chemicals into other than legitimate
      channels;
        (2) compliance by the applicant with applicable Federal, State,
      and local law;
        (3) any prior conviction record of the applicant under Federal
      or State laws relating to controlled substances or to chemicals
      controlled under Federal or State law;
        (4) any past experience of the applicant in the manufacture and
      distribution of chemicals; and
        (5) such other factors as are relevant to and consistent with
      the public health and safety.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 303, Oct. 27, 1970, 84 Stat. 1253;
    Pub. L. 93-281, Sec. 3, May 14, 1974, 88 Stat. 124; Pub. L. 95-633,
    title I, Sec. 109, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 98-473,
    title II, Sec. 511, Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103-200,
    Sec. 3(c), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 106-310, div. B,
    title XXXV, Sec. 3502(a), Oct. 17, 2000, 114 Stat. 1222; Pub. L.
    107-273, div. B, title II, Sec. 2501, Nov. 2, 2002, 116 Stat. 1803;
    Pub. L. 109-56, Sec. 1(a), (b), Aug. 2, 2005, 119 Stat. 591; Pub.
    L. 109-177, title VII, Sec. 712(a)(3), Mar. 9, 2006, 120 Stat. 263;
    Pub. L. 109-469, title XI, Sec. 1102, Dec. 29, 2006, 120 Stat.
    3540.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, IV, and V, referred to in subsecs. (a) to
    (f) and (g)(2), are set out in section 812(c) of this title.
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (g)(2)(C)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.
      This chapter, referred to in subsec. (g)(2)(J)(ii)(II), was in
    the original "this Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84
    Stat. 1236, as amended. For complete classification of this Act to
    the Code, see Short Title note set out under section 801 of this
    title and Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (g)(2)(B)(iii). Pub. L. 109-469, Sec. 1102(1),
    substituted "unless, not sooner than 1 year after the date on which
    the practitioner submitted the initial notification, the
    practitioner submits a second notification to the Secretary of the
    need and intent of the practitioner to treat up to 100 patients. A
    second notification under this clause shall contain the
    certifications required by clauses (i) and (ii) of this
    subparagraph. The" for "except that the".
      Subsec. (g)(2)(J)(i). Pub. L. 109-469, Sec. 1102(2)(A),
    substituted "thereafter." for "thereafter except as provided in
    clause (iii) (relating to a decision by the Secretary or the
    Attorney General that this paragraph should not remain in effect)."
      Subsec. (g)(2)(J)(ii). Pub. L. 109-469, Sec. 1102(2)(B),
    substituted "December 29, 2006" for "October 17, 2000" in
    introductory provisions.
      Subsec. (g)(2)(J)(iii). Pub. L. 109-469, Sec. 1102(2)(C),
    substituted "subparagraph (B)(iii) should be applied by limiting
    the total number of patients a practitioner may treat to 30, then
    the provisions in such subparagraph (B)(iii) permitting more than
    30 patients shall not apply, effective" for "this paragraph should
    not remain in effect, this paragraph ceases to be in effect".
      Subsec. (h). Pub. L. 109-177 substituted "clause (iv) or (v) of
    section 802(39)(A) of this title" for "section 802(39)(A)(iv) of
    this title" in introductory provisions.
      2005 - Subsec. (g)(2)(B)(iii). Pub. L. 109-56, Sec. 1(b),
    substituted "The total" for "In any case in which the practitioner
    is not in a group practice, the total".
      Subsec. (g)(2)(B)(iv). Pub. L. 109-56, Sec. 1(a), struck out cl.
    (iv) which read as follows: "In any case in which the practitioner
    is in a group practice, the total number of such patients of the
    group practice at any one time will not exceed the applicable
    number. For purposes of this clause, the applicable number is 30,
    except that the Secretary may by regulation change such total
    number, and the Secretary for such purposes may by regulation
    establish different categories on the basis of the number of
    practitioners in a group practice and establish for the various
    categories different numerical limitations on the number of such
    patients that the group practice may have."
      2002 - Subsec. (g)(2)(I). Pub. L. 107-273, Sec. 2501(1), which
    directed the substitution of "on the date of approval by the Food
    and Drug Administration of a drug in schedule III, IV, or V, a
    State may not preclude a practitioner from dispensing or
    prescribing such drug, or combination of such drugs," for "on
    October 17, 2000, a State may not preclude a practitioner from
    dispensing or prescribing drugs in schedule III, IV, or V, or
    combinations of such drugs,", was executed by making the
    substitution for the phrase which in the original began with "on
    the date of the enactment of the Drug Addiction Treatment Act of
    2000," rather than the editorial translation "on October 17, 2000,"
    to reflect the probable intent of Congress.
      Subsec. (g)(2)(J)(i). Pub. L. 107-273, Sec. 2501(2), which
    directed the substitution of "the date referred to in subparagraph
    (I)," for "October 17, 2000," was executed by making the
    substitution for text which in the original read "the date of the
    enactment of the Drug Addiction Treatment Act of 2000," rather than
    the editorial translation "October 17, 2000," to reflect the
    probable intent of Congress.
      2000 - Subsec. (g). Pub. L. 106-310 designated existing
    provisions as par. (1), substituted "Except as provided in
    paragraph (2), practitioners who dispense" for "Practitioners who
    dispense", redesignated former pars. (1) to (3) as subpars. (A) to
    (C), respectively, of par. (1) and redesignated former subpars. (A)
    and (B) of former par. (2) as cls. (i) and (ii), respectively, of
    subpar. (B) of par. (1), and added par. (2).
      1993 - Subsec. (h). Pub. L. 103-200 added subsec. (h).
      1984 - Subsec. (f). Pub. L. 98-473 amended subsec. (f) generally,
    substituting provisions relating to registration authority of
    Attorney General respecting dispensation or conduct of research
    with controlled research, and separate authority of Secretary
    respecting registration, for provisions relating to general
    registration requirements respecting dispensation or conduct of
    research with controlled or nonnarcotic controlled substances.
      1978 - Subsec. (f). Pub. L. 95-633 inserted provision relating to
    the construction of the Convention on Psychotropic Substances.
      1974 - Subsec. (g). Pub. L. 93-281 added subsec. (g).

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Pub. L. 109-56, Sec. 1(c), Aug. 2, 2005, 119 Stat. 591, provided
    that: "This section [amending this section] shall take effect on
    the date of enactment of this Act [Aug. 2, 2005]."

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

                         PROVISIONAL REGISTRATION                     
      For provisional registration of persons engaged in manufacturing,
    distributing, or dispensing of controlled substances on the day
    before the effective date of section 822 of this title who are
    registered on such date under section 360 of this title or section
    4722 of Title 26, Internal Revenue Code, see section 703 of Pub. L.
    91-513, set out as a note under section 822 of this title.

-FOOTNOTE-               

    (!1) So in original. Probably should be "combinations of
         drugs.".


-End-



-CITE-
    21 USC Sec. 824                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 824. Denial, revocation, or suspension of registration

-STATUTE-
    (a) Grounds
      A registration pursuant to section 823 of this title to
    manufacture, distribute, or dispense a controlled substance or a
    list I chemical may be suspended or revoked by the Attorney General
    upon a finding that the registrant - 
        (1) has materially falsified any application filed pursuant to
      or required by this subchapter or subchapter II of this chapter;
        (2) has been convicted of a felony under this subchapter or
      subchapter II of this chapter or any other law of the United
      States, or of any State, relating to any substance defined in
      this subchapter as a controlled substance or a list I chemical;
        (3) has had his State license or registration suspended,
      revoked, or denied by competent State authority and is no longer
      authorized by State law to engage in the manufacturing,
      distribution, or dispensing of controlled substances or list I
      chemicals or has had the suspension, revocation, or denial of his
      registration recommended by competent State authority;
        (4) has committed such acts as would render his registration
      under section 823 of this title inconsistent with the public
      interest as determined under such section; or
        (5) has been excluded (or directed to be excluded) from
      participation in a program pursuant to section 1320a-7(a) of
      title 42.

    A registration pursuant to section 823(g)(1) of this title to
    dispense a narcotic drug for maintenance treatment or
    detoxification treatment may be suspended or revoked by the
    Attorney General upon a finding that the registrant has failed to
    comply with any standard referred to in section 823(g)(1) of this
    title.
    (b) Limits of revocation or suspension
      The Attorney General may limit revocation or suspension of a
    registration to the particular controlled substance or list I
    chemical with respect to which grounds for revocation or suspension
    exist.
    (c) Service of show cause order; proceedings
      Before taking action pursuant to this section, or pursuant to a
    denial of registration under section 823 of this title, the
    Attorney General shall serve upon the applicant or registrant an
    order to show cause why registration should not be denied, revoked,
    or suspended. The order to show cause shall contain a statement of
    the basis thereof and shall call upon the applicant or registrant
    to appear before the Attorney General at a time and place stated in
    the order, but in no event less than thirty days after the date of
    receipt of the order. Proceedings to deny, revoke, or suspend shall
    be conducted pursuant to this section in accordance with subchapter
    II of chapter 5 of title 5. Such proceedings shall be independent
    of, and not in lieu of, criminal prosecutions or other proceedings
    under this subchapter or any other law of the United States.
    (d) Suspension of registration in cases of imminent danger
      The Attorney General may, in his discretion, suspend any
    registration simultaneously with the institution of proceedings
    under this section, in cases where he finds that there is an
    imminent danger to the public health or safety. A failure to comply
    with a standard referred to in section 823(g)(1) of this title may
    be treated under this subsection as grounds for immediate
    suspension of a registration granted under such section. A
    suspension under this subsection shall continue in effect until the
    conclusion of such proceedings, including judicial review thereof,
    unless sooner withdrawn by the Attorney General or dissolved by a
    court of competent jurisdiction.
    (e) Suspension and revocation of quotas
      The suspension or revocation of a registration under this section
    shall operate to suspend or revoke any quota applicable under
    section 826 of this title.
    (f) Disposition of controlled substances or list I chemicals
      In the event the Attorney General suspends or revokes a
    registration granted under section 823 of this title, all
    controlled substances or list I chemicals owned or possessed by the
    registrant pursuant to such registration at the time of suspension
    or the effective date of the revocation order, as the case may be,
    may, in the discretion of the Attorney General, be placed under
    seal. No disposition may be made of any controlled substances or
    list I chemicals under seal until the time for taking an appeal has
    elapsed or until all appeals have been concluded except that a
    court, upon application therefor, may at any time order the sale of
    perishable controlled substances or list I chemicals. Any such
    order shall require the deposit of the proceeds of the sale with
    the court. Upon a revocation order becoming final, all such
    controlled substances or list I chemicals (or proceeds of sale
    deposited in court) shall be forfeited to the United States; and
    the Attorney General shall dispose of such controlled substances or
    list I chemicals in accordance with section 881(e) of this title.
    All right, title, and interest in such controlled substances or
    list I chemicals shall vest in the United States upon a revocation
    order becoming final.
    (g) Seizure or placement under seal of controlled substances or
      list I chemicals
      The Attorney General may, in his discretion, seize or place under
    seal any controlled substances or list I chemicals owned or
    possessed by a registrant whose registration has expired or who has
    ceased to practice or do business in the manner contemplated by his
    registration. Such controlled substances or list I chemicals shall
    be held for the benefit of the registrant, or his successor in
    interest. The Attorney General shall notify a registrant, or his
    successor in interest, who has any controlled substance or list I
    chemical seized or placed under seal of the procedures to be
    followed to secure the return of the controlled substance or list I
    chemical and the conditions under which it will be returned. The
    Attorney General may not dispose of any controlled substance or
    list I chemical seized or placed under seal under this subsection
    until the expiration of one hundred and eighty days from the date
    such substance or chemical was seized or placed under seal.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 304, Oct. 27, 1970, 84 Stat. 1255;
    Pub. L. 93-281, Sec. 4, May 14, 1974, 88 Stat. 125; Pub. L. 98-473,
    title II, Secs. 304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073;
    Pub. L. 100-93, Sec. 8(j), Aug. 18, 1987, 101 Stat. 695; Pub. L.
    103-200, Sec. 3(d), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103-322,
    title XXXIII, Sec. 330024(e), Sept. 13, 1994, 108 Stat. 2151; Pub.
    L. 106-310, div. B, title XXXV, Sec. 3502(b), Oct. 17, 2000, 114
    Stat. 1227.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in subsec. (a)(1), (2), was in the
    original "this title", meaning title II of Pub. L. 91-513, Oct. 27,
    1970, 84 Stat. 1242, as amended, and is popularly known as the
    "Controlled Substances Act". For complete classification of title
    II to the Code, see second paragraph of Short Title note set out
    under section 801 of this title and Tables.
      Subchapter II of this chapter, referred to in subsec. (a)(1),
    (2), was in the original "title III", meaning title III of Pub. L.
    91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
    subchapter II of this chapter. For classification of Part B,
    consisting of sections 1101 to 1105 of title III, see Tables.


-MISC1-
                                AMENDMENTS                            
      2000 - Subsec. (a). Pub. L. 106-310, Sec. 3502(b)(1), substituted
    "section 823(g)(1) of this title" for "section 823(g) of this
    title" in two places in concluding provisions.
      Subsec. (d). Pub. L. 106-310, Sec. 3502(b)(2), substituted
    "section 823(g)(1) of this title" for "section 823(g) of this
    title".
      1994 - Subsec. (g). Pub. L. 103-322 inserted "or chemical" after
    "such substance" in last sentence.
      1993 - Subsec. (a). Pub. L. 103-200, Sec. 3(d)(1), inserted "or a
    list I chemical" after "controlled substance" in introductory
    provisions and par. (2) and inserted "or list I chemicals" after
    "controlled substances" in par. (3).
      Subsec. (b). Pub. L. 103-200, Sec. 3(d)(2), inserted "or list I
    chemical" after "controlled substance".
      Subsec. (f). Pub. L. 103-200, Sec. 3(d)(3), inserted "or list I
    chemicals" after "controlled substances" wherever appearing.
      Subsec. (g). Pub. L. 103-200, Sec. 3(d)(4), inserted "or list I
    chemicals" after "controlled substances" in two places and "or list
    I chemical" after "controlled substance" wherever appearing.
      1987 - Subsec. (a)(5). Pub. L. 100-93 added par. (5).
      1984 - Subsec. (a)(3). Pub. L. 98-473, Sec. 512(1), inserted
    provisions relating to suspension, etc., recommended by competent
    State authority.
      Subsec. (a)(4). Pub. L. 98-473, Sec. 512(2), added par. (4).
      Subsec. (f). Pub. L. 98-473, Sec. 304, inserted provisions
    relating to vesting of right, title, and interest in the United
    States.
      Subsec. (g). Pub. L. 98-473, Sec. 513, added subsec. (g).
      1974 - Subsec. (a). Pub. L. 93-281, Sec. 4(a), provided for
    revocation or suspension of a registration pursuant to section
    823(g) of this title for failure of a registrant to comply with
    standards referred to in such section 823(g).
      Subsec. (d). Pub. L. 93-281, Sec. 4(b), substituted "A suspension
    under this subsection" for "Such suspension" in third sentence.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by Pub. L. 103-322 effective 120 days after Dec. 17,
    1993, see section 330024(f) of Pub. L. 103-322, set out as a note
    under section 802 of this title.

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                     EFFECTIVE DATE OF 1987 AMENDMENT                 
      Amendment by Pub. L. 100-93 effective at end of fourteen-day
    period beginning Aug. 18, 1987, and inapplicable to administrative
    proceedings commenced before end of such period, see section 15(a)
    of Pub. L. 100-93, set out as a note under section 1320a-7 of Title
    42, The Public Health and Welfare.

                         PROVISIONAL REGISTRATION                     
      Applicability of this section to provisional registrations, see
    section 703 of Pub. L. 91-513, set out as a note under section 822
    of this title.

-End-



-CITE-
    21 USC Sec. 825                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 825. Labeling and packaging

-STATUTE-
    (a) Symbol
      It shall be unlawful to distribute a controlled substance in a
    commercial container unless such container, when and as required by
    regulations of the Attorney General, bears a label (as defined in
    section 321(k) of this title) containing an identifying symbol for
    such substance in accordance with such regulations. A different
    symbol shall be required for each schedule of controlled
    substances.
    (b) Unlawful distribution without identifying symbol
      It shall be unlawful for the manufacturer of any controlled
    substance to distribute such substance unless the labeling (as
    defined in section 321(m) of this title) of such substance
    contains, when and as required by regulations of the Attorney
    General, the identifying symbol required under subsection (a) of
    this section.
    (c) Warning on label
      The Secretary shall prescribe regulations under section 353(b) of
    this title which shall provide that the label of a drug listed in
    schedule II, III, or IV shall, when dispensed to or for a patient,
    contain a clear, concise warning that it is a crime to transfer the
    drug to any person other than the patient.
    (d) Containers to be securely sealed
      It shall be unlawful to distribute controlled substances in
    schedule I or II, and narcotic drugs in schedule III or IV, unless
    the bottle or other container, stopper, covering, or wrapper
    thereof is securely sealed as required by regulations of the
    Attorney General.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 305, Oct. 27, 1970, 84 Stat. 1256.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, and IV, referred to in subsecs. (c) and
    (d), are set out in section 812(c) of this title.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, but with Attorney General authorized to
    postpone such effective date for such period as he might determine
    to be necessary for the efficient administration of this
    subchapter, see section 704(c) of Pub. L. 91-513, set out as a note
    under section 801 of this title.

-End-



-CITE-
    21 USC Sec. 826                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 826. Production quotas for controlled substances

-STATUTE-
    (a) Establishment of total annual needs
      The Attorney General shall determine the total quantity and
    establish production quotas for each basic class of controlled
    substance in schedules I and II and for ephedrine, pseudoephedrine,
    and phenylpropanolamine to be manufactured each calendar year to
    provide for the estimated medical, scientific, research, and
    industrial needs of the United States, for lawful export
    requirements, and for the establishment and maintenance of reserve
    stocks. Production quotas shall be established in terms of
    quantities of each basic class of controlled substance and not in
    terms of individual pharmaceutical dosage forms prepared from or
    containing such a controlled substance.
    (b) Individual production quotas; revised quotas
      The Attorney General shall limit or reduce individual production
    quotas to the extent necessary to prevent the aggregate of
    individual quotas from exceeding the amount determined necessary
    each year by the Attorney General under subsection (a) of this
    section. The quota of each registered manufacturer for each basic
    class of controlled substance in schedule I or II or for ephedrine,
    pseudoephedrine, or phenylpropanolamine shall be revised in the
    same proportion as the limitation or reduction of the aggregate of
    the quotas. However, if any registrant, before the issuance of a
    limitation or reduction in quota, has manufactured in excess of his
    revised quota, the amount of the excess shall be subtracted from
    his quota for the following year.
    (c) Manufacturing quotas for registered manufacturers
      On or before October 1 of each year, upon application therefor by
    a registered manufacturer, the Attorney General shall fix a
    manufacturing quota for the basic classes of controlled substances
    in schedules I and II and for ephedrine, pseudoephedrine, and
    phenylpropanolamine that the manufacturer seeks to produce. The
    quota shall be subject to the provisions of subsections (a) and (b)
    of this section. In fixing such quotas, the Attorney General shall
    determine the manufacturer's estimated disposal, inventory, and
    other requirements for the calendar year; and, in making his
    determination, the Attorney General shall consider the
    manufacturer's current rate of disposal, the trend of the national
    disposal rate during the preceding calendar year, the
    manufacturer's production cycle and inventory position, the
    economic availability of raw materials, yield and stability
    problems, emergencies such as strikes and fires, and other factors.
    (d) Quotas for registrants who have not manufactured controlled
      substance during one or more preceding years
      The Attorney General shall, upon application and subject to the
    provisions of subsections (a) and (b) of this section, fix a quota
    for a basic class of controlled substance in schedule I or II for
    any registrant who has not manufactured that basic class of
    controlled substance or ephedrine, pseudoephedrine, or
    phenylpropanolamine during one or more preceding calendar years. In
    fixing such quota, the Attorney General shall take into account the
    registrant's reasonably anticipated requirements for the current
    year; and, in making his determination of such requirements, he
    shall consider such factors specified in subsection (c) of this
    section as may be relevant.
    (e) Quota increases
      At any time during the year any registrant who has applied for or
    received a manufacturing quota for a basic class of controlled
    substance in schedule I or II or for ephedrine, pseudoephedrine, or
    phenylpropanolamine may apply for an increase in that quota to meet
    his estimated disposal, inventory, and other requirements during
    the remainder of that year. In passing upon the application the
    Attorney General shall take into consideration any occurrences
    since the filing of the registrant's initial quota application that
    may require an increased manufacturing rate by the registrant
    during the balance of the year. In passing upon the application the
    Attorney General may also take into account the amount, if any, by
    which the determination of the Attorney General under subsection
    (a) of this section exceeds the aggregate of the quotas of all
    registrants under this section.
    (f) Incidental production exception
      Notwithstanding any other provisions of this subchapter, no
    registration or quota may be required for the manufacture of such
    quantities of controlled substances in schedules I and II or
    ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally
    and necessarily result from the manufacturing process used for the
    manufacture of a controlled substance or of ephedrine,
    pseudoephedrine, or phenylpropanolamine with respect to which its
    manufacturer is duly registered under this subchapter. The Attorney
    General may, by regulation, prescribe restrictions on the retention
    and disposal of such incidentally produced substances or chemicals.
    (g) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine
      Each reference in this section to ephedrine, pseudoephedrine, or
    phenylpropanolamine includes each of the salts, optical isomers,
    and salts of optical isomers of such chemical.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 306, Oct. 27, 1970, 84 Stat. 1257;
    Pub. L. 94-273, Sec. 3(16), Apr. 21, 1976, 90 Stat. 377; Pub. L.
    109-177, title VII, Sec. 713, Mar. 9, 2006, 120 Stat. 264.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I and II, referred to in text, are set out in section
    812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a). Pub. L. 109-177, Sec. 713(1), inserted "and
    for ephedrine, pseudoephedrine, and phenylpropanolamine" after "for
    each basic class of controlled substance in schedules I and II".
      Subsec. (b). Pub. L. 109-177, Sec. 713(2), inserted "or for
    ephedrine, pseudoephedrine, or phenylpropanolamine" after "for each
    basic class of controlled substance in schedule I or II".
      Subsec. (c). Pub. L. 109-177, Sec. 713(3), inserted "and for
    ephedrine, pseudoephedrine, and phenylpropanolamine" after "for the
    basic classes of controlled substances in schedules I and II".
      Subsec. (d). Pub. L. 109-177, Sec. 713(4), inserted "or
    ephedrine, pseudoephedrine, or phenylpropanolamine" after "that
    basic class of controlled substance".
      Subsec. (e). Pub. L. 109-177, Sec. 713(5), inserted "or for
    ephedrine, pseudoephedrine, or phenylpropanolamine" after "for a
    basic class of controlled substance in schedule I or II".
      Subsec. (f). Pub. L. 109-177, Sec. 713(6), inserted "or
    ephedrine, pseudoephedrine, or phenylpropanolamine" after
    "controlled substances in schedules I and II", "or of ephedrine,
    pseudoephedrine, or phenylpropanolamine" after "the manufacture of
    a controlled substance", and "or chemicals" after "such
    incidentally produced substances".
      Subsec. (g). Pub. L. 109-177, Sec. 713(7), added subsec. (g).
      1976 - Subsec. (c). Pub. L. 94-273 substituted "October" for
    "July".

                              EFFECTIVE DATE                          
      Section effective on first day of seventh calendar month that
    begins after Oct. 26, 1970, but with Attorney General authorized to
    postpone such effective date for such period as he might determine
    to be necessary for the efficient administration of this
    subchapter, see section 704(c) of Pub. L. 91-513, set out as a note
    under section 801 of this title.

           COORDINATION WITH UNITED STATES TRADE REPRESENTATIVE       
      Pub. L. 109-177, title VII, Sec. 718, Mar. 9, 2006, 120 Stat.
    267, provided that: "In implementing sections 713 through 717 and
    section 721 of this title [amending this section and sections 830,
    842, 952, 960, and 971 of this title], the Attorney General shall
    consult with the United States Trade Representative to ensure
    implementation complies with all applicable international treaties
    and obligations of the United States."

-End-



-CITE-
    21 USC Sec. 827                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 827. Records and reports of registrants

-STATUTE-
    (a) Inventory
      Except as provided in subsection (c) of this section - 
        (1) every registrant under this subchapter shall, on May 1,
      1971, or as soon thereafter as such registrant first engages in
      the manufacture, distribution, or dispensing of controlled
      substances, and every second year thereafter, make a complete and
      accurate record of all stocks thereof on hand, except that the
      regulations prescribed under this section shall permit each such
      biennial inventory (following the initial inventory required by
      this paragraph) to be prepared on such registrant's regular
      general physical inventory date (if any) which is nearest to and
      does not vary by more than six months from the biennial date that
      would otherwise apply;
        (2) on the effective date of each regulation of the Attorney
      General controlling a substance that immediately prior to such
      date was not a controlled substance, each registrant under this
      subchapter manufacturing, distributing, or dispensing such
      substance shall make a complete and accurate record of all stocks
      thereof on hand; and
        (3) on and after May 1, 1971, every registrant under this
      subchapter manufacturing, distributing, or dispensing a
      controlled substance or substances shall maintain, on a current
      basis, a complete and accurate record of each such substance
      manufactured, received, sold, delivered, or otherwise disposed of
      by him, except that this paragraph shall not require the
      maintenance of a perpetual inventory.
    (b) Availability of records
      Every inventory or other record required under this section (1)
    shall be in accordance with, and contain such relevant information
    as may be required by, regulations of the Attorney General, (2)
    shall (A) be maintained separately from all other records of the
    registrant, or (B) alternatively, in the case of nonnarcotic
    controlled substances, be in such form that information required by
    the Attorney General is readily retrievable from the ordinary
    business records of the registrant, and (3) shall be kept and be
    available, for at least two years, for inspection and copying by
    officers or employees of the United States authorized by the
    Attorney General.
    (c) Nonapplicability
      The foregoing provisions of this section shall not apply - 
        (1)(A) to the prescribing of controlled substances in schedule
      II, III, IV, or V by practitioners acting in the lawful course of
      their professional practice unless such substance is prescribed
      in the course of maintenance or detoxification treatment of an
      individual; or
        (B) to the administering of a controlled substance in schedule
      II, III, IV, or V unless the practitioner regularly engages in
      the dispensing or administering of controlled substances and
      charges his patients, either separately or together with charges
      for other professional services, for substances so dispensed or
      administered or unless such substance is administered in the
      course of maintenance treatment or detoxification treatment of an
      individual;
        (2)(A) to the use of controlled substances, at establishments
      registered under this subchapter which keep records with respect
      to such substances, in research conducted in conformity with an
      exemption granted under section 355(i) or 360b(j) of this title;
        (B) to the use of controlled substances, at establishments
      registered under this subchapter which keep records with respect
      to such substances, in preclinical research or in teaching; or
        (3) to the extent of any exemption granted to any person, with
      respect to all or part of such provisions, by the Attorney
      General by or pursuant to regulation on the basis of a finding
      that the application of such provisions (or part thereof) to such
      person is not necessary for carrying out the purposes of this
      subchapter.

    Nothing in the Convention on Psychotropic Substances shall be
    construed as superseding or otherwise affecting the provisions of
    paragraph (1)(B), (2), or (3) of this subsection.
    (d) Periodic reports to Attorney General
      Every manufacturer registered under section 823 of this title
    shall, at such time or times and in such form as the Attorney
    General may require, make periodic reports to the Attorney General
    of every sale, delivery or other disposal by him of any controlled
    substance, and each distributor shall make such reports with
    respect to narcotic controlled substances, identifying by the
    registration number assigned under this subchapter the person or
    establishment (unless exempt from registration under section 822(d)
    of this title) to whom such sale, delivery, or other disposal was
    made.
    (e) Reporting and recordkeeping requirements of drug conventions
      In addition to the reporting and recordkeeping requirements under
    any other provision of this subchapter, each manufacturer
    registered under section 823 of this title shall, with respect to
    narcotic and nonnarcotic controlled substances manufactured by it,
    make such reports to the Attorney General, and maintain such
    records, as the Attorney General may require to enable the United
    States to meet its obligations under articles 19 and 20 of the
    Single Convention on Narcotic Drugs and article 16 of the
    Convention on Psychotropic Substances. The Attorney General shall
    administer the requirements of this subsection in such a manner as
    to avoid the unnecessary imposition of duplicative requirements
    under this subchapter on manufacturers subject to the requirements
    of this subsection.
    (f) Investigational uses of drugs; procedures
      Regulations under sections 355(i) and 360(j) of this title,
    relating to investigational use of drugs, shall include such
    procedures as the Secretary, after consultation with the Attorney
    General, determines are necessary to insure the security and
    accountability of controlled substances used in research to which
    such regulations apply.
    (g) Change of address
      Every registrant under this subchapter shall be required to
    report any change of professional or business address in such
    manner as the Attorney General shall by regulation require.
    (h) Reporting requirements for GHB
      In the case of a drug product containing gamma hydroxybutyric
    acid for which an application has been approved under section 355
    of this title, the Attorney General may, in addition to any other
    requirements that apply under this section with respect to such a
    drug product, establish any of the following as reporting
    requirements:
        (1) That every person who is registered as a manufacturer of
      bulk or dosage form, as a packager, repackager, labeler,
      relabeler, or distributor shall report acquisition and
      distribution transactions quarterly, not later than the 15th day
      of the month succeeding the quarter for which the report is
      submitted, and annually report end-of-year inventories.
        (2) That all annual inventory reports shall be filed no later
      than January 15 of the year following that for which the report
      is submitted and include data on the stocks of the drug product,
      drug substance, bulk drug, and dosage forms on hand as of the
      close of business December 31, indicating whether materials
      reported are in storage or in process of manufacturing.
        (3) That every person who is registered as a manufacturer of
      bulk or dosage form shall report all manufacturing transactions
      both inventory increases, including purchases, transfers, and
      returns, and reductions from inventory, including sales,
      transfers, theft, destruction, and seizure, and shall provide
      data on material manufactured, manufactured from other material,
      use in manufacturing other material, and use in manufacturing
      dosage forms.
        (4) That all reports under this section must include the
      registered person's registration number as well as the
      registration numbers, names, and other identifying information of
      vendors, suppliers, and customers, sufficient to allow the
      Attorney General to track the receipt and distribution of the
      drug.
        (5) That each dispensing practitioner shall maintain for each
      prescription the name of the prescribing practitioner, the
      prescribing practitioner's Federal and State registration
      numbers, with the expiration dates of these registrations,
      verification that the prescribing practitioner possesses the
      appropriate registration to prescribe this controlled substance,
      the patient's name and address, the name of the patient's
      insurance provider and documentation by a medical practitioner
      licensed and registered to prescribe the drug of the patient's
      medical need for the drug. Such information shall be available
      for inspection and copying by the Attorney General.
        (6) That section 830(b)(3) of this title (relating to mail
      order reporting) applies with respect to gamma hydroxybutyric
      acid to the same extent and in the same manner as such section
      applies with respect to the chemicals and drug products specified
      in subparagraph (A)(i) of such section.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 307, Oct. 27, 1970, 84 Stat. 1258;
    Pub. L. 93-281, Sec. 5, May 14, 1974, 88 Stat. 125; Pub. L. 95-633,
    title I, Secs. 104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub.
    L. 98-473, title II, Secs. 514, 515, Oct. 12, 1984, 98 Stat. 2074;
    Pub. L. 106-172, Sec. 4, Feb. 18, 2000, 114 Stat. 9.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules II, III, IV, and V, referred to in subsec. (c), are set
    out in section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      2000 - Subsec. (h). Pub. L. 106-172 added subsec. (h).
      1984 - Subsec. (c)(1)(A). Pub. L. 98-473, Sec. 514(a),
    substituted "to the prescribing of controlled substances in
    schedule II, III, IV, or V by practitioners acting in the lawful
    course of their professional practice unless such substance is
    prescribed in the course of maintenance or detoxification treatment
    of an individual" for "with respect to any narcotic controlled
    substance in schedule II, III, IV, or V, to the prescribing or
    administering of such substance by a practitioner in the lawful
    course of his professional practice unless such substance was
    prescribed or administered in the course of maintenance treatment
    or detoxification treatment of an individual".
      Subsec. (c)(1)(B). Pub. L. 98-473, Sec. 514(b), substituted "to
    the administering of a controlled substance in schedule II, III,
    IV, or V unless the practitioner regularly engages in the
    dispensing or administering of controlled substances and charges
    his patients, either separately or together with charges for other
    professional services, for substances so dispensed or administered
    or unless such substance is administered in the course of
    maintenance treatment or detoxification treatment of an individual"
    for "with respect to nonnarcotic controlled substances in schedule
    II, III, IV, or V, to any practitioner who dispenses such
    substances to his patients, unless the practitioner is regularly
    engaged in charging his patients, either separately or together
    with charges for other professional services, for substances so
    dispensed".
      Subsec. (g). Pub. L. 98-473, Sec. 515, added subsec. (g).
      1978 - Subsec. (c). Pub. L. 95-633, Sec. 110, inserted provision
    following par. (3) relating to the construction of the Convention
    on Psychotropic Substances.
      Subsecs. (e), (f). Pub. L. 95-633 added subsec. (e) and
    redesignated former subsec. (e) as (f).
      1974 - Subsec. (c)(1)(A). Pub. L. 93-281 substituted "any
    narcotic controlled substance" for "narcotic controlled substances"
    and made section applicable to any narcotic controlled substance
    prescribed or administered in the course of maintenance treatment
    or detoxification treatment of an individual.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

-End-



-CITE-
    21 USC Sec. 828                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 828. Order forms

-STATUTE-
    (a) Unlawful distribution of controlled substances
      It shall be unlawful for any person to distribute a controlled
    substance in schedule I or II to another except in pursuance of a
    written order of the person to whom such substance is distributed,
    made on a form to be issued by the Attorney General in blank in
    accordance with subsection (d) of this section and regulations
    prescribed by him pursuant to this section.
    (b) Nonapplicability of provisions
      Nothing in subsection (a) of this section shall apply to - 
        (1) the exportation of such substances from the United States
      in conformity with subchapter II of this chapter;
        (2) the delivery of such a substance to or by a common or
      contract carrier for carriage in the lawful and usual course of
      its business, or to or by a warehouseman for storage in the
      lawful and usual course of its business; but where such carriage
      or storage is in connection with the distribution by the owner of
      the substance to a third person, this paragraph shall not relieve
      the distributor from compliance with subsection (a) of this
      section.
    (c) Preservation and availability
      (1) Every person who in pursuance of an order required under
    subsection (a) of this section distributes a controlled substance
    shall preserve such order for a period of two years, and shall make
    such order available for inspection and copying by officers and
    employees of the United States duly authorized for that purpose by
    the Attorney General, and by officers or employees of States or
    their political subdivisions who are charged with the enforcement
    of State or local laws regulating the production, or regulating the
    distribution or dispensing, of controlled substances and who are
    authorized under such laws to inspect such orders.
      (2) Every person who gives an order required under subsection (a)
    of this section shall, at or before the time of giving such order,
    make or cause to be made a duplicate thereof on a form to be issued
    by the Attorney General in blank in accordance with subsection (d)
    of this section and regulations prescribed by him pursuant to this
    section, and shall, if such order is accepted, preserve such
    duplicate for a period of two years and make it available for
    inspection and copying by the officers and employees mentioned in
    paragraph (1) of this subsection.
    (d) Issuance
      (1) The Attorney General shall issue forms pursuant to
    subsections (a) and (c)(2) of this section only to persons validly
    registered under section 823 of this title (or exempted from
    registration under section 822(d) of this title). Whenever any such
    form is issued to a person, the Attorney General shall, before
    delivery thereof, insert therein the name of such person, and it
    shall be unlawful for any other person (A) to use such form for the
    purpose of obtaining controlled substances or (B) to furnish such
    form to any person with intent thereby to procure the distribution
    of such substances.
      (2) The Attorney General may charge reasonable fees for the
    issuance of such forms in such amounts as he may prescribe for the
    purpose of covering the cost to the United States of issuing such
    forms, and other necessary activities in connection therewith.
    (e) Unlawful acts
      It shall be unlawful for any person to obtain by means of order
    forms issued under this section controlled substances for any
    purpose other than their use, distribution, dispensing, or
    administration in the conduct of a lawful business in such
    substances or in the course of his professional practice or
    research.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 308, Oct. 27, 1970, 84 Stat. 1259.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I and II, referred to in subsec. (a), are set out in
    section 812(c) of this title.

-End-



-CITE-
    21 USC Sec. 829                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 829. Prescriptions

-STATUTE-
    (a) Schedule II substances
      Except when dispensed directly by a practitioner, other than a
    pharmacist, to an ultimate user, no controlled substance in
    schedule II, which is a prescription drug as determined under the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may
    be dispensed without the written prescription of a practitioner,
    except that in emergency situations, as prescribed by the Secretary
    by regulation after consultation with the Attorney General, such
    drug may be dispensed upon oral prescription in accordance with
    section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall
    be retained in conformity with the requirements of section 827 of
    this title. No prescription for a controlled substance in schedule
    II may be refilled.
    (b) Schedule III and IV substances
      Except when dispensed directly by a practitioner, other than a
    pharmacist, to an ultimate user, no controlled substance in
    schedule III or IV, which is a prescription drug as determined
    under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
    seq.], may be dispensed without a written or oral prescription in
    conformity with section 503(b) of that Act [21 U.S.C. 353(b)]. Such
    prescriptions may not be filled or refilled more than six months
    after the date thereof or be refilled more than five times after
    the date of the prescription unless renewed by the practitioner.
    (c) Schedule V substances
      No controlled substance in schedule V which is a drug may be
    distributed or dispensed other than for a medical purpose.
    (d) Non-prescription drugs with abuse potential
      Whenever it appears to the Attorney General that a drug not
    considered to be a prescription drug under the Federal Food, Drug,
    and Cosmetic Act [21 U.S.C. 301 et seq.] should be so considered
    because of its abuse potential, he shall so advise the Secretary
    and furnish to him all available data relevant thereto.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 309, Oct. 27, 1970, 84 Stat. 1260.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (a), (b), and (d), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.
      Schedules II, III, IV, and V, referred to in subsecs. (a) to (c),
    are set out in section 812(c) of this title.


-MISC1-
                   EFFECT OF SCHEDULING ON PRESCRIPTIONS               
      Pub. L. 101-647, title XIX, Sec. 1902(c), Nov. 29, 1990, 104
    Stat. 4852, provided that: "Any prescription for anabolic steroids
    subject to refill on or after the date of enactment of the
    amendments made by this section [Nov. 29, 1990] may be refilled
    without restriction under section 309(a) of the Controlled
    Substances Act (21 U.S.C. 829(a))."

-End-



-CITE-
    21 USC Sec. 830                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part C - Registration of Manufacturers, Distributors, and Dispensers
              of Controlled Substances                

-HEAD-
    Sec. 830. Regulation of listed chemicals and certain machines

-STATUTE-
    (a) Record of regulated transactions
      (1) Each regulated person who engages in a regulated transaction
    involving a listed chemical, a tableting machine, or an
    encapsulating machine shall keep a record of the transaction for
    two years after the date of the transaction.
      (2) A record under this subsection shall be retrievable and shall
    include the date of the regulated transaction, the identity of each
    party to the regulated transaction, a statement of the quantity and
    form of the listed chemical, a description of the tableting machine
    or encapsulating machine, and a description of the method of
    transfer. Such record shall be available for inspection and copying
    by the Attorney General.
      (3) It is the duty of each regulated person who engages in a
    regulated transaction to identify each other party to the
    transaction. It is the duty of such other party to present proof of
    identity to the regulated person. The Attorney General shall
    specify by regulation the types of documents and other evidence
    that constitute proof of identity for purposes of this paragraph.
    (b) Reports to Attorney General
      (1) Each regulated person shall report to the Attorney General,
    in such form and manner as the Attorney General shall prescribe by
    regulation - 
        (A) any regulated transaction involving an extraordinary
      quantity of a listed chemical, an uncommon method of payment or
      delivery, or any other circumstance that the regulated person
      believes may indicate that the listed chemical will be used in
      violation of this subchapter;
        (B) any proposed regulated transaction with a person whose
      description or other identifying characteristic the Attorney
      General furnishes in advance to the regulated person;
        (C) any unusual or excessive loss or disappearance of a listed
      chemical under the control of the regulated person; and
        (D) any regulated transaction in a tableting machine or an
      encapsulating machine.

    Each report under subparagraph (A) shall be made at the earliest
    practicable opportunity after the regulated person becomes aware of
    the circumstance involved. A regulated person may not complete a
    transaction with a person whose description or identifying
    characteristic is furnished to the regulated person under
    subparagraph (B) unless the transaction is approved by the Attorney
    General. The Attorney General shall make available to regulated
    persons guidance documents describing transactions and
    circumstances for which reports are required under subparagraph (A)
    and subparagraph (C).
      (2) A regulated person that manufactures a listed chemical shall
    report annually to the Attorney General, in such form and manner
    and containing such specific data as the Attorney General shall
    prescribe by regulation, information concerning listed chemicals
    manufactured by the person. The requirement of the preceding
    sentence shall not apply to the manufacture of a drug product that
    is exempted under section 802(39)(A)(iv) of this title.
      (3) Mail order reporting. - (A) As used in this paragraph:
        (i) The term "drug product" means an active ingredient in
      dosage form that has been approved or otherwise may be lawfully
      marketed under the Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
      seq.] for distribution in the United States.
        (ii) The term "valid prescription" means a prescription which
      is issued for a legitimate medical purpose by an individual
      practitioner licensed by law to administer and prescribe the
      drugs concerned and acting in the usual course of the
      practitioner's professional practice.

      (B) Each regulated person who engages in a transaction with a
    nonregulated person or who engages in an export transaction which -
    
        (i) involves ephedrine, pseudoephedrine, or phenylpropanolamine
      (including drug products containing these chemicals); and
        (ii) uses or attempts to use the Postal Service or any private
      or commercial carrier;

    shall, on a monthly basis, submit a report of each such transaction
    conducted during the previous month to the Attorney General in such
    form, containing such data, and at such times as the Attorney
    General shall establish by regulation.
      (C) The data required for such reports shall include - 
        (i) the name of the purchaser;
        (ii) the quantity and form of the ephedrine, pseudoephedrine,
      or phenylpropanolamine purchased; and
        (iii) the address to which such ephedrine, pseudoephedrine, or
      phenylpropanolamine was sent.

      (D) Except as provided in subparagraph (E), the following
    distributions to a nonregulated person, and the following export
    transactions, shall not be subject to the reporting requirement in
    subparagraph (B):
        (i) Distributions of sample packages of drug products when such
      packages contain not more than two solid dosage units or the
      equivalent of two dosage units in liquid form, not to exceed 10
      milliliters of liquid per package, and not more than one package
      is distributed to an individual or residential address in any 30-
      day period.
        (ii) Distributions of drug products by retail distributors that
      may not include face-to-face transactions to the extent that such
      distributions are consistent with the activities authorized for a
      retail distributor as specified in section 802(49) of this title,
      except that this clause does not apply to sales of scheduled
      listed chemical products at retail.
        (iii) Distributions of drug products to a resident of a long
      term care facility (as that term is defined in regulations
      prescribed by the Attorney General) or distributions of drug
      products to a long term care facility for dispensing to or for
      use by a resident of that facility.
        (iv) Distributions of drug products pursuant to a valid
      prescription.
        (v) Exports which have been reported to the Attorney General
      pursuant to section 954 or 971 of this title or which are subject
      to a waiver granted under section 971(f)(2) of this title.
        (vi) Any quantity, method, or type of distribution or any
      quantity, method, or type of distribution of a specific listed
      chemical (including specific formulations or drug products) or of
      a group of listed chemicals (including specific formulations or
      drug products) which the Attorney General has excluded by
      regulation from such reporting requirement on the basis that such
      reporting is not necessary for the enforcement of this subchapter
      or subchapter II of this chapter.

      (E) The Attorney General may revoke any or all of the exemptions
    listed in subparagraph (D) for an individual regulated person if he
    finds that drug products distributed by the regulated person are
    being used in violation of this subchapter or subchapter II of this
    chapter. The regulated person shall be notified of the revocation,
    which will be effective upon receipt by the person of such notice,
    as provided in section 971(c)(1) of this title, and shall have the
    right to an expedited hearing as provided in section 971(c)(2) of
    this title.
    (c) Confidentiality of information obtained by Attorney General;
      non-disclosure; exceptions
      (1) Except as provided in paragraph (2), any information obtained
    by the Attorney General under this section which is exempt from
    disclosure under section 552(a) of title 5, by reason of section
    552(b)(4) of such title, is confidential and may not be disclosed
    to any person.
      (2) Information referred to in paragraph (1) may be disclosed
    only - 
        (A) to an officer or employee of the United States engaged in
      carrying out this subchapter, subchapter II of this chapter, or
      the customs laws;
        (B) when relevant in any investigation or proceeding for the
      enforcement of this subchapter, subchapter II of this chapter, or
      the customs laws;
        (C) when necessary to comply with an obligation of the United
      States under a treaty or other international agreement; or
        (D) to a State or local official or employee in conjunction
      with the enforcement of controlled substances laws or chemical
      control laws.

      (3) The Attorney General shall - 
        (A) take such action as may be necessary to prevent
      unauthorized disclosure of information by any person to whom such
      information is disclosed under paragraph (2); and
        (B) issue guidelines that limit, to the maximum extent
      feasible, the disclosure of proprietary business information,
      including the names or identities of United States exporters of
      listed chemicals, to any person to whom such information is
      disclosed under paragraph (2).

      (4) Any person who is aggrieved by a disclosure of information in
    violation of this section may bring a civil action against the
    violator for appropriate relief.
      (5) Notwithstanding paragraph (4), a civil action may not be
    brought under such paragraph against investigative or law
    enforcement personnel of the Drug Enforcement Administration.
    (d) Scheduled listed chemicals; restrictions on sales quantity;
      requirements regarding nonliquid forms
      With respect to ephedrine base, pseudoephedrine base, or
    phenylpropanolamine base in a scheduled listed chemical product - 
        (1) the quantity of such base sold at retail in such a product
      by a regulated seller, or a distributor required to submit
      reports by subsection (b)(3) may not, for any purchaser, exceed a
      daily amount of 3.6 grams, without regard to the number of
      transactions; and
        (2) such a seller or distributor may not sell such a product in
      nonliquid form (including gel caps) at retail unless the product
      is packaged in blister packs, each blister containing not more
      than 2 dosage units, or where the use of blister packs is
      technically infeasible, the product is packaged in unit dose
      packets or pouches.
    (e) Scheduled listed chemicals; behind-the-counter access; logbook
      requirement; training of sales personnel; privacy protections
      (1) Requirements regarding retail transactions
        (A) In general
          Each regulated seller shall ensure that, subject to
        subparagraph (F), sales by such seller of a scheduled listed
        chemical product at retail are made in accordance with the
        following:
            (i) In offering the product for sale, the seller places the
          product such that customers do not have direct access to the
          product before the sale is made (in this paragraph referred
          to as "behind-the-counter" placement). For purposes of this
          paragraph, a behind-the-counter placement of a product
          includes circumstances in which the product is stored in a
          locked cabinet that is located in an area of the facility
          involved to which customers do have direct access.
            (ii) The seller delivers the product directly into the
          custody of the purchaser.
            (iii) The seller maintains, in accordance with criteria
          issued by the Attorney General, a written or electronic list
          of such sales that identifies the products by name, the
          quantity sold, the names and addresses of purchasers, and the
          dates and times of the sales (which list is referred to in
          this subsection as the "logbook"), except that such
          requirement does not apply to any purchase by an individual
          of a single sales package if that package contains not more
          than 60 milligrams of pseudoephedrine.
            (iv) In the case of a sale to which the requirement of
          clause (iii) applies, the seller does not sell such a product
          unless - 
              (I) the prospective purchaser - 
                (aa) presents an identification card that provides a
              photograph and is issued by a State or the Federal
              Government, or a document that, with respect to
              identification, is considered acceptable for purposes of
              sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of
              title 8, Code of Federal Regulations (as in effect on or
              after March 9, 2006); and
                (bb) signs the logbook and enters in the logbook his or
              her name, address, and the date and time of the sale; and

              (II) the seller - 
                (aa) determines that the name entered in the logbook
              corresponds to the name provided on such identification
              and that the date and time entered are correct; and
                (bb) enters in the logbook the name of the product and
              the quantity sold.

            (v) The logbook includes, in accordance with criteria of
          the Attorney General, a notice to purchasers that entering
          false statements or misrepresentations in the logbook may
          subject the purchasers to criminal penalties under section
          1001 of title 18, which notice specifies the maximum fine and
          term of imprisonment under such section.
            (vi) The seller maintains each entry in the logbook for not
          fewer than two years after the date on which the entry is
          made.
            (vii) In the case of individuals who are responsible for
          delivering such products into the custody of purchasers or
          who deal directly with purchasers by obtaining payments for
          the products, the seller has submitted to the Attorney
          General a self-certification that all such individuals have,
          in accordance with criteria under subparagraph (B)(ii),
          undergone training provided by the seller to ensure that the
          individuals understand the requirements that apply under this
          subsection and subsection (d).
            (viii) The seller maintains a copy of such certification
          and records demonstrating that individuals referred to in
          clause (vii) have undergone the training.
            (ix) If the seller is a mobile retail vendor:
              (I) The seller complies with clause (i) by placing the
            product in a locked cabinet.
              (II) The seller does not sell more than 7.5 grams of
            ephedrine base, pseudoephedrine base, or
            phenylpropanolamine base in such products per customer
            during a 30-day period.
        (B) Additional provisions regarding certifications and training
          (i) In general
            A regulated seller may not sell any scheduled listed
          chemical product at retail unless the seller has submitted to
          the Attorney General the self-certification referred to in
          subparagraph (A)(vii). The certification is not effective for
          purposes of the preceding sentence unless, in addition to
          provisions regarding the training of individuals referred to
          in such subparagraph, the certification includes a statement
          that the seller understands each of the requirements that
          apply under this paragraph and under subsection (d) and
          agrees to comply with the requirements.
          (ii) Issuance of criteria; self-certification
            The Attorney General shall by regulation establish criteria
          for certifications under this paragraph. The criteria shall -
          
              (I) provide that the certifications are self-
            certifications provided through the program under clause
            (iii);
              (II) provide that a separate certification is required
            for each place of business at which a regulated seller
            sells scheduled listed chemical products at retail; and
              (III) include criteria for training under subparagraph
            (A)(vii).
          (iii) Program for regulated sellers
            The Attorney General shall establish a program regarding
          such certifications and training in accordance with the
          following:
              (I) The program shall be carried out through an Internet
            site of the Department of Justice and such other means as
            the Attorney General determines to be appropriate.
              (II) The program shall inform regulated sellers that
            section 1001 of title 18 applies to such certifications.
              (III) The program shall make available to such sellers an
            explanation of the criteria under clause (ii).
              (IV) The program shall be designed to permit the
            submission of the certifications through such Internet
            site.
              (V) The program shall be designed to automatically
            provide the explanation referred to in subclause (III), and
            an acknowledgement that the Department has received a
            certification, without requiring direct interactions of
            regulated sellers with staff of the Department (other than
            the provision of technical assistance, as appropriate).
          (iv) Availability of certification to State and local
            officials
            Promptly after receiving a certification under subparagraph
          (A)(vii), the Attorney General shall make available a copy of
          the certification to the appropriate State and local
          officials.
        (C) Privacy protections
          In order to protect the privacy of individuals who purchase
        scheduled listed chemical products, the Attorney General shall
        by regulation establish restrictions on disclosure of
        information in logbooks under subparagraph (A)(iii). Such
        regulations shall - 
            (i) provide for the disclosure of the information as
          appropriate to the Attorney General and to State and local
          law enforcement agencies; and
            (ii) prohibit accessing, using, or sharing information in
          the logbooks for any purpose other than to ensure compliance
          with this subchapter or to facilitate a product recall to
          protect public health and safety.
        (D) False statements or misrepresentations by purchasers
          For purposes of section 1001 of title 18, entering
        information in the logbook under subparagraph (A)(iii) shall be
        considered a matter within the jurisdiction of the executive,
        legislative, or judicial branch of the Government of the United
        States.
        (E) Good faith protection
          A regulated seller who in good faith releases information in
        a logbook under subparagraph (A)(iii) to Federal, State, or
        local law enforcement authorities is immune from civil
        liability for such release unless the release constitutes gross
        negligence or intentional, wanton, or willful misconduct.
        (F) Inapplicability of requirements to certain sales
          Subparagraph (A) does not apply to the sale at retail of a
        scheduled listed chemical product if a report on the sales
        transaction is required to be submitted to the Attorney General
        under subsection (b)(3).
        (G) Certain measures regarding theft and diversion
          A regulated seller may take reasonable measures to guard
        against employing individuals who may present a risk with
        respect to the theft and diversion of scheduled listed chemical
        products, which may include, notwithstanding State law, asking
        applicants for employment whether they have been convicted of
        any crime involving or related to such products or controlled
        substances.
      (2) Mail-order reporting; verification of identity of purchaser;
        30-day restriction on quantities for individual purchasers
        Each regulated person who makes a sale at retail of a scheduled
      listed chemical product and is required under subsection (b)(3)
      to submit a report of the sales transaction to the Attorney
      General is subject to the following:
          (A) The person shall, prior to shipping the product, confirm
        the identity of the purchaser in accordance with procedures
        established by the Attorney General. The Attorney General shall
        by regulation establish such procedures.
          (B) The person may not sell more than 7.5 grams of ephedrine
        base, pseudoephedrine base, or phenylpropanolamine base in such
        products per customer during a 30-day period.
      (3) Exemptions for certain products
        Upon the application of a manufacturer of a scheduled listed
      chemical product, the Attorney General may by regulation provide
      that the product is exempt from the provisions of subsection (d)
      and paragraphs (1) and (2) of this subsection if the Attorney
      General determines that the product cannot be used in the illicit
      manufacture of methamphetamine.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 310, as added Pub. L. 95-633, title
    II, Sec. 202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100-
    690, title VI, Sec. 6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub.
    L. 103-200, Secs. 2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341;
    Pub. L. 104-237, title II, Sec. 208, title IV, Sec. 402, Oct. 3,
    1996, 110 Stat. 3104, 3111; Pub. L. 106-310, div. B, title XXXVI,
    Sec. 3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109-177, title
    VII, Secs. 711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar.
    9, 2006, 120 Stat. 257, 261, 267.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Food, Drug, and Cosmetic Act, referred to in subsec.
    (b)(3)(A)(i), probably means the Federal Food, Drug, and Cosmetic
    Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
    is classified generally to chapter 9 (Sec. 301 et seq.) of this
    title. For complete classification of this Act to the Code, see
    section 301 of this title and Tables.
      This subchapter, referred to in subsecs. (b)(3)(D)(vi), (E) and
    (e)(1)(C)(ii), was in the original "this title", meaning title II
    of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended, and is
    popularly known as the "Controlled Substances Act". For complete
    classification of title II to the Code, see second paragraph of
    Short Title note set out under section 801 of this title and
    Tables.
      Subchapter II of this chapter, referred to in subsecs.
    (b)(3)(D)(iv), (E) and (c)(2)(A), (B), was in the original "title
    III", meaning title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
    1285, as amended. Part A of title III comprises subchapter II of
    this chapter. For classification of Part B, consisting of sections
    1101 to 1105 of title III, see Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (b)(3)(D)(ii). Pub. L. 109-177, Sec. 711(c)(2),
    inserted ", except that this clause does not apply to sales of
    scheduled listed chemical products at retail" before period at end.
      Pub. L. 109-177, Sec. 711(a)(2)(B), substituted "section 802(49)"
    for "section 802(46)".
      Subsec. (b)(3)(D)(v). Pub. L. 109-177, Sec. 716(b)(2),
    substituted "section 971(f)(2)" for "section 971(e)(2)".
      Subsec. (d). Pub. L. 109-177, Sec. 711(b)(1), added subsec. (d).
      Subsec. (e)(1). Pub. L. 109-177, Sec. 711(b)(1), added subsec.
    heading and par. (1).
      Subsec. (e)(2). Pub. L. 109-177, Sec. 711(c)(1), added par. (2).
      Subsec. (e)(3). Pub. L. 109-177, Sec. 711(d), added par. (3).
      2000 - Subsec. (b)(3). Pub. L. 106-310 added subpars. (A), (D),
    and (E), redesignated former subpars. (A) and (B) as (B) and (C),
    respectively, and inserted "or who engages in an export
    transaction" after "nonregulated person" in introductory provisions
    of subpar. (B).
      1996 - Subsec. (a)(1). Pub. L. 104-237, Sec. 208, substituted
    "for two years after the date of the transaction." for the dash
    after "record of the transaction" and struck out subpars. (A) and
    (B) which read as follows:
      "(A) for 4 years after the date of the transaction, if the listed
    chemical is a list I chemical or if the transaction involves a
    tableting machine or an encapsulating machine; and
      "(B) for 2 years after the date of the transaction, if the listed
    chemical is a list II chemical."
      Subsec. (b)(3). Pub. L. 104-237, Sec. 402, added par. (3).
      1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 2(c)(1), substituted
    "list I chemical" for "precursor chemical" in subpar. (A) and "a
    list II chemical" for "an essential chemical" in subpar. (B).
      Subsec. (b). Pub. L. 103-200, Sec. 10, designated existing
    provisions as par. (1), redesignated former pars. (1) to (4) as
    subpars. (A) to (D), respectively, in concluding provisions,
    substituted "subparagraph (A)" for "paragraph (1)" in two places,
    "subparagraph (B)" for "paragraph (2)", and "subparagraph (C)" for
    "paragraph (3)", and added par. (2).
      Subsec. (c)(2)(D). Pub. L. 103-200, Sec. 2(c)(2), substituted
    "chemical control laws" for "precursor chemical laws".
      1988 - Pub. L. 100-690 amended section generally, substituting
    provisions relating to regulation of listed chemicals and certain
    machines for provisions relating to reporting by any person who
    distributes, sells, or imports any piperidine.

                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Pub. L. 109-177, title VII, Sec. 711(b)(2), Mar. 9, 2006, 120
    Stat. 261, provided that: "With respect to subsections (d) and
    (e)(1) of section 310 of the Controlled Substances Act [21 U.S.C.
    830(d), (e)(1)], as added by paragraph (1) of this subsection:
        "(A) Such subsection (d) applies on and after the expiration of
      the 30-day period beginning on the date of the enactment of this
      Act [Mar. 9, 2006].
        "(B) Such subsection (e)(1) applies on and after September 30,
      2006."
      Pub. L. 109-177, title VII, Sec. 711(c)(3), Mar. 9, 2006, 120
    Stat. 261, provided that: "The amendments made by paragraphs (1)
    and (2) [amending this section] apply on and after the expiration
    of the 30-day period beginning on the date of the enactment of this
    Act [Mar. 9, 2006]."

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
    1988, see section 6061 of Pub. L. 100-690, set out as a note under
    section 802 of this title.

        EFFECTIVE DATE; TIME TO SUBMIT PIPERIDINE REPORT; REQUIRED
                                INFORMATION
      Section 203(a) of title II of Pub. L. 95-633 provided that:
      "(1) Except as provided under paragraph (2), the amendments made
    by this title [enacting this section and amending sections 841 to
    843 of this title] shall take effect on the date of the enactment
    of this Act [Nov. 10, 1978].
      "(2) Any person required to submit a report under section
    310(a)(1) of the Controlled Substances Act [subsec. (a)(1) of this
    section] respecting a distribution, sale, or importation of
    piperidine during the 90 days after the date of the enactment of
    this Act [Nov. 10, 1978] may submit such report any time up to 97
    days after such date of enactment.
      "(3) Until otherwise provided by the Attorney General by
    regulation, the information required to be reported by a person
    under section 310(a)(1) of the Controlled Substances Act (as added
    by section 202(a)(2) of this title) [subsec. (a)(1) of this
    section] with respect to the person's distribution, sale, or
    importation of piperidine shall - 
        "(A) be the information described in subparagraphs (A) and (B)
      of such section, and
        "(B) except as provided in paragraph (2) of this subsection, be
      reported not later than seven days after the date of such
      distribution, sale, or importation."

                                  REPEALS                              
      Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
    repealed section 203(d) of Pub. L. 95-633, which had provided for
    the repeal of this section effective Jan. 1, 1981.

                   REGULATIONS FOR PIPERIDINE REPORTING               
      Section 203(b) of Pub. L. 95-633 required the Attorney General to
    publish proposed interim regulations for piperidine reporting under
    section 830(a) of this title not later than 30 days after
    enactment, and final interim regulations not later than 75 days
    after enactment, such final interim regulations to be effective on
    and after the ninety-first day after enactment.

     REPORT TO PRESIDENT AND CONGRESS ON EFFECTIVENESS OF TITLE II OF
                              PUB. L. 95-633
      Section 203(c) of Pub. L. 95-633 required the Attorney General to
    analyze and evaluate the impact and effectiveness of the amendments
    made by title II of Pub. L. 95-633, and report to the President and
    Congress not later than Mar. 1, 1980.

-End-


-CITE-
    21 USC Part D - Offenses and Penalties                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
                      PART D - OFFENSES AND PENALTIES                  

-End-



-CITE-
    21 USC Sec. 841                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 841. Prohibited acts A

-STATUTE-
    (a) Unlawful acts
      Except as authorized by this subchapter, it shall be unlawful for
    any person knowingly or intentionally - 
        (1) to manufacture, distribute, or dispense, or possess with
      intent to manufacture, distribute, or dispense, a controlled
      substance; or
        (2) to create, distribute, or dispense, or possess with intent
      to distribute or dispense, a counterfeit substance.
    (b) Penalties
      Except as otherwise provided in section 849, 859, 860, or 861 of
    this title, any person who violates subsection (a) of this section
    shall be sentenced as follows:
      (1)(A) In the case of a violation of subsection (a) of this
    section involving - 
        (i) 1 kilogram or more of a mixture or substance containing a
      detectable amount of heroin;
        (ii) 5 kilograms or more of a mixture or substance containing a
      detectable amount of - 
          (I) coca leaves, except coca leaves and extracts of coca
        leaves from which cocaine, ecgonine, and derivatives of
        ecgonine or their salts have been removed;
          (II) cocaine, its salts, optical and geometric isomers, and
        salts of isomers;
          (III) ecgonine, its derivatives, their salts, isomers, and
        salts of isomers; or
          (IV) any compound, mixture, or preparation which contains any
        quantity of any of the substances referred to in subclauses (I)
        through (III);

        (iii) 50 grams or more of a mixture or substance described in
      clause (ii) which contains cocaine base;
        (iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or
      more of a mixture or substance containing a detectable amount of
      phencyclidine (PCP);
        (v) 10 grams or more of a mixture or substance containing a
      detectable amount of lysergic acid diethylamide (LSD);
        (vi) 400 grams or more of a mixture or substance containing a
      detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-
      piperidinyl ] propanamide or 100 grams or more of a mixture or
      substance containing a detectable amount of any analogue of N-
      phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
        (vii) 1000 kilograms or more of a mixture or substance
      containing a detectable amount of marihuana, or 1,000 or more
      marihuana plants regardless of weight; or
        (viii) 50 grams or more of methamphetamine, its salts, isomers,
      and salts of its isomers or 500 grams or more of a mixture or
      substance containing a detectable amount of methamphetamine, its
      salts, isomers, or salts of its isomers;

    such person shall be sentenced to a term of imprisonment which may
    not be less than 10 years or more than life and if death or serious
    bodily injury results from the use of such substance shall be not
    less than 20 years or more than life, a fine not to exceed the
    greater of that authorized in accordance with the provisions of
    title 18 or $4,000,000 if the defendant is an individual or
    $10,000,000 if the defendant is other than an individual, or both.
    If any person commits such a violation after a prior conviction for
    a felony drug offense has become final, such person shall be
    sentenced to a term of imprisonment which may not be less than 20
    years and not more than life imprisonment and if death or serious
    bodily injury results from the use of such substance shall be
    sentenced to life imprisonment, a fine not to exceed the greater of
    twice that authorized in accordance with the provisions of title 18
    or $8,000,000 if the defendant is an individual or $20,000,000 if
    the defendant is other than an individual, or both. If any person
    commits a violation of this subparagraph or of section 849, 859,
    860, or 861 of this title after two or more prior convictions for a
    felony drug offense have become final, such person shall be
    sentenced to a mandatory term of life imprisonment without release
    and fined in accordance with the preceding sentence.
    Notwithstanding section 3583 of title 18, any sentence under this
    subparagraph shall, in the absence of such a prior conviction,
    impose a term of supervised release of at least 5 years in addition
    to such term of imprisonment and shall, if there was such a prior
    conviction, impose a term of supervised release of at least 10
    years in addition to such term of imprisonment. Notwithstanding any
    other provision of law, the court shall not place on probation or
    suspend the sentence of any person sentenced under this
    subparagraph. No person sentenced under this subparagraph shall be
    eligible for parole during the term of imprisonment imposed
    therein.
      (B) In the case of a violation of subsection (a) of this section
    involving - 
        (i) 100 grams or more of a mixture or substance containing a
      detectable amount of heroin;
        (ii) 500 grams or more of a mixture or substance containing a
      detectable amount of - 
          (I) coca leaves, except coca leaves and extracts of coca
        leaves from which cocaine, ecgonine, and derivatives of
        ecgonine or their salts have been removed;
          (II) cocaine, its salts, optical and geometric isomers, and
        salts of isomers;
          (III) ecgonine, its derivatives, their salts, isomers, and
        salts of isomers; or
          (IV) any compound, mixture, or preparation which contains any
        quantity of any of the substances referred to in subclauses (I)
        through (III);

        (iii) 5 grams or more of a mixture or substance described in
      clause (ii) which contains cocaine base;
        (iv) 10 grams or more of phencyclidine (PCP) or 100 grams or
      more of a mixture or substance containing a detectable amount of
      phencyclidine (PCP);
        (v) 1 gram or more of a mixture or substance containing a
      detectable amount of lysergic acid diethylamide (LSD);
        (vi) 40 grams or more of a mixture or substance containing a
      detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-
      piperidinyl ] propanamide or 10 grams or more of a mixture or
      substance containing a detectable amount of any analogue of N-
      phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
        (vii) 100 kilograms or more of a mixture or substance
      containing a detectable amount of marihuana, or 100 or more
      marihuana plants regardless of weight; or
        (viii) 5 grams or more of methamphetamine, its salts, isomers,
      and salts of its isomers or 50 grams or more of a mixture or
      substance containing a detectable amount of methamphetamine, its
      salts, isomers, or salts of its isomers;

    such person shall be sentenced to a term of imprisonment which may
    not be less than 5 years and not more than 40 years and if death or
    serious bodily injury results from the use of such substance shall
    be not less than 20 years or more than life, a fine not to exceed
    the greater of that authorized in accordance with the provisions of
    title 18 or $2,000,000 if the defendant is an individual or
    $5,000,000 if the defendant is other than an individual, or both.
    If any person commits such a violation after a prior conviction for
    a felony drug offense has become final, such person shall be
    sentenced to a term of imprisonment which may not be less than 10
    years and not more than life imprisonment and if death or serious
    bodily injury results from the use of such substance shall be
    sentenced to life imprisonment, a fine not to exceed the greater of
    twice that authorized in accordance with the provisions of title 18
    or $4,000,000 if the defendant is an individual or $10,000,000 if
    the defendant is other than an individual, or both. Notwithstanding
    section 3583 of title 18, any sentence imposed under this
    subparagraph shall, in the absence of such a prior conviction,
    include a term of supervised release of at least 4 years in
    addition to such term of imprisonment and shall, if there was such
    a prior conviction, include a term of supervised release of at
    least 8 years in addition to such term of imprisonment.
    Notwithstanding any other provision of law, the court shall not
    place on probation or suspend the sentence of any person sentenced
    under this subparagraph. No person sentenced under this
    subparagraph shall be eligible for parole during the term of
    imprisonment imposed therein.
      (C) In the case of a controlled substance in schedule I or II,
    gamma hydroxybutyric acid (including when scheduled as an approved
    drug product for purposes of section 3(a)(1)(B) of the Hillory J.
    Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000),
    or 1 gram of flunitrazepam, except as provided in subparagraphs
    (A), (B), and (D), such person shall be sentenced to a term of
    imprisonment of not more than 20 years and if death or serious
    bodily injury results from the use of such substance shall be
    sentenced to a term of imprisonment of not less than twenty years
    or more than life, a fine not to exceed the greater of that
    authorized in accordance with the provisions of title 18 or
    $1,000,000 if the defendant is an individual or $5,000,000 if the
    defendant is other than an individual, or both. If any person
    commits such a violation after a prior conviction for a felony drug
    offense has become final, such person shall be sentenced to a term
    of imprisonment of not more than 30 years and if death or serious
    bodily injury results from the use of such substance shall be
    sentenced to life imprisonment, a fine not to exceed the greater of
    twice that authorized in accordance with the provisions of title 18
    or $2,000,000 if the defendant is an individual or $10,000,000 if
    the defendant is other than an individual, or both. Notwithstanding
    section 3583 of title 18, any sentence imposing a term of
    imprisonment under this paragraph shall, in the absence of such a
    prior conviction, impose a term of supervised release of at least 3
    years in addition to such term of imprisonment and shall, if there
    was such a prior conviction, impose a term of supervised release of
    at least 6 years in addition to such term of imprisonment.
    Notwithstanding any other provision of law, the court shall not
    place on probation or suspend the sentence of any person sentenced
    under the provisions of this subparagraph which provide for a
    mandatory term of imprisonment if death or serious bodily injury
    results, nor shall a person so sentenced be eligible for parole
    during the term of such a sentence.
      (D) In the case of less than 50 kilograms of marihuana, except in
    the case of 50 or more marihuana plants regardless of weight, 10
    kilograms of hashish, or one kilogram of hashish oil or in the case
    of any controlled substance in schedule III (other than gamma
    hydroxybutyric acid), or 30 milligrams of flunitrazepam, such
    person shall, except as provided in paragraphs (4) and (5) of this
    subsection, be sentenced to a term of imprisonment of not more than
    5 years, a fine not to exceed the greater of that authorized in
    accordance with the provisions of title 18 or $250,000 if the
    defendant is an individual or $1,000,000 if the defendant is other
    than an individual, or both. If any person commits such a violation
    after a prior conviction for a felony drug offense has become
    final, such person shall be sentenced to a term of imprisonment of
    not more than 10 years, a fine not to exceed the greater of twice
    that authorized in accordance with the provisions of title 18 or
    $500,000 if the defendant is an individual or $2,000,000 if the
    defendant is other than an individual, or both. Notwithstanding
    section 3583 of title 18, any sentence imposing a term of
    imprisonment under this paragraph shall, in the absence of such a
    prior conviction, impose a term of supervised release of at least 2
    years in addition to such term of imprisonment and shall, if there
    was such a prior conviction, impose a term of supervised release of
    at least 4 years in addition to such term of imprisonment.
      (2) In the case of a controlled substance in schedule IV, such
    person shall be sentenced to a term of imprisonment of not more
    than 3 years, a fine not to exceed the greater of that authorized
    in accordance with the provisions of title 18 or $250,000 if the
    defendant is an individual or $1,000,000 if the defendant is other
    than an individual, or both. If any person commits such a violation
    after one or more prior convictions of him for an offense
    punishable under this paragraph, or for a felony under any other
    provision of this subchapter or subchapter II of this chapter or
    other law of a State, the United States, or a foreign country
    relating to narcotic drugs, marihuana, or depressant or stimulant
    substances, have become final, such person shall be sentenced to a
    term of imprisonment of not more than 6 years, a fine not to exceed
    the greater of twice that authorized in accordance with the
    provisions of title 18 or $500,000 if the defendant is an
    individual or $2,000,000 if the defendant is other than an
    individual, or both. Any sentence imposing a term of imprisonment
    under this paragraph shall, in the absence of such a prior
    conviction, impose a term of supervised release of at least one
    year in addition to such term of imprisonment and shall, if there
    was such a prior conviction, impose a term of supervised release of
    at least 2 years in addition to such term of imprisonment.
      (3) In the case of a controlled substance in schedule V, such
    person shall be sentenced to a term of imprisonment of not more
    than one year, a fine not to exceed the greater of that authorized
    in accordance with the provisions of title 18 or $100,000 if the
    defendant is an individual or $250,000 if the defendant is other
    than an individual, or both. If any person commits such a violation
    after one or more convictions of him for an offense punishable
    under this paragraph, or for a crime under any other provision of
    this subchapter or subchapter II of this chapter or other law of a
    State, the United States, or a foreign country relating to narcotic
    drugs, marihuana, or depressant or stimulant substances, have
    become final, such person shall be sentenced to a term of
    imprisonment of not more than 2 years, a fine not to exceed the
    greater of twice that authorized in accordance with the provisions
    of title 18 or $200,000 if the defendant is an individual or
    $500,000 if the defendant is other than an individual, or both.
      (4) Notwithstanding paragraph (1)(D) of this subsection, any
    person who violates subsection (a) of this section by distributing
    a small amount of marihuana for no remuneration shall be treated as
    provided in section 844 of this title and section 3607 of title 18.
      (5) Any person who violates subsection (a) of this section by
    cultivating or manufacturing a controlled substance on Federal
    property shall be imprisoned as provided in this subsection and
    shall be fined any amount not to exceed - 
        (A) the amount authorized in accordance with this section;
        (B) the amount authorized in accordance with the provisions of
      title 18;
        (C) $500,000 if the defendant is an individual; or
        (D) $1,000,000 if the defendant is other than an individual;

    or both.
      (6) Any person who violates subsection (a) of this section, or
    attempts to do so, and knowingly or intentionally uses a poison,
    chemical, or other hazardous substance on Federal land, and, by
    such use - 
        (A) creates a serious hazard to humans, wildlife, or domestic
      animals,
        (B) degrades or harms the environment or natural resources, or
        (C) pollutes an aquifer, spring, stream, river, or body of
      water,

    shall be fined in accordance with title 18 or imprisoned not more
    than five years, or both.
      (7) Penalties for distribution. - 
        (A) In general. - Whoever, with intent to commit a crime of
      violence, as defined in section 16 of title 18 (including rape),
      against an individual, violates subsection (a) of this section by
      distributing a controlled substance or controlled substance
      analogue to that individual without that individual's knowledge,
      shall be imprisoned not more than 20 years and fined in
      accordance with title 18.
        (B) Definition. - For purposes of this paragraph, the term
      "without that individual's knowledge" means that the individual
      is unaware that a substance with the ability to alter that
      individual's ability to appraise conduct or to decline
      participation in or communicate unwillingness to participate in
      conduct is administered to the individual.
    (c) Offenses involving listed chemicals
      Any person who knowingly or intentionally - 
        (1) possesses a listed chemical with intent to manufacture a
      controlled substance except as authorized by this subchapter;
        (2) possesses or distributes a listed chemical knowing, or
      having reasonable cause to believe, that the listed chemical will
      be used to manufacture a controlled substance except as
      authorized by this subchapter; or
        (3) with the intent of causing the evasion of the recordkeeping
      or reporting requirements of section 830 of this title, or the
      regulations issued under that section, receives or distributes a
      reportable amount of any listed chemical in units small enough so
      that the making of records or filing of reports under that
      section is not required;

    shall be fined in accordance with title 18 or imprisoned not more
    than 20 years in the case of a violation of paragraph (1) or (2)
    involving a list I chemical or not more than 10 years in the case
    of a violation of this subsection other than a violation of
    paragraph (1) or (2) involving a list I chemical, or both.
    (d) Boobytraps on Federal property; penalties; "boobytrap" defined
      (1) Any person who assembles, maintains, places, or causes to be
    placed a boobytrap on Federal property where a controlled substance
    is being manufactured, distributed, or dispensed shall be sentenced
    to a term of imprisonment for not more than 10 years or fined under
    title 18, or both.
      (2) If any person commits such a violation after 1 or more prior
    convictions for an offense punishable under this subsection, such
    person shall be sentenced to a term of imprisonment of not more
    than 20 years or fined under title 18, or both.
      (3) For the purposes of this subsection, the term "boobytrap"
    means any concealed or camouflaged device designed to cause bodily
    injury when triggered by any action of any unsuspecting person
    making contact with the device. Such term includes guns,
    ammunition, or explosive devices attached to trip wires or other
    triggering mechanisms, sharpened stakes, and lines or wires with
    hooks attached.
    (e) Ten-year injunction as additional penalty
      In addition to any other applicable penalty, any person convicted
    of a felony violation of this section relating to the receipt,
    distribution, manufacture, exportation, or importation of a listed
    chemical may be enjoined from engaging in any transaction involving
    a listed chemical for not more than ten years.
    (f) Wrongful distribution or possession of listed chemicals
      (1) Whoever knowingly distributes a listed chemical in violation
    of this subchapter (other than in violation of a recordkeeping or
    reporting requirement of section 830 of this title) shall, except
    to the extent that paragraph (12), (13), or (14) of section 842(a)
    of this title applies, be fined under title 18 or imprisoned not
    more than 5 years, or both.
      (2) Whoever possesses any listed chemical, with knowledge that
    the recordkeeping or reporting requirements of section 830 of this
    title have not been adhered to, if, after such knowledge is
    acquired, such person does not take immediate steps to remedy the
    violation shall be fined under title 18 or imprisoned not more than
    one year, or both.
    (g) Internet sales of date rape drugs
      (1) Whoever knowingly uses the Internet to distribute a date rape
    drug to any person, knowing or with reasonable cause to believe
    that - 
        (A) the drug would be used in the commission of criminal sexual
      conduct; or
        (B) the person is not an authorized purchaser;

    shall be fined under this subchapter or imprisoned not more than 20
    years, or both.
      (2) As used in this subsection:
        (A) The term "date rape drug" means - 
          (i) gamma hydroxybutyric acid (GHB) or any controlled
        substance analogue of GHB, including gamma butyrolactone (GBL)
        or 1,4-butanediol;
          (ii) ketamine;
          (iii) flunitrazepam; or
          (iv) any substance which the Attorney General designates,
        pursuant to the rulemaking procedures prescribed by section 553
        of title 5, to be used in committing rape or sexual assault.

      The Attorney General is authorized to remove any substance from
      the list of date rape drugs pursuant to the same rulemaking
      authority.
        (B) The term "authorized purchaser" means any of the following
      persons, provided such person has acquired the controlled
      substance in accordance with this chapter:
          (i) A person with a valid prescription that is issued for a
        legitimate medical purpose in the usual course of professional
        practice that is based upon a qualifying medical relationship
        by a practitioner registered by the Attorney General. A
        "qualifying medical relationship" means a medical relationship
        that exists when the practitioner has conducted at least 1
        medical evaluation with the authorized purchaser in the
        physical presence of the practitioner, without regard to
        whether portions of the evaluation are conducted by other heath
        (!1) professionals. The preceding sentence shall not be
        construed to imply that 1 medical evaluation demonstrates that
        a prescription has been issued for a legitimate medical purpose
        within the usual course of professional practice.

          (ii) Any practitioner or other registrant who is otherwise
        authorized by their registration to dispense, procure,
        purchase, manufacture, transfer, distribute, import, or export
        the substance under this chapter.
          (iii) A person or entity providing documentation that
        establishes the name, address, and business of the person or
        entity and which provides a legitimate purpose for using any
        "date rape drug" for which a prescription is not required.

      (3) The Attorney General is authorized to promulgate regulations
    for record-keeping and reporting by persons handling 1,4-butanediol
    in order to implement and enforce the provisions of this section.
    Any record or report required by such regulations shall be
    considered a record or report required under this chapter.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 401, Oct. 27, 1970, 84 Stat. 1260;
    Pub. L. 95-633, title II, Sec. 201, Nov. 10, 1978, 92 Stat. 3774;
    Pub. L. 96-359, Sec. 8(c), Sept. 26, 1980, 94 Stat. 1194; Pub. L.
    98-473, title II, Secs. 224(a), 502, 503(b)(1), (2), Oct. 12, 1984,
    98 Stat. 2030, 2068, 2070; Pub. L. 99-570, title I, Secs. 1002,
    1003(a), 1004(a), 1005(a), 1103, title XV, Sec. 15005, Oct. 27,
    1986, 100 Stat. 3207-2, 3207-5, 3207-6, 3207-11, 3702-192; Pub. L.
    100-690, title VI, Secs. 6055, 6254(h), 6452(a), 6470(g), (h),
    6479, Nov. 18, 1988, 102 Stat. 4318, 4367, 4371, 4378, 4381; Pub.
    L. 101-647, title X, Sec. 1002(e), title XII, Sec. 1202, title
    XXXV, Sec. 3599K, Nov. 29, 1990, 104 Stat. 4828, 4830, 4932; Pub.
    L. 103-322, title IX, Sec. 90105(a), (c), title XVIII, Sec.
    180201(b)(2)(A), Sept. 13, 1994, 108 Stat. 1987, 1988, 2047; Pub.
    L. 104-237, title II, Sec. 206(a), title III, Sec. 302(a), Oct. 3,
    1996, 110 Stat. 3103, 3105; Pub. L. 104-305, Sec. 2(a), (b)(1),
    Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105-277, div. E, Sec. 2(a),
    Oct. 21, 1998, 112 Stat. 2681-759; Pub. L. 106-172, Secs. 3(b)(1),
    5(b), 9, Feb. 18, 2000, 114 Stat. 9, 10, 13; Pub. L. 107-273, div.
    B, title III, Sec. 3005(a), title IV, Sec. 4002(d)(2)(A), Nov. 2,
    2002, 116 Stat. 1805, 1809; Pub. L. 109-177, title VII, Secs.
    711(f)(1)(B), 732, Mar. 9, 2006, 120 Stat. 262, 270; Pub. L. 109-
    248, title II, Sec. 201, July 27, 2006, 120 Stat. 611.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in subsecs. (a), (b)(1) to (3),
    (c)(1), (2), (f)(1), and (g)(1), was in the original "this title",
    meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242,
    as amended, and is popularly known as the "Controlled Substances
    Act". For complete classification of title II to the Code, see
    second paragraph of Short Title note set out under section 801 of
    this title and Tables.
      Schedules I, II, III, IV, and V, referred to in subsec. (b), are
    set out in section 812(c) of this title.
      Subchapter II of this chapter, referred to in subsec. (b)(1) to
    (3), was in the original "title III", meaning title III of Pub. L.
    91-513, Oct. 27, 1970, 84 Stat. 1285, as amended. Part A of title
    III comprises subchapter II of this chapter. For classification of
    Part B, consisting of sections 1101 to 1105 of title III, see
    Tables.
      Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid
    Date-Rape Prohibition Act of 2000, referred to in subsec.
    (b)(1)(C), is section 3(a)(1)(B) of Pub. L. 106-172, which is set
    out in a note under section 812 of this title.
      This chapter, referred to in subsec. (g)(2)(B), (3), was in the
    original "this Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84
    Stat. 1236. For complete classification of this Act to the Code,
    see Short Title note set out under section 801 of this title and
    Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (b)(5). Pub. L. 109-177, Sec. 732, inserted "or
    manufacturing" after "cultivating" in introductory provisions.
      Subsec. (f)(1). Pub. L. 109-177, Sec. 711(f)(1)(B), inserted ",
    except to the extent that paragraph (12), (13), or (14) of section
    842(a) of this title applies," after "shall".
      Subsec. (g). Pub. L. 109-248 added subsec. (g).
      2002 - Subsec. (b)(1)(A), (B). Pub. L. 107-273, Sec. 3005(a),
    substituted "Notwithstanding section 3583 of title 18, any
    sentence" for "Any sentence" in concluding provisions.
      Subsec. (b)(1)(C), (D). Pub. L. 107-273, Sec. 3005(a),
    substituted "Notwithstanding section 3583 of title 18, any
    sentence" for "Any sentence".
      Subsec. (d)(1). Pub. L. 107-273, Sec. 4002(d)(2)(A)(i),
    substituted "or fined under title 18, or both" for "and shall be
    fined not more than $10,000".
      Subsec. (d)(2). Pub. L. 107-273, Sec. 4002(d)(2)(A)(ii),
    substituted "or fined under title 18, or both" for "and shall be
    fined not more than $20,000".
      2000 - Subsec. (b)(1)(C). Pub. L. 106-172, Sec. 3(b)(1)(A),
    inserted "gamma hydroxybutyric acid (including when scheduled as an
    approved drug product for purposes of section 3(a)(1)(B) of the
    Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act
    of 2000)," after "schedule I or II," in first sentence.
      Subsec. (b)(1)(D). Pub. L. 106-172, Sec. 3(b)(1)(B), substituted
    "(other than gamma hydroxybutyric acid), or 30" for ", or 30".
      Subsec. (b)(7)(A). Pub. L. 106-172, Sec. 5(b), inserted "or
    controlled substance analogue" after "distributing a controlled
    substance".
      Subsecs. (c) to (g). Pub. L. 106-172, Sec. 9, redesignated
    subsecs. (d) to (g) as (c) to (f), respectively.
      1998 - Subsec. (b)(1). Pub. L. 105-277 in subpar. (A)(viii)
    substituted "50 grams" and "500 grams" for "100 grams" and "1
    kilogram", respectively, and in subpar. (B)(viii) substituted "5
    grams" and "50 grams" for "10 grams" and "100 grams", respectively.
      1996 - Subsec. (b)(1)(C). Pub. L. 104-305, Sec. 2(b)(1)(A),
    inserted ", or 1 gram of flunitrazepam," after "schedule I or II".
      Subsec. (b)(1)(D). Pub. L. 104-305, Sec. 2(b)(1)(B), inserted "or
    30 milligrams of flunitrazepam," after "schedule III,".
      Subsec. (b)(7). Pub. L. 104-305, Sec. 2(a), added par. (7).
      Subsec. (d). Pub. L. 104-237, Sec. 302(a), in concluding
    provisions, substituted "not more than 20 years in the case of a
    violation of paragraph (1) or (2) involving a list I chemical or
    not more than 10 years in the case of a violation of this
    subsection other than a violation of paragraph (1) or (2) involving
    a list I chemical," for "not more than 10 years,".
      Subsec. (f). Pub. L. 104-237, Sec. 206(a), inserted "manufacture,
    exportation," after "distribution," and struck out "regulated"
    after "engaging in any".
      1994 - Subsec. (b). Pub. L. 103-322, Sec. 180201(b)(2)(A),
    inserted "849," before "859," in introductory provisions.
      Subsec. (b)(1)(A). Pub. L. 103-322, Secs. 90105(c),
    180201(b)(2)(A), in concluding provisions, inserted "849," before
    "859," and struck out "For purposes of this subparagraph, the term
    'felony drug offense' means an offense that is a felony under any
    provision of this subchapter or any other Federal law that
    prohibits or restricts conduct relating to narcotic drugs,
    marihuana, or depressant or stimulant substances or a felony under
    any law of a State or a foreign country that prohibits or restricts
    conduct relating to narcotic drugs, marihuana, or depressant or
    stimulant substances." before "Any sentence under this
    subparagraph".
      Subsec. (b)(1)(B). Pub. L. 103-322, Sec. 90105(a), in sentence in
    concluding provisions beginning "If any person commits",
    substituted "a prior conviction for a felony drug offense has
    become final" for "one or more prior convictions for an offense
    punishable under this paragraph, or for a felony under any other
    provision of this subchapter or subchapter II of this chapter or
    other law of a State, the United States, or a foreign country
    relating to narcotic drugs, marihuana, or depressant or stimulant
    substances, have become final".
      Subsec. (b)(1)(C). Pub. L. 103-322, Sec. 90105(a), in sentence
    beginning "If any person commits", substituted "a prior conviction
    for a felony drug offense has become final" for "one or more prior
    convictions for an offense punishable under this paragraph, or for
    a felony under any other provision of this subchapter or subchapter
    II of this chapter or other law of a State, the United States or a
    foreign country relating to narcotic drugs, marihuana, or
    depressant or stimulant substances, have become final".
      Subsec. (b)(1)(D). Pub. L. 103-322, Sec. 90105(a), in sentence
    beginning "If any person commits", substituted "a prior conviction
    for a felony drug offense has become final" for "one or more prior
    convictions of him for an offense punishable under this paragraph,
    or for a felony under any other provision of this subchapter or
    subchapter II of this chapter or other law of a State, the United
    States, or a foreign country relating to narcotic drugs, marihuana,
    or depressant or stimulant substances, have become final".
      1990 - Subsec. (b). Pub. L. 101-647, Sec. 1002(e)(1), substituted
    "section 859, 860, or 861" for "section 845, 845a, or 845b" in
    introductory provisions.
      Subsec. (b)(1)(A). Pub. L. 101-647, Sec. 1002(e)(1), substituted
    "section 859, 860, or 861" for "section 845, 845a, or 845b" in
    concluding provisions.
      Subsec. (b)(1)(A)(ii)(IV). Pub. L. 101-647, Sec. 3599K,
    substituted "any of the substances" for "any of the substance".
      Subsec. (b)(1)(A)(viii). Pub. L. 101-647, Sec. 1202, substituted
    "or 1 kilogram or more of a mixture or substance containing a
    detectable amount of methamphetamine" for "or 100 grams or more of
    a mixture or substance containing a detectable amount of
    methamphetamine".
      Subsec. (b)(1)(B)(ii)(IV). Pub. L. 101-647, Sec. 3599K,
    substituted "any of the substances" for "any of the substance".
      Subsec. (c). Pub. L. 101-647, Sec. 1002(e)(2), directed amendment
    of subsec. (c) by substituting "section 859, 860, or 861 of this
    title" for "section 845, 845a, or 845b of this title". Subsec. (c)
    was previously repealed by Pub. L. 98-473, Sec. 224(a)(2), as
    renumbered by Pub. L. 99-570, Sec. 1005(a), effective Nov. 1, 1987,
    and applicable only to offenses committed after the taking effect
    of such amendment. See 1984 Amendment note and Effective Date of
    1984 Amendment note below.
      1988 - Subsec. (b)(1)(A). Pub. L. 100-690, Secs. 6452(a),
    6470(g), 6479(1), inserted ", or 1,000 or more marihuana plants
    regardless of weight" in cl. (vii), added cl. (viii), substituted
    "a prior conviction for a felony drug offense has become final" for
    "one or more prior convictions for an offense punishable under this
    paragraph, or for a felony under any other provision of this
    subchapter or subchapter II of this chapter or other law of a
    State, the United States, or a foreign country relating to narcotic
    drugs, marihuana, or depressant or stimulant substances, have
    become final" in second sentence, and added provisions relating to
    sentencing for a person who violates this subpar. or section 485,
    485a, or 485b of this title after two or more prior convictions for
    a felony drug offense have become final and defining "felony drug
    offense".
      Subsec. (b)(1)(B). Pub. L. 100-690, Secs. 6470(h), 6479(2),
    inserted ", or 100 or more marihuana plants regardless of weight"
    in cl. (vii) and added cl. (viii).
      Subsec. (b)(1)(D). Pub. L. 100-690, Sec. 6479(3), substituted "50
    or more marihuana plants" for "100 or more marihuana plants".
      Subsec. (b)(6). Pub. L. 100-690, Sec. 6254(h), added par. (6).
      Subsec. (d). Pub. L. 100-690, Sec. 6055(a), amended subsec. (d)
    generally. Prior to amendment, subsec. (d) read as follows: "Any
    person who knowingly or intentionally - 
        "(1) possesses any piperidine with intent to manufacture
      phencyclidine except as authorized by this subchapter, or
        "(2) possesses any piperidine knowing, or having reasonable
      cause to believe, that the piperidine will be used to manufacture
      phencyclidine except as authorized by this subchapter,
    shall be sentenced to a term of imprisonment of not more than 5
    years, a fine not to exceed the greater of that authorized in
    accordance with the provisions of title 18 or $250,000 if the
    defendant is an individual or $1,000,000 if the defendant is other
    than an individual, or both."
      Subsecs. (f), (g). Pub. L. 100-690, Sec. 6055(b), added subsecs.
    (f) and (g).
      1986 - Pub. L. 99-570, Sec. 1005(a), amended Pub. L. 98-473, Sec.
    224(a). See 1984 Amendment note below.
      Subsec. (b). Pub. L. 99-570, Sec. 1103(a), substituted ", 845a,
    or 845b" for "or 845a" in introductory provisions.
      Subsec. (b)(1)(A). Pub. L. 99-570, Sec. 1002(2), amended subpar.
    (A) generally. Prior to amendment, subpar. (A) read as follows: "In
    the case of a violation of subsection (a) of this section involving
    - 
        "(i) 100 grams or more of a controlled substance in schedule I
      or II which is a mixture or substance containing a detectable
      amount of a narcotic drug other than a narcotic drug consisting
      of - 
          "(I) coca leaves;
          "(II) a compound, manufacture, salt, derivative, or
        preparation of coca leaves; or
          "(III) a substance chemically identical thereto;
        "(ii) a kilogram or more of any other controlled substance in
      schedule I or II which is a narcotic drug;
        "(iii) 500 grams or more of phencyclidine (PCP); or
        "(iv) 5 grams or more of lysergic acid diethylamide (LSD);
    such person shall be sentenced to a term of imprisonment of not
    more than 20 years, a fine of not more than $250,000, or both. If
    any person commits such a violation after one or more prior
    convictions of him for an offense punishable under this paragraph,
    or for a felony under any other provision of this subchapter or
    subchapter II of this chapter or other law of a State, the United
    States, or a foreign country relating to narcotic drugs, marihuana,
    or depressant or stimulant substances, have become final, such
    person shall be sentenced to a term of imprisonment of not more
    than 40 years, a fine of not more than $500,000, or both".
      Subsec. (b)(1)(B). Pub. L. 99-570, Sec. 1002(2), amended subpar.
    (B) generally. Prior to amendment, subpar. (B) read as follows: "In
    the case of a controlled substance in schedule I or II except as
    provided in subparagraphs (A) and (C),, such person shall be
    sentenced to a term of imprisonment of not more than 15 years, a
    fine of not more than $125,000, or both. If any person commits such
    a violation after one or more prior convictions of him for an
    offense punishable under this paragraph, or for a felony under any
    other provision of this subchapter or subchapter II of this chapter
    or other law of a State, the United States, or a foreign country
    relating to narcotic drugs, marihuana, or depressant or stimulant
    substances, have become final, such person shall be sentenced to a
    term of imprisonment of not more than 30 years, a fine of not more
    than $250,000, or both. Any sentence imposing a term of
    imprisonment under this paragraph shall, in the absence of such a
    prior conviction, impose a special parole term of at least 3 years
    in addition to such term of imprisonment and shall, if there was
    such a prior conviction, impose a special parole term of at least 6
    years in addition to such term of imprisonment."
      Subsec. (b)(1)(C). Pub. L. 99-570, Sec. 1002(2), added subpar.
    (C). Former subpar. (C) redesignated (D).
      Subsec. (b)(1)(D). Pub. L. 99-570, Sec. 1004(a), substituted
    "term of supervised release" for "special parole term" in two
    places.
      Pub. L. 99-570, Secs. 1002(1), 1003(a)(1), redesignated former
    subpar. (C) as (D), substituted "a fine not to exceed the greater
    of that authorized in accordance with the provisions of title 18 or
    $250,000 if the defendant is an individual or $1,000,000 if the
    defendant is other than an individual" for "a fine of not more than
    $50,000" and "a fine not to exceed the greater of twice that
    authorized in accordance with the provisions of title 18 or
    $500,000 if the defendant is an individual or $2,000,000 if the
    defendant is other than an individual" for "a fine of not more than
    $100,000", and inserted "except in the case of 100 or more
    marihuana plants regardless of weight,".
      Subsec. (b)(2). Pub. L. 99-570, Sec. 1004(a), substituted "term
    of supervised release" for "special parole term" in two places.
      Pub. L. 99-570, Sec. 1003(a)(2), substituted "a fine not to
    exceed the greater of that authorized in accordance with the
    provisions of title 18 or $250,000 if the defendant is an
    individual or $1,000,000 if the defendant is other than an
    individual" for "a fine of not more than $25,000" and "a fine not
    to exceed the greater of twice that authorized in accordance with
    the provisions of title 18 or $500,000 if the defendant is an
    individual or $2,000,000 if the defendant is other than an
    individual" for "a fine of not more than $50,000".
      Subsec. (b)(3). Pub. L. 99-570, Sec. 1003(a)(3), substituted "a
    fine not to exceed the greater of that authorized in accordance
    with the provisions of title 18 or $100,000 if the defendant is an
    individual or $250,000 if the defendant is other than an
    individual" for "a fine of not more than $10,000" and "a fine not
    to exceed the greater of twice that authorized in accordance with
    the provisions of title 18 or $200,000 if the defendant is an
    individual or $500,000 if the defendant is other than an
    individual" for "a fine of not more than $20,000".
      Subsec. (b)(4). Pub. L. 99-570, Sec. 1003(a)(4), which directed
    the substitution of "1(D)" for "1(C)" was executed by substituting
    "(1)(D)" for "(1)(C)" as the probable intent of Congress.
      Subsec. (b)(5). Pub. L. 99-570, Sec. 1003(a)(5), amended par. (5)
    generally. Prior to amendment, par. (5) read as follows:
    "Notwithstanding paragraph (1), any person who violates subsection
    (a) of this section by cultivating a controlled substance on
    Federal property shall be fined not more than - 
        "(A) $500,000 if such person is an individual; and
        "(B) $1,000,000 if such person is not an individual."
      Subsec. (c). Pub. L. 99-570, Sec. 1004(a), substituted "term of
    supervised release" for "special parole term" wherever appearing,
    effective Nov. 1, 1987, the effective date of the repeal of subsec.
    (c) by Pub. L. 98-473, Sec. 224(a)(2). See 1984 Amendment note
    below.
      Pub. L. 99-570, Sec. 1103(b), substituted ", 845a, or 845b" for
    "845a" in two places.
      Subsec. (d). Pub. L. 99-570, Sec. 1003(a)(6), substituted "a fine
    not to exceed the greater of that authorized in accordance with the
    provisions of title 18 or $250,000 if the defendant is an
    individual or $1,000,000 if the defendant is other than an
    individual" for "a fine of not more than $15,000".
      Subsec. (e). Pub. L. 99-570, Sec. 15005, added subsec. (e).
      1984 - Subsec. (b). Pub. L. 98-473, Sec. 503(b)(1), inserted
    reference to section 845a of this title in provisions preceding
    par. (1)(A).
      Pub. L. 98-473, Sec. 224(a)(1)-(3), (5), which directed amendment
    of this subsection effective Nov. 1, 1987 (see section 235(a)(1) of
    Pub. L. 98-473 set out as an Effective Date note under section 3551
    of Title 18, Crimes and Criminal Procedure) was repealed by Pub. L.
    99-570, Sec. 1005(a), and the remaining pars. (4) and (6) of Pub.
    L. 98-473, Sec. 224(a), were redesignated as pars. (1) and (2),
    respectively.
      Subsec. (b)(1)(A). Pub. L. 98-473, Sec. 502(1)(A), added subpar.
    (A). Former subpar. (A) redesignated (B).
      Subsec. (b)(1)(B). Pub. L. 98-473, Sec. 502(1)(A), (B),
    redesignated former subpar. (A) as (B), substituted "except as
    provided in subparagraphs (A) and (C)," for "which is a narcotic
    drug", "$125,000" for "$25,000", and "$250,000" for "$50,000", and
    inserted references to laws of a State and a foreign country.
    Former subpar. (B) redesignated (C).
      Subsec. (b)(1)(C). Pub. L. 98-473, Sec. 502(1)(A), (C),
    redesignated former subpar. (B) as (C), substituted "less than 50
    kilograms of marihuana, 10 kilograms of hashish, or one kilogram of
    hashish oil" for "a controlled substance in schedule I or II which
    is not a narcotic drug", "and (5)" for ", (5), and (6)", "$50,000"
    for "$15,000", and "$100,000" for "$30,000", and inserted
    references to laws of a State and a foreign country.
      Subsec. (b)(2). Pub. L. 98-473, Sec. 502(2), substituted
    "$25,000" for "$10,000" and "$50,000" for "$20,000", and inserted
    references to laws of a State or of a foreign country.
      Subsec. (b)(3). Pub. L. 98-473, Sec. 502(3), substituted
    "$10,000" for "$5,000" and "$20,000" for "$10,000", and inserted
    references to laws of a State or of a foreign country.
      Subsec. (b)(4). Pub. L. 98-473, Sec. 502(4), substituted "(1)(C)"
    for "(1)(B)".
      Pub. L. 98-473, Sec. 224(a)(1), as renumbered by Pub. L. 99-570,
    Sec. 1005(a), substituted "in section 844 of this title and section
    3607 of title 18" for "in subsections (a) and (b) of section 844 of
    this title".
      Subsec. (b)(5). Pub. L. 98-473, Sec. 502(5), (6), added par. (5)
    and struck out former par. (5) which related to penalties for
    manufacturing, etc., phencyclidine.
      Subsec. (b)(6). Pub. L. 98-473, Sec. 502(5), struck out par. (6)
    which related to penalties for violations involving a quantity of
    marihuana exceeding 1,000 pounds.
      Subsec. (c). Pub. L. 98-473, Sec. 224(a)(2), as renumbered by
    Pub. L. 99-570, Sec. 1005(a), struck out subsec. (c) which read as
    follows: "A special parole term imposed under this section or
    section 845, 845a, or 845b of this title may be revoked if its
    terms and conditions are violated. In such circumstances the
    original term of imprisonment shall be increased by the period of
    the special parole term and the resulting new term of imprisonment
    shall not be diminished by the time which was spent on special
    parole. A person whose special parole term has been revoked may be
    required to serve all or part of the remainder of the new term of
    imprisonment. A special parole term provided for in this section or
    section 845, 845a, or 845b of this title shall be in addition to,
    and not in lieu of, any other parole provided for by law."
      Pub. L. 98-473, Sec. 503(b)(2), inserted reference to section
    845a of this title in two places.
      1980 - Subsec. (b)(1)(B). Pub. L. 96-359, Sec. 8(c)(1), inserted
    reference to par. (6) of this subsection.
      Subsec. (b)(6). Pub. L. 96-359, Sec. 8(c)(2), added par. (6).
      1978 - Subsec. (b)(1)(B). Pub. L. 95-633, Sec. 201(1), inserted
    ", except as provided in paragraphs (4) and (5) of this
    subsection," after "such person shall".
      Subsec. (b)(5). Pub. L. 95-633, Sec. 201(2), added par. (5).
      Subsec. (d). Pub. L. 95-633, Sec. 201(3), added subsec. (d).

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by section 6055 of Pub. L. 100-690 effective 120 days
    after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set out
    as a note under section 802 of this title.

                     EFFECTIVE DATE OF 1986 AMENDMENT                 
      Section 1004(b) of Pub. L. 99-570 provided that: "The amendments
    made by this section [amending this section and sections 845, 845a,
    960, and 962 of this title] shall take effect on the date of the
    taking effect of section 3583 of title 18, United States Code [Nov.
    1, 1987]."

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by section 224(a) of Pub. L. 98-473 effective Nov. 1,
    1987, and applicable only to offenses committed after the taking
    effect of such amendment, see section 235(a)(1) of Pub. L. 98-473,
    set out as an Effective Date note under section 3551 of Title 18,
    Crimes and Criminal Procedure.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
    203(a) of Pub. L. 95-633 set out as an Effective Date note under
    section 830 of this title.

                                  REPEALS                              
      Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
    repealed section 203(d) of Pub. L. 95-633, which had provided for
    the repeal of subsec. (d) of this section effective Jan. 1, 1981.

-FOOTNOTE-
    (!1) So in original. Probably should be "health".


-End-



-CITE-
    21 USC Sec. 842                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 842. Prohibited acts B

-STATUTE-
    (a) Unlawful acts
      It shall be unlawful for any person - 
        (1) who is subject to the requirements of part C to distribute
      or dispense a controlled substance in violation of section 829 of
      this title;
        (2) who is a registrant to distribute or dispense a controlled
      substance not authorized by his registration to another
      registrant or other authorized person or to manufacture a
      controlled substance not authorized by his registration;
        (3) who is a registrant to distribute a controlled substance in
      violation of section 825 of this title;
        (4) to remove, alter, or obliterate a symbol or label required
      by section 825 of this title;
        (5) to refuse or negligently fail to make, keep, or furnish any
      record, report, notification, declaration, order or order form,
      statement, invoice, or information required under this subchapter
      or subchapter II of this chapter;
        (6) to refuse any entry into any premises or inspection
      authorized by this subchapter or subchapter II of this chapter;
        (7) to remove, break, injure, or deface a seal placed upon
      controlled substances pursuant to section 824(f) or 881 of this
      title or to remove or dispose of substances so placed under seal;
        (8) to use, to his own advantage, or to reveal, other than to
      duly authorized officers or employees of the United States, or to
      the courts when relevant in any judicial proceeding under this
      subchapter or subchapter II of this chapter, any information
      acquired in the course of an inspection authorized by this
      subchapter concerning any method or process which as a trade
      secret is entitled to protection, or to use to his own advantage
      or reveal (other than as authorized by section 830 of this title)
      any information that is confidential under such section;
        (9) who is a regulated person to engage in a regulated
      transaction without obtaining the identification required by
      830(a)(3) of this title.(!1)

        (10) negligently to fail to keep a record or make a report
      under section 830 of this title;
        (11) to distribute a laboratory supply to a person who uses, or
      attempts to use, that laboratory supply to manufacture a
      controlled substance or a listed chemical, in violation of this
      subchapter or subchapter II of this chapter, with reckless
      disregard for the illegal uses to which such a laboratory supply
      will be put;
        (12) who is a regulated seller, or a distributor required to
      submit reports under subsection (b)(3) of section 830 of this
      title - 
          (A) to sell at retail a scheduled listed chemical product in
        violation of paragraph (1) of subsection (d) of such section,
        knowing at the time of the transaction involved (independent of
        consulting the logbook under subsection (e)(1)(A)(iii) of such
        section) that the transaction is a violation; or
          (B) to knowingly or recklessly sell at retail such a product
        in violation of paragraph (2) of such subsection (d);

        (13) who is a regulated seller to knowingly or recklessly sell
      at retail a scheduled listed chemical product in violation of
      subsection (e) of such section; or
        (14) who is a regulated seller or an employee or agent of such
      seller to disclose, in violation of regulations under
      subparagraph (C) of section 830(e)(1) of this title, information
      in logbooks under subparagraph (A)(iii) of such section, or to
      refuse to provide such a logbook to Federal, State, or local law
      enforcement authorities.

    As used in paragraph (11), the term "laboratory supply" means a
    listed chemical or any chemical, substance, or item on a special
    surveillance list published by the Attorney General, which contains
    chemicals, products, materials, or equipment used in the
    manufacture of controlled substances and listed chemicals. For
    purposes of paragraph (11), there is a rebuttable presumption of
    reckless disregard at trial if the Attorney General notifies a firm
    in writing that a laboratory supply sold by the firm, or any other
    person or firm, has been used by a customer of the notified firm,
    or distributed further by that customer, for the unlawful
    production of controlled substances or listed chemicals a firm
    distributes and 2 weeks or more after the notification the notified
    firm distributes a laboratory supply to the customer.
    (b) Manufacture
      It shall be unlawful for any person who is a registrant to
    manufacture a controlled substance in schedule I or II, or
    ephedrine, pseudoephedrine, or phenylpropanolamine or any of the
    salts, optical isomers, or salts of optical isomers of such
    chemical, which is - 
        (1) not expressly authorized by his registration and by a quota
      assigned to him pursuant to section 826 of this title; or
        (2) in excess of a quota assigned to him pursuant to section
      826 of this title.
    (c) Penalties
      (1)(A) Except as provided in subparagraph (B) of this paragraph
    and paragraph (2), any person who violates this section shall, with
    respect to any such violation, be subject to a civil penalty of not
    more than $25,000. The district courts of the United States (or,
    where there is no such court in the case of any territory or
    possession of the United States, then the court in such territory
    or possession having the jurisdiction of a district court of the
    United States in cases arising under the Constitution and laws of
    the United States) shall have jurisdiction in accordance with
    section 1355 of title 28 to enforce this paragraph.
      (B) In the case of a violation of paragraph (5) or (10) of
    subsection (a) of this section, the civil penalty shall not exceed
    $10,000.
      (2)(A) If a violation of this section is prosecuted by an
    information or indictment which alleges that the violation was
    committed knowingly and the trier of fact specifically finds that
    the violation was so committed, such person shall, except as
    otherwise provided in subparagraph (B) of this paragraph, be
    sentenced to imprisonment of not more than one year or a fine under
    title 18, or both.
      (B) If a violation referred to in subparagraph (A) was committed
    after one or more prior convictions of the offender for an offense
    punishable under this paragraph (2), or for a crime under any other
    provision of this subchapter or subchapter II of this chapter or
    other law of the United States relating to narcotic drugs,
    marihuana, or depressant or stimulant substances, have become
    final, such person shall be sentenced to a term of imprisonment of
    not more than 2 years, a fine under title 18, or both.
      (C) In addition to the penalties set forth elsewhere in this
    subchapter or subchapter II of this chapter, any business that
    violates paragraph (11) of subsection (a) of this section shall,
    with respect to the first such violation, be subject to a civil
    penalty of not more than $250,000, but shall not be subject to
    criminal penalties under this section, and shall, for any
    succeeding violation, be subject to a civil fine of not more than
    $250,000 or double the last previously imposed penalty, whichever
    is greater.
      (3) Except under the conditions specified in paragraph (2) of
    this subsection, a violation of this section does not constitute a
    crime, and a judgment for the United States and imposition of a
    civil penalty pursuant to paragraph (1) shall not give rise to any
    disability or legal disadvantage based on conviction for a criminal
    offense.
      (4)(A) If a regulated seller, or a distributor required to submit
    reports under section 830(b)(3) of this title, violates paragraph
    (12) of subsection (a) of this section, or if a regulated seller
    violates paragraph (13) of such subsection, the Attorney General
    may by order prohibit such seller or distributor (as the case may
    be) from selling any scheduled listed chemical product. Any sale of
    such a product in violation of such an order is subject to the same
    penalties as apply under paragraph (2).
      (B) An order under subparagraph (A) may be imposed only through
    the same procedures as apply under section 824(c) of this title for
    an order to show cause.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 402, Oct. 27, 1970, 84 Stat. 1262;
    Pub. L. 95-633, title II, Sec. 202(b)(1), (2), Nov. 10, 1978, 92
    Stat. 3776; Pub. L. 100-690, title VI, Sec. 6056, Nov. 18, 1988,
    102 Stat. 4318; Pub. L. 104-237, title II, Sec. 205, Oct. 3, 1996,
    110 Stat. 3103; Pub. L. 105-277, div. A, Sec. 101(b) [title I, Sec.
    117], Oct. 21, 1998, 112 Stat. 2681-50, 2681-68; Pub. L. 107-273,
    div. B, title IV, Sec. 4002(b)(16), (d)(2)(B), Nov. 2, 2002, 116
    Stat. 1808, 1809; Pub. L. 109-177, title VII, Secs. 711(f)(1)(A),
    (2), 714, Mar. 9, 2006, 120 Stat. 262-264.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I and II, referred to in subsec. (b), are set out in
    section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a)(12) to (14). Pub. L. 109-177, Sec.
    711(f)(1)(A), added pars. (12) to (14).
      Subsec. (b). Pub. L. 109-177, Sec. 714, inserted ", or ephedrine,
    pseudoephedrine, or phenylpropanolamine or any of the salts,
    optical isomers, or salts of optical isomers of such chemical,"
    after "manufacture a controlled substance in schedule I or II" in
    introductory provisions.
      Subsec. (c)(4). Pub. L. 109-177, Sec. 711(f)(2), added par. (4).
      2002 - Subsec. (c)(2)(A). Pub. L. 107-273, Sec. 4002(d)(2)(B)(i),
    substituted "under title 18" for "of not more than $25,000".
      Subsec. (c)(2)(B). Pub. L. 107-273, Sec. 4002(d)(2)(B)(ii),
    substituted "under title 18" for "of $50,000".
      Subsec. (c)(2)(C). Pub. L. 107-273, Sec. 4002(b)(16), realigned
    margins.
      1998 - Subsec. (a)(5). Pub. L. 105-277, Sec. 101(b) [title I,
    Sec. 117(1)], inserted "negligently" before "fail".
      Subsec. (a)(10). Pub. L. 105-277, Sec. 101(b) [title I, Sec.
    117(2)], inserted "negligently" before "to fail".
      Subsec. (c)(1). Pub. L. 105-277, Sec. 101(b) [title I, Sec.
    117(3)], designated existing provisions as subpar. (A), inserted
    "subparagraph (B) of this paragraph and" before "paragraph (2)",
    and added subpar. (B).
      1996 - Subsec. (a). Pub. L. 104-237, Sec. 205(a), added par. (11)
    and closing provisions.
      Subsec. (c)(2)(C). Pub. L. 104-237, Sec. 205(b), added subpar.
    (C).
      1988 - Subsec. (a)(8). Pub. L. 100-690, Sec. 6056(a), inserted ",
    or to use to his own advantage or reveal (other than as authorized
    by section 830 of this title) any information that is confidential
    under such section" after "protection".
      Subsec. (a)(9). Pub. L. 100-690, Sec. 6056(b), amended par. (9)
    generally. Prior to amendment, par. (9) read as follows: "to
    distribute or sell piperidine in violation of regulations
    established under section 830(a)(2) of this title, respecting
    presentation of identification."
      Subsec. (a)(10). Pub. L. 100-690, Sec. 6056(d), added par. (10).
      Subsec. (c)(2)(C). Pub. L. 100-690, Sec. 6056(c), struck out
    subpar. (C) which read as follows: "Subparagraphs (A) and (B) shall
    not apply to a violation of subsection (a)(5) of this section with
    respect to a refusal or failure to make a report required under
    section 830(a) of this title (relating to piperidine reporting)."
      1978 - Subsec. (a)(9). Pub. L. 95-633, Sec. 202(b)(1), added par.
    (9).
      Subsec. (c)(2)(C). Pub. L. 95-633, Sec. 202(b)(2), added subpar.
    (C).

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
    1988, see section 6061 of Pub. L. 100-690, set out as a note under
    section 802 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
    203(a) of Pub. L. 95-633 set out as an Effective Date note under
    section 830 of this title.

                                  REPEALS                              
      Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
    repealed section 203(d) of Pub. L. 95-633, which had provided for
    the repeal of subsecs. (a)(9) and (c)(2)(C) of this section
    effective Jan. 1, 1981.

-FOOTNOTE-               

    (!1) So in original. Probably should be "section 830(a)(3) of
         this title;".


-End-



-CITE-
    21 USC Sec. 843                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 843. Prohibited acts C

-STATUTE-
    (a) Unlawful acts
      It shall be unlawful for any person knowingly or intentionally - 
        (1) who is a registrant to distribute a controlled substance
      classified in schedule I or II, in the course of his legitimate
      business, except pursuant to an order or an order form as
      required by section 828 of this title;
        (2) to use in the course of the manufacture, distribution, or
      dispensing of a controlled substance, or to use for the purpose
      of acquiring or obtaining a controlled substance, a registration
      number which is fictitious, revoked, suspended, expired, or
      issued to another person;
        (3) to acquire or obtain possession of a controlled substance
      by misrepresentation, fraud, forgery, deception, or subterfuge;
        (4)(A) to furnish false or fraudulent material information in,
      or omit any material information from, any application, report,
      record, or other document required to be made, kept, or filed
      under this subchapter or subchapter II of this chapter, or (B) to
      present false or fraudulent identification where the person is
      receiving or purchasing a listed chemical and the person is
      required to present identification under section 830(a) of this
      title;
        (5) to make, distribute, or possess any punch, die, plate,
      stone, or other thing designed to print, imprint, or reproduce
      the trademark, trade name, or other identifying mark, imprint, or
      device of another or any likeness of any of the foregoing upon
      any drug or container or labeling thereof so as to render such
      drug a counterfeit substance;
        (6) to possess any three-neck round-bottom flask, tableting
      machine, encapsulating machine, or gelatin capsule, or any
      equipment, chemical, product, or material which may be used to
      manufacture a controlled substance or listed chemical, knowing,
      intending, or having reasonable cause to believe, that it will be
      used to manufacture a controlled substance or listed chemical in
      violation of this subchapter or subchapter II of this chapter;
        (7) to manufacture, distribute, export, or import any three-
      neck round-bottom flask, tableting machine, encapsulating
      machine, or gelatin capsule, or any equipment, chemical, product,
      or material which may be used to manufacture a controlled
      substance or listed chemical, knowing, intending, or having
      reasonable cause to believe, that it will be used to manufacture
      a controlled substance or listed chemical in violation of this
      subchapter or subchapter II of this chapter or, in the case of an
      exportation, in violation of this subchapter or subchapter II of
      this chapter or of the laws of the country to which it is
      exported;
        (8) to create a chemical mixture for the purpose of evading a
      requirement of section 830 of this title or to receive a chemical
      mixture created for that purpose; or
        (9) to distribute, import, or export a list I chemical without
      the registration required by this subchapter or subchapter II of
      this chapter.
    (b) Communication facility
      It shall be unlawful for any person knowingly or intentionally to
    use any communication facility in committing or in causing or
    facilitating the commission of any act or acts constituting a
    felony under any provision of this subchapter or subchapter II of
    this chapter. Each separate use of a communication facility shall
    be a separate offense under this subsection. For purposes of this
    subsection, the term "communication facility" means any and all
    public and private instrumentalities used or useful in the
    transmission of writing, signs, signals, pictures, or sounds of all
    kinds and includes mail, telephone, wire, radio, and all other
    means of communication.
    (c) Advertisement
      It shall be unlawful for any person to place in any newspaper,
    magazine, handbill, or other publications, any written
    advertisement knowing that it has the purpose of seeking or
    offering illegally to receive, buy, or distribute a Schedule (!1) I
    controlled substance. As used in this section the term
    "advertisement" includes, in addition to its ordinary meaning, such
    advertisements as those for a catalog of Schedule (!1) I controlled
    substances and any similar written advertisement that has the
    purpose of seeking or offering illegally to receive, buy, or
    distribute a Schedule (!1) I controlled substance. The term
    "advertisement" does not include material which merely advocates
    the use of a similar material, which advocates a position or
    practice, and does not attempt to propose or facilitate an actual
    transaction in a Schedule (!1) I controlled substance.

    (d) Penalties
      (1) Except as provided in paragraph (2), any person who violates
    this section shall be sentenced to a term of imprisonment of not
    more than 4 years, a fine under title 18, or both; except that if
    any person commits such a violation after one or more prior
    convictions of him for violation of this section, or for a felony
    under any other provision of this subchapter or subchapter II of
    this chapter or other law of the United States relating to narcotic
    drugs, marihuana, or depressant or stimulant substances, have
    become final, such person shall be sentenced to a term of
    imprisonment of not more than 8 years, a fine under title 18, or
    both.
      (2) Any person who, with the intent to manufacture or to
    facilitate the manufacture of methamphetamine, violates paragraph
    (6) or (7) of subsection (a) of this section, shall be sentenced to
    a term of imprisonment of not more than 10 years, a fine under
    title 18, or both; except that if any person commits such a
    violation after one or more prior convictions of that person - 
        (A) for a violation of paragraph (6) or (7) of subsection (a)
      of this section;
        (B) for a felony under any other provision of this subchapter
      or subchapter II of this chapter; or
        (C) under any other law of the United States or any State
      relating to controlled substances or listed chemicals,

    has become final, such person shall be sentenced to a term of
    imprisonment of not more than 20 years, a fine under title 18, or
    both.
    (e) Additional penalties
      In addition to any other applicable penalty, any person convicted
    of a felony violation of this section relating to the receipt,
    distribution, manufacture, exportation, or importation of a listed
    chemical may be enjoined from engaging in any transaction involving
    a listed chemical for not more than ten years.
    (f) Injunctions
      (1) In addition to any penalty provided in this section, the
    Attorney General is authorized to commence a civil action for
    appropriate declaratory or injunctive relief relating to violations
    of this section, section 842 of this title, or 856 (!2) of this
    title.

      (2) Any action under this subsection may be brought in the
    district court of the United States for the district in which the
    defendant is located or resides or is doing business.
      (3) Any order or judgment issued by the court pursuant to this
    subsection shall be tailored to restrain violations of this section
    or section 842 of this title.
      (4) The court shall proceed as soon as practicable to the hearing
    and determination of such an action. An action under this
    subsection is governed by the Federal Rules of Civil Procedure
    except that, if an indictment has been returned against the
    respondent, discovery is governed by the Federal Rules of Criminal
    Procedure.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 403, Oct. 27, 1970, 84 Stat. 1263;
    Pub. L. 95-633, title II, Sec. 202(b)(3), Nov. 10, 1978, 92 Stat.
    3776; Pub. L. 98-473, title II, Sec. 516, Oct. 12, 1984, 98 Stat.
    2074; Pub. L. 99-570, title I, Sec. 1866(a), Oct. 27, 1986, 100
    Stat. 3207-54; Pub. L. 100-690, title VI, Sec. 6057, Nov. 18, 1988,
    102 Stat. 4319; Pub. L. 103-200, Sec. 3(g), Dec. 17, 1993, 107
    Stat. 2337; Pub. L. 103-322, title IX, Sec. 90106, Sept. 13, 1994,
    108 Stat. 1988; Pub. L. 104-237, title II, Secs. 203(a), 206(b),
    Oct. 3, 1996, 110 Stat. 3102, 3103; Pub. L. 107-273, div. B, title
    IV, Sec. 4002(d)(2)(C), Nov. 2, 2002, 116 Stat. 1810; Pub. L. 108-
    21, title VI, Sec. 608(d), Apr. 30, 2003, 117 Stat. 691.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I and II, referred to in subsecs. (a)(1) and (c), are
    set out in section 812(c) of this title.
      The Federal Rules of Civil Procedure, referred to in subsec.
    (f)(4), are set out in the Appendix to Title 28, Judiciary and
    Judicial Procedure.
      The Federal Rules of Criminal Procedure, referred to in subsec.
    (f)(4), are set out in the Appendix to Title 18, Crimes and
    Criminal Procedure.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (f)(1). Pub. L. 108-21 substituted "this section,
    section 842 of this title, or 856 of this title" for "this section
    or section 842 of this title".
      2002 - Subsec. (d). Pub. L. 107-273 substituted "under title 18,
    or both;" for "of not more than $30,000, or both;" in two places
    and "under title 18, or both." for "of not more than $60,000, or
    both." in two places.
      1996 - Subsec. (d). Pub. L. 104-237, Sec. 203(a), inserted par.
    (1) designation, substituted "Except as provided in paragraph (2),
    any person" for "Any person", and added par. (2).
      Subsec. (e). Pub. L. 104-237, Sec. 206(b)(1), inserted
    "manufacture, exportation," after "distribution," and struck out
    "regulated" after "engaging in any".
      Subsec. (f). Pub. L. 104-237, Sec. 206(b)(2), added subsec. (f).
      1994 - Subsecs. (c) to (e). Pub. L. 103-322 added subsec. (c) and
    redesignated former subsecs. (c) and (d) as (d) and (e),
    respectively.
      1993 - Subsec. (a)(6), (7). Pub. L. 103-200, Sec. 3(g)(1),
    amended pars. (6) and (7) generally. Prior to amendment, pars. (6)
    and (7) read as follows:
      "(6) to possess any three-neck round-bottom flask, tableting
    machine, encapsulating machine, gelatin capsule, or equipment
    specially designed or modified to manufacture a controlled
    substance, with intent to manufacture a controlled substance except
    as authorized by this subchapter;
      "(7) to manufacture, distribute, or import any three-neck round-
    bottom flask, tableting machine, encapsulating machine, gelatin
    capsule, or equipment specially designed or modified to manufacture
    a controlled substance, knowing that it will be used to manufacture
    a controlled substance except as authorized by this subchapter;
    or".
      Subsec. (a)(9). Pub. L. 103-200, Sec. 3(g)(2), (3), added par.
    (9).
      1988 - Subsec. (a)(4)(B). Pub. L. 100-690, Sec. 6057(a)(1),
    substituted "a listed chemical" for "piperidine".
      Subsec. (a)(6) to (8). Pub. L. 100-690, Sec. 6057(a)(2)-(4),
    added pars. (6) to (8).
      Subsec. (d). Pub. L. 100-690, Sec. 6057(b), added subsec. (d).
      1986 - Subsec. (a)(2). Pub. L. 99-570 substituted a semicolon for
    the period at end.
      1984 - Subsec. (a)(2). Pub. L. 98-473 added applicability to
    dispensing, acquiring, or obtaining a controlled substance, and
    applicability to an expired number.
      1978 - Subsec. (a)(4). Pub. L. 95-633, Sec. 202(b)(3), designated
    existing provisions as subpar. (A) and added subpar. (B).

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
    1988, see section 6061 of Pub. L. 100-690, set out as a note under
    section 802 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective Nov. 10, 1978, except as
    otherwise provided, see section 203(a) of Pub. L. 95-633, set out
    as an Effective Date note under section 830 of this title.

                                  REPEALS                              
      Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
    repealed section 203(d) of Pub. L. 95-633, which had provided for
    the repeal of subsec. (a)(4)(B) of this section effective Jan. 1,
    1981.

-FOOTNOTE-
    (!1) So in original. Probably should not be capitalized.

    (!2) So in original. Probably should be preceded by "section".


-End-



-CITE-
    21 USC Sec. 844                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 844. Penalties for simple possession

-STATUTE-
    (a) Unlawful acts; penalties
      It shall be unlawful for any person knowingly or intentionally to
    possess a controlled substance unless such substance was obtained
    directly, or pursuant to a valid prescription or order, from a
    practitioner, while acting in the course of his professional
    practice, or except as otherwise authorized by this subchapter or
    subchapter II of this chapter. It shall be unlawful for any person
    knowingly or intentionally to possess any list I chemical obtained
    pursuant to or under authority of a registration issued to that
    person under section 823 of this title or section 958 of this title
    if that registration has been revoked or suspended, if that
    registration has expired, or if the registrant has ceased to do
    business in the manner contemplated by his registration. It shall
    be unlawful for any person to knowingly or intentionally purchase
    at retail during a 30 day period more than 9 grams of ephedrine
    base, pseudoephedrine base, or phenylpropanolamine base in a
    scheduled listed chemical product, except that, of such 9 grams,
    not more than 7.5 grams may be imported by means of shipping
    through any private or commercial carrier or the Postal Service.
    Any person who violates this subsection may be sentenced to a term
    of imprisonment of not more than 1 year, and shall be fined a
    minimum of $1,000, or both, except that if he commits such offense
    after a prior conviction under this subchapter or subchapter II of
    this chapter, or a prior conviction for any drug, narcotic, or
    chemical offense chargeable under the law of any State, has become
    final, he shall be sentenced to a term of imprisonment for not less
    than 15 days but not more than 2 years, and shall be fined a
    minimum of $2,500, except, further, that if he commits such offense
    after two or more prior convictions under this subchapter or
    subchapter II of this chapter, or two or more prior convictions for
    any drug, narcotic, or chemical offense chargeable under the law of
    any State, or a combination of two or more such offenses have
    become final, he shall be sentenced to a term of imprisonment for
    not less than 90 days but not more than 3 years, and shall be fined
    a minimum of $5,000. Notwithstanding the preceding sentence, a
    person convicted under this subsection for the possession of a
    mixture or substance which contains cocaine base shall be
    imprisoned not less than 5 years and not more than 20 years, and
    fined a minimum of $1,000, if the conviction is a first conviction
    under this subsection and the amount of the mixture or substance
    exceeds 5 grams, if the conviction is after a prior conviction for
    the possession of such a mixture or substance under this subsection
    becomes final and the amount of the mixture or substance exceeds 3
    grams, or if the conviction is after 2 or more prior convictions
    for the possession of such a mixture or substance under this
    subsection become final and the amount of the mixture or substance
    exceeds 1 gram. Notwithstanding any penalty provided in this
    subsection, any person convicted under this subsection for the
    possession of flunitrazepam shall be imprisoned for not more than 3
    years, shall be fined as otherwise provided in this section, or
    both. The imposition or execution of a minimum sentence required to
    be imposed under this subsection shall not be suspended or
    deferred. Further, upon conviction, a person who violates this
    subsection shall be fined the reasonable costs of the investigation
    and prosecution of the offense, including the costs of prosecution
    of an offense as defined in sections 1918 and 1920 of title 28,
    except that this sentence shall not apply and a fine under this
    section need not be imposed if the court determines under the
    provision of title 18 that the defendant lacks the ability to pay.
    (b) Repealed. Pub. L. 98-473, title II, Sec. 219(a), Oct. 12, 1984,
      98 Stat. 2027
    (c) "Drug, narcotic, or chemical offense" defined
      As used in this section, the term "drug, narcotic, or chemical
    offense" means any offense which proscribes the possession,
    distribution, manufacture, cultivation, sale, transfer, or the
    attempt or conspiracy to possess, distribute, manufacture,
    cultivate, sell or transfer any substance the possession of which
    is prohibited under this subchapter.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 404, Oct. 27, 1970, 84 Stat. 1264;
    Pub. L. 98-473, title II, Sec. 219, Oct. 12, 1984, 98 Stat. 2027;
    Pub. L. 99-570, title I, Sec. 1052, Oct. 27, 1986, 100 Stat. 3207-
    8; Pub. L. 100-690, title VI, Secs. 6371, 6480, Nov. 18, 1988, 102
    Stat. 4370, 4382; Pub. L. 101-647, title XII, Sec. 1201, title XIX,
    Sec. 1907, Nov. 29, 1990, 104 Stat. 4829, 4854; Pub. L. 104-237,
    title II, Sec. 201(a), Oct. 3, 1996, 110 Stat. 3101; Pub. L. 104-
    305, Sec. 2(c), Oct. 13, 1996, 110 Stat. 3808; Pub. L. 109-177,
    title VII, Sec. 711(e)(1), Mar. 9, 2006, 120 Stat. 262.)


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a). Pub. L. 109-177 inserted after second
    sentence "It shall be unlawful for any person to knowingly or
    intentionally purchase at retail during a 30 day period more than 9
    grams of ephedrine base, pseudoephedrine base, or
    phenylpropanolamine base in a scheduled listed chemical product,
    except that, of such 9 grams, not more than 7.5 grams may be
    imported by means of shipping through any private or commercial
    carrier or the Postal Service."
      1996 - Subsec. (a). Pub. L. 104-305 inserted "Notwithstanding any
    penalty provided in this subsection, any person convicted under
    this subsection for the possession of flunitrazepam shall be
    imprisoned for not more than 3 years, shall be fined as otherwise
    provided in this section, or both." after "mixture or substance
    exceeds 1 gram."
      Pub. L. 104-237, Sec. 201(a)(1), inserted after first sentence
    "It shall be unlawful for any person knowingly or intentionally to
    possess any list I chemical obtained pursuant to or under authority
    of a registration issued to that person under section 823 of this
    title or section 958 of this title if that registration has been
    revoked or suspended, if that registration has expired, or if the
    registrant has ceased to do business in the manner contemplated by
    his registration." and substituted "drug, narcotic, or chemical"
    for "drug or narcotic" in two places.
      Subsec. (c). Pub. L. 104-237, Sec. 201(a)(2), substituted "drug,
    narcotic, or chemical" for "drug or narcotic".
      1990 - Subsec. (a). Pub. L. 101-647, Sec. 1907, inserted subsec.
    (a) designation.
      Pub. L. 101-647, Sec. 1201, substituted "shall be imprisoned not
    less than 5 years and not more than 20 years, and fined a minimum
    of $1,000" for "shall be fined under title 18 or imprisoned not
    less than 5 years and not more than 20 years, or both".
      1988 - Subsec. (a). Pub. L. 100-690, Sec. 6480(1)(A)-(C), struck
    out "but not more than $5,000" after "$1,000", "but not more than
    $10,000" after "$2,500", and "but not more than $25,000" after
    "$5,000" in second sentence.
      Pub. L. 100-690, Sec. 6371, inserted provisions relating to
    increased penalties in cases of certain serious crack possession
    offenses, making offenders subject to fines under title 18 or
    imprisonment to terms not less than 5 years nor more than 20 years,
    or both.
      1986 - Subsec. (a). Pub. L. 99-570 amended subsec. (a) generally.
    Prior to amendment, subsec. (a) read as follows: "It shall be
    unlawful for any person knowingly or intentionally to possess a
    controlled substance unless such substance was obtained directly,
    or pursuant to a valid prescription or order, from a practitioner,
    while acting in the course of his professional practice, or except
    as otherwise authorized by this subchapter or subchapter II of this
    chapter. Any person who violates this subsection shall be sentenced
    to a term of imprisonment of not more than one year, a fine of not
    more than $5,000, or both, except that if he commits such offense
    after a prior conviction or convictions under this subsection have
    become final, he shall be sentenced to a term of imprisonment of
    not more than 2 years, a fine of not more than $10,000 or both."
      Subsec. (b). Pub. L. 99-570, in amending subsec. (b) generally,
    substituted "Upon the discharge of such person and dismissal of the
    proceedings" for "Upon the dismissal of such person and discharge
    of the proceedings" in par. (2).
      Subsec. (c). Pub. L. 99-570, in amending section generally, added
    subsec. (c).
      1984 - Pub. L. 98-473 struck out subsec. (a) designation and
    struck out subsec. (b) which related to probation before judgment
    and expunging of records for first offense.

                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Pub. L. 109-177, title VII, Sec. 711(e)(2), Mar. 9, 2006, 120
    Stat. 262, provided that: "The amendment made by paragraph (1)
    [amending this section] applies on and after the expiration of the
    30-day period beginning on the date of the enactment of this Act
    [Mar. 9, 2006]."

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by Pub. L. 98-473 effective Nov. 1, 1987, and
    applicable only to offenses committed after the taking effect of
    such amendment, see section 235(a)(1) of Pub. L. 98-473, set out as
    an Effective Date note under section 3551 of Title 18, Crimes and
    Criminal Procedure.

-End-



-CITE-
    21 USC Sec. 844a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 844a. Civil penalty for possession of small amounts of certain
      controlled substances

-STATUTE-
    (a) In general
      Any individual who knowingly possesses a controlled substance
    that is listed in section 841(b)(1)(A) of this title in violation
    of section 844 of this title in an amount that, as specified by
    regulation of the Attorney General, is a personal use amount shall
    be liable to the United States for a civil penalty in an amount not
    to exceed $10,000 for each such violation.
    (b) Income and net assets
      The income and net assets of an individual shall not be relevant
    to the determination whether to assess a civil penalty under this
    section or to prosecute the individual criminally. However, in
    determining the amount of a penalty under this section, the income
    and net assets of an individual shall be considered.
    (c) Prior conviction
      A civil penalty may not be assessed under this section if the
    individual previously was convicted of a Federal or State offense
    relating to a controlled substance.
    (d) Limitation on number of assessments
      A civil penalty may not be assessed on an individual under this
    section on more than two separate occasions.
    (e) Assessment
      A civil penalty under this section may be assessed by the
    Attorney General only by an order made on the record after
    opportunity for a hearing in accordance with section 554 of title
    5. The Attorney General shall provide written notice to the
    individual who is the subject of the proposed order informing the
    individual of the opportunity to receive such a hearing with
    respect to the proposed order. The hearing may be held only if the
    individual makes a request for the hearing before the expiration of
    the 30-day period beginning on the date such notice is issued.
    (f) Compromise
      The Attorney General may compromise, modify, or remit, with or
    without conditions, any civil penalty imposed under this section.
    (g) Judicial review
      If the Attorney General issues an order pursuant to subsection
    (e) of this section after a hearing described in such subsection,
    the individual who is the subject of the order may, before the
    expiration of the 30-day period beginning on the date the order is
    issued, bring a civil action in the appropriate district court of
    the United States. In such action, the law and the facts of the
    violation and the assessment of the civil penalty shall be
    determined de novo, and shall include the right of a trial by jury,
    the right to counsel, and the right to confront witnesses. The
    facts of the violation shall be proved beyond a reasonable doubt.
    (h) Civil action
      If an individual does not request a hearing pursuant to
    subsection (e) of this section and the Attorney General issues an
    order pursuant to such subsection, or if an individual does not
    under subsection (g) of this section seek judicial review of such
    an order, the Attorney General may commence a civil action in any
    appropriate district court of the United States for the purpose of
    recovering the amount assessed and an amount representing interest
    at a rate computed in accordance with section 1961 of title 28.
    Such interest shall accrue from the expiration of the 30-day period
    described in subsection (g) of this section. In such an action, the
    decision of the Attorney General to issue the order, and the amount
    of the penalty assessed by the Attorney General, shall not be
    subject to review.
    (i) Limitation
      The Attorney General may not under this subsection (!1) commence
    proceeding against an individual after the expiration of the 5-year
    period beginning on the date on which the individual allegedly
    violated subsection (a) of this section.

    (j) Expungement procedures
      The Attorney General shall dismiss the proceedings under this
    section against an individual upon application of such individual
    at any time after the expiration of 3 years if - 
        (1) the individual has not previously been assessed a civil
      penalty under this section;
        (2) the individual has paid the assessment;
        (3) the individual has complied with any conditions imposed by
      the Attorney General;
        (4) the individual has not been convicted of a Federal or State
      offense relating to a controlled substance; and
        (5) the individual agrees to submit to a drug test, and such
      test shows the individual to be drug free.

    A nonpublic record of a disposition under this subsection shall be
    retained by the Department of Justice solely for the purpose of
    determining in any subsequent proceeding whether the person
    qualified for a civil penalty or expungement under this section. If
    a record is expunged under this subsection, an individual
    concerning whom such an expungement has been made shall not be held
    thereafter under any provision of law to be guilty of perjury,
    false swearing, or making a false statement by reason of his
    failure to recite or acknowledge a proceeding under this section or
    the results thereof in response to an inquiry made of him for any
    purpose.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 405, formerly Pub. L. 100-690,
    title VI, Sec. 6486, Nov. 18, 1988, 102 Stat. 4384, renumbered Sec.
    405 of Pub. L. 91-513, and amended Pub. L. 101-647, title X, Sec.
    1002(g)(1), (2), Nov. 29, 1990, 104 Stat. 4828.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 405 of Pub. L. 91-513 was renumbered section 418
    and is classified to section 859 of this title.

                                AMENDMENTS                            
      1990 - Subsec. (a). Pub. L. 101-647, Sec. 1002(g)(2)(A), made
    technical amendments to references to sections 841(b)(1)(A) and 844
    of this title to correct references to corresponding provisions of
    original act.
      Subsecs. (c), (j)(4). Pub. L. 101-647, Sec. 1002(g)(2)(B), (C),
    struck out "as defined in section 802 of this title" after
    "controlled substance".

-FOOTNOTE-
    (!1) So in original. Probably should be "section".


-End-



-CITE-
    21 USC Secs. 845 to 845b                                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Secs. 845 to 845b. Transferred

-COD-
                               CODIFICATION                           
      Section 845, Pub. L. 91-513, title II, Sec. 405, Oct. 27, 1970,
    84 Stat. 1265, as amended, which related to distribution of
    controlled substances to persons under age twenty-one, was
    renumbered Sec. 418 of Pub. L. 91-513 by Pub. L. 101-647, title X,
    Sec. 1002(a)(1), Nov. 29, 1990, 104 Stat. 4827, and transferred to
    section 859 of this title.
      Section 845a, Pub. L. 91-513, title II, Sec. 405A, as added Pub.
    L. 98-473, title II, Sec. 503(a), Oct. 12, 1984, 98 Stat. 2069, and
    amended, which related to distribution or manufacturing of
    controlled substances in or near schools and colleges, was
    renumbered Sec. 419 of Pub. L. 91-513 by Pub. L. 101-647, title X,
    Sec. 1002(b), Nov. 29, 1990, 104 Stat. 4827, and transferred to
    section 860 of this title.
      Section 845b, Pub. L. 91-513, title II, Sec. 405B, as added Pub.
    L. 99-570, title I, Sec. 1102, Oct. 27, 1986, 100 Stat. 3207-10,
    and amended, which related to employment or use of persons under 18
    years of age in drug operations, was renumbered Sec. 420 of Pub. L.
    91-513 by Pub. L. 101-647, title X, Sec. 1002(c), Nov. 29, 1990,
    104 Stat. 4827, and transferred to section 861 of this title.

-End-



-CITE-
    21 USC Sec. 846                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 846. Attempt and conspiracy

-STATUTE-
      Any person who attempts or conspires to commit any offense
    defined in this subchapter shall be subject to the same penalties
    as those prescribed for the offense, the commission of which was
    the object of the attempt or conspiracy.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 406, Oct. 27, 1970, 84 Stat. 1265;
    Pub. L. 100-690, title VI, Sec. 6470(a), Nov. 18, 1988, 102 Stat.
    4377.)


-MISC1-
                                AMENDMENTS                            
      1988 - Pub. L. 100-690 substituted "shall be subject to the same
    penalties as those prescribed for the offense" for "is punishable
    by imprisonment or fine or both which may not exceed the maximum
    punishment prescribed for the offense".

-End-



-CITE-
    21 USC Sec. 847                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 847. Additional penalties

-STATUTE-
      Any penalty imposed for violation of this subchapter shall be in
    addition to, and not in lieu of, any civil or administrative
    penalty or sanction authorized by law.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 407, Oct. 27, 1970, 84 Stat. 1265.)

-End-



-CITE-
    21 USC Sec. 848                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 848. Continuing criminal enterprise

-STATUTE-
    (a) Penalties; forfeitures
      Any person who engages in a continuing criminal enterprise shall
    be sentenced to a term of imprisonment which may not be less than
    20 years and which may be up to life imprisonment, to a fine not to
    exceed the greater of that authorized in accordance with the
    provisions of title 18 or $2,000,000 if the defendant is an
    individual or $5,000,000 if the defendant is other than an
    individual, and to the forfeiture prescribed in section 853 of this
    title; except that if any person engages in such activity after one
    or more prior convictions of him under this section have become
    final, he shall be sentenced to a term of imprisonment which may
    not be less than 30 years and which may be up to life imprisonment,
    to a fine not to exceed the greater of twice the amount authorized
    in accordance with the provisions of title 18 or $4,000,000 if the
    defendant is an individual or $10,000,000 if the defendant is other
    than an individual, and to the forfeiture prescribed in section 853
    of this title.
    (b) Life imprisonment for engaging in continuing criminal
      enterprise
      Any person who engages in a continuing criminal enterprise shall
    be imprisoned for life and fined in accordance with subsection (a)
    of this section, if - 
        (1) such person is the principal administrator, organizer, or
      leader of the enterprise or is one of several such principal
      administrators, organizers, or leaders; and
        (2)(A) the violation referred to in subsection (c)(1) of this
      section involved at least 300 times the quantity of a substance
      described in subsection 841(b)(1)(B) of this title, or
        (B) the enterprise, or any other enterprise in which the
      defendant was the principal or one of several principal
      administrators, organizers, or leaders, received $10 million
      dollars in gross receipts during any twelve-month period of its
      existence for the manufacture, importation, or distribution of a
      substance described in section 841(b)(1)(B) of this title.
    (c) "Continuing criminal enterprise" defined
      For purposes of subsection (a) of this section, a person is
    engaged in a continuing criminal enterprise if - 
        (1) he violates any provision of this subchapter or subchapter
      II of this chapter the punishment for which is a felony, and
        (2) such violation is a part of a continuing series of
      violations of this subchapter or subchapter II of this chapter - 
          (A) which are undertaken by such person in concert with five
        or more other persons with respect to whom such person occupies
        a position of organizer, a supervisory position, or any other
        position of management, and
          (B) from which such person obtains substantial income or
        resources.
    (d) Suspension of sentence and probation prohibited
      In the case of any sentence imposed under this section,
    imposition or execution of such sentence shall not be suspended,
    probation shall not be granted, and the Act of July 15, 1932 (D.C.
    Code, secs. 24-203 - 24-207), shall not apply.
    (e) Death penalty
      (1) In addition to the other penalties set forth in this section -
     
        (A) any person engaging in or working in furtherance of a
      continuing criminal enterprise, or any person engaging in an
      offense punishable under section 841(b)(1)(A) of this title or
      section 960(b)(1) of this title who intentionally kills or
      counsels, commands, induces, procures, or causes the intentional
      killing of an individual and such killing results, shall be
      sentenced to any term of imprisonment, which shall not be less
      than 20 years, and which may be up to life imprisonment, or may
      be sentenced to death; and
        (B) any person, during the commission of, in furtherance of, or
      while attempting to avoid apprehension, prosecution or service of
      a prison sentence for, a felony violation of this subchapter or
      subchapter II of this chapter who intentionally kills or
      counsels, commands, induces, procures, or causes the intentional
      killing of any Federal, State, or local law enforcement officer
      engaged in, or on account of, the performance of such officer's
      official duties and such killing results, shall be sentenced to
      any term of imprisonment, which shall not be less than 20 years,
      and which may be up to life imprisonment, or may be sentenced to
      death.

      (2) As used in paragraph (1)(B), the term "law enforcement
    officer" means a public servant authorized by law or by a
    Government agency or Congress to conduct or engage in the
    prevention, investigation, prosecution or adjudication of an
    offense, and includes those engaged in corrections, probation, or
    parole functions.
    (g) (!1) to (p) Repealed. Pub. L. 109-177, title II, Sec. 221(2),
      Mar. 9, 2006, 120 Stat. 231

    (q) Repealed. Pub. L. 109-177, title II, Secs. 221(4), 222(c), Mar.
      9, 2006, 120 Stat. 231, 232
    (r) Repealed. Pub. L. 109-177, title II, Sec. 221(3), Mar. 9, 2006,
      120 Stat. 231
    (s) Special provision for methamphetamine
      For the purposes of subsection (b), in the case of continuing
    criminal enterprise involving methamphetamine or its salts,
    isomers, or salts of isomers, paragraph (2)(A) shall be applied by
    substituting "200" for "300", and paragraph (2)(B) shall be applied
    by substituting "$5,000,000" for "$10 million dollars".

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 408, Oct. 27, 1970, 84 Stat. 1265;
    Pub. L. 98-473, title II, Secs. 224(b), formerly Sec. 224(c), 305,
    Oct. 12, 1984, 98 Stat. 2030, 2050; Pub. L. 99-570, title I, Secs.
    1005(b)(2), 1252, 1253, Oct. 27, 1986, 100 Stat. 3207-6, 3207-14;
    Pub. L. 100-690, title VI, Sec. 6481, title VII, Sec. 7001, Nov.
    18, 1988, 102 Stat. 4382, 4387; Pub. L. 103-322, title XXXIII,
    Secs. 330003(e), 330009(d), 330014, Sept. 13, 1994, 108 Stat. 2141,
    2143, 2146; Pub. L. 104-132, title I, Sec. 108, title IX, Sec.
    903(b), Apr. 24, 1996, 110 Stat. 1226, 1318; Pub. L. 109-177, title
    II, Secs. 221, 222(c), title VII, Sec. 733, Mar. 9, 2006, 120 Stat.
    231, 232, 270.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of July 15, 1932 (D.C. Code, secs. 24-203 - 24-207), referred
    to in subsec. (d), is act July 15, 1932, ch. 492, 47 Stat. 696, as
    amended, which is not classified to the Code.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (e)(2). Pub. L. 109-177, Sec. 221(1), substituted
    "(1)(B)" for "(1)(b)".
      Subsecs. (g) to (p). Pub. L. 109-177, Sec. 221(2), struck out
    subsecs. (g) to (p) which related to hearing and sentencing
    procedures in death penalty cases and sentencing in capital cases
    in which the death penalty is not sought or imposed.
      Subsec. (q). Pub. L. 109-177, Secs. 221(4), 222(c), struck out
    subsec. (q) which related to appeal in capital cases and counsel
    for financially unable defendants.
      Subsec. (r). Pub. L. 109-177, Sec. 221(3), struck out subsec. (r)
    which provided for refusal by State and Federal correctional
    employees to participate in executions.
      Subsec. (s). Pub. L. 109-177, Sec. 733, added subsec. (s).
      1996 - Subsec. (q)(9). Pub. L. 104-132, Sec. 108, amended par.
    (9) generally. Prior to amendment, par. (9) read as follows: "Upon
    a finding in ex parte proceedings that investigative, expert or
    other services are reasonably necessary for the representation of
    the defendant, whether in connection with issues relating to guilt
    or sentence, the court shall authorize the defendant's attorneys to
    obtain such services on behalf of the defendant and shall order the
    payment of fees and expenses therefore, under paragraph (10). Upon
    a finding that timely procurement of such services could not
    practicably await prior authorization, the court may authorize the
    provision of and payment for such services nunc pro tunc."
      Subsec. (q)(10). Pub. L. 104-132, Sec. 903(b), amended par. (10)
    generally. Prior to amendment, par. (10) read as follows:
    "Notwithstanding the rates and maximum limits generally applicable
    to criminal cases and any other provision of law to the contrary,
    the court shall fix the compensation to be paid to attorneys
    appointed under this subsection and the fees and expenses to be
    paid for investigative, expert, and other reasonably necessary
    services authorized under paragraph (9), at such rates or amounts
    as the court determines to be reasonably necessary to carry out the
    requirements of paragraphs (4) through (9)."
      1994 - Subsec. (b)(2)(A). Pub. L. 103-322, Sec. 330003(e),
    substituted "subsection (c)(1) of this section" for "subsection
    (d)(1) of this section".
      Subsec. (n)(11). Pub. L. 103-322, Sec. 330014, made technical
    amendment to reference to section 859 of this title to correct
    reference to corresponding section of original act.
      Subsec. (q)(8). Pub. L. 103-322, Sec. 330009(d), substituted
    "applications for writ" for "applications, for writ".
      1988 - Subsec. (a). Pub. L. 100-690, Sec. 6481(a), increased
    minimum term of imprisonment for first violations to 20 from 10
    years and for subsequent violations to 30 from 20 years.
      Subsecs. (c), (d). Pub. L. 100-690, Sec. 6481(b), redesignated
    subsecs. (d) and (e) as (c) and (d), respectively.
      Subsec. (e). Pub. L. 100-690, Sec. 7001(a)(2), added subsec. (e).
    Former subsec. (e) redesignated (d).
      Pub. L. 100-690, Sec. 7001(a)(1), which directed redesignation of
    former subsec. (e) as (f), could not be executed because of prior
    redesignation of former subsec. (e) as (d) by Pub. L. 100-690, Sec.
    6481(b), which resulted in there not being a subsec. (f).
      Subsecs. (g) to (r). Pub. L. 100-690, Sec. 7001(b), added
    subsecs. (g) to (r).
      1986 - Subsec. (a). Pub. L. 99-570, Sec. 1252, substituted "to a
    fine not to exceed the greater of that authorized in accordance
    with the provisions of title 18 or $2,000,000 if the defendant is
    an individual or $5,000,000 if the defendant is other than an
    individual," for "to a fine of not more than $100,000," and "to a
    fine not to exceed the greater of twice the amount authorized in
    accordance with the provisions of title 18 or $4,000,000 if the
    defendant is an individual or $10,000,000 if the defendant is other
    than an individual," for "to a fine of not more than $200,000,".
      Subsecs. (b) to (e). Pub. L. 99-570, Sec. 1253, added subsec. (b)
    and redesignated former subsecs. (b) and (c) as (d) and (e),
    respectively, which resulted in there not being a subsec. (c).
      1984 - Subsec. (a). Pub. L. 98-473, Sec. 305, struck out par. (1)
    designation, substituted references to section 853 of this title
    for references to paragraph (2) in two places, and struck out par.
    (2) which related to forfeitures to the United States by any person
    convicted under par. (1).
      Subsec. (d). Pub. L. 98-473, Sec. 305(b), struck out subsec. (d)
    relating to jurisdiction of courts of the United States.
      Subsec. (e). Pub. L. 98-473, Sec. 224(b), as renumbered by Pub.
    L. 99-570, Sec. 1005(b)(2), which directed the amendment of subsec.
    (c) of this section by striking out "and section 4202 of title 18
    of the United States Code", was executed by striking out that
    language in subsec. (e) to reflect the probable intent of Congress
    and the intervening amendment by Pub. L. 99-570, Sec. 1253, which
    redesignated subsec. (c) as (e). See 1986 Amendment note above.

                     EFFECTIVE DATE OF 1996 AMENDMENT                 
      Amendment by section 903(b) of Pub. L. 104-132 effective as to
    cases commenced or appeals perfected on or after Apr. 24, 1996, see
    section 903(c) of Pub. L. 104-132, set out as a note under section
    3006A of Title 18, Crimes and Criminal Procedure.

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by section 224(b) of Pub. L. 98-473 effective Nov. 1,
    1987, and applicable only to offenses committed after the taking
    effect of such amendment, see section 235(a)(1) of Pub. L. 98-473,
    set out as an Effective Date note under section 3551 of Title 18,
    Crimes and Criminal Procedure.

                      GAO STUDY OF COST OF EXECUTIONS                  
      Section 7002 of title VII of Pub. L. 100-690, directed
    Comptroller General to conduct a study of cost of executions and
    report to Congress, prior to repeal by Pub. L. 104-66, title I,
    Sec. 1091(d), Dec. 21, 1995, 109 Stat. 722.

-FOOTNOTE-
    (!1) So in original. Section does not contain a subsec. (f), see
         1988 Amendment note below.


-End-



-CITE-
    21 USC Sec. 849                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 849. Transportation safety offenses

-STATUTE-
    (a) Definitions
      In this section - 
        "safety rest area" means a roadside facility with parking
      facilities for the rest or other needs of motorists.
        "truck stop" means a facility (including any parking lot
      appurtenant thereto) that - 
          (A) has the capacity to provide fuel or service, or both, to
        any commercial motor vehicle (as defined in section 31301 of
        title 49), operating in commerce (as defined in that section);
        and
          (B) is located within 2,500 feet of the National System of
        Interstate and Defense Highways or the Federal-Aid Primary
        System.
    (b) First offense
      A person who violates section 841(a)(1) of this title or section
    856 of this title by distributing or possessing with intent to
    distribute a controlled substance in or on, or within 1,000 feet
    of, a truck stop or safety rest area is (except as provided in
    subsection (b) (!1) of this section) subject to - 

        (1) twice the maximum punishment authorized by section 841(b)
      of this title; and
        (2) twice any term of supervised release authorized by section
      841(b) of this title for a first offense.
    (c) Subsequent offense
      A person who violates section 841(a)(1) of this title or section
    856 of this title by distributing or possessing with intent to
    distribute a controlled substance in or on, or within 1,000 feet
    of, a truck stop or a safety rest area after a prior conviction or
    convictions under subsection (a) (!2) of this section have become
    final is subject to - 

        (1) 3 times the maximum punishment authorized by section 841(b)
      of this title; and
        (2) 3 times any term of supervised release authorized by
      section 841(b) of this title for a first offense.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 409, as added Pub. L. 103-322,
    title XVIII, Sec. 180201(b)(1), Sept. 13, 1994, 108 Stat. 2046.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 849, Pub. L. 91-513, title II, Sec. 409, Oct. 27,
    1970, 84 Stat. 1266; Pub. L. 99-514, Sec. 2, Oct. 22, 1986, 100
    Stat. 2095, related to dangerous special drug offender sentencing,
    prior to repeal by Pub. L. 98-473, title II, Secs. 219(a),
    235(a)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, eff. Nov. 1, 1987,
    and applicable only to offenses committed after the taking effect
    of such repeal.

-FOOTNOTE-
    (!1) So in original. Probably should be subsection "(c)".

    (!2) So in original. Probably should be subsection "(b)".


-End-



-CITE-
    21 USC Sec. 850                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 850. Information for sentencing

-STATUTE-
      Except as otherwise provided in this subchapter or section
    242a(a) (!1) of title 42, no limitation shall be placed on the
    information concerning the background, character, and conduct of a
    person convicted of an offense which a court of the United States
    may receive and consider for the purpose of imposing an appropriate
    sentence under this subchapter or subchapter II of this chapter.


-SOURCE-
    (Pub. L. 91-513, title II, Sec. 410, Oct. 27, 1970, 84 Stat. 1269.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 242a of title 42, referred to in text, was repealed by
    Pub. L. 106-310, div. B, title XXXII, Sec. 3201(b)(1), Oct. 17,
    2000, 114 Stat. 1190.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 851                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 851. Proceedings to establish prior convictions

-STATUTE-
    (a) Information filed by United States Attorney
      (1) No person who stands convicted of an offense under this part
    shall be sentenced to increased punishment by reason of one or more
    prior convictions, unless before trial, or before entry of a plea
    of guilty, the United States attorney files an information with the
    court (and serves a copy of such information on the person or
    counsel for the person) stating in writing the previous convictions
    to be relied upon. Upon a showing by the United States attorney
    that facts regarding prior convictions could not with due diligence
    be obtained prior to trial or before entry of a plea of guilty, the
    court may postpone the trial or the taking of the plea of guilty
    for a reasonable period for the purpose of obtaining such facts.
    Clerical mistakes in the information may be amended at any time
    prior to the pronouncement of sentence.
      (2) An information may not be filed under this section if the
    increased punishment which may be imposed is imprisonment for a
    term in excess of three years unless the person either waived or
    was afforded prosecution by indictment for the offense for which
    such increased punishment may be imposed.
    (b) Affirmation or denial of previous conviction
      If the United States attorney files an information under this
    section, the court shall after conviction but before pronouncement
    of sentence inquire of the person with respect to whom the
    information was filed whether he affirms or denies that he has been
    previously convicted as alleged in the information, and shall
    inform him that any challenge to a prior conviction which is not
    made before sentence is imposed may not thereafter be raised to
    attack the sentence.
    (c) Denial; written response; hearing
      (1) If the person denies any allegation of the information of
    prior conviction, or claims that any conviction alleged is invalid,
    he shall file a written response to the information. A copy of the
    response shall be served upon the United States attorney. The court
    shall hold a hearing to determine any issues raised by the response
    which would except the person from increased punishment. The
    failure of the United States attorney to include in the information
    the complete criminal record of the person or any facts in addition
    to the convictions to be relied upon shall not constitute grounds
    for invalidating the notice given in the information required by
    subsection (a)(1) of this section. The hearing shall be before the
    court without a jury and either party may introduce evidence.
    Except as otherwise provided in paragraph (2) of this subsection,
    the United States attorney shall have the burden of proof beyond a
    reasonable doubt on any issue of fact. At the request of either
    party, the court shall enter findings of fact and conclusions of
    law.
      (2) A person claiming that a conviction alleged in the
    information was obtained in violation of the Constitution of the
    United States shall set forth his claim, and the factual basis
    therefor, with particularity in his response to the information.
    The person shall have the burden of proof by a preponderance of the
    evidence on any issue of fact raised by the response. Any challenge
    to a prior conviction, not raised by response to the information
    before an increased sentence is imposed in reliance thereon, shall
    be waived unless good cause be shown for failure to make a timely
    challenge.
    (d) Imposition of sentence
      (1) If the person files no response to the information, or if the
    court determines, after hearing, that the person is subject to
    increased punishment by reason of prior convictions, the court
    shall proceed to impose sentence upon him as provided by this part.
      (2) If the court determines that the person has not been
    convicted as alleged in the information, that a conviction alleged
    in the information is invalid, or that the person is otherwise not
    subject to an increased sentence as a matter of law, the court
    shall, at the request of the United States attorney, postpone
    sentence to allow an appeal from that determination. If no such
    request is made, the court shall impose sentence as provided by
    this part. The person may appeal from an order postponing sentence
    as if sentence had been pronounced and a final judgment of
    conviction entered.
    (e) Statute of limitations
      No person who stands convicted of an offense under this part may
    challenge the validity of any prior conviction alleged under this
    section which occurred more than five years before the date of the
    information alleging such prior conviction.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 411, Oct. 27, 1970, 84 Stat. 1269.)

-End-



-CITE-
    21 USC Sec. 852                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 852. Application of treaties and other international
      agreements

-STATUTE-
      Nothing in the Single Convention on Narcotic Drugs, the
    Convention on Psychotropic Substances, or other treaties or
    international agreements shall be construed to limit the provision
    of treatment, education, or rehabilitation as alternatives to
    conviction or criminal penalty for offenses involving any drug or
    other substance subject to control under any such treaty or
    agreement.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 412, as added Pub. L. 95-633, title
    I, Sec. 107(a), Nov. 10, 1978, 92 Stat. 3773.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective on date the Convention on Psychotropic
    Substances enters into force in the United States [July 15, 1980],
    see section 112 of Pub. L. 95-633, set out as a note under section
    801a of this title.

-End-



-CITE-
    21 USC Sec. 853                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 853. Criminal forfeitures

-STATUTE-
    (a) Property subject to criminal forfeiture
      Any person convicted of a violation of this subchapter or
    subchapter II of this chapter punishable by imprisonment for more
    than one year shall forfeit to the United States, irrespective of
    any provision of State law - 
        (1) any property constituting, or derived from, any proceeds
      the person obtained, directly or indirectly, as the result of
      such violation;
        (2) any of the person's property used, or intended to be used,
      in any manner or part, to commit, or to facilitate the commission
      of, such violation; and
        (3) in the case of a person convicted of engaging in a
      continuing criminal enterprise in violation of section 848 of
      this title, the person shall forfeit, in addition to any property
      described in paragraph (1) or (2), any of his interest in, claims
      against, and property or contractual rights affording a source of
      control over, the continuing criminal enterprise.

    The court, in imposing sentence on such person, shall order, in
    addition to any other sentence imposed pursuant to this subchapter
    or subchapter II of this chapter, that the person forfeit to the
    United States all property described in this subsection. In lieu of
    a fine otherwise authorized by this part, a defendant who derives
    profits or other proceeds from an offense may be fined not more
    than twice the gross profits or other proceeds.
    (b) Meaning of term "property"
      Property subject to criminal forfeiture under this section
    includes - 
        (1) real property, including things growing on, affixed to, and
      found in land; and
        (2) tangible and intangible personal property, including
      rights, privileges, interests, claims, and securities.
    (c) Third party transfers
      All right, title, and interest in property described in
    subsection (a) of this section vests in the United States upon the
    commission of the act giving rise to forfeiture under this section.
    Any such property that is subsequently transferred to a person
    other than the defendant may be the subject of a special verdict of
    forfeiture and thereafter shall be ordered forfeited to the United
    States, unless the transferee establishes in a hearing pursuant to
    subsection (n) of this section that he is a bona fide purchaser for
    value of such property who at the time of purchase was reasonably
    without cause to believe that the property was subject to
    forfeiture under this section.
    (d) Rebuttable presumption
      There is a rebuttable presumption at trial that any property of a
    person convicted of a felony under this subchapter or subchapter II
    of this chapter is subject to forfeiture under this section if the
    United States establishes by a preponderance of the evidence that -
    
        (1) such property was acquired by such person during the period
      of the violation of this subchapter or subchapter II of this
      chapter or within a reasonable time after such period; and
        (2) there was no likely source for such property other than the
      violation of this subchapter or subchapter II of this chapter.
    (e) Protective orders
      (1) Upon application of the United States, the court may enter a
    restraining order or injunction, require the execution of a
    satisfactory performance bond, or take any other action to preserve
    the availability of property described in subsection (a) of this
    section for forfeiture under this section - 
        (A) upon the filing of an indictment or information charging a
      violation of this subchapter or subchapter II of this chapter for
      which criminal forfeiture may be ordered under this section and
      alleging that the property with respect to which the order is
      sought would, in the event of conviction, be subject to
      forfeiture under this section; or
        (B) prior to the filing of such an indictment or information,
      if, after notice to persons appearing to have an interest in the
      property and opportunity for a hearing, the court determines that
      - 
          (i) there is a substantial probability that the United States
        will prevail on the issue of forfeiture and that failure to
        enter the order will result in the property being destroyed,
        removed from the jurisdiction of the court, or otherwise made
        unavailable for forfeiture; and
          (ii) the need to preserve the availability of the property
        through the entry of the requested order outweighs the hardship
        on any party against whom the order is to be entered:

    Provided, however, That an order entered pursuant to subparagraph
    (B) shall be effective for not more than ninety days, unless
    extended by the court for good cause shown or unless an indictment
    or information described in subparagraph (A) has been filed.
      (2) A temporary restraining order under this subsection may be
    entered upon application of the United States without notice or
    opportunity for a hearing when an information or indictment has not
    yet been filed with respect to the property, if the United States
    demonstrates that there is probable cause to believe that the
    property with respect to which the order is sought would, in the
    event of conviction, be subject to forfeiture under this section
    and that provision of notice will jeopardize the availability of
    the property for forfeiture. Such a temporary order shall expire
    not more than ten days after the date on which it is entered,
    unless extended for good cause shown or unless the party against
    whom it is entered consents to an extension for a longer period. A
    hearing requested concerning an order entered under this paragraph
    shall be held at the earliest possible time and prior to the
    expiration of the temporary order.
      (3) The court may receive and consider, at a hearing held
    pursuant to this subsection, evidence and information that would be
    inadmissible under the Federal Rules of Evidence.
      (4) Order to repatriate and deposit. - 
        (A) In general. - Pursuant to its authority to enter a pretrial
      restraining order under this section, the court may order a
      defendant to repatriate any property that may be seized and
      forfeited, and to deposit that property pending trial in the
      registry of the court, or with the United States Marshals Service
      or the Secretary of the Treasury, in an interest-bearing account,
      if appropriate.
        (B) Failure to comply. - Failure to comply with an order under
      this subsection, or an order to repatriate property under
      subsection (p) of this section, shall be punishable as a civil or
      criminal contempt of court, and may also result in an enhancement
      of the sentence of the defendant under the obstruction of justice
      provision of the Federal Sentencing Guidelines.
    (f) Warrant of seizure
      The Government may request the issuance of a warrant authorizing
    the seizure of property subject to forfeiture under this section in
    the same manner as provided for a search warrant. If the court
    determines that there is probable cause to believe that the
    property to be seized would, in the event of conviction, be subject
    to forfeiture and that an order under subsection (e) of this
    section may not be sufficient to assure the availability of the
    property for forfeiture, the court shall issue a warrant
    authorizing the seizure of such property.
    (g) Execution
      Upon entry of an order of forfeiture under this section, the
    court shall authorize the Attorney General to seize all property
    ordered forfeited upon such terms and conditions as the court shall
    deem proper. Following entry of an order declaring the property
    forfeited, the court may, upon application of the United States,
    enter such appropriate restraining orders or injunctions, require
    the execution of satisfactory performance bonds, appoint receivers,
    conservators, appraisers, accountants, or trustees, or take any
    other action to protect the interest of the United States in the
    property ordered forfeited. Any income accruing to or derived from
    property ordered forfeited under this section may be used to offset
    ordinary and necessary expenses to the property which are required
    by law, or which are necessary to protect the interests of the
    United States or third parties.
    (h) Disposition of property
      Following the seizure of property ordered forfeited under this
    section, the Attorney General shall direct the disposition of the
    property by sale or any other commercially feasible means, making
    due provision for the rights of any innocent persons. Any property
    right or interest not exercisable by, or transferable for value to,
    the United States shall expire and shall not revert to the
    defendant, nor shall the defendant or any person acting in concert
    with him or on his behalf be eligible to purchase forfeited
    property at any sale held by the United States. Upon application of
    a person, other than the defendant or a person acting in concert
    with him or on his behalf, the court may restrain or stay the sale
    or disposition of the property pending the conclusion of any appeal
    of the criminal case giving rise to the forfeiture, if the
    applicant demonstrates that proceeding with the sale or disposition
    of the property will result in irreparable injury, harm, or loss to
    him.
    (i) Authority of the Attorney General
      With respect to property ordered forfeited under this section,
    the Attorney General is authorized to - 
        (1) grant petitions for mitigation or remission of forfeiture,
      restore forfeited property to victims of a violation of this
      subchapter, or take any other action to protect the rights of
      innocent persons which is in the interest of justice and which is
      not inconsistent with the provisions of this section;
        (2) compromise claims arising under this section;
        (3) award compensation to persons providing information
      resulting in a forfeiture under this section;
        (4) direct the disposition by the United States, in accordance
      with the provisions of section 881(e) of this title, of all
      property ordered forfeited under this section by public sale or
      any other commercially feasible means, making due provision for
      the rights of innocent persons; and
        (5) take appropriate measures necessary to safeguard and
      maintain property ordered forfeited under this section pending
      its disposition.
    (j) Applicability of civil forfeiture provisions
      Except to the extent that they are inconsistent with the
    provisions of this section, the provisions of section 881(d) of
    this title shall apply to a criminal forfeiture under this section.
    (k) Bar on intervention
      Except as provided in subsection (n) of this section, no party
    claiming an interest in property subject to forfeiture under this
    section may - 
        (1) intervene in a trial or appeal of a criminal case involving
      the forfeiture of such property under this section; or
        (2) commence an action at law or equity against the United
      States concerning the validity of his alleged interest in the
      property subsequent to the filing of an indictment or information
      alleging that the property is subject to forfeiture under this
      section.
    (l) Jurisdiction to enter orders
      The district courts of the United States shall have jurisdiction
    to enter orders as provided in this section without regard to the
    location of any property which may be subject to forfeiture under
    this section or which has been ordered forfeited under this
    section.
    (m) Depositions
      In order to facilitate the identification and location of
    property declared forfeited and to facilitate the disposition of
    petitions for remission or mitigation of forfeiture, after the
    entry of an order declaring property forfeited to the United
    States, the court may, upon application of the United States, order
    that the testimony of any witness relating to the property
    forfeited be taken by deposition and that any designated book,
    paper, document, record, recording, or other material not
    privileged be produced at the same time and place, in the same
    manner as provided for the taking of depositions under Rule 15 of
    the Federal Rules of Criminal Procedure.
    (n) Third party interests
      (1) Following the entry of an order of forfeiture under this
    section, the United States shall publish notice of the order and of
    its intent to dispose of the property in such manner as the
    Attorney General may direct. The Government may also, to the extent
    practicable, provide direct written notice to any person known to
    have alleged an interest in the property that is the subject of the
    order of forfeiture as a substitute for published notice as to
    those persons so notified.
      (2) Any person, other than the defendant, asserting a legal
    interest in property which has been ordered forfeited to the United
    States pursuant to this section may, within thirty days of the
    final publication of notice or his receipt of notice under
    paragraph (1), whichever is earlier, petition the court for a
    hearing to adjudicate the validity of his alleged interest in the
    property. The hearing shall be held before the court alone, without
    a jury.
      (3) The petition shall be signed by the petitioner under penalty
    of perjury and shall set forth the nature and extent of the
    petitioner's right, title, or interest in the property, the time
    and circumstances of the petitioner's acquisition of the right,
    title, or interest in the property, any additional facts supporting
    the petitioner's claim, and the relief sought.
      (4) The hearing on the petition shall, to the extent practicable
    and consistent with the interests of justice, be held within thirty
    days of the filing of the petition. The court may consolidate the
    hearing on the petition with a hearing on any other petition filed
    by a person other than the defendant under this subsection.
      (5) At the hearing, the petitioner may testify and present
    evidence and witnesses on his own behalf, and cross-examine
    witnesses who appear at the hearing. The United States may present
    evidence and witnesses in rebuttal and in defense of its claim to
    the property and cross-examine witnesses who appear at the hearing.
    In addition to testimony and evidence presented at the hearing, the
    court shall consider the relevant portions of the record of the
    criminal case which resulted in the order of forfeiture.
      (6) If, after the hearing, the court determines that the
    petitioner has established by a preponderance of the evidence that -
     
        (A) the petitioner has a legal right, title, or interest in the
      property, and such right, title, or interest renders the order of
      forfeiture invalid in whole or in part because the right, title,
      or interest was vested in the petitioner rather than the
      defendant or was superior to any right, title, or interest of the
      defendant at the time of the commission of the acts which gave
      rise to the forfeiture of the property under this section; or
        (B) the petitioner is a bona fide purchaser for value of the
      right, title, or interest in the property and was at the time of
      purchase reasonably without cause to believe that the property
      was subject to forfeiture under this section;

    the court shall amend the order of forfeiture in accordance with
    its determination.
      (7) Following the court's disposition of all petitions filed
    under this subsection, or if no such petitions are filed following
    the expiration of the period provided in paragraph (2) for the
    filing of such petitions, the United States shall have clear title
    to property that is the subject of the order of forfeiture and may
    warrant good title to any subsequent purchaser or transferee.
    (o) Construction
      The provisions of this section shall be liberally construed to
    effectuate its remedial purposes.
    (p) Forfeiture of substitute property
      (1) In general
        Paragraph (2) of this subsection shall apply, if any property
      described in subsection (a) of this section, as a result of any
      act or omission of the defendant - 
          (A) cannot be located upon the exercise of due diligence;
          (B) has been transferred or sold to, or deposited with, a
        third party;
          (C) has been placed beyond the jurisdiction of the court;
          (D) has been substantially diminished in value; or
          (E) has been commingled with other property which cannot be
        divided without difficulty.
      (2) Substitute property
        In any case described in any of subparagraphs (A) through (E)
      of paragraph (1), the court shall order the forfeiture of any
      other property of the defendant, up to the value of any property
      described in subparagraphs (A) through (E) of paragraph (1), as
      applicable.
      (3) Return of property to jurisdiction
        In the case of property described in paragraph (1)(C), the
      court may, in addition to any other action authorized by this
      subsection, order the defendant to return the property to the
      jurisdiction of the court so that the property may be seized and
      forfeited.
    (q) Restitution for cleanup of clandestine laboratory sites
      The court, when sentencing a defendant convicted of an offense
    under this subchapter or subchapter II of this chapter involving
    the manufacture, the possession, or the possession with intent to
    distribute, of amphetamine or methamphetamine, shall - 
        (1) order restitution as provided in sections 3612 and 3664 of
      title 18;
        (2) order the defendant to reimburse the United States, the
      State or local government concerned, or both the United States
      and the State or local government concerned for the costs
      incurred by the United States or the State or local government
      concerned, as the case may be, for the cleanup associated with
      the manufacture of amphetamine or methamphetamine by the
      defendant, or on premises or in property that the defendant owns,
      resides, or does business in; and
        (3) order restitution to any person injured as a result of the
      offense as provided in section 3663A of title 18.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 413, as added and amended Pub. L.
    98-473, title II, Secs. 303, 2301(d)-(f), Oct. 12, 1984, 98 Stat.
    2044, 2192, 2193; Pub. L. 99-570, title I, Secs. 1153(b), 1864,
    Oct. 27, 1986, 100 Stat. 3207-13, 3207-54; Pub. L. 104-237, title
    II, Sec. 207, Oct. 3, 1996, 110 Stat. 3104; Pub. L. 106-310, div.
    B, title XXXVI, Sec. 3613(a), Oct. 17, 2000, 114 Stat. 1229; Pub.
    L. 107-56, title III, Sec. 319(d), Oct. 26, 2001, 115 Stat. 314;
    Pub. L. 109-177, title VII, Sec. 743(a), Mar. 9, 2006, 120 Stat.
    272.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Rules of Evidence, referred to in subsec. (e)(3), are
    set out in the Appendix to Title 28, Judiciary and Judicial
    Procedure.
      The Federal Rules of Criminal Procedure, referred to in subsec.
    (m), are set out in the Appendix to Title 18, Crimes and Criminal
    Procedure.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (q). Pub. L. 109-177, Sec. 743(a)(1), inserted ",
    the possession, or the possession with intent to distribute," after
    "manufacture" in introductory provisions.
      Subsec. (q)(2). Pub. L. 109-177, Sec. 743(a)(2), inserted ", or
    on premises or in property that the defendant owns, resides, or
    does business in" after "by the defendant".
      2001 - Subsec. (e)(4). Pub. L. 107-56, Sec. 319(d)(2), added par.
    (4).
      Subsec. (p). Pub. L. 107-56, Sec. 319(d)(1), inserted heading and
    amended text of subsec. (p) generally. Prior to amendment, text
    read as follows: "If any of the property described in subsection
    (a) of this section, as a result of any act or omission of the
    defendant - 
        "(1) cannot be located upon the exercise of due diligence;
        "(2) has been transferred or sold to, or deposited with, a
      third party;
        "(3) has been placed beyond the jurisdiction of the court;
        "(4) has been substantially diminished in value; or
        "(5) has been commingled with other property which cannot be
      divided without difficulty;
    the court shall order the forfeiture of any other property of the
    defendant up to the value of any property described in paragraphs
    (1) through (5)."
      2000 - Subsec. (q). Pub. L. 106-310, Sec. 3613(a)(1), (2), in
    introductory provisions, inserted "amphetamine or" before
    "methamphetamine" and substituted "shall" for "may".
      Subsec. (q)(2). Pub. L. 106-310, Sec. 3613(a)(2), (3), inserted
    ", the State or local government concerned, or both the United
    States and the State or local government concerned" after "to
    reimburse the United States", "or the State or local government
    concerned, as the case may be," after "costs incurred by the United
    States", and "amphetamine or" before "methamphetamine".
      Subsec. (q)(3). Pub. L. 106-310, Sec. 3613(a)(4), substituted
    "section 3663A of title 18" for "section 3663 of title 18".
      1996 - Subsec. (q). Pub. L. 104-237 added subsec. (q).
      1986 - Subsec. (c). Pub. L. 99-570, Sec. 1864(1), substituted
    "subsection (n)" for "subsection (o)".
      Subsec. (f). Pub. L. 99-570, Sec. 1864(2), substituted
    "subsection (e)" for "subsection (f)".
      Subsec. (i)(1). Pub. L. 99-570, Sec. 1864(3), substituted "this
    subchapter" for "this chapter".
      Subsec. (k). Pub. L. 99-570, Sec. 1864(1), (4), which directed
    the substitution of "subsection (n)" for "subsection (o)" in "the
    second subsection (h)", and directed the redesignation of "the
    second subsection (h)" as subsection (k), were executed to this
    subsection because the "second subsection (h)" had been editorially
    redesignated subsec. (k) to reflect the probable intent of
    Congress. See 1984 Amendment note below.
      Subsec. (p). Pub. L. 99-570, Sec. 1153(b), which directed that
    "section 413 of title II of the Comprehensive Drug Abuse Prevention
    and Control Act of 1975" be amended "by redesignating subsection
    '(p)' as subsection '(q)' " and adding subsec. (p) was executed to
    this section, which is section 413 of the Comprehensive Drug Abuse
    Prevention and Control Act of 1970, as the probable intent of
    Congress, by adding a subsec. (p) in view of the prior
    redesignation of subsec. (p) as (o) by Pub. L. 98-473, Sec.
    2301(e)(2). See 1984 Amendment note below.
      1984 - Subsec. (a). Pub. L. 98-473, Sec. 2301(d), inserted "In
    lieu of a fine otherwise authorized by this part, a defendant who
    derives profits or other proceeds from an offense may be fined not
    more than twice the gross profits or other proceeds."
      Subsec. (d). Pub. L. 98-473, Sec. 2301(e), struck out subsec. (d)
    which related to forfeiture of property other than that described
    in subsec. (a) and the conditions therefor, and redesignated former
    subsec. (e) as (d).
      Subsecs. (e) to (p). Pub. L. 98-473, Sec. 2301(e)(2), which
    directed that this section be amended by redesignating subsecs.
    (e), (f), (g), (h), (i), (l), (m), (n), (o), and (p) as subsecs.
    (d), (e), (f), (g), (h), (i), (j), (h), (l), (m), (n), and (o),
    respectively, was executed by redesignating subsecs. (e) to (p) as
    (d) to (o), respectively, to give effect to the probable intent of
    Congress.
      Subsec. (n)(1). Pub. L. 98-473, Sec. 2301(f), struck out "for at
    least seven successive court days" after "to dispose of the
    property".

                              SAVINGS CLAUSE                          
      Pub. L. 109-177, title VII, Sec. 743(b), Mar. 9, 2006, 120 Stat.
    273, provided that: "Nothing in this section [amending this
    section] shall be interpreted or construed to amend, alter, or
    otherwise affect the obligations, liabilities and other
    responsibilities of any person under any Federal or State
    environmental laws."

-End-



-CITE-
    21 USC Sec. 853a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 853a. Transferred

-COD-
                               CODIFICATION                           
      Section, Pub. L. 100-690, title V, Sec. 5301, Nov. 18, 1988, 102
    Stat. 4310, which related to denial of Federal benefits to drug
    traffickers and possessors, was renumbered section 421 of the
    Controlled Substances Act by Pub. L. 101-647, title X, Sec.
    1002(d)(1), Nov. 29, 1990, 104 Stat. 4827, and is classified to
    section 862 of this title.

-End-



-CITE-
    21 USC Sec. 854                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 854. Investment of illicit drug profits

-STATUTE-
    (a) Prohibition
      It shall be unlawful for any person who has received any income
    derived, directly or indirectly, from a violation of this
    subchapter or subchapter II of this chapter punishable by
    imprisonment for more than one year in which such person has
    participated as a principal within the meaning of section 2 of
    title 18, to use or invest, directly or indirectly, any part of
    such income, or the proceeds of such income, in acquisition of any
    interest in, or the establishment or operation of, any enterprise
    which is engaged in, or the activities of which affect interstate
    or foreign commerce. A purchase of securities on the open market
    for purposes of investment, and without the intention of
    controlling or participating in the control of the issuer, or of
    assisting another to do so, shall not be unlawful under this
    section if the securities of the issuer held by the purchaser, the
    members of his immediate family, and his or their accomplices in
    any violation of this subchapter or subchapter II of this chapter
    after such purchase do not amount in the aggregate to 1 per centum
    of the outstanding securities of any one class, and do not confer,
    either in law or in fact, the power to elect one or more directors
    of the issuer.
    (b) Penalty
      Whoever violates this section shall be fined not more than
    $50,000 or imprisoned not more than ten years, or both.
    (c) "Enterprise" defined
      As used in this section, the term "enterprise" includes any
    individual, partnership, corporation, association, or other legal
    entity, and any union or group of individuals associated in fact
    although not a legal entity.
    (d) Construction
      The provisions of this section shall be liberally construed to
    effectuate its remedial purposes.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 414, as added Pub. L. 98-473, title
    II, Sec. 303, Oct. 12, 1984, 98 Stat. 2049.)

-End-



-CITE-
    21 USC Sec. 855                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 855. Alternative fine

-STATUTE-
      In lieu of a fine otherwise authorized by this part, a defendant
    who derives profits or other proceeds from an offense may be fined
    not more than twice the gross profits or other proceeds.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 415, as added Pub. L. 98-473, title
    II, Sec. 2302, Oct. 12, 1984, 98 Stat. 2193.)

-End-



-CITE-
    21 USC Sec. 856                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 856. Maintaining drug-involved premises

-STATUTE-
    (a) Unlawful acts
      Except as authorized by this subchapter, it shall be unlawful to -
     
        (1) knowingly open, lease, rent, use, or maintain any place,
      whether permanently or temporarily, for the purpose of
      manufacturing, distributing, or using any controlled substance;
        (2) manage or control any place, whether permanently or
      temporarily, either as an owner, lessee, agent, employee,
      occupant, or mortgagee, and knowingly and intentionally rent,
      lease, profit from, or make available for use, with or without
      compensation, the place for the purpose of unlawfully
      manufacturing, storing, distributing, or using a controlled
      substance.
    (b) Criminal penalties
      Any person who violates subsection (a) of this section shall be
    sentenced to a term of imprisonment of not more than 20 years or a
    fine of not more than $500,000, or both, or a fine of $2,000,000
    for a person other than an individual.
    (c) Violation as offense against property
      A violation of subsection (a) of this section shall be considered
    an offense against property for purposes of section
    3663A(c)(1)(A)(ii) of title 18.
    (d) Civil penalites
      (1) Any person who violates subsection (a) of this section shall
    be subject to a civil penalty of not more than the greater of - 
        (A) $250,000; or
        (B) 2 times the gross receipts, either known or estimated, that
      were derived from each violation that is attributable to the
      person.

      (2) If a civil penalty is calculated under paragraph (1)(B), and
    there is more than 1 defendant, the court may apportion the penalty
    between multiple violators, but each violator shall be jointly and
    severally liable for the civil penalty under this subsection.
    (e) Declaratory and injunctive remedies
      Any person who violates subsection (a) of this section shall be
    subject to declaratory and injunctive remedies as set forth in
    section 843(f) of this title.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 416, as added Pub. L. 99-570, title
    I, Sec. 1841(a), Oct. 27, 1986, 100 Stat. 3207-52; amended Pub. L.
    106-310, div. B, title XXXVI, Sec. 3613(e), Oct. 17, 2000, 114
    Stat. 1230; Pub. L. 108-21, title VI, Sec. 608(b)(1), (2), (c),
    Apr. 30, 2003, 117 Stat. 691.)


-MISC1-
                                AMENDMENTS                            
      2003 - Pub. L. 108-21, Sec. 608(b)(2), substituted "Maintaining
    drug-involved premises" for "Establishment of manufacturing
    operations" in section catchline.
      Subsec. (a)(1). Pub. L. 108-21, Sec. 608(b)(1)(A), substituted
    "open, lease, rent, use, or maintain any place, whether permanently
    or temporarily," for "open or maintain any place".
      Subsec. (a)(2). Pub. L. 108-21, Sec. 608(b)(1)(B), added par. (2)
    and struck out former par. (2) which read as follows: "manage or
    control any building, room, or enclosure, either as an owner,
    lessee, agent, employee, or mortgagee, and knowingly and
    intentionally rent, lease, or make available for use, with or
    without compensation, the building, room, or enclosure for the
    purpose of unlawfully manufacturing, storing, distributing, or
    using a controlled substance."
      Subsecs. (d), (e). Pub. L. 108-21, Sec. 608(c), added subsecs.
    (d) and (e).
      2000 - Subsec. (c). Pub. L. 106-310 added subsec. (c).

-End-



-CITE-
    21 USC Sec. 857                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 857. Repealed.

-MISC1-
    Sec. 857. Repealed. Pub. L. 101-647, title XXIV, Sec. 2401(d), Nov.
      29, 1990, 104 Stat. 4859.
      Section, Pub. L. 99-570, title I, Sec. 1822, Oct. 27, 1986, 100
    Stat. 3207-51; Pub. L. 100-690, title VI, Sec. 6485, Nov. 18, 1988,
    102 Stat. 4384; Pub. L. 101-647, title XXIV, Sec. 2401(b), Nov. 29,
    1990, 104 Stat. 4859, related to interstate and foreign sale and
    transportation of drug paraphernalia.
      Subsec. (a), which related to unlawful acts, was repealed.
      Subsecs. (b) to (f) were redesignated as subsecs. (b) to (f) of
    section 422 of the Controlled Substances Act by section 2401(b) of
    Pub. L. 101-647 and transferred to section 863(b) to (f) of this
    title.

                              EFFECTIVE DATE                          
      Section 1823 of Pub. L. 99-570 which provided that subtitle O
    (Secs. 1821-1823) of title I of Pub. L. 99-570, enacting this
    section and provisions set out as a note under section 801 of this
    title, was to become effective 90 days after Oct. 27, 1986, was
    repealed by Pub. L. 101-647, title XXIV, Sec. 2401(d), Nov. 29,
    1990, 104 Stat. 4859.

-End-



-CITE-
    21 USC Sec. 858                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 858. Endangering human life while illegally manufacturing
      controlled substance

-STATUTE-
      Whoever, while manufacturing a controlled substance in violation
    of this subchapter, or attempting to do so, or transporting or
    causing to be transported materials, including chemicals, to do so,
    creates a substantial risk of harm to human life shall be fined in
    accordance with title 18 or imprisoned not more than 10 years, or
    both.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 417, as added Pub. L. 100-690,
    title VI, Sec. 6301(a), Nov. 18, 1988, 102 Stat. 4370.)

-End-



-CITE-
    21 USC Sec. 859                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 859. Distribution to persons under age twenty-one

-STATUTE-
    (a) First offense
      Except as provided in section 860 of this title, any person at
    least eighteen years of age who violates section 841(a)(1) of this
    title by distributing a controlled substance to a person under
    twenty-one years of age is (except as provided in subsection (b) of
    this section) subject to (1) twice the maximum punishment
    authorized by section 841(b) of this title, and (2) at least twice
    any term of supervised release authorized by section 841(b) of this
    title, for a first offense involving the same controlled substance
    and schedule. Except to the extent a greater minimum sentence is
    otherwise provided by section 841(b) of this title, a term of
    imprisonment under this subsection shall be not less than one year.
    The mandatory minimum sentencing provisions of this subsection
    shall not apply to offenses involving 5 grams or less of marihuana.
    (b) Second offense
      Except as provided in section 860 of this title, any person at
    least eighteen years of age who violates section 841(a)(1) of this
    title by distributing a controlled substance to a person under
    twenty-one years of age after a prior conviction under subsection
    (a) of this section (or under section 333(b) of this title as in
    effect prior to May 1, 1971) has become final, is subject to (1)
    three times the maximum punishment authorized by section 841(b) of
    this title, and (2) at least three times any term of supervised
    release authorized by section 841(b) of this title, for a second or
    subsequent offense involving the same controlled substance and
    schedule. Except to the extent a greater minimum sentence is
    otherwise provided by section 841(b) of this title, a term of
    imprisonment under this subsection shall be not less than one year.
    Penalties for third and subsequent convictions shall be governed by
    section 841(b)(1)(A) of this title.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 418, formerly Sec. 405, Oct. 27,
    1970, 84 Stat. 1265; Pub. L. 98-473, title II, Secs. 224(b),
    503(b)(3), Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99-570,
    title I, Secs. 1004(a), 1005(b)(1), 1105(a), (b), Oct. 27, 1986,
    100 Stat. 3207-6, 3207-11; Pub. L. 100-690, title VI, Secs.
    6452(b), 6455, 6456, Nov. 18, 1988, 102 Stat. 4371, 4372;
    renumbered Sec. 418 and amended Pub. L. 101-647, title X, Secs.
    1002(a), 1003(a), title XXXV, Sec. 3599L, Nov. 29, 1990, 104 Stat.
    4827, 4828, 4932.)

-COD-
                               CODIFICATION                           
      Section was classified to section 845 of this title prior to
    renumbering by Pub. L. 101-647.


-MISC1-
                                AMENDMENTS                            
      1990 - Subsec. (a). Pub. L. 101-647, Sec. 1003(a)(1), substituted
    "subject to (1) twice the maximum punishment authorized by section
    841(b) of this title" for "punishable by (1) a term of
    imprisonment, or a fine, or both, up to twice that authorized by
    section 841(b) of this title".
      Pub. L. 101-647, Sec. 1002(a)(2)(A), substituted "section 860"
    for "section 845a".
      Subsec. (b). Pub. L. 101-647, Sec. 3599L, substituted "has become
    final" for "have become final".
      Pub. L. 101-647, Sec. 1003(a)(2), substituted "subject to (1)
    three times the maximum punishment authorized by section 841(b) of
    this title" for "punishable by (1) a term of imprisonment, or a
    fine, or both, up to three times that authorized by section 841(b)
    of this title".
      Pub. L. 101-647, Sec. 1002(a)(2)(B), substituted "section 860"
    for "section 845a".
      1988 - Subsec. (a). Pub. L. 100-690, Sec. 6455, inserted at end
    "The mandatory minimum sentencing provisions of this subsection
    shall not apply to offenses involving 5 grams or less of
    marihuana."
      Subsec. (b). Pub. L. 100-690, Sec. 6452(b), struck out "or
    subsequent" after "Second" in heading, and in text struck out "or
    convictions" after "a prior conviction", and inserted at end
    "Penalties for third and subsequent convictions shall be governed
    by section 841(b)(1)(A) of this title."
      Pub. L. 100-690, Sec. 6456, struck out "The mandatory minimum
    sentencing provisions of this paragraph shall not apply to offenses
    involving 5 grams or less of marihuana."
      1986 - Subsec. (a). Pub. L. 99-570, Sec. 1105(a), inserted
    "Except to the extent a greater minimum sentence is otherwise
    provided by section 841(b) of this title, a term of imprisonment
    under this subsection shall be not less than one year."
      Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
    release" for "special parole term".
      Subsec. (b). Pub. L. 99-570, Sec. 1105(b), inserted "Except to
    the extent a greater minimum sentence is otherwise provided by
    section 841(b) of this title, a term of imprisonment under this
    subsection shall be not less than one year. The mandatory minimum
    sentencing provisions of this paragraph shall not apply to offenses
    involving 5 grams or less of marihuana."
      Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
    release" for "special parole term".
      1984 - Subsecs. (a), (b). Pub. L. 98-473, Sec. 503(b)(3),
    substituted "Except as provided in section 845a of this title, any"
    for "Any".
      Pub. L. 98-473, Sec. 224(b), which directed amendment of this
    section effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98-
    473 set out as an Effective Date note under section 3551 of Title
    18, Crimes and Criminal Procedure) was repealed by Pub. L. 99-570,
    Sec. 1005(b)(1).

                     EFFECTIVE DATE OF 1986 AMENDMENT                 
      Amendment by section 1004(a) of Pub. L. 99-570 effective on date
    of taking effect of section 3583 of Title 18, Crimes and Criminal
    Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
    out as a note under section 841 of this title.

-End-



-CITE-
    21 USC Sec. 860                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 860. Distribution or manufacturing in or near schools and
      colleges

-STATUTE-
    (a) Penalty
      Any person who violates section 841(a)(1) of this title or
    section 856 of this title by distributing, possessing with intent
    to distribute, or manufacturing a controlled substance in or on, or
    within one thousand feet of, the real property comprising a public
    or private elementary, vocational, or secondary school or a public
    or private college, junior college, or university, or a playground,
    or housing facility owned by a public housing authority, or within
    100 feet of a public or private youth center, public swimming pool,
    or video arcade facility, is (except as provided in subsection (b)
    of this section) subject to (1) twice the maximum punishment
    authorized by section 841(b) of this title; and (2) at least twice
    any term of supervised release authorized by section 841(b) of this
    title for a first offense. A fine up to twice that authorized by
    section 841(b) of this title may be imposed in addition to any term
    of imprisonment authorized by this subsection. Except to the extent
    a greater minimum sentence is otherwise provided by section 841(b)
    of this title, a person shall be sentenced under this subsection to
    a term of imprisonment of not less than one year. The mandatory
    minimum sentencing provisions of this paragraph shall not apply to
    offenses involving 5 grams or less of marihuana.
    (b) Second offenders
      Any person who violates section 841(a)(1) of this title or
    section 856 of this title by distributing, possessing with intent
    to distribute, or manufacturing a controlled substance in or on, or
    within one thousand feet of, the real property comprising a public
    or private elementary, vocational, or secondary school or a public
    or private college, junior college, or university, or a playground,
    or housing facility owned by a public housing authority, or within
    100 feet of a public or private youth center, public swimming pool,
    or video arcade facility, after a prior conviction under subsection
    (a) of this section has become final is punishable (1) by the
    greater of (A) a term of imprisonment of not less than three years
    and not more than life imprisonment or (B) three times the maximum
    punishment authorized by section 841(b) of this title for a first
    offense, and (2) at least three times any term of supervised
    release authorized by section 841(b) of this title for a first
    offense. A fine up to three times that authorized by section 841(b)
    of this title may be imposed in addition to any term of
    imprisonment authorized by this subsection. Except to the extent a
    greater minimum sentence is otherwise provided by section 841(b) of
    this title, a person shall be sentenced under this subsection to a
    term of imprisonment of not less than three years. Penalties for
    third and subsequent convictions shall be governed by section
    841(b)(1)(A) of this title.
    (c) Employing children to distribute drugs near schools or
      playgrounds
      Notwithstanding any other law, any person at least 21 years of
    age who knowingly and intentionally - 
        (1) employs, hires, uses, persuades, induces, entices, or
      coerces a person under 18 years of age to violate this section;
      or
        (2) employs, hires, uses, persuades, induces, entices, or
      coerces a person under 18 years of age to assist in avoiding
      detection or apprehension for any offense under this section by
      any Federal, State, or local law enforcement official,

    is punishable by a term of imprisonment, a fine, or both, up to
    triple those authorized by section 841 of this title.
    (d) Suspension of sentence; probation; parole
      In the case of any mandatory minimum sentence imposed under this
    section, imposition or execution of such sentence shall not be
    suspended and probation shall not be granted. An individual
    convicted under this section shall not be eligible for parole until
    the individual has served the mandatory minimum term of
    imprisonment as provided by this section.
    (e) Definitions
      For the purposes of this section - 
        (1) The term "playground" means any outdoor facility (including
      any parking lot appurtenant thereto) intended for recreation,
      open to the public, and with any portion thereof containing three
      or more separate apparatus intended for the recreation of
      children including, but not limited to, sliding boards,
      swingsets, and teeterboards.
        (2) The term "youth center" means any recreational facility
      and/or gymnasium (including any parking lot appurtenant thereto),
      intended primarily for use by persons under 18 years of age,
      which regularly provides athletic, civic, or cultural activities.
        (3) The term "video arcade facility" means any facility,
      legally accessible to persons under 18 years of age, intended
      primarily for the use of pinball and video machines for amusement
      containing a minimum of ten pinball and/or video machines.
        (4) The term "swimming pool" includes any parking lot
      appurtenant thereto.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 419, formerly Sec. 405A, as added
    Pub. L. 98-473, title II, Sec. 503(a), Oct. 12, 1984, 98 Stat.
    2069; amended Pub. L. 99-570, title I, Secs. 1004(a), 1104,
    1105(c), 1841(b), 1866(b), (c), Oct. 27, 1986, 100 Stat. 3207-6,
    3207-11, 3207-52, 3207-55; Pub. L. 99-646, Sec. 28, Nov. 10, 1986,
    100 Stat. 3598; Pub. L. 100-690, title VI, Secs. 6452(b)(1), 6457,
    6458, Nov. 18, 1988, 102 Stat. 4371, 4373; renumbered Sec. 419 and
    amended Pub. L. 101-647, title X, Secs. 1002(b), 1003(b), title
    XII, Sec. 1214, title XV, Sec. 1502, title XXXV, Sec. 3599L, Nov.
    29, 1990, 104 Stat. 4827, 4829, 4833, 4836, 4932; Pub. L. 103-322,
    title XIV, Sec. 140006, title XXXII, Sec. 320107, title XXXIII,
    Sec. 330009(a), Sept. 13, 1994, 108 Stat. 2032, 2111, 2143.)

-COD-
                               CODIFICATION                           
      Section was classified to section 845a of this title prior to
    renumbering by Pub. L. 101-647.


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (a). Pub. L. 103-322, Sec. 320107, substituted
    "playground, or housing facility owned by a public housing
    authority, or within" for "playground, or within".
      Subsec. (b). Pub. L. 103-322, Secs. 320107, 330009(a),
    substituted "playground, or housing facility owned by a public
    housing authority, or within" for "playground, or within" and
    inserted a period at end of penultimate sentence.
      Subsecs. (c) to (e). Pub. L. 103-322, Sec. 140006, added subsec.
    (c) and redesignated former subsecs. (c) and (d) as (d) and (e),
    respectively.
      1990 - Subsec. (a). Pub. L. 101-647, Sec. 1502(1), inserted "or a
    playground," after "university," and struck out "playground," after
    "within 100 feet of a".
      Pub. L. 101-647, Sec. 1214(1)(C), substituted "a person shall be
    sentenced under this subsection to a term of imprisonment of not
    less than one year" for "a term of imprisonment under this
    subsection shall be not less than one year".
      Pub. L. 101-647, Sec. 1214(1)(B), inserted "A fine up to twice
    that authorized by section 841(b) of this title may be imposed in
    addition to any term of imprisonment authorized by this
    subsection."
      Pub. L. 101-647, Sec. 1214(1)(A), which directed the amendment of
    par. (1) by striking out ", or a fine, or both," could not be
    executed because those words did not appear. See note below.
      Pub. L. 101-647, Sec. 1003(b)(1), which directed the substitution
    of "subject to (1) twice the maximum punishment authorized by
    section 841(b) of this title" for "punishable (1) by a term of
    imprisonment, or a fine, or both, up to twice that authorized by
    section 841(b) of this title", was executed by making the
    substitution for "punishable (1) by a term of imprisonment, or
    fine, or both, up to twice that authorized by section 841(b) of
    this title" to reflect the probable intent of Congress.
      Subsec. (b). Pub. L. 101-647, Sec. 3599L, substituted "has become
    final" for "have become final".
      Pub. L. 101-647, Sec. 1502(2), inserted "or a playground," after
    "university," and struck out "playground," after "within 100 feet
    of a".
      Pub. L. 101-647, Sec. 1214(2)(B), inserted after first sentence
    "A fine up to three times that authorized by section 841(b) of this
    title may be imposed in addition to any term of imprisonment
    authorized by this subsection. Except to the extent a greater
    minimum sentence is otherwise provided by section 841(b) of this
    title, a person shall be sentenced under this subsection to a term
    of imprisonment of not less than three years".
      Subsec. (b)(1)(B). Pub. L. 101-647, Sec. 1214(2)(A), which
    directed the amendment of subpar. (B) by striking ", or a fine up
    to three times that" through "or both", could not be executed
    because the language did not appear after execution of the
    intervening amendment by Pub. L. 101-647, Sec. 1003(b)(2). See
    below.
      Pub. L. 101-647, Sec. 1003(b)(2), substituted "three times the
    maximum punishment authorized by section 841(b) of this title for a
    first offense" for "a term of imprisonment of up to three times
    that authorized by section 841(b) of this title for a first
    offense, or a fine up to three times that authorized by section
    841(b) of this title for a first offense, or both".
      Subsec. (c). Pub. L. 101-647, Sec. 1214(3), inserted "mandatory
    minimum" after "In the case of any", struck out "subsection (b) of"
    after "imposed under", and substituted "An individual convicted
    under this section shall not be eligible for parole until the
    individual has served the mandatory minimum term of imprisonment as
    provided by this section" for "An individual convicted under
    subsection (b) of this section shall not be eligible for parole
    under chapter 311 of title 18 until the individual has served the
    minimum sentence required by such subsection".
      1988 - Subsec. (a). Pub. L. 100-690, Secs. 6457, 6458(a),
    inserted ", possessing with intent to distribute," after
    "distributing" and ", or within 100 feet of a playground, public or
    private youth center, public swimming pool, or video arcade
    facility," after "university".
      Subsec. (b). Pub. L. 100-690, Secs. 6452(b)(1), 6457, 6458(a),
    inserted ", possessing with intent to distribute," after
    "distributing", and ", or within 100 feet of a playground, public
    or private youth center, public swimming pool, or video arcade
    facility," after "university", substituted "a prior conviction" for
    "a prior conviction or convictions", and inserted at end "Penalties
    for third and subsequent convictions shall be governed by section
    841(b)(1)(A) of this title."
      Subsec. (d). Pub. L. 100-690, Sec. 6458(b), added subsec. (d).
      1986 - Subsec. (a). Pub. L. 99-570, Secs. 1104(a), (b), 1105(c),
    1841(b)(1), inserted "or section 856 of this title" and "or
    manufacturing", substituted "a public or private elementary,
    vocational, or secondary school or a public or private college,
    junior college, or university" for "a public or private elementary
    or secondary school", struck out "involving the same controlled
    substance and schedule" after "for a first offense", and inserted
    "Except to the extent a greater minimum sentence is otherwise
    provided by section 841(b) of this title, a term of imprisonment
    under this subsection shall be not less than one year. The
    mandatory minimum sentencing provisions of this paragraph shall not
    apply to offenses involving 5 grams or less of marihuana."
      Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
    release" for "special parole term".
      Subsec. (b). Pub. L. 99-646 which directed that "parole" be
    inserted after "(2) at least three times any special" could not be
    executed in view of prior amendment by Pub. L. 99-570, Sec. 1104(c)
    below.
      Pub. L. 99-570, Sec. 1166(b), which directed that "term of
    supervised release" be substituted for "special term" could not be
    executed in view of prior amendment by Pub. L. 99-570, Sec. 1104(c)
    below.
      Pub. L. 99-570, Secs. 1104(a), 1841(b)(2), inserted reference to
    section 856 of this title, inserted "or manufacturing" after
    "distributing" and substituted "a public or private elementary,
    vocational, or secondary school or a public or private college,
    junior college, or university" for "a public or private elementary
    or secondary school".
      Pub. L. 99-570, Sec. 1104(c), amended cls. (1) and (2) generally.
    Prior to amendment, cls. (1) and (2) read as follows: "(1) by a
    term of imprisonment of not less than three years and not more than
    life imprisonment and (2) at least three times any special term
    authorized by section 841(b) of this title for a second or
    subsequent offense involving the same controlled substance and
    schedule."
      Subsec. (c). Pub. L. 99-570, Sec. 1866(c), substituted reference
    to chapter 311 of title 18 for reference to section 4202 of that
    title.

                     EFFECTIVE DATE OF 1986 AMENDMENT                 
      Amendment by section 1004(a) of Pub. L. 99-570 effective on date
    of taking effect of section 3583 of Title 18, Crimes and Criminal
    Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
    out as a note under section 841 of this title.

-End-



-CITE-
    21 USC Sec. 860a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 860a. Consecutive sentence for manufacturing or distributing,
      or possessing with intent to manufacture or distribute,
      methamphetamine on premises where children are present or reside

-STATUTE-
      Whoever violates section 841(a)(1) of this title by manufacturing
    or distributing, or possessing with intent to manufacture or
    distribute, methamphetamine or its salts, isomers or salts of
    isomers on premises in which an individual who is under the age of
    18 years is present or resides, shall, in addition to any other
    sentence imposed, be imprisoned for a period of any term of years
    but not more than 20 years, subject to a fine, or both.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 419a, as added Pub. L. 109-177,
    title VII, Sec. 734(a), Mar. 9, 2006, 120 Stat. 270.)

-End-



-CITE-
    21 USC Sec. 861                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 861. Employment or use of persons under 18 years of age in
      drug operations

-STATUTE-
    (a) Unlawful acts
      It shall be unlawful for any person at least eighteen years of
    age to knowingly and intentionally - 
        (1) employ, hire, use, persuade, induce, entice, or coerce, a
      person under eighteen years of age to violate any provision of
      this subchapter or subchapter II of this chapter;
        (2) employ, hire, use, persuade, induce, entice, or coerce, a
      person under eighteen years of age to assist in avoiding
      detection or apprehension for any offense of this subchapter or
      subchapter II of this chapter by any Federal, State, or local law
      enforcement official; or
        (3) receive a controlled substance from a person under 18 years
      of age, other than an immediate family member, in violation of
      this subchapter or subchapter II of this chapter.
    (b) Penalty for first offense
      Any person who violates subsection (a) of this section is subject
    to twice the maximum punishment otherwise authorized and at least
    twice any term of supervised release otherwise authorized for a
    first offense. Except to the extent a greater minimum sentence is
    otherwise provided, a term of imprisonment under this subsection
    shall not be less than one year.
    (c) Penalty for subsequent offenses
      Any person who violates subsection (a) of this section after a
    prior conviction under subsection (a) of this section has become
    final, is subject to three times the maximum punishment otherwise
    authorized and at least three times any term of supervised release
    otherwise authorized for a first offense. Except to the extent a
    greater minimum sentence is otherwise provided, a term of
    imprisonment under this subsection shall not be less than one year.
    Penalties for third and subsequent convictions shall be governed by
    section 841(b)(1)(A) of this title.
    (d) Penalty for providing or distributing controlled substance to
      underage person
      Any person who violates subsection (a)(1) or (2) of this section
    (!1)

        (1) by knowingly providing or distributing a controlled
      substance or a controlled substance analogue to any person under
      eighteen years of age; or
        (2) if the person employed, hired, or used is fourteen years of
      age or younger,

    shall be subject to a term of imprisonment for not more than five
    years or a fine of not more than $50,000, or both, in addition to
    any other punishment authorized by this section.
    (e) Suspension of sentence; probation; parole
      In any case of any sentence imposed under this section,
    imposition or execution of such sentence shall not be suspended and
    probation shall not be granted. An individual convicted under this
    section of an offense for which a mandatory minimum term of
    imprisonment is applicable shall not be eligible for parole under
    section 4202 of title 18 (!2) until the individual has served the
    mandatory term of imprisonment as enhanced by this section.

    (f) Distribution of controlled substance to pregnant individual
      Except as authorized by this subchapter, it shall be unlawful for
    any person to knowingly or intentionally provide or distribute any
    controlled substance to a pregnant individual in violation of any
    provision of this subchapter. Any person who violates this
    subsection shall be subject to the provisions of subsections (b),
    (c), and (e) of this section.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 420, formerly Sec. 405B, as added
    Pub. L. 99-570, title I, Sec. 1102, Oct. 27, 1986, 100 Stat. 3207-
    10; amended Pub. L. 100-690, title VI, Secs. 6452(b)(1), 6459,
    6470(d), Nov. 18, 1988, 102 Stat. 4371, 4373, 4378; renumbered Sec.
    420 and amended Pub. L. 101-647, title X, Secs. 1002(c), 1003(c),
    title XXXV, Sec. 3599L, Nov. 29, 1990, 104 Stat. 4827, 4829, 4932.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 4202 of title 18, referred to in subsec. (e), which, as
    originally enacted in Title 18, Crimes and Criminal Procedure,
    related to eligibility of prisoners for parole, was repealed and a
    new section 4202 enacted as part of the repeal and enactment of a
    new chapter 311 (Sec. 4201 et seq.) of Title 18, by Pub. L. 94-233,
    Sec. 2, Mar. 15, 1976, 90 Stat. 219. For provisions relating to the
    eligibility of prisoners for parole, see section 4205 of Title 18.
    Pub. L. 98-473, title II, Secs. 218(a)(5), 235(a)(1), (b)(1), Oct.
    12, 1984, 98 Stat. 2027, 2031, 2032, as amended, provided that,
    effective on the first day of the first calendar month beginning 36
    months after Oct. 12, 1984 (Nov. 1, 1987), chapter 311 of Title 18
    is repealed, subject to remaining effective for five years after
    Nov. 1, 1987, in certain circumstances. See Effective Date note set
    out under section 3551 of Title 18.

-COD-
                               CODIFICATION                           
      Section was classified to section 845b of this title prior to
    renumbering by Pub. L. 101-647.


-MISC1-
                                AMENDMENTS                            
      1990 - Subsec. (b). Pub. L. 101-647, Sec. 1003(c)(1), which
    directed the substitution of "is subject to twice the maximum
    punishment otherwise authorized" for "is punishable by a term of
    imprisonment up to twice that authorized, or up to twice the fine
    authorized, or both," was executed by making the substitution for
    "is punishable by a term of imprisonment up to twice that otherwise
    authorized, or up to twice the fine otherwise authorized, or both,"
    to reflect the probable intent of Congress.
      Subsec. (c). Pub. L. 101-647, Sec. 3599L, substituted "has become
    final" for "have become final".
      Pub. L. 101-647, Sec. 1003(c)(2), which directed the substitution
    of "is subject to three times the maximum punishment otherwise
    authorized" for "is punishable by a term of imprisonment up to
    three times that authorized, or up to three times the fine
    authorized, or both," was executed by making the substitution for
    "is punishable by a term of imprisonment up to three times that
    otherwise authorized, or up to three times the fine otherwise
    authorized, or both," to reflect the probable intent of Congress.
      1988 - Subsec. (a)(3). Pub. L. 100-690, Sec. 6459, added par.
    (3).
      Subsec. (c). Pub. L. 100-690, Sec. 6452(b)(1), struck out "or
    convictions" after "a prior conviction" and inserted at end
    "Penalties for third and subsequent convictions shall be governed
    by section 841(b)(1)(A) of this title."
      Subsec. (e). Pub. L. 100-690, Sec. 6470(d), struck out "required
    by section 841(b) of this title" after "mandatory term of
    imprisonment".

-FOOTNOTE-               

    (!1) So in original. Probably should be followed by a dash.

    (!2) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 862                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 862. Denial of Federal benefits to drug traffickers and
      possessors

-STATUTE-
    (a) Drug traffickers
      (1) Any individual who is convicted of any Federal or State
    offense consisting of the distribution of controlled substances
    shall - 
        (A) at the discretion of the court, upon the first conviction
      for such an offense be ineligible for any or all Federal benefits
      for up to 5 years after such conviction;
        (B) at the discretion of the court, upon a second conviction
      for such an offense be ineligible for any or all Federal benefits
      for up to 10 years after such conviction; and
        (C) upon a third or subsequent conviction for such an offense
      be permanently ineligible for all Federal benefits.

      (2) The benefits which are denied under this subsection shall not
    include benefits relating to long-term drug treatment programs for
    addiction for any person who, if there is a reasonable body of
    evidence to substantiate such declaration, declares himself to be
    an addict and submits himself to a long-term treatment program for
    addiction, or is deemed to be rehabilitated pursuant to rules
    established by the Secretary of Health and Human Services.
    (b) Drug possessors
      (1) Any individual who is convicted of any Federal or State
    offense involving the possession of a controlled substance (as such
    term is defined for purposes of this subchapter) shall - 
        (A) upon the first conviction for such an offense and at the
      discretion of the court - 
          (i) be ineligible for any or all Federal benefits for up to
        one year;
          (ii) be required to successfully complete an approved drug
        treatment program which includes periodic testing to insure
        that the individual remains drug free;
          (iii) be required to perform appropriate community service;
        or
          (iv) any combination of clause (i), (ii), or (iii); and

        (B) upon a second or subsequent conviction for such an offense
      be ineligible for all Federal benefits for up to 5 years after
      such conviction as determined by the court. The court shall
      continue to have the discretion in subparagraph (A) above. In
      imposing penalties and conditions under subparagraph (A), the
      court may require that the completion of the conditions imposed
      by clause (ii) or (iii) be a requirement for the reinstatement of
      benefits under clause (i).

      (2) The penalties and conditions which may be imposed under this
    subsection shall be waived in the case of a person who, if there is
    a reasonable body of evidence to substantiate such declaration,
    declares himself to be an addict and submits himself to a long-term
    treatment program for addiction, or is deemed to be rehabilitated
    pursuant to rules established by the Secretary of Health and Human
    Services.
    (c) Suspension of period of ineligibility
      The period of ineligibility referred to in subsections (a) and
    (b) of this section shall be suspended if the individual - 
        (A) completes a supervised drug rehabilitation program after
      becoming ineligible under this section;
        (B) has otherwise been rehabilitated; or
        (C) has made a good faith effort to gain admission to a
      supervised drug rehabilitation program, but is unable to do so
      because of inaccessibility or unavailability of such a program,
      or the inability of the individual to pay for such a program.
    (d) Definitions
      As used in this section - 
        (1) the term "Federal benefit" - 
          (A) means the issuance of any grant, contract, loan,
        professional license, or commercial license provided by an
        agency of the United States or by appropriated funds of the
        United States; and
          (B) does not include any retirement, welfare, Social
        Security, health, disability, veterans benefit, public housing,
        or other similar benefit, or any other benefit for which
        payments or services are required for eligibility; and

        (2) the term "veterans benefit" means all benefits provided to
      veterans, their families, or survivors by virtue of the service
      of a veteran in the Armed Forces of the United States.
    (e) Inapplicability of this section to Government witnesses
      The penalties provided by this section shall not apply to any
    individual who cooperates or testifies with the Government in the
    prosecution of a Federal or State offense or who is in a Government
    witness protection program.
    (f) Indian provision
      Nothing in this section shall be construed to affect the
    obligation of the United States to any Indian or Indian tribe
    arising out of any treaty, statute, Executive order, or the trust
    responsibility of the United States owing to such Indian or Indian
    tribe. Nothing in this subsection shall exempt any individual
    Indian from the sanctions provided for in this section, provided
    that no individual Indian shall be denied any benefit under Federal
    Indian programs comparable to those described in subsection
    (d)(1)(B) or (d)(2) of this section.
    (g) Presidential report
      (1) On or before May 1, 1989, the President shall transmit to the
    Congress a report - 
        (A) delineating the role of State courts in implementing this
      section;
        (B) describing the manner in which Federal agencies will
      implement and enforce the requirements of this section;
        (C) detailing the means by which Federal and State agencies,
      courts, and law enforcement agencies will exchange and share the
      data and information necessary to implement and enforce the
      withholding of Federal benefits; and
        (D) recommending any modifications to improve the
      administration of this section or otherwise achieve the goal of
      discouraging the trafficking and possession of controlled
      substances.

      (2) No later than September 1, 1989, the Congress shall consider
    the report of the President and enact such changes as it deems
    appropriate to further the goals of this section.
    (h) Effective date
      The denial of Federal benefits set forth in this section shall
    take effect for convictions occurring after September 1, 1989.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 421, formerly Pub. L. 100-690,
    title V, Sec. 5301, Nov. 18, 1988, 102 Stat. 4310; renumbered Sec.
    421 of Pub. L. 91-513 and amended Pub. L. 101-647, title X, Sec.
    1002(d), Nov. 29, 1990, 104 Stat. 4827.)

-COD-
                               CODIFICATION                           
      Section was classified to section 853a of this title prior to
    renumbering by Pub. L. 101-647.


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-647, Sec. 1002(d)(1), renumbered section 853a
    of this title as this section.
      Subsec. (a)(1). Pub. L. 101-647, Sec. 1002(d)(2), struck out "(as
    such terms are defined for purposes of the Controlled Substances
    Act)" after "controlled substances" in introductory provisions.

-End-



-CITE-
    21 USC Sec. 862a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 862a. Denial of assistance and benefits for certain drug-
      related convictions

-STATUTE-
    (a) In general
      An individual convicted (under Federal or State law) of any
    offense which is classified as a felony by the law of the
    jurisdiction involved and which has as an element the possession,
    use, or distribution of a controlled substance (as defined in
    section 802(6) of this title) shall not be eligible for - 
        (1) assistance under any State program funded under part A of
      title IV of the Social Security Act [42 U.S.C. 601 et seq.], or
        (2) benefits under the food stamp program (as defined in
      section 3(h) of the Food Stamp Act of 1977 [7 U.S.C. 2012(h)]) or
      any State program carried out under the Food Stamp Act of 1977 [7
      U.S.C. 2011 et seq.].
    (b) Effects on assistance and benefits for others
      (1) Program of temporary assistance for needy families
        The amount of assistance otherwise required to be provided
      under a State program funded under part A of title IV of the
      Social Security Act [42 U.S.C. 601 et seq.] to the family members
      of an individual to whom subsection (a) of this section applies
      shall be reduced by the amount which would have otherwise been
      made available to the individual under such part.
      (2) Benefits under the Food Stamp Act of 1977
        The amount of benefits otherwise required to be provided to a
      household under the food stamp program (as defined in section
      3(h) of the Food Stamp Act of 1977 [7 U.S.C. 2012(h)]), or any
      State program carried out under the Food Stamp Act of 1977 [7
      U.S.C. 2011 et seq.], shall be determined by considering the
      individual to whom subsection (a) of this section applies not to
      be a member of such household, except that the income and
      resources of the individual shall be considered to be income and
      resources of the household.
    (c) Enforcement
      A State that has not exercised its authority under subsection
    (d)(1)(A) of this section shall require each individual applying
    for assistance or benefits referred to in subsection (a) of this
    section, during the application process, to state, in writing,
    whether the individual, or any member of the household of the
    individual, has been convicted of a crime described in subsection
    (a) of this section.
    (d) Limitations
      (1) State elections
        (A) Opt out
          A State may, by specific reference in a law enacted after
        August 22, 1996, exempt any or all individuals domiciled in the
        State from the application of subsection (a) of this section.
        (B) Limit period of prohibition
          A State may, by law enacted after August 22, 1996, limit the
        period for which subsection (a) of this section shall apply to
        any or all individuals domiciled in the State.
      (2) Inapplicability to convictions occurring on or before August
        22, 1996
        Subsection (a) of this section shall not apply to a conviction
      if the conviction is for conduct occurring on or before August
      22, 1996.
    (e) "State" defined
      For purposes of this section, the term "State" has the meaning
    given it - 
        (1) in section 419(5) of the Social Security Act [42 U.S.C.
      619(5)], when referring to assistance provided under a State
      program funded under part A of title IV of the Social Security
      Act [42 U.S.C. 601 et seq.], and
        (2) in section 3(m) of the Food Stamp Act of 1977 [7 U.S.C.
      2012(m)], when referring to the food stamp program (as defined in
      section 3(h) of the Food Stamp Act of 1977 [7 U.S.C. 2012(h)]) or
      any State program carried out under the Food Stamp Act of 1977 [7
      U.S.C. 2011 et seq.].
    (f) Rule of interpretation
      Nothing in this section shall be construed to deny the following
    Federal benefits:
        (1) Emergency medical services under title XIX of the Social
      Security Act [42 U.S.C. 1396 et seq.].
        (2) Short-term, noncash, in-kind emergency disaster relief.
        (3)(A) Public health assistance for immunizations.
        (B) Public health assistance for testing and treatment of
      communicable diseases if the Secretary of Health and Human
      Services determines that it is necessary to prevent the spread of
      such disease.
        (4) Prenatal care.
        (5) Job training programs.
        (6) Drug treatment programs.

-SOURCE-
    (Pub. L. 104-193, title I, Sec. 115, Aug. 22, 1996, 110 Stat. 2180;
    Pub. L. 105-33, title V, Sec. 5516(a), Aug. 5, 1997, 111 Stat.
    620.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Social Security Act, referred to in subsecs. (a)(1), (b)(1),
    (e)(1), and (f)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
    amended. Part A of title IV of the Act is classified generally to
    part A (Sec. 601 et seq.) of subchapter IV of chapter 7 of Title
    42, The Public Health and Welfare. Title XIX of the Act is
    classified generally to subchapter XIX (Sec. 1396 et seq.) of
    chapter 7 of Title 42. For complete classification of this Act to
    the Code, see section 1305 of Title 42 and Tables.
      The Food Stamp Act of 1977, referred to in subsecs. (a)(2),
    (b)(2), and (e)(2), is Pub. L. 88-525, Aug. 31, 1964, 78 Stat. 703,
    as amended, which is classified generally to chapter 51 (Sec. 2011
    et seq.) of Title 7, Agriculture. For complete classification of
    this Act to the Code, see Short Title note set out under section
    2011 of Title 7 and Tables.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Personal Responsibility and
    Work Opportunity Reconciliation Act of 1996, and not as part of the
    Controlled Substances Act which comprises this subchapter.


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (d)(2). Pub. L. 105-33 substituted "a conviction
    if the conviction is for conduct" for "convictions".

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 5518(d) of title V of Pub. L. 105-33 provided that: "The
    amendments made by this chapter to a provision of the Personal
    Responsibility and Work Opportunity Reconciliation Act of 1996
    [Pub. L. 104-193] that have not become part of another statute
    [chapter 1 (Secs. 5501-5518) of subtitle F of title V of Pub. L.
    105-33, amending this section, sections 601 to 603, 604 to 608, 609
    to 611, and 612 to 617 of Title 42, The Public Health and Welfare,
    and provisions set out as notes under section 612c of Title 7,
    Agriculture, and sections 601 and 613 of Title 42] shall take
    effect as if the amendments had been included in the provision at
    the time the provision became law."

                              EFFECTIVE DATE                          
      Section effective July 1, 1997, with transition rules relating to
    State options to accelerate such date, rules relating to claims,
    actions, and proceedings commenced before such date, rules relating
    to closing out of accounts for terminated or substantially modified
    programs and continuance in office of Assistant Secretary for
    Family Support, and provisions relating to termination of
    entitlement under AFDC program, see section 116 of Pub. L. 104-193,
    as amended, set out as an Effective Date note under section 601 of
    Title 42, The Public Health and Welfare.

-End-



-CITE-
    21 USC Sec. 862b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 862b. Sanctioning for testing positive for controlled
      substances

-STATUTE-
      Notwithstanding any other provision of law, States shall not be
    prohibited by the Federal Government from testing welfare
    recipients for use of controlled substances nor from sanctioning
    welfare recipients who test positive for use of controlled
    substances.

-SOURCE-
    (Pub. L. 104-193, title IX, Sec. 902, Aug. 22, 1996, 110 Stat.
    2347.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Personal Responsibility and
    Work Opportunity Reconciliation Act of 1996, and not as part of the
    Controlled Substances Act which comprises this subchapter.

-End-



-CITE-
    21 USC Sec. 863                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 863. Drug paraphernalia

-STATUTE-
    (a) In general
      It is unlawful for any person - 
        (1) to sell or offer for sale drug paraphernalia;
        (2) to use the mails or any other facility of interstate
      commerce to transport drug paraphernalia; or
        (3) to import or export drug paraphernalia.
    (b) Penalties
      Anyone convicted of an offense under subsection (a) of this
    section shall be imprisoned for not more than three years and fined
    under title 18.
    (c) Seizure and forfeiture
      Any drug paraphernalia involved in any violation of subsection
    (a) of this section shall be subject to seizure and forfeiture upon
    the conviction of a person for such violation. Any such
    paraphernalia shall be delivered to the Administrator of General
    Services, General Services Administration, who may order such
    paraphernalia destroyed or may authorize its use for law
    enforcement or educational purposes by Federal, State, or local
    authorities.
    (d) "Drug paraphernalia" defined
      The term "drug paraphernalia" means any equipment, product, or
    material of any kind which is primarily intended or designed for
    use in manufacturing, compounding, converting, concealing,
    producing, processing, preparing, injecting, ingesting, inhaling,
    or otherwise introducing into the human body a controlled
    substance, possession of which is unlawful under this subchapter.
    It includes items primarily intended or designed for use in
    ingesting, inhaling, or otherwise introducing marijuana,(!1)
    cocaine, hashish, hashish oil, PCP, methamphetamine, or
    amphetamines into the human body, such as - 

        (1) metal, wooden, acrylic, glass, stone, plastic, or ceramic
      pipes with or without screens, permanent screens, hashish heads,
      or punctured metal bowls;
        (2) water pipes;
        (3) carburetion tubes and devices;
        (4) smoking and carburetion masks;
        (5) roach clips: meaning objects used to hold burning material,
      such as a marihuana cigarette, that has become too small or too
      short to be held in the hand;
        (6) miniature spoons with level capacities of one-tenth cubic
      centimeter or less;
        (7) chamber pipes;
        (8) carburetor pipes;
        (9) electric pipes;
        (10) air-driven pipes;
        (11) chillums;
        (12) bongs;
        (13) ice pipes or chillers;
        (14) wired cigarette papers; or
        (15) cocaine freebase kits.
    (e) Matters considered in determination of what constitutes drug
      paraphernalia
      In determining whether an item constitutes drug paraphernalia, in
    addition to all other logically relevant factors, the following may
    be considered:
        (1) instructions, oral or written, provided with the item
      concerning its use;
        (2) descriptive materials accompanying the item which explain
      or depict its use;
        (3) national and local advertising concerning its use;
        (4) the manner in which the item is displayed for sale;
        (5) whether the owner, or anyone in control of the item, is a
      legitimate supplier of like or related items to the community,
      such as a licensed distributor or dealer of tobacco products;
        (6) direct or circumstantial evidence of the ratio of sales of
      the item(s) to the total sales of the business enterprise;
        (7) the existence and scope of legitimate uses of the item in
      the community; and
        (8) expert testimony concerning its use.
    (f) Exemptions
      This section shall not apply to - 
        (1) any person authorized by local, State, or Federal law to
      manufacture, possess, or distribute such items; or
        (2) any item that, in the normal lawful course of business, is
      imported, exported, transported, or sold through the mail or by
      any other means, and traditionally intended for use with tobacco
      products, including any pipe, paper, or accessory.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 422, as added and amended Pub. L.
    101-647, title XXIV, Sec. 2401(a)-(c), Nov. 29, 1990, 104 Stat.
    4858, 4859; Pub. L. 106-310, div. B, title XXXVI, Sec. 3614, Oct.
    17, 2000, 114 Stat. 1230.)

-COD-
                               CODIFICATION                           
      The text of section 857(b) to (f) of this title, which was
    transferred to subsecs. (b) to (f) of this section by Pub. L. 101-
    647, Sec. 2401(b), was based on Pub. L. 99-570, title I, Sec.
    1822(b)-(f), Oct. 27, 1986, 100 Stat. 3207-51; Pub. L. 100-690,
    title VI, Sec. 6485, Nov. 18, 1988, 102 Stat. 4384.


-MISC1-
                                AMENDMENTS                            
      2000 - Subsec. (d). Pub. L. 106-310 inserted "methamphetamine,"
    after "PCP," in introductory provisions.
      1990 - Subsec. (b). Pub. L. 101-647, Sec. 2401(c)(1), substituted
    "fined under title 18" for "fined not more than $100,000".
      Pub. L. 101-647, Sec. 2401(b), redesignated subsec. (b) of
    section 857 of this title as subsec. (b) of this section. See
    Codification note above.
      Subsecs. (c) to (e). Pub. L. 101-647, Sec. 2401(b), redesignated
    subsecs. (c) to (e) of section 857 of this title as subsecs. (c) to
    (e) of this section. See Codification note above.
      Subsec. (f). Pub. L. 101-647, Sec. 2401(c)(2), made technical
    amendment to reference to "This section" to correct reference to
    corresponding provision of original act.
      Pub. L. 101-647, Sec. 2401(b), redesignated subsec. (f) of
    section 857 of this title as subsec. (f) of this section. See
    Codification note above.

-FOOTNOTE-
    (!1) So in original. Probably should be "marihuana,".


-End-



-CITE-
    21 USC Sec. 864                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 864. Anhydrous ammonia

-STATUTE-
      (a) It is unlawful for any person - 
        (1) to steal anhydrous ammonia, or
        (2) to transport stolen anhydrous ammonia across State lines,

    knowing, intending, or having reasonable cause to believe that such
    anhydrous ammonia will be used to manufacture a controlled
    substance in violation of this part.
      (b) Any person who violates subsection (a) of this section shall
    be imprisoned or fined, or both, in accordance with section 843(d)
    of this title as if such violation were a violation of a provision
    of section 843 of this title.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 423, as added Pub. L. 106-310, div.
    B, title XXXVI, Sec. 3653(a), Oct. 17, 2000, 114 Stat. 1240.)

-End-



-CITE-
    21 USC Sec. 865                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part D - Offenses and Penalties

-HEAD-
    Sec. 865. Smuggling methamphetamine or methamphetamine precursor
      chemicals into the United States while using facilitated entry
      programs

-STATUTE-
    (a) Enhanced prison sentence
      The sentence of imprisonment imposed on a person convicted of an
    offense under the Controlled Substances Act (21 U.S.C. 801 et seq.)
    or the Controlled Substances Import and Export Act (21 U.S.C. 951
    et seq.), involving methamphetamine or any listed chemical that is
    defined in section 102(33) of the Controlled Substances Act (21
    U.S.C. 802(33),(!1) shall, if the offense is committed under the
    circumstance described in subsection (b), be increased by a
    consecutive term of imprisonment of not more than 15 years.

    (b) Circumstances
      For purposes of subsection (a), the circumstance described in
    this subsection is that the offense described in subsection (a) was
    committed by a person who - 
        (1) was enrolled in, or who was acting on behalf of any person
      or entity enrolled in, any dedicated commuter lane, alternative
      or accelerated inspection system, or other facilitated entry
      program administered or approved by the Federal Government for
      use in entering the United States; and
        (2) committed the offense while entering the United States,
      using such lane, system, or program.
    (c) Permanent ineligibility
      Any person whose term of imprisonment is increased under
    subsection (a) shall be permanently and irrevocably barred from
    being eligible for or using any lane, system, or program described
    in subsection (b)(1).

-SOURCE-
    (Pub. L. 109-177, title VII, Sec. 731, Mar. 9, 2006, 120 Stat.
    270.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Controlled Substances Act, referred to in subsec. (a), is
    title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
    amended, which is classified principally to this subchapter. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 801 of this title and Tables.
      The Controlled Substances Import and Export Act, referred to in
    subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84
    Stat. 1285, as amended, which is classified principally to
    subchapter II (Sec. 951 et seq.) of this chapter. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 951 of this title and Tables.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the USA PATRIOT Improvement and
    Reauthorization Act of 2005 and also as part of the Combat
    Methamphetamine Epidemic Act of 2005, and not as part of the
    Controlled Substances Act which comprises this subchapter.

-FOOTNOTE-
    (!1) So in original. A second closing parenthesis probably should
         precede the comma.


-End-


-CITE-
    21 USC Part E - Administrative and Enforcement Provisions    01/03/2007 

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
            PART E - ADMINISTRATIVE AND ENFORCEMENT PROVISIONS        

-End-



-CITE-
    21 USC Sec. 871                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 871. Attorney General

-STATUTE-
    (a) Delegation of functions
      The Attorney General may delegate any of his functions under this
    subchapter to any officer or employee of the Department of Justice.
    (b) Rules and regulations
      The Attorney General may promulgate and enforce any rules,
    regulations, and procedures which he may deem necessary and
    appropriate for the efficient execution of his functions under this
    subchapter.
    (c) Acceptance of devises, bequests, gifts, and donations
      The Attorney General may accept in the name of the Department of
    Justice any form of devise, bequest, gift, or donation where the
    donor intends to donate property for the purpose of preventing or
    controlling the abuse of controlled substances. He may take all
    appropriate steps to secure possession of such property and may
    sell, assign, transfer, or convey any such property other than
    moneys.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 501, Oct. 27, 1970, 84 Stat. 1270.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in subsecs. (a) and (b), was in the
    original "this title", meaning title II of Pub. L. 91-513, Oct. 27,
    1970, 84 Stat. 1242, as amended, and is popularly known as the
    "Controlled Substances Act". For complete classification of title
    II to the Code, see second paragraph of Short Title note set out
    under section 801 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 871a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 871a. Semiannual reports to Congress

-STATUTE-
    (a) In general
      The Attorney General shall, on a semiannual basis, submit to the
    congressional committees and organizations specified in subsection
    (b) reports that - 
        (1) describe the allocation of the resources of the Drug
      Enforcement Administration and the Federal Bureau of
      Investigation for the investigation and prosecution of alleged
      violations of the Controlled Substances Act [21 U.S.C. 801 et
      seq.] involving methamphetamine; and
        (2) the measures being taken to give priority in the allocation
      of such resources to such violations involving - 
          (A) persons alleged to have imported into the United States
        substantial quantities of methamphetamine or scheduled listed
        chemicals (as defined pursuant to the amendment made by section
        711(a)(1)); (!1)

          (B) persons alleged to have manufactured methamphetamine; and
          (C) circumstances in which the violations have endangered
        children.
    (b) Congressional committees
      The congressional committees and organizations referred to in
    subsection (a) are - 
        (1) in the House of Representatives, the Committee on the
      Judiciary, the Committee on Energy and Commerce, and the
      Committee on Government Reform; and
        (2) in the Senate, the Committee on the Judiciary, the
      Committee on Commerce, Science, and Transportation, and the
      Caucus on International Narcotics Control.

-SOURCE-
    (Pub. L. 109-177, title VII, Sec. 736, Mar. 9, 2006, 120 Stat.
    271.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Controlled Substances Act, referred to in subsec. (a)(1), is
    title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
    amended, which is classified principally to this subchapter. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 801 of this title and Tables.
      Section 711(a)(1), referred to in subsec. (a)(2)(A), is section
    711(a)(1) of Pub. L. 109-177, which amended section 802 of this
    title.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the USA PATRIOT Improvement and
    Reauthorization Act of 2005 and also as part of the Combat
    Methamphetamine Epidemic Act of 2005, and not as part of the
    Controlled Substances Act which comprises this subchapter.

-FOOTNOTE-               

    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 872                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 872. Education and research programs of Attorney General

-STATUTE-
    (a) Authorization
      The Attorney General is authorized to carry out educational and
    research programs directly related to enforcement of the laws under
    his jurisdiction concerning drugs or other substances which are or
    may be subject to control under this subchapter. Such programs may
    include - 
        (1) educational and training programs on drug abuse and
      controlled substances law enforcement for local, State, and
      Federal personnel;
        (2) studies or special projects designed to compare the
      deterrent effects of various enforcement strategies on drug use
      and abuse;
        (3) studies or special projects designed to assess and detect
      accurately the presence in the human body of drugs or other
      substances which are or may be subject to control under this
      subchapter, including the development of rapid field
      identification methods which would enable agents to detect
      microquantities of such drugs or other substances;
        (4) studies or special projects designed to evaluate the nature
      and sources of the supply of illegal drugs throughout the
      country;
        (5) studies or special projects to develop more effective
      methods to prevent diversion of controlled substances into
      illegal channels; and
        (6) studies or special projects to develop information
      necessary to carry out his functions under section 811 of this
      title.
    (b) Contracts
      The Attorney General may enter into contracts for such
    educational and research activities without performance bonds and
    without regard to section 5 of title 41.
    (c) Identification of research populations; authorization to
      withhold
      The Attorney General may authorize persons engaged in research to
    withhold the names and other identifying characteristics of persons
    who are the subjects of such research. Persons who obtain this
    authorization may not be compelled in any Federal, State, or local
    civil, criminal, administrative, legislative, or other proceeding
    to identify the subjects of research for which such authorization
    was obtained.
    (d) Affect of treaties and other international agreements on
      confidentiality
      Nothing in the Single Convention on Narcotic Drugs, the
    Convention on Psychotropic Substances, or other treaties or
    international agreements shall be construed to limit, modify, or
    prevent the protection of the confidentiality of patient records or
    of the names and other identifying characteristics of research
    subjects as provided by any Federal, State, or local law or
    regulation.
    (e) Use of controlled substances in research
      The Attorney General, on his own motion or at the request of the
    Secretary, may authorize the possession, distribution, and
    dispensing of controlled substances by persons engaged in research.
    Persons who obtain this authorization shall be exempt from State or
    Federal prosecution for possession, distribution, and dispensing of
    controlled substances to the extent authorized by the Attorney
    General.
    (f) Program to curtail diversion of precursor and essential
      chemicals
      The Attorney General shall maintain an active program, both
    domestic and international, to curtail the diversion of precursor
    chemicals and essential chemicals used in the illicit manufacture
    of controlled substances.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 502, Oct. 27, 1970, 84 Stat. 1271;
    Pub. L. 95-633, title I, Sec. 108(a), Nov. 10, 1978, 92 Stat. 3773;
    Pub. L. 100-690, title VI, Sec. 6060, Nov. 18, 1988, 102 Stat.
    4320.)


-MISC1-
                                AMENDMENTS                            
      1988 - Subsec. (f). Pub. L. 100-690 added subsec. (f).
      1978 - Subsecs. (d), (e). Pub. L. 95-633 added subsec. (d) and
    redesignated former subsec. (d) as (e).

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
    1988, see section 6061 of Pub. L. 100-690, set out as a note under
    section 802 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

     TRAINING FOR DRUG ENFORCEMENT ADMINISTRATION AND STATE AND LOCAL
      LAW ENFORCEMENT PERSONNEL RELATING TO CLANDESTINE LABORATORIES
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3623, Oct. 17, 2000,
    114 Stat. 1231, provided that:
      "(a) In General. - 
        "(1) Requirement. - The Administrator of the Drug Enforcement
      Administration shall carry out the programs described in
      subsection (b) with respect to the law enforcement personnel of
      States and localities determined by the Administrator to have
      significant levels of methamphetamine-related or amphetamine-
      related crime or projected by the Administrator to have the
      potential for such levels of crime in the future.
        "(2) Duration. - The duration of any program under that
      subsection may not exceed 3 years.
      "(b) Covered Programs. - The programs described in this
    subsection are as follows:
        "(1) Advanced mobile clandestine laboratory training teams. - A
      program of advanced mobile clandestine laboratory training teams,
      which shall provide information and training to State and local
      law enforcement personnel in techniques utilized in conducting
      undercover investigations and conspiracy cases, and other
      information designed to assist in the investigation of the
      illegal manufacturing and trafficking of amphetamine and
      methamphetamine.
        "(2) Basic clandestine laboratory certification training. - A
      program of basic clandestine laboratory certification training,
      which shall provide information and training - 
          "(A) to Drug Enforcement Administration personnel and State
        and local law enforcement personnel for purposes of enabling
        such personnel to meet any certification requirements under law
        with respect to the handling of wastes created by illegal
        amphetamine and methamphetamine laboratories; and
          "(B) to State and local law enforcement personnel for
        purposes of enabling such personnel to provide the information
        and training covered by subparagraph (A) to other State and
        local law enforcement personnel.
        "(3) Clandestine laboratory recertification and awareness
      training. - A program of clandestine laboratory recertification
      and awareness training, which shall provide information and
      training to State and local law enforcement personnel for
      purposes of enabling such personnel to provide recertification
      and awareness training relating to clandestine laboratories to
      additional State and local law enforcement personnel.
      "(c) Authorization of Appropriations. - There are authorized to
    be appropriated for each of fiscal years 2000, 2001, and 2002
    amounts as follows:
        "(1) $1,500,000 to carry out the program described in
      subsection (b)(1).
        "(2) $3,000,000 to carry out the program described in
      subsection (b)(2).
        "(3) $1,000,000 to carry out the program described in
      subsection (b)(3)."

                EDUCATIONAL PROGRAM FOR POLICE DEPARTMENTS            
      Pub. L. 104-305, Sec. 4, Oct. 13, 1996, 110 Stat. 3809, provided
    that: "The Attorney General may - 
        "(1) create educational materials regarding the use of
      controlled substances (as that term is defined in section 102 of
      the Controlled Substances Act [21 U.S.C. 802]) in the furtherance
      of rapes and sexual assaults; and
        "(2) disseminate those materials to police departments
      throughout the United States."

      STUDY AND REPORT ON MEASURES TO PREVENT SALES OF AGENTS USED IN
                        METHAMPHETAMINE PRODUCTION
      Pub. L. 104-237, title II, Sec. 202, Oct. 3, 1996, 110 Stat.
    3101, provided that:
      "(a) Study. - The Attorney General of the United States shall
    conduct a study on possible measures to effectively prevent the
    diversion of red phosphorous, iodine, hydrochloric gas, and other
    agents for use in the production of methamphetamine. Nothing in
    this section shall preclude the Attorney General from taking any
    action the Attorney General already is authorized to take with
    regard to the regulation of listed chemicals under current law.
      "(b) Report. - Not later than January 1, 1998, the Attorney
    General shall submit a report to the Congress of its findings
    pursuant to the study conducted under subsection (a) on the need
    for and advisability of preventive measures.
      "(c) Considerations. - In developing recommendations under
    subsection (b), the Attorney General shall consider - 
        "(1) the use of red phosphorous, iodine, hydrochloric gas, and
      other agents in the illegal manufacture of methamphetamine;
        "(2) the use of red phosphorous, iodine, hydrochloric gas, and
      other agents for legitimate, legal purposes, and the impact any
      regulations may have on these legitimate purposes; and
        "(3) comments and recommendations from law enforcement,
      manufacturers of such chemicals, and the consumers of such
      chemicals for legitimate, legal purposes."

-End-



-CITE-
    21 USC Sec. 872a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 872a. Public-private education program

-STATUTE-
    (a) Advisory panel
      The Attorney General shall establish an advisory panel consisting
    of an appropriate number of representatives from Federal, State,
    and local law enforcement and regulatory agencies with experience
    in investigating and prosecuting illegal transactions of precursor
    chemicals. The Attorney General shall convene the panel as often as
    necessary to develop and coordinate educational programs for
    wholesale and retail distributors of precursor chemicals and
    supplies.
    (b) Continuation of current efforts
      The Attorney General shall continue to - 
        (1) maintain an active program of seminars and training to
      educate wholesale and retail distributors of precursor chemicals
      and supplies regarding the identification of suspicious
      transactions and their responsibility to report such
      transactions; and
        (2) provide assistance to State and local law enforcement and
      regulatory agencies to facilitate the establishment and
      maintenance of educational programs for distributors of precursor
      chemicals and supplies.

-SOURCE-
    (Pub. L. 104-237, title V, Sec. 503, Oct. 3, 1996, 110 Stat. 3112.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Comprehensive Methamphetamine
    Control Act of 1996, and not as part of the Controlled Substances
    Act which comprises this subchapter.

-End-



-CITE-
    21 USC Sec. 873                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 873. Cooperative arrangements

-STATUTE-
    (a) Cooperation of Attorney General with local, State, and Federal
      agencies
      The Attorney General shall cooperate with local, State, and
    Federal agencies concerning traffic in controlled substances and in
    suppressing the abuse of controlled substances. To this end, he is
    authorized to - 
        (1) arrange for the exchange of information between
      governmental officials concerning the use and abuse of controlled
      substances;
        (2) cooperate in the institution and prosecution of cases in
      the courts of the United States and before the licensing boards
      and courts of the several States;
        (3) conduct training programs on controlled substance law
      enforcement for local, State, and Federal personnel;
        (4) maintain in the Department of Justice a unit which will
      accept, catalog, file, and otherwise utilize all information and
      statistics, including records of controlled substance abusers and
      other controlled substance law offenders, which may be received
      from Federal, State, and local agencies, and make such
      information available for Federal, State, and local law
      enforcement purposes;
        (5) conduct programs of eradication aimed at destroying wild or
      illicit growth of plant species from which controlled substances
      may be extracted;
        (6) assist State and local governments in suppressing the
      diversion of controlled substances from legitimate medical,
      scientific, and commercial channels by - 
          (A) making periodic assessments of the capabilities of State
        and local governments to adequately control the diversion of
        controlled substances;
          (B) providing advice and counsel to State and local
        governments on the methods by which such governments may
        strengthen their controls against diversion; and
          (C) establishing cooperative investigative efforts to control
        diversion; and

        (7) notwithstanding any other provision of law, enter into
      contractual agreements with State and local law enforcement
      agencies to provide for cooperative enforcement and regulatory
      activities under this chapter.(!1)

    (b) Requests by Attorney General for assistance from Federal
      agencies or instrumentalities
      When requested by the Attorney General, it shall be the duty of
    any agency or instrumentality of the Federal Government to furnish
    assistance, including technical advice, to him for carrying out his
    functions under this subchapter; except that no such agency or
    instrumentality shall be required to furnish the name of, or other
    identifying information about, a patient or research subject whose
    identity it has undertaken to keep confidential.
    (c) Descriptive and analytic reports by Attorney General to State
      agencies of distribution patterns of schedule II substances
      having highest rates of abuse
      The Attorney General shall annually (1) select the controlled
    substance (or controlled substances) contained in schedule II
    which, in the Attorney General's discretion, is determined to have
    the highest rate of abuse, and (2) prepare and make available to
    regulatory, licensing, and law enforcement agencies of States
    descriptive and analytic reports on the actual distribution
    patterns in such States of each such controlled substance.
    (d) Grants by Attorney General
      (1) The Attorney General may make grants, in accordance with
    paragraph (2), to State and local governments to assist in meeting
    the costs of - 
        (A) collecting and analyzing data on the diversion of
      controlled substances,
        (B) conducting investigations and prosecutions of such
      diversions,
        (C) improving regulatory controls and other authorities to
      control such diversions,
        (D) programs to prevent such diversions,
        (E) preventing and detecting forged prescriptions, and
        (F) training law enforcement and regulatory personnel to
      improve the control of such diversions.

      (2) No grant may be made under paragraph (1) unless an
    application therefor is submitted to the Attorney General in such
    form and manner as the Attorney General may prescribe. No grant may
    exceed 80 per centum of the costs for which the grant is made, and
    no grant may be made unless the recipient of the grant provides
    assurances satisfactory to the Attorney General that it will
    obligate funds to meet the remaining 20 per centum of such costs.
    The Attorney General shall review the activities carried out with
    grants under paragraph (1) and shall report annually to Congress on
    such activities.
      (3) To carry out this subsection there is authorized to be
    appropriated $6,000,000 for fiscal year 1985 and $6,000,000 for
    fiscal year 1986.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 503, Oct. 27, 1970, 84 Stat. 1271;
    Pub. L. 96-359, Sec. 8(a) Sept. 26, 1980, 94 Stat. 1194; Pub. L. 98-
    473, title II, Sec. 517, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 99-
    570, title I, Sec. 1868, Oct. 27, 1986, 100 Stat. 3207-55; Pub. L.
    99-646, Sec. 85, Nov. 10, 1986, 100 Stat. 3620.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in subsec. (a)(7), was in the original
    as added by Pub. L. 99-646 "this Act", meaning Pub. L. 91-513, Oct.
    27, 1970, 84 Stat. 1236, as amended. In the subsec. (a)(7) added by
    Pub. L. 99-570, the reference was "this title", meaning title II of
    Pub. L. 91-513 which is popularly known as the "Controlled
    Substances Act" and is classified principally to this subchapter.
    For complete classification of this Act and title II to the Code,
    see Short Title note set out under section 801 of this title and
    Tables.
      Schedule II, referred to in subsec. (c), is set out in section
    812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      1986 - Subsec. (a)(7). Pub. L. 99-570 and Pub. L. 99-646 made
    substantially identical amendment, adding par. (7).
      1984 - Subsec. (a)(6). Pub. L. 98-473, Sec. 517(a), added par.
    (6).
      Subsec. (d). Pub. L. 98-473, Sec. 517(b), added subsec. (d).
      1980 - Subsec. (c). Pub. L. 96-359 added subsec. (c).

             ANNUAL REPORT ON COUNTERDRUG INTELLIGENCE MATTERS         
      Pub. L. 107-306, title VIII, Sec. 826, Nov. 27, 2002, 116 Stat.
    2429, provided that:
      "(a) Annual Report. - The Counterdrug Intelligence Coordinating
    Group shall submit to the appropriate committees of Congress each
    year a report on current counterdrug intelligence matters. The
    report shall include the recommendations of the Counterdrug
    Intelligence Coordinating Group on the appropriate number of
    permanent staff, and of detailed personnel, for the staff of the
    Counterdrug Intelligence Executive Secretariat.
      "(b) Submittal Date. - The date of the submittal each year of the
    report required by subsection (a) shall be the date provided in
    section 507 of the National Security Act of 1947 [50 U.S.C. 415b],
    as added by section 811 of this Act.
      "(c) Appropriate Committees of Congress Defined. - In this
    section, the term 'appropriate committees of Congress' means - 
        "(1) the Committees on Appropriations of the Senate and House
      of Representatives; and
        "(2) the congressional intelligence committees (as defined in
      section 3 of the National Security Act of 1947 (50 U.S.C.
      401a))."

        COMBATING AMPHETAMINE AND METHAMPHETAMINE MANUFACTURING AND
                                TRAFFICKING
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3625, Oct. 17, 2000,
    114 Stat. 1233, provided that:
      "(a) Activities. - In order to combat the illegal manufacturing
    and trafficking in amphetamine and methamphetamine, the
    Administrator of the Drug Enforcement Administration may - 
        "(1) assist State and local law enforcement in small and mid-
      sized communities in all phases of investigations related to
      such manufacturing and trafficking, including assistance with
      foreign-language interpretation;
        "(2) staff additional regional enforcement and mobile
      enforcement teams related to such manufacturing and trafficking;
        "(3) establish additional resident offices and posts of duty to
      assist State and local law enforcement in rural areas in
      combating such manufacturing and trafficking;
        "(4) provide the Special Operations Division of the
      Administration with additional agents and staff to collect,
      evaluate, interpret, and disseminate critical intelligence
      targeting the command and control operations of major amphetamine
      and methamphetamine manufacturing and trafficking organizations;
        "(5) enhance the investigative and related functions of the
      Chemical Control Program of the Administration to implement more
      fully the provisions of the Comprehensive Methamphetamine Control
      Act of 1996 (Public Law 104-237) [see Short Title of 1996
      Amendments note set out under section 801 of this title];
        "(6) design an effective means of requiring an accurate
      accounting of the import and export of list I chemicals, and
      coordinate investigations relating to the diversion of such
      chemicals;
        "(7) develop a computer infrastructure sufficient to receive,
      process, analyze, and redistribute time-sensitive enforcement
      information from suspicious order reporting to field offices of
      the Administration and other law enforcement and regulatory
      agencies, including the continuing development of the Suspicious
      Order Reporting and Tracking System (SORTS) and the Chemical
      Transaction Database (CTRANS) of the Administration;
        "(8) establish an education, training, and communication
      process in order to alert the industry to current trends and
      emerging patterns in the illegal manufacturing of amphetamine and
      methamphetamine; and
        "(9) carry out such other activities as the Administrator
      considers appropriate.
      "(b) Additional Positions and Personnel. - 
        "(1) In general. - In carrying out activities under subsection
      (a), the Administrator may establish in the Administration not
      more than 50 full-time positions, including not more than 31
      special-agent positions, and may appoint personnel to such
      positions.
        "(2) Particular positions. - In carrying out activities under
      paragraphs (5) through (8) of subsection (a), the Administrator
      may establish in the Administration not more than 15 full-time
      positions, including not more than 10 diversion investigator
      positions, and may appoint personnel to such positions. Any
      positions established under this paragraph are in addition to any
      positions established under paragraph (1).
      "(c) Authorization of Appropriations. - There are authorized to
    be appropriated for the Drug Enforcement Administration for each
    fiscal year after fiscal year 1999, $9,500,000 for purposes of
    carrying out the activities authorized by subsection (a) and
    employing personnel in positions established under subsection (b),
    of which $3,000,000 shall be available for activities under
    paragraphs (5) through (8) of subsection (a) and for employing
    personnel in positions established under subsection (b)(2)."

                     NATIONAL DRUG INTELLIGENCE CENTER                 
      Pub. L. 108-487, title I, Sec. 104(e), Dec. 23, 2004, 118 Stat.
    3942, provided that:
      "(1) In general. - Of the amount authorized to be appropriated in
    subsection (a) [118 Stat. 3941], $42,322,000 shall be available for
    the National Drug Intelligence Center. Within such amount, funds
    provided for research, development, testing, and evaluation
    purposes shall remain available until September 30, 2006, and funds
    provided for procurement purposes shall remain available until
    September 30, 2007.
      "(2) Transfer of funds. - The Director of National Intelligence
    shall transfer to the Attorney General funds available for the
    National Drug Intelligence Center under paragraph (1). The Attorney
    General shall utilize funds so transferred for the activities of
    the National Drug Intelligence Center.
      "(3) Limitation. - Amounts available for the National Drug
    Intelligence Center may not be used in contravention of the
    provisions of section 103(d)(1) of the National Security Act of
    1947 (50 U.S.C. 403-3(d)(1)).
      "(4) Authority. - Notwithstanding any other provision of law, the
    Attorney General shall retain full authority over the operations of
    the National Drug Intelligence Center."
      Similar provisions were contained in the following prior
    authorization acts:
      Pub. L. 108-177, title I, Sec. 104(e), Dec. 13, 2003, 117 Stat.
    2602.
      Pub. L. 107-306, title I, Sec. 104(e), Nov. 27, 2002, 116 Stat.
    2387.
      Pub. L. 107-108, title I, Sec. 104(e), Dec. 28, 2001, 115 Stat.
    1396.
      Pub. L. 106-567, title I, Sec. 104(e), Dec. 27, 2000, 114 Stat.
    2834.
      Pub. L. 106-120, title I, Sec. 104(e), Dec. 3, 1999, 113 Stat.
    1609.
      Pub. L. 105-272, title I, Sec. 104(e), Oct. 20, 1998, 112 Stat.
    2398.
      Pub. L. 105-107, title I, Sec. 104(e), Nov. 20, 1997, 111 Stat.
    2250.
      Pub. L. 104-293, title I, Sec. 104(d), Oct. 11, 1996, 110 Stat.
    3464.

      Pub. L. 103-139, title VIII, Sec. 8056, Nov. 11, 1993, 107 Stat.
    1452, provided that: "During the current fiscal year and
    thereafter, there is established, under the direction and control
    of the Attorney General, the National Drug Intelligence Center,
    whose mission it shall be to coordinate and consolidate drug
    intelligence from all national security and law enforcement
    agencies, and produce information regarding the structure,
    membership, finances, communications, and activities of drug
    trafficking organizations: Provided, That funding for the operation
    of the National Drug Intelligence Center, including personnel costs
    associated therewith, shall be provided from the funds appropriated
    to the Department of Defense."
      Similar provisions were contained in the following prior
    appropriation act:
      Pub. L. 102-396, title IX, Sec. 9078, Oct. 6, 1992, 106 Stat.
    1919.

-FOOTNOTE-               

    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 874                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 874. Advisory committees

-STATUTE-
      The Attorney General may from time to time appoint committees to
    advise him with respect to preventing and controlling the abuse of
    controlled substances. Members of the committees may be entitled to
    receive compensation at the rate of $100 for each day (including
    traveltime) during which they are engaged in the actual performance
    of duties. While traveling on official business in the performance
    of duties for the committees, members of the committees shall be
    allowed expenses of travel, including per diem instead of
    subsistence, in accordance with subchapter I of chapter 57 of title
    5.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 504, Oct. 27, 1970, 84 Stat. 1272.)


-MISC1-
                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

-End-



-CITE-
    21 USC Sec. 875                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 875. Administrative hearings

-STATUTE-
    (a) Power of Attorney General
      In carrying out his functions under this subchapter, the Attorney
    General may hold hearings, sign and issue subpenas, administer
    oaths, examine witnesses, and receive evidence at any place in the
    United States.
    (b) Procedures applicable
      Except as otherwise provided in this subchapter, notice shall be
    given and hearings shall be conducted under appropriate procedures
    of subchapter II of chapter 5 of title 5.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 505, Oct. 27, 1970, 84 Stat. 1272.)

-End-



-CITE-
    21 USC Sec. 876                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 876. Subpenas

-STATUTE-
    (a) Authorization of use by Attorney General
      In any investigation relating to his functions under this
    subchapter with respect to controlled substances, listed chemicals,
    tableting machines, or encapsulating machines, the Attorney General
    may subpena witnesses, compel the attendance and testimony of
    witnesses, and require the production of any records (including
    books, papers, documents, and other tangible things which
    constitute or contain evidence) which the Attorney General finds
    relevant or material to the investigation. The attendance of
    witnesses and the production of records may be required from any
    place in any State or in any territory or other place subject to
    the jurisdiction of the United States at any designated place of
    hearing; except that a witness shall not be required to appear at
    any hearing more than 500 miles distant from the place where he was
    served with a subpena. Witnesses summoned under this section shall
    be paid the same fees and mileage that are paid witnesses in the
    courts of the United States.
    (b) Service
      A subpena issued under this section may be served by any person
    designated in the subpena to serve it. Service upon a natural
    person may be made by personal delivery of the subpena to him.
    Service may be made upon a domestic or foreign corporation or upon
    a partnership or other unincorporated association which is subject
    to suit under a common name, by delivering the subpena to an
    officer, to a managing or general agent, or to any other agent
    authorized by appointment or by law to receive service of process.
    The affidavit of the person serving the subpena entered on a true
    copy thereof by the person serving it shall be proof of service.
    (c) Enforcement
      In the case of contumacy by or refusal to obey a subpena issued
    to any person, the Attorney General may invoke the aid of any court
    of the United States within the jurisdiction of which the
    investigation is carried on or of which the subpenaed person is an
    inhabitant, or in which he carries on business or may be found, to
    compel compliance with the subpena. The court may issue an order
    requiring the subpenaed person to appear before the Attorney
    General to produce records, if so ordered, or to give testimony
    touching the matter under investigation. Any failure to obey the
    order of the court may be punished by the court as a contempt
    thereof. All process in any such case may be served in any judicial
    district in which such person may be found.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 506, Oct. 27, 1970, 84 Stat. 1272;
    Pub. L. 100-690, title VI, Sec. 6058, Nov. 18, 1988, 102 Stat.
    4319.)


-MISC1-
                                AMENDMENTS                            
      1988 - Subsec. (a). Pub. L. 100-690 inserted "listed chemicals,
    tableting machines, or encapsulating machines," after "with respect
    to controlled substances,".

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
    1988, see section 6061 of Pub. L. 100-690, set out as a note under
    section 802 of this title.

-End-



-CITE-
    21 USC Sec. 877                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 877. Judicial review

-STATUTE-
      All final determinations, findings, and conclusions of the
    Attorney General under this subchapter shall be final and
    conclusive decisions of the matters involved, except that any
    person aggrieved by a final decision of the Attorney General may
    obtain review of the decision in the United States Court of Appeals
    for the District of Columbia or for the circuit in which his
    principal place of business is located upon petition filed with the
    court and delivered to the Attorney General within thirty days
    after notice of the decision. Findings of fact by the Attorney
    General, if supported by substantial evidence, shall be conclusive.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 507, Oct. 27, 1970, 84 Stat. 1273.)

-End-



-CITE-
    21 USC Sec. 878                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 878. Powers of enforcement personnel

-STATUTE-
      (a) Any officer or employee of the Drug Enforcement
    Administration or any State or local law enforcement officer
    designated by the Attorney General may - 
        (1) carry firearms;
        (2) execute and serve search warrants, arrest warrants,
      administrative inspection warrants, subpenas, and summonses
      issued under the authority of the United States;
        (3) make arrests without warrant (A) for any offense against
      the United States committed in his presence, or (B) for any
      felony, cognizable under the laws of the United States, if he has
      probable cause to believe that the person to be arrested has
      committed or is committing a felony;
        (4) make seizures of property pursuant to the provisions of
      this subchapter; and
        (5) perform such other law enforcement duties as the Attorney
      General may designate.

      (b) State and local law enforcement officers performing functions
    under this section shall not be deemed Federal employees and shall
    not be subject to provisions of law relating to Federal employees,
    except that such officers shall be subject to section 3374(c) of
    title 5.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 508, Oct. 27, 1970, 84 Stat. 1273;
    Pub. L. 96-132, Sec. 16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L.
    99-570, title I, Sec. 1869, Oct. 27, 1986, 100 Stat. 3207-55; Pub.
    L. 99-646, Sec. 86, Nov. 10, 1986, 100 Stat. 3620.)


-MISC1-
                                AMENDMENTS                            
      1986 - Pub. L. 99-570 and Pub. L. 99-646 amended section
    substantially identically designating existing provisions as
    subsec. (a) and adding subsec. (b), with the exception of the
    amendment of subsec. (a) for which Pub. L. 99-570 directed the
    insertion of "or (with respect to offenses under this subchapter or
    subchapter II of this chapter) any State or local law enforcement
    officer" and Pub. L. 99-646 directed the insertion of "or any State
    or local law enforcement officer", the latter of which was executed
    to reflect the probable intent of Congress.
      1979 - Pub. L. 96-132 substituted "Drug Enforcement
    Administration" for "Bureau of Narcotics and Dangerous Drugs".

-End-



-CITE-
    21 USC Sec. 879                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 879. Search warrants

-STATUTE-
      A search warrant relating to offenses involving controlled
    substances may be served at any time of the day or night if the
    judge or United States magistrate judge issuing the warrant is
    satisfied that there is probable cause to believe that grounds
    exist for the warrant and for its service at such time.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 509, Oct. 27, 1970, 84 Stat. 1274;
    Pub. L. 93-481, Sec. 3, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 101-
    650, title III, Sec. 321, Dec. 1, 1990, 104 Stat. 5117.)


-MISC1-
                                AMENDMENTS                            
      1974 - Pub. L. 93-481 struck out designation "(a)" before "A
    search warrant", and struck out subsec. (b) which permitted
    officers authorized to execute search warrants to break open and
    enter premises under certain circumstances and which required that
    such officers identify themselves and give reasons and authority
    for their entry after such entry.

-CHANGE-
                              CHANGE OF NAME                          
      "United States magistrate judge" substituted in text for "United
    States magistrate" pursuant to section 321 of Pub. L. 101-650, set
    out as a note under section 631 of Title 28, Judiciary and Judicial
    Procedure.

-End-



-CITE-
    21 USC Sec. 880                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 880. Administrative inspections and warrants

-STATUTE-
    (a) "Controlled premises" defined
      As used in this section, the term "controlled premises" means - 
        (1) places where original or other records or documents
      required under this subchapter are kept or required to be kept,
      and
        (2) places, including factories, warehouses, and other
      establishments, and conveyances, where persons registered under
      section 823 of this title (or exempt from registration under
      section 822(d) of this title or by regulation of the Attorney
      General) or regulated persons may lawfully hold, manufacture,
      distribute, dispense, administer, or otherwise dispose of
      controlled substances or listed chemicals or where records
      relating to those activities are maintained.
    (b) Grant of authority; scope of inspections
      (1) For the purpose of inspecting, copying, and verifying the
    correctness of records, reports, or other documents required to be
    kept or made under this subchapter and otherwise facilitating the
    carrying out of his functions under this subchapter, the Attorney
    General is authorized, in accordance with this section, to enter
    controlled premises and to conduct administrative inspections
    thereof, and of the things specified in this section, relevant to
    those functions.
      (2) Such entries and inspections shall be carried out through
    officers or employees (hereinafter referred to as "inspectors")
    designated by the Attorney General. Any such inspector, upon
    stating his purpose and presenting to the owner, operator, or agent
    in charge of such premises (A) appropriate credentials and (B) a
    written notice of his inspection authority (which notice in the
    case of an inspection requiring, or in fact supported by, an
    administrative inspection warrant shall consist of such warrant),
    shall have the right to enter such premises and conduct such
    inspection at reasonable times.
      (3) Except as may otherwise be indicated in an applicable
    inspection warrant, the inspector shall have the right - 
        (A) to inspect and copy records, reports, and other documents
      required to be kept or made under this subchapter;
        (B) to inspect, within reasonable limits and in a reasonable
      manner, controlled premises and all pertinent equipment, finished
      and unfinished drugs, listed chemicals, and other substances or
      materials, containers, and labeling found therein, and, except as
      provided in paragraph (4) of this subsection, all other things
      therein (including records, files, papers, processes, controls,
      and facilities) appropriate for verification of the records,
      reports, and documents referred to in clause (A) or otherwise
      bearing on the provisions of this subchapter; and
        (C) to inventory any stock of any controlled substance or
      listed chemical therein and obtain samples of any such substance
      or chemical.

      (4) Except when the owner, operator, or agent in charge of the
    controlled premises so consents in writing, no inspection
    authorized by this section shall extend to - 
        (A) financial data;
        (B) sales data other than shipment data; or
        (C) pricing data.
    (c) Situations not requiring warrants
      A warrant under this section shall not be required for the
    inspection of books and records pursuant to an administrative
    subpena issued in accordance with section 876 of this title, nor
    for entries and administrative inspections (including seizures of
    property) - 
        (1) with the consent of the owner, operator, or agent in charge
      of the controlled premises;
        (2) in situations presenting imminent danger to health or
      safety;
        (3) in situations involving inspection of conveyances where
      there is reasonable cause to believe that the mobility of the
      conveyance makes it impracticable to obtain a warrant;
        (4) in any other exceptional or emergency circumstance where
      time or opportunity to apply for a warrant is lacking; or
        (5) in any other situations where a warrant is not
      constitutionally required.
    (d) Administrative inspection warrants; issuance; execution;
      probable cause
      Issuance and execution of administrative inspection warrants
    shall be as follows:
        (1) Any judge of the United States or of a State court of
      record, or any United States magistrate judge, may, within his
      territorial jurisdiction, and upon proper oath or affirmation
      showing probable cause, issue warrants for the purpose of
      conducting administrative inspections authorized by this
      subchapter or regulations thereunder, and seizures of property
      appropriate to such inspections. For the purposes of this
      section, the term "probable cause" means a valid public interest
      in the effective enforcement of this subchapter or regulations
      thereunder sufficient to justify administrative inspections of
      the area, premises, building, or conveyance, or contents thereof,
      in the circumstances specified in the application for the
      warrant.
        (2) A warrant shall issue only upon an affidavit of an officer
      or employee having knowledge of the facts alleged, sworn to
      before the judge or magistrate judge and establishing the grounds
      for issuing the warrant. If the judge or magistrate judge is
      satisfied that grounds for the application exist or that there is
      probable cause to believe they exist, he shall issue a warrant
      identifying the area, premises, building, or conveyance to be
      inspected, the purpose of such inspection, and, where
      appropriate, the type of property to be inspected, if any. The
      warrant shall identify the items or types of property to be
      seized, if any. The warrant shall be directed to a person
      authorized under subsection (b)(2) of this section to execute it.
      The warrant shall state the grounds for its issuance and the name
      of the person or persons whose affidavit has been taken in
      support thereof. It shall command the person to whom it is
      directed to inspect the area, premises, building, or conveyance
      identified for the purpose specified, and, where appropriate,
      shall direct the seizure of the property specified. The warrant
      shall direct that it be served during normal business hours. It
      shall designate the judge or magistrate judge to whom it shall be
      returned.
        (3) A warrant issued pursuant to this section must be executed
      and returned within ten days of its date unless, upon a showing
      by the United States of a need therefor, the judge or magistrate
      judge allows additional time in the warrant. If property is
      seized pursuant to a warrant, the person executing the warrant
      shall give to the person from whom or from whose premises the
      property was taken a copy of the warrant and a receipt for the
      property taken or shall leave the copy and receipt at the place
      from which the property was taken. The return of the warrant
      shall be made promptly and shall be accompanied by a written
      inventory of any property taken. The inventory shall be made in
      the presence of the person executing the warrant and of the
      person from whose possession or premises the property was taken,
      if they are present, or in the presence of at least one credible
      person other than the person making such inventory, and shall be
      verified by the person executing the warrant. The judge or
      magistrate judge, upon request, shall deliver a copy of the
      inventory to the person from whom or from whose premises the
      property was taken and the applicant for the warrant.
        (4) The judge or magistrate judge who has issued a warrant
      under this section shall attach to the warrant a copy of the
      return and all papers filed in connection therewith and shall
      file them with the clerk of the district court of the United
      States for the judicial district in which the inspection was
      made.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 510, Oct. 27, 1970, 84 Stat. 1274;
    Pub. L. 101-647, title XXXV, Sec. 3599M, Nov. 29, 1990, 104 Stat.
    4932; Pub. L. 101-650, title III, Sec. 321, Dec. 1, 1990, 104 Stat.
    5117; Pub. L. 103-200, Sec. 6, Dec. 17, 1993, 107 Stat. 2339.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a)(2). Pub. L. 103-200, Sec. 6(1), amended par.
    (2) generally. Prior to amendment, par. (2) read as follows:
    "places, including factories, warehouses, or other establishments,
    and conveyances, where persons registered under section 823 of this
    title (or exempted from registration under section 822(d) of this
    title) may lawfully hold, manufacture, or distribute, dispense,
    administer, or otherwise dispose of controlled substances."
      Subsec. (b)(3)(B). Pub. L. 103-200, Sec. 6(2)(A), inserted ",
    listed chemicals," after "unfinished drugs".
      Subsec. (b)(3)(C). Pub. L. 103-200, Sec. 6(2)(B), inserted "or
    listed chemical" after "controlled substance" and "or chemical"
    after "such substance".
      1990 - Subsec. (b)(3)(B). Pub. L. 101-647 substituted "paragraph
    (4)" for "paragraph (5)".

-CHANGE-
                              CHANGE OF NAME                          
      "United States magistrate judge" and "magistrate judge"
    substituted for "United States magistrate" and "magistrate",
    respectively, wherever appearing in subsec. (d) pursuant to section
    321 of Pub. L. 101-650, set out as a note under section 631 of
    Title 28, Judiciary and Judicial Procedure.


-MISC2-
                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

-End-



-CITE-
    21 USC Sec. 881                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 881. Forfeitures

-STATUTE-
    (a) Subject property
      The following shall be subject to forfeiture to the United States
    and no property right shall exist in them:
        (1) All controlled substances which have been manufactured,
      distributed, dispensed, or acquired in violation of this
      subchapter.
        (2) All raw materials, products, and equipment of any kind
      which are used, or intended for use, in manufacturing,
      compounding, processing, delivering, importing, or exporting any
      controlled substance or listed chemical in violation of this
      subchapter.
        (3) All property which is used, or intended for use, as a
      container for property described in paragraph (1), (2), or (9).
        (4) All conveyances, including aircraft, vehicles, or vessels,
      which are used, or are intended for use, to transport, or in any
      manner to facilitate the transportation, sale, receipt,
      possession, or concealment of property described in paragraph
      (1), (2), or (9).
        (5) All books, records, and research, including formulas,
      microfilm, tapes, and data which are used, or intended for use,
      in violation of this subchapter.
        (6) All moneys, negotiable instruments, securities, or other
      things of value furnished or intended to be furnished by any
      person in exchange for a controlled substance or listed chemical
      in violation of this subchapter, all proceeds traceable to such
      an exchange, and all moneys, negotiable instruments, and
      securities used or intended to be used to facilitate any
      violation of this subchapter.
        (7) All real property, including any right, title, and interest
      (including any leasehold interest) in the whole of any lot or
      tract of land and any appurtenances or improvements, which is
      used, or intended to be used, in any manner or part, to commit,
      or to facilitate the commission of, a violation of this
      subchapter punishable by more than one year's imprisonment.
        (8) All controlled substances which have been possessed in
      violation of this subchapter.
        (9) All listed chemicals, all drug manufacturing equipment, all
      tableting machines, all encapsulating machines, and all gelatin
      capsules, which have been imported, exported, manufactured,
      possessed, distributed, dispensed, acquired, or intended to be
      distributed, dispensed, acquired, imported, or exported, in
      violation of this subchapter or subchapter II of this chapter.
        (10) Any drug paraphernalia (as defined in section 863 of this
      title).
        (11) Any firearm (as defined in section 921 of title 18) used
      or intended to be used to facilitate the transportation, sale,
      receipt, possession, or concealment of property described in
      paragraph (1) or (2) and any proceeds traceable to such property.
    (b) Seizure procedures
      Any property subject to forfeiture to the United States under
    this section may be seized by the Attorney General in the manner
    set forth in section 981(b) of title 18.
    (c) Custody of Attorney General
      Property taken or detained under this section shall not be
    repleviable, but shall be deemed to be in the custody of the
    Attorney General, subject only to the orders and decrees of the
    court or the official having jurisdiction thereof. Whenever
    property is seized under any of the provisions of this subchapter,
    the Attorney General may - 
        (1) place the property under seal;
        (2) remove the property to a place designated by him; or
        (3) require that the General Services Administration take
      custody of the property and remove it, if practicable, to an
      appropriate location for disposition in accordance with law.
    (d) Other laws and proceedings applicable
      The provisions of law relating to the seizure, summary and
    judicial forfeiture, and condemnation of property for violation of
    the customs laws; the disposition of such property or the proceeds
    from the sale thereof; the remission or mitigation of such
    forfeitures; and the compromise of claims shall apply to seizures
    and forfeitures incurred, or alleged to have been incurred, under
    any of the provisions of this subchapter, insofar as applicable and
    not inconsistent with the provisions hereof; except that such
    duties as are imposed upon the customs officer or any other person
    with respect to the seizure and forfeiture of property under the
    customs laws shall be performed with respect to seizures and
    forfeitures of property under this subchapter by such officers,
    agents, or other persons as may be authorized or designated for
    that purpose by the Attorney General, except to the extent that
    such duties arise from seizures and forfeitures effected by any
    customs officer.
    (e) Disposition of forfeited property
      (1) Whenever property is civilly or criminally forfeited under
    this subchapter the Attorney General may - 
        (A) retain the property for official use or, in the manner
      provided with respect to transfers under section 1616a of title
      19, transfer the property to any Federal agency or to any State
      or local law enforcement agency which participated directly in
      the seizure or forfeiture of the property;
        (B) except as provided in paragraph (4), sell, by public sale
      or any other commercially feasible means, any forfeited property
      which is not required to be destroyed by law and which is not
      harmful to the public;
        (C) require that the General Services Administration take
      custody of the property and dispose of it in accordance with law;
        (D) forward it to the Bureau of Narcotics and Dangerous Drugs
      for disposition (including delivery for medical or scientific use
      to any Federal or State agency under regulations of the Attorney
      General); or
        (E) transfer the forfeited personal property or the proceeds of
      the sale of any forfeited personal or real property to any
      foreign country which participated directly or indirectly in the
      seizure or forfeiture of the property, if such a transfer - 
          (i) has been agreed to by the Secretary of State;
          (ii) is authorized in an international agreement between the
        United States and the foreign country; and
          (iii) is made to a country which, if applicable, has been
        certified under section 2291j(b) of title 22.

      (2)(A) The proceeds from any sale under subparagraph (B) of
    paragraph (1) and any moneys forfeited under this subchapter shall
    be used to pay - 
        (i) all property expenses of the proceedings for forfeiture and
      sale including expenses of seizure, maintenance of custody,
      advertising, and court costs; and
        (ii) awards of up to $100,000 to any individual who provides
      original information which leads to the arrest and conviction of
      a person who kills or kidnaps a Federal drug law enforcement
      agent.

    Any award paid for information concerning the killing or kidnapping
    of a Federal drug law enforcement agent, as provided in clause
    (ii), shall be paid at the discretion of the Attorney General.
      (B) The Attorney General shall forward to the Treasurer of the
    United States for deposit in accordance with section 524(c) of
    title 28, any amounts of such moneys and proceeds remaining after
    payment of the expenses provided in subparagraph (A), except that,
    with respect to forfeitures conducted by the Postal Service, the
    Postal Service shall deposit in the Postal Service Fund, under
    section 2003(b)(7) of title 39, such moneys and proceeds.
      (3) The Attorney General shall assure that any property
    transferred to a State or local law enforcement agency under
    paragraph (1)(A) - 
        (A) has a value that bears a reasonable relationship to the
      degree of direct participation of the State or local agency in
      the law enforcement effort resulting in the forfeiture, taking
      into account the total value of all property forfeited and the
      total law enforcement effort with respect to the violation of law
      on which the forfeiture is based; and
        (B) will serve to encourage further cooperation between the
      recipient State or local agency and Federal law enforcement
      agencies.

      (4)(A) With respect to real property described in subparagraph
    (B), if the chief executive officer of the State involved submits
    to the Attorney General a request for purposes of such
    subparagraph, the authority established in such subparagraph is in
    lieu of the authority established in paragraph (1)(B).
      (B) In the case of property described in paragraph (1)(B) that is
    civilly or criminally forfeited under this subchapter, if the
    property is real property that is appropriate for use as a public
    area reserved for recreational or historic purposes or for the
    preservation of natural conditions, the Attorney General, upon the
    request of the chief executive officer of the State in which the
    property is located, may transfer title to the property to the
    State, either without charge or for a nominal charge, through a
    legal instrument providing that - 
        (i) such use will be the principal use of the property; and
        (ii) title to the property reverts to the United States in the
      event that the property is used otherwise.
    (f) Forfeiture and destruction of schedule I and II substances
      (1) All controlled substances in schedule I or II that are
    possessed, transferred, sold, or offered for sale in violation of
    the provisions of this subchapter; all dangerous, toxic, or
    hazardous raw materials or products subject to forfeiture under
    subsection (a)(2) of this section; and any equipment or container
    subject to forfeiture under subsection (a)(2) or (3) of this
    section which cannot be separated safely from such raw materials or
    products shall be deemed contraband and seized and summarily
    forfeited to the United States. Similarly, all substances in
    schedule I or II, which are seized or come into the possession of
    the United States, the owners of which are unknown, shall be deemed
    contraband and summarily forfeited to the United States.
      (2) The Attorney General may direct the destruction of all
    controlled substances in schedule I or II seized for violation of
    this subchapter; all dangerous, toxic, or hazardous raw materials
    or products subject to forfeiture under subsection (a)(2) of this
    section; and any equipment or container subject to forfeiture under
    subsection (a)(2) or (3) of this section which cannot be separated
    safely from such raw materials or products under such circumstances
    as the Attorney General may deem necessary.
    (g) Plants
      (1) All species of plants from which controlled substances in
    schedules I and II may be derived which have been planted or
    cultivated in violation of this subchapter, or of which the owners
    or cultivators are unknown, or which are wild growths, may be
    seized and summarily forfeited to the United States.
      (2) The failure, upon demand by the Attorney General or his duly
    authorized agent, of the person in occupancy or in control of land
    or premises upon which such species of plants are growing or being
    stored, to produce an appropriate registration, or proof that he is
    the holder thereof, shall constitute authority for the seizure and
    forfeiture.
      (3) The Attorney General, or his duly authorized agent, shall
    have authority to enter upon any lands, or into any dwelling
    pursuant to a search warrant, to cut, harvest, carry off, or
    destroy such plants.
    (h) Vesting of title in United States
      All right, title, and interest in property described in
    subsection (a) of this section shall vest in the United States upon
    commission of the act giving rise to forfeiture under this section.
    (i) Stay of civil forfeiture proceedings
      The provisions of section 981(g) of title 18 regarding the stay
    of a civil forfeiture proceeding shall apply to forfeitures under
    this section.
    (j) Venue
      In addition to the venue provided for in section 1395 of title 28
    or any other provision of law, in the case of property of a
    defendant charged with a violation that is the basis for forfeiture
    of the property under this section, a proceeding for forfeiture
    under this section may be brought in the judicial district in which
    the defendant owning such property is found or in the judicial
    district in which the criminal prosecution is brought.
    (l) (!1) Agreement between Attorney General and Postal Service for
      performance of functions

      The functions of the Attorney General under this section shall be
    carried out by the Postal Service pursuant to such agreement as may
    be entered into between the Attorney General and the Postal
    Service.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 511, Oct. 27, 1970, 84 Stat. 1276;
    Pub. L. 95-633, title III, Sec. 301(a), Nov. 10, 1978, 92 Stat.
    3777; Pub. L. 96-132, Sec. 14, Nov. 30, 1979, 93 Stat. 1048; Pub.
    L. 98-473, title II, Secs. 306, 309, 518, Oct. 12, 1984, 98 Stat.
    2050, 2051, 2075; Pub. L. 99-570, title I, Secs. 1006(c), 1865,
    1992, Oct. 27, 1986, 100 Stat. 3207-7, 3207-54, 3207-59; Pub. L. 99-
    646, Sec. 74, Nov. 10, 1986, 100 Stat. 3618; Pub. L. 100-690,
    title V, Sec. 5105, title VI, Secs. 6059, 6074, 6075, 6077(a), (b),
    6253, Nov. 18, 1988, 102 Stat. 4301, 4319, 4323-4325, 4363; Pub. L.
    101-189, div. A, title XII, Sec. 1215(a), Nov. 29, 1989, 103 Stat.
    1569; Pub. L. 101-647, title XX, Secs. 2003, 2004, 2007, 2008, Nov.
    29, 1990, 104 Stat. 4855, 4856; Pub. L. 102-239, Sec. 2, Dec. 17,
    1991, 105 Stat. 1912; Pub. L. 103-447, title I, Sec. 102(d), Nov.
    2, 1994, 108 Stat. 4693; Pub. L. 104-237, title II, Sec. 201(b),
    Oct. 3, 1996, 110 Stat. 3101; Pub. L. 106-185, Secs. 2(c)(2), 5(b),
    8(b), Apr. 25, 2000, 114 Stat. 210, 214, 216; Pub. L. 107-273, div.
    B, title IV, Sec. 4002(e)(3), Nov. 2, 2002, 116 Stat. 1810.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Subchapter II of this chapter, referred to in subsec. (a)(9), was
    in the original "title III", meaning title III of Pub. L. 91-513,
    Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
    subchapter II of this chapter. For classification of Part B,
    consisting of sections 1101 to 1105 of title III, see Tables.
      The customs laws, referred to in subsec. (d), are classified
    generally to Title 19, Customs Duties.
      Schedules I and II, referred to in subsecs. (f) and (g), are set
    out in section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a)(10). Pub. L. 107-273 substituted "section 863
    of this title" for "section 1822 of the Mail Order Drug
    Paraphernalia Control Act".
      2000 - Subsec. (a)(4). Pub. L. 106-185, Sec. 2(c)(2), struck out
    before period at end ", except that - 
        "(A) no conveyance used by any person as a common carrier in
      the transaction of business as a common carrier shall be
      forfeited under the provisions of this section unless it shall
      appear that the owner or other person in charge of such
      conveyance was a consenting party or privy to a violation of this
      subchapter or subchapter II of this chapter;
        "(B) no conveyance shall be forfeited under the provisions of
      this section by reason of any act or omission established by the
      owner thereof to have been committed or omitted by any person
      other than such owner while such conveyance was unlawfully in the
      possession of a person other than the owner in violation of the
      criminal laws of the United States, or of any State; and
        "(C) no conveyance shall be forfeited under this paragraph to
      the extent of an interest of an owner, by reason of any act or
      omission established by that owner to have been committed or
      omitted without the knowledge, consent, or willful blindness of
      the owner".
      Subsec. (a)(6). Pub. L. 106-185, Sec. 2(c)(2), struck out before
    period at end ", except that no property shall be forfeited under
    this paragraph, to the extent of the interest of an owner, by
    reason of any act or omission established by that owner to have
    been committed or omitted without the knowledge or consent of that
    owner".
      Subsec. (a)(7). Pub. L. 106-185, Sec. 2(c)(2), struck out before
    period at end ", except that no property shall be forfeited under
    this paragraph, to the extent of an interest of an owner, by reason
    of any act or omission established by that owner to have been
    committed or omitted without the knowledge or consent of that
    owner".
      Subsec. (b). Pub. L. 106-185, Sec. 5(b), inserted heading and
    amended text of subsec. (b) generally. Prior to amendment, subsec.
    (b) authorized the Attorney General to seize property under this
    subchapter upon process issued pursuant to the Supplemental Rules
    for Certain Admirality and Maritime claims and to seize it without
    process in certain described circumstances.
      Subsec. (i). Pub. L. 106-185, Sec. 8(b), inserted heading and
    amended text of subsec. (i) generally. Prior to amendment, text
    read as follows: "The filing of an indictment or information
    alleging a violation of this subchapter or subchapter II of this
    chapter, or a violation of State or local law that could have been
    charged under this subchapter or subchapter II of this chapter,
    which is also related to a civil forfeiture proceeding under this
    section shall, upon motion of the United States and for good cause
    shown, stay the civil forfeiture proceeding."
      1996 - Subsec. (a)(2), (6). Pub. L. 104-237, Sec. 201(b)(1),
    inserted "or listed chemical" after "controlled substance".
      Subsec. (a)(9). Pub. L. 104-237, Sec. 201(b)(2), substituted
    "possessed, distributed, dispensed, acquired, or intended to be
    distributed, dispensed, acquired," for "possessed, distributed, or
    intended to be distributed," and struck out "a felony provision of"
    after "in violation of".
      1994 - Subsec. (e)(1)(E)(iii). Pub. L. 103-447 substituted
    "section 2291j(b) of title 22" for "section 2291(h) of title 22".
      1991 - Subsec. (e)(1)(B). Pub. L. 102-239, Sec. 2(1), substituted
    "except as provided in paragraph (4), sell" for "sell".
      Subsec. (e)(4). Pub. L. 102-239, Sec. 2(2), added par. (4).
      1990 - Subsec. (a)(10). Pub. L. 101-647, Sec. 2007, added par.
    (10).
      Subsec. (a)(11). Pub. L. 101-647, Sec. 2008, added par. (11).
      Subsec. (e)(1)(B). Pub. L. 101-647, Sec. 2003, inserted ", by
    public sale or any other commercially feasible means," after
    "sell".
      Subsec. (f). Pub. L. 101-647, Sec. 2004, inserted "; all
    dangerous, toxic, or hazardous raw materials or products subject to
    forfeiture under subsection (a)(2) of this section; and any
    equipment or container subject to forfeiture under subsection
    (a)(2) or (3) of this section which cannot be separated safely from
    such raw materials or products" after "this subchapter" in pars.
    (1) and (2).
      1989 - Subsec. (e)(3)(B). Pub. L. 101-189 amended subpar. (B)
    generally. Prior to amendment, subpar. (B) read as follows: "is not
    so transferred to circumvent any requirement of State law that
    prohibits forfeiture or limits use or disposition of property
    forfeited to State or local agencies."
      1988 - Subsec. (a)(3). Pub. L. 100-690, Sec. 6059(b), inserted
    reference to par. (9).
      Subsec. (a)(4). Pub. L. 100-690, Secs. 6059(b), 6075, inserted in
    introductory provisions reference to par. (9) and added subpar.
    (C).
      Subsec. (a)(7). Pub. L. 100-690, Sec. 5105, inserted "(including
    any leasehold interest)" after "interest".
      Subsec. (a)(9). Pub. L. 100-690, Sec. 6059(a), added par. (9).
      Subsec. (e)(1)(A). Pub. L. 100-690, Sec. 6077(b), amended subpar.
    (A) generally. Prior to amendment, subpar. (A) read as follows:
    "retain the property for official use or transfer the custody or
    ownership of any forfeited property to any Federal, State, or local
    agency pursuant to section 1616a of title 19;".
      Subsec. (e)(1)(E). Pub. L. 100-690, Sec. 6074, added subpar. (E).
      Subsec. (e)(2)(B). Pub. L. 100-690, Sec. 6253(b), provided for
    deposit of moneys and proceeds in Postal Service Fund in cases of
    forfeitures conducted by Postal Service.
      Subsec. (e)(3). Pub. L. 100-690, Sec. 6077(a), added par. (3).
      Subsec. (l). Pub. L. 100-690, Sec. 6253(a), added subsec. (l).
      1986 - Subsec. (b). Pub. L. 99-570, Sec. 1865(1)-(3), and Pub. L.
    99-646, Sec. 74(1)-(3), in making identical amendments in
    introductory provision and par. (4), struck out "or criminal" after
    "subject to civil" and inserted paragraph permitting the Government
    to request issuance of a warrant authorizing seizure of property
    subject to forfeiture under this section in the same manner as
    provided for a search warrant under the Federal Rules of Criminal
    Procedure.
      Subsec. (e). Pub. L. 99-570, Sec. 1992, designated existing
    provisions as par. (1) and former pars. (1) to (4) as subpars. (A)
    to (D), respectively, and added par. (2) in lieu of former
    concluding provisions which read as follows: "The Attorney General
    shall ensure the equitable transfer pursuant to paragraph (1) of
    any forfeited property to the appropriate State or local law
    enforcement agency so as to reflect generally the contribution of
    any such agency participating directly in any of the acts which led
    to the seizure or forfeiture of such property. A decision by the
    Attorney General pursuant to paragraph (1) shall not be subject to
    review. The proceeds from any sale under paragraph (2) and any
    moneys forfeited under this subchapter shall be used to pay all
    proper expenses of the proceedings for forfeiture and sale
    including expenses of seizure, maintenance of custody, advertising,
    and court costs. The Attorney General shall forward to the
    Treasurer of the United States for deposit in accordance with
    section 524(c) of title 28 any amounts of such moneys and proceeds
    remaining after payment of such expenses."
      Subsec. (f). Pub. L. 99-570, Sec. 1006(c), which directed the
    amendment of section 511 of the "Comprehensive Drug Abuse
    Prevention Act of 1978" was executed to this section which is
    section 511 of the Comprehensive Drug Abuse Prevention Act of 1970,
    as the probable intent of Congress, by designating existing
    provisions as par. (1), inserting "or II" in two places, and adding
    par. (2).
      Subsec. (i). Pub. L. 99-570, Sec. 1865(b) and Pub. L. 99-646,
    Sec. 74(b), made identical amendments, inserting ", or a violation
    of State or local law that could have been charged under this
    subchapter or subchapter II of this chapter,".
      1984 - Subsec. (a)(7). Pub. L. 98-473, Sec. 306(a), added par.
    (7).
      Subsec. (a)(8). Pub. L. 98-473, Sec. 518, added par. (8).
      Subsec. (b). Pub. L. 98-473, Sec. 306(b)(1), inserted "civil or
    criminal" after "property subject to".
      Subsec. (b)(4). Pub. L. 98-473, Sec. 306(b)(2), substituted "is
    subject to civil or criminal forfeiture under" for "has been used
    or is intended to be used in violation of".
      Subsec. (c). Pub. L. 98-473, Sec. 306(c)(1), in provisions
    preceding par. (1), inserted "any of" after "seized under".
      Subsec. (c)(3). Pub. L. 98-473, Sec. 306(c)(2), inserted ", if
    practicable," after "remove it".
      Subsec. (d). Pub. L. 98-473, Sec. 306(d), inserted "any of" after
    "incurred, under".
      Subsec. (e). Pub. L. 98-473, Secs. 306(e), 309, inserted "civilly
    or criminally" after "Whenever property is" and in provisions
    preceding par. (1), inserted provisions relating to transfer of
    custody or ownership of forfeited property in par. (1), substituted
    "and dispose of it" for "and remove it for disposition" in par.
    (3), and, in provisions following par. (4), inserted sentence
    requiring the Attorney General to ensure equitable transfer of any
    forfeited property, and substituted "accordance with section 524(c)
    of title 28" for "the general fund of the United States Treasury".
      Subsecs. (h) to (j). Pub. L. 98-473, Sec. 306(f), added subsecs.
    (h) to (j).
      1979 - Subsec. (d). Pub. L. 96-132 substituted "The provisions"
    for "All provisions" and struck out "and the award of compensation
    to informers in respect of such forfeitures" after "compromise of
    claims".
      1978 - Subsec. (a)(6). Pub. L. 95-633, Sec. 301(1), added par.
    (6).
      Subsec. (e). Pub. L. 95-633, Sec. 301(a)(2), (3), struck out of
    cl. (2) provisions relating to use of proceeds of sale and inserted
    last sentence relating to the forwarding by the Attorney General of
    money and proceeds remaining after payment of expenses.

                     EFFECTIVE DATE OF 2000 AMENDMENT                 
      Amendment by Pub. L. 106-185 applicable to any forfeiture
    proceeding commenced on or after the date that is 120 days after
    Apr. 25, 2000, see section 21 of Pub. L. 106-185, set out as a note
    under section 1324 of Title 8, Aliens and Nationality.

                     EFFECTIVE DATE OF 1989 AMENDMENT                 
      Section 1215(b) of Pub. L. 101-189 provided that: "The amendment
    made by subsection (a) [amending this section] shall take effect as
    of October 1, 1989."

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by section 6059 of Pub. L. 100-690 effective 120 days
    after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set out
    as a note under section 802 of this title.
      Section 6077(c) of Pub. L. 100-690, as amended by Pub. L. 101-
    162, title II, Sec. 208, Nov. 21, 1989, 103 Stat. 1005, provided
    that: "Section 551(e)(3)(B) of the Controlled Substances Act
    [probably means section 511(e)(3)(B) of the Controlled Substances
    Act, 21 U.S.C. 881(e)(3)(B)], as enacted by subsection (a), shall
    apply with respect to fiscal years beginning after September 30,
    1991."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Bureau of Narcotics and Dangerous Drugs, including office of
    Director thereof, in Department of Justice abolished by Reorg. Plan
    No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, set
    out in the Appendix to Title 5, Government Organization and
    Employees. Reorg. Plan No. 2 of 1973 also created in Department of
    Justice a single, comprehensive agency for enforcement of drug laws
    to be known as Drug Enforcement Administration, empowered Attorney
    General to authorize performance by officers, employees, and
    agencies of Department of functions transferred to him, and
    directed Attorney General to coordinate all drug law enforcement
    functions to assure maximum cooperation between Drug Enforcement
    Administration, Federal Bureau of Investigation, and other units of
    Department of Justice involved in drug law enforcement.


-MISC2-
                      CONSTRUCTIVE SEIZURE PROCEDURES                  
      Pub. L. 101-225, title II, Sec. 210, Dec. 12, 1989, 103 Stat.
    1913, provided that: "Not later than 6 months after the date of
    enactment of this Act [Dec. 12, 1989], the Secretary of
    Transportation and the Secretary of the Treasury, in order to avoid
    the devastating economic effects on innocent owners of seizures of
    their vessels, shall develop a procedure for constructive seizure
    of vessels of the United States engaged in commercial service as
    defined in section 2101 of title 46, United States Code, that are
    suspected of being used for committing violations of law involving
    personal use quantities of controlled substances."

      REGULATIONS FOR EXPEDITED ADMINISTRATIVE FORFEITURE PROCEDURES  
      Section 6079 of Pub. L. 100-690 provided that:
      "(a) In General. - Not later than 90 days after the date of
    enactment of this Act [Nov. 18, 1988], the Attorney General and the
    Secretary of the Treasury shall consult, and after providing a 30-
    day public comment period, shall prescribe regulations for
    expedited administrative procedures for seizures under section
    511(a)(4), (6), and (7) of the Controlled Substances Act (21 U.S.C.
    881(a)(4), (6), and (7)); section 596 of the Tariff Act of 1930 (19
    U.S.C. 1595a(a)); and section 2 of the Act of August 9, 1939 (53
    Stat. 1291; 49 U.S.C. App. 782 [now 49 U.S.C. 80303]) for
    violations involving the possession of personal use quantities of a
    controlled substance.
      "(b) Specifications. - The regulations prescribed pursuant to
    subsection (a) shall - 
        "(1) minimize the adverse impact caused by prolonged detention,
      and
        "(2) provide for a final administrative determination of the
      case within 21 days of seizure, or provide a procedure by which
      the defendant can obtain release of the property pending a final
      determination of the case. Such regulations shall provide that
      the appropriate agency official rendering a final determination
      shall immediately return the property if the following conditions
      are established:
          "(A) the owner or interested party did not know of or consent
        to the violation;
          "(B) the owner establishes a valid, good faith interest in
        the seized property as owner or otherwise; and
          "(C)(1) the owner establishes that the owner at no time had
        any knowledge or reason to believe that the property in which
        the owner claims an interest was being or would be used in a
        violation of the law; and
          "(2) if the owner at any time had, or should have had,
        knowledge or reason to believe that the property in which the
        owner claims an interest was being or would be used in a
        violation of the law, that the owner did what reasonably could
        be expected to prevent the violation.
    An owner shall not have the seized property returned under this
    subsection if the owner had not acted in a normal and customary
    manner to ascertain how the property would be used.
      "(c) Notice. - At the time of seizure or upon issuance of a
    summons to appear under subsection (d), the officer making the
    seizure shall furnish to any person in possession of the conveyance
    a written notice specifying the procedures under this section. At
    the earliest practicable opportunity after determining ownership of
    the seized conveyance, the head of the department or agency that
    seizes the conveyance shall furnish a written notice to the owner
    and other interested parties (including lienholders) of the legal
    and factual basis of the seizure.
      "(d) Summons in Lieu of Seizure of Commercial Fishing Industry
    Vessels. - Not later than 90 days after the enactment of this Act
    [Nov. 18, 1988], the Attorney General, the Secretary of the
    Treasury, and the Secretary of Transportation shall prescribe joint
    regulations, after a public comment period of at least 30 days,
    providing for issuance of a summons to appear in lieu of seizure of
    a commercial fishing industry vessel as defined in section
    2101(11a), (11b), and (11c) of title 46, United States Code, for
    violations involving the possession of personal use quantities of a
    controlled substance. These regulations shall apply when the
    violation is committed on a commercial fishing industry vessel that
    is proceeding to or from a fishing area or intermediate port of
    call, or is actively engaged in fishing operations. The authority
    provided under this section shall not affect existing authority to
    arrest an individual for drug-related offenses or to release that
    individual into the custody of the vessel's master. Upon answering
    a summons to appear, the procedures set forth in subsections (a),
    (b), and (c) of this section shall apply. The jurisdiction of the
    district court for any forfeiture incurred shall not be affected by
    the use of a summons under this section.
      "(e) Personal Use Quantities of a Controlled Substance. - For the
    purposes of this section, personal use quantities of a controlled
    substance shall not include sweepings or other evidence of non-
    personal use amounts."

-FOOTNOTE-
    (!1) So in original. No subsec. (k) has been enacted.


-End-



-CITE-
    21 USC Secs. 881-1, 881a                                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Secs. 881-1, 881a. Transferred

-COD-
                               CODIFICATION                           
      Section 881-1, Pub. L. 91-513, title II, Sec. 511A, as added Pub.
    L. 100-690, title VI, Sec. 6080(a), Nov. 18, 1988, 102 Stat. 4326,
    which related to expedited procedures for seized conveyances, was
    renumbered Sec. 518 of Pub. L. 91-513 by Pub. L. 101-647, title X,
    Sec. 1002(h)(1), Nov. 29, 1990, 104 Stat. 4828, transferred to
    section 888 of this title and subsequently repealed.
      Section 881a, Pub. L. 99-198, title XVII, Sec. 1764, Dec. 23,
    1985, 99 Stat. 1652, which related to production control of
    controlled substances, was renumbered section 519 of the Controlled
    Substances Act by Pub. L. 101-647, title X, Sec. 1002(h)(2), Nov.
    29, 1990, 104 Stat. 4828, and is classified to section 889 of this
    title.

-End-



-CITE-
    21 USC Sec. 882                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 882. Injunctions

-STATUTE-
    (a) Jurisdiction
      The district courts of the United States and all courts
    exercising general jurisdiction in the territories and possessions
    of the United States shall have jurisdiction in proceedings in
    accordance with the Federal Rules of Civil Procedure to enjoin
    violations of this subchapter.
    (b) Jury trial
      In case of an alleged violation of an injunction or restraining
    order issued under this section, trial shall, upon demand of the
    accused, be by a jury in accordance with the Federal Rules of Civil
    Procedure.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 512, Oct. 27, 1970, 84 Stat. 1278.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Rules of Civil Procedure, referred to in subsecs. (a)
    and (b), are set out in the Appendix to Title 28, Judiciary and
    Judicial Procedure.

-End-



-CITE-
    21 USC Sec. 883                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 883. Enforcement proceedings

-STATUTE-
      Before any violation of this subchapter is reported by the
    Administrator of the Drug Enforcement Administration to any United
    States attorney for institution of a criminal proceeding, the
    Administrator may require that the person against whom such
    proceeding is contemplated is given appropriate notice and an
    opportunity to present his views, either orally or in writing, with
    regard to such contemplated proceeding.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 513, Oct. 27, 1970, 84 Stat. 1278;
    Pub. L. 96-132, Sec. 16(c), Nov. 30, 1979, 93 Stat. 1049.)


-MISC1-
                                AMENDMENTS                            
      1979 - Pub. L. 96-132 substituted "Administrator of the Drug
    Enforcement Administration" for "Director of the Bureau of
    Narcotics and Dangerous Drugs" and "Administrator may" for
    "Director may".

-End-



-CITE-
    21 USC Sec. 884                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 884. Immunity and privilege

-STATUTE-
    (a) Refusal to testify
      Whenever a witness refuses, on the basis of his privilege against
    self-incrimination, to testify or provide other information in a
    proceeding before a court or grand jury of the United States,
    involving a violation of this subchapter, and the person presiding
    over the proceeding communicates to the witness an order issued
    under this section, the witness may not refuse to comply with the
    order on the basis of his privilege against self-incrimination. But
    no testimony or other information compelled under the order issued
    under subsection (b) of this section or any information obtained by
    the exploitation of such testimony or other information, may be
    used against the witness in any criminal case, including any
    criminal case brought in a court of a State, except a prosecution
    for perjury, giving a false statement, or otherwise failing to
    comply with the order.
    (b) Order of United States district court
      In the case of any individual who has been or may be called to
    testify or provide other information at any proceeding before a
    court or grand jury of the United States, the United States
    district court for the judicial district in which the proceeding is
    or may be held shall issue, upon the request of the United States
    attorney for such district, an order requiring such individual to
    give any testimony or provide any other information which he
    refuses to give or provide on the basis of his privilege against
    self-incrimination.
    (c) Request by United States attorney
      A United States attorney may, with the approval of the Attorney
    General or the Deputy Attorney General, the Associate Attorney
    General, or any Assistant Attorney General designated by the
    Attorney General, request an order under subsection (b) of this
    section when in his judgment - 
        (1) the testimony or other information from such individual may
      be necessary to the public interest; and
        (2) such individual has refused or is likely to refuse to
      testify or provide other information on the basis of his
      privilege against self-incrimination.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 514, Oct. 27, 1970, 84 Stat. 1278;
    Pub. L. 100-690, title VII, Sec. 7020(f), Nov. 18, 1988, 102 Stat.
    4396.)


-MISC1-
                                AMENDMENTS                            
      1988 - Subsec. (c). Pub. L. 100-690 inserted reference to
    Associate Attorney General.

-End-



-CITE-
    21 USC Sec. 885                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 885. Burden of proof; liabilities

-STATUTE-
    (a) Exemptions and exceptions; presumption in simple possession
      offenses
      (1) It shall not be necessary for the United States to negative
    any exemption or exception set forth in this subchapter in any
    complaint, information, indictment, or other pleading or in any
    trial, hearing, or other proceeding under this subchapter, and the
    burden of going forward with the evidence with respect to any such
    exemption or exception shall be upon the person claiming its
    benefit.
      (2) In the case of a person charged under section 844(a) of this
    title with the possession of a controlled substance, any label
    identifying such substance for purposes of section 353(b)(2) of
    this title shall be admissible in evidence and shall be prima facie
    evidence that such substance was obtained pursuant to a valid
    prescription from a practitioner while acting in the course of his
    professional practice.
    (b) Registration and order forms
      In the absence of proof that a person is the duly authorized
    holder of an appropriate registration or order form issued under
    this subchapter, he shall be presumed not to be the holder of such
    registration or form, and the burden of going forward with the
    evidence with respect to such registration or form shall be upon
    him.
    (c) Use of vehicles, vessels, and aircraft
      The burden of going forward with the evidence to establish that a
    vehicle, vessel, or aircraft used in connection with controlled
    substances in schedule I was used in accordance with the provisions
    of this subchapter shall be on the persons engaged in such use.
    (d) Immunity of Federal, State, local and other officials
      Except as provided in sections 2234 and 2235 of title 18, no
    civil or criminal liability shall be imposed by virtue of this
    subchapter upon any duly authorized Federal officer lawfully
    engaged in the enforcement of this subchapter, or upon any duly
    authorized officer of any State, territory, political subdivision
    thereof, the District of Columbia, or any possession of the United
    States, who shall be lawfully engaged in the enforcement of any law
    or municipal ordinance relating to controlled substances.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 515, Oct. 27, 1970, 84 Stat. 1279.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedule I, referred to in subsec. (c), is set out in section
    812(c) of this title.

-End-



-CITE-
    21 USC Sec. 886                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 886. Payments and advances

-STATUTE-
    (a) Payment to informers
      The Attorney General is authorized to pay any person, from funds
    appropriated for the Drug Enforcement Administration, for
    information concerning a violation of this subchapter, such sum or
    sums of money as he may deem appropriate, without reference to any
    moieties or rewards to which such person may otherwise be entitled
    by law.
    (b) Reimbursement for purchase of controlled substances
      Moneys expended from appropriations of the Drug Enforcement
    Administration for purchase of controlled substances and
    subsequently recovered shall be reimbursed to the current
    appropriation for the Administration.(!1)

    (c) Advance of funds for enforcement purposes
      The Attorney General is authorized to direct the advance of funds
    by the Treasury Department in connection with the enforcement of
    this subchapter.
    (d) Drug Pollution Fund
      (1) There is established in the Treasury a trust fund to be known
    as the "Drug Pollution Fund" (hereinafter referred to in this
    subsection as the "Fund"), consisting of amounts appropriated or
    credited to such Fund under section 841(b)(6) of this title.
      (2) There are hereby appropriated to the Fund amounts equivalent
    to the fines imposed under section 841(b)(6) of this title.
      (3) Amounts in the Fund shall be available, as provided in
    appropriations Acts, for the purpose of making payments in
    accordance with paragraph (4) for the clean up of certain pollution
    resulting from the actions referred to in section 841(b)(6) of this
    title.
      (4)(A) The Secretary of the Treasury, after consultation with the
    Attorney General, shall make payments under paragraph (3), in such
    amounts as the Secretary determines appropriate, to the heads of
    executive agencies or departments that meet the requirements of
    subparagraph (B).
      (B) In order to receive a payment under paragraph (3), the head
    of an executive agency or department shall submit an application in
    such form and containing such information as the Secretary of the
    Treasury shall by regulation require. Such application shall
    contain a description of the fine imposed under section 841(b)(6)
    of this title, the circumstances surrounding the imposition of such
    fine, and the type and severity of pollution that resulted from the
    actions to which such fine applies.
      (5) For purposes of subchapter B of chapter 98 of title 26, the
    Fund established under this paragraph shall be treated in the same
    manner as a trust fund established under subchapter A of such
    chapter.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 516, Oct. 27, 1970, 84 Stat. 1279;
    Pub. L. 96-132, Sec. 16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L.
    100-690, title VI, Sec. 6254(i), Nov. 18, 1988, 102 Stat. 4367.)

-COD-
                               CODIFICATION                           
      In subsec. (b), "Administration" substituted for "Bureau" as the
    probable intent of Congress in view of amendment by Pub. L. 96-132,
    which substituted references to the Drug Enforcement Administration
    for references to the Bureau of Narcotics and Dangerous Drugs
    wherever appearing in text.


-MISC1-
                                AMENDMENTS                            
      1988 - Subsec. (d). Pub. L. 100-690 added subsec. (d).
      1979 - Subsecs. (a), (b). Pub. L. 96-132 substituted "Drug
    Enforcement Administration" for "Bureau of Narcotics and Dangerous
    Drugs".

       REIMBURSEMENT BY DRUG ENFORCEMENT ADMINISTRATION OF EXPENSES
            INCURRED TO REMEDIATE METHAMPHETAMINE LABORATORIES
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3672, Oct. 17, 2000,
    114 Stat. 1246, provided that:
      "(a) Reimbursement Authorized. - The Attorney General, acting
    through the Administrator of the Drug Enforcement Administration,
    may reimburse States, units of local government, Indian tribal
    governments, other public entities, and multi-jurisdictional or
    regional consortia thereof for expenses incurred to clean up and
    safely dispose of substances associated with clandestine
    methamphetamine laboratories which may present a danger to public
    health or the environment.
      "(b) Additional DEA Personnel. - From amounts appropriated or
    otherwise made available to carry out this section, the Attorney
    General may hire not more than five additional Drug Enforcement
    Administration personnel to administer this section.
      "(c) Authorization of Appropriations. - There is authorized to be
    appropriated to the Attorney General to carry out this section
    $20,000,000 for fiscal year 2001."

-FOOTNOTE-               

    (!1) See Codification note below.


-End-



-CITE-
    21 USC Sec. 886a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 886a. Diversion Control Fee Account

-STATUTE-
    (1) In general
      There is established in the general fund of the Treasury a
    separate account which shall be known as the Diversion Control Fee
    Account. For fiscal year 1993 and thereafter:
        (A) There shall be deposited as offsetting receipts into that
      account all fees collected by the Drug Enforcement
      Administration, in excess of $15,000,000, for the operation of
      its diversion control program.
        (B) Such amounts as are deposited into the Diversion Control
      Fee Account shall remain available until expended and shall be
      refunded out of that account by the Secretary of the Treasury, at
      least on a quarterly basis, to reimburse the Drug Enforcement
      Administration for expenses incurred in the operation of the
      diversion control program. Such reimbursements shall be made
      without distinguishing between expenses related to controlled
      substance activities and expenses related to chemical activities.
        (C) Fees charged by the Drug Enforcement Administration under
      its diversion control program shall be set at a level that
      ensures the recovery of the full costs of operating the various
      aspects of that program.
        (D) The amount required to be refunded from the Diversion
      Control Fee Account for fiscal year 1994 and thereafter shall be
      refunded in accordance with estimates made in the budget request
      of the Attorney General for those fiscal years. Any proposed
      changes in the amounts designated in said budget requests shall
      only be made after notification to the Committees on
      Appropriations of the House of Representatives and the Senate
      fifteen days in advance.
    (2) Definitions
      In this section:
      (A) Diversion control program
        The term "diversion control program" means the controlled
      substance and chemical diversion control activities of the Drug
      Enforcement Administration.
      (B) Controlled substance and chemical diversion control
        activities
        The term "controlled substance and chemical diversion control
      activities" means those activities related to the registration
      and control of the manufacture, distribution, dispensing,
      importation, and exportation of controlled substances and listed
      chemicals.

-SOURCE-
    (Pub. L. 102-395, title I, Sec. 111(b), Oct. 6, 1992, 106 Stat.
    1843; Pub. L. 105-362, title X, Sec. 1001(b), Nov. 10, 1998, 112
    Stat. 3291; Pub. L. 108-447, div. B, title VI, Sec. 633(a), Dec. 8,
    2004, 118 Stat. 2921.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Departments of Commerce,
    Justice, and State, the Judiciary, and Related Agencies
    Appropriations Act, 1993, and not as part of the Controlled
    Substances Act which comprises this subchapter.


-MISC1-
                                AMENDMENTS                            
      2004 - Pub. L. 108-447, Sec. 633(a)(2) to (4), designated
    existing provisions as par. (1) and inserted heading, substituted
    "program. Such reimbursements shall be made without distinguishing
    between expenses related to controlled substance activities and
    expenses related to chemical activities" for "program" in par.
    (1)(B), and added par. (2).
      Pub. L. 108-447, Sec. 633(a)(1), which directed redesignation of
    pars. (1) to (5) as subpars. (A) to (E) and adjustment of margins,
    was executed by redesignating pars. (1) to (4) as (A) to (D),
    respectively, to reflect the probable intent of Congress, because
    Pub. L. 105-362 struck out par. (5). See 1998 Amendment note below.
      1998 - Par. (5). Pub. L. 105-362 struck out par. (5) which read
    as follows: "The Attorney General shall prepare and submit annually
    to the Congress, statements of financial condition of the account,
    including the beginning balance, receipts, refunds to
    appropriations, transfers to the general fund, and the ending
    balance."

-End-



-CITE-
    21 USC Sec. 887                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 887. Coordination and consolidation of post-seizure
      administration

-STATUTE-
      The Attorney General and the Secretary of the Treasury shall take
    such action as may be necessary to develop and maintain a joint
    plan to coordinate and consolidate post-seizure administration of
    property seized under this subchapter, subchapter II of this
    chapter, or provisions of the customs laws relating to controlled
    substances.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 517, as added Pub. L. 100-690,
    title VI, Sec. 6078(a), Nov. 18, 1988, 102 Stat. 4325.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The customs laws, referred to in text, are classified generally
    to Title 19, Customs Duties.

-End-



-CITE-
    21 USC Sec. 888                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 888. Repealed.

-MISC1-
    Sec. 888. Repealed. Pub. L. 106-185, Sec. 2(c)(3), Apr. 25, 2000,
      114 Stat. 210.
      Section, Pub. L. 91-513, title II, Sec. 518, formerly Sec. 511A,
    as added Pub. L. 100-690, title VI, Sec. 6080(a), Nov. 18, 1988,
    102 Stat. 4326; renumbered Sec. 518, Pub. L. 101-647, title X, Sec.
    1002(h)(1), Nov. 29, 1990, 104 Stat. 4828, related to expedited
    procedures for seized conveyances.
      Section was classified to section 881-1 of this title prior to
    renumbering by Pub. L. 101-647.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal applicable to any forfeiture proceeding commenced on or
    after the date that is 120 days after Apr. 25, 2000, see section 21
    of Pub. L. 106-185, set out as an Effective Date of 2000 Amendment
    note under section 1324 of Title 8, Aliens and Nationality.

-End-



-CITE-
    21 USC Sec. 889                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 889. Production control of controlled substances

-STATUTE-
    (a) Definitions
      As used in this section:
        (1) The term "controlled substance" has the same meaning given
      such term in section 802(6) of this title.
        (2) The term "Secretary" means the Secretary of Agriculture.
        (3) The term "State" means each of the fifty States, the
      District of Columbia, the Commonwealth of Puerto Rico, Guam, the
      Virgin Islands of the United States, American Samoa, the
      Commonwealth of the Northern Mariana Islands, or the Trust
      Territory of the Pacific Islands.
    (b) Persons ineligible for Federal agricultural program benefits
      Notwithstanding any other provision of law, following December
    23, 1985, any person who is convicted under Federal or State law of
    planting, cultivation, growing, producing, harvesting, or storing a
    controlled substance in any crop year shall be ineligible for - 
        (1) as to any commodity produced during that crop year, and the
      four succeeding crop years, by such person - 
          (A) any price support or payment made available under the
        Agricultural Act of 1949 (7 U.S.C. 1421 et seq.), the Commodity
        Credit Corporation Charter Act (15 U.S.C. 714 et seq.), or any
        other Act;
          (B) a farm storage facility loan made under section 4(h) of
        the Commodity Credit Corporation Charter Act (15 U.S.C.
        714b(h));
          (C) crop insurance under the Federal Crop Insurance Act (7
        U.S.C. 1501 et seq.);
          (D) a disaster payment made under the Agricultural Act of
        1949 (7 U.S.C. 1421 et seq.); or
          (E) a loan made, insured or guaranteed under the Consolidated
        Farm and Rural Development Act (7 U.S.C. 1921 et seq.) or any
        other provision of law administered by the Farmers Home
        Administration; or

        (2) a payment made under section 4 or 5 of the Commodity Credit
      Corporation Charter Act (15 U.S.C. 714b or 714c) for the storage
      of an agricultural commodity that is - 
          (A) produced during that crop year, or any of the four
        succeeding crop years, by such person; and
          (B) acquired by the Commodity Credit Corporation.
    (c) Regulations
      Not later than 180 days after December 23, 1985, the Secretary
    shall issue such regulations as the Secretary determines are
    necessary to carry out this section, including regulations that - 
        (1) define the term "person";
        (2) govern the determination of persons who shall be ineligible
      for program benefits under this section; and
        (3) protect the interests of tenants and sharecroppers.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 519, formerly Pub. L. 99-198, title
    XVII, Sec. 1764, Dec. 23, 1985, 99 Stat. 1652; renumbered Sec. 519
    of Pub. L. 91-513, Pub. L. 101-647, title X, Sec. 1002(h)(2), Nov.
    29, 1990, 104 Stat. 4828.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Agricultural Act of 1949, referred to in subsec. (b)(1)(A),
    (D), is act Oct. 31, 1949, ch. 792, 63 Stat. 1051, as amended,
    which is classified principally to chapter 35A (Sec. 1421 et seq.)
    of Title 7, Agriculture. For complete classification of this Act to
    the Code, see Short Title note set out under section 1421 of Title
    7 and Tables.
      The Commodity Credit Corporation Charter Act, referred to in
    subsec. (b)(1)(A), is act June 29, 1948, ch. 704, 62 Stat. 1070, as
    amended, and is classified generally to subchapter II (Sec. 714 et
    seq.) of chapter 15 of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 714 of Title 15 and Tables.
      The Federal Crop Insurance Act, referred to in subsec. (b)(1)(C),
    is title V of act Feb. 16, 1938, ch. 30, 52 Stat. 72, as amended,
    which is classified generally to chapter 36 (Sec. 1501 et seq.) of
    Title 7, Agriculture. For complete classification of this Act to
    the Code, see section 1501 of Title 7 and Tables.
      The Consolidated Farm and Rural Development Act, referred to in
    subsec. (b)(1)(E), is title III of Pub. L. 87-128, Aug. 8, 1961, 75
    Stat. 307, as amended, which is classified principally to chapter
    50 (Sec. 1921 et seq.) of Title 7. For complete classification of
    this Act to the Code, see Short Title note set out under section
    1921 of Title 7 and Tables.

-COD-
                               CODIFICATION                           
      Section was classified to section 881a of this title prior to
    renumbering by Pub. L. 101-647.


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-647 renumbered section 881a of this title as
    this section.


-TRANS-
           TERMINATION OF TRUST TERRITORY OF THE PACIFIC ISLANDS       
      For termination of Trust Territory of the Pacific Islands, see
    note set out preceding section 1681 of Title 48, Territories and
    Insular Possessions.

-End-



-CITE-
    21 USC Sec. 890                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part E - Administrative and Enforcement Provisions

-HEAD-
    Sec. 890. Review of Federal sales of chemicals usable to
      manufacture controlled substances

-STATUTE-
      A Federal department or agency may not sell from the stocks of
    the department or agency any chemical which, as determined by the
    Administrator of the Drug Enforcement Administration, could be used
    in the manufacture of a controlled substance unless the
    Administrator certifies in writing to the head of the department or
    agency that there is no reasonable cause to believe that the sale
    of the chemical would result in the illegal manufacture of a
    controlled substance.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 520, as added Pub. L. 104-201, div.
    A, title X, Sec. 1034(a), Sept. 23, 1996, 110 Stat. 2640.)

-End-


-CITE-
    21 USC Part F - General Provisions                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part F - General Provisions

-HEAD-
                        PART F - GENERAL PROVISIONS                    

-COD-
                               CODIFICATION                           
      The letter designation for this Part F was, in the original, Part
    G. The original Part F of title II of Pub. L. 91-513, consisting of
    section 601 thereof, is set out as a note under section 801 of this
    title. The original Part G of title II of Pub. L. 91-513 consisted
    of sections 701 to 709. Sections 701 to 705 amended and repealed
    sections in this title and in Title 18, Crimes and Criminal
    Procedure, and Title 42, The Public Health and Welfare, and enacted
    provisions set out as notes under sections 321, 801, and 822 of
    this title. See Tables for classifications of said sections 701 to
    705. Sections 706 to 709 of Pub. L. 91-513 are set out as sections
    901 to 904 of this title and, for purposes of codification,
    comprise this Part F.

-End-



-CITE-
    21 USC Sec. 901                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part F - General Provisions

-HEAD-
    Sec. 901. Severability

-STATUTE-
      If a provision of this chapter is held invalid, all valid
    provisions that are severable shall remain in effect. If a
    provision of this chapter is held invalid in one or more of its
    applications, the provision shall remain in effect in all its valid
    applications that are severable.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 706, Oct. 27, 1970, 84 Stat. 1284.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1236, as
    amended. For complete classification of this Act to the Code, see
    Short Title note set out under section 801 of this title and
    Tables.

-End-



-CITE-
    21 USC Sec. 902                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part F - General Provisions

-HEAD-
    Sec. 902. Savings provisions

-STATUTE-
      Nothing in this chapter, except this part and, to the extent of
    any inconsistency, sections 827(e) and 829 of this title, shall be
    construed as in any way affecting, modifying, repealing, or
    superseding the provisions of the Federal Food, Drug, and Cosmetic
    Act [21 U.S.C. Sec. 301 et seq.].

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 707, Oct. 27, 1970, 84 Stat. 1284.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in text, is
    act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
    classified generally to chapter 9 (Sec. 301 et seq.) of this title.
    For complete classification of this Act to the Code, see section
    301 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 903                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part F - General Provisions

-HEAD-
    Sec. 903. Application of State law

-STATUTE-
      No provision of this subchapter shall be construed as indicating
    an intent on the part of the Congress to occupy the field in which
    that provision operates, including criminal penalties, to the
    exclusion of any State law on the same subject matter which would
    otherwise be within the authority of the State, unless there is a
    positive conflict between that provision of this subchapter and
    that State law so that the two cannot consistently stand together.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 708, Oct. 27, 1970, 84 Stat. 1284.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, referred to in text, was in the original "this
    title", meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
    1242, as amended, and is popularly known as the "Controlled
    Substances Act". For complete classification of title II to the
    Code, see second paragraph of Short Title note set out under
    section 801 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 904                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER I - CONTROL AND ENFORCEMENT
    Part F - General Provisions

-HEAD-
    Sec. 904. Payment of tort claims

-STATUTE-
      Notwithstanding section 2680(k) of title 28, the Attorney
    General, in carrying out the functions of the Department of Justice
    under this subchapter, is authorized to pay tort claims in the
    manner authorized by section 2672 of title 28, when such claims
    arise in a foreign country in connection with the operations of the
    Drug Enforcement Administration abroad.

-SOURCE-
    (Pub. L. 91-513, title II, Sec. 709, Oct. 27, 1970, 84 Stat. 1284;
    Pub. L. 93-481, Sec. 1, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 95-
    137, Sec. 1(a), Oct. 18, 1977, 91 Stat. 1169; Pub. L. 96-132,
    Secs. 13, 15, Nov. 30, 1979, 93 Stat. 1048; Pub. L. 97-414, Sec.
    9(g)(1), Jan. 4, 1983, 96 Stat. 2064.)


-MISC1-
                                AMENDMENTS                            
      1983 - Pub. L. 97-414 struck out subsecs. (a) and (b) which had
    provided, respectively, that (a) there were authorized to be
    appropriated $105,000,000 for the fiscal year ending June 30, 1975,
    $175,000,000 for the fiscal year ending June 30, 1976, $200,000,000
    for the fiscal year ending September 30, 1977, $188,000,000 for the
    fiscal year ending September 30, 1978, $215,000,000 for the fiscal
    year ending September 30, 1979, and $198,336,000 for the fiscal
    year ending September 30, 1980, for the expenses of the Department
    of Justice in carrying out its functions under this subchapter, and
    that (b) no funds appropriated under any other provision of this
    chapter could be used for the expenses of the Department of Justice
    for which funds were authorized to be appropriated by former
    subsection (a) of this section, and removed the subsection
    designator (c) before "Notwithstanding".
      1979 - Subsec. (a). Pub. L. 96-132, Sec. 15, inserted provisions
    authorizing appropriations of $198,336,000 for the fiscal year
    ending Sept. 30, 1980.
      Subsec. (c). Pub. L. 96-132, Sec. 13, added subsec. (c).
      1977 - Subsec. (a). Pub. L. 95-137 substituted "September 30,
    1977, $188,000,000 for the fiscal year ending September 30, 1978,
    and $215,000,000 for the fiscal year ending September 30, 1979,"
    for "June 30, 1977," and struck out "(other than its expenses
    incurred in connection with carrying out section 803(a) of this
    title)".
      1974 - Pub. L. 93-481 designated existing provisions as subsec.
    (a), substituted authorization of appropriations for fiscal years
    ending June 30, 1975, June 30, 1976, and June 30, 1977, for
    authorization of appropriations for fiscal years ending June 30,
    1972, June 30, 1973, and June 30, 1974, and added subsec. (b).

-End-


-CITE-
    21 USC SUBCHAPTER II - IMPORT AND EXPORT                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
                     SUBCHAPTER II - IMPORT AND EXPORT                 

-COD-
                               CODIFICATION                           
      This subchapter is comprised of Part A of title III of Pub. L. 91-
    513, Oct. 27, 1970, 84 Stat. 1285. Part B of title III contains
    amendatory, repealing, and transitional provisions generally
    classified elsewhere.

-End-



-CITE-
    21 USC Sec. 951                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 951. Definitions

-STATUTE-
      (a) For purposes of this subchapter - 
        (1) The term "import" means, with respect to any article, any
      bringing in or introduction of such article into any area
      (whether or not such bringing in or introduction constitutes an
      importation within the meaning of the tariff laws of the United
      States).
        (2) The term "customs territory of the United States" has the
      meaning assigned to such term by general note 2 of the Harmonized
      Tariff Schedule of the United States.

      (b) Each term defined in section 802 of this title shall have the
    same meaning for purposes of this subchapter as such term has for
    purposes of subchapter I of this chapter.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1001, Oct. 27, 1970, 84 Stat.
    1285; Pub. L. 100-418, title I, Sec. 1214(m), Aug. 23, 1988, 102
    Stat. 1158.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Harmonized Tariff Schedule of the United States, referred to
    in subsec. (a)(2), is not set out in the Code. See Publication of
    Harmonized Tariff Schedule note set out under section 1202 of Title
    19, Customs Duties.
      This subchapter, referred to in subsecs. (a) and (b), was in the
    original "this title", meaning title III of Pub. L. 91-513, Oct.
    27, 1970, 84 Stat. 1285, as amended. Part A of title III comprises
    this subchapter. For classification of Part B, consisting of
    sections 1101 to 1105 of title III, see Tables.


-MISC1-
                                AMENDMENTS                            
      1988 - Subsec. (a)(2). Pub. L. 100-418 substituted "general note
    2 of the Harmonized Tariff Schedule of the United States" for
    "general headnote 2 to the Tariff Schedules of the United States".

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-418 effective Jan. 1, 1989, and
    applicable with respect to articles entered on or after such date,
    see section 1217(b)(1) of Pub. L. 100-418, set out as an Effective
    Date note under section 3001 of Title 19, Customs Duties.

                              EFFECTIVE DATE                          
      Section 1105(a)-(c) of title III of Pub. L. 91-513, as amended by
    Pub. L. 99-514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095, provided
    that:
      "(a) Except as otherwise provided in this section, this title
    [see Short Title note below] shall become effective on the first
    day of the seventh calendar month that begins after the day
    immediately preceding the date of enactment [Oct. 27, 1970].
      "(b) Sections 1000, 1001, 1006, 1015, 1016, 1103, 1104 [see Short
    Title note below and sections 171 note, 951, 956, 957 note, 965,
    and 966 of this title], and this section shall become effective
    upon enactment [Oct. 27, 1970].
      "(c)(1) If the Attorney General, pursuant to the authority of
    section 704(c) of title II [set out as a note under section 801 of
    this title], postpones the effective date of section 306 (relating
    to manufacturing quotas) [section 826 of this title] for any period
    beyond the date specified in section 704(a) [set out as a note
    under section 801 of this title], and such postponement applies to
    narcotic drugs, the repeal of the Narcotics Manufacturing Act of
    1960 [sections 501 to 517 of this title] by paragraph (10) of
    section 1101(a) of this title is hereby postponed for the same
    period, except that the postponement made by this paragraph shall
    not apply to the repeal of sections 4, 5, 13, 15, and 16 of that
    Act [which were classified to sections 182, 503, 511, and 513 of
    this title and sections 4702, 4731, and 4731 note of Title 26,
    Internal Revenue Code].
      "(2) Effective for any period of postponement, by paragraph (1)
    of this subsection, of the repeal of provisions of the Narcotics
    Manufacturing Act of 1960 [sections 501 to 517 of this title], that
    Act shall be applied subject to the following modifications:
      "(A) The term 'narcotic drug' shall mean a narcotic drug as
    defined in section 102(16) of title II [section 802(16) of this
    title], and all references, in the Narcotics Manufacturing Act of
    1960 [sections 501 to 517 of this title], to a narcotic drug as
    defined by section 4731 of the Internal Revenue Code of 1986
    [formerly I.R.C. 1954, section 4731 of Title 26] are amended to
    refer to a narcotic drug as defined by such section 102(16)
    [section 802(16) of this title].
      "(B) On and after the date prescribed by the Attorney General
    pursuant to clause (2) of section 703(c) of title II, [set out as a
    note under section 822 of this title], the requirements of a
    manufacturer's license with respect to a basic class of narcotic
    drug under the Narcotics Manufacturing Act of 1960 [sections 501 to
    517 of this title], and of a registration under section 4722 of the
    Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722
    of Title 26] as a prerequisite to issuance of such a license, shall
    be superseded by a requirement of actual registration (as
    distinguished from provisional registration) as a manufacturer of
    that class of drug under section 303(a) of title II [section 823(a)
    of this title].
      "(C) On and after the effective date of the repeal of such
    section 4722 [section 4722 of title 26] by section 1101(b)(3) of
    this title, but prior to the date specified in subparagraph (B) of
    this paragraph, the requirement of registration under such section
    4722 [section 4722 of title 26] as a prerequisite of a
    manufacturer's license under the Narcotics Manufacturing Act of
    1960 [sections 501 to 517 of this title] shall be superseded by a
    requirement of either (i) actual registration as a manufacturer
    under section 303 of title II [section 823 of this title] or (ii)
    provisional registration (by virtue of a preexisting registration
    under such section 4722) under section 703 of title II [set out as
    a note under section 822 of this title]."

                                SHORT TITLE                            
      Section 1000 of title III of Pub. L. 91-513 provided that: "This
    title [enacting this subchapter, amending sections 162 and 967 of
    this title, section 4251 of Title 18, Crimes and Criminal
    Procedure, section 1584 of Title 19, Customs Duties, sections 4901,
    4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and 7655 of
    Title 26, Internal Revenue Code, section 2901 of Title 28,
    Judiciary and Judicial Procedure, sections 529d, 529e, and 529f of
    former Title 31, Money and Finance, section 304m of former Title
    40, Public Buildings, Property, and Works, section 3411 of Title
    42, The Public Health and Welfare, section 239a of former Title 46,
    Shipping, and section 787 of former Title 49, Transportation,
    repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193,
    197, 198, 199, and 501 to 517 of this title, sections 1401 to 1407,
    and 3616 of Title 18, sections 4701 to 4707, 4711 to 4716, 4721 to
    4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to
    4776, 7237, 7238, and 7491 of Title 26, sections 529a and 529g of
    former Title 31, section 1421m of Title 48, Territories and Insular
    Possessions, and enacting provisions set out as notes under this
    section and sections 171 and 957 of this title] may be cited as the
    'Controlled Substances Import and Export Act'."

                           RULES AND REGULATIONS                       
      Section 1105(d) of Pub. L. 91-513 provided: "Any orders, rules
    and regulations which have been promulgated under any law affected
    by this title [see Short Title note above] and which are in effect
    on the day preceding enactment of this title [Oct. 27, 1970] shall
    continue in effect until modified, superseded, or repealed."

-End-



-CITE-
    21 USC Sec. 952                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 952. Importation of controlled substances

-STATUTE-
    (a) Controlled substances in schedule I or II and narcotic drugs in
      schedule III, IV, or V; exceptions
      It shall be unlawful to import into the customs territory of the
    United States from any place outside thereof (but within the United
    States), or to import into the United States from any place outside
    thereof, any controlled substance in schedule I or II of subchapter
    I of this chapter, or any narcotic drug in schedule III, IV, or V
    of subchapter I of this chapter, or ephedrine, pseudoephedrine, or
    phenylpropanolamine, except that - 
        (1) such amounts of crude opium, poppy straw, concentrate of
      poppy straw, and coca leaves, and of ephedrine, pseudoephedrine,
      and phenylpropanolamine, as the Attorney General finds to be
      necessary to provide for medical, scientific, or other legitimate
      purposes, and
        (2) such amounts of any controlled substance in schedule I or
      II or any narcotic drug in schedule III, IV, or V that the
      Attorney General finds to be necessary to provide for the
      medical, scientific, or other legitimate needs of the United
      States - 
          (A) during an emergency in which domestic supplies of such
        substance or drug are found by the Attorney General to be
        inadequate,
          (B) in any case in which the Attorney General finds that
        competition among domestic manufacturers of the controlled
        substance is inadequate and will not be rendered adequate by
        the registration of additional manufacturers under section 823
        of this title, or
          (C) in any case in which the Attorney General finds that such
        controlled substance is in limited quantities exclusively for
        scientific, analytical, or research uses,

    may be so imported under such regulations as the Attorney General
    shall prescribe. No crude opium may be so imported for the purpose
    of manufacturing heroin or smoking opium.
    (b) Nonnarcotic controlled substances in schedule III, IV, or V
      It shall be unlawful to import into the customs territory of the
    United States from any place outside thereof (but within the United
    States), or to import into the United States from  any  place 
    outside  thereof,  any  nonnarcotic controlled substance in
    schedule III, IV, or V, unless such nonnarcotic controlled
    substance - 
        (1) is imported for medical, scientific, or other legitimate
      uses, and
        (2) is imported pursuant to such notification, or declaration,
      or in the case of any nonnarcotic controlled substance in
      schedule III, such import permit, notification, or declaration,
      as the Attorney General may by regulation prescribe, except that
      if a nonnarcotic controlled substance in schedule IV or V is also
      listed in schedule I or II of the Convention on Psychotropic
      Substances it shall be imported pursuant to such import permit
      requirements, prescribed by regulation of the Attorney General,
      as are required by the Convention.
    (c) Coca leaves
      In addition to the amount of coca leaves authorized to be
    imported into the United States under subsection (a) of this
    section, the Attorney General may permit the importation of
    additional amounts of coca leaves. All cocaine and ecgonine (and
    all salts, derivatives, and preparations from which cocaine or
    ecgonine may be synthesized or made) contained in such additional
    amounts of coca leaves imported under this subsection shall be
    destroyed under the supervision of an authorized representative of
    the Attorney General.
    (d) Application for increased importation of ephedrine,
      pseudoephedrine, or phenylpropanolamine
      (1) With respect to a registrant under section 958 of this title
    who is authorized under subsection (a)(1) to import ephedrine,
    pseudoephedrine, or phenylpropanolamine, at any time during the
    year the registrant may apply for an increase in the amount of such
    chemical that the registrant is authorized to import, and the
    Attorney General may approve the application if the Attorney
    General determines that the approval is necessary to provide for
    medical, scientific, or other legitimate purposes regarding the
    chemical.
      (2) With respect to the application under paragraph (1):
        (A) Not later than 60 days after receiving the application, the
      Attorney General shall approve or deny the application.
        (B) In approving the application, the Attorney General shall
      specify the period of time for which the approval is in effect,
      or shall provide that the approval is effective until the
      registrant involved is notified in writing by the Attorney
      General that the approval is terminated.
        (C) If the Attorney General does not approve or deny the
      application before the expiration of the 60-day period under
      subparagraph (A), the application is deemed to be approved, and
      such approval remains in effect until the Attorney General
      notifies the registrant in writing that the approval is
      terminated.
    (e) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine
      Each reference in this section to ephedrine, pseudoephedrine, or
    phenylpropanolamine includes each of the salts, optical isomers,
    and salts of optical isomers of such chemical.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1002, Oct. 27, 1970, 84 Stat.
    1285; Pub. L. 95-633, title I, Sec. 105, Nov. 10, 1978, 92 Stat.
    3772; Pub. L. 98-473, title II, Secs. 519-521, Oct. 12, 1984, 98
    Stat. 2075; Pub. L. 109-177, title VII, Sec. 715, Mar. 9, 2006, 120
    Stat. 264.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, IV, and V, referred to in subsecs. (a) and
    (b), are set out in section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a). Pub. L. 109-177, Sec. 715(1)(A), inserted "or
    ephedrine, pseudoephedrine, or phenylpropanolamine," after
    "schedule III, IV, or V of subchapter I of this chapter," in
    introductory provisions.
      Subsec. (a)(1). Pub. L. 109-177, Sec. 715(1)(B), inserted ", and
    of ephedrine, pseudoephedrine, and phenylpropanolamine," after
    "coca leaves".
      Subsecs. (d), (e). Pub. L. 109-177, Sec. 715(2), added subsecs.
    (d) and (e).
      1984 - Subsec. (a)(1). Pub. L. 98-473, Sec. 519, amended par. (1)
    generally, inserting references to poppy straw and concentrate of
    poppy straw.
      Subsec. (a)(2)(C). Pub. L. 98-473, Sec. 520, added subpar. (C).
      Subsec. (b)(2). Pub. L. 98-473, Sec. 521, substituted "is
    imported pursuant to such notification, or declaration, or in the
    case of any nonnarcotic controlled substance in schedule III, such
    import permit, notification, or declaration, as the Attorney
    General may by regulation prescribe, except that if a nonnarcotic
    controlled substance in schedule IV or V is also listed in schedule
    I or II of the Convention on Psychotropic Substances it shall be
    imported pursuant to such import permit requirements, prescribed by
    regulation of the Attorney General, as are required by the
    Convention" for "is imported pursuant to such notification or
    declaration requirements as the Attorney General may by regulation
    prescribe, except that if a nonnarcotic controlled substance in
    schedule III, IV, or V is also listed in schedule I or II of the
    Convention on Psychotropic Substances it shall be imported pursuant
    to such import permit requirements, prescribed by regulation of the
    Attorney General, as are required by the Convention".
      1978 - Subsec. (b)(2). Pub. L. 95-633 inserted provision relating
    to exception for nonnarcotic controlled substances listed in
    schedule I or II of the Convention on Psychotropic Substances.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

-End-



-CITE-
    21 USC Sec. 953                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 953. Exportation of controlled substances

-STATUTE-
    (a) Narcotic drugs in schedule I, II, III, or IV
      It shall be unlawful to export from the United States any
    narcotic drug in schedule I, II, III, or IV unless - 
        (1) it is exported to a country which is a party to - 
          (A) the International Opium Convention of 1912 for the
        Suppression of the Abuses of Opium, Morphine, Cocaine, and
        Derivative Drugs, or to the International Opium Convention
        signed at Geneva on February 19, 1925; or
          (B) the Convention for Limiting the Manufacture and
        Regulating the Distribution of Narcotic Drugs concluded at
        Geneva, July 13, 1931, as amended by the protocol signed at
        Lake Success on December 11, 1946, and the protocol bringing
        under international control drugs outside the scope of the
        convention of July 13, 1931, for limiting the manufacture and
        regulating the distribution of narcotic drugs (as amended by
        the protocol signed at Lake Success on December 11, 1946),
        signed at Paris, November 19, 1948; or
          (C) the Single Convention on Narcotic Drugs, 1961, signed at
        New York, March 30, 1961;

        (2) such country has instituted and maintains, in conformity
      with the conventions to which it is a party, a system for the
      control of imports of narcotic drugs which the Attorney General
      deems adequate;
        (3) the narcotic drug is consigned to a holder of such permits
      or licenses as may be required under the laws of the country of
      import, and a permit or license to import such drug has been
      issued by the country of import;
        (4) substantial evidence is furnished to the Attorney General
      by the exporter that (A) the narcotic drug is to be applied
      exclusively to medical or scientific uses within the country of
      import, and (B) there is an actual need for the narcotic drug for
      medical or scientific uses within such country; and
        (5) a permit to export the narcotic drug in each instance has
      been issued by the Attorney General.
    (b) Exception for exportation for special scientific purposes
      Notwithstanding subsection (a) of this section, the Attorney
    General may authorize any narcotic drug (including crude opium and
    coca leaves) in schedule I, II, III, or IV to be exported from the
    United States to a country which is a party to any of the
    international instruments mentioned in subsection (a) of this
    section if the particular drug is to be applied to a special
    scientific purpose in the country of destination and the
    authorities of such country will permit the importation of the
    particular drug for such purpose.
    (c) Nonnarcotic controlled substances in schedule I or II
      It shall be unlawful to export from the United States any
    nonnarcotic controlled substance in schedule I or II unless - 
        (1) it is exported to a country which has instituted and
      maintains a system which the Attorney General deems adequate for
      the control of imports of such substances;
        (2) the controlled substance is consigned to a holder of such
      permits or licenses as may be required under the laws of the
      country of import;
        (3) substantial evidence is furnished to the Attorney General
      that (A) the controlled substance is to be applied exclusively to
      medical, scientific, or other legitimate uses within the country
      to which exported, (B) it will not be exported from such country,
      and (C) there is an actual need for the controlled substance for
      medical, scientific, or other legitimate uses within the country;
      and
        (4) a permit to export the controlled substance in each
      instance has been issued by the Attorney General.
    (d) Exception for exportation for special scientific purposes
      Notwithstanding subsection (c) of this section, the Attorney
    General may authorize any nonnarcotic controlled substance in
    schedule I or II to be exported from the United States if the
    particular substance is to be applied to a special scientific
    purpose in the country of destination and the authorities of such
    country will permit the importation of the particular drug for such
    purpose.
    (e) Nonnarcotic controlled substances in schedule III or IV;
      controlled substances in schedule V
      It shall be unlawful to export from the United States to any
    other country any nonnarcotic controlled substance in schedule III
    or IV or any controlled substances in schedule V unless - 
        (1) there is furnished (before export) to the Attorney General
      documentary proof that importation is not contrary to the laws or
      regulations of the country of destination for consumption for
      medical, scientific, or other legitimate purposes;
        (2) it is exported pursuant to such notification or
      declaration, or in the case of any nonnarcotic controlled
      substance in schedule III, such export permit, notification, or
      declaration as the Attorney General may by regulation prescribe;
      and
        (3) in the case of a nonnarcotic controlled substance in
      schedule IV or V which is also listed in schedule I or II of the
      Convention on Psychotropic Substances, it is exported pursuant to
      such export permit requirements, prescribed by regulation of the
      Attorney General, as are required by the Convention.
    (f) Exception for exportation for subsequent export
      Notwithstanding subsections (a)(4) and (c)(3) of this section,
    the Attorney General may authorize any controlled substance that is
    in schedule I or II, or is a narcotic drug in schedule III or IV,
    to be exported from the United States to a country for subsequent
    export from that country to another country, if each of the
    following conditions is met:
        (1) Both the country to which the controlled substance is
      exported from the United States (referred to in this subsection
      as the "first country") and the country to which the controlled
      substance is exported from the first country (referred to in this
      subsection as the "second country") are parties to the Single
      Convention on Narcotic Drugs, 1961, and the Convention on
      Psychotropic Substances, 1971.
        (2) The first country and the second country have each
      instituted and maintain, in conformity with such Conventions, a
      system of controls of imports of controlled substances which the
      Attorney General deems adequate.
        (3) With respect to the first country, the controlled substance
      is consigned to a holder of such permits or licenses as may be
      required under the laws of such country, and a permit or license
      to import the controlled substance has been issued by the
      country.
        (4) With respect to the second country, substantial evidence is
      furnished to the Attorney General by the person who will export
      the controlled substance from the United States that - 
          (A) the controlled substance is to be consigned to a holder
        of such permits or licenses as may be required under the laws
        of such country, and a permit or license to import the
        controlled substance is to be issued by the country; and
          (B) the controlled substance is to be applied exclusively to
        medical, scientific, or other legitimate uses within the
        country.

        (5) The controlled substance will not be exported from the
      second country.
        (6) Within 30 days after the controlled substance is exported
      from the first country to the second country, the person who
      exported the controlled substance from the United States delivers
      to the Attorney General documentation certifying that such export
      from the first country has occurred.
        (7) A permit to export the controlled substance from the United
      States has been issued by the Attorney General.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1003, Oct. 27, 1970, 84 Stat.
    1286; Pub. L. 95-633, title I, Sec. 106, Nov. 10, 1978, 92 Stat.
    3772; Pub. L. 98-473, title II, Sec. 522, Oct. 12, 1984, 98 Stat.
    2076; Pub. L. 109-57, Sec. 1(b), Aug. 2, 2005, 119 Stat. 592.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, IV and V, referred to in text, are set out
    in section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Subsec. (f). Pub. L. 109-57 added subsec. (f).
      1984 - Subsec. (e). Pub. L. 98-473 in cl. (1) inserted provisions
    for consumption for medical, etc., purposes, added cls. (2) and
    (3), and struck out former cls. (2) to (4), respectively, relating
    to a special controlled substance invoice, two additional copies of
    the invoice, and exportation of a nonnarcotic controlled substance
    in schedule III, IV, or V, also listed in schedule I or II of the
    Convention.
      1978 - Subsec. (e)(4). Pub. L. 95-633 added par. (4).

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

-End-



-CITE-
    21 USC Sec. 954                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 954. Transshipment and in-transit shipment of controlled
      substances

-STATUTE-
      Notwithstanding sections 952, 953, and 957 of this title - 
        (1) A controlled substance in schedule I may - 
          (A) be imported into the United States for transshipment to
        another country, or
          (B) be transferred or transshipped from one vessel, vehicle,
        or aircraft to another vessel, vehicle, or aircraft within the
        United States for immediate exportation,

      if and only if it is so imported, transferred, or transshipped
      (i) for scientific, medical, or other legitimate purposes in the
      country of destination, and (ii) with the prior written approval
      of the Attorney General (which shall be granted or denied within
      21 days of the request).
        (2) A controlled substance in schedule II, III, or IV may be so
      imported, transferred, or transshipped if and only if advance
      notice is given to the Attorney General in accordance with
      regulations of the Attorney General.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1004, Oct. 27, 1970, 84 Stat.
    1287.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, and IV, referred to in text, are set out in
    section 812(c) of this title.

-End-



-CITE-
    21 USC Sec. 955                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 955. Possession on board vessels, etc., arriving in or
      departing from United States

-STATUTE-
      It shall be unlawful for any person to bring or possess on board
    any vessel or aircraft, or on board any vehicle of a carrier,
    arriving in or departing from the United States or the customs
    territory of the United States, a controlled substance in schedule
    I or II or a narcotic drug in schedule III or IV, unless such
    substance or drug is a part of the cargo entered in the manifest or
    part of the official supplies of the vessel, aircraft, or vehicle.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1005, Oct. 27, 1970, 84 Stat.
    1287.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, and IV, referred to in text, are set out in
    section 812(c) of this title.

-End-



-CITE-
    21 USC Secs. 955a to 955d                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Secs. 955a to 955d. Transferred

-COD-
                               CODIFICATION                           
      Sections, Pub. L. 96-350, Secs. 1-4, Sept. 15, 1980, 94 Stat.
    1159, 1160, relating to maritime drug law enforcement, were
    transferred to sections 1901 to 1904 of the former Appendix to
    Title 46, Shipping. Sections 1901 to 1904 of the former Appendix to
    Title 46 were repealed and restated in chapter 705 of Title 46,
    Shipping, by Pub. L. 109-304, Secs. 10(2), 19, Oct. 6, 2006, 120
    Stat. 1683, 1710. For disposition of sections of the former
    Appendix to Title 46, see Disposition Table preceding section 101
    of Title 46.

-End-



-CITE-
    21 USC Sec. 956                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 956. Exemption authority

-STATUTE-
    (a) Individual possessing controlled substance
      (1) Subject to paragraph (2), the Attorney General may by
    regulation exempt from sections 952(a) and (b), 953, 954, and 955
    of this title any individual who has a controlled substance (except
    a substance in schedule I) in his possession for his personal
    medical use, or for administration to an animal accompanying him,
    if he lawfully obtained such substance and he makes such
    declaration (or gives such other notification) as the Attorney
    General may by regulation require.
      (2) Notwithstanding any exemption under paragraph (1), a United
    States resident who enters the United States through an
    international land border with a controlled substance (except a
    substance in schedule I) for which the individual does not possess
    a valid prescription issued by a practitioner (as defined in
    section 802 of this title) in accordance with applicable Federal
    and State law (or documentation that verifies the issuance of such
    a prescription to that individual) may not import the controlled
    substance into the United States in an amount that exceeds 50
    dosage units of the controlled substance.
    (b) Compound, mixture, or preparation
      The Attorney General may by regulation except any compound,
    mixture, or preparation containing any depressant or stimulant
    substance listed in paragraph (a) or (b) of schedule III or in
    schedule IV or V from the application of all or any part of this
    subchapter if (1) the compound, mixture, or preparation contains
    one or more active medicinal ingredients not having a depressant or
    stimulant effect on the central nervous system, and (2) such
    ingredients are included therein in such combinations, quantity,
    proportion, or concentration as to vitiate the potential for abuse
    of the substances which do have a depressant or stimulant effect on
    the central nervous system.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1006, Oct. 27, 1970, 84 Stat.
    1288; Pub. L. 105-277, div. C, title VIII, Sec. 872(a), Oct. 21,
    1998, 112 Stat. 2681-707; Pub. L. 105-357, Sec. 2(a), Nov. 10,
    1998, 112 Stat. 3271.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, III, IV, and V, referred to in text, are set out in
    section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      1998 - Subsec. (a). Pub. L. 105-277 and Pub. L. 105-357 amended
    subsec. (a) identically, designating existing provisions as par.
    (1), substituting "Subject to paragraph (2), the Attorney General"
    for "The Attorney General", and adding par. (2).

                        FEDERAL MINIMUM REQUIREMENT                    
      Pub. L. 105-357, Sec. 2(b), Nov. 10, 1998, 112 Stat. 3271,
    provided that: "Section 1006(a)(2) of the Controlled Substances
    Import and Export Act [21 U.S.C. 956(a)(2)], as added by this
    section, is a minimum Federal requirement and shall not be
    construed to limit a State from imposing any additional
    requirement."
      Pub. L. 105-277, div. C, title VIII, Sec. 872(b), Oct. 21, 1998,
    112 Stat. 2681-707, enacted a provision substantially identical to
    that enacted by Pub. L. 105-357, Sec. 2(b), set out above.

          JURISDICTION OF SECRETARY OF HEALTH AND HUMAN SERVICES      
      Pub. L. 105-277, div. C, title VIII, Sec. 872(c), Oct. 21, 1998,
    112 Stat. 2681-707, and Pub. L. 105-357, Sec. 2(c), Nov. 10, 1998,
    112 Stat. 3271, provided that: "The amendment made by subsection
    (a) [amending this section] shall not be construed to affect the
    jurisdiction of the Secretary of Health and Human Services under
    the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.)."

-End-



-CITE-
    21 USC Sec. 957                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 957. Persons required to register

-STATUTE-
    (a) Coverage
      No person may - 
        (1) import into the customs territory of the United States from
      any place outside thereof (but within the United States), or
      import into the United States from any place outside thereof, any
      controlled substance or list I chemical, or
        (2) export from the United States any controlled substance or
      list I chemical,

    unless there is in effect with respect to such person a
    registration issued by the Attorney General under section 958 of
    this title, or unless such person is exempt from registration under
    subsection (b) of this section.
    (b) Exemptions
      (1) The following persons shall not be required to register under
    the provisions of this section and may lawfully possess a
    controlled substance or list I chemical:
        (A) An agent or an employee of any importer or exporter
      registered under section 958 of this title if such agent or
      employee is acting in the usual course of his business or
      employment.
        (B) A common or contract carrier or warehouseman, or an
      employee thereof, whose possession of any controlled substance or
      list I chemical is in the usual course of his business or
      employment.
        (C) An ultimate user who possesses such substance for a purpose
      specified in section 802(25) (!1) of this title and in conformity
      with an exemption granted under section 956(a) of this title.


      (2) The Attorney General may, by regulation, waive the
    requirement for registration of certain importers and exporters if
    he finds it consistent with the public health and safety; and may
    authorize any such importer or exporter to possess controlled
    substances or list I chemicals for purposes of importation and
    exportation.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1007, Oct. 27, 1970, 84 Stat.
    1288; Pub. L. 98-473, title II, Sec. 523, Oct. 12, 1984, 98 Stat.
    2076; Pub. L. 103-200, Sec. 3(e), Dec. 17, 1993, 107 Stat. 2337.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 802(25) of this title, referred to in subsec. (b)(1)(C),
    was redesignated section 802(26) of this title by Pub. L. 98-473,
    title II, Sec. 507(a), Oct. 12, 1984, 98 Stat. 2071, and was
    further redesignated section 802(27) of this title by Pub. L. 99-
    570, title I, Sec. 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207-6.


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 3(e)(1)(A), inserted
    "or list I chemical" after "controlled substance".
      Subsec. (a)(2). Pub. L. 103-200, Sec. 3(e)(1)(B), substituted "or
    list I chemical," for "in schedule I, II, III, IV, or V,".
      Subsec. (b)(1). Pub. L. 103-200, Sec. 3(e)(2)(A), inserted "or
    list I chemical" after "controlled substance" in introductory
    provisions and subpar. (B).
      Subsec. (b)(2). Pub. L. 103-200, Sec. 3(e)(2)(B), inserted "or
    list I chemicals" after "controlled substances".
      1984 - Subsec. (a)(2). Pub. L. 98-473 inserted reference to
    schedule V.

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                         PROVISIONAL REGISTRATION                     
      Section 1104 of Pub. L. 91-513, as amended by Pub. L. 99-514,
    Sec. 2, Oct. 22, 1986, 100 Stat. 2095, provided that:
      "(a)(1) Any person - 
        "(A) who is engaged in importing or exporting any controlled
      substance on the day before the effective date of section 1007
      [May 1, 1971],
        "(B) who notifies the Attorney General that he is so engaged,
      and
        "(C) who is registered on such day under section 510 of the
      Federal Food, Drug, and Cosmetic Act [section 360 of this title]
      or under section 4722 of the Internal Revenue Code of 1986
      [formerly I.R.C. 1954, section 4722 of title 26],
    shall, with respect to each establishment for which such
    registration is in effect under any such section, be deemed to have
    a provisional registration under section 1008 [section 958 of this
    title] for the import or export (as the case may be) of controlled
    substances.
      "(2) During the period his provisional registration is in effect
    under this section, the registration number assigned such person
    under such section 510 or under such section 4722 (as the case may
    be) shall be his registration number for purposes of part A of this
    title [this subchapter].
      "(b) The provisions of section 304 [section 824 of this title],
    relating to suspension and revocation of registration, shall apply
    to a provisional registration under this section.
      "(c) Unless sooner suspended or revoked under subsection (b), a
    provisional registration of a person under subsection (a)(1) of
    this section shall be in effect until - 
        "(1) the date on which such person has registered with the
      Attorney General under section 1008 [section 958 of this title]
      or has had his registration denied under such section, or
        "(2) such date as may be prescribed by the Attorney General for
      registration of importers or exporters, as the case may be,
    whichever occurs first."

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 958                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 958. Registration requirements

-STATUTE-
    (a) Applicants to import or export controlled substances in
      schedule I or II
      The Attorney General shall register an applicant to import or
    export a controlled substance in schedule I or II if he determines
    that such registration is consistent with the public interest and
    with United States obligations under international treaties,
    conventions, or protocols in effect on May 1, 1971. In determining
    the public interest, the factors enumerated in paragraph (1)
    through (6) of section 823(a) of this title shall be considered.
    (b) Activity limited to specified substances
      Registration granted under this section shall not entitle a
    registrant to import or export controlled substances other than
    specified in the registration.
    (c) Applicants to import controlled substances in schedule III, IV,
      or V or to export controlled substances in schedule III or IV;
      applicants to import or export list I chemicals
      (1) The Attorney General shall register an applicant to import a
    controlled substance in schedule III, IV, or V or to export a
    controlled substance in schedule III or IV, unless he determines
    that the issuance of such registration is inconsistent with the
    public interest. In determining the public interest, the factors
    enumerated in paragraphs (1) through (6) of section 823(d) of this
    title shall be considered.
      (2)(A) The Attorney General shall register an applicant to import
    or export a list I chemical unless the Attorney General determines
    that registration of the applicant is inconsistent with the public
    interest. Registration under this subsection shall not be required
    for the import or export of a drug product that is exempted under
    section 802(39)(A)(iv) of this title.
      (B) In determining the public interest for the purposes of
    subparagraph (A), the Attorney General shall consider the factors
    specified in section 823(h) of this title.
    (d) Denial of application
      (1) The Attorney General may deny an application for registration
    under subsection (a) of this section if he is unable to determine
    that such registration is consistent with the public interest (as
    defined in subsection (a) of this section) and with the United
    States obligations under international treaties, conventions, or
    protocols in effect on May 1, 1971.
      (2) The Attorney General may deny an application for registration
    under subsection (c) of this section, or revoke or suspend a
    registration under subsection (a) or (c) of this section, if he
    determines that such registration is inconsistent with the public
    interest (as defined in subsection (a) or (c) of this section) or
    with the United States obligations under international treaties,
    conventions, or protocols in effect on May 1, 1971.
      (3) The Attorney General may limit the revocation or suspension
    of a registration to the particular controlled substance, or
    substances, or list I chemical or chemicals, with respect to which
    grounds for revocation or suspension exist.
      (4) Before taking action pursuant to this subsection, the
    Attorney General shall serve upon the applicant or registrant an
    order to show cause as to why the registration should not be
    denied, revoked, or suspended. The order to show cause shall
    contain a statement of the basis thereof and shall call upon the
    applicant or registrant to appear before the Attorney General, or
    his designee, at a time and place stated in the order, but in no
    event less than thirty days after the date of receipt of the order.
    Proceedings to deny, revoke, or suspend shall be conducted pursuant
    to this subsection in accordance with subchapter II of chapter 5 of
    title 5. Such proceedings shall be independent of, and not in lieu
    of, criminal prosecutions or other proceedings under this
    subchapter or any other law of the United States.
      (5) The Attorney General may, in his discretion, suspend any
    registration simultaneously with the institution of proceedings
    under this subsection, in cases where he finds that there is an
    imminent danger to the public health and safety. Such suspension
    shall continue in effect until the conclusion of such proceedings,
    including judicial review thereof, unless sooner withdrawn by the
    Attorney General or dissolved by a court of competent jurisdiction.
      (6) In the event that the Attorney General suspends or revokes a
    registration granted under this section, all controlled substances
    or list I chemicals owned or possessed by the registrant pursuant
    to such registration at the time of suspension or the effective
    date of the revocation order, as the case may be, may, in the
    discretion of the Attorney General, be seized or placed under seal.
    No disposition may be made of any controlled substances or list I
    chemicals under seal until the time for taking an appeal has
    elapsed or until all appeals have been concluded, except that a
    court, upon application therefor, may at any time order the sale of
    perishable controlled substances or list I chemicals. Any such
    order shall require the deposit of the proceeds of the sale with
    the court. Upon a revocation order becoming final, all such
    controlled substances or list I chemicals (or proceeds of the sale
    thereof which have been deposited with the court) shall be
    forfeited to the United States; and the Attorney General shall
    dispose of such controlled substances or list I chemicals in
    accordance with section 881(e) of this title.
    (e) Registration period
      No registration shall be issued under this subchapter for a
    period in excess of one year. Unless the regulations of the
    Attorney General otherwise provide, sections 822(f), 825, 827, and
    830 of this title shall apply to persons registered under this
    section to the same extent such sections apply to persons
    registered under section 823 of this title.
    (f) Rules and regulations
      The Attorney General is authorized to promulgate rules and
    regulations and to charge reasonable fees relating to the
    registration and control of importers and exporters of controlled
    substances or listed chemicals.
    (g) Scope of authorized activity
      Persons registered by the Attorney General under this section to
    import or export controlled substances or list I chemicals may
    import or export (and for the purpose of so importing or exporting,
    may possess) such substances to the extent authorized by their
    registration and in conformity with the other provisions of this
    subchapter and subchapter I of this chapter.
    (h) Separate registrations for each principal place of business
      A separate registration shall be required at each principal place
    of business where the applicant imports or exports controlled
    substances or list I chemicals.
    (i) Emergency situations
      Except in emergency situations as described in section
    952(a)(2)(A) of this title, prior to issuing a registration under
    this section to a bulk manufacturer of a controlled substance in
    schedule I or II, and prior to issuing a regulation under section
    952(a) of this title authorizing the importation of such a
    substance, the Attorney General shall give manufacturers holding
    registrations for the bulk manufacture of the substance an
    opportunity for a hearing.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1008, Oct. 27, 1970, 84 Stat.
    1289; Pub. L. 98-473, title II, Secs. 524, 525, Oct. 12, 1984, 98
    Stat. 2076; Pub. L. 99-570, title I, Sec. 1866(d), Oct. 27, 1986,
    100 Stat. 3207-55; Pub. L. 103-200, Sec. 3(f), Dec. 17, 1993, 107
    Stat. 2337; Pub. L. 108-447, div. B, title VI, Sec. 633(c), Dec. 8,
    2004, 118 Stat. 2922.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, IV, and V, referred to in subsecs. (a),
    (c), and (i), are set out in section 812(c) of this title.
      This subchapter, referred to in subsecs. (d)(4) and (g), was in
    the original "this title", meaning title III of Pub. L. 91-513,
    Oct. 27, 1970, 84 Stat. 1285, as amended. Part A of title III
    comprises this subchapter. For classification of Part B, consisting
    of sections 1101 to 1105 of title III, see Tables.

-COD-
                               CODIFICATION                           
      In subsecs. (a) and (d), "May 1, 1971" substituted for "the
    effective date of this section" and "the effective date of this
    part", respectively.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (f). Pub. L. 108-447, which directed amendment of
    subsec. (f) of section 1088 of the Controlled Substances Import and
    Export Act by inserting "and control" after "the registration" and
    substituting "listed chemicals" for "list I chemicals under this
    section", was executed to subsec. (f) of this section, which is
    section 1008 of the Controlled Substances Import and Export Act, to
    reflect the probable intent of Congress.
      1993 - Subsec. (c). Pub. L. 103-200, Sec. 3(f)(1), designated
    existing provisions as par. (1) and added par. (2).
      Subsec. (d)(3). Pub. L. 103-200, Sec. 3(f)(2)(A), inserted "or
    list I chemical or chemicals," after "substances,".
      Subsec. (d)(6). Pub. L. 103-200, Sec. 3(f)(2)(B), inserted "or
    list I chemicals" after "controlled substances" wherever appearing.
      Subsec. (e). Pub. L. 103-200, Sec. 3(f)(3), inserted reference to
    section 830 of this title.
      Subsecs. (f) to (h). Pub. L. 103-200, Sec. 3(f)(4), inserted "or
    list I chemicals" after "controlled substances".
      1986 - Subsec. (e). Pub. L. 99-570 substituted "sections" for
    first reference to "section".
      1984 - Subsec. (b). Pub. L. 98-473, Sec. 524, substituted
    "Registration granted under this section shall not entitle a
    registrant to import or export controlled substances other than
    specified in the registration" for "Registration granted under
    subsection (a) of this section shall not entitle a registrant to
    import or export controlled substances in schedule I or II other
    than those specified in the registration".
      Subsecs. (d) to (i). Pub. L. 98-473, Sec. 525, added subsec. (d),
    redesignated former subsec. (d) as (e) and struck out reference to
    section 824 of this title, and redesignated former subsecs. (e) to
    (h) as (f) to (i), respectively.

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

-End-



-CITE-
    21 USC Sec. 959                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 959. Possession, manufacture, or distribution of controlled
      substance

-STATUTE-
    (a) Manufacture or distribution for purpose of unlawful importation
      It shall be unlawful for any person to manufacture or distribute
    a controlled substance in schedule I or II or flunitrazepam or
    listed chemical - 
        (1) intending that such substance or chemical will be
      unlawfully imported into the United States or into waters within
      a distance of 12 miles of the coast of the United States; or
        (2) knowing that such substance or chemical will be unlawfully
      imported into the United States or into waters within a distance
      of 12 miles of the coast of the United States.
    (b) Possession, manufacture, or distribution by person on board
      aircraft
      It shall be unlawful for any United States citizen on board any
    aircraft, or any person on board an aircraft owned by a United
    States citizen or registered in the United States, to - 
        (1) manufacture or distribute a controlled substance or listed
      chemical; or
        (2) possess a controlled substance or listed chemical with
      intent to distribute.
    (c) Acts committed outside territorial jurisdiction of United
      States; venue
      This section is intended to reach acts of manufacture or
    distribution committed outside the territorial jurisdiction of the
    United States. Any person who violates this section shall be tried
    in the United States district court at the point of entry where
    such person enters the United States, or in the United States
    District Court for the District of Columbia.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1009, Oct. 27, 1970, 84 Stat.
    1289; Pub. L. 99-570, title III, Sec. 3161(a), Oct. 27, 1986, 100
    Stat. 3207-94; Pub. L. 104-237, title I, Sec. 102(a), (b), Oct. 3,
    1996, 110 Stat. 3100; Pub. L. 104-305, Sec. 2(b)(2)(A), Oct. 13,
    1996, 110 Stat. 3807.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I and II, referred to in subsec. (a), are set out in
    section 812(c) of this title.


-MISC1-
                                AMENDMENTS                            
      1996 - Subsec. (a). Pub. L. 104-305 inserted "or flunitrazepam"
    after "schedule I or II" in introductory provisions.
      Pub. L. 104-237, Sec. 102(a), inserted "or listed chemical" after
    "schedule I or II" in introductory provisions and "or chemical"
    after "substance" in pars. (1) and (2).
      Subsec. (b). Pub. L. 104-237, Sec. 102(b), inserted "or listed
    chemical" after "controlled substance" in pars. (1) and (2).
      1986 - Pub. L. 99-570 designated first sentence as subsec. (a)
    and inserted "or into waters within a distance of 12 miles of the
    coast of the United States" in pars. (1) and (2), added subsec.
    (b), and designated last two sentences as subsec. (c).

-End-



-CITE-
    21 USC Sec. 960                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 960. Prohibited acts A

-STATUTE-
    (a) Unlawful acts
      Any person who - 
        (1) contrary to section 952, 953, or 957 of this title,
      knowingly or intentionally imports or exports a controlled
      substance,
        (2) contrary to section 955 of this title, knowingly or
      intentionally brings or possesses on board a vessel, aircraft, or
      vehicle a controlled substance, or
        (3) contrary to section 959 of this title, manufactures,
      possesses with intent to distribute, or distributes a controlled
      substance,

    shall be punished as provided in subsection (b) of this section.
    (b) Penalties
      (1) In the case of a violation of subsection (a) of this section
    involving - 
        (A) 1 kilogram or more of a mixture or substance containing a
      detectable amount of heroin;
        (B) 5 kilograms or more of a mixture or substance containing a
      detectable amount of - 
          (i) coca leaves, except coca leaves and extracts of coca
        leaves from which cocaine, ecgonine, and derivatives of
        ecgonine or their salts have been removed;
          (ii) cocaine, its salts, optical and geometric isomers, and
        salts or isomers;
          (iii) ecgonine, its derivatives, their salts, isomers, and
        salts of isomers; or
          (iv) any compound, mixture, or preparation which contains any
        quantity of any of the substances referred to in clauses (i)
        through (iii);

        (C) 50 grams or more of a mixture or substance described in
      subparagraph (B) which contains cocaine base;
        (D) 100 grams or more of phencyclidine (PCP) or 1 kilogram or
      more of a mixture or substance containing a detectable amount of
      phencyclidine (PCP);
        (E) 10 grams or more of a mixture or substance containing a
      detectable amount of lysergic acid diethylamide (LSD);
        (F) 400 grams or more of a mixture or substance containing a
      detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-
      piperidinyl] propanamide or 100 grams or more of a mixture or
      substance containing a detectable amount of any analogue of N-
      phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
        (G) 1000 kilograms or more of a mixture or substance containing
      a detectable amount of marihuana; or
        (H) 50 grams or more of methamphetamine, its salts, isomers,
      and salts of its isomers or 500 grams or more of a mixture or
      substance containing a detectable amount of methamphetamine, its
      salts, isomers, or salts of its isomers.(!1)


    the person committing such violation shall be sentenced to a term
    of imprisonment of not less than 10 years and not more than life
    and if death or serious bodily injury results from the use of such
    substance shall be sentenced to a term of imprisonment of not less
    than 20 years and not more than life, a fine not to exceed the
    greater of that authorized in accordance with the provisions of
    title 18 or $4,000,000 if the defendant is an individual or
    $10,000,000 if the defendant is other than an individual, or both.
    If any person commits such a violation after a prior conviction for
    a felony drug offense has become final, such person shall be
    sentenced to a term of imprisonment of not less than 20 years and
    not more than life imprisonment and if death or serious bodily
    injury results from the use of such substance shall be sentenced to
    life imprisonment, a fine not to exceed the greater of twice that
    authorized in accordance with the provisions of title 18 or
    $8,000,000 if the defendant is an individual or $20,000,000 if the
    defendant is other than an individual, or both. Notwithstanding
    section 3583 of title 18, any sentence under this paragraph shall,
    in the absence of such a prior conviction, impose a term of
    supervised release of at least 5 years in addition to such term of
    imprisonment and shall, if there was such a prior conviction,
    impose a term of supervised release of at least 10 years in
    addition to such term of imprisonment. Notwithstanding any other
    provision of law, the court shall not place on probation or suspend
    the sentence of any person sentenced under this paragraph. No
    person sentenced under this paragraph shall be eligible for parole
    during the term of imprisonment imposed therein.
      (2) In the case of a violation of subsection (a) of this section
    involving - 
        (A) 100 grams or more of a mixture or substance containing a
      detectable amount of heroin;
        (B) 500 grams or more of a mixture or substance containing a
      detectable amount of - 
          (i) coca leaves, except coca leaves and extracts of coca
        leaves from which cocaine, ecgonine, and derivatives of
        ecgonine or their salts have been removed;
          (ii) cocaine, its salts, optical and geometric isomers, and
        salts or isomers;
          (iii) ecgonine, its derivatives, their salts, isomers, and
        salts of isomers; or
          (iv) any compound, mixture, or preparation which contains any
        quantity of any of the substances referred to in clauses (i)
        through (iii);

        (C) 5 grams or more of a mixture or substance described in
      subparagraph (B) which contains cocaine base;
        (D) 10 grams or more of phencyclidine (PCP) or 100 grams or
      more of a mixture or substance containing a detectable amount of
      phencyclidine (PCP);
        (E) 1 gram or more of a mixture or substance containing a
      detectable amount of lysergic acid diethylamide (LSD);
        (F) 40 grams or more of a mixture or substance containing a
      detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-
      piperidinyl] propanamide or 10 grams or more of a mixture or
      substance containing a detectable amount of any analogue of N-
      phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
        (G) 100 kilograms or more of a mixture or substance containing
      a detectable amount of marihuana; or
        (H) 5 grams or more of methamphetamine, its salts, isomers, and
      salts of its isomers or 50 grams or more of a mixture or
      substance containing a detectable amount of methamphetamine, its
      salts, isomers, or salts of its isomers.(!2)


    the person committing such violat ion shall be sentenced to a term
    of imprisonment of not less than 5 years and not more than 40 years
    and if death or serious bodily injury results from the use of such
    substance shall be sentenced to a term of imprisonment of not less
    than twenty years and not more than life, a fine not to exceed the
    greater of that authorized in accordance with the provisions of
    title 18 or $2,000,000 if the defendant is an individual or
    $5,000,000 if the defendant is other than an individual, or both.
    If any person commits such a violation after a prior conviction for
    a felony drug offense has become final, such person shall be
    sentenced to a term of imprisonment of not less than 10 years and
    not more than life imprisonment and if death or serious bodily
    injury results from the use of such substance shall be sentenced to
    life imprisonment, a fine not to exceed the greater of twice that
    authorized in accordance with the provisions of title 18 or
    $4,000,000 if the defendant is an individual or $10,000,000 if the
    defendant is other than an individual, or both. Notwithstanding
    section 3583 of title 18, any sentence imposed under this paragraph
    shall, in the absence of such a prior conviction, include a term of
    supervised release of at least 4 years in addition to such term of
    imprisonment and shall, if there was such a prior conviction,
    include a term of supervised release of at least 8 years in
    addition to such term of imprisonment. Notwithstanding any other
    provision of law, the court shall not place on probation or suspend
    the sentence of any person sentenced under this paragraph. No
    person sentenced under this paragraph shall be eligible for parole
    during the term of imprisonment imposed therein.
      (3) In the case of a violation under subsection (a) of this
    section involving a controlled substance in schedule I or II, gamma
    hydroxybutyric acid (including when scheduled as an approved drug
    product for purposes of section 3(a)(1)(B) of the Hillory J. Farias
    and Samantha Reid Date-Rape Drug Prohibition Act of 2000), or
    flunitrazepam, the person committing such violation shall, except
    as provided in paragraphs (1), (2), and (4), be sentenced to a term
    of imprisonment of not more than 20 years and if death or serious
    bodily injury results from the use of such substance shall be
    sentenced to a term of imprisonment of not less than twenty years
    and not more than life, a fine not to exceed the greater of that
    authorized in accordance with the provisions of title 18 or
    $1,000,000 if the defendant is an individual or $5,000,000 if the
    defendant is other than an individual, or both. If any person
    commits such a violation after a prior conviction for a felony drug
    offense has become final, such person shall be sentenced to a term
    of imprisonment of not more than 30 years and if death or serious
    bodily injury results from the use of such substance shall be
    sentenced to life imprisonment, a fine not to exceed the greater of
    twice that authorized in accordance with the provisions of title 18
    or $2,000,000 if the defendant is an individual or $10,000,000 if
    the defendant is other than an individual, or both. Notwithstanding
    section 3583 of title 18, any sentence imposing a term of
    imprisonment under this paragraph shall, in the absence of such a
    prior conviction, impose a term of supervised release of at least 3
    years in addition to such term of imprisonment and shall, if there
    was such a prior conviction, impose a term of supervised release of
    at least 6 years in addition to such term of imprisonment.
    Notwithstanding the prior sentence, and notwithstanding any other
    provision of law, the court shall not place on probation or suspend
    the sentence of any person sentenced under the provisions of this
    paragraph which provide for a mandatory term of imprisonment if
    death or serious bodily injury results, nor shall a person so
    sentenced be eligible for parole during the term of such a
    sentence.
      (4) In the case of a violation under subsection (a) of this
    section with respect to less than 50 kilograms of marihuana, except
    in the case of 100 or more marihuana plants regardless of weight,
    less than 10 kilograms of hashish, less than one kilogram of
    hashish oil, or any quantity of a controlled substance in schedule
    III, IV, or V,(!3) (except a violation involving flunitrazepam and
    except a violation involving gamma hydroxybutyric acid) the person
    committing such violation shall be imprisoned not more than five
    years, or be fined not to exceed the greater of that authorized in
    accordance with the provisions of title 18 or $250,000 if the
    defendant is an individual or $1,000,000 if the defendant is other
    than an individual, or both. If a sentence under this paragraph
    provides for imprisonment, the sentence shall, notwithstanding
    section 3583 of title 18, in addition to such term of imprisonment,
    include (A) a term of supervised release of not less than two years
    if such controlled substance is in schedule I, II, III, or (B) a
    term of supervised release of not less than one year if such
    controlled substance is in schedule IV.

    (c) Repealed. Pub. L. 98-473, title II, Sec. 225, formerly Sec.
      225(a), Oct. 12, 1984, 98 Stat. 2030, as amended by Pub. L. 99-
      570, title I, Sec. 1005(c), Oct. 27, 1986, 100 Stat. 3207-6
    (d) Penalty for importation or exportation
      A person who knowingly or intentionally - 
        (1) imports or exports a listed chemical with intent to
      manufacture a controlled substance in violation of this
      subchapter or subchapter I of this chapter;
        (2) exports a listed chemical in violation of the laws of the
      country to which the chemical is exported or serves as a broker
      or trader for an international transaction involving a listed
      chemical, if the transaction is in violation of the laws of the
      country to which the chemical is exported;
        (3) imports or exports a listed chemical knowing, or having
      reasonable cause to believe, that the chemical will be used to
      manufacture a controlled substance in violation of this
      subchapter or subchapter I of this chapter;
        (4) exports a listed chemical, or serves as a broker or trader
      for an international transaction involving a listed chemical,
      knowing, or having reasonable cause to believe, that the chemical
      will be used to manufacture a controlled substance in violation
      of the laws of the country to which the chemical is exported;
        (5) imports or exports a listed chemical, with the intent to
      evade the reporting or recordkeeping requirements of section 971
      of this title applicable to such importation or exportation by
      falsely representing to the Attorney General that the importation
      or exportation qualifies for a waiver of the 15-day notification
      requirement granted pursuant to paragraph (2) or (3) of section
      971(f) of this title by misrepresenting the actual country of
      final destination of the listed chemical or the actual listed
      chemical being imported or exported;
        (6) imports a listed chemical in violation of section 952 of
      this title, imports or exports such a chemical in violation of
      section 957 or 971 of this title, or transfers such a chemical in
      violation of section 971(d) of this title; or
        (7) manufactures, possesses with intent to distribute, or
      distributes a listed chemical in violation of section 959 of this
      title.(!4)


    shall be fined in accordance with title 18, imprisoned not more
    than 20 years in the case of a violation of paragraph (1) or (3)
    involving a list I chemical or not more than 10 years in the case
    of a violation of this subsection other than a violation of
    paragraph (1) or (3) involving a list I chemical, or both.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1010, Oct. 27, 1970, 84 Stat.
    1290; Pub. L. 98-473, title II, Secs. 225, formerly Sec. 225(a),
    504, Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99-570, title I,
    Secs. 1004(a), 1005(c), 1302, 1866(e), Oct. 27, 1986, 100 Stat.
    3207-6, 3207-15, 3207-55; Pub. L. 100-690, title VI, Secs. 6053(c),
    6475, Nov. 18, 1988, 102 Stat. 4315, 4380; Pub. L. 101-647, title
    XII, Sec. 1204, title XXXV, Sec. 3599J, Nov. 29, 1990, 104 Stat.
    4830, 4932; Pub. L. 103-200, Secs. 4(b), 5(b), Dec. 17, 1993, 107
    Stat. 2338, 2339; Pub. L. 103-322, title IX, Sec. 90105(a), title
    XXXIII, Sec. 330024(d)(2), Sept. 13, 1994, 108 Stat. 1987, 2151;
    Pub. L. 104-237, title I, Sec. 102(c), title III, Sec. 302(b), Oct.
    3, 1996, 110 Stat. 3100, 3105; Pub. L. 104-305, Sec. 2(b)(2)(B),
    (C), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105-277, div. E, Sec.
    2(b), Oct. 21, 1998, 112 Stat. 2681-759; Pub. L. 106-172, Sec.
    3(b)(2), Feb. 18, 2000, 114 Stat. 9; Pub. L. 107-273, div. B, title
    III, Sec. 3005(b), Nov. 2, 2002, 116 Stat. 1806; Pub. L. 109-177,
    title VII, Secs. 716(b)(1)(A), 717, Mar. 9, 2006, 120 Stat. 267.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Schedules I, II, III, IV, and V, referred to in subsec. (b), are
    set out in section 812(c) of this title.
      Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid
    Date-Rape Prohibition Act of 2000, referred to in subsec. (b)(3),
    is section 3(a)(1)(B) of Pub. L. 106-172, which is set out in a
    note under section 812 of this title.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (d)(5). Pub. L. 109-177, Sec. 716(b)(1)(A),
    substituted "paragraph (2) or (3) of section 971(f) of this title"
    for "section 971(e)(2) or (3) of this title".
      Subsec. (d)(6). Pub. L. 109-177, Sec. 717, amended par. (6)
    generally. Prior to amendment, par. (6) read as follows: "imports
    or exports a listed chemical in violation of section 957 or 971 of
    this title; or".
      2002 - Subsec. (b)(1), (2). Pub. L. 107-273, Sec. 3005(b)(1),
    substituted "Notwithstanding section 3583 of title 18, any
    sentence" for "Any sentence" in concluding provisions.
      Subsec. (b)(3). Pub. L. 107-273, Sec. 3005(b)(1), substituted
    "Notwithstanding section 3583 of title 18, any sentence" for "Any
    sentence".
      Subsec. (b)(4). Pub. L. 107-273, Sec. 3005(b)(2), inserted
    "notwithstanding section 3583 of title 18," before "in addition to
    such term of imprisonment".
      2000 - Subsec. (b)(3). Pub. L. 106-172, Sec. 3(b)(2)(A), inserted
    "gamma hydroxybutyric acid (including when scheduled as an approved
    drug product for purposes of section 3(a)(1)(B) of the Hillory J.
    Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000),"
    after "schedule I or II," in first sentence.
      Subsec. (b)(4). Pub. L. 106-172, Sec. 3(b)(2)(B), substituted
    "flunitrazepam and except a violation involving gamma
    hydroxybutyric acid)" for "flunitrazepam)".
      1998 - Subsec. (b)(1)(H). Pub. L. 105-277, Sec. 2(b)(1),
    substituted "50 grams" and "500 grams" for "100 grams" and "1
    kilogram", respectively.
      Subsec. (b)(2)(H). Pub. L. 105-277, Sec. 2(b)(2), substituted "5
    grams" and "50 grams" for "10 grams" and "100 grams", respectively.
      1996 - Subsec. (b)(3). Pub. L. 104-305, Sec. 2(b)(2)(B), inserted
    "or flunitrazepam," after "schedule I or II,".
      Subsec. (b)(4). Pub. L. 104-305, Sec. 2(b)(2)(C), inserted
    "(except a violation involving flunitrazepam)" after "schedule III,
    IV, or V,".
      Subsec. (d). Pub. L. 104-237, Sec. 302(b), in closing provisions,
    substituted "not more than 20 years in the case of a violation of
    paragraph (1) or (3) involving a list I chemical or not more than
    10 years in the case of a violation of this subsection other than a
    violation of paragraph (1) or (3) involving a list I chemical," for
    "not more than 10 years,".
      Subsec. (d)(7). Pub. L. 104-237, Sec. 102(c), added par. (7).
      1994 - Subsec. (b)(1), (2). Pub. L. 103-322, Sec. 90105(a), in
    sentence in concluding provisions beginning "If any person
    commits", substituted "a prior conviction for a felony drug offense
    has become final" for "one or more prior convictions for an offense
    punishable under this subsection, or for a felony under any other
    provision of this subchapter or subchapter I of this chapter or
    other law of a State, the United States, or a foreign country
    relating to narcotic drugs, marihuana, or depressant or stimulant
    substances, have become final".
      Subsec. (b)(3). Pub. L. 103-322, Sec. 90105(a), in sentence
    beginning "If any person commits", substituted "a prior conviction
    for a felony drug offense has become final" for "one or more prior
    convictions for an offense punishable under this subsection, or for
    a felony under any other provision of this subchapter or subchapter
    I of this chapter or other law of a State, the United States or a
    foreign country relating to narcotic drugs, marihuana, or
    depressant or stimulant substances, have become final".
      Subsec. (d)(5), (6). Pub. L. 103-322, Sec. 330024(d)(2), amended
    directory language of Pub. L. 103-200, Sec. 5(b)(3). See 1993
    Amendment note below.
      1993 - Subsec. (d). Pub. L. 103-200, Sec. 5(b), as amended by
    Pub. L. 103-322, Sec. 330024(d)(2), added pars. (5) and (6).
      Pub. L. 103-200, Sec. 4(b), amended subsec. (d) generally. Prior
    to amendment, subsec. (d) read as follows: "Any person who
    knowingly or intentionally - 
        "(1) imports or exports a listed chemical with intent to
      manufacture a controlled substance in violation of this
      subchapter or, in the case of an exportation, in violation of the
      law of the country to which the chemical is exported; or
        "(2) imports or exports a listed chemical knowing, or having
      reasonable cause to believe, that the listed chemical will be
      used to manufacture a controlled substance in violation of this
      subchapter or, in the case of an exportation, in violation of the
      law of the country to which the chemical is exported;
    shall be fined in accordance with title 18, or imprisoned not more
    than 10 years, or both."
      1990 - Subsec. (b)(1)(H). Pub. L. 101-647, Sec. 1204(a), added
    subpar. (H).
      Subsec. (b)(2). Pub. L. 101-647, Sec. 3599J, substituted
    "supervised" for "suspervised" in two places in concluding
    provisions.
      Subsec. (b)(2)(H). Pub. L. 101-647, Sec. 1204(b), added subpar.
    (H).
      1988 - Subsec. (a)(3). Pub. L. 100-690, Sec. 6475, substituted
    "manufactures, possesses with intent to distribute, or distributes
    a controlled substance" for "manufactures or distributes a
    controlled substance".
      Subsec. (d). Pub. L. 100-690, Sec. 6053(c), added subsec. (d).
      1986 - Pub. L. 99-570, Sec. 1005(c), amended Pub. L. 98-473, Sec.
    225. See 1984 Amendment note below.
      Subsec. (b)(1), (2). Pub. L. 99-570, Sec. 1302(a)(2), added pars.
    (1) and (2) and struck out former pars. (1) and (2) which read as
    follows:
      "(1) In the case of a violation under subsection (a) of this
    section involving - 
        "(A) 100 grams or more of a mixture or substance containing a
      detectable amount of a narcotic drug in schedule I or II other
      than a narcotic drug consisting of - 
          "(i) coca leaves;
          "(ii) a compound, manufacture, salt, derivative, or
        preparation of coca leaves; or
          "(iii) a substance chemically identical thereto;
        "(B) a kilogram or more of any other narcotic drug in schedule
      I or II;
        "(C) 500 grams or more of phencyclidine (PCP);
        "(D) 5 grams or more of lysergic acid diethylamide (LSD);
    the person committing such violation shall be imprisoned for not
    more than twenty years, or fined not more than $250,000, or both.
      "(2) In the case of a violation under subsection (a) of this
    section with respect to a controlled substance in schedule I or II,
    the person committing such violation shall, except as provided in
    paragraphs (1) and (3), be imprisoned not more than fifteen years,
    or fined not more than $125,000, or both. If a sentence under this
    paragraph provides for imprisonment, the sentence shall include a
    special parole term of not less than three years in addition to
    such term of imprisonment."
      Subsec. (b)(3). Pub. L. 99-570, Sec. 1302(a)(2), added par. (3).
    Former par. (3) redesignated (4).
      Subsec. (b)(4). Pub. L. 99-570, Sec. 1302(a)(1), (3), (b)(2),
    (3), redesignated former par. (3) as (4), inserted "except in the
    case of 100 or more marihuana plants regardless of weight," and
    substituted "fined not to exceed the greater of that authorized in
    accordance with the provisions of title 18 or $250,000 if the
    defendant is an individual or $1,000,000 if the defendant is other
    than an individual" for "fined not more than $50,000".
      Pub. L. 99-570, Secs. 1302(b)(1), 1866(e), made identical
    amendment striking out ", except as provided in paragraph (4)"
    after "such violation shall".
      Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
    release" for "special parole term" in two places.
      Subsec. (c). Pub. L. 99-570, Sec. 1004(a), substituted "term of
    supervised release" for "special parole term" wherever appearing,
    effective Nov. 1, 1987, the effective date of the repeal of subsec.
    (c) by Pub. L. 98-473, Sec. 225. See 1984 Amendment note below.
      1984 - Subsec. (b). Pub. L. 98-473, Sec. 225(a), which directed
    amendment of this subsection effective Nov. 1, 1987 (see section
    235(a)(1) of Pub. L. 98-473 set out as an Effective Date note under
    section 3551 of Title 18, Crimes and Criminal Procedure) was
    omitted in the general amendment of section 225 of Pub. L. 98-473
    by Pub. L. 99-570, Sec. 1005(c).
      Subsec. (b)(1). Pub. L. 98-473, Sec. 504(1), added par. (1).
    Former par. (1) redesignated (2).
      Subsec. (b)(2). Pub. L. 98-473, Sec. 504(1), (2), redesignated
    former par. (1) as (2), inserted provisions excepting pars. (1) and
    (3), and substituted reference to controlled substance for
    reference to narcotic drug, and "$125,000" for "$25,000". Former
    par. (2) redesignated (3).
      Subsec. (b)(3). Pub. L. 98-473, Sec. 504(1), (3), redesignated
    former par. (2) as (3) and substituted "less than 50 kilograms of
    marihuana, less than 10 kilograms of hashish, less than one
    kilogram of hashish oil, or any quantity of a controlled substance
    in schedule III, IV, or V, the person committing such violation
    shall, except as provided in paragraph (4)" for "a controlled
    substance other than a narcotic drug in schedule I or II, the
    person committing such violation shall", and "$50,000" for
    "$15,000".
      Subsec. (c). Pub. L. 98-473, Sec. 225, as amended by Pub. L. 99-
    570, Sec. 1005(c), struck out subsec. (c) which related to special
    parole terms imposed under this section or section 962 of this
    title. Notwithstanding directory language that the amendment be
    made to "Section 1515 of the Controlled Substances Import and
    Export Act (21 U.S.C. 960)", the amendment was executed to this
    section as the probable intent of Congress.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by section 330024(d)(2) of Pub. L. 103-322 effective
    120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103-
    322, set out as a note under section 802 of this title.

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by section 6053(c) of Pub. L. 100-690 effective 120
    days after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set
    out as a note under section 802 of this title.

                     EFFECTIVE DATE OF 1986 AMENDMENT                 
      Amendment by section 1004(a) of Pub. L. 99-570 effective on date
    of taking effect of section 3583 of Title 18, Crimes and Criminal
    Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
    out as a note under section 841 of this title.

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by section 225 of Pub. L. 98-473 effective Nov. 1,
    1987, and applicable only to offenses committed after the taking
    effect of such amendment, see section 235(a)(1) of Pub. L. 98-473,
    set out as an Effective Date note under section 3551 of Title 18,
    Crimes and Criminal Procedure.

-FOOTNOTE-               

    (!1) So in original. The period probably should be a semicolon.

               

    (!2) So in original. The period probably should be a semicolon.

    (!3) So in original.

               

    (!4) So in original. The period probably should be a comma.


-End-



-CITE-
    21 USC Sec. 960a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 960a. Foreign terrorist organizations, terrorist persons and
      groups

-STATUTE-
    (a) Prohibited acts
      Whoever engages in conduct that would be punishable under section
    841(a) (!1) of this title if committed within the jurisdiction of
    the United States, or attempts or conspires to do so, knowing or
    intending to provide, directly or indirectly, anything of pecuniary
    value to any person or organization that has engaged or engages in
    terrorist activity (as defined in section 1182(a)(3)(B) of title 8)
    or terrorism (as defined in section 2656f(d)(2) of title 22), shall
    be sentenced to a term of imprisonment of not less than twice the
    minimum punishment under section 841(b)(1),(!1) and not more than
    life, a fine in accordance with the provisions of title 18, or
    both. Notwithstanding section 3583 of title 18, any sentence
    imposed under this subsection shall include a term of supervised
    release of at least 5 years in addition to such term of
    imprisonment.

    (b) Jurisdiction
      There is jurisdiction over an offense under this section if - 
        (1) the prohibited drug activity or the terrorist offense is in
      violation of the criminal laws of the United States;
        (2) the offense, the prohibited drug activity, or the terrorist
      offense occurs in or affects interstate or foreign commerce;
        (3) an offender provides anything of pecuniary value for a
      terrorist offense that causes or is designed to cause death or
      serious bodily injury to a national of the United States while
      that national is outside the United States, or substantial damage
      to the property of a legal entity organized under the laws of the
      United States (including any of its States, districts,
      commonwealths, territories, or possessions) while that property
      is outside of the United States;
        (4) the offense or the prohibited drug activity occurs in whole
      or in part outside of the United States (including on the high
      seas), and a perpetrator of the offense or the prohibited drug
      activity is a national of the United States or a legal entity
      organized under the laws of the United States (including any of
      its States, districts, commonwealths, territories, or
      possessions); or
        (5) after the conduct required for the offense occurs an
      offender is brought into or found in the United States, even if
      the conduct required for the offense occurs outside the United
      States.
    (c) Proof requirements
      To violate subsection (a), a person must have knowledge that the
    person or organization has engaged or engages in terrorist activity
    (as defined in section 1182(a)(3)(B) of title 8) or terrorism (as
    defined in section 2656f(d)(2) of title 22).
    (d) Definition
      As used in this section, the term "anything of pecuniary value"
    has the meaning given the term in section 1958(b)(1) of title 18.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1010A, as added Pub. L. 109-177,
    title I, Sec. 122, Mar. 9, 2006, 120 Stat. 225.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 841, referred to in the original in subsec. (a), probably
    should have been a reference to section 401 of Pub. L. 91-513,
    which is classified to section 841 of this title. Pub. L. 91-513
    does not contain a section 841.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 961                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 961. Prohibited acts B

-STATUTE-
      Any person who violates section 954 of this title or fails to
    notify the Attorney General of an importation or exportation under
    section 971 of this title shall be subject to the following
    penalties:
        (1) Except as provided in paragraph (2), any such person shall,
      with respect to any such violation, be subject to a civil penalty
      of not more than $25,000. Sections 842(c)(1) and (c)(3) of this
      title shall apply to any civil penalty assessed under this
      paragraph.
        (2) If such a violation is prosecuted by an information or
      indictment which alleges that the violation was committed
      knowingly or intentionally and the trier of fact specifically
      finds that the violation was so committed, such person shall be
      sentenced to imprisonment for not more than one year or a fine of
      not more than $25,000 or both.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1011, Oct. 27, 1970, 84 Stat.
    1290; Pub. L. 100-690, title VI, Sec. 6053(d), Nov. 18, 1988, 102
    Stat. 4316.)


-MISC1-
                                AMENDMENTS                            
      1988 - Pub. L. 100-690 inserted "or fails to notify the Attorney
    General of an importation or exportation under section 971 of this
    title".

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
    1988, see section 6061 of Pub. L. 100-690, set out as a note under
    section 802 of this title.

-End-



-CITE-
    21 USC Sec. 962                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 962. Second or subsequent offenses

-STATUTE-
    (a) Term of imprisonment and fine
      Any person convicted of any offense under this subchapter is, if
    the offense is a second or subsequent offense, punishable by a term
    of imprisonment twice that otherwise authorized, by twice the fine
    otherwise authorized, or by both. If the conviction is for an
    offense punishable under section 960(b) of this title, and if it is
    the offender's second or subsequent offense, the court shall
    impose, in addition to any term of imprisonment and fine, twice the
    term of supervised release otherwise authorized.
    (b) Determination of status
      For purposes of this section, a person shall be considered
    convicted of a second or subsequent offense if, prior to the
    commission of such offense, one or more prior convictions of such
    person for a felony drug offense have become final.
    (c) Procedures applicable
      Section 851 of this title shall apply with respect to any
    proceeding to sentence a person under this section.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1012, Oct. 27, 1970, 84 Stat.
    1290; Pub. L. 98-473, title II, Secs. 225(b), 505, Oct. 12, 1984,
    98 Stat. 2030, 2070; Pub. L. 99-570, title I, Secs. 1004(a),
    1005(c), Oct. 27, 1986, 100 Stat. 3207-6; Pub. L. 103-322, title
    IX, Sec. 90105(b), Sept. 13, 1994, 108 Stat. 1988.)


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (b). Pub. L. 103-322 substituted "one or more
    prior convictions of such person for a felony drug offense have
    become final" for "one or more prior convictions of him for a
    felony under any provision of this subchapter or subchapter I of
    this chapter or other law of a State, the United States, or a
    foreign country relating to narcotic drugs, marihuana, or
    depressant or stimulant drugs, have become final".
      1986 - Subsec. (a). Pub. L. 99-570, Sec. 1005(c), amended Pub. L.
    98-473, Sec. 225. See 1984 Amendment note below.
      Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
    release" for "special parole term".
      1984 - Subsec. (a). Pub. L. 98-473, Sec. 225(b), which directed
    amendment of this section effective Nov. 1, 1987 (see section
    235(a)(1) of Pub. L. 98-473 set out as an Effective Date note under
    section 3551 of Title 18, Crimes and Criminal Procedure) was
    omitted in the general amendment of section 225 of Pub. L. 98-473
    by Pub. L. 99-570, Sec. 1005(c).
      Subsec. (b). Pub. L. 98-473, Sec. 505, inserted references to
    laws of a State or of a foreign country.

                     EFFECTIVE DATE OF 1986 AMENDMENT                 
      Amendment by section 1004(a) of Pub. L. 99-570 effective on date
    of taking effect of section 3583 of Title 18, Crimes and Criminal
    Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
    out as a note under section 841 of this title.

-End-



-CITE-
    21 USC Sec. 963                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 963. Attempt and conspiracy

-STATUTE-
      Any person who attempts or conspires to commit any offense
    defined in this subchapter shall be subject to the same penalties
    as those prescribed for the offense, the commission of which was
    the object of the attempt or conspiracy.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1013, Oct. 27, 1970, 84 Stat.
    1291; Pub. L. 100-690, title VI, Sec. 6470(a), Nov. 18, 1988, 102
    Stat. 4377.)


-MISC1-
                                AMENDMENTS                            
      1988 - Pub. L. 100-690 substituted "shall be subject to the same
    penalties as those prescribed for the offense" for "is punishable
    by imprisonment or fine or both which may not exceed the maximum
    punishment prescribed for the offense".

-End-



-CITE-
    21 USC Sec. 964                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 964. Additional penalties

-STATUTE-
      Any penalty imposed for violation of this subchapter shall be in
    addition to, and not in lieu of, any civil or administrative
    penalty or sanction authorized by law.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1014, Oct. 27, 1970, 84 Stat.
    1291.)

-End-



-CITE-
    21 USC Sec. 965                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 965. Applicability of part E of subchapter I

-STATUTE-
      Part E of subchapter I of this chapter shall apply with respect
    to functions of the Attorney General (and of officers and employees
    of the Bureau of Narcotics and Dangerous Drugs) under this
    subchapter, to administrative and judicial proceedings under this
    subchapter, and to violations of this subchapter, to the same
    extent that such part applies to functions of the Attorney General
    (and such officers and employees) under subchapter I of this
    chapter, to such proceedings under subchapter I of this chapter,
    and to violations of subchapter I of this chapter. For purposes of
    the application of this section to section 880 or 881 of this
    title, any reference in such section 880 or 881 of this title to
    "this subchapter" shall be deemed to be a reference to this
    subchapter, any reference to section 823 of this title shall be
    deemed to be a reference to section 958 of this title, and any
    reference to section 822(d) of this title shall be deemed to be a
    reference to section 957(b)(2) of this title.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1015, Oct. 27, 1970, 84 Stat.
    1291; Pub. L. 95-633, title III, Sec. 301(b), Nov. 10, 1978, 92
    Stat. 3778.)


-MISC1-
                                AMENDMENTS                            
      1978 - Pub. L. 95-633 inserted "or 881" after "880" wherever
    appearing.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For abolition of Bureau of Narcotics and Dangerous Drugs,
    including Office of Director thereof, and creation of a single
    comprehensive agency for enforcement of drug laws by Reorg. Plan
    No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, see
    note set out under section 881 of this title.

-End-



-CITE-
    21 USC Sec. 966                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 966. Authority of Secretary of the Treasury

-STATUTE-
      Nothing in this chapter shall derogate from the authority of the
    Secretary of the Treasury under the customs and related laws.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1016, Oct. 27, 1970, 84 Stat.
    1291.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1236, as
    amended. For complete classification of this Act to the Code, see
    Short Title note set out under section 801 of this title and
    Tables.
      The customs laws, referred to in text, are classified generally
    to Title 19, Customs Duties.

-End-



-CITE-
    21 USC Sec. 967                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 967. Smuggling of controlled substances; investigations;
      oaths; subpenas; witnesses; evidence; production of records;
      territorial limits; fees and mileage of witnesses

-STATUTE-
      For the purpose of any investigation which, in the opinion of the
    Secretary of the Treasury, is necessary and proper to the
    enforcement of section 545 of title 18 (relating to smuggling goods
    into the United States) with respect to any controlled substance
    (as defined in section 802 of this title), the Secretary of the
    Treasury may administer oaths and affirmations, subpena witnesses,
    compel their attendance, take evidence, and require the production
    of records (including books, papers, documents and tangible things
    which constitute or contain evidence) relevant or material to the
    investigation. The attendance of witnesses and the production of
    records may be required from any place within the customs territory
    of the United States, except that a witness shall not be required
    to appear at any hearing distant more than 100 miles from the place
    where he was served with subpena. Witnesses summoned by the
    Secretary shall be paid the same fees and mileage that are paid
    witnesses in the courts of the United States. Oaths and
    affirmations may be made at any place subject to the jurisdiction
    of the United States.

-SOURCE-
    (Aug. 11, 1955, ch. 800, Sec. 1, 69 Stat. 684; Pub. L. 91-513,
    title III, Sec. 1102(t), Oct. 27, 1970, 84 Stat. 1294.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Comprehensive Drug Abuse
    Prevention and Control Act of 1970 which comprises this chapter.
      Section was formerly classified to section 1034 of Title 31 prior
    to the general revision and enactment of Title 31, Money and
    Finance, by Pub. L. 97-258, Sec. 1, Sept. 13, 1982, 96 Stat. 877.
      Section was also formerly classified to section 198a of this
    title.


-MISC1-
                                AMENDMENTS                            
      1970 - Pub. L. 91-513 substituted "section 545 of title 18
    (relating to smuggling goods into the United States) with respect
    to any controlled substance (as defined in section 802 of this
    title)" for "the laws of the United States relating to narcotic
    drugs and marihuana" and substituted the customs territory of the
    United States for any State or any territory or other place subject
    to the jurisdiction of the United States is the defined area from
    within which the attendance of witnesses and the production of
    records may be required, and struck out provisions making the
    discretion of the Secretary of the Treasury the determinative
    factor as to what is relevant or material to the investigation.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub.
    L. 91-513, set out as an Effective Date note under section 951 of
    this title.

                             SAVINGS PROVISION                         
      Prosecutions for any violation of law occurring, and civil
    seizures or forfeitures and injunctive proceedings commenced, prior
    to the effective date of amendment of this section by section 1102
    of Pub. L. 91-513 not to be affected or abated by reason thereof,
    see section 1103 of Pub. L. 91-513, set out as a note under
    sections 171 to 174 of this title.

-End-



-CITE-
    21 USC Sec. 968                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 968. Service of subpena; proof of service

-STATUTE-
      A subpena of the Secretary of the Treasury may be served by any
    person designated in the subpena to serve it. Service upon a
    natural person may be made by personal delivery of the subpena to
    him. Service may be made upon a domestic or foreign corporation or
    upon a partnership or other unincorporated association which is
    subject to suit under a common name, by delivering the subpena to
    an officer, a managing or general agent, or to any other agent
    authorized by appointment or by law to receive service of process.
    The affidavit of the person serving the subpena entered on a true
    copy thereof by the person serving it shall be proof of service.

-SOURCE-
    (Aug. 11, 1955, ch. 800, Sec. 2, 69 Stat. 685.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Comprehensive Drug Abuse
    Prevention and Control Act of 1970 which comprises this chapter.
      Section was formerly classified to section 1035 of Title 31 prior
    to the general revision and enactment of Title 31, Money and
    Finance, by Pub. L. 97-258, Sec. 1, Sept. 13, 1982, 96 Stat. 877.
      Section was also formerly classified to section 198b of this
    title.

-End-



-CITE-
    21 USC Sec. 969                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 969. Contempt proceedings

-STATUTE-
      In case of contumacy by, or refusal to obey a subpena issued to,
    any person, the Secretary of the Treasury may invoke the aid of any
    court of the United States within the jurisdiction of which the
    investigation is carried on or of which the subpenaed person is an
    inhabitant, carries on business or may be found, to compel
    compliance with the subpena of the Secretary of the Treasury. The
    court may issue an order requiring the subpenaed person to appear
    before the Secretary of the Treasury there to produce records, if
    so ordered, or to give testimony touching the matter under
    investigation. Any failure to obey the order of the court may be
    punished by the court as a contempt thereof. All process in any
    such case may be served in the judicial district whereof the
    subpenaed person is an inhabitant or wherever he may be found.

-SOURCE-
    (Aug. 11, 1955, ch. 800, Sec. 3, 69 Stat. 685.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Comprehensive Drug Abuse
    Prevention and Control Act of 1970 which comprises this chapter.
      Section was formerly classified to section 1036 of Title 31 prior
    to the general revision and enactment of Title 31, Money and
    Finance, by Pub. L. 97-258, Sec. 1, Sept. 13, 1982, 96 Stat. 877.
      Section was also formerly classified to section 198c of this
    title.

-End-



-CITE-
    21 USC Sec. 970                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 970. Criminal forfeitures

-STATUTE-
      Section 853 of this title, relating to criminal forfeitures,
    shall apply in every respect to a violation of this subchapter
    punishable by imprisonment for more than one year.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1017, as added Pub. L. 98-473,
    title II, Sec. 307, Oct. 12, 1984, 98 Stat. 2051.)

-End-



-CITE-
    21 USC Sec. 971                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
    SUBCHAPTER II - IMPORT AND EXPORT

-HEAD-
    Sec. 971. Notification, suspension of shipment, and penalties with
      respect to importation and exportation of listed chemicals

-STATUTE-
    (a) Notification prior to transaction
      Each regulated person who imports or exports a listed chemical
    shall notify the Attorney General of the importation or exportation
    not later than 15 days before the transaction is to take place.
    (b) Regular customers or importers
      (1) The Attorney General shall provide by regulation for
    circumstances in which the requirement of subsection (a) of this
    section does not apply to a transaction between a regulated person
    and a regular customer or to a transaction that is an importation
    by a regular importer. At the time of any importation or
    exportation constituting a transaction referred to in the preceding
    sentence, the regulated person shall notify the Attorney General of
    the transaction.
      (2) The regulations under this subsection shall provide that the
    initial notification under subsection (a) of this section with
    respect to a customer of a regulated person or to an importer
    shall, upon the expiration of the 15-day period, qualify the
    customer as a regular customer or the importer as a regular
    importer, unless the Attorney General otherwise notifies the
    regulated person in writing.
    (c) Suspension of importation or exportation; disqualification of
      regular customers or importers; hearing
      (1) The Attorney General may order the suspension of any
    importation or exportation of a listed chemical (other than a
    regulated transaction to which the requirement of subsection (a) of
    this section does not apply by reason of subsection (b) of this
    section) or may disqualify any regular customer or regular importer
    on the ground that the chemical may be diverted to the clandestine
    manufacture of a controlled substance (without regard to the form
    of the chemical that may be diverted, including the diversion of a
    finished drug product to be manufactured from bulk chemicals to be
    transferred). From and after the time when the Attorney General
    provides written notice of the order (including a statement of the
    legal and factual basis for the order) to the regulated person, the
    regulated person may not carry out the transaction.
      (2) Upon written request to the Attorney General, a regulated
    person to whom an order applies under paragraph (1) is entitled to
    an agency hearing on the record in accordance with subchapter II of
    chapter 5 of title 5. The hearing shall be held on an expedited
    basis and not later than 45 days after the request is made, except
    that the hearing may be held at a later time, if so requested by
    the regulated person.
    (d) Information required in notice; updated notice for change in
      circumstances
      (1)(A) Information provided in a notice under subsection (a) or
    (b) shall include the name of the person to whom the importer or
    exporter involved intends to transfer the listed chemical involved,
    and the quantity of such chemical to be transferred.
      (B) In the case of a notice under subsection (b) submitted by a
    regular importer, if the transferee identified in the notice is not
    a regular customer, such importer may not transfer the listed
    chemical until after the expiration of the 15-day period beginning
    on the date on which the notice is submitted to the Attorney
    General.
      (C) After a notice under subsection (a) or (b) is submitted to
    the Attorney General, if circumstances change and the importer or
    exporter will not be transferring the listed chemical to the
    transferee identified in the notice, or will be transferring a
    greater quantity of the chemical than specified in the notice, the
    importer or exporter shall update the notice to identify the most
    recent prospective transferee or the most recent quantity or both
    (as the case may be) and may not transfer the listed chemical until
    after the expiration of the 15-day period beginning on the date on
    which the update is submitted to the Attorney General, except that
    such 15-day restriction does not apply if the prospective
    transferee identified in the update is a regular customer. The
    preceding sentence applies with respect to changing circumstances
    regarding a transferee or quantity identified in an update to the
    same extent and in the same manner as such sentence applies with
    respect to changing circumstances regarding a transferee or
    quantity identified in the original notice under subsection (a) or
    (b).
      (D) In the case of a transfer of a listed chemical that is
    subject to a 15-day restriction under subparagraph (B) or (C), the
    transferee involved shall, upon the expiration of the 15-day
    period, be considered to qualify as a regular customer, unless the
    Attorney General otherwise notifies the importer or exporter
    involved in writing.
      (2) With respect to a transfer of a listed chemical with which a
    notice or update referred to in paragraph (1) is concerned:
        (A) The Attorney General, in accordance with the same
      procedures as apply under subsection (c)(2) - 
          (i) may order the suspension of the transfer of the listed
        chemical by the importer or exporter involved, except for a
        transfer to a regular customer, on the ground that the chemical
        may be diverted to the clandestine manufacture of a controlled
        substance (without regard to the form of the chemical that may
        be diverted, including the diversion of a finished drug product
        to be manufactured from bulk chemicals to be transferred),
        subject to the Attorney General ordering such suspension before
        the expiration of the 15-day period referred to in paragraph
        (1) with respect to the importation or exportation (in any case
        in which such a period applies); and
          (ii) may, for purposes of clause (i) and paragraph (1),
        disqualify a regular customer on such ground.

        (B) From and after the time when the Attorney General provides
      written notice of the order under subparagraph (A) (including a
      statement of the legal and factual basis for the order) to the
      importer or exporter, the importer or exporter may not carry out
      the transfer.

      (3) For purposes of this subsection:
        (A) The terms "importer" and "exporter" mean a regulated person
      who imports or exports a listed chemical, respectively.
        (B) The term "transfer", with respect to a listed chemical,
      includes the sale of the chemical.
        (C) The term "transferee" means a person to whom an importer or
      exporter transfers a listed chemical.
    (e) Broker or trader for international transaction in listed
      chemical
      A person located in the United States who is a broker or trader
    for an international transaction in a listed chemical that is a
    regulated transaction solely because of that person's involvement
    as a broker or trader shall, with respect to that transaction, be
    subject to all of the notification, reporting, recordkeeping, and
    other requirements placed upon exporters of listed chemicals by
    this subchapter and subchapter I of this chapter.
    (f) Application of notification requirement to exports of listed
      chemical; waiver
      (1) The Attorney General may by regulation require that the 15-
    day notification requirement of subsection (a) of this section
    apply to all exports of a listed chemical to a specified country,
    regardless of the status of certain customers in such country as
    regular customers, if the Attorney General finds that such
    notification is necessary to support effective chemical diversion
    control programs or is required by treaty or other international
    agreement to which the United States is a party.
      (2) The Attorney General may by regulation waive the 15-day
    notification requirement for exports of a listed chemical to a
    specified country if the Attorney General determines that such
    notification is not required for effective chemical diversion
    control. If the notification requirement is waived, exporters of
    the listed chemical shall be required to submit to the Attorney
    General reports of individual exportations or periodic reports of
    such exportation of the listed chemical, at such time or times and
    containing such information as the Attorney General shall establish
    by regulation.
      (3) The Attorney General may by regulation waive the 15-day
    notification requirement for the importation of a listed chemical
    if the Attorney General determines that such notification is not
    necessary for effective chemical diversion control. If the
    notification requirement is waived, importers of the listed
    chemical shall be required to submit to the Attorney General
    reports of individual importations or periodic reports of the
    importation of the listed chemical, at such time or times and
    containing such information as the Attorney General shall establish
    by regulation.
    (g) Return declaration
      Within 30 days after a transaction covered by this section is
    completed, the importer or exporter shall send the Attorney General
    a return declaration containing particulars of the transaction,
    including the date, quantity, chemical, container, name of
    transferees, and such other information as the Attorney General may
    specify in regulations. For importers, a single return declaration
    may include the particulars of both the importation and
    distribution. If the importer has not distributed all chemicals
    imported by the end of the initial 30-day period, the importer
    shall file supplemental return declarations no later than 30 days
    from the date of any further distribution, until the distribution
    or other disposition of all chemicals imported pursuant to the
    import notification or any update are accounted for.
    (h) Importation and distribution of ephedrine, pseudoephedrine, or
      phenylpropanolamine
      (1) With respect to a regulated person importing ephedrine,
    pseudoephedrine, or phenylpropanolamine (referred to in this
    section as an "importer"), a notice of importation under subsection
    (a) or (b) shall include all information known to the importer on
    the chain of distribution of such chemical from the manufacturer to
    the importer.
      (2) For the purpose of preventing or responding to the diversion
    of ephedrine, pseudoephedrine, or phenylpropanolamine for use in
    the illicit production of methamphetamine, the Attorney General
    may, in the case of any person who is a manufacturer or distributor
    of such chemical in the chain of distribution referred to in
    paragraph (1) (which person is referred to in this subsection as a
    "foreign-chain distributor"), request that such distributor provide
    to the Attorney General information known to the distributor on the
    distribution of the chemical, including sales.
      (3) If the Attorney General determines that a foreign-chain
    distributor is refusing to cooperate with the Attorney General in
    obtaining the information referred to in paragraph (2), the
    Attorney General may, in accordance with procedures that apply
    under subsection (c), issue an order prohibiting the importation of
    ephedrine, pseudoephedrine, or phenylpropanolamine in any case in
    which such distributor is part of the chain of distribution for
    such chemical. Not later than 60 days prior to issuing the order,
    the Attorney General shall publish in the Federal Register a notice
    of intent to issue the order. During such 60-day period, imports of
    the chemical with respect to such distributor may not be restricted
    under this paragraph.

-SOURCE-
    (Pub. L. 91-513, title III, Sec. 1018, as added Pub. L. 100-690,
    title VI, Sec. 6053(a), Nov. 18, 1988, 102 Stat. 4314; amended Pub.
    L. 103-200, Secs. 4(a), 5(a), 9(b), Dec. 17, 1993, 107 Stat. 2338-
    2340; Pub. L. 103-322, title XXXIII, Sec. 330024(c), Sept. 13,
    1994, 108 Stat. 2150; Pub. L. 109-177, title VII, Secs. 716(a),
    (b)(1)(B), 721, Mar. 9, 2006, 120 Stat. 265, 267.)


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (b)(1). Pub. L. 109-177, Sec. 716(a)(1),
    substituted "or to a transaction that is an importation by a
    regular importer" for "or to an importation by a regular importer".
      Subsec. (c)(1). Pub. L. 109-177, Sec. 716(b)(1)(B), inserted
    "(without regard to the form of the chemical that may be diverted,
    including the diversion of a finished drug product to be
    manufactured from bulk chemicals to be transferred)" after
    "manufacture of a controlled substance".
      Subsecs. (d) to (f). Pub. L. 109-177, Sec. 716(a)(2), (3), added
    subsec. (d) and redesignated former subsecs. (d) and (e) as (e) and
    (f), respectively.
      Subsec. (g). Pub. L. 109-177, Sec. 716(a)(4), added subsec. (g).
      Subsec. (h). Pub. L. 109-177, Sec. 721, added subsec. (h).
      1994 - Subsecs. (b)(1), (2), (c)(1). Pub. L. 103-322, Sec.
    330024(c)(2), made technical amendment to directory language of
    Pub. L. 103-200, Sec. 9(b). See 1993 Amendment notes below.
      Subsec. (e). Pub. L. 103-322, Sec. 330024(c)(1), made technical
    amendment to directory language of Pub. L. 103-200, Sec. 5(a). See
    1993 Amendment note below.
      1993 - Subsec. (b)(1). Pub. L. 103-200, Sec. 9(b)(1)(A), as
    amended by Pub. L. 103-322, Sec. 330024(c)(2), substituted "to an
    importation by a regular importer" for "regular supplier of the
    regulated person".
      Subsec. (b)(2). Pub. L. 103-200, Sec. 9(b)(1)(B), as amended by
    Pub. L. 103-322, Sec. 330024(c)(2), substituted "a customer of a
    regulated person or to an importer" for "a customer or supplier of
    a regulated person" and "the importer as a regular importer" for
    "regular supplier".
      Subsec. (c)(1). Pub. L. 103-200, Sec. 9(b)(2), as amended by Pub.
    L. 103-322, Sec. 330024(c)(2), substituted "regular importer" for
    "regular supplier".
      Subsec. (d). Pub. L. 103-200, Sec. 4(a), added subsec. (d).
      Subsec. (e). Pub. L. 103-200, Sec. 5(a), as amended by Pub. L.
    103-322, Sec. 330024(c)(1), added subsec. (e).

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by Pub. L. 103-322 effective 120 days after Dec. 17,
    1993, see section 330024(f) of Pub. L. 103-322, set out as a note
    under section 802 of this title.

                     EFFECTIVE DATE OF 1993 AMENDMENT                 
      Amendment by Pub. L. 103-200 effective on date that is 120 days
    after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
    a note under section 802 of this title.

                              EFFECTIVE DATE                          
      Section 6053(b) of Pub. L. 100-690 provided that:
      "(1) Not later than 45 days after the date of the enactment of
    this Act [Nov. 18, 1988], the Attorney General shall forward to the
    Director of the Office of Management and Budget proposed
    regulations required by the amendment made by subsection (a)
    [enacting this section].
      "(2) Not later than 55 days after the date of the enactment of
    this Act, the Director of the Office of Management and Budget shall
    - 
        "(A) review such proposed regulations of the Attorney General;
      and
        "(B) forward any comments and recommendations for modifications
      to the Attorney General.
      "(3) Not later than 60 days after the date of the enactment of
    this Act, the Attorney General shall publish the proposed final
    regulations required by the amendment made by subsection (a).
      "(4) Not later than 120 days after the date of the enactment of
    this Act, the Attorney General shall promulgate final regulations
    required by the amendment made by subsection (a).
      "(5) Subsection (a) of section 1018 of the Controlled Substances
    Import and Export Act [subsection (a) of this section], as added by
    subsection (a) of this section, shall take effect 90 days after the
    promulgation of the final regulations under paragraph (4).
      "(6) Each regulated person shall provide to the Attorney General
    the identity of any regular customer or regular supplier of the
    regulated person not later than 30 days after the promulgation of
    the final regulations under paragraph (4). Not later than 60 days
    after the end of such 30-day period, each regular customer and
    regular supplier so identified shall be a regular customer or
    regular supplier for purposes of any applicable exception from the
    requirement of subsection (a) of such section 1018, unless the the
    [sic] Attorney General otherwise notifies the regulated person in
    writing."
      Section effective 120 days after Nov. 18, 1988 [except subsec.
    (a), see above], see section 6061 of Pub. L. 100-690, set out as an
    Effective Date of 1988 Amendment note under section 802 of this
    title.

     EXCEPTION FOR IODINE TO IMPORTATION AND EXPORTATION REQUIREMENTS
                           FOR LISTED CHEMICALS
      Pub. L. 104-237, title II, Sec. 204(b), Oct. 3, 1996, 110 Stat.
    3102, provided that:
      "(1) Iodine shall not be subject to the requirements for listed
    chemicals provided in section 1018 of the Controlled Substances
    Import and Export Act (21 U.S.C. 971).
      "(2) Effect of Exception. - The exception made by paragraph (1)
    shall not limit the authority of the Attorney General to impose the
    requirements for listed chemicals provided in section 1018 of the
    Controlled Substances Import and Export Act (21 U.S.C. 971)."

-End-


-CITE-
    21 USC CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL
           PROGRAMS AND ACTIVITIES                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND
                  ACTIVITIES                      

-HEAD-
       CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND
                                ACTIVITIES

-End-



-CITE-
    21 USC Secs. 1001 to 1007                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND
                  ACTIVITIES                      

-HEAD-
    Secs. 1001 to 1007. Repealed.

-MISC1-
    Secs. 1001 to 1007. Repealed. Pub. L. 97-35, title V, Sec.
      587(a)(3), Aug. 13, 1981, 95 Stat. 480.
      Section 1001, Pub. L. 91-527, Sec. 2, Dec. 3, 1970, 84 Stat.
    1385; Pub. L. 93-422, Sec. 2(b), Sept. 21, 1974, 88 Stat. 1154;
    Pub. L. 95-336, Sec. 2, Aug. 4, 1978, 92 Stat. 451, set forth
    Congressional declaration of purpose for Alcohol and Drug Abuse
    Education Act.
      Section 1002, Pub. L. 91-527, Sec. 3, Dec. 3, 1970, 84 Stat.
    1386; Pub. L. 93-422, Sec. 2(c), Sept. 21, 1974, 88 Stat. 1155;
    Pub. L. 95-336, Secs. 3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S.
    Res. 30, Mar. 7, 1979; Pub. L. 96-88, title III, Sec. 301(a)(1),
    (2)(Q), (b)(1), title V, Sec. 507, Oct. 17, 1979, 93 Stat. 677,
    678, 692, set forth grant and contract authority, etc., for
    projects and programs.
      Section 1003, Pub. L. 91-527, Sec. 4, Dec. 3, 1970, 84 Stat.
    1387; Pub. L. 93-422, Sec. 2(d), Sept. 21, 1974, 88 Stat. 1157;
    Pub. L. 96-88, title III, Sec. 301(a)(1), title V, Sec. 507, Oct.
    17, 1979, 93 Stat. 677, 692, related to recordkeeping requirements,
    and access to and inspection of records.
      Section 1004, Pub. L. 91-527, Sec. 5, Dec. 3, 1970, 84 Stat.
    1388; Pub. L. 93-422, Sec. 2(e), Sept. 21, 1974, 88 Stat. 1157;
    Pub. L. 96-88, title V, Sec. 508(i), Oct. 17, 1979, 93 Stat. 693,
    related to technical assistance to local agencies, etc.
      Section 1005, Pub. L. 91-527, Sec. 6, Dec. 3, 1970, 84 Stat.
    1388, related to nature of payments.
      Section 1006, Pub. L. 91-527, Sec. 7, Dec. 3, 1970, 84 Stat.
    1388, related to utilization of services and facilities of Federal
    agencies and public and private agencies and institutions.
      Section 1007, Pub. L. 91-527, Sec. 8, Dec. 3, 1970, 84 Stat.
    1388; Pub. L. 93-422, Sec. 2(f), Sept. 21, 1974, 88 Stat. 1157;
    Pub. L. 95-336, Sec. 5, Aug. 4, 1978, 92 Stat. 453; Pub. L. 96-88,
    title III, Sec. 301(a)(1), (2)(Q), title V, Sec. 507, Oct. 17,
    1979, 93 Stat. 677, 678, 692, defined "Secretary" and "State".

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Oct. 1, 1982, see section 587(a) of Pub. L. 97-
    35, set out as section 3863(a) of Title 20, Education.

-End-


-CITE-
    21 USC CHAPTER 15 - EGG PRODUCTS INSPECTION                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
                   CHAPTER 15 - EGG PRODUCTS INSPECTION               

-MISC1-
    Sec.                                                     
    1031.       Congressional statement of findings.                  
    1032.       Congressional declaration of policy.                  
    1033.       Definitions.                                          
    1034.       Inspection of egg products.                           
    1035.       Sanitary operating practices in official plants.      
    1036.       Pasteurization and labeling of egg products at
                 official plants.                                     
    1037.       Prohibited acts.                                      
    1038.       Cooperation with appropriate State and other
                 governmental agencies; utilization of employees;
                 reimbursement.                                       
    1039.       Eggs and egg products not intended for use as human
                 food; inspection; denaturing or otherwise
                 identifying.                                         
    1040.       Recordkeeping requirements; persons required to
                 maintain records; scope of disclosure; access to
                 records.                                             
    1041.       Enforcement provisions.                               
    1042.       Reporting of violation to United States attorney for
                 institution of criminal proceedings; procedure;
                 presentation of views.                               
    1043.       Rules and regulations; administration and enforcement.
    1044.       Exemption of certain activities.                      
    1045.       Limitation on entry of eggs and egg products and other
                 materials into official plants.                      
    1046.       Imports.                                              
    1047.       Refusal or withdrawal of inspection services; hearing;
                 grounds; person deemed to have responsible connection
                 with business; finality of order of Secretary;
                 judicial review; other provisions for refusal of
                 services unaffected.                                 
    1048.       Administrative detention of violative articles;
                 duration; release; removal of official marks.        
    1049.       Seizure and condemnation proceedings.                 
    1050.       Jurisdiction of district courts; United States as
                 plaintiff in enforcement and restraining proceedings;
                 subpenas for witnesses.                              
    1051.       Other Federal laws applicable for administration and
                 enforcement of chapter; prosecution of inquiries;
                 exercise of jurisdiction.                            
    1052.       State or local regulation.                            
    1053.       Inspection and administration costs.                  
    1054.       Annual report to Congressional committees.            
    1055.       Authorization of appropriations.                      
    1056.       Separability.                                         

-End-



-CITE-
    21 USC Sec. 1031                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1031. Congressional statement of findings

-STATUTE-
      Eggs and egg products are an important source of the Nation's
    total supply of food, and are used in food in various forms. They
    are consumed throughout the Nation and the major portion thereof
    moves in interstate or foreign commerce. It is essential, in the
    public interest, that the health and welfare of consumers be
    protected by the adoption of measures prescribed herein for
    assuring that eggs and egg products distributed to them and used in
    products consumed by them are wholesome, otherwise not adulterated,
    and properly labeled and packaged. Lack of effective regulation for
    the handling or disposition of unwholesome, otherwise adulterated,
    or improperly labeled or packaged egg products and certain
    qualities of eggs is injurious to the public welfare and destroys
    markets for wholesome, not adulterated, and properly labeled and
    packaged eggs and egg products and results in sundry losses to
    producers and processors, as well as injury to consumers.
    Unwholesome, otherwise adulterated, or improperly labeled or
    packaged products can be sold at lower prices and compete unfairly
    with the wholesome, not adulterated, and properly labeled and
    packaged products, to the detriment of consumers and the public
    generally. It is hereby found that all egg products and the
    qualities of eggs which are regulated under this chapter are either
    in interstate or foreign commerce, or substantially affect such
    commerce, and that regulation by the Secretary of Agriculture and
    the Secretary of Health and Human Services, and cooperation by the
    States and other jurisdictions, as contemplated by this chapter,
    are appropriate to prevent and eliminate burdens upon such
    commerce, to effectively regulate such commerce, and to protect the
    health and welfare of consumers.

-SOURCE-
    (Pub. L. 91-597, Sec. 2, Dec. 29, 1970, 84 Stat. 1620; Pub. L. 96-
    88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    Act", meaning Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
    amended, which enacted this chapter, amended sections 633 and 636
    of Title 15, Commerce and Trade, and enacted provisions set out as
    notes under this section. For complete classification of this Act
    to the Code, see Short Title note set out below and Tables.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in text pursuant to
    section 509(b) of Pub. L. 96-88, which is classified to section
    3508(b) of Title 20, Education.


-MISC1-
                              EFFECTIVE DATE                          
      Section 29 of Pub. L. 91-597 provided that: "The provisions of
    this Act [enacting this chapter, amending sections 633 and 636 of
    Title 15, Commerce and Trade, and enacting provisions set out as
    notes under this section] with respect to egg products shall take
    effect six months after enactment [Dec. 29, 1970]. Otherwise, this
    Act shall take effect eighteen months after enactment."

                                SHORT TITLE                            
      Section 1 of Pub. L. 91-597 provided: "That this Act [enacting
    this chapter, amending sections 633 and 636 of Title 15, Commerce
    and Trade, and enacting provisions set as notes under this section]
    may be cited as the 'Egg Products Inspection Act'."

                 MAINTENANCE OF EGGS AT PROPER TEMPERATURE             
      Pub. L. 102-237, title X, Sec. 1012(a), Dec. 13, 1991, 105 Stat.
    1899, provided that:
      "(1) Findings. - Congress finds that - 
        "(A) food borne illness is a serious health problem;
        "(B) its incidence can be reduced through proper handling of
      food; and
        "(C) eggs are perishable and therefore are particularly
      susceptible to supporting microbial growth if proper temperature
      controls are not maintained.
      "(2) Purposes. - It is the purpose of this section [amending
    sections 1034, 1037, 1041, 1042, 1046, and 1052 of this title and
    enacting provisions set out as a note under section 1034 of this
    title] to prescribe the temperature at which eggs are maintained in
    order to reduce the potential for harmful microbial growth to
    protect the health and welfare of consumers."

-End-



-CITE-
    21 USC Sec. 1032                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1032. Congressional declaration of policy

-STATUTE-
      It is hereby declared to be the policy of the Congress to provide
    for the inspection of certain egg products, restrictions upon the
    disposition of certain qualities of eggs, and uniformity of
    standards for eggs, and otherwise regulate the processing and
    distribution of eggs and egg products as hereinafter prescribed to
    prevent the movement or sale for human food, of eggs and egg
    products which are adulterated or misbranded or otherwise in
    violation of this chapter.

-SOURCE-
    (Pub. L. 91-597, Sec. 3, Dec. 29, 1970, 84 Stat. 1621.)

-End-



-CITE-
    21 USC Sec. 1033                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1033. Definitions

-STATUTE-
      For purposes of this chapter - 
      (a) The term "adulterated" applies to any egg or egg product
    under one or more of the following circumstances - 
        (1) if it bears or contains any poisonous or deleterious
      substance which may render it injurious to health; but in case
      the substance is not an added substance, such article shall not
      be considered adulterated under this clause if the quantity of
      such substance in or on such article does not ordinarily render
      it injurious to health;
        (2)(A) if it bears or contains any added poisonous or added
      deleterious substance (other than one which is (i) a pesticide
      chemical in or on a raw agricultural commodity; (ii) a food
      additive; or (iii) a color additive) which may, in the judgment
      of the Secretary, make such article unfit for human food;
        (B) if it is, in whole or in part, a raw agricultural commodity
      and such commodity bears or contains a pesticide chemical which
      is unsafe within the meaning of section 346a of this title;
        (C) if it bears or contains any food additive which is unsafe
      within the meaning of section 348 of this title;
        (D) if it bears or contains any color additive which is unsafe
      within the meaning of section 379e of this title: Provided, That
      an article which is not otherwise deemed adulterated under clause
      (B), (C), or (D) shall nevertheless be deemed adulterated if use
      of the pesticide chemical, food additive, or color additive, in
      or on such article, is prohibited by regulations of the Secretary
      in official plants;
        (3) if it consists in whole or in part of any filthy, putrid,
      or decomposed substance, or if it is otherwise unfit for human
      food;
        (4) if it has been prepared, packaged, or held under insanitary
      conditions whereby it may have become contaminated with filth, or
      whereby it may have been rendered injurious to health;
        (5) if it is an egg which has been subjected to incubation or
      the product of any egg which has been subjected to incubation;
        (6) if its container is composed, in whole or in part, of any
      poisonous or deleterious substance which may render the contents
      injurious to health;
        (7) if it has been intentionally subjected to radiation, unless
      the use of the radiation was in conformity with a regulation or
      exemption in effect pursuant to section 348 of this title; or
        (8) if any valuable constituent has been in whole or in part
      omitted or abstracted therefrom; or if any substance has been
      substituted, wholly or in part therefor; or if damage or
      inferiority has been concealed in any manner; or if any substance
      has been added thereto or mixed or packed therewith so as to
      increase its bulk or weight, or reduce its quality or strength,
      or make it appear better or of greater value than it is.

      (b) The term "capable of use as human food" shall apply to any
    egg or egg product, unless it is denatured, or otherwise
    identified, as required by regulations prescribed by the Secretary
    to deter its use as human food.
      (c) The term "commerce" means interstate, foreign, or intrastate
    commerce.
      (d) The term "container" or "package" includes any box, can, tin,
    plastic, or other receptacle, wrapper, or cover.
      (1) The term "immediate container" means any consumer package; or
    any other container in which egg products, not consumer packaged,
    are packed.
      (2) The term "shipping container" means any container used in
    packaging a product packed in an immediate container.
      (e) The term "egg handler" means any person who engages in any
    business in commerce which involves buying or selling any eggs (as
    a poultry producer or otherwise), or processing any egg products,
    or otherwise using any eggs in the preparation of human food.
      (f) The term "egg product" means any dried, frozen, or liquid
    eggs, with or without added ingredients, excepting products which
    contain eggs only in a relatively small proportion or historically
    have not been, in the judgment of the Secretary, considered by
    consumers as products of the egg food industry, and which may be
    exempted by the Secretary under such conditions as he may prescribe
    to assure that the egg ingredients are not adulterated and such
    products are not represented as egg products.
      (g) The term "egg" means the shell egg of the domesticated
    chicken, turkey, duck, goose, or guinea.
      (1) The term "check" means an egg that has a broken shell or
    crack in the shell but has its shell membranes intact and contents
    not leaking.
      (2) The term "clean and sound shell egg" means any egg whose
    shell is free of adhering dirt or foreign material and is not
    cracked or broken.
      (3) The term "dirty egg" means an egg that has a shell that is
    unbroken and has adhering dirt or foreign material.
      (4) The term "incubator reject" means an egg that has been
    subjected to incubation and has been removed from incubation during
    the hatching operations as infertile or otherwise unhatchable.
      (5) The term "inedible" means eggs of the following descriptions:
    black rots, yellow rots, white rots, mixed rots (addled eggs), sour
    eggs, eggs with green whites, eggs with stuck yolks, moldy eggs,
    musty eggs, eggs showing blood rings, and eggs containing embryo
    chicks (at or beyond the blood ring stage).
      (6) The term "leaker" means an egg that has a crack or break in
    the shell and shell membranes to the extent that the egg contents
    are exposed or are exuding or free to exude through the shell.
      (7) The term "loss" means an egg that is unfit for human food
    because it is smashed or broken so that its contents are leaking;
    or overheated, frozen, or contaminated; or an incubator reject; or
    because it contains a bloody white, large meat spots, a large
    quantity of blood, or other foreign material.
      (8) The term "restricted egg" means any check, dirty egg,
    incubator reject, inedible, leaker, or loss.
      (h) The term "Fair Packaging and Labeling Act" [15 U.S.C. 1451 et
    seq.] means the Act so entitled, approved November 3, 1966 (80
    Stat. 1296), and Acts amendatory thereof or supplementary thereto.
      (i) The term "Federal Food, Drug, and Cosmetic Act" [21 U.S.C.
    301 et seq.] means the Act so entitled, approved June 25, 1938 (52
    Stat. 1040), and Acts amendatory thereof or supplementary thereto.
      (j) The term "inspection" means the application of such
    inspection methods and techniques as are deemed necessary by the
    responsible Secretary to carry out the provisions of this chapter.
      (k) The term "inspector" means:
        (1) any employee or official of the United States Government
      authorized to inspect eggs or egg products under the authority of
      this chapter; or
        (2) any employee or official of the government of any State or
      local jurisdiction authorized by the Secretary to inspect eggs or
      egg products under the authority of this chapter, under an
      agreement entered into between the Secretary and the appropriate
      State or other agency.

      (l) The term "misbranded" shall apply to egg products which are
    not labeled and packaged in accordance with the requirements
    prescribed by regulations of the Secretary under section 1036 of
    this title.
      (m) The term "official certificate" means any certificate
    prescribed by regulations of the Secretary for issuance by an
    inspector or other person performing official functions under this
    chapter.
      (n) The term "official device" means any device prescribed or
    authorized by the Secretary for use in applying any official mark.
      (o) The term "official inspection legend" means any symbol
    prescribed by regulations of the Secretary showing that egg
    products were inspected in accordance with this chapter.
      (p) The term "official mark" means the official inspection legend
    or any other symbol prescribed by regulations of the Secretary to
    identify the status of any article under this chapter.
      (q) The term "official plant" means any plant, as determined by
    the Secretary, at which inspection of the processing of egg
    products is maintained by the Department of Agriculture under the
    authority of this chapter.
      (r) The term "official standards" means the standards of quality,
    grades, and weight classes for eggs, in effect upon the effective
    date of this chapter, or as thereafter amended, under the
    Agricultural Marketing Act of 1946 (60 Stat. 1087, as amended; 7
    U.S.C. 1621 et seq.).
      (s) The term "pasteurize" means the subjecting of each particle
    of egg products to heat or other treatments to destroy harmful
    viable micro-organisms by such processes as may be prescribed by
    regulations of the Secretary.
      (t) The term "person" means any individual, partnership,
    corporation, association, or other business unit.
      (u) The terms "pesticide chemical," "food additive," "color
    additive," and "raw agricultural commodity" shall have the same
    meaning for purposes of this chapter as under the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
      (v) The term "plant" means any place of business where egg
    products are processed.
      (w) The term "processing" means manufacturing egg products,
    including breaking eggs or filtering, mixing, blending,
    pasteurizing, stabilizing, cooling, freezing, drying, or packaging
    egg products.
      (x) The term "Secretary" means the Secretary of Agriculture or
    his delegate.
      (y) The term "State" means any State of the United States, the
    Commonwealth of Puerto Rico, the Virgin Islands of the United
    States, and the District of Columbia.
      (z) The term "United States" means the States.

-SOURCE-
    (Pub. L. 91-597, Sec. 4, Dec. 29, 1970, 84 Stat. 1621; Pub. L. 102-
    571, title I, Sec. 107(15), Oct. 29, 1992, 106 Stat. 4499.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Fair Packaging and Labeling Act, referred to in subsec. (h),
    is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
    is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
    15, Commerce and Trade. For complete classification of this Act to
    the Code, see Short Title note set out under section 1451 of Title
    15 and Tables.
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (i) and (u), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.
      The effective date of this chapter, referred to in subsec. (r),
    means the effective date of Pub. L. 91-597. For such effective
    date, see Effective Date note set out under section 1031 of this
    title.
      The Agricultural Marketing Act of 1946, referred to in subsec.
    (r), is title II of act Aug. 14, 1946, ch. 966, 60 Stat. 1087, as
    amended, which is classified generally to chapter 38 (Sec. 1621 et
    seq.) of Title 7, Agriculture. For complete classification of this
    Act to the Code, see Short Title note set out under section 1621 of
    Title 7 and Tables.


-MISC1-
                                AMENDMENTS                            
      1992 - Subsec. (a)(2)(D). Pub. L. 102-571 substituted "379e" for
    "376".

-End-



-CITE-
    21 USC Sec. 1034                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1034. Inspection of egg products

-STATUTE-
    (a) Processing operations and establishments subject to coverage;
      rules and regulations
      For the purpose of preventing the entry into or flow or movement
    in commerce of, or the burdening of commerce by, any egg product
    which is capable of use as human food and is misbranded or
    adulterated, the Secretary shall, whenever processing operations
    are being conducted, cause continuous inspection to be made, in
    accordance with the regulations promulgated under this chapter, of
    the processing of egg products, in each plant processing egg
    products for commerce, unless exempted under section 1044 of this
    title. Without restricting the application of the preceding
    sentence to other kinds of establishments within its provisions,
    any food manufacturing establishment, institution, or restaurant
    which uses any eggs that do not meet the requirements of section
    1044(a)(1) of this title in the preparation of any articles for
    human food shall be deemed to be a plant processing egg products,
    with respect to such operations.
    (b) Authority of Secretary to retain, segregate, and reinspect eggs
      and egg products
      The Secretary, at any time, shall cause such retention,
    segregation, and reinspection as he deems necessary of eggs and egg
    products capable of use as human food in each official plant.
    (c) Condemnation of adulterated products; destruction or
      reprocessing; procedure upon appeal from determination of
      adulteration
      Eggs and egg products found to be adulterated at official plants
    shall be condemned and, if no appeal be taken from such
    determination of condemnation, such articles shall be destroyed for
    human food purposes under the supervision of an inspector:
    Provided, That articles which may by reprocessing be made not
    adulterated need not be condemned and destroyed if so reprocessed
    under the supervision of an inspector and thereafter found to be
    not adulterated. If an appeal be taken from such determination, the
    eggs or egg products shall be appropriately marked and segregated
    pending completion of an appeal inspection, which appeal shall be
    at the cost of the appellant if the Secretary determines that the
    appeal is frivolous. If the determination of condemnation is
    sustained, the eggs or egg products shall be destroyed for human
    food purposes under the supervision of an inspector.
    (d) Inspection of business premises, facilities, inventory,
      operations, and records of egg handlers; inspection of records
      and inventory of others required to keep records; authority of
      Secretary of Health and Human Services to inspect food
      manufacturing establishments, institutions, and restaurants;
      access to places of business
      The Secretary shall cause such other inspections to be made of
    the business premises, facilities, inventory, operations, and
    records of egg handlers, and the records and inventory of other
    persons required to keep records under section 1040 of this title,
    as he deems appropriate (and in the case of shell egg packers,
    packing eggs for the ultimate consumer, at least once each calendar
    quarter) to assure that only eggs fit for human food are used for
    such purpose, and otherwise to assure compliance by egg handlers
    and other persons with the requirements of section 1037 of this
    title, except that the Secretary of Health and Human Services shall
    cause such inspections to be made as he deems appropriate to assure
    compliance with such requirements at food manufacturing
    establishments, institutions, and restaurants, other than plants
    processing egg products. Representatives of said Secretaries shall
    be afforded access to all such places of business for purposes of
    making the inspections provided for in this chapter.
    (e) Refrigeration and labeling requirements
      (1) Subject to paragraphs (2), (3), and (4), the Secretary shall
    make such inspections as the Secretary considers appropriate of a
    facility of an egg handler (including a transport vehicle) to
    determine if shell eggs destined for the ultimate consumer - 
        (A) are being held under refrigeration at an ambient
      temperature of no greater than 45 degrees Fahrenheit after
      packing; and
        (B) contain labeling that indicates that refrigeration is
      required.

      (2) In the case of a shell egg packer packing eggs for the
    ultimate consumer, the Secretary shall make an inspection in
    accordance with paragraph (1) at least once each calendar quarter.
      (3) The Secretary of Health and Human Services shall cause such
    inspections to be made as the Secretary considers appropriate to
    ensure compliance with the requirements of paragraph (1) at food
    manufacturing establishments, institutions, and restaurants, other
    than plants packing eggs.
      (4) The Secretary shall not make an inspection as provided in
    paragraph (1) on any egg handler with a flock of not more than
    3,000 layers.
      (5) A representative of the Secretary and the Secretary of Health
    and Human Services shall be afforded access to a place of business
    referred to in this subsection, including a transport vehicle, for
    purposes of making an inspection required under this subsection.

-SOURCE-
    (Pub. L. 91-597, Sec. 5, Dec. 29, 1970, 84 Stat. 1624; Pub. L. 96-
    88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
    237, title X, Sec. 1012(b), Dec. 13, 1991, 105 Stat. 1899.)


-MISC1-
                                AMENDMENTS                            
      1991 - Subsec. (e). Pub. L. 102-237 added subsec. (e).

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in subsec. (d)
    pursuant to section 509(b) of Pub. L. 96-88, which is classified to
    section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1991 AMENDMENT                 
      Section 1012(h) of Pub. L. 102-237 provided that: "This section
    and the amendments made by this section [amending this section and
    sections 1037, 1041, 1042, 1046, and 1052 of this title and
    enacting provisions set out as a note under section 1031 of this
    title] shall become effective 12 months after the Secretary of
    Agriculture promulgates final regulations implementing this section
    and the amendments." [Final regulations were promulgated Aug. 20,
    1998, effective Aug. 27, 1999. See 63 F.R. 45663.]

-End-



-CITE-
    21 USC Sec. 1035                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1035. Sanitary operating practices in official plants

-STATUTE-
    (a) Premises, facilities, and equipment
      Each official plant shall be operated in accordance with such
    sanitary practices and shall have such premises, facilities, and
    equipment as are required by regulations promulgated by the
    Secretary to effectuate the purposes of this chapter, including
    requirements for segregation and disposition of restricted eggs.
    (b) Refusal by Secretary to inspect nonconforming plants
      The Secretary shall refuse to render inspection to any plant
    whose premises, facilities, or equipment, or the operation thereof,
    fail to meet the requirements of this section.

-SOURCE-
    (Pub. L. 91-597, Sec. 6, Dec. 29, 1970, 84 Stat. 1625.)

-End-



-CITE-
    21 USC Sec. 1036                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1036. Pasteurization and labeling of egg products at official
      plants

-STATUTE-
    (a) Contents of label
      Egg products inspected at any official plant under the authority
    of this chapter and found to be not adulterated shall be
    pasteurized before they leave the official plant, except as
    otherwise permitted by regulations of the Secretary, and shall at
    the time they leave the official plant, bear in distinctly legible
    form on their shipping containers or immediate containers, or both,
    when required by regulations of the Secretary, the official
    inspection legend and official plant number, of the plant where the
    products were processed, and such other information as the
    Secretary may require by regulations to describe the products
    adequately and to assure that they will not have false or
    misleading labeling.
    (b) False or misleading or use of nonapproved labeling or
      containers; determination by Secretary; procedures applicable;
      appeal
      No labeling or container shall be used for egg products at
    official plants if it is false or misleading or has not been
    approved as required by the regulations of the Secretary. If the
    Secretary has reason to believe that any labeling or the size or
    form of any container in use or proposed for use with respect to
    egg products at any official plant is false or misleading in any
    particular, he may direct that such use be withheld unless the
    labeling or container is modified in such manner as he may
    prescribe so that it will not be false or misleading. If the person
    using or proposing to use the labeling or container does not accept
    the determination of the Secretary, such person may request a
    hearing, but the use of the labeling or container shall, if the
    Secretary so directs, be withheld pending hearing and final
    determination by the Secretary. Any such determination by the
    Secretary shall be conclusive unless, within thirty days after
    receipt of notice of such final determination, the person adversely
    affected thereby appeals to the United States court of appeals for
    the circuit in which such person has its principal place of
    business or to the United States Court of Appeals for the District
    of Columbia Circuit. The provisions of section 194 of title 7,(!1)
    shall be applicable to appeals taken under this section.


-SOURCE-
    (Pub. L. 91-597, Sec. 7, Dec. 29, 1970, 84 Stat. 1625.)

-FOOTNOTE-
    (!1) So in original. The comma probably should not appear.


-End-



-CITE-
    21 USC Sec. 1037                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1037. Prohibited acts

-STATUTE-
      (a)(1) No person shall buy, sell, or transport, or offer to buy
    or sell, or offer or receive for transportation, in any business in
    commerce any restricted eggs, capable of use as human food, except
    as authorized by regulations of the Secretary under such conditions
    as he may prescribe to assure that only eggs fit for human food are
    used for such purpose.
      (2) No egg handler shall possess with intent to use, or use, any
    restricted eggs in the preparation of human food for commerce
    except that such eggs may be so possessed and used when authorized
    by regulations of the Secretary under such conditions as he may
    prescribe to assure that only eggs fit for human food are used for
    such purpose.
      (b)(1) No person shall process any egg products for commerce at
    any plant except in compliance with the requirements of this
    chapter.
      (2) No person shall buy, sell, or transport, or offer to buy or
    sell, or offer or receive for transportation, in commerce any egg
    products required to be inspected under this chapter unless they
    have been so inspected and are labeled and packaged in accordance
    with the requirements of section 1036 of this title.
      (3) No operator of any official plant shall fail to comply with
    any requirements of section 1035(a) of this title or the
    regulations thereunder.
      (4) No operator of any official plant shall allow any egg
    products to be moved from such plant if they are adulterated or
    misbranded and capable of use as human food.
      (c) No egg handler shall possess any eggs after the eggs have
    been packed into a container that is destined for the ultimate
    consumer unless the eggs are stored and transported under
    refrigeration at an ambient temperature of no greater than 45
    degrees Fahrenheit, as prescribed by rules and regulations
    promulgated by the Secretary.
      (d) No person shall violate any provision of section 1039, 1040
    or 1046 of this title.
      (e) No person shall - 
        (1) manufacture, cast, print, lithograph, or otherwise make any
      device containing any official mark or simulation thereof, or any
      label bearing any such mark or simulation, or any form of
      official certificate or simulation thereof, except as authorized
      by the Secretary;
        (2) forge or alter any official device, mark, or certificate;
        (3) without authorization from the Secretary, use any official
      device, mark, or certificate, or simulation thereof, or detach,
      deface, or destroy any official device or mark; or use any
      labeling or container ordered to be withheld from use under
      section 1036 of this title after final judicial affirmance of
      such order or expiration of the time for appeal if no appeal is
      taken under said section;
        (4) contrary to the regulations prescribed by the Secretary,
      fail to use, or to detach, deface, or destroy any official
      device, mark, or certificate;
        (5) knowingly possess, without promptly notifying the Secretary
      or his representative, any official device or any counterfeit,
      simulated, forged, or improperly altered official certificate or
      any device or label, or any eggs or egg products bearing any
      counterfeit, simulated, forged, or improperly altered official
      mark;
        (6) knowingly make any false statement in any shipper's
      certificate or other nonofficial or official certificate provided
      for in the regulations prescribed by the Secretary;
        (7) knowingly represent that any article has been inspected or
      exempted, under this chapter, when, in fact, it has,
      respectively, not been so inspected or exempted; and
        (8) refuse access, at any reasonable time, to any
      representative of the Secretary of Agriculture or the Secretary
      of Health and Human Services, to any plant or other place of
      business subject to inspection under any provisions of this
      chapter.

      (f) No person, while an official or employee of the United States
    Government or any State or local governmental agency, or
    thereafter, shall use to his own advantage, or reveal other than to
    the authorized representatives of the United States Government or
    any State or other government in their official capacity, or as
    ordered by a court in a judicial proceeding, any information
    acquired under the authority of this chapter concerning any matter
    which is entitled to protection as a trade secret.

-SOURCE-
    (Pub. L. 91-597, Sec. 8, Dec. 29, 1970, 84 Stat. 1626; Pub. L. 96-
    88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
    237, title X, Sec. 1012(c), Dec. 13, 1991, 105 Stat. 1899.)


-MISC1-
                                AMENDMENTS                            
      1991 - Subsecs. (c) to (f). Pub. L. 102-237 added subsec. (c) and
    redesignated former subsecs. (c) to (e) as (d) to (f),
    respectively.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in subsec. (e)(8)
    pursuant to section 509(b) of Pub. L. 96-88, which is classified to
    section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1991 AMENDMENT                 
      Amendment by Pub. L. 102-237 effective 12 months after
    promulgation of final implementing regulations, see section 1012(h)
    of Pub. L. 102-237, set out as a note under section 1034 of this
    title.

-End-



-CITE-
    21 USC Sec. 1038                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1038. Cooperation with appropriate State and other
      governmental agencies; utilization of employees; reimbursement

-STATUTE-
      The Secretary shall, whenever he determines that it would
    effectuate the purposes of this chapter, cooperate with appropriate
    State and other governmental agencies, in carrying out any
    provisions of this chapter. In carrying out the provisions of this
    chapter, the Secretary may conduct such examinations,
    investigations, and inspections as he determines practicable
    through any officer or employee of any such agency commissioned by
    him for such purpose. The Secretary shall reimburse the States and
    other agencies for the costs incurred by them in such cooperative
    programs.

-SOURCE-
    (Pub. L. 91-597, Sec. 9, Dec. 29, 1970, 84 Stat. 1627.)

-End-



-CITE-
    21 USC Sec. 1039                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1039. Eggs and egg products not intended for use as human
      food; inspection; denaturing or otherwise identifying

-STATUTE-
      Inspection shall not be provided under this chapter at any plant
    for the processing of any egg products which are not intended for
    use as human food, but such articles, prior to their offer for sale
    or transportation in commerce, shall be denatured or otherwise
    identified as prescribed by regulations of the Secretary to deter
    their use for human food. No person shall buy, sell, or transport
    or offer to buy or sell, or offer or receive for transportation, in
    commerce, any restricted eggs or egg products which are not
    intended for use as human food unless they are denatured or
    otherwise identified as required by the regulations of the
    Secretary.

-SOURCE-
    (Pub. L. 91-597, Sec. 10, Dec. 29, 1970, 84 Stat. 1627.)

-End-



-CITE-
    21 USC Sec. 1040                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1040. Recordkeeping requirements; persons required to maintain
      records; scope of disclosure; access to records

-STATUTE-
      For the purpose of enforcing the provisions of this chapter and
    the regulations promulgated thereunder, all persons engaged in the
    business of transporting, shipping, or receiving any eggs or egg
    products in commerce or holding such articles so received, and all
    egg handlers, shall maintain such records showing, for such time
    and in such form and manner, as the Secretary of Agriculture or the
    Secretary of Health and Human Services may prescribe, to the extent
    that they are concerned therewith, the receipt, delivery, sale,
    movement, and disposition of all eggs and egg products handled by
    them, and shall, upon the request of a duly authorized
    representative of either of said Secretaries, permit him at
    reasonable times to have access to and to copy all such records.

-SOURCE-
    (Pub. L. 91-597, Sec. 11, Dec. 29, 1970, 84 Stat. 1627; Pub. L. 96-
    88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted in text for
    "Secretary of Health, Education, and Welfare" pursuant to section
    509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
    Title 20, Education.

-End-



-CITE-
    21 USC Sec. 1041                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1041. Enforcement provisions

-STATUTE-
    (a) Violations of section 1037; term of imprisonment and fine
      Any person who commits any offense prohibited by section 1037 of
    this title shall upon conviction be subject to imprisonment for not
    more than one year, or a fine of not more than $5,000, or both such
    imprisonment and fine, but if such violation involves intent to
    defraud, or any distribution or attempted distribution of any
    article that is known to be adulterated (except as defined in
    section 1033(a)(8) of this title), such person shall be subject to
    imprisonment for not more than three years or a fine of not more
    than $10,000, or both.
    (b) Persons preventing enforcement of chapter; term of imprisonment
      and fine
      Any person who forcibly assaults, resists, opposes, impedes,
    intimidates, or interferes with any person while engaged in or on
    account of the performance of his official duties under this
    chapter shall be fined not more than $5,000 or imprisoned not more
    than three years or both. Whoever, in the commission of any such
    act, uses a deadly or dangerous weapon, shall be fined not more
    than $10,000 or imprisoned not more than ten years, or both.
    Whoever kills any person while engaged in or on account of the
    performance of his official duties under this chapter shall be
    punished as provided under sections 1111 and 1112 of title 18.
    (c) Civil penalty
      (1)(A) Except as otherwise provided in this subsection, any
    person who violates any provision of this chapter or any regulation
    issued under this chapter, other than a violation for which a
    criminal penalty has been imposed under this chapter, may be
    assessed a civil penalty by the Secretary of not more than $5,000
    for each such violation. Each violation to which this subparagraph
    applies shall be considered a separate offense.
      (B) No penalty shall be assessed against any person under this
    subsection unless the person is given notice and opportunity for a
    hearing on the record before the Secretary in accordance with
    sections 554 and 556 of title 5.
      (C) The amount of the civil penalty imposed under this subsection
    - 
        (i) shall be assessed by the Secretary, by written order,
      taking into account the gravity of the violation, degree of
      culpability, and history of prior offenses; and
        (ii) may be reviewed only as provided in paragraph (2).

      (2)(A) The determination and order of the Secretary under this
    subsection shall be final and conclusive unless the person against
    whom such a violation is found under paragraph (1) files an
    application for judicial review within 30 days after service of the
    order in the United States court of appeals for the circuit in
    which the person has its principal place of business or in the
    United States Court of Appeals for the District of Columbia
    Circuit.
      (B) Judicial review of any such order shall be based on the
    record on which the determination and order are based.
      (C) If the court determines that additional evidence needs to be
    taken, the court shall order the hearing to be reopened for this
    purpose in such manner and on such terms and conditions as the
    court considers proper. The Secretary may modify the findings of
    the Secretary as to the facts, or make new findings, on the basis
    of the additional evidence so taken.
      (3) If any person fails to pay an assessment of a civil penalty
    after the penalty has become a final and unappealable order, or
    after the appropriate court of appeals has entered a final judgment
    in favor of the Secretary, the Secretary shall refer the matter to
    the Attorney General. The Attorney General shall institute a civil
    action to recover the amount assessed in an appropriate district
    court of the United States. In the collection action, the validity
    and appropriateness of the Secretary's order imposing the civil
    penalty shall not be subject to review.
      (4) All penalties collected under this subsection shall be paid
    into the Treasury of the United States.
      (5) The Secretary may compromise, modify, or remit, with or
    without conditions, any civil penalty assessed under this
    subsection.
      (6) Paragraph (1) shall not apply to an official plant.
    (d) Scope of liability for violations of section 1037
      When construing or enforcing the provisions of section 1037 of
    this title, the act, omission, or failure of any person acting for
    or employed by any individual, partnership, corporation, or
    association within the scope of his employment or office shall in
    every case be deemed the act, omission, or failure of such
    individual, partnership, corporation, or association, as well as of
    such person.
    (e) Penalties applicable to carriers or warehousemen
      No carrier or warehouseman shall be subject to the penalties of
    this chapter, other than the penalties for violation of section
    1040 of this title or subsection (c) of this section, by reason of
    his receipt, carriage, holding, or delivery, in the usual course of
    business, as a carrier or warehouseman of eggs or egg products
    owned by another person unless the carrier or warehouseman has
    knowledge, or is in possession of facts which would cause a
    reasonable person to believe that such eggs or egg products were
    not eligible for transportation under, or were otherwise in
    violation of, this chapter, or unless the carrier or warehouseman
    refuses to furnish on request of a representative of the Secretary
    the name and address of the person from whom he received such eggs
    or egg products and copies of all documents, if there be any,
    pertaining to the delivery of the eggs or egg products to, or by,
    such carrier or warehouseman.

-SOURCE-
    (Pub. L. 91-597, Sec. 12, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 102-
    237, title X, Sec. 1012(d), Dec. 13, 1991, 105 Stat. 1899.)


-MISC1-
                                AMENDMENTS                            
      1991 - Subsec. (a). Pub. L. 102-237, Sec. 1012(d)(1), (2),
    substituted "$5,000" for "$1,000" in first sentence, and
    redesignated last sentence, relating to scope of liability for
    violations of section 1037 of this title, as subsec. (d).
      Subsec. (b). Pub. L. 102-237, Sec. 1012(d)(4), redesignated
    subsec. (c) as (b). Former subsec. (b) redesignated (e).
      Subsec. (c). Pub. L. 102-237, Sec. 1012(d)(5), added subsec. (c).
    Former subsec. (c) redesignated (b).
      Subsec. (d). Pub. L. 102-237, Sec. 1012(d)(2), designated last
    sentence of subsec. (a), relating to scope of liability for
    violations of section 1037 of this title, as subsec. (d).
      Subsec. (e). Pub. L. 102-237, Sec. 1012(d)(3), redesignated
    subsec. (b) as (e).

                     EFFECTIVE DATE OF 1991 AMENDMENT                 
      Amendment by Pub. L. 102-237 effective 12 months after
    promulgation of final implementing regulations, see section 1012(h)
    of Pub. L. 102-237, set out as a note under section 1034 of this
    title.

-End-



-CITE-
    21 USC Sec. 1042                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1042. Reporting of violation to United States attorney for
      institution of criminal proceedings; procedure; presentation of
      views

-STATUTE-
      Before any violation of this chapter is reported by the Secretary
    of Agriculture or Secretary of Health and Human Services to any
    United States attorney for institution of a criminal proceeding,
    the person against whom such proceeding is contemplated shall be
    given reasonable notice of the alleged violation and opportunity to
    present his views orally or in writing with regard to such
    contemplated proceeding. Nothing in this chapter shall be construed
    as requiring the Secretary of Agriculture or Secretary of Health
    and Human Services to report for criminal prosecution violations of
    this chapter whenever he believes that the public interest will be
    adequately served and compliance with this chapter obtained by a
    suitable written notice of warning or an action to assess civil
    penalties.

-SOURCE-
    (Pub. L. 91-597, Sec. 13, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 96-
    88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
    237, title X, Sec. 1012(e), Dec. 13, 1991, 105 Stat. 1900.)


-MISC1-
                                AMENDMENTS                            
      1991 - Pub. L. 102-237 inserted "or an action to assess civil
    penalties" before period at end.

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted in text for
    "Secretary of Health, Education, and Welfare" pursuant to section
    509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
    Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1991 AMENDMENT                 
      Amendment by Pub. L. 102-237 effective 12 months after
    promulgation of final implementing regulations, see section 1012(h)
    of Pub. L. 102-237, set out as a note under section 1034 of this
    title.

-End-



-CITE-
    21 USC Sec. 1043                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1043. Rules and regulations; administration and enforcement

-STATUTE-
      The Secretary shall promulgate such rules and regulations as he
    deems necessary to carry out the purposes or provisions of this
    chapter, and shall be responsible for the administration and
    enforcement of this chapter except as otherwise provided in section
    1034(d) of this title.

-SOURCE-
    (Pub. L. 91-597, Sec. 14, Dec. 29, 1970, 84 Stat. 1629.)

-End-



-CITE-
    21 USC Sec. 1044                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1044. Exemption of certain activities

-STATUTE-
    (a) Regulation for exemptions
      The Secretary may, by regulation and under such conditions and
    procedures as he may prescribe, exempt from specific provisions of
    this chapter - 
        (1) the sale, transportation, possession, or use of eggs which
      contain no more restricted eggs than are allowed by the tolerance
      in the official standards of United States consumer grades for
      shell eggs;
        (2) the processing of egg products at any plant where the
      facilities and operating procedures meet such sanitary standards
      as may be prescribed by the Secretary, and where the eggs
      received or used in the manufacture of egg products contain no
      more restricted eggs than are allowed by the official standards
      of United States consumer grades for shell eggs, and the egg
      products processed at such plant;
        (3) the sale of eggs by any poultry producer from his own
      flocks directly to a household consumer exclusively for use by
      such consumer and members of his household and his nonpaying
      guests and employees, and the transportation, possession, and use
      of such eggs in accordance with this paragraph;
        (4) the processing of egg products by any poultry producer from
      eggs of his own flocks' production for sale of such products
      directly to a household consumer exclusively for use by such
      consumer and members of his household and his nonpaying guests
      and employees, and the egg products so processed when handled in
      accordance with this paragraph;
        (5) the sale of eggs by shell egg packers on his own premises
      directly to household consumers for use by such consumer and
      members of his household and his nonpaying guests and employees,
      and the transportation, possession, and use of such eggs in
      accordance with this paragraph;
        (6) for such period of time (not to exceed two years) during
      the initiation of operations under this chapter as the Secretary
      determines that it is impracticable to provide inspection, the
      processing of egg products at any class of plants and the egg
      products processed at such plants; and
        (7) the sale of eggs by any egg producer with an annual egg
      production from a flock of three thousand or less hens.
    (b) Plants located in noncontiguous areas of United States
      The Secretary shall, by regulation and under such procedures as
    he may prescribe, exempt any plant located within noncontiguous
    areas of the United States from specific provisions of this
    chapter, where, despite good faith efforts by the owner of such
    plant, such owner has not been able to bring his plant into full
    compliance with this chapter: Provided, That in order to provide at
    least minimum standards for the protection of the public health,
    whenever processing operations are being conducted at any such
    plant, continuous inspection shall be maintained to assure that it
    is operated in a sanitary manner. No exemption under this
    subsection shall be granted for a period extending beyond December
    31, 1971.
    (c) Suspension or termination of exemptions
      The Secretary may immediately suspend or terminate any exemption
    under subsection (a)(2) or (6) of this section at any time with
    respect to any person, if the conditions of exemption prescribed by
    this section or the regulations of the Secretary are not being met.
    The Secretary may modify or revoke any regulation granting
    exemption under this chapter whenever he deems such action
    appropriate to effectuate the purposes of this chapter.

-SOURCE-
    (Pub. L. 91-597, Sec. 15, Dec. 29, 1970, 84 Stat. 1629; Pub. L. 92-
    67, Aug. 6, 1971, 85 Stat. 173.)


-MISC1-
                                AMENDMENTS                            
      1971 - Subsecs. (b), (c). Pub. L. 92-67 added subsec. (b) and
    redesignated former subsec. (b) as (c).

-End-



-CITE-
    21 USC Sec. 1045                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1045. Limitation on entry of eggs and egg products and other
      materials into official plants

-STATUTE-
      The Secretary may limit the entry of eggs and egg products and
    other materials into official plants under such conditions as he
    may prescribe to assure that allowing the entry of such articles
    into such plants will be consistent with the purposes of this
    chapter.

-SOURCE-
    (Pub. L. 91-597, Sec. 16, Dec. 29, 1970, 84 Stat. 1630.)

-End-



-CITE-
    21 USC Sec. 1046                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1046. Imports

-STATUTE-
    (a) Authorization for importation of restricted eggs; prerequisites
      for importation of egg products; treatment as domestic articles
      subject to this chapter; marking and labeling exemption for
      personal consumption
      (1) No restricted eggs capable of use as human food shall be
    imported into the United States except as authorized by regulations
    of the Secretary.
      (2) No egg products capable of use as human food shall be
    imported into the United States unless they were processed under an
    approved continuous inspection system of the government of the
    foreign country of origin or subdivision thereof and are labeled
    and packaged in accordance with, and otherwise comply with the
    standards of this chapter and regulations issued thereunder
    applicable to such articles within the United States.
      (3) No eggs packed into a container that is destined for the
    ultimate consumer shall be imported into the United States unless
    the eggs are accompanied by a certification that the eggs have at
    all times after packaging been stored and transported under
    refrigeration at an ambient temperature of no greater than 45
    degrees Fahrenheit, as required by sections 1034(e) and 1037(c) of
    this title.
      (4) All such imported articles shall upon entry into the United
    States be deemed and treated as domestic articles subject to the
    other provisions of this chapter: Provided, That they shall be
    labeled as required by such regulations for imported articles:
    Provided further, That nothing in this section shall apply to eggs
    or egg products purchased outside the United States by any
    individual for consumption by him and members of his household and
    his nonpaying guests and employees.
    (b) Terms and conditions for destruction
      The Secretary may prescribe the terms and conditions for the
    destruction of all such articles which are imported contrary to
    this section, unless (1) they are exported by the consignee within
    the time fixed therefor by the Secretary or (2) in the case of
    articles which are not in compliance solely because of misbranding,
    such articles are brought into compliance with this chapter under
    supervision of authorized representatives of the Secretary.
    (c) Payment of storage, cartage, and labor charges by owner or
      consignee; liens
      All charges for storage, cartage, and labor with respect to any
    article which is imported contrary to this section shall be paid by
    the owner or consignee, and in default of such payment shall
    constitute a lien against such article and any other article
    thereafter imported under this chapter by or for such owner or
    consignee.
    (d) Prohibition
      The importation of any article contrary to this section is
    prohibited.

-SOURCE-
    (Pub. L. 91-597, Sec. 17, Dec. 29, 1970, 84 Stat. 1630; Pub. L. 102-
    237, title X, Sec. 1012(f), Dec. 13, 1991, 105 Stat. 1901.)


-MISC1-
                                AMENDMENTS                            
      1991 - Subsec. (a). Pub. L. 102-237 designated first sentence as
    par. (1) and second sentence as par. (2), added par. (3), and
    designated third sentence as par. (4).

                     EFFECTIVE DATE OF 1991 AMENDMENT                 
      Amendment by Pub. L. 102-237 effective 12 months after
    promulgation of final implementing regulations, see section 1012(h)
    of Pub. L. 102-237, set out as a note under section 1034 of this
    title.

-End-



-CITE-
    21 USC Sec. 1047                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1047. Refusal or withdrawal of inspection services; hearing;
      grounds; person deemed to have responsible connection with
      business; finality of order of Secretary; judicial review; other
      provisions for refusal of services unaffected

-STATUTE-
      The Secretary (for such period, or indefinitely, as he deems
    necessary to effectuate the purposes of this chapter) may refuse to
    provide or may withdraw inspection service under this chapter with
    respect to any plant if he determines, after opportunity for a
    hearing is accorded to the applicant for, or recipient of, such
    service, that such applicant or recipient is unfit to engage in any
    business requiring inspection under this chapter because the
    applicant or recipient or anyone responsibly connected with the
    applicant or recipient has been convicted in any Federal or State
    court, within the previous ten years, of (1) any felony or more
    than one misdemeanor under any law based upon the acquiring,
    handling, or distributing of adulterated, mislabeled, or
    deceptively packaged food or fraud in connection with transactions
    in food, or (2) any felony, involving fraud, bribery, extortion, or
    any other act or circumstances indicating a lack of the integrity
    needed for the conduct of operations affecting the public health.
      For the purpose of this section, a person shall be deemed to be
    responsibly connected with the business if he is a partner,
    officer, director, holder, or owner of 10 per centum or more of its
    voting stock, or employee in a managerial or executive capacity.
      The determination and order of the Secretary with respect thereto
    under this section shall be final and conclusive unless the
    affected applicant for, or recipient of, inspection service files
    application for judicial review within thirty days after the
    effective date of such order in the United States court of appeals
    for the circuit in which such applicant or recipient has its
    principal place of business or in the United States Court of
    Appeals for the District of Columbia Circuit. Judicial review of
    any such order shall be upon the record upon which the
    determination and order are based. The provisions of section 194 of
    title 7 shall be applicable to appeals taken under this section.
      This section shall not affect in any way other provisions of this
    chapter for refusal of inspection services.

-SOURCE-
    (Pub. L. 91-597, Sec. 18, Dec. 29, 1970, 84 Stat. 1630.)

-End-



-CITE-
    21 USC Sec. 1048                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1048. Administrative detention of violative articles;
      duration; release; removal of official marks

-STATUTE-
      Whenever any eggs or egg products subject to this chapter, are
    found by any authorized representative of the Secretary upon any
    premises and there is reason to believe that they are or have been
    processed, bought, sold, possessed, used, transported, or offered
    or received for sale or transportation in violation of this chapter
    or that they are in any other way in violation of this chapter, or
    whenever any restricted eggs capable of use as human food are found
    by such a representative in the possession of any person not
    authorized to acquire such eggs under the regulations of the
    Secretary, such articles may be detained by such representative for
    a reasonable period but not to exceed twenty days, pending action
    under section 1049 of this title or notification of any Federal,
    State, or other governmental authorities having jurisdiction over
    such articles and shall not be moved by any person from the place
    at which they are located when so detained until released by such
    representative. All official marks may be required by such
    representative to be removed from such articles before they are
    released unless it appears to the satisfaction of the Secretary
    that the articles are eligible to retain such marks.

-SOURCE-
    (Pub. L. 91-597, Sec. 19, Dec. 29, 1970, 84 Stat. 1631.)

-End-



-CITE-
    21 USC Sec. 1049                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1049. Seizure and condemnation proceedings

-STATUTE-
    (a) Jurisdiction; disposal of condemned articles; court costs and
      fees; conformity to supplemental rules for admiralty and maritime
      claims; jury trial; United States as plaintiff
      Any eggs or egg products that are or have been processed, bought,
    sold, possessed, used, transported, or offered or received for sale
    or transportation, in violation of this chapter, or in any other
    way are in violation of this chapter; and any restricted eggs,
    capable of use as human food, in the possession of any person not
    authorized to acquire such eggs under the regulations of the
    Secretary shall be liable to be proceeded against and seized and
    condemned, at any time, on a complaint in any United States
    district court or other proper court as provided in section 1050 of
    this title within the jurisdiction of which the articles are found.
    If the articles are condemned they shall, after entry of the
    decree, be disposed of by destruction or sale as the court may
    direct and the proceeds, if sold, less the court costs and fees,
    and storage and other proper expenses, shall be paid into the
    Treasury of the United States, but the articles shall not be sold
    contrary to the provision of this chapter, the Federal Food, Drug,
    and Cosmetic Act [21 U.S.C. 301 et seq.] or the Fair Packaging and
    Labeling Act [15 U.S.C. 1451 et seq.], or the laws of the
    jurisdiction in which they are sold: Provided, That upon the
    execution and delivery of a good and sufficient bond conditioned
    that the articles shall not be sold or otherwise disposed of
    contrary to the provisions of this chapter, the Federal Food, Drug,
    and Cosmetic Act, the Fair Packaging and Labeling Act, or the laws
    of the jurisdiction in which disposal is made, the court may direct
    that they be delivered to the owner thereof subject to such
    supervision by authorized representatives of the Secretary as is
    necessary to insure compliance with the applicable laws. When a
    decree of condemnation is entered against the articles and they are
    released under bond, or destroyed, court costs and fees, and
    storage and other proper expenses shall be awarded against the
    person, if any, intervening as claimant thereof. The proceedings in
    such cases shall conform, as nearly as may be, to the supplemental
    rules for certain admiralty and maritime claims, except that either
    party may demand trial by jury of any issue of fact joined in any
    case, and all such proceedings shall be at the suit of and in the
    name of the United States.
    (b) Condemnation or seizure under other provisions unaffected
      The provisions of this section shall in no way derogate from
    authority for condemnation or seizure conferred by other provisions
    of this chapter, or other laws.

-SOURCE-
    (Pub. L. 91-597, Sec. 20, Dec. 29, 1970, 84 Stat. 1631.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.
      The Fair Packaging and Labeling Act, referred to in subsec. (a),
    is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
    is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
    15, Commerce and Trade. For complete classification of this Act to
    the Code, see Short Title note set out under section 1451 of Title
    15 and Tables.

-End-



-CITE-
    21 USC Sec. 1050                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1050. Jurisdiction of district courts; United States as
      plaintiff in enforcement and restraining proceedings; subpenas
      for witnesses

-STATUTE-
      The United States district courts and the District Court of the
    Virgin Islands are vested with jurisdiction specifically to
    enforce, and to prevent and restrain violations of, this chapter,
    and shall have jurisdiction in all other cases, arising under this
    chapter, except as provided in section 1047 of this title. All
    proceedings for the enforcement or to restrain violations of this
    chapter shall be by and in the name of the United States. Subpenas
    for witnesses who are required to attend a court of the United
    States, in any district, may run into any other district in any
    such proceeding.

-SOURCE-
    (Pub. L. 91-597, Sec. 21, Dec. 29, 1970, 84 Stat. 1632.)

-End-



-CITE-
    21 USC Sec. 1051                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1051. Other Federal laws applicable for administration and
      enforcement of chapter; prosecution of inquiries; exercise of
      jurisdiction

-STATUTE-
      For the efficient administration and enforcement of this chapter,
    the provisions (including penalties) of sections 46, 48, 49, and 50
    of title 15 (except paragraphs (c) through (h) of section 46 and
    the last paragraph of section 49 (!1) of title 15), and the
    provisions of section 409(l) (!1) of title 47, are made applicable
    to the jurisdiction, powers, and duties of the Secretary in
    administering and enforcing the provisions of this chapter and to
    any person with respect to whom such authority is exercised. The
    Secretary, in person or by such agents as he may designate, may
    prosecute any inquiry necessary to his duties under this chapter in
    any part of the United States, and the powers conferred by said
    sections 49 and 50 of title 15, on the district courts of the
    United States may be exercised for the purposes of this chapter by
    any court designated in section 1050 of this title.


-SOURCE-
    (Pub. L. 91-597, Sec. 22, Dec. 29, 1970, 84 Stat. 1632.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The last paragraph of section 49 of title 15, and the provisions
    of section 409(l) of title 47, referred to in text, which related
    to immunity of witnesses, were repealed by sections 211 and 242,
    respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
    929, 930. For provisions relating to immunity of witnesses, see
    section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 1052                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1052. State or local regulation

-STATUTE-
    (a) Prohibition against additional or different requirements than
      Federal requirements relating to premises, facilities, and
      operations at official plants; authority to impose recordkeeping
      and related requirements consistent with Federal requirements
      Requirements within the scope of this chapter with respect to
    premises, facilities, and operations of any official plant which
    are in addition to or different than those made under this chapter
    may not be imposed by any State or local jurisdiction except that
    any such jurisdiction may impose recordkeeping and other
    requirements within the scope of section 1040 of this title, if
    consistent therewith, with respect to any such plant.
    (b) Prohibition against additional or different standards than
      Federal standards of quality, etc., or requiring labeling to show
      area of production or origin; authority to require name, address,
      and license number of processor or packer on containers;
      prohibition against additional or different requirements than
      Federal requirements relating to labeling, packaging or
      ingredients; authority to prevent distribution of violative
      articles; validity of nonconflicting laws
      For eggs which have moved or are moving in interstate or foreign
    commerce, (1) no State or local jurisdiction may require the use of
    standards of quality, condition, weight, quantity, or grade which
    are in addition to or different from the official Federal
    standards, (2) with respect to egg handlers specified in paragraphs
    (1) and (2) of section 1034(e) of this title, no State or local
    jurisdiction may impose temperature requirements pertaining to eggs
    packaged for the ultimate consumer which are in addition to, or
    different from, Federal requirements, and (3) no State or local
    jurisdiction other than those in noncontiguous areas of the United
    States may require labeling to show the State or other geographical
    area of production or origin: Provided, however, That this shall
    not preclude a State from requiring that the name, address, and
    license number of the person processing or packaging eggs, be shown
    on each container. Labeling, packaging, or ingredient requirements,
    in addition to or different than those made under this chapter, the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and
    the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.], may
    not be imposed by any State or local jurisdiction, with respect to
    egg products processed at any official plant in accordance with the
    requirements under this chapter and such Acts. However, any State
    or local jurisdiction may exercise jurisdiction with respect to
    eggs and egg products for the purpose of preventing the
    distribution for human food purposes of any such articles which are
    outside of such a plant and are in violation of any of said Federal
    Acts or any State or local law consistent therewith. Otherwise the
    provisions of this chapter shall not invalidate any law or other
    provisions of any State or other jurisdiction in the absence of a
    conflict with this chapter.
    (c) Applicability of other Federal laws and authority of other
      Federal officials relating to eggs, egg products, or other food
      products unaffected; authority of Secretary of Agriculture to
      regulate official plants processing egg products
      The provisions of this chapter shall not affect the applicability
    of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
    or the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.] or
    other Federal laws to eggs, egg products, or other food products or
    diminish any authority conferred on the Secretary of Health and
    Human Services or other Federal officials by such other laws,
    except that the Secretary of Agriculture shall have exclusive
    jurisdiction to regulate official plants processing egg products
    and operations thereof as to all matters within the scope of this
    chapter.
    (d) Detainer authority
      The detainer authority conferred on representatives of the
    Secretary of Agriculture by section 1048 of this title shall also
    apply to any authorized representative of the Secretary of Health
    and Human Services for the purposes of section 1034(d) of this
    title, with respect to any eggs or egg products that are outside
    any plant processing egg products.

-SOURCE-
    (Pub. L. 91-597, Sec. 23, Dec. 29, 1970, 84 Stat. 1632; Pub. L. 96-
    88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
    237, title X, Sec. 1012(g), Dec. 13, 1991, 105 Stat. 1901.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (b) and (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.
      The Fair Packaging and Labeling Act, referred to in subsecs. (b)
    and (c), is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as
    amended, which is classified generally to chapter 39 (Sec. 1451 et
    seq.) of Title 15, Commerce and Trade. For complete classification
    of this Act to the Code, see Short Title note set out under section
    1451 of Title 15 and Tables.


-MISC1-
                                AMENDMENTS                            
      1991 - Subsec. (b). Pub. L. 102-237 substituted "(2) with respect
    to egg handlers specified in paragraphs (1) and (2) of section
    1034(e) of this title, no State or local jurisdiction may impose
    temperature requirements pertaining to eggs packaged for the
    ultimate consumer which are in addition to, or different from,
    Federal requirements, and (3)" for "and (2)".

-CHANGE-
                              CHANGE OF NAME                          
      "Secretary of Health and Human Services" substituted for
    "Secretary of Health, Education, and Welfare" in subsecs. (c) and
    (d) pursuant to section 509(b) of Pub. L. 96-88, which is
    classified to section 3508(b) of Title 20, Education.


-MISC2-
                     EFFECTIVE DATE OF 1991 AMENDMENT                 
      Amendment by Pub. L. 102-237 effective 12 months after
    promulgation of final implementing regulations, see section 1012(h)
    of Pub. L. 102-237, set out as a note under section 1034 of this
    title.

-End-



-CITE-
    21 USC Sec. 1053                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1053. Inspection and administration costs

-STATUTE-
    (a) Overtime and holiday work costs; availability of funds
      The cost of inspection rendered under the requirements of this
    chapter, and other costs of administration of this chapter, shall
    be borne by the United States, except that the cost of overtime and
    holiday work performed in official plants subject to the provisions
    of this chapter at such rates as the Secretary may determine shall
    be borne by such official plants. Sums received by the Secretary
    from official plants under this section shall be available without
    fiscal year limitation to carry out the purposes of this chapter.
    (b) "Holiday" defined
      The term "holiday" for the purposes of assessment or
    reimbursement of the cost of inspection performed under this
    chapter, the Wholesome Poultry Products Act [21 U.S.C. 467a et
    seq.] and the Wholesome Meat Act [21 U.S.C. 601 et seq.] shall mean
    the legal public holidays specified by the Congress in section
    6103(a) of title 5.

-SOURCE-
    (Pub. L. 91-597, Sec. 24, Dec. 29, 1970, 84 Stat. 1633.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Wholesome Poultry Products Act, referred to in subsec. (b),
    is Pub. L. 90-492, Aug. 18, 1968, 82 Stat. 791, as amended, which
    enacted sections 467a to 467f and 470 of this title, amended
    sections 451 to 461, 463 to 465, and 467 of this title, and enacted
    provisions set out as notes under section 451 of this title. For
    complete classification of this Act to the Code, see Short Title of
    1968 Amendment note set out under section 451 of this title and
    Tables.
      The Wholesome Meat Act, referred to in subsec. (b), is Pub. L. 90-
    201, Dec. 15, 1967, 81 Stat. 584, as amended, which enacted
    sections 601, 602, 624, 641 to 645, 661, 671 to 680, and 691 of
    this title, amended sections 603 to 623 of this title, repealed
    section 96 of this title and section 1306(b) of Title 19, Customs
    Duties, and enacted provisions set out as notes under section 601
    of this title. For complete classification of this Act to the Code,
    see Short Title note set out under section 601 of this title and
    Tables.

-End-



-CITE-
    21 USC Sec. 1054                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1054. Annual report to Congressional committees

-STATUTE-
      (a) (!1) Not later than March 1 of each year following December
    29, 1970, the Secretary shall submit to the Committee on
    Agriculture of the House of Representatives and the Committee on
    Agriculture, Nutrition, and Forestry of the Senate a comprehensive
    and detailed written report with respect to - 

        (1) the processing, storage, handling, and distribution of eggs
      and egg products subject to the provisions of this chapter; the
      inspection of establishments operated in connection therewith;
      the effectiveness of the operation of the inspection, including
      the effectiveness of the operations of State egg inspection
      programs; and recommendations for legislation to improve such
      program; and
        (2) the administration of section 1046 of this title (relating
      to imports) during the immediately preceding calendar year,
      including but not limited to - 
          (A) a certification by the Secretary that foreign plants
        exporting eggs or egg products to the United States have
        complied with requirements of this chapter and regulations
        issued thereunder;
          (B) the names and locations of plants authorized or permitted
        to export eggs or egg products to the United States;
          (C) the number of inspectors employed by the Department of
        Agriculture in the calendar year concerned who were assigned to
        inspect plants referred to in paragraph (B) hereof and the
        frequency with which each such plant was inspected by such
        inspectors;
          (D) the number of inspectors that were licensed by each
        country from which any imports were received and that were
        assigned, during the calendar year concerned, to inspect such
        imports and the facilities in which such imports were handled;
        and the frequency and effectiveness of such inspections;
          (E) the total volume of eggs and egg products which was
        imported into the United States during the calendar year
        concerned from each country, including a separate itemization
        of the volume of each major category of such imports from each
        country during such year, and a detailed report of rejections
        of plants and products because of failure to meet appropriate
        standards prescribed by this chapter; and
          (F) recommendations for legislation to improve such program.

-SOURCE-
    (Pub. L. 91-597, Sec. 26, Dec. 29, 1970, 84 Stat. 1634; Pub. L. 103-
    437, Sec. 8(4), Nov. 2, 1994, 108 Stat. 4588.)


-MISC1-
                                AMENDMENTS                            
      1994 - Pub. L. 103-437 substituted "Agriculture, Nutrition, and
    Forestry" for "Agriculture and Forestry" in introductory
    provisions.

-FOOTNOTE-
    (!1) So in original. No subsec. (b) has been enacted.


-End-



-CITE-
    21 USC Sec. 1055                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1055. Authorization of appropriations

-STATUTE-
      Such sums as are necessary to carry out the provisions of this
    chapter are hereby authorized to be appropriated.

-SOURCE-
    (Pub. L. 91-597, Sec. 27, Dec. 29, 1970, 84 Stat. 1635.)

-End-



-CITE-
    21 USC Sec. 1056                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 15 - EGG PRODUCTS INSPECTION

-HEAD-
    Sec. 1056. Separability

-STATUTE-
      If any provision of this chapter or the application thereof to
    any person or circumstances is held invalid, the validity of the
    remainder of the chapter and of the application of such provision
    to other persons and circumstances shall not be affected thereby.

-SOURCE-
    (Pub. L. 91-597, Sec. 28, Dec. 29, 1970, 84 Stat. 1635.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    Act", meaning Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
    amended, which enacted this chapter, amended sections 633 and 636
    of Title 15, Commerce and Trade, and enacted provisions set out as
    notes under section 1031 of this title. For complete classification
    of this Act to the Code, see Short Title note set out under section
    1031 of this title and Tables.

-End-


-CITE-
    21 USC CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND
           REHABILITATION                                  01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION

-HEAD-
     CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION 


-MISC1-
                     SUBCHAPTER I - GENERAL PROVISIONS                 
    Sec.                                                     
    1101.       Congressional findings.                               
    1102.       Congressional declaration of national policy.         
    1103, 1104. Repealed.                                             

              SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION          
    1111 to 1114. Repealed.                                           
    1115.       Notice relating to the control of dangerous drugs.    
    1116 to 1155. Repealed or Omitted.                                

               SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY           
    1161 to 1165. Repealed.                                           

                  SUBCHAPTER IV - OTHER FEDERAL PROGRAMS              
    1171.       Drug abuse prevention function appropriations.        
    1172 to 1176. Repealed, Transferred, or Omitted.                  
    1177.       Special project grants and contracts.                 
    1178.       Records and audit.                                    
    1179.       National Drug Abuse Training Center.                  
    1180.       Transferred.                                          
    1181.       Contract authority.                                   

              SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE          
    1191 to 1194. Transferred or Repealed.                            

-End-


-CITE-
    21 USC SUBCHAPTER I - GENERAL PROVISIONS                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER I - GENERAL PROVISIONS

-HEAD-
                     SUBCHAPTER I - GENERAL PROVISIONS                 

-End-



-CITE-
    21 USC Sec. 1101                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER I - GENERAL PROVISIONS

-HEAD-
    Sec. 1101. Congressional findings

-STATUTE-
      The Congress makes the following findings:
        (1) Drug abuse is rapidly increasing in the United States and
      now afflicts urban, suburban, and rural areas of the Nation.
        (2) Drug abuse seriously impairs individual, as well as
      societal, health and well-being.
        (3) Drug abuse, especially heroin addiction, substantially
      contributes to crime.
        (4) The adverse impact of drug abuse inflicts increasing pain
      and hardship on individuals, families, and communities and
      undermines our institutions.
        (5) Too little is known about drug abuse, especially the
      causes, and ways to treat and prevent drug abuse.
        (6) The success of Federal drug abuse programs and activities
      requires a recognition that education, treatment, rehabilitation,
      research, training, and law enforcement efforts are interrelated.
        (7) The effectiveness of efforts by State and local governments
      and by the Federal Government to control and treat drug abuse in
      the United States has been hampered by a lack of coordination
      among the States, between States and localities, among the
      Federal Government, States and localities, and throughout the
      Federal establishment.
        (8) Control of drug abuse requires the development of a
      comprehensive, coordinated long-term Federal strategy that
      encompasses both effective law enforcement against illegal drug
      traffic and effective health programs to rehabilitate victims of
      drug abuse.
        (9) The increasing rate of drug abuse constitutes a serious and
      continuing threat to national health and welfare, requiring an
      immediate and effective response on the part of the Federal
      Government.
        (10) Although the Congress observed a significant apparent
      reduction in the rate of increase of drug abuse during the three-
      year period subsequent to March 21, 1972, and in certain areas
      of the country apparent temporary reductions in its incidence,
      the increase and spread of heroin consumption since 1974, and the
      continuing abuse of other dangerous drugs, clearly indicate the
      need for effective, ongoing, and highly visible Federal
      leadership in the formation and execution of a comprehensive,
      coordinated drug abuse policy.
        (11) Shifts in the usage of various drugs and in the Nation's
      demographic composition require a Federal strategy to adjust the
      focus of drug abuse programs to meet new needs and priorities on
      a cost-effective basis.
        (12) The growing extent of drug abuse indicates an urgent need
      for prevention and intervention programs designed to reach the
      general population and members of high risk populations such as
      youth, women, and the elderly.
        (13) Effective control of drug abuse requires high-level
      coordination of Federal international and domestic activities
      relating to both supply of, and demand for, commonly abused
      drugs.
        (14) Local governments with high concentrations of drug abuse
      should be actively involved in the planning and coordination of
      efforts to combat drug abuse.

-SOURCE-
    (Pub. L. 92-255, title I, Sec. 101, Mar. 21, 1972, 86 Stat. 66;
    Pub. L. 94-237, Sec. 1, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96-
    181, Sec. 2, Jan. 2, 1980, 93 Stat. 1309.)


-MISC1-
                                AMENDMENTS                            
      1980 - Pars. (11) to (14). Pub. L. 96-181 added pars. (11) to
    (14).
      1976 - Par. (10). Pub. L. 94-237 added par. (10).

                       SHORT TITLE OF 1980 AMENDMENT                   
      Section 1(a) of Pub. L. 96-181 provided that: "This Act [enacting
    sections 1111 to 1117 and 1181 of this title, amending this
    section, sections 1102, 1162, 1164, 1176, 1177, 1180, and 1191 to
    1193 of this title, and sections 218, 300l-2, 300m-3, and 3733 of
    Title 42, The Public Health and Welfare, omitting sections 1118 to
    1120 and 1131 to 1133 of this title, enacting provisions set out as
    notes under this section and section 1193 of this title, and
    amending provisions set out as a note below] may be cited as the
    'Drug Abuse Prevention, Treatment, and Rehabilitation Amendments of
    1979'."

                       SHORT TITLE OF 1978 AMENDMENT                   
      Pub. L. 95-461, Sec. 1, Oct. 14, 1978, 92 Stat. 1268, provided
    that: "This Act [enacting section 1194 of this title, amending
    sections 1172, 1176, 1177, 1192, and 1193 of this title, enacting a
    provision set out as a note under section 1172 of this title and
    amending a provision set out as a note under section 242 of Title
    42, The Public Health and Welfare] may be cited as the 'Drug Abuse
    Prevention and Treatment Amendments of 1978'. "

                                SHORT TITLE                            
      Section 1 of Pub. L. 92-255, as amended by Pub. L. 96-181, Sec.
    15(a), Jan. 2, 1980, 93 Stat. 1316, provided that: "This Act
    [enacting this chapter, and amending sections 5313, 5315, and 5316
    of Title 5, Government Organization and Employees, and sections
    218, 246, 257, 2684, 2688a, 2688k, 2688n-1, and 2688t of Title 42,
    The Public Health and Welfare] may be cited as the 'Drug Abuse
    Prevention, Treatment, and Rehabilitation Act'."

         REFERENCES TO DRUG ABUSE OFFICE AND TREATMENT ACT OF 1972     
      Section 15(b) of Pub. L. 96-181 provided in part that: "Whenever
    reference is made in any other Federal law, regulation, ruling, or
    order to the Drug Abuse Office and Treatment Act of 1972, the
    reference shall be considered to be made to the Drug Abuse
    Prevention, Treatment, and Rehabilitation Act."

-End-



-CITE-
    21 USC Sec. 1102                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER I - GENERAL PROVISIONS

-HEAD-
    Sec. 1102. Congressional declaration of national policy

-STATUTE-
      The Congress declares that it is the policy of the United States
    and the purpose of this chapter to focus the comprehensive
    resources of the Federal Government and bring them to bear on drug
    abuse with the objective of significantly reducing the incidence,
    as well as the social and personal costs, of drug abuse in the
    United States, and to develop and assure the implementation of a
    comprehensive, coordinated long-term Federal strategy to combat
    drug abuse. To reach these goals, the Congress further declares
    that it is the policy of the United States and the purpose of this
    chapter to meet the problems of drug abuse through - 
        (1) comprehensive Federal, State, and local planning for, and
      effective use of, Federal assistance to States and to community-
      based programs to meet the urgent needs of special populations,
      in coordination with all other governmental and nongovernmental
      sources of assistance;
        (2) the development and support of community-based prevention
      programs;
        (3) the development and encouragement of effective occupational
      prevention and treatment programs within the Government and in
      cooperation with the private sector; and
        (4) increased Federal commitment to research into the
      behavioral and biomedical etiology of, the treatment of, and the
      mental and physical health and social and economic consequences
      of, drug abuse.

-SOURCE-
    (Pub. L. 92-255, title I, Sec. 102, Mar. 21, 1972, 86 Stat. 66;
    Pub. L. 94-237, Sec. 2, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96-
    181, Sec. 3, Jan. 2, 1980, 93 Stat. 1309.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    Act", meaning Pub. L. 92-255, Mar. 21, 1972, 86 Stat. 65, as
    amended, known as the Drug Abuse Prevention, Treatment, and
    Rehabilitation Act, which comprises this chapter. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 1101 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      1980 - Pub. L. 96-181 inserted additional declarations of policy
    prescribing methods and programs by which the goals are to be
    reached.
      1976 - Pub. L. 94-237 substituted "objective of significantly
    reducing the incidence, as well as the social and personal costs,
    of drug abuse in the United States, and to develop and assure the
    implementation of" for "immediate objective of significantly
    reducing the incidence of drug abuse in the United States within
    the shortest possible period of time, and to develop".

-End-



-CITE-
    21 USC Sec. 1103                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER I - GENERAL PROVISIONS

-HEAD-
    Sec. 1103. Repealed.

-MISC1-
    Sec. 1103. Repealed. Pub. L. 100-690, title I, Sec. 1007(c)(1),
      Nov. 18, 1988, 102 Stat. 4187.
      Section, Pub. L. 92-255, title I, Sec. 103, Mar. 21, 1972, 86
    Stat. 67; Pub. L. 94-237, Secs. 3, 4(a), Mar. 19, 1976, 90 Stat.
    241, defined "drug abuse prevention function", "drug traffic
    prevention function", and "drug abuse function".

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100-
    690.

-End-



-CITE-
    21 USC Sec. 1104                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER I - GENERAL PROVISIONS

-HEAD-
    Sec. 1104. Repealed.

-MISC1-
    Sec. 1104. Repealed. Pub. L. 94-237, Sec. 4(c)(1), Mar. 19, 1976,
      90 Stat. 244.
      Section, Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86
    Stat. 67, provided, effective June 30, 1975, that the Special
    Action Office for Drug Abuse Prevention, each of the positions in
    the Office of Director, Deputy Director, and Assistant Director,
    and the National Advisory Council for Drug Abuse Prevention were
    abolished and former subchapter II of this chapter was repealed.

-End-


-CITE-
    21 USC SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
              SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION          

-End-



-CITE-
    21 USC Secs. 1111 to 1114                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Secs. 1111 to 1114. Repealed.

-MISC1-
    Secs. 1111 to 1114. Repealed. Pub. L. 100-690, title I, Sec.
      1007(c)(1), Nov. 18, 1988, 102 Stat. 4187.
      Section 1111, Pub. L. 92-255, title II, Sec. 201, as added Pub.
    L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98-
    473, title II, Sec. 1306, Oct. 12, 1984, 98 Stat. 2170, related to
    concentration of Federal effort in drug abuse prevention.
      A prior section 1111, Pub. L. 92-255, title II, Sec. 201, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
    provided for the establishment of the Office of Drug Abuse Policy,
    was omitted in the general revision of this subchapter by Pub. L.
    96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309. Previously, the Office
    of Drug Abuse Policy was abolished and the functions of the Office
    and its Director were transferred to the President by sections 3
    and 5 of Reorg. Plan No. 1 of 1977, effective Mar. 27, 1978, as
    provided by Ex. Ord. No. 12045, Mar. 27, 1978, 43 F.R. 13347, set
    out as notes preceding section 101 of Title 3, The President.
      Another prior section 1111, Pub. L. 92-255, title II, Sec. 201,
    Mar. 21, 1972, 86 Stat. 67, which provided for the establishment of
    the Special Action Office for Drug Abuse Prevention, was repealed
    by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67,
    eff. June 30, 1975.
      Section 1112, Pub. L. 92-255, title II, Sec. 202, as added Pub.
    L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310, related to
    designation of a representative to direct activities required by
    this subchapter.
      A prior section 1112, Pub. L. 92-255, title II, Sec. 202, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242;
    amended Pub. L. 95-83, title III, Sec. 311(d), Aug. 1, 1977, 91
    Stat. 398, which provided for the appointment of the Director of
    the Office of Drug Abuse Policy, was omitted in the general
    revision of this subchapter by Pub. L. 96-181, Sec. 4, Jan. 2,
    1980, 93 Stat. 1309.
      Another prior section 1112, Pub. L. 92-255, title II, Sec. 202,
    Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a
    Director of the Special Action Office for Drug Abuse Prevention,
    was repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972,
    86 Stat. 67, eff. June 30, 1975.
      Section 1113, Pub. L. 92-255, title II, Sec. 203, as added Pub.
    L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310, related to
    employment of officers and employees.
      A prior section 1113, Pub. L. 92-255, title II, Sec. 203, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
    provided for the appointment and functions of Deputy Director of
    the Office of Drug Abuse Policy, was omitted in the general
    revision of this subchapter by Pub. L. 96-181, Sec. 4, Jan. 2,
    1980, 93 Stat. 1309.
      Another prior section 1113, Pub. L. 92-255, title II, Sec. 203,
    Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a
    Deputy Director of the Special Office for Drug Abuse Prevention,
    was repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972,
    86 Stat. 67, eff. June 30, 1975.
      Section 1114, Pub. L. 92-255, title II, Sec. 204, as added Pub.
    L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310, related to
    acceptance of uncompensated services.
      A prior section 1114, Pub. L. 92-255, title II, Sec. 204, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
    provided for the delegation of functions by the Director of the
    Office of Drug Abuse Policy, was omitted in the general revision of
    this subchapter by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat.
    1309.
      Another prior section 1114, Pub. L. 92-255, title II, Sec. 204,
    Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of
    six Assistant Directors, was repealed by Pub. L. 92-255, title I,
    Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
      Provisions similar to this section were contained in section 1117
    of this title prior to the general revision of this subchapter by
    Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100-
    690.


-EXEC-
                         EXECUTIVE ORDER NO. 12368                     
      Ex. Ord. No. 12368, June 24, 1982, 47 F.R. 27843, as amended by
    Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, related to
    assignment of drug abuse policy functions.

-End-



-CITE-
    21 USC Sec. 1115                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Sec. 1115. Notice relating to the control of dangerous drugs

-STATUTE-
      Whenever the Attorney General determines that there is evidence
    that - 
        (1) a drug or other substance, which is not a controlled
      substance (as defined in section 802(6) of this title), has a
      potential for abuse, or
        (2) a controlled substance should be transferred or removed
      from a schedule under section 812 of this title,

    he shall, prior to initiating any proceeding under section 811(a)
    of this title, give the President timely notice of such
    determination. Information forwarded to the Attorney General
    pursuant to section 811(f) of this title shall also be forwarded by
    the Secretary of Health and Human Services to the President.

-SOURCE-
    (Pub. L. 92-255, title II, Sec. 201, formerly Sec. 205, as added
    Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1311; amended Pub.
    L. 97-35, title IX, Sec. 973(a), Aug. 13, 1981, 95 Stat. 598;
    renumbered Sec. 201, Pub. L. 100-690, title I, Sec. 1007(c)(1),
    Nov. 18, 1988, 102 Stat. 4187.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 201 of Pub. L. 92-255, title II, as added Pub. L.
    96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98-
    473, title II, Sec. 1306, Oct. 12, 1984, 98 Stat. 2170, related to
    concentration of Federal effort in drug abuse prevention, prior to
    repeal by Pub. L. 100-690, title I, Sec. 1007(c)(1), Nov. 18, 1988,
    102 Stat. 4187.
      A prior section 1115, Pub. L. 92-255, title II, Sec. 205, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
    provided for employment, functions, and travel expenses of
    employees, was omitted in the general revision of this subchapter
    by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
      Another prior section 1115, Pub. L. 92-255, title II, Sec. 205,
    Mar. 21, 1972, 86 Stat. 68, provided for the delegation of
    functions by the Director, prior to repeal by Pub. L. 92-255, title
    I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
      Provisions similar to this section were contained in section 1118
    of this title prior to the general revision of this subchapter by
    Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.

                                AMENDMENTS                            
      1981 - Pub. L. 97-35 substituted "Health and Human Services" for
    "Health, Education, and Welfare".

-End-



-CITE-
    21 USC Sec. 1116                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Sec. 1116. Repealed.

-MISC1-
    Sec. 1116. Repealed. Pub. L. 100-690, title I, Sec. 1007(c)(1),
      Nov. 18, 1988, 102 Stat. 4187.
      Section, Pub. L. 92-255, title II, Sec. 206, as added Pub. L. 96-
    181, Sec. 4, Jan. 2, 1980, 93 Stat. 1311, provided that this
    subchapter not be construed as limiting the statutory authority of
    the Secretary of Defense or the Administrator of Veterans' Affairs.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100-
    690.
      A prior section 1116, Pub. L. 92-255, title II, Sec. 206, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
    provided for the employment and compensation of experts and
    consultants, was omitted in the general revision of this subchapter
    by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
      Another prior section 1116, Pub. L. 92-255, title II, Sec. 206,
    Mar. 21, 1972, 86 Stat. 68, which provided for the employment and
    prescription of functions for officers and employees by the
    Director, was repealed by Pub. L. 92-255, title I, Sec. 104, Mar.
    21, 1972, 86 Stat. 67, eff. June 30, 1975.
      Provisions similar to this section were contained in section 1119
    of this title prior to the general revision of this subchapter by
    Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.

-End-



-CITE-
    21 USC Sec. 1117                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Sec. 1117. Repealed.

-MISC1-
    Sec. 1117. Repealed. Pub. L. 98-24, Sec. 4(b), Apr. 26, 1983, 97
      Stat. 183.
      Section, Pub. L. 92-255, title II, Sec. 207, as added Pub. L. 96-
    181, Sec. 4, Jan. 2, 1980, 93 Stat. 1311, required the President
    to make annual reports to the Congress on the drug abuse prevention
    activities under this subchapter. See section 290aa-4 of Title 42,
    The Public Health and Welfare.
      A prior section 1117, Pub. L. 92-255, title II, Sec. 207, as
    added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which
    provided for acceptance of uncompensated services, was omitted in
    the general revision of this subchapter by Pub. L. 96-181, Sec. 4,
    Jan. 2, 1980, 93 Stat. 1309.
      Another prior section 1117, Pub. L. 92-255, title II, Sec. 207,
    Mar. 21, 1972, 86 Stat. 68, which provided for the procurement of
    experts and consultants by the Director, was repealed by Pub. L. 92-
    255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30,
    1975.

-End-



-CITE-
    21 USC Secs. 1118 to 1120                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Secs. 1118 to 1120. Omitted

-COD-
                               CODIFICATION                           
      Section 1118, Pub. L. 92-255, title II, Sec. 208, as added Pub.
    L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
    giving of notice to Director prior to initiation of a section
    811(a) proceeding, was omitted in the general revision of title II
    of Pub. L. 92-255 by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat.
    1309. See section 1115 of this title.
      A prior section 1118, Pub. L. 92-255, title II, Sec. 208, Mar.
    21, 1972, 86 Stat. 68, which provided for acceptance of
    uncompensated services by Director, was repealed by Pub. L. 92-255,
    title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
      Section 1119, Pub. L. 92-255, title II, Sec. 210, as added Pub.
    L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
    effect of this subchapter on statutory requirements and
    authorities, was omitted in the general revision of title II of
    Pub. L. 92-255 by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat.
    1309. See section 1116 of this title.
      A prior section 1119, Pub. L. 92-255, title II, Sec. 209, Mar.
    21, 1972, 86 Stat. 68, which provided for notice by Attorney
    General to Director with respect to control of dangerous drugs, was
    repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86
    Stat. 67, eff. June 30, 1975.
      A prior section 210 of Pub. L. 92-255, title II, Mar. 21, 1972,
    86 Stat. 69, which provided for authority of Director to make
    grants and enter into contract, was repealed by Pub. L. 92-255,
    title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
      Section 1120, Pub. L. 92-255, title II, Sec. 211, as added Pub.
    L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
    authorization of appropriations with regard to this subchapter, was
    omitted in the general revision of title II of Pub. L. 92-255 by
    Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
      A prior section 1120, Pub. L. 92-255, title II, Sec. 210, Mar.
    21, 1972, 86 Stat. 69, which provided for authority of Director to
    make grants and enter into contracts, was repealed by Pub. L. 92-
    255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30,
    1975.
      A prior section 211 of Pub. L. 92-255, title II, Mar. 21, 1972,
    86 Stat. 69, which provided for appointment of an acting Director
    until position was initially filled, was repealed by Pub. L. 92-
    255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30,
    1975.

-End-



-CITE-
    21 USC Secs. 1121 to 1123                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Secs. 1121 to 1123. Repealed.

-MISC1-
    Secs. 1121 to 1123. Repealed. Pub. L. 92-255, title I, Sec. 104,
      Mar. 21, 1972, 86 Stat. 67.
      Section 1121, Pub. L. 92-255, title II, Sec. 211, Mar. 21, 1972,
    86 Stat. 69, provided for appointment of an acting Director until
    position was initially filled.
      Section 1122, Pub. L. 92-255, title II, Sec. 213, Mar. 21, 1972,
    86 Stat. 69, prohibited Director or any other Federal officer from
    waiving or disregarding any limitation or requirement prescribed by
    law with respect to any Federal program or activity.
      Section 1123, Pub. L. 92-255, title II, Sec. 214, Mar. 21, 1972,
    86 Stat. 70, provided for authorization of appropriations, and
    fiscal year availability of such appropriations.

                         EFFECTIVE DATE OF REPEAL                     
      Section 1104 of this title, prior to repeal by section 4(c)(1) of
    Pub. L. 94-237, provided for repeal of sections effective June 30,
    1975.

-End-



-CITE-
    21 USC Secs. 1131 to 1133                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Secs. 1131 to 1133. Omitted

-COD-
                               CODIFICATION                           
      Section 1131, Pub. L. 92-255, title II, Sec. 221, as added Pub.
    L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
    functions of Director concerning planning and policies, was omitted
    in the general revision of title II of Pub. L. 92-255 by Pub. L. 96-
    181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309. See section 1111 of this
    title.
      A prior section 1131, Pub. L. 92-255, title II, Sec. 221, Mar.
    21, 1972, 86 Stat. 70, which provided for establishment of overall
    planning and policy and the criteria to achieve objectives and
    priorities for all Federal drug abuse prevention functions, was
    repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86
    Stat. 67, eff. June 30, 1975.
      Section 1132, Pub. L. 92-255, title II, Sec. 222, as added Pub.
    L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which authorized
    President to designate Director to represent United States in
    negotiations concerning drug abuse functions, was omitted in the
    general revision of title II of Pub. L. 92-255 by Pub. L. 96-181,
    Sec. 4, Jan. 2, 1980, 93 Stat. 1309. See section 1112 of this
    title.
      A prior section 1132, Pub. L. 92-255, title II, Sec. 222, Mar.
    21, 1972, 86 Stat. 71, which provided for review and modification
    of implementation plans and budget requests, was repealed by Pub.
    L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June
    30, 1975.
      Section 1133, Pub. L. 92-255, title II, Sec. 223, as added Pub.
    L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 244, which related to
    an annual report to President and Congress on activities of Office
    of Drug Abuse Policy, was omitted in the general revision of title
    II of Pub. L. 92-255 by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93
    Stat. 1309. See section 1117 of this title.
      A prior section 1133, Pub. L. 92-255, title II, Sec. 223, Mar.
    21, 1972, 86 Stat. 71, which provided for establishment and the
    objectives of a Special Fund, was repealed by Pub. L. 92-255, title
    I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

-End-



-CITE-
    21 USC Secs. 1134 to 1143                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Secs. 1134 to 1143. Repealed.

-MISC1-
    Secs. 1134 to 1143. Repealed. Pub. L. 92-255, title I, Sec. 104,
      Mar. 21, 1972, 86 Stat. 67.
      Section 1134, Pub. L. 92-255, title II, Sec. 224, Mar. 21, 1972,
    86 Stat. 71, provided for establishment of research and development
    programs by Director.
      Section 1135, Pub. L. 92-255, title II, Sec. 225, Mar. 21, 1972,
    86 Stat. 72, provided for establishment of a single non-Federal
    share requirement.
      Section 1136, Pub. L. 92-255, title II, Sec. 226, Mar. 21, 1972,
    86 Stat. 72, provided for Director to make drug prevention function
    recommendations to President and to consult with responsible
    agencies with respect to drug prevention functions.
      Section 1137, Pub. L. 92-255, title II, Sec. 227, Mar. 21, 1972,
    86 Stat. 72, provided for resolution of agency conflicts with
    regard to drug prevention functions.
      Section 1138, Pub. L. 92-255, title II, Sec. 228, Mar. 21, 1972,
    86 Stat. 72, provided for communications and liaison with respect
    to drug prevention functions by one of Assistant Directors.
      Section 1139, Pub. L. 92-255, title II, Sec. 229, Mar. 21, 1972,
    86 Stat. 72, provided, with respect to drug prevention functions,
    coordination of State and local governments, availability of
    information and other services and activities.
      Section 1140, Pub. L. 92-255, title II, Sec. 230, Mar. 21, 1972,
    86 Stat. 73, provided for a management oversight review by a
    Federal officer.
      Section 1141, Pub. L. 92-255, title II, Sec. 231, Mar. 21, 1972,
    86 Stat. 73, provided for convening of a council of officials of
    Federal agencies responsible for drug prevention functions by
    Director.
      Section 1142, Pub. L. 92-255, title II, Sec. 232, Mar. 21, 1972,
    86 Stat. 73, provided for designation of the Director to represent
    Government in international negotiations related to drug prevention
    functions.
      Section 1143, Pub. L. 92-255, title II, Sec. 233, Mar. 21, 1972,
    86 Stat. 73, provided for an annual written report to the President
    by the Director.

                         EFFECTIVE DATE OF REPEAL                     
      Section 1104 of this title, prior to repeal by section 4(c)(1) of
    Pub. L. 94-237, provided for repeal of sections effective June 30,
    1975.

-End-



-CITE-
    21 USC Secs. 1151 to 1155                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION

-HEAD-
    Secs. 1151 to 1155. Repealed.

-MISC1-
    Secs. 1151 to 1155. Repealed. Pub. L. 92-255, title I, Sec. 104,
      Mar. 21, 1972, 86 Stat. 67.
      Section 1151, Pub. L. 92-255, title II, Sec. 251, Mar. 21, 1972,
    86 Stat. 74, provided for establishment of a National Advisory
    Council for Drug Abuse Prevention.
      Section 1152, Pub. L. 92-255, title II, Sec. 252, Mar. 21, 1972,
    86 Stat. 74, provided for membership of National Advisory Council
    for Drug Abuse Prevention.
      Section 1153, Pub. L. 92-255, title II, Sec. 253, Mar. 21, 1972,
    86 Stat. 74, provided for designation of chairman of National
    Advisory Council for Drug Abuse Prevention.
      Section 1154, Pub. L. 92-255, title II, Sec. 254, Mar. 21, 1972,
    86 Stat. 74, provided for compensation and expenses for members of
    National Advisory Council for Drug Abuse Prevention.
      Section 1155, Pub. L. 92-255, title II, Sec. 255, Mar. 21, 1972,
    86 Stat. 74, set forth functions of National Advisory Council for
    Drug Abuse Prevention.

                         EFFECTIVE DATE OF REPEAL                     
      Section 1104 of this title, prior to repeal by section 4(c)(1) of
    Pub. L. 94-237, provided for repeal of sections effective June 30,
    1975.

-End-


-CITE-
    21 USC SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY

-HEAD-
               SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY           

-End-



-CITE-
    21 USC Secs. 1161 to 1165                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY

-HEAD-
    Secs. 1161 to 1165. Repealed.

-MISC1-
    Secs. 1161 to 1165. Repealed. Pub. L. 98-509, title III, Sec.
      301(d), Oct. 19, 1984, 98 Stat. 2364.
      Section 1161, Pub. L. 92-255, title III, Sec. 301, Mar. 21, 1972,
    86 Stat. 74, related to development, and initial promulgation no
    later than nine months after Mar. 21, 1972, by the President, of a
    national drug abuse strategy.
      Section 1162, Pub. L. 92-255, title III, Sec. 302, Mar. 21, 1972,
    86 Stat. 75; Pub. L. 94-237, Sec. 4(c)(2), (3), (5)(A), Mar. 19,
    1976, 90 Stat. 244; Pub. L. 96-181, Sec. 5(a), (b), Jan. 2, 1980,
    93 Stat. 1311; Pub. L. 97-35, title IX, Sec. 973(b), Aug. 13, 1981,
    95 Stat. 598, related to establishment and membership of a Strategy
    Council, interim provision of services by the Director, and review
    and commentary on the national drug abuse strategy by those Federal
    officials participating in its preparation.
      Section 1163, Pub. L. 92-255, title III, Sec. 303, Mar. 21, 1972,
    86 Stat. 75, related to contents of the national drug abuse
    strategy.
      Section 1164, Pub. L. 92-255, title III, Sec. 304, Mar. 21, 1972,
    86 Stat. 75; Pub. L. 94-237, Sec. 4(c)(4), Mar. 19, 1976, 90 Stat.
    244; Pub. L. 96-181, Sec. 5(c), Jan. 2, 1980, 93 Stat. 1311,
    related to preparation of the national drug abuse strategy.
      Section 1165, Pub. L. 92-255, title III, Sec. 305, Mar. 21, 1972,
    86 Stat. 75; Pub. L. 94-237, Sec. 5, Mar. 19, 1976, 90 Stat. 244;
    Pub. L. 98-24, Sec. 4(a), Apr. 26, 1983, 97 Stat. 183, related to
    submission by the President to the Congress, on or before Aug. 1,
    1984, and every two years thereafter, of a written report
    describing the national drug abuse strategy, and prescribed the
    contents of the report.

-End-


-CITE-
    21 USC SUBCHAPTER IV - OTHER FEDERAL PROGRAMS               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
                  SUBCHAPTER IV - OTHER FEDERAL PROGRAMS              

-End-



-CITE-
    21 USC Sec. 1171                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1171. Drug abuse prevention function appropriations

-STATUTE-
      Any request for appropriations by a department or agency of the
    Government submitted after March 21, 1972, shall specify (1) on a
    line item basis, that part of the appropriations which the
    department or agency is requesting to carry out its drug abuse
    prevention functions, and (2) the authorization of the
    appropriations requested to carry out each of its drug abuse
    prevention functions.

-SOURCE-
    (Pub. L. 92-255, title IV, Sec. 404, Mar. 21, 1972, 86 Stat. 77.)

-End-



-CITE-
    21 USC Sec. 1172                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1172. Repealed.

-MISC1-
    Sec. 1172. Repealed. Pub. L. 98-24, Sec. 2(c)(2), Apr. 26, 1983, 97
      Stat. 182.
      Section, Pub. L. 92-255, title IV, Sec. 405, Mar. 21, 1972, 86
    Stat. 77; Pub. L. 95-461, Sec. 3(b), Oct. 14, 1978, 92 Stat. 1268;
    Pub. L. 97-35, title IX, Sec. 973(c)(1), Aug. 13, 1981, 95 Stat.
    598, required that the Secretary of Health and Human Services make
    periodic reports to the Congress and to the President on drug abuse
    in the United States. See section 290aa-4 of Title 42, The Public
    Health and Welfare.

-End-



-CITE-
    21 USC Sec. 1173                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1173. Transferred and Omitted

-COD-
                               CODIFICATION                           
      Section, Pub. L. 92-255, title IV, Sec. 406, Mar. 21, 1972, 86
    Stat. 78; Pub. L. 97-35, title IX, Sec. 968(a), Aug. 13, 1981, 95
    Stat. 595, established additional drug abuse prevention functions
    of the Secretary of Health and Human Services.
      Subsec. (a) was redesignated as section 503(e) of the Public
    Health Service Act by Pub. L. 98-24, Sec. 2(b)(5), Apr. 26, 1983,
    97 Stat. 177, and was classified to former section 290aa-2(e) of
    Title 42, The Public Health and Welfare, prior to repeal by Pub. L.
    102-321, title I, Sec. 101(b), July 10, 1992, 106 Stat. 331.
      Subsec. (b), which directed that the Secretary carry out his
    functions under subsec. (a) of this section through the National
    Institute on Drug Abuse, was omitted.

-End-



-CITE-
    21 USC Secs. 1174, 1175                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Secs. 1174, 1175. Transferred

-COD-
                               CODIFICATION                           
      Section 1174, Pub. L. 92-255, title IV, Sec. 407, Mar. 21, 1972,
    86 Stat. 78; Pub. L. 94-237, Sec. 6(a), Mar. 19, 1976, 90 Stat.
    244; Pub. L. 94-581, title I, Sec. 111(c)(2), Oct. 21, 1976, 90
    Stat. 2852, which prohibited discrimination against drug abusers by
    general hospitals, was redesignated section 526 of the Public
    Health Service Act by Pub. L. 98-24, Sec. 2(b)(16)(B), Apr. 26,
    1983, 97 Stat. 182, and is classified to section 290ee-2 of Title
    42, The Public Health and Welfare.
      Section 1175, Pub. L. 92-255, title IV, Sec. 408, Mar. 21, 1972,
    86 Stat. 79; Pub. L. 93-282, title III, Sec. 303(a), (b), May 14,
    1974, 88 Stat. 137, 138; Pub. L. 94-237, Sec. 4(c)(5)(A), (B), Mar.
    19, 1976, 90 Stat. 244; Pub. L. 94-581, title I, Sec. 111(c)(3),
    Oct. 21, 1976, 90 Stat. 2852; Pub. L. 97-35, title IX, Sec. 973(d),
    Aug. 13, 1981, 95 Stat. 598, which related to confidentiality of
    patients' records, was redesignated section 527 of the Public
    Health Service Act by Pub. L. 98-24, Sec. 2(b)(16)(B), Apr. 26,
    1983, 97 Stat. 182, and is classified to section 290ee-3 of Title
    42.

-End-



-CITE-
    21 USC Sec. 1176                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1176. Repealed.

-MISC1-
    Sec. 1176. Repealed. Pub. L. 97-35, title IX, Sec. 969(a), Aug. 13,
      1981, 95 Stat. 595.
      Section, Pub. L. 92-255, title IV, Sec. 409, Mar. 21, 1972, 86
    Stat. 80; Pub. L. 94-237, Secs. 7, 8(a), 9(a)(1), (b)(1), Mar. 19,
    1976, 90 Stat. 245-247; Pub. L. 94-371, Sec. 10(a)(1), (b)(1), July
    26, 1976, 90 Stat. 1040; Pub. L. 95-83, title III, Sec. 311(a)(3),
    Aug. 1, 1977, 91 Stat. 397; Pub. L. 95-461, Secs. 2(a), 4, Oct. 14,
    1978, 92 Stat. 1268, 1269; Pub. L. 96-79, title I, Sec. 115(j)(2),
    Oct. 4, 1979, 93 Stat. 610; Pub. L. 96-181, Sec. 6, Jan. 2, 1980,
    93 Stat. 1311, provided for creation and funding through the fiscal
    year ending Sept. 30, 1981, of a program of formula grants to
    States to operate State plans for the establishment, conduct, and
    coordination of projects for the development of more effective drug
    abuse prevention functions in the States and for the evaluation of
    such programs.

-End-



-CITE-
    21 USC Sec. 1177                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1177. Special project grants and contracts

-STATUTE-
    (a) Scope of programs; priority
      The Secretary (!1) acting through the National Institute on Drug
    Abuse, may make grants to and enter into contracts with individuals
    and public and private nonprofit entities - 

        (1) to provide training seminars, educational programs, and
      technical assistance for the development, demonstration, and
      evaluation of drug abuse prevention, treatment, and
      rehabilitation programs; and
        (2) to conduct demonstration and evaluation projects, with a
      high priority on prevention and early intervention projects and
      on identifying new and more effective drug abuse prevention,
      treatment, and rehabilitation programs.

    In the implementation of his authority under this section, the
    Secretary shall accord a high priority to applications for grants
    or contracts for primary prevention programs. For purposes of the
    preceding sentence, primary prevention programs include programs
    designed to discourage persons from beginning drug abuse. To the
    extent that appropriations authorized under this section are used
    to fund treatment services, the Secretary shall not limit such
    funding to treatment for opiate abuse, but shall also provide
    support for treatment for non-opiate drug abuse including polydrug
    abuse. Furthermore, nothing shall prevent the use of funds provided
    under this section for programs and projects aimed at the
    prevention, treatment, and rehabilitation of alcohol abuse and
    alcoholism as well as drug abuse.
    (b) Authorization of appropriations
      There are authorized to be appropriated $25,000,000 for the
    fiscal year ending June 30, 1972; $65,000,000 for the fiscal year
    ending June 30, 1973; $100,000,000 for the fiscal year ending June
    30, 1974; $160,000,000 for each of the fiscal years ending June 30,
    1975 and June 30, 1976; $40,000,000 for the period July 1, 1976,
    through September 30, 1976; and $160,000,000 for each of the fiscal
    years ending September 30, 1977, and September 30, 1978, to carry
    out this section. For the fiscal year ending September 30, 1979,
    there is authorized to be appropriated (1) $153,000,000 for grants
    and contracts under paragraphs (3) and (6) of subsection (a) of
    this section for drug abuse treatment programs, and (2) $24,000,000
    for grants and contracts under such subsection for other programs
    and activities. For grants and contracts under paragraphs (3) and
    (6) of subsection (a) of this section for drug abuse treatment
    programs there is authorized to be appropriated $149,000,000 for
    the fiscal year ending September 30, 1980, and $155,000,000 for the
    fiscal year ending September 30, 1981; and for grants and contracts
    under such subsection for other programs and activities there is
    authorized to be appropriated $20,000,000 for the fiscal year
    ending September 30, 1980, and $30,000,000 for the fiscal year
    ending September 30, 1981. Of the funds appropriated under the
    preceding sentence for the fiscal year ending September 30, 1980,
    at least 7 percent of the funds shall be obligated for grants and
    contracts for primary prevention and intervention programs designed
    to discourage individuals, particularly those in high risk
    populations, from abusing drugs; and of the funds appropriated
    under the preceding sentence for the next fiscal year, at least 10
    percent of the funds shall be obligated for such grants and
    contracts. For carrying out the purposes of this section, there are
    authorized to be appropriated $15,000,000 for the fiscal year
    ending September 30, 1982. Of the funds appropriated under the
    preceding sentence, at least 25 per centum of the funds shall be
    obligated for grants and contracts for primary prevention and
    intervention programs designed to discourage individuals,
    particularly individuals in high risk populations, from abusing
    drugs.
    (c) Coordination of applications for programs in a State;
      precedence restriction; project evaluation; application approval;
      criteria; proposed performance standards or research protocol
      (1) In carrying out this section, the Secretary shall require
    coordination of all applications for programs in a State and shall
    not give precedence to public agencies over private agencies,
    institutions, and organizations, or to State agencies over local
    agencies.
      (2) Each applicant within a State, upon filing its application
    with the Secretary for a grant or contract under this section,
    shall submit a copy of its application for review by the State
    agency (if any) responsible for the administration of drug abuse
    prevention activities. Such State agency shall be given not more
    than thirty days from the date of receipt of the application to
    submit to the Secretary, in writing, an evaluation of the project
    set forth in the application. Such evaluation shall include
    comments on the relationship of the project to other projects
    pending and approved and to any State comprehensive plan for
    treatment and prevention of drug abuse. The State shall furnish the
    applicant a copy of any such evaluation. A State if it so desires
    may, in writing, waive its rights under this paragraph.
      (3) Approval of any application for a grant or contract under
    this section by the Secretary, including the earmarking of
    financial assistance for a program or project, may be granted only
    if the application substantially meets a set of criteria that - 
        (A) provide that the activities and services for which
      assistance under this section is sought will be substantially
      administered by or under the supervision of the applicant;
        (B) provide for such methods of administration as are necessary
      for the proper and efficient operation of such programs or
      projects; and
        (C) provide for such fiscal control and fund accounting
      procedures as may be necessary to assure proper disbursement of
      and accounting for Federal funds paid to the applicant.

      (4) Each applicant within a State, upon filing its application
    with the Secretary for a grant or contract to provide treatment or
    rehabilitation services shall provide a proposed performance
    standard or standards, to measure, or research protocol to
    determine, the effectiveness of such treatment or rehabilitation
    program or project.
    (d) Programs and projects aimed at underserved groups;
      encouragement and special consideration given to applications
      The Secretary shall encourage the submission of and give special
    consideration to applications under this section to programs and
    projects aimed at underserved populations such as racial and ethnic
    minorities, Native Americans (including Native Hawaiians and Native
    American Pacific Islanders), youth, the elderly, women, handicapped
    individuals, and families of drug abusers.
    (e) Payments; advances; reimbursement; installments
      Payment under grants or contracts under this section may be made
    in advance or by way of reimbursement and in such installments as
    the Secretary may determine.
    (f) Prevention and treatment services
      Projects and programs for which grants and contracts are made or
    entered into under this section shall, in the case of prevention
    and treatment services, seek to (1) be responsive to special
    requirements of handicapped individuals in receiving such services;
    (2) whenever possible, be community based, insure care of good
    quality in general community care facilities and under health
    insurance plans, and be integrated with, and provide for the active
    participation of, a wide range of public and nongovernmental
    agencies, organizations, institutions, and individuals; (3) where a
    substantial number of the individuals in the population served by
    the project or program are of limited English-speaking ability (A)
    utilize the services of outreach workers fluent in the language
    spoken by a predominant number of such individuals and develop a
    plan and make arrangements responsive to the needs of such
    population for providing services to the extent practicable in the
    language and cultural context most appropriate to such individuals,
    and (B) identify an individual who is fluent both in that language
    and English and whose responsibilities shall include providing
    guidance to the individuals of limited English-speaking ability and
    to appropriate staff members with respect to cultural sensitivities
    and bridging linguistic and cultural differences; and (4) where
    appropriate, utilize existing community resources (including
    community mental health centers).
    (g) Authorization by chief executive officer of State required;
      maximum amount and duration of grants
      (1) No grant may be made under this section to a State or to any
    entity within the government of a State unless the grant
    application has been duly authorized by the chief executive officer
    of such State.
      (2) No grant or contract may be made under this section for a
    period in excess of five years.
      (3)(A) The amount of any grant or contract under this section may
    not exceed 100 per centum of the cost of carrying out the grant or
    contract in the first fiscal year for which the grant or contract
    is made under this section, 80 per centum of such cost in the
    second fiscal year for which the grant or contract is made under
    this section, 70 per centum of such cost in the third fiscal year
    for which the grant or contract is made under this section, and 60
    per centum of such cost in each of the fourth and fifth fiscal
    years for which the grant or contract is made under this section.
      (B) For purposes of this paragraph, no grant or contract shall be
    considered to have been made under this section for a fiscal year
    ending before September 30, 1981.

-SOURCE-
    (Pub. L. 92-255, title IV, Sec. 410, Mar. 21, 1972, 86 Stat. 82;
    Pub. L. 94-237, Secs. 10, 11, Mar. 19, 1976, 90 Stat. 247; Pub. L.
    94-371, Sec. 10(c)(1), July 26, 1976, 90 Stat. 1040; Pub. L. 95-
    461, Secs. 2(b), 6(a), Oct. 14, 1978, 92 Stat. 1268, 1270; Pub. L.
    96-181, Sec. 7, Jan. 2, 1980, 93 Stat. 1312; Pub. L. 97-35, title
    IX, Sec. 970(b)-(f), Aug. 13, 1981, 95 Stat. 596, 597; Pub. L. 98-
    24, Sec. 5(a)(3), Apr. 26, 1983, 97 Stat. 183.)


-MISC1-
                                AMENDMENTS                            
      1983 - Subsec. (d). Pub. L. 98-24 substituted "Native Americans
    (including Native Hawaiians and Native American Pacific Islanders)"
    for "native Americans".
      1981 - Subsec. (a). Pub. L. 97-35, Sec. 970(b), substituted "The
    Secretary acting through the National Institute on Drug Abuse, may
    make grants to and enter into contracts with individuals, and
    public and private nonprofit entities" for "The Secretary shall" in
    introductory provision preceding par. (1), reduced the enumeration
    of authorized activities of the Secretary from six paragraphs to
    two paragraphs thereby eliminating provisions relating to the
    recruitment, training, and employment of participants in treatment
    programs, the establishment, conduct, and evaluation of drug abuse
    prevention, treatment, and rehabilitation programs, the development
    of methods to deal with drug abuse in particular areas, the
    improvement of drug maintenance techniques or programs, and the
    establishment, conduct, and evaluation of drug abuse prevention and
    treatment programs, and inserted provision that nothing shall
    prevent the use of funds provided under this section for programs
    and projects aimed at the prevention, treatment, and rehabilitation
    of alcohol abuse and alcoholism as well as drug abuse.
      Subsec. (b). Pub. L. 97-35, Sec. 970(c), inserted provisions
    relating to fiscal year ending Sept. 30, 1982.
      Subsec. (c)(2). Pub. L. 97-35, Sec. 970(d)(1), substituted
    "responsible for the administration of drug abuse prevention
    activities" for "designated or established under section 1176 of
    this title" and "any State" for "the State" and struck out
    reference to drug abuse under section 1176 of this title.
      Subsec. (c)(3)(D). Pub. L. 97-35, Sec. 970(d)(2), struck out
    subpar. (D) which had provided that approval of a grant or contract
    could be granted only if the application provided for reasonable
    assurances that Federal funds made available under this section
    would be used to supplement and increase the level of State, local,
    and other non-Federal funds that would in the absence of such
    Federal funds be made available for the programs described in this
    section and would not supplant State or local funds.
      Subsec. (d). Pub. L. 97-35, Sec. 970(e), inserted applicability
    to racial and ethnic minorities, handicapped, native Americans, and
    families of drug abusers.
      Subsec. (g). Pub. L. 97-35, Sec. 970(f), added subsec. (g).
      1980 - Subsec. (a)(1). Pub. L. 96-181, Sec. 7(a)(1), substituted
    "development, demonstration and evaluation of drug abuse" for
    "development of drug abuse".
      Subsec. (a)(5). Pub. L. 96-181, Sec. 7(a)(2), substituted "drug
    maintenance and detoxification techniques" for "drug maintenance
    techniques".
      Subsec. (a)(6). Pub. L. 96-181, Sec. 7(a)(3), in provisions
    relating to evaluation of drug abuse prevention and treatment
    programs, inserted provision that such evaluation be with
    particular emphasis on replicating effective prevention and
    treatment programs.
      Subsec. (b). Pub. L. 96-181, Sec. 7(b), inserted authorization of
    appropriations for grants and contracts under pars. (3) and (6) of
    subsec. (a) and for other programs and activities for fiscal years
    ending Sept. 30, 1980, and Sept. 30, 1981, and required certain
    percentage of appropriated funds to be obligated for grants and
    contracts for primary prevention and intervention programs designed
    to discourage individuals from abusing drugs.
      Subsec. (d). Pub. L. 96-181, Sec. 7(c), inserted provisions for
    special consideration to applications for programs and projects for
    prevention and treatment of drug abuse and drug dependence by
    elderly.
      Subsec. (f). Pub. L. 96-181, Sec. 7(d), added subsec. (f).
      1978 - Subsec. (a). Pub. L. 95-461, Sec. 6(a), inserted provision
    requiring Secretary to act through National Institute on Drug Abuse
    in making special project grants.
      Subsec. (b). Pub. L. 95-461, Sec. 2(b), inserted provisions
    authorizing appropriations for fiscal year ending Sept. 30, 1979.
      1976 - Subsec. (a). Pub. L. 94-237, Sec. 10(a), inserted
    provisions which authorized Secretary to give a high priority to
    applications for grants and contracts for primary prevention
    programs, and set forth programs included within primary prevention
    programs and scope of Secretary's funding authority.
      Subsec. (b). Pub. L. 94-237, Sec. 11, substituted "$160,000,000
    for each of the fiscal years ending June 30, 1975 and June 30,
    1976; $40,000,000 for the period July 1, 1976, through September
    30, 1976; and $160,000,000 for each of the fiscal years ending
    September 30, 1977, and September 30, 1978," for "and $160,000,000
    for the fiscal year ending June 30, 1975,".
      Subsec. (c)(4). Pub. L. 94-237, Sec. 10(b), added par. (4).
      Subsecs. (d), (e). Pub. L. 94-371 added subsec. (d) and
    redesignated former subsec. (d) as (e).

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Section 10(c)(2) of Pub. L. 94-371 provided that: "The amendment
    made by paragraph (1) [amending this section] shall apply with
    respect to applications submitted for grants or contracts under
    section 410 of the Drug Abuse Office and Treatment Act of 1972
    [this section] after June 30, 1976."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 1178                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1178. Records and audit

-STATUTE-
    (a) Assistance records; contents
      Each recipient of assistance under section 1177 of this title
    pursuant to grants or contracts entered into under other than
    competitive bidding procedures shall keep such records as the
    Secretary shall prescribe, including records which fully disclose
    the amount and disposition by such recipient of the proceeds of
    such grant or contract, the total cost of the project or
    undertaking in connection with which such grant or contract is
    given or used, and the amount of that portion of the cost of the
    project or undertaking supplied by other sources, and such other
    records as will facilitate an effective audit.
    (b) Access to pertinent information for audit and examination
      The Secretary and Comptroller General of the United States, or
    any of their duly authorized representatives, shall have access for
    the purpose of audit and examination to any books, documents,
    papers, and records of such recipients that are pertinent to such
    grants or contracts.

-SOURCE-
    (Pub. L. 92-255, title IV, Sec. 411, Mar. 21, 1972, 86 Stat. 83;
    Pub. L. 97-35, title IX, Sec. 971, Aug. 13, 1981, 95 Stat. 597.)


-MISC1-
                                AMENDMENTS                            
      1981 - Subsec. (a). Pub. L. 97-35 struck out reference to section
    1176 of this title.

-End-



-CITE-
    21 USC Sec. 1179                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1179. National Drug Abuse Training Center

-STATUTE-
    (a) Establishment; functions; general policies; transfer of
      supervision
      The Director shall establish a National Drug Abuse Training
    Center (hereinafter in this section referred to as the "Center") to
    develop, conduct, and support a full range of training programs
    relating to drug abuse prevention functions. The Director shall
    consult with the National Advisory Council for Drug Abuse
    Prevention regarding the general policies of the Center. The
    Director may supervise the operation of the Center initially, but
    shall transfer the supervision of the operation of the Center to
    the National Institute on Drug Abuse not later than December 31,
    1974.
    (b) Activities and material
      The Center shall conduct or arrange for training programs,
    seminars, meetings, conferences, and other related activities,
    including the furnishing of training and educational materials for
    use by others.
    (c) Persons eligible for services and facilities
      The services and facilities of the Center shall, in accordance
    with regulations prescribed by the Director, be available to (1)
    Federal, State, and local governmental officials, and their
    respective staffs, (2) medical and paramedical personnel, and
    educators, and (3) other persons, including drug dependent persons,
    requiring training or education in drug abuse prevention.
    (d) Authorization of appropriations; fiscal year availability
      (1) For the purpose of carrying out this section, there are
    authorized to be appropriated $1,000,000 for the fiscal year ending
    June 30, 1972, $3,000,000 for the fiscal year ending June 30, 1973,
    $5,000,000 for the fiscal year ending June 30, 1974, and $6,000,000
    for the fiscal year ending June 30, 1975.
      (2) Sums appropriated under this subsection shall remain
    available for obligation or expenditure in the fiscal year for
    which appropriated and in the fiscal year next following.

-SOURCE-
    (Pub. L. 92-255, title IV, Sec. 412, Mar. 21, 1972, 86 Stat. 84.)


-MISC1-
            NATIONAL ADVISORY COUNCIL FOR DRUG ABUSE PREVENTION        
      Section 1151 of this title, which established the National
    Advisory Council for Drug Abuse Prevention, was repealed by Pub. L.
    92-255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June
    30, 1975.

-End-



-CITE-
    21 USC Sec. 1180                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1180. Transferred

-COD-
                               CODIFICATION                           
      Section, Pub. L. 92-255, title IV, Sec. 413, Mar. 21, 1972, 86
    Stat. 84; Pub. L. 96-181, Sec. 8(a), (b)(1), Jan. 2, 1980, 93 Stat.
    1313, 1314; Pub. L. 97-35, title IX, Sec. 973(e), Aug. 13, 1981, 95
    Stat. 598, which related to drug abuse among government and other
    employees, was redesignated section 525 of the Public Health
    Service Act by Pub. L. 98-24, Sec. 2(b)(16)(A), Apr. 26, 1983, 97
    Stat. 182, and is classified to section 290ee-1 of Title 42, The
    Public Health and Welfare.

-End-



-CITE-
    21 USC Sec. 1181                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER IV - OTHER FEDERAL PROGRAMS

-HEAD-
    Sec. 1181. Contract authority

-STATUTE-
      The authority of the Secretary to enter into contracts under this
    subchapter and subchapter V of this chapter shall be effective for
    any fiscal year only to such extent or in such amounts as are
    provided in advance by appropriation Acts.

-SOURCE-
    (Pub. L. 92-255, title IV, Sec. 414, as added Pub. L. 96-181, Sec.
    9(a), Jan. 2, 1980, 93 Stat. 1314.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Subchapter V of this chapter, referred to in text, consisted of
    sections 501 to 504 of title V of Pub. L. 92-255, Mar. 21, 1972, 86
    Stat. 85, which were classified to sections 1191 to 1194 of this
    title, respectively. Sections 501 to 503 were made part of the
    Public Health Service Act by Pub. L. 98-24, Sec. 2(b)(4), (11),
    (15), Apr. 26, 1983, 97 Stat. 177, 180, 181, and were transferred
    to former sections 290aa-2, 290ee, and 290cc, respectively, of
    Title 42, The Public Health and Welfare. Section 290aa-2 of Title
    42 was repealed by Pub. L. 102-321, Sec. 101(b). Section 290cc of
    Title 42 was repealed by Pub. L. 102-321, Sec. 123(c). Section
    290ee of Title 42 was omitted in the general revision of part D of
    subchapter III-A of chapter 6A of Title 42 by Pub. L. 102-321.
    Section 1194 of this title was repealed by Pub. L. 98-24, Sec.
    2(c)(2).

-End-


-CITE-
    21 USC SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE

-HEAD-
              SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE          

-End-



-CITE-
    21 USC Secs. 1191 to 1193                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE

-HEAD-
    Secs. 1191 to 1193. Transferred

-COD-
                               CODIFICATION                           
      Section 1191, Pub. L. 92-255, title V, Sec. 501, Mar. 21, 1972,
    86 Stat. 85; Pub. L. 93-282, title II, Sec. 204, May 14, 1974, 88
    Stat. 136; Pub. L. 94-237, Sec. 12(a), Mar. 19, 1976, 90 Stat. 247;
    Pub. L. 96-181, Sec. 10, Jan. 2, 1980, 93 Stat. 1314; Pub. L. 97-
    35, title IX, Sec. 973(f), Aug. 13, 1981, 95 Stat. 598, which
    established the National Institute on Drug Abuse, was redesignated
    section 503(a)-(d) of the Public Health Service Act by Pub. L. 98-
    24, Sec. 2(b)(4), Apr. 26, 1983, 97 Stat. 177, transferred to
    section 290aa-2(a)-(d) of Title 42, The Public Health and Welfare,
    and subsequently repealed.
      Section 1192, Pub. L. 92-255, title V, Sec. 502, as added Pub. L.
    94-237, Sec. 12(b)(1), Mar. 19, 1976, 90 Stat. 247; amended Pub. L.
    95-461, Sec. 5, Oct. 14, 1978, 92 Stat. 1269; Pub. L. 96-181, Sec.
    11, Jan. 2, 1980, 93 Stat. 1315, which related to the coordination,
    information, assistance, and assignment activities and services,
    was redesignated section 524 of the Public Health Service Act by
    Pub. L. 98-24, Sec. 2(b)(15), Apr. 26, 1983, 97 Stat. 181,
    transferred to section 290ee of Title 42, and subsequently omitted.
      Section 1193, Pub. L. 92-255, title V, Sec. 503, as added Pub. L.
    94-237, Sec. 13(a), Mar. 19, 1976, 90 Stat. 248; amended Pub. L. 95-
    461, Sec. 2(c), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 96-181, Sec.
    12, Jan. 2, 1980, 93 Stat. 1315; Pub. L. 97-35, title IX, Sec.
    972(a), (b), Aug. 13, 1981, 95 Stat. 597, which related to research
    and development functions, was redesignated section 515 of the
    Public Health Service Act by Pub. L. 98-24, Sec. 2(b)(11), Apr. 26,
    1983, 97 Stat. 180, transferred to section 290cc of Title 42, and
    subsequently repealed.


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 502 of Pub. L. 92-255, Mar. 21, 1972, 86 Stat.
    85, amended section 217 of the Public Health Service Act by adding
    subsec. (e) [section 218(e) of Title 42, The Public Health and
    Welfare], and amended section 266 of the Community Mental Health
    Centers Act [former section 2688t of Title 42].

-End-



-CITE-
    21 USC Sec. 1194                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
    SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE

-HEAD-
    Sec. 1194. Repealed.

-MISC1-
    Sec. 1194. Repealed. Pub. L. 98-24, Sec. 2(c)(2), Apr. 26, 1983, 97
      Stat. 182.
      Section, Pub. L. 92-255, title V, Sec. 504, as added Pub. L. 95-
    461, Sec. 6(b)(1), Oct. 14, 1978, 92 Stat. 1270, related to review
    by the Secretary of programs and activities. See section 290aa-5 of
    Title 42, The Public Health and Welfare.

-End-


-CITE-
    21 USC CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY

-HEAD-
               CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY           

-End-



-CITE-
    21 USC Secs. 1201 to 1204                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY

-HEAD-
    Secs. 1201 to 1204. Repealed.

-MISC1-
    Secs. 1201 to 1204. Repealed. Pub. L. 100-690, title I, Sec.
      1007(a)(3), Nov. 18, 1988, 102 Stat. 4187.
      Section 1201, Pub. L. 98-473, title II, Sec. 1302, Oct. 12, 1984,
    98 Stat. 2168, set forth Congressional findings and declaration of
    purpose relating to illegal flow of narcotics into United States.
      Section 1202, Pub. L. 98-473, title II, Sec. 1303, Oct. 12, 1984,
    98 Stat. 2168, established National Drug Enforcement Policy Board.
      Section 1203, Pub. L. 98-473, title II, Sec. 1304, Oct. 12, 1984,
    98 Stat. 2169, delineated responsibilities and functions of
    National Drug Enforcement Policy Board.
      Section 1204, Pub. L. 98-473, title II, Sec. 1305, Oct. 12, 1984,
    98 Stat. 2170, related to reports to Congress.

                         EFFECTIVE DATE OF REPEAL                     
      Section 1007(a)(3) of Pub. L. 100-690 provided that the repeal of
    this chapter is effective on 30th day after first Director of
    National Drug Control Policy is confirmed by the Senate.

                                SHORT TITLE                            
      Pub. L. 98-473, title II, Sec. 1301, Oct. 12, 1984, 98 Stat.
    2168, which provided that chapter XIII (Secs. 1301 to 1307) of
    title II of Pub. L. 98-473 was to be cited as the National
    Narcotics Act of 1984, was repealed by Pub. L. 100-690, title I,
    Sec. 1007(a)(3), Nov. 18, 1988, 102 Stat. 4187.


-EXEC-
                         EXECUTIVE ORDER NO. 12590                     
      Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, as amended by
    Ex. Ord. No. 13284, Sec. 11, Jan. 23, 2003, 68 F.R. 4076, provided
    for the establishment of a National Drug Policy Board, designated
    its membership and functions, and authorized coordinating groups.

-End-


-CITE-
    21 USC CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON
           ALCOHOL AND DRUG ABUSE PREVENTION               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE
                  PREVENTION                      

-HEAD-
    CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE
                                PREVENTION

-End-



-CITE-
    21 USC Secs. 1301 to 1308                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE
                  PREVENTION                      

-HEAD-
    Secs. 1301 to 1308. Omitted

-COD-
                               CODIFICATION                           
      Section 1301, Pub. L. 99-570, title VIII, Sec. 8002, Oct. 27,
    1986, 100 Stat. 3207-161 related to the establishment of the
    President's Media Commission on Alcohol and Drug Abuse Prevention.
      Section 1302, Pub. L. 99-570, title VIII, Sec. 8003, Oct. 27,
    1986, 100 Stat. 3207-161, related to duties of the Commission.
      Section 1303, Pub. L. 99-570, title VIII, Sec. 8004, Oct. 27,
    1986, 100 Stat. 3207-162, required appointment of members of the
    Commission within 30 days after Oct. 27, 1986.
      Section 1304, Pub. L. 99-570, title VIII, Sec. 8005, Oct. 27,
    1986, 100 Stat. 3207-162, related to meetings.
      Section 1305, Pub. L. 99-570, title VIII, Sec. 8006, Oct. 27,
    1986, 100 Stat. 3207-163, related to employment of Director and
    staff and the procurement of the services of experts and
    consultants.
      Section 1306, Pub. L. 99-570, title VIII, Sec. 8007, Oct. 27,
    1986, 100 Stat. 3207-163, related to the powers of the Commission.
      Section 1307, Pub. L. 99-570, title VIII, Sec. 8008, Oct. 27,
    1986, 100 Stat. 3207-163, related to an annual report to Congress.
      Section 1308, Pub. L. 99-570, title VIII, Sec. 8009, Oct. 27,
    1986, 100 Stat. 3207-163, related to termination of Commission
    three years after the date on which members of the Commission were
    first appointed unless the President extended the authority of the
    Commission by Executive order.


-MISC1-
                                SHORT TITLE                            
      Pub. L. 99-570, title VIII, Sec. 8001, Oct. 27, 1986, 100 Stat.
    3207-161, provided that title VIII of Pub. L. 99-570, which enacted
    this chapter, was to be cited as the "President's Media Commission
    on Alcohol and Drug Abuse Prevention Act".

-End-


-CITE-
    21 USC CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-
              CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS          

-MISC1-
    Sec.                                                     
    1401.       Pesticide monitoring and enforcement information.     
    1402.       Foreign pesticide information.                        
    1403.       Pesticide analytical methods.                         

-End-



-CITE-
    21 USC Sec. 1401                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-
    Sec. 1401. Pesticide monitoring and enforcement information

-STATUTE-
    (a) Data management systems
      (1) Not later than 480 days after August 23, 1988, the Secretary
    of Health and Human Services shall place in effect computerized
    data management systems for the Food and Drug Administration under
    which the Administration will - 
        (A) record, summarize, and evaluate the results of its program
      for monitoring food products for pesticide residues,
        (B) identify gaps in its pesticide monitoring program in the
      monitoring of (i) pesticides, (ii) food products, and (iii) food
      from specific countries and from domestic sources,
        (C) detect trends in the presence of pesticide residues in food
      products and identify public health problems emerging from the
      occurrence of pesticide residues in food products,
        (D) focus its testing resources for monitoring pesticide
      residues in food on detecting those residues which pose a public
      health concern,
        (E) prepare summaries of the information listed in subsection
      (b) of this section, and
        (F) provide information to assist the Environmental Protection
      Agency in carrying out its responsibilities under the Federal
      Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et
      seq.] and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
      et seq.].

      (2) As soon as practicable, the Secretary of Health and Human
    Services shall develop a means to enable the computerized data
    management systems placed into effect under paragraph (1) to make
    the summary described in subsection (c) of this section.
      (3)(A) Paragraph (1) does not limit the authority of the Food and
    Drug Administration to - 
        (i) use the computerized data management systems placed in
      effect under paragraph (1), or
        (ii) develop additional data management systems,

    to facilitate the regulation of any substance or product covered
    under the requirements of the Federal Food, Drug, and Cosmetic Act
    [21 U.S.C. 301 et seq.].
      (B) In placing into effect the computerized data management
    systems under paragraph (1) and in carrying out paragraph (2), the
    Secretary shall comply with applicable regulations governing
    computer system design and procurement.
    (b) Information
      The Food and Drug Administration shall use the computerized data
    management systems placed into effect under subsection (a)(1) of
    this section to prepare a summary of - 
        (1) information on - 
          (A) the types of imported and domestically produced food
        products analyzed for compliance with the requirements of the
        Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
        regarding the presence of pesticide residues,
          (B) the number of samples of each such food product analyzed
        for such compliance by country of origin,
          (C) the pesticide residues which may be detected using the
        testing methods employed,
          (D) the pesticide residues in such food detected and the
        levels detected,
          (E) the compliance status of each sample of such food tested
        and the violation rate for each country-product combination,
        and
          (F) the action taken with respect to each sample of such food
        found to be in violation of the Federal Food, Drug, and
        Cosmetic Act [21 U.S.C. 301 et seq.] and its ultimate
        disposition, and

        (2) information on - 
          (A) the country of origin of each imported food product
        referred to in paragraph (1)(A), and
          (B) the United States district of entry for each such
        imported food product.
    (c) Volume data
      The Food and Drug Administration shall use the computerized data
    management systems placed into effect under subsection (a)(1) of
    this section to summarize the volume of each type of food product
    subject to the requirements of the Federal Food, Drug, and Cosmetic
    Act [21 U.S.C. 301 et seq.] which is imported into the United
    States and which has an entry value which exceeds an amount
    established by the Secretary of Health and Human Services. The
    summary shall be made by country of origin and district of entry.
    Information with respect to volumes of food products to be included
    in the summary shall, to the extent feasible, be obtained from data
    bases of other Federal agencies.
    (d) Compilation
      Not later than 90 days after the expiration of 1 year after the
    data management systems are placed into effect under subsection (a)
    of this section and annually thereafter, the Secretary of Health
    and Human Services shall compile a summary of the information
    described in subsection (b) of this section with respect to the
    previous year. When the Food and Drug Administration is able to
    make summaries under subsection (c) of this section, the Secretary
    shall include in the compilation under the preceding sentence a
    compilation of the information described in subsection (c) of this
    section. Compilations under this subsection shall be made available
    to Federal and State agencies and other interested persons.

-SOURCE-
    (Pub. L. 100-418, title IV, Sec. 4702, Aug. 23, 1988, 102 Stat.
    1412.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Insecticide, Fungicide, and Rodenticide Act, referred
    to in subsec. (a)(1)(F), is act June 25, 1947, ch. 125, as amended
    generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
    classified generally to subchapter II (Sec. 136 et seq.) of chapter
    6 of Title 7, Agriculture. For complete classification of this Act
    to the Code, see Short Title note set out under section 136 of
    Title 7 and Tables.
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (a) to (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to chapter 9 (Sec. 301 et
    seq.) of this title. For complete classification of this Act to the
    Code, see section 301 of this title and Tables.


-MISC1-
                                SHORT TITLE                            
      Section 4701 of Pub. L. 100-418 provided that: "This subtitle
    [subtitle G (Secs. 4701-4704) of title IV of Pub. L. 100-418,
    enacting this chapter] may be cited as the 'Pesticide Monitoring
    Improvements Act of 1988'."

          IMPORTED MEAT, POULTRY PRODUCTS, EGGS, AND EGG PRODUCTS      
      Section 4506 of Pub. L. 100-418 provided that:
      "(a) Report. - Not later than 90 days after the date of the
    enactment of this Act [Aug. 23, 1988], the Secretary of Agriculture
    shall submit a report to Congress - 
        "(1) specifying the planned distribution, in fiscal years 1988
      and 1989, of the resources of the Department of Agriculture
      available for sampling imported covered products to ensure
      compliance with the requirements of the Federal Meat Inspection
      Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
      (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21
      U.S.C. 1031 et seq.) that govern the level of residues of
      pesticides, drugs, and other products permitted in or on such
      products;
        "(2) describing current methods used by the Secretary to
      enforce the requirements of such Acts with respect to the level
      of residues of pesticides, drugs, and other products permitted in
      or on such products;
        "(3) responding to the audit report of the Inspector General of
      the Department of Agriculture, Number 38002 - 2 - hy, dated
      January 14, 1987;
        "(4) providing a summary with respect to the importation of
      covered products during fiscal years 1987 and 1988 that specifies
      - 
          "(A) the number of samples of each such product taken during
        each such fiscal year in carrying out the requirements
        described in paragraph (1); and
          "(B) for each violation of such requirements during each such
        fiscal year - 
            "(i) the covered products with respect to which such
          violation occurred;
            "(ii) the residue in or on such product in violation of
          such requirements;
            "(iii) the country exporting such product;
            "(iv) the actions taken in response to such violation and
          the reasons for such actions; and
            "(v) the level of testing conducted by the countries
          exporting such products;
        "(5) describing any research conducted by the Secretary to
      develop improved methods to detect residues subject to such
      requirements in or on covered products; and
        "(6) providing any recommendations the Secretary considers
      appropriate for legislation to add or modify penalties for
      violations of laws, regulations, and other enforcement
      requirements governing the level of residues that are permitted
      in or on imported covered products.
      "(b) Revision. - Not later than November 15, 1989, the Secretary
    of Agriculture shall revise, as necessary, the report prepared
    under subsection (a) and submit the revision to Congress.
      "(c) Definition. - As used in this section, the term 'covered
    products' means meat, poultry products, eggs, and egg products."

-End-



-CITE-
    21 USC Sec. 1402                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-
    Sec. 1402. Foreign pesticide information

-STATUTE-
    (a) Cooperative agreements
      The Secretary of Health and Human Services shall enter into
    cooperative agreements with the governments of the countries which
    are the major sources of food imports into the United States
    subject to pesticide residue monitoring by the Food and Drug
    Administration for the purpose of improving the ability of the Food
    and Drug Administration to assure compliance with the pesticide
    tolerance requirements of the Federal Food, Drug, and Cosmetic Act
    [21 U.S.C. 301 et seq.] with regard to imported food.
    (b) Information activities
      (1) The cooperative agreements entered into under subsection (a)
    of this section with governments of foreign countries shall specify
    the action to be taken by the parties to the agreements to
    accomplish the purpose described in subsection (a) of this section,
    including the means by which the governments of the foreign
    countries will provide to the Secretary of Health and Human
    Services current information identifying each of the pesticides
    used in the production, transportation, and storage of food
    products imported from production regions of such countries into
    the United States.
      (2) In the case of a foreign country with which the Secretary is
    unable to enter into an agreement under subsection (a) of this
    section or for which the information provided under paragraph (1)
    is insufficient to assure an effective pesticide monitoring
    program, the Secretary shall, to the extent practicable, obtain the
    information described in paragraph (1) with respect to such country
    from other Federal or international agencies or private sources.
      (3) The Secretary of Health and Human Services shall assure that
    appropriate offices of the Food and Drug Administration which are
    engaged in the monitoring of imported food for pesticide residues
    receive the information obtained under paragraph (1) or (2).
      (4) The Secretary of Health and Human Services shall make
    available any information obtained under paragraph (1) or (2) to
    State agencies engaged in the monitoring of imported food for
    pesticide residues other than information obtained from private
    sources the disclosure of which to such agencies is restricted.
    (c) Coordination with other agencies
      The Secretary of Health and Human Services shall - 
        (1) notify in writing the Department of Agriculture, the
      Environmental Protection Agency, and the Department of State at
      the initiation of negotiations with a foreign country to develop
      a cooperative agreement under subsection (a) of this section; and
        (2) coordinate the activities of the Department of Health and
      Human Services with the activities of those departments and
      agencies, as appropriate, during the course of such negotiations.
    (d) Report
      Not later than one year after August 23, 1988, the Secretary of
    Health and Human Services shall report to the Committee on
    Agriculture, Nutrition, and Forestry and the Committee on Labor and
    Human Resources of the Senate and the House of Representatives on
    the activities undertaken by the Secretary to implement this
    section. The report shall be made available to appropriate Federal
    and State agencies and to interested persons.

-SOURCE-
    (Pub. L. 100-418, title IV, Sec. 4703, Aug. 23, 1988, 102 Stat.
    1413.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.

-End-



-CITE-
    21 USC Sec. 1403                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-
    Sec. 1403. Pesticide analytical methods

-STATUTE-
      The Secretary of Health and Human Services shall, in consultation
    with the Administrator of the Environmental Protection Agency - 
        (1) develop a detailed long-range plan and timetable for
      research that is necessary for the development of and validation
      of - 
          (A) new and improved analytical methods capable of detecting
        at one time the presence of multiple pesticide residues in
        food, and
          (B) rapid pesticide analytical methods, and

        (2) conduct a review to determine whether the use of rapid
      pesticide analytical methods by the Secretary would enable the
      Secretary to improve the cost-effectiveness of monitoring and
      enforcement activities under the Federal Food, Drug, and Cosmetic
      Act [21 U.S.C. 301 et seq.], including increasing the number of
      pesticide residues which can be detected and the number of tests
      for pesticide residues which can be conducted in a cost-effective
      manner.

    The Secretary shall report the plan developed under paragraph (1),
    the resources necessary to carry out the research described in such
    paragraph, recommendations for the implementation of such research,
    and the result of the review conducted under paragraph (2) not
    later than the expiration of 240 days after August 23, 1988, to the
    Committee on Agriculture, Nutrition, and Forestry and the Committee
    on Labor and Human Resources of the Senate and the House of
    Representatives.

-SOURCE-
    (Pub. L. 100-418, title IV, Sec. 4704, Aug. 23, 1988, 102 Stat.
    1414.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in text, is
    act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
    classified generally to chapter 9 (Sec. 301 et seq.) of this title.
    For complete classification of this Act to the Code, see section
    301 of this title and Tables.

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.

-End-


-CITE-
    21 USC CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM

-HEAD-
                CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM            


-MISC1-
           SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY       
    Sec.                                                     
    1501, 1502. Repealed.                                             
    1502a.      Transferred.                                          
    1503 to 1505. Repealed.                                           
    1505a.      Annual report on development and deployment of
                 narcotics detection technologies.                    
    1506 to 1509. Repealed.                                           

                   SUBCHAPTER II - DRUG-FREE COMMUNITIES               
    1521.       Findings.                                             
    1522.       Purposes.                                             
    1523.       Definitions.                                          
    1524.       Authorization of appropriations.                      

              PART A - DRUG-FREE COMMUNITIES SUPPORT PROGRAM          
    1531.       Establishment of drug-free communities support
                 program.                                             
    1532.       Program authorization.                                
    1533.       Information collection and dissemination with respect
                 to grant recipients.                                 
    1534.       Technical assistance and training.                    
    1535.       Supplemental grants for coalition mentoring
                 activities.                                          

                       PART B - ADVISORY COMMISSION                   
    1541.       Establishment of Advisory Commission.                 
    1542.       Duties.                                               
    1543.       Membership.                                           
    1544.       Compensation.                                         
    1545.       Terms of office.                                      
    1546.       Meetings.                                             
    1547.       Staff.                                                
    1548.       Termination.                                          

-End-


-CITE-
    21 USC SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL
           POLICY                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
           SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY       

-End-



-CITE-
    21 USC Secs. 1501, 1502                                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
    Secs. 1501, 1502. Repealed.

-MISC1-
    Secs. 1501, 1502. Repealed. Pub. L. 100-690, title I, Sec. 1009,
      Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, Sec.
      2(b), June 27, 1997, 111 Stat. 234.
      Section 1501, Pub. L. 100-690, title I, Sec. 1002, Nov. 18, 1988,
    102 Stat. 4181, established Office of National Drug Control Policy
    in Executive Office of President. See section 1702 of this title.
      Section 1502, Pub. L. 100-690, title I, Sec. 1003, Nov. 18, 1988,
    102 Stat. 4182; Pub. L. 103-322, title IX, Secs. 90201, 90202,
    90207, Sept. 13, 1994, 108 Stat. 1990, 1991, 1995, related to
    appointment and duties of Director, Deputy Directors, and Associate
    Director of Office of National Drug Control Policy. See section
    1703 of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100-
    690, as amended, which was formerly classified to section 1506 of
    this title.

                       SHORT TITLE OF 1997 AMENDMENT                   
      Pub. L. 105-20, Sec. 1, June 27, 1997, 111 Stat. 224, provided
    that: "This Act [enacting subchapter II of this chapter and
    amending former sections 1504, 1506 to 1508 of this title, section
    2291 of Title 22, Foreign Relations and Intercourse, and provisions
    set out as notes under this section] may be cited as the 'Drug-Free
    Communities Act of 1997'."

                                SHORT TITLE                            
      Section 1 of Pub. L. 100-690 provided that: "This Act [see Tables
    for classification] may be cited as the 'Anti-Drug Abuse Act of
    1988'."
      Section 1001 of Pub. L. 100-690 provided that: "This subtitle
    [subtitle A (Secs. 1001-1048) of title I of Pub. L. 100-690,
    enacting this chapter, amending section 1115 of this title,
    sections 5312, 5314, and 5315 of Title 5, Government Organization
    and Employees, section 1105 of Title 31, Money and Finance, and
    section 402 of Title 50, War and National Defense, repealing
    sections 1103, 1111 to 1114, 1116, and 1201 to 1204 of this title,
    enacting provisions set out as notes under sections 1201 and 1501
    of this title, and repealing provisions set out as notes under
    section 1201 of this title may be cited as the 'National Narcotics
    Leadership Act of 1988'."

                REFERENCES TO SUBTITLE A OF PUB. L. 100-690            
      Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111 Stat. 234, provided
    that: "Each reference in Federal law to subtitle A of the Anti-Drug
    Abuse Act of 1988 [see section 1001 of Pub. L. 100-690, set out
    above], with the exception of section 1001 of such subtitle, in any
    provision of law that is in effect on the day before the date of
    enactment of this Act [June 27, 1997] shall be deemed to be a
    reference to chapter 1 of the National Narcotics Leadership Act of
    1988 [chapter 1 of subtitle A (Secs. 1002-1012) of title I of Pub.
    L. 100-690, see Tables for classification] (as so designated by
    this section)."

-End-



-CITE-
    21 USC Sec. 1502a                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1502a. Transferred

-COD-
                               CODIFICATION                           
      Section, Pub. L. 100-690, title I, Sec. 1003A, as added Pub. L.
    101-510, div. A, title X, Sec. 1011, Nov. 5, 1990, 104 Stat. 1633,
    and amended, which related to the Counter-Drug Technology
    Assessment Center, was renumbered section 1008 of Pub. L. 100-690
    by Pub. L. 103-322, title IX, Sec. 90204(c)(2), (3), Sept. 13,
    1994, 108 Stat. 1994, and transferred to former section 1505 of
    this title.

-End-



-CITE-
    21 USC Secs. 1503 to 1505                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
    Secs. 1503 to 1505. Repealed.

-MISC1-
    Secs. 1503 to 1505. Repealed. Pub. L. 100-690, title I, Sec. 1009,
      Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, Sec.
      2(b), June 27, 1997, 111 Stat. 234.
      Section 1503, Pub. L. 100-690, title I, Sec. 1004, Nov. 18, 1988,
    102 Stat. 4184, related to coordination between Office of National
    Drug Control Policy and executive branch departments and agencies.
    See section 1704 of this title.
      Section 1504, Pub. L. 100-690, title I, Sec. 1005, Nov. 18, 1988,
    102 Stat. 4185; Pub. L. 103-322, title IX, Sec. 90203, Sept. 13,
    1994, 108 Stat. 1991; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111
    Stat. 234, related to annual development and submission of National
    Drug Control Strategy by President to Congress. See section 1705 of
    this title.
      Section 1505, Pub. L. 100-690, title I, Sec. 1008, formerly Sec.
    1003A, as added Pub. L. 101-510, div. A, title X, Sec. 1011, Nov.
    5, 1990, 104 Stat. 1633; renumbered Sec. 1008 and amended Pub. L.
    103-322, title IX, Sec. 90204(a), (b), (c)(2), (3), Sept. 13, 1994,
    108 Stat. 1993, 1994, established Counter-Drug Technology
    Assessment Center within Office of National Drug Control Policy.
    See section 1707 of this title.
      A prior section 1505, Pub. L. 100-690, title I, Sec. 1008, Nov.
    18, 1988, 102 Stat. 4188, provided for an executive reorganization
    study and report to Congress and the President no later than Jan.
    15, 1990, prior to repeal by Pub. L. 103-322, Sec. 90204(c)(1).

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100-
    690, as amended, which was formerly classified to section 1506 of
    this title.

-End-



-CITE-
    21 USC Sec. 1505a                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1505a. Annual report on development and deployment of
      narcotics detection technologies

-STATUTE-
    (a) Report requirement
      Not later than December 1st of each year, the Director of the
    Office of National Drug Control Policy shall submit to Congress and
    the President a report on the development and deployment of
    narcotics detection technologies by Federal agencies. Each such
    report shall be prepared in consultation with the Secretary of
    Defense, the Secretary of State, the Secretary of Homeland
    Security, and the Secretary of the Treasury.
    (b) Matters to be included
      Each report under subsection (a) of this section shall include - 
        (1) a description of each project implemented by a Federal
      agency relating to the development or deployment of narcotics
      detection technology;
        (2) the agency responsible for each project described in
      paragraph (1);
        (3) the amount of funds obligated or expended to carry out each
      project described in paragraph (1) during the fiscal year in
      which the report is submitted or during any fiscal year preceding
      the fiscal year in which the report is submitted;
        (4) the amount of funds estimated to be obligated or expended
      for each project described in paragraph (1) during any fiscal
      year after the fiscal year in which the report is submitted to
      Congress; and
        (5) a detailed timeline for implementation of each project
      described in paragraph (1).

-SOURCE-
    (Pub. L. 105-85, div. A, title X, Sec. 1034, Nov. 18, 1997, 111
    Stat. 1884; Pub. L. 107-296, title XVII, Sec. 1704(e)(10), Nov. 25,
    2002, 116 Stat. 2315.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the National Defense Authorization
    Act for Fiscal Year 1998, and not as part of the National Narcotics
    Leadership Act of 1988 which comprises this chapter.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-296 substituted "of Homeland
    Security" for "of Transportation".

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Amendment by Pub. L. 107-296 effective on the date of transfer of
    the Coast Guard to the Department of Homeland Security, see section
    1704(g) of Pub. L. 107-296, set out as a note under section 101 of
    Title 10, Armed Forces.

-End-



-CITE-
    21 USC Secs. 1506 to 1508                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
    Secs. 1506 to 1508. Repealed.

-MISC1-
    Secs. 1506 to 1508. Repealed. Pub. L. 100-690, title I, Sec. 1009,
      Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, Sec.
      2(b), June 27, 1997, 111 Stat. 234.
      Section 1506, Pub. L. 100-690, title I, Sec. 1009, Nov. 18, 1988,
    102 Stat. 4188; Pub. L. 103-322, title IX, Sec. 90208(a), Sept. 13,
    1994, 108 Stat. 1995; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111
    Stat. 234, repealed this subchapter, and the amendments made by
    this subchapter, except for section 1007, effective Sept. 30, 1997.
      Section 1507, Pub. L. 100-690, title I, Sec. 1010, Nov. 18, 1988,
    102 Stat. 4188; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111 Stat.
    234, defined terms for purposes of this subchapter. See section
    1701 of this title.
      Section 1508, Pub. L. 100-690, title I, Sec. 1011, Nov. 18, 1988,
    102 Stat. 4189; Pub. L. 103-322, title IX, Sec. 90206, Sept. 13,
    1994, 108 Stat. 1995; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111
    Stat. 234, authorized appropriations to carry out this subchapter.
    See section 1711 of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100-
    690, as amended, which was formerly classified to section 1506 of
    this title.

-End-



-CITE-
    21 USC Sec. 1509                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1509. Repealed.

-MISC1-
    Sec. 1509. Repealed. Pub. L. 109-469, title XI, Sec. 1101(b), Dec.
      29, 2006, 120 Stat. 3539.
      Section, Pub. L. 100-690, title VI, Sec. 6073, Nov. 18, 1988, 102
    Stat. 4323; Pub. L. 101-647, title XX, Sec. 2001(b), Nov. 29, 1990,
    104 Stat. 4854; Pub. L. 102-393, title VI, Sec. 638(c), Oct. 6,
    1992, 106 Stat. 1788; Pub. L. 103-322, title IX, Sec. 90205(a),
    (d), Sept. 13, 1994, 108 Stat. 1994, 1995; Pub. L. 105-277, div. C,
    title VII, Sec. 712, Oct. 21, 1998, 112 Stat. 2681-692, related to
    establishment of Special Forfeiture Fund.

-End-


-CITE-
    21 USC SUBCHAPTER II - DRUG-FREE COMMUNITIES                01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES

-HEAD-
                   SUBCHAPTER II - DRUG-FREE COMMUNITIES               

-End-



-CITE-
    21 USC Sec. 1521                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES

-HEAD-
    Sec. 1521. Findings

-STATUTE-
      Congress finds the following:
        (1) Substance abuse among youth has more than doubled in the 5-
      year period preceding 1996, with substantial increases in the
      use of marijuana, inhalants, cocaine, methamphetamine, LSD, and
      heroin.
        (2) The most dramatic increases in substance abuse has occurred
      among 13- and 14-year-olds.
        (3) Casual or periodic substance abuse by youth today will
      contribute to hard core or chronic substance abuse by the next
      generation of adults.
        (4) Substance abuse is at the core of other problems, such as
      rising violent teenage and violent gang crime, increasing health
      care costs, HIV infections, teenage pregnancy, high school
      dropouts, and lower economic productivity.
        (5) Increases in substance abuse among youth are due in large
      part to an erosion of understanding by youth of the high risks
      associated with substance abuse, and to the softening of peer
      norms against use.
        (6)(A) Substance abuse is a preventable behavior and a
      treatable disease; and
        (B)(i) during the 13-year period beginning with 1979, monthly
      use of illegal drugs among youth 12 to 17 years of age declined
      by over 70 percent; and
        (ii) data suggests that if parents would simply talk to their
      children regularly about the dangers of substance abuse, use
      among youth could be expected to decline by as much as 30
      percent.
        (7) Community anti-drug coalitions throughout the United States
      are successfully developing and implementing comprehensive, long-
      term strategies to reduce substance abuse among youth on a
      sustained basis.
        (8) Intergovernmental cooperation and coordination through
      national, State, and local or tribal leadership and partnerships
      are critical to facilitate the reduction of substance abuse among
      youth in communities throughout the United States.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1021, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 224.)


-MISC1-
       FIVE-YEAR EXTENSION OF DRUG-FREE COMMUNITIES SUPPORT PROGRAM   
      Pub. L. 107-82, Sec. 1(a), Dec. 14, 2001, 115 Stat. 814, provided
    that: "Congress makes the following findings:
        "(1) In the next 15 years, the youth population in the United
      States will grow by 21 percent, adding 6,500,000 youth to the
      population of the United States. Even if drug use rates remain
      constant, there will be a huge surge in drug-related problems,
      such as academic failure, drug-related violence, and HIV
      incidence, simply due to this population increase.
        "(2) According to the 1994-1996 National Household Survey, 60
      percent of students age 12 to 17 who frequently cut classes and
      who reported delinquent behavior in the past 6 months used
      marijuana 52 days or more in the previous year.
        "(3) The 2000 Washington Kids Count survey conducted by the
      University of Washington reported that students whose peers have
      little or no involvement with drinking and drugs have higher math
      and reading scores than students whose peers had low level
      drinking or drug use.
        "(4) Substance abuse prevention works. In 1999, only 10 percent
      of teens saw marijuana users as popular, compared to 17 percent
      in 1998 and 19 percent in 1997. The rate of past-month use of any
      drug among 12- to 17-year-olds declined 26 percent between 1997
      and 1999. Marijuana use for sixth through eighth graders is at
      the lowest point in 5 years, as is use of cocaine, inhalants, and
      hallucinogens.
        "(5) Community Anti-Drug Coalitions throughout the United
      States are successfully developing and implementing
      comprehensive, long-term strategies to reduce substance abuse
      among youth on a sustained basis. For example:
          "(A) The Boston Coalition brought college and university
        presidents together to create the Cooperative Agreement on
        Underage Drinking. This agreement represents the first
        coordinated effort of Boston's many institutions of higher
        education to address issues such as binge drinking, underage
        drinking, and changing the norms surrounding alcohol abuse that
        exist on college and university campuses.
          "(B) In 2000, the Coalition for a Drug-Free Greater
        Cincinnati surveyed more than 47,000 local students in grades 7
        through 12. The results provided evidence that the Coalition's
        initiatives are working. For the first time in a decade, teen
        drug use in Greater Cincinnati appears to be leveling off. The
        data collected from the survey has served as a tool to
        strengthen relationships between schools and communities, as
        well as facilitate the growth of anti-drug coalitions in
        communities where such coalitions had not existed.
          "(C) The Miami Coalition used a three-part strategy to
        decrease the percentage of high school seniors who reported
        using marijuana at least once during the most recent 30-day
        period. The development of a media strategy, the creation of a
        network of prevention agencies, and discussions with high
        school students about the dangers of marijuana all contributed
        to a decrease in the percentage of seniors who reported using
        marijuana from over 22 percent in 1995 to 9 percent in 1997.
        The Miami Coalition was able to achieve these results while
        national rates of marijuana use were increasing.
          "(D) The Nashville Prevention Partnership worked with
        elementary and middle school children in an attempt to
        influence them toward positive life goals and discourage them
        from using substances. The Partnership targeted an area in East
        Nashville and created after school programs, mentoring
        opportunities, attendance initiatives, and safe passages to and
        from school. Attendance and test scores increased as a result
        of the program.
          "(E) At a youth-led town meeting sponsored by the Bering
        Strait Community Partnership in Nome, Alaska, youth identified
        a need for a safe, substance-free space. With help from a
        variety of community partners, the Partnership staff and youth
        members created the Java Hut, a substance-free coffeehouse
        designed for youth. The Java Hut is helping to change norms in
        the community by providing a fun, youth-friendly atmosphere and
        activities that are not centered around alcohol or marijuana.
          "(F) Portland's Regional Drug Initiative (RDI) has promoted
        the establishment of drug-free workplaces among the city's
        large and small employers. Over 3,000 employers have attended
        an RDI training session, and of those, 92 percent have
        instituted drug-free workplace policies. As a result, there has
        been a 5.5 percent decrease in positive workplace drug tests.
          "(G) San Antonio Fighting Back worked to increase the age at
        which youth first used illegal substances. Research suggests
        that the later the age of first use, the lower the risk that a
        young person will become a regular substance abuser. As a
        result, the age of first illegal drug use increased from 9.4
        years in 1992 to 13.5 years in 1997.
          "(H) In 1990, multiple data sources confirmed a trend of
        increased alcohol use by teenagers in the Troy community. Using
        its 'multiple strategies over multiple sectors' approach, the
        Troy Coalition worked with parents, physicians, students,
        coaches, and others to address this problem from several
        angles. As a result, the rate of twelfth grade students who had
        consumed alcohol in the past month decreased from 62.1 percent
        to 53.3 percent between 1991 and 1998, and the rate of eighth
        grade students decreased from 26.3 percent to 17.4 percent. The
        Troy Coalition believes that this decline represents not only a
        change in behavior on the part of students, but also a change
        in the norms of the community.
        "(6) Despite these successes, drug use continues to be a
      serious problem facing communities across the United States. For
      example:
          "(A) According to the Pulse Check: Trends in Drug Abuse Mid-
        Year 2000 report - 
            "(i) crack and powder cocaine remains the most serious drug
          problem;
            "(ii) marijuana remains the most widely available illicit
          drug, and its potency is on the rise;
            "(iii) treatment sources report an increase in admissions
          with marijuana as the primary drug of abuse - and adolescents
          outnumber other age groups entering treatment for marijuana;
            "(iv) 80 percent of Pulse Check sources reported increased
          availability of club drugs, with ecstasy (MDMA) and ketamine
          the most widely cited club drugs and seven sources reporting
          that powder cocaine is being used as a club drug by young
          adults;
            "(v) ecstasy abuse and trafficking is expanding, no longer
          confined to the 'rave' scene;
            "(vi) the sale and use of club drugs has grown from
          nightclubs and raves to high schools, the streets,
          neighborhoods, open venues, and younger ages;
            "(vii) ecstasy users often are unknowingly purchasing
          adulterated tablets or some other substance sold as MDMA; and
            "(viii) along with reports of increased heroin snorting as
          a route of administration for initiates, there is also an
          increase in injecting initiates and the negative health
          consequences associated with injection (for example,
          increases in HIV/AIDS and Hepatitis C) suggesting that there
          is a generational forgetting of the dangers of injection of
          the drug.
          "(B) The 2000 Parent's Resource Institute for Drug Education
        study reported that 23.6 percent of children in the sixth
        through twelfth grades used illicit drugs in the past year. The
        same study found that monthly usage among this group was 15.3
        percent.
          "(C) According to the 2000 Monitoring the Future study, the
        use of ecstasy among eighth graders increased from 1.7 percent
        in 1999 to 3.1 percent in 2000, among tenth graders from 4.4
        percent to 5.4 percent, and from 5.6 percent to 8.2 percent
        among twelfth graders.
          "(D) A 1999 Mellman Group study found that - 
            "(i) 56 percent of the population in the United States
          believed that drug use was increasing in 1999;
            "(ii) 92 percent of the population viewed illegal drug use
          as a serious problem in the United States; and
            "(iii) 73 percent of the population viewed illegal drug use
          as a serious problem in their communities.
        "(7) According to the 2001 report of the National Center on
      Addiction and Substance Abuse at Columbia University entitled
      'Shoveling Up: The Impact of Substance Abuse on State Budgets',
      using the most conservative assumption, in 1998 States spent
      $77,900,000,000 to shovel up the wreckage of substance abuse,
      only $3,000,000,000 to prevent and treat the problem and
      $433,000,000 for alcohol and tobacco regulation and compliance.
      This $77,900,000,000 burden was distributed as follows:
          "(A) $30,700,000,000 in the justice system (77 percent of
        justice spending).
          "(B) $16,500,000,000 in education costs (10 percent of
        education spending).
          "(C) $15,200,000,000 in health costs (25 percent of health
        spending).
          "(D) $7,700,000,000 in child and family assistance (32
        percent of child and family assistance spending).
          "(E) $5,900,000,000 in mental health and developmental
        disabilities (31 percent of mental health spending).
          "(F) $1,500,000,000 in public safety (26 percent of public
        safety spending) and $400,000,000 for the state workforce.
        "(8) Intergovernmental cooperation and coordination through
      national, State, and local or tribal leadership and partnerships
      are critical to facilitate the reduction of substance abuse among
      youth in communities across the United States.
        "(9) Substance abuse is perceived as a much greater problem
      nationally than at the community level. According to a 2001 study
      sponsored by The Pew Charitable Trusts, between 1994 and 2000 - 
          "(A) there was a 43 percent increase in the percentage of
        Americans who felt progress was being made in the war on drugs
        at the community level;
          "(B) only 9 percent of Americans say drug abuse is a 'crisis'
        in their neighborhood, compared to 27 percent who say this
        about the nation; and
          "(C) the percentage of those who felt we lost ground in the
        war on drugs on a community level fell by more than a quarter,
        from 51 percent in 1994 to 37 percent in 2000."

     AUTHORIZATION FOR NATIONAL COMMUNITY ANTIDRUG COALITION INSTITUTE 
      Pub. L. 107-82, Sec. 4, Dec. 14, 2001, 115 Stat. 821, as amended
    by Pub. L. 109-469, title VIII, Sec. 805, Dec. 29, 2006, 120 Stat.
    3535, provided that:
      "(a) In General. - The Director of the Office of National Drug
    Control Policy shall, using amounts authorized to be appropriated
    by subsection (d), make a directed grant to Community Anti-Drug
    Coalitions of America to provide for the continuation of the
    National Community Anti-drug Coalition Institute.
      "(b) Use of Grant Amount. - The organization receiving the grant
    under subsection (a) shall establish a National Community Antidrug
    Coalition Institute to - 
        "(1) provide education, training, and technical assistance for
      coalition leaders and community teams, with emphasis on the
      development of coalitions serving economically disadvantaged
      areas;
        "(2) develop and disseminate evaluation tools, mechanisms, and
      measures to better assess and document coalition performance
      measures and outcomes; and
        "(3) bridge the gap between research and practice by
      translating knowledge from research into practical information.
      "(c) Authorization of Appropriations. - There is authorized to be
    appropriated for purposes of activities under this section,
    including the grant under subsection (a), amounts as follows:
        "(1) For each of fiscal years 2002 and 2003, $2,000,000.
        "(2) For each of fiscal years 2004 and 2005, $1,000,000.
        "(3) For each of fiscal years 2006 and 2007, $750,000.
        "(4) For each of the fiscal years 2008 through 2012,
      $2,000,000."

                 PROHIBITION AGAINST DUPLICATION OF EFFORT             
      Pub. L. 107-82, Sec. 5, Dec. 14, 2001, 115 Stat. 821, provided
    that: "The Director of the Office of National Drug Control Policy
    shall ensure that the same or similar activities are not carried
    out, through the use of funds for administrative costs provided
    under subchapter II [probably means chapter 2] of the National
    Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.) or funds
    provided under section 4 of this Act [set out as a note above], by
    more than one recipient of such funds."

-End-



-CITE-
    21 USC Sec. 1522                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES

-HEAD-
    Sec. 1522. Purposes

-STATUTE-
      The purposes of this subchapter are - 
        (1) to reduce substance abuse among youth in communities
      throughout the United States, and over time, to reduce substance
      abuse among adults;
        (2) to strengthen collaboration among communities, the Federal
      Government, and State, local, and tribal governments;
        (3) to enhance intergovernmental cooperation and coordination
      on the issue of substance abuse among youth;
        (4) to serve as a catalyst for increased citizen participation
      and greater collaboration among all sectors and organizations of
      a community that first demonstrates a long-term commitment to
      reducing substance abuse among youth;
        (5) to rechannel resources from the fiscal year 1998 Federal
      drug control budget to provide technical assistance, guidance,
      and financial support to communities that demonstrate a long-term
      commitment in reducing substance abuse among youth;
        (6) to disseminate to communities timely information regarding
      the state-of-the-art practices and initiatives that have proven
      to be effective in reducing substance abuse among youth;
        (7) to enhance, not supplant, local community initiatives for
      reducing substance abuse among youth; and
        (8) to encourage the creation of and support for community anti-
      drug coalitions throughout the United States.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1022, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 225.)

-End-



-CITE-
    21 USC Sec. 1523                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES

-HEAD-
    Sec. 1523. Definitions

-STATUTE-
      In this subchapter:
      (1) Administrator
        The term "Administrator" means the Administrator appointed by
      the Director under section 1531(c) of this title.
      (2) Advisory Commission
        The term "Advisory Commission" means the Advisory Commission
      established under section 1541 of this title.
      (3) Community
        The term "community" shall have the meaning provided that term
      by the Administrator, in consultation with the Advisory
      Commission.
      (4) Director
        The term "Director" means the Director of the Office of
      National Drug Control Policy.
      (5) Eligible coalition
        The term "eligible coalition" means a coalition that meets the
      applicable criteria under section 1532(a) of this title.
      (6) Grant recipient
        The term "grant recipient" means the recipient of a grant award
      under section 1532 of this title.
      (7) Nonprofit organization
        The term "nonprofit organization" means an organization
      described under section 501(c)(3) of title 26 that is exempt from
      taxation under section 501(a) of title 26.
      (8) Program
        The term "Program" means the program established under section
      1531(a) of this title.
      (9) Substance abuse
        The term "substance abuse" means - 
          (A) the illegal use or abuse of drugs, including substances
        listed in schedules I through V of section 812 of this title;
          (B) the abuse of inhalants; or
          (C) the use of alcohol, tobacco, or other related product as
        such use is prohibited by State or local law.
      (10) Youth
        The term "youth" shall have the meaning provided that term by
      the Administrator, in consultation with the Advisory Commission.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1023, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 225.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 812 of this title, referred to in par. (9)(A), was in the
    original "section 112 of the Controlled Substances Act (21 U.S.C.
    812)", and was translated as reading "section 202", meaning section
    202 of Pub. L. 91-513, to reflect the probable intent of Congress,
    because Pub. L. 91-513 does not contain a section 112.

-End-



-CITE-
    21 USC Sec. 1524                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES

-HEAD-
    Sec. 1524. Authorization of appropriations

-STATUTE-
    (a) In general
      There are authorized to be appropriated to the Office of National
    Drug Control Policy to carry out this subchapter - 
        (1) $10,000,000 for fiscal year 1998;
        (2) $20,000,000 for fiscal year 1999;
        (3) $30,000,000 for fiscal year 2000;
        (4) $40,000,000 for fiscal year 2001;
        (5) $50,600,000 for fiscal year 2002;
        (6) $60,000,000 for fiscal year 2003;
        (7) $70,000,000 for fiscal year 2004;
        (8) $80,000,000 for fiscal year 2005;
        (9) $90,000,000 for fiscal year 2006;
        (10) $99,000,000 for fiscal year 2007;
        (11) $109,000,000 for fiscal year 2008;
        (12) $114,000,000 for fiscal year 2009;
        (13) $119,000,000 for fiscal year 2010;
        (14) $124,000,000 for fiscal year 2011; and
        (15) $129,000,000 for fiscal year 2012.
    (b) Administrative costs
      (1) Limitation
        Not more than 3 percent of the funds appropriated for this
      subchapter may be used by the Office of National Drug Control
      Policy to pay for administrative costs associated with their
      responsibilities under the subchapter.
      (2) Designated agency
        The agency delegated to carry out this program under section
      1531(d) of this title may use up to 5 percent of the funds
      allocated for grants under this subchapter for administrative
      costs associated with carrying out the program.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1024, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 226; amended Pub. L. 107-82, Sec.
    1(b), (c), Dec. 14, 2001, 115 Stat. 817; Pub. L. 109-469, title
    VIII, Sec. 801, Dec. 29, 2006, 120 Stat. 3535.)

-COD-
                               CODIFICATION                           
      Pub. L. 109-469, Sec. 801, which directed amendment of section
    1024 of the "Drug-Free Communities Act of 1997", was executed to
    this section, which is section 1024 of the National Narcotics
    Leadership Act of 1988, to reflect the probable intent of Congress.
    See 2006 Amendment notes below.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a)(11) to (15). Pub. L. 109-469, Sec. 801(a),
    added pars. (11) to (15). See Codification note above.
      Subsec. (b). Pub. L. 109-469, Sec. 801(b), amended subsec. (b)
    generally. See Codification note above. Prior to amendment, text
    read as follows: "Not more than the following percentages of the
    amounts authorized under subsection (a) of this section may be used
    to pay administrative costs:
        "(1) 10 percent for fiscal year 1998.
        "(2) 6 percent for fiscal year 1999.
        "(3) 4 percent for fiscal year 2000.
        "(4) 3 percent for fiscal year 2001.
        "(5) 6 percent for each of fiscal years 2002 through 2007."
      2001 - Subsec. (a)(5) to (10). Pub. L. 107-82, Sec. 1(b), added
    pars. (5) to (10) and struck out former par. (5) which read as
    follows: "$43,500,000 for fiscal year 2002."
      Subsec. (b)(5). Pub. L. 107-82, Sec. 1(c), added par. (5) and
    struck out former par. (5) which read as follows: "3 percent for
    fiscal year 2002."

-End-


-CITE-
    21 USC Part A - Drug-Free Communities Support Program       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part A - Drug-Free Communities Support Program

-HEAD-
              PART A - DRUG-FREE COMMUNITIES SUPPORT PROGRAM          

-End-



-CITE-
    21 USC Sec. 1531                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part A - Drug-Free Communities Support Program

-HEAD-
    Sec. 1531. Establishment of drug-free communities support program

-STATUTE-
    (a) Establishment
      The Director shall establish a program to support communities in
    the development and implementation of comprehensive, long-term
    plans and programs to prevent and treat substance abuse among
    youth.
    (b) Program
      In carrying out the Program, the Director shall - 
        (1) make and track grants to grant recipients;
        (2) provide for technical assistance and training, data
      collection, and dissemination of information on state-of-the-art
      practices that the Director determines to be effective in
      reducing substance abuse; and
        (3) provide for the general administration of the Program.
    (c) Administration
      Not later than 30 days after receiving recommendations from the
    Advisory Commission under section 1542(a)(1) of this title, the
    Director shall appoint an Administrator to carry out the Program.
    (d) Contracting
      The Director may employ any necessary staff and may enter into
    contracts or agreements with national drug control agencies,
    including interagency agreements to delegate authority for the
    execution of grants and for such other activities necessary to
    carry out this subchapter.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1031, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 226.)

-End-



-CITE-
    21 USC Sec. 1532                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part A - Drug-Free Communities Support Program

-HEAD-
    Sec. 1532. Program authorization

-STATUTE-
    (a) Grant eligibility
      To be eligible to receive an initial grant or a renewal grant
    under this part, a coalition shall meet each of the following
    criteria:
      (1) Application
        The coalition shall submit an application to the Administrator
      in accordance with section 1533(a)(2) of this title.
      (2) Major sector involvement
        (A) In general
          The coalition shall consist of 1 or more representatives of
        each of the following categories:
            (i) Youth.
            (ii) Parents.
            (iii) Businesses.
            (iv) The media.
            (v) Schools.
            (vi) Organizations serving youth.
            (vii) Law enforcement.
            (viii) Religious or fraternal organizations.
            (ix) Civic and volunteer groups.
            (x) Health care professionals.
            (xi) State, local, or tribal governmental agencies with
          expertise in the field of substance abuse (including, if
          applicable, the State authority with primary authority for
          substance abuse).
            (xii) Other organizations involved in reducing substance
          abuse.
        (B) Elected officials
          If feasible, in addition to representatives from the
        categories listed in subparagraph (A), the coalition shall have
        an elected official (or a representative of an elected
        official) from - 
            (i) the Federal Government; and
            (ii) the government of the appropriate State and political
          subdivision thereof or the governing body or an Indian tribe
          (as that term is defined in section 450b(e) of title 25).
        (C) Representation
          An individual who is a member of the coalition may serve on
        the coalition as a representative of not more than 1 category
        listed under subparagraph (A).
      (3) Commitment
        The coalition shall demonstrate, to the satisfaction of the
      Administrator - 
          (A) that the representatives of the coalition have worked
        together on substance abuse reduction initiatives, which, at a
        minimum, includes initiatives that target drugs referenced in
        section 1523(9)(A) of this title, for a period of not less than
        6 months, acting through entities such as task forces,
        subcommittees, or community boards; and
          (B) substantial participation from volunteer leaders in the
        community involved (especially in cooperation with individuals
        involved with youth such as parents, teachers, coaches, youth
        workers, and members of the clergy).
      (4) Mission and strategies
        The coalition shall, with respect to the community involved - 
          (A) have as its principal mission the reduction of substance
        abuse, which, at a minimum, includes the use and abuse of drugs
        referenced in section 1523(9)(A) of this title, in a
        comprehensive and long-term manner, with a primary focus on
        youth in the community;
          (B) describe and document the nature and extent of the
        substance abuse problem, which, at a minimum, includes the use
        and abuse of drugs referenced in section 1523(9)(A) of this
        title, in the community;
          (C)(i) provide a description of substance abuse prevention
        and treatment programs and activities, which, at a minimum,
        includes programs and activities relating to the use and abuse
        of drugs referenced in section 1523(9)(A) of this title, in
        existence at the time of the grant application; and
          (ii) identify substance abuse programs and service gaps,
        which, at a minimum, includes programs and gaps relating to the
        use and abuse of drugs referenced in section 1523(9)(A) of this
        title, in the community;
          (D) develop a strategic plan to reduce substance abuse among
        youth, which, at a minimum, includes the use and abuse of drugs
        referenced in section 1523(9)(A) of this title, in a
        comprehensive and long-term fashion; and
          (E) work to develop a consensus regarding the priorities of
        the community to combat substance abuse among youth, which, at
        a minimum, includes the use and abuse of drugs referenced in
        section 1523(9)(A) of this title.
      (5) Sustainability
        The coalition shall demonstrate that the coalition is an
      ongoing concern by demonstrating that the coalition - 
          (A) is - 
            (i)(I) a nonprofit organization; or
            (II) an entity that the Administrator determines to be
          appropriate; or
            (ii) part of, or is associated with, an established legal
          entity;

          (B) receives financial support (including, in the discretion
        of the Administrator, in-kind contributions) from non-Federal
        sources; and
          (C) has a strategy to solicit substantial financial support
        from non-Federal sources to ensure that the coalition and the
        programs operated by the coalition are self-sustaining.
      (6) Accountability
        The coalition shall - 
          (A) establish a system to measure and report outcomes - 
            (i) consistent with common indicators and evaluation
          protocols established by the Administrator; and
            (ii) approved by the Administrator;

          (B) conduct - 
            (i) for an initial grant under this part, an initial
          benchmark survey of drug use among youth (or use local
          surveys or performance measures available or accessible in
          the community at the time of the grant application); and
            (ii) biennial surveys (or incorporate local surveys in
          existence at the time of the evaluation) to measure the
          progress and effectiveness of the coalition; and

          (C) provide assurances that the entity conducting an
        evaluation under this paragraph, or from which the coalition
        receives information, has experience - 
            (i) in gathering data related to substance abuse among
          youth; or
            (ii) in evaluating the effectiveness of community anti-drug
          coalitions.
      (7) Additional criteria
        The Director shall not impose any eligibility criteria on new
      applicants or renewal grantees not provided in this subchapter.
    (b) Grant amounts
      (1) In general
        (A) Grants
          (i) In general
            Subject to clause (iv), for a fiscal year, the
          Administrator may grant to an eligible coalition under this
          paragraph, an amount not to exceed the amount of non-Federal
          funds raised by the coalition, including in-kind
          contributions, for that fiscal year.
          (ii) Suspension of grants
            If such grant recipient fails to continue to meet the
          criteria specified in subsection (a) of this section, the
          Administrator may suspend the grant, after providing written
          notice to the grant recipient and an opportunity to appeal.
          (iii) Renewal grants
            Subject to clause (iv), the Administrator may award a
          renewal grant to a grant recipient under this subparagraph
          for each fiscal year following the fiscal year for which an
          initial grant is awarded, in an amount not to exceed the
          amount of non-Federal funds raised by the coalition,
          including in-kind contributions, for that fiscal year, during
          the 4-year period following the period of the initial grant.
          (iv) Limitation
            The amount of a grant award under this subparagraph may not
          exceed $125,000 for a fiscal year.
        (B) Coalition awards
          (i) In general
            Except as provided in clause (ii), the Administrator may,
          with respect to a community, make a grant to 1 eligible
          coalition that represents that community.
          (ii) Exception
            The Administrator may make a grant to more than 1 eligible
          coalition that represents a community if - 
              (I) the eligible coalitions demonstrate that the
            coalitions are collaborating with one another; and
              (II) each of the coalitions has independently met the
            requirements set forth in subsection (a) of this section.
      (2) Rural coalition grants
        (A) In general
          (i) In general
            In addition to awarding grants under paragraph (1), to
          stimulate the development of coalitions in sparsely populated
          and rural areas, the Administrator, in consultation with the
          Advisory Commission, may award a grant in accordance with
          this section to a coalition that represents a county with a
          population that does not exceed 30,000 individuals. In
          awarding a grant under this paragraph, the Administrator may
          waive any requirement under subsection (a) of this section if
          the Administrator considers that waiver to be appropriate.
          (ii) Matching requirement
            Subject to subparagraph (C), for a fiscal year, the
          Administrator may grant to an eligible coalition under this
          paragraph, an amount not to exceed the amount of non-Federal
          funds raised by the coalition, including in-kind
          contributions, for that fiscal year.
          (iii) Suspension of grants
            If such grant recipient fails to continue to meet any
          criteria specified in subsection (a) of this section that has
          not been waived by the Administrator pursuant to clause (i),
          the Administrator may suspend the grant, after providing
          written notice to the grant recipient and an opportunity to
          appeal.
        (B) Renewal grants
          The Administrator may award a renewal grant to an eligible
        coalition that is a grant recipient under this paragraph for
        each fiscal year following the fiscal year for which an initial
        grant is awarded, in an amount not to exceed the amount of non-
        Federal funds raised by the coalition, including in-kind
        contributions, during the 4-year period following the period of
        the initial grant.
        (C) Limitations
          (i) Amount
            The amount of a grant award under this paragraph shall not
          exceed $125,000 for a fiscal year.
          (ii) Awards
            With respect to a county referred to in subparagraph (A),
          the Administrator may award a grant under this section to not
          more than 1 eligible coalition that represents the county.
      (3) Additional grants
        (A) In general
          Subject to subparagraph (F), the Administrator may award an
        additional grant under this paragraph to an eligible coalition
        awarded a grant under paragraph (1) or (2) for any first fiscal
        year after the end of the 4-year period following the period of
        the initial grant under paragraph (1) or (2), as the case may
        be.
        (B) Scope of grants
          A coalition awarded a grant under paragraph (1) or (2),
        including a renewal grant under such paragraph, may not be
        awarded another grant under such paragraph, and is eligible for
        an additional grant under this section only under this
        paragraph.
        (C) No priority for applications
          The Administrator may not afford a higher priority in the
        award of an additional grant under this paragraph than the
        Administrator would afford the applicant for the grant if the
        applicant were submitting an application for an initial grant
        under paragraph (1) or (2) rather than an application for a
        grant under this paragraph.
        (D) Renewal grants
          Subject to subparagraph (F), the Administrator may award a
        renewal grant to a grant recipient under this paragraph for
        each of the fiscal years of the 4-fiscal-year period following
        the fiscal year for which the initial additional grant under
        subparagraph (A) is awarded in an amount not to exceed amounts
        as follows:
            (i) For the first and second fiscal years of that 4-fiscal-
          year period, the amount equal to 80 percent of the non-
          Federal funds, including in-kind contributions, raised by
          the coalition for the applicable fiscal year.
            (ii) For the third and fourth fiscal years of that 4-fiscal-
          year period, the amount equal to 67 percent of the non-
          Federal funds, including in-kind contributions, raised by
          the coalition for the applicable fiscal year.
        (E) Suspension
          If a grant recipient under this paragraph fails to continue
        to meet the criteria specified in subsection (a) of this
        section, the Administrator may suspend the grant, after
        providing written notice to the grant recipient and an
        opportunity to appeal.
        (F) Limitation
          The amount of a grant award under this paragraph may not
        exceed $125,000 for a fiscal year.
      (4) Process for suspension
        A grantee shall not be suspended or terminated under paragraph
      (1)(A)(ii), (2)(A)(iii), or (3)(E) unless that grantee is
      afforded a fair, timely, and independent appeal prior to such
      suspension or termination.
    (c) Treatment of funds for coalitions representing certain
      organizations
      Funds appropriated for the substance abuse activities of a
    coalition that includes a representative of the Bureau of Indian
    Affairs, the Indian Health Service, or a tribal government agency
    with expertise in the field of substance abuse may be counted as
    non-Federal funds raised by the coalition for purposes of this
    section.
    (d) Priority in awarding grants
      In awarding grants under subsection (b)(1)(A)(i) of this section,
    priority shall be given to a coalition serving economically
    disadvantaged areas.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1032, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 227; amended Pub. L. 107-82, Sec.
    1(d), (g), (h), Dec. 14, 2001, 115 Stat. 818, 819; Pub. L. 109-469,
    title VIII, Secs. 802(a), 803, 804, Dec. 29, 2006, 120 Stat. 3535.)

-COD-
                               CODIFICATION                           
      Pub. L. 109-469, Secs. 802(a), 803, 804, which directed amendment
    of section 1032 of the "Drug-Free Communities Act of 1997", were
    executed to this section, which is section 1032 of the National
    Narcotics Leadership Act of 1988, to reflect the probable intent of
    Congress. See 2006 Amendment notes below.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a)(7). Pub. L. 109-469, Sec. 804, added par. (7).
    See Codification note above.
      Subsec. (b)(1)(A)(iv), (2)(C)(i), (3)(F). Pub. L. 109-469, Sec.
    803, substituted "$125,000" for "$100,000". See Codification note
    above.
      Subsec. (b)(4). Pub. L. 109-469, Sec. 802(a), added par. (4). See
    Codification note above.
      2001 - Subsec. (b)(3). Pub. L. 107-82, Sec. 1(d), added par. (3).
      Subsec. (c). Pub. L. 107-82, Sec. 1(g), added subsec. (c).
      Subsec. (d). Pub. L. 107-82, Sec. 1(h), added subsec. (d).

                            REPORT TO CONGRESS                        
      Pub. L. 109-469, title VIII, Sec. 802(b), Dec. 29, 2006, 120
    Stat. 3535, provided that: "Not later than 60 days after the date
    of enactment of this Act [Dec. 29, 2006], the Director of the
    Office of National Drug Control Policy shall submit to Congress a
    report detailing the appeals process required by section 1032(b)(4)
    of the Drug-Free Communities Act of 1997 [probably means 21 U.S.C.
    1532(b)(4)], as added by subsection (a) [see 2006 Amendments note
    above]."

-End-



-CITE-
    21 USC Sec. 1533                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part A - Drug-Free Communities Support Program

-HEAD-
    Sec. 1533. Information collection and dissemination with respect to
      grant recipients

-STATUTE-
    (a) Coalition information
      (1) General auditing authority
        For the purpose of audit and examination, the Administrator - 
          (A) shall have access to any books, documents, papers, and
        records that are pertinent to any grant or grant renewal
        request under this subchapter; and
          (B) may periodically request information from a grant
        recipient to ensure that the grant recipient meets the
        applicable criteria under section 1532(a) of this title.
      (2) Application process
        The Administrator shall issue a request for proposal regarding,
      with respect to the grants awarded under section 1532 of this
      title, the application process, grant renewal, and suspension or
      withholding of renewal grants. Each application under this
      paragraph shall be in writing and shall be subject to review by
      the Administrator.
      (3) Reporting
        The Administrator shall, to the maximum extent practicable and
      in a manner consistent with applicable law, minimize reporting
      requirements by a grant recipient and expedite any application
      for a renewal grant made under this part.
    (b) Data collection and dissemination
      (1) In general
        The Administrator may collect data from - 
          (A) national substance abuse organizations that work with
        eligible coalitions, community anti-drug coalitions,
        departments or agencies of the Federal Government, or State or
        local governments and the governing bodies of Indian tribes;
        and
          (B) any other entity or organization that carries out
        activities that relate to the purposes of the Program.
      (2) Activities of Administrator
        The Administrator may - 
          (A) evaluate the utility of specific initiatives relating to
        the purposes of the Program;
          (B) conduct an evaluation of the Program; and
          (C) disseminate information described in this subsection to -
        
            (i) eligible coalitions and other substance abuse
          organizations; and
            (ii) the general public.
      (3) Consultation
        The Administrator shall carry out activities under this
      subsection in consultation with the Advisory Commission and the
      National Community Antidrug Coalition Institute.
      (4) Limitation on use of certain funds for evaluation of Program
        Amounts for activities under paragraph (2)(B) may not be
      derived from amounts under section 1524(a) of this title except
      for amounts that are available under section 1524(b) of this
      title for administrative costs.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1033, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 230; amended Pub. L. 107-82, Sec.
    1(e), (f), Dec. 14, 2001, 115 Stat. 818.)


-MISC1-
                                AMENDMENTS                            
      2001 - Subsec. (b)(3). Pub. L. 107-82, Sec. 1(e), added par. (3).
      Subsec. (b)(4). Pub. L. 107-82, Sec. 1(f), added par. (4).

-End-



-CITE-
    21 USC Sec. 1534                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part A - Drug-Free Communities Support Program

-HEAD-
    Sec. 1534. Technical assistance and training

-STATUTE-
    (a) In general
      (1) Technical assistance and agreements
        With respect to any grant recipient or other organization, the
      Administrator may - 
          (A) offer technical assistance and training; and
          (B) enter into contracts and cooperative agreements.
      (2) Coordination of programs
        The Administrator may facilitate the coordination of programs
      between a grant recipient and other organizations and entities.
    (b) Training
      The Administrator may provide training to any representative
    designated by a grant recipient in - 
        (1) coalition building;
        (2) task force development;
        (3) mediation and facilitation, direct service, assessment and
      evaluation; or
        (4) any other activity related to the purposes of the Program.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1034, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 231.)

-End-



-CITE-
    21 USC Sec. 1535                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part A - Drug-Free Communities Support Program

-HEAD-
    Sec. 1535. Supplemental grants for coalition mentoring activities

-STATUTE-
    (a) Authority to make grants
      As part of the program established under section 1531 of this
    title, the Director may award an initial grant under this
    subsection, and renewal grants under subsection (f) of this
    section, to any coalition awarded a grant under section 1532 of
    this title that meets the criteria specified in subsection (d) of
    this section in order to fund coalition mentoring activities by
    such coalition in support of the program.
    (b) Treatment with other grants
      (1) Supplement
        A grant awarded to a coalition under this section is in
      addition to any grant awarded to the coalition under section 1532
      of this title.
      (2) Requirement for basic grant
        A coalition may not be awarded a grant under this section for a
      fiscal year unless the coalition was awarded a grant or renewal
      grant under section 1532(b) of this title for that fiscal year.
    (c) Application
      A coalition seeking a grant under this section shall submit to
    the Administrator an application for the grant in such form and
    manner as the Administrator may require.
    (d) Criteria
      A coalition meets the criteria specified in this subsection if
    the coalition - 
        (1) has been in existence for at least 5 years;
        (2) has achieved, by or through its own efforts, measurable
      results in the prevention and treatment of substance abuse among
      youth;
        (3) has staff or members willing to serve as mentors for
      persons seeking to start or expand the activities of other
      coalitions in the prevention and treatment of substance abuse;
        (4) has demonstrable support from some members of the community
      in which the coalition mentoring activities to be supported by
      the grant under this section are to be carried out; and
        (5) submits to the Administrator a detailed plan for the
      coalition mentoring activities to be supported by the grant under
      this section.
    (e) Use of grant funds
      A coalition awarded a grant under this section shall use the
    grant amount for mentoring activities to support and encourage the
    development of new, self-supporting community coalitions that are
    focused on the prevention and treatment of substance abuse in such
    new coalitions' communities. The mentoring coalition shall
    encourage such development in accordance with the plan submitted by
    the mentoring coalition under subsection (d)(5) of this section.
    (f) Renewal grants
      The Administrator may make a renewal grant to any coalition
    awarded a grant under subsection (a) of this section, or a previous
    renewal grant under this subsection, if the coalition, at the time
    of application for such renewal grant - 
        (1) continues to meet the criteria specified in subsection (d)
      of this section; and
        (2) has made demonstrable progress in the development of one or
      more new, self-supporting community coalitions that are focused
      on the prevention and treatment of substance abuse.
    (g) Grant amounts
      (1) In general
        Subject to paragraphs (2) and (3), the total amount of grants
      awarded to a coalition under this section for a fiscal year may
      not exceed the amount of non-Federal funds raised by the
      coalition, including in-kind contributions, for that fiscal year.
      Funds appropriated for the substance abuse activities of a
      coalition that includes a representative of the Bureau of Indian
      Affairs, the Indian Health Service, or a tribal government agency
      with expertise in the field of substance abuse may be counted as
      non-Federal funds raised by the coalition.
      (2) Initial grants
        The amount of the initial grant awarded to a coalition under
      subsection (a) of this section may not exceed $75,000.
      (3) Renewal grants
        The total amount of renewal grants awarded to a coalition under
      subsection (f) of this section for any fiscal year may not exceed
      $75,000.
    (h) Fiscal year limitation on amount available for grants
      The total amount available for grants under this section,
    including renewal grants under subsection (f) of this section, in
    any fiscal year may not exceed the amount equal to five percent of
    the amount authorized to be appropriated by section 1524(a) of this
    title for that fiscal year.
    (i) Priority in awarding initial grants
      In awarding initial grants under this section, priority shall be
    given to a coalition that expressly proposes to provide mentorship
    to a coalition or aspiring coalition serving economically
    disadvantaged areas.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1035, as added Pub. L. 107-82, Sec.
    2, Dec. 14, 2001, 115 Stat. 819.)

-End-


-CITE-
    21 USC Part B - Advisory Commission                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
                       PART B - ADVISORY COMMISSION                   

-End-



-CITE-
    21 USC Sec. 1541                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1541. Establishment of Advisory Commission

-STATUTE-
    (a) Establishment
      There is established a commission to be known as the "Advisory
    Commission on Drug-Free Communities".
    (b) Purpose
      The Advisory Commission shall advise, consult with, and make
    recommendations to the Director concerning matters related to the
    activities carried out under the Program.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1041, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 231.)

-End-



-CITE-
    21 USC Sec. 1542                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1542. Duties

-STATUTE-
    (a) In general
      The Advisory Commission - 
        (1) shall, not later than 30 days after its first meeting, make
      recommendations to the Director regarding the selection of an
      Administrator;
        (2) may make recommendations to the Director regarding any
      grant, contract, or cooperative agreement made by the Program;
        (3) may make recommendations to the Director regarding the
      activities of the Program;
        (4) may make recommendations to the Director regarding any
      policy or criteria established by the Director to carry out the
      Program;
        (5) may - 
          (A) collect, by correspondence or by personal investigation,
        information concerning initiatives, studies, services,
        programs, or other activities of coalitions or organizations
        working in the field of substance abuse in the United States or
        any other country; and
          (B) with the approval of the Director, make the information
        referred to in subparagraph (A) available through appropriate
        publications or other methods for the benefit of eligible
        coalitions and the general public; and

        (6) may appoint subcommittees and convene workshops and
      conferences.
    (b) Recommendations
      If the Director rejects any recommendation of the Advisory
    Commission under subsection (a)(1) of this section, the Director
    shall notify the Advisory Commission in writing of the reasons for
    the rejection not later than 15 days after receiving the
    recommendation.
    (c) Conflict of interest
      A member of the Advisory Commission shall recuse himself or
    herself from any decision that would constitute a conflict of
    interest.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1042, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 231.)

-End-



-CITE-
    21 USC Sec. 1543                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1543. Membership

-STATUTE-
    (a) In general
      The President shall appoint 11 members to the Advisory Commission
    as follows:
        (1) four members shall be appointed from the general public and
      shall include leaders - 
          (A) in fields of youth development, public policy, law, or
        business; or
          (B) of nonprofit organizations or private foundations that
        fund substance abuse programs.

        (2) four members shall be appointed from the leading
      representatives of national substance abuse reduction
      organizations, of which no fewer than three members shall have
      extensive training or experience in drug prevention.
        (3) three members shall be appointed from the leading
      representatives of State substance abuse reduction organizations.
    (b) Chairperson
      The Advisory Commission shall elect a chairperson or co-
    chairpersons from among its members.
    (c) Ex officio members
      The ex officio membership of the Advisory Commission shall
    consist of any two officers or employees of the United States that
    the Director determines to be necessary for the Advisory Commission
    to effectively carry out its functions.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1043, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 232.)

-End-



-CITE-
    21 USC Sec. 1544                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1544. Compensation

-STATUTE-
    (a) In general
      Members of the Advisory Commission who are officers or employees
    of the United States shall not receive any additional compensation
    for service on the Advisory Commission. The remaining members of
    the Advisory Commission shall receive, for each day (including
    travel time) that they are engaged in the performance of the
    functions of the Advisory Commission, compensation at rates not to
    exceed the daily equivalent to the annual rate of basic pay payable
    for grade GS-10 of the General Schedule.
    (b) Travel expenses
      Each member of the Advisory Commission shall receive travel
    expenses, including per diem in lieu of subsistence, in accordance
    with sections 5702 and 5703 of title 5.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1044, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 232.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Grade GS-10 of the General Schedule, referred to in subsec. (a),
    is set out under section 5332 of Title 5, Government Organization
    and Employees.

-End-



-CITE-
    21 USC Sec. 1545                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1545. Terms of office

-STATUTE-
    (a) In general
      Subject to subsection (b) of this section, the term of office of
    a member of the Advisory Commission shall be 3 years, except that,
    as designated at the time of appointment - 
        (1) of the initial members appointed under section 1543(a)(1)
      of this title, two shall be appointed for a term of 2 years;
        (2) of the initial members appointed under section 1543(a)(2)
      of this title, two shall be appointed for a term of 2 years; and
        (3) of the initial members appointed under section 1543(a)(3)
      of this title, one shall be appointed for a term of 1 year.
    (b) Vacancies
      Any member appointed to fill a vacancy for an unexpired term of a
    member shall serve for the remainder of the unexpired term. A
    member of the Advisory Commission may serve after the expiration of
    such member's term until a successor has been appointed and taken
    office.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1045, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 233.)

-End-



-CITE-
    21 USC Sec. 1546                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1546. Meetings

-STATUTE-
    (a) In general
      After its initial meeting, the Advisory Commission shall meet,
    with the advanced approval of the Administrator, at the call of the
    Chairperson (or Co-chairpersons) of the Advisory Commission or a
    majority of its members or upon the request of the Director or
    Administrator of the Program.
    (b) Quorum
      Six members of the Advisory Commission shall constitute a quorum.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1046, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 233.)

-End-



-CITE-
    21 USC Sec. 1547                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1547. Staff

-STATUTE-
      The Administrator shall make available to the Advisory Commission
    adequate staff, information, and other assistance.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1047, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 233.)

-End-



-CITE-
    21 USC Sec. 1548                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
    SUBCHAPTER II - DRUG-FREE COMMUNITIES
    Part B - Advisory Commission

-HEAD-
    Sec. 1548. Termination

-STATUTE-
      The Advisory Commission shall terminate at the end of fiscal year
    2007.

-SOURCE-
    (Pub. L. 100-690, title I, Sec. 1048, as added Pub. L. 105-20, Sec.
    2(a)(2), June 27, 1997, 111 Stat. 234; amended Pub. L. 107-82, Sec.
    3, Dec. 14, 2001, 115 Stat. 820.)


-MISC1-
                                AMENDMENTS                            
      2001 - Pub. L. 107-82 substituted "2007" for "2002".

-End-


-CITE-
    21 USC CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
                CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE            

-MISC1-
    Sec.                                                     
    1601.       Findings.                                             
    1602.       Definitions.                                          
    1603.       General requirements; applicability; preemption.      
    1604.       Liability of biomaterials suppliers.                  
    1605.       Procedures for dismissal of civil actions against
                 biomaterials suppliers.                              
    1606.       Subsequent impleader of dismissed biomaterials
                 supplier.                                            

-End-



-CITE-
    21 USC Sec. 1601                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
    Sec. 1601. Findings

-STATUTE-
      The Congress finds that - 
        (1) each year millions of citizens of the United States depend
      on the availability of lifesaving or life-enhancing medical
      devices, many of which are permanently implantable within the
      human body;
        (2) a continued supply of raw materials and component parts is
      necessary for the invention, development, improvement, and
      maintenance of the supply of the devices;
        (3) most of the medical devices are made with raw materials and
      component parts that - 
          (A) move in interstate commerce;
          (B) are not designed or manufactured specifically for use in
        medical devices; and
          (C) come in contact with internal human tissue;

        (4) the raw materials and component parts also are used in a
      variety of nonmedical products;
        (5) because small quantities of the raw materials and component
      parts are used for medical devices, sales of raw materials and
      component parts for medical devices constitute an extremely small
      portion of the overall market for the raw materials and component
      parts;
        (6) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
      301 et seq.) manufacturers of medical devices are required to
      demonstrate that the medical devices are safe and effective,
      including demonstrating that the products are properly designed
      and have adequate warnings or instructions;
        (7) notwithstanding the fact that raw materials and component
      parts suppliers do not design, produce, or test a final medical
      device, the suppliers have been the subject of actions alleging
      inadequate - 
          (A) design and testing of medical devices manufactured with
        materials or parts supplied by the suppliers; or
          (B) warnings related to the use of such medical devices;

        (8) even though suppliers of raw materials and component parts
      have very rarely been held liable in such actions, such suppliers
      have ceased supplying certain raw materials and component parts
      for use in medical devices for a number of reasons, including
      concerns about the costs of such litigation;
        (9) unless alternate sources of supply can be found, the
      unavailability of raw materials and component parts for medical
      devices will lead to unavailability of lifesaving and life-
      enhancing medical devices;
        (10) because other suppliers of the raw materials and component
      parts in foreign nations are refusing to sell raw materials or
      component parts for use in manufacturing certain medical devices
      in the United States, the prospects for development of new
      sources of supply for the full range of threatened raw materials
      and component parts for medical devices are remote;
        (11) it is unlikely that the small market for such raw
      materials and component parts in the United States could support
      the large investment needed to develop new suppliers of such raw
      materials and component parts;
        (12) attempts to develop such new suppliers would raise the
      cost of medical devices;
        (13) courts that have considered the duties of the suppliers of
      the raw materials and component parts have generally found that
      the suppliers do not have a duty - 
          (A) to evaluate the safety and efficacy of the use of a raw
        material or component part in a medical device; or
          (B) to warn consumers concerning the safety and effectiveness
        of a medical device;

        (14) because medical devices and the raw materials and
      component parts used in their manufacture move in interstate
      commerce, a shortage of such raw materials and component parts
      affects interstate commerce;
        (15) in order to safeguard the availability of a wide variety
      of lifesaving and life-enhancing medical devices, immediate
      action is needed - 
          (A) to clarify the permissible bases of liability for
        suppliers of raw materials and component parts for medical
        devices; and
          (B) to provide expeditious procedures to dispose of
        unwarranted suits against the suppliers in such manner as to
        minimize litigation costs;

        (16) the several States and their courts are the primary
      architects and regulators of our tort system; Congress, however,
      must, in certain circumstances involving the national interest,
      address tort issues, and a threatened shortage of raw materials
      and component parts for lifesaving medical devices is one such
      circumstance; and
        (17) the protections set forth in this chapter are needed to
      assure the continued supply of materials for lifesaving medical
      devices, although such protections do not protect negligent
      suppliers.

-SOURCE-
    (Pub. L. 105-230, Sec. 2, Aug. 13, 1998, 112 Stat. 1519.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in par.
    (6), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to chapter 9 (Sec. 301 et seq.) of
    this title. For complete classification of this Act to the Code,
    see section 301 of this title and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Pub. L. 105-230, Sec. 8, Aug. 13, 1998, 112 Stat. 1529, provided
    that: "This Act [enacting this chapter] shall apply to all civil
    actions covered under this Act that are commenced on or after the
    date of enactment of this Act [Aug. 13, 1998], including any such
    action with respect to which the harm asserted in the action or the
    conduct that caused the harm occurred before the date of enactment
    of this Act."

                                SHORT TITLE                            
      Pub. L. 105-230, Sec. 1, Aug. 13, 1998, 112 Stat. 1519, provided
    that: "This Act [enacting this chapter] may be cited as the
    'Biomaterials Access Assurance Act of 1998'."

-End-



-CITE-
    21 USC Sec. 1602                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
    Sec. 1602. Definitions

-STATUTE-
       As used in this chapter:
      (1) Biomaterials supplier
        (A) In general
          The term "biomaterials supplier" means an entity that
        directly or indirectly supplies a component part or raw
        material for use in the manufacture of an implant.
        (B) Persons included
          Such term includes any person who - 
            (i) has submitted master files to the Secretary for
          purposes of premarket approval of a medical device; or
            (ii) licenses a biomaterials supplier to produce component
          parts or raw materials.
      (2) Claimant
        (A) In general
          The term "claimant" means any person who brings a civil
        action, or on whose behalf a civil action is brought, arising
        from harm allegedly caused directly or indirectly by an
        implant, including a person other than the individual into
        whose body, or in contact with whose blood or tissue, the
        implant is placed, who claims to have suffered harm as a result
        of the implant.
        (B) Action brought on behalf of an estate
          With respect to an action brought on behalf of or through the
        estate of a deceased individual into whose body, or in contact
        with whose blood or tissue the implant was placed, such term
        includes the decedent that is the subject of the action.
        (C) Action brought on behalf of a minor or incompetent
          With respect to an action brought on behalf of or through a
        minor or incompetent, such term includes the parent or guardian
        of the minor or incompetent.
        (D) Exclusions
          Such term does not include - 
            (i) a provider of professional health care services in any
          case in which - 
              (I) the sale or use of an implant is incidental to such
            services; and
              (II) the essence of the professional health care services
            provided is the furnishing of judgment, skill, or services;

            (ii) a person acting in the capacity of a manufacturer,
          seller, or biomaterials supplier; or
            (iii) a person alleging harm caused by either the silicone
          gel or the silicone envelope utilized in a breast implant
          containing silicone gel, except that - 
              (I) neither the exclusion provided by this clause nor any
            other provision of this chapter may be construed as a
            finding that silicone gel (or any other form of silicone)
            may or may not cause harm; and
              (II) the existence of the exclusion under this clause may
            not - 
                (aa) be disclosed to a jury in any civil action or
              other proceeding; and
                (bb) except as necessary to establish the applicability
              of this chapter, otherwise be presented in any civil
              action or other proceeding.
      (3) Component part
        (A) In general
          The term "component part" means a manufactured piece of an
        implant.
        (B) Certain components
          Such term includes a manufactured piece of an implant that - 
            (i) has significant non-implant applications; and
            (ii) alone, has no implant value or purpose, but when
          combined with other component parts and materials,
          constitutes an implant.
      (4) Harm
        (A) In general
          The term "harm" means - 
            (i) any injury to or damage suffered by an individual;
            (ii) any illness, disease, or death of that individual
          resulting from that injury or damage; and
            (iii) any loss to that individual or any other individual
          resulting from that injury or damage.
        (B) Exclusion
          The term does not include any commercial loss or loss of or
        damage to an implant.
      (5) Implant
        The term "implant" means - 
          (A) a medical device that is intended by the manufacturer of
        the device - 
            (i) to be placed into a surgically or naturally formed or
          existing cavity of the body for a period of at least 30 days;
          or
            (ii) to remain in contact with bodily fluids or internal
          human tissue through a surgically produced opening for a
          period of less than 30 days; and

          (B) suture materials used in implant procedures.
      (6) Manufacturer
        The term "manufacturer" means any person who, with respect to
      an implant - 
          (A) is engaged in the manufacture, preparation, propagation,
        compounding, or processing (as defined in section 360(a)(1) of
        this title) of the implant; and
          (B) is required - 
            (i) to register with the Secretary pursuant to section 360
          of this title and the regulations issued under such section;
          and
            (ii) to include the implant on a list of devices filed with
          the Secretary pursuant to section 360(j) of this title and
          the regulations issued under such section.
      (7) Medical device
        The term "medical device" means a device, as defined in section
      321(h) of this title, and includes any device component of any
      combination product as that term is used in section 353(g) of
      this title.
      (8) Raw material
        The term "raw material" means a substance or product that - 
          (A) has a generic use; and
          (B) may be used in an application other than an implant.
      (9) Secretary
        The term "Secretary" means the Secretary of Health and Human
      Services.
      (10) Seller
        (A) In general
          The term "seller" means a person who, in the course of a
        business conducted for that purpose, sells, distributes,
        leases, packages, labels, or otherwise places an implant in the
        stream of commerce.
        (B) Exclusions
          The term does not include - 
            (i) a seller or lessor of real property;
            (ii) a provider of professional health care services in any
          case in which - 
              (I) the sale or use of the implant is incidental to such
            services; and
              (II) the essence of the professional health care services
            provided is the furnishing of judgment, skill, or services;
            or

            (iii) any person who acts in only a financial capacity with
          respect to the sale of an implant.

-SOURCE-
    (Pub. L. 105-230, Sec. 3, Aug. 13, 1998, 112 Stat. 1520.)

-End-



-CITE-
    21 USC Sec. 1603                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
    Sec. 1603. General requirements; applicability; preemption

-STATUTE-
    (a) General requirements
      (1) In general
        In any civil action covered by this chapter, a biomaterials
      supplier may - 
          (A) raise any exclusion from liability set forth in section
        1604 of this title; and
          (B) make a motion for dismissal or for summary judgment as
        set forth in section 1605 of this title.
      (2) Procedures
        Notwithstanding any other provision of law, a Federal or State
      court in which an action covered by this chapter is pending
      shall, in connection with a motion under section 1605 or 1606 of
      this title, use the procedures set forth in this chapter.
    (b) Applicability
      (1) In general
        Except as provided in paragraph (2), this chapter applies to
      any civil action brought by a claimant, whether in a Federal or
      State court, on the basis of any legal theory, for harm allegedly
      caused, directly or indirectly, by an implant.
      (2) Exclusion
        A civil action brought by a purchaser of a medical device,
      purchased for use in providing professional health care services,
      for loss or damage to an implant or for commercial loss to the
      purchaser - 
          (A) shall not be considered an action that is subject to this
        chapter; and
          (B) shall be governed by applicable commercial or contract
        law.
    (c) Scope of preemption
      (1) In general
        This chapter supersedes any State law regarding recovery for
      harm caused by an implant and any rule of procedure applicable to
      a civil action to recover damages for such harm only to the
      extent that this chapter establishes a rule of law applicable to
      the recovery of such damages.
      (2) Applicability of other laws
        Any issue that arises under this chapter and that is not
      governed by a rule of law applicable to the recovery of damages
      described in paragraph (1) shall be governed by applicable
      Federal or State law.
    (d) Statutory construction
      Nothing in this chapter may be construed - 
        (1) to affect any defense available to a defendant under any
      other provisions of Federal or State law in an action alleging
      harm caused by an implant; or
        (2) to create a cause of action or Federal court jurisdiction
      pursuant to section 1331 or 1337 of title 28 that otherwise would
      not exist under applicable Federal or State law.

-SOURCE-
    (Pub. L. 105-230, Sec. 4, Aug. 13, 1998, 112 Stat. 1523.)

-End-



-CITE-
    21 USC Sec. 1604                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
    Sec. 1604. Liability of biomaterials suppliers

-STATUTE-
    (a) In general
      Except as provided in section 1606 of this title, a biomaterials
    supplier shall not be liable for harm to a claimant caused by an
    implant unless such supplier is liable - 
        (1) as a manufacturer of the implant, as provided in subsection
      (b) of this section;
        (2) as a seller of the implant, as provided in subsection (c)
      of this section; or
        (3) for furnishing raw materials or component parts for the
      implant that failed to meet applicable contractual requirements
      or specifications, as provided in subsection (d) of this section.
    (b) Liability as manufacturer
      (1) In general
        A biomaterials supplier may, to the extent required and
      permitted by any other applicable law, be liable for harm to a
      claimant caused by an implant if the biomaterials supplier is the
      manufacturer of the implant.
      (2) Grounds for liability
        The biomaterials supplier may be considered the manufacturer of
      the implant that allegedly caused harm to a claimant only if the
      biomaterials supplier - 
          (A)(i) registered or was required to register with the
        Secretary pursuant to section 360 of this title and the
        regulations issued under such section; and
          (ii) included or was required to include the implant on a
        list of devices filed with the Secretary pursuant to section
        360(j) of this title and the regulations issued under such
        section;
          (B) is the subject of a declaration issued by the Secretary
        pursuant to paragraph (3) that states that the supplier, with
        respect to the implant that allegedly caused harm to the
        claimant, was required to - 
            (i) register with the Secretary under section 360 of this
          title, and the regulations issued under such section, but
          failed to do so; or
            (ii) include the implant on a list of devices filed with
          the Secretary pursuant to section 360(j) of this title and
          the regulations issued under such section, but failed to do
          so; or

          (C) is related by common ownership or control to a person
        meeting all the requirements described in subparagraph (A) or
        (B), if the court deciding a motion to dismiss in accordance
        with section 1605(c)(3)(B)(i) of this title finds, on the basis
        of affidavits submitted in accordance with section 1605 of this
        title, that it is necessary to impose liability on the
        biomaterials supplier as a manufacturer because the related
        manufacturer meeting the requirements of subparagraph (A) or
        (B) lacks sufficient financial resources to satisfy any
        judgment that the court feels it is likely to enter should the
        claimant prevail.
      (3) Administrative procedures
        (A) In general
          The Secretary may issue a declaration described in paragraph
        (2)(B) on the motion of the Secretary or on petition by any
        person, after providing - 
            (i) notice to the affected persons; and
            (ii) an opportunity for an informal hearing.
        (B) Docketing and final decision
          Immediately upon receipt of a petition filed pursuant to this
        paragraph, the Secretary shall docket the petition. Not later
        than 120 days after the petition is filed, the Secretary shall
        issue a final decision on the petition.
        (C) Applicability of statute of limitations
          Any applicable statute of limitations shall toll during the
        period from the time a claimant files a petition with the
        Secretary under this paragraph until such time as either (i)
        the Secretary issues a final decision on the petition, or (ii)
        the petition is withdrawn.
        (D) Stay pending petition for declaration
          If a claimant has filed a petition for a declaration with
        respect to a defendant, and the Secretary has not issued a
        final decision on the petition, the court shall stay all
        proceedings with respect to that defendant until such time as
        the Secretary has issued a final decision on the petition.
    (c) Liability as seller
      A biomaterials supplier may, to the extent required and permitted
    by any other applicable law, be liable as a seller for harm to a
    claimant caused by an implant only if - 
        (1) the biomaterials supplier - 
          (A) held title to the implant and then acted as a seller of
        the implant after its initial sale by the manufacturer; or
          (B) acted under contract as a seller to arrange for the
        transfer of the implant directly to the claimant after the
        initial sale by the manufacturer of the implant; or

        (2) the biomaterials supplier is related by common ownership or
      control to a person meeting all the requirements described in
      paragraph (1), if a court deciding a motion to dismiss in
      accordance with section 1605(c)(3)(B)(ii) of this title finds, on
      the basis of affidavits submitted in accordance with section 1605
      of this title, that it is necessary to impose liability on the
      biomaterials supplier as a seller because the related seller
      meeting the requirements of paragraph (1) lacks sufficient
      financial resources to satisfy any judgment that the court feels
      it is likely to enter should the claimant prevail.
    (d) Liability for failure to meet applicable contractual
      requirements or specifications
      A biomaterials supplier may, to the extent required and permitted
    by any other applicable law, be liable for harm to a claimant
    caused by an implant if the claimant in an action shows, by a
    preponderance of the evidence, that - 
        (1) the biomaterials supplier supplied raw materials or
      component parts for use in the implant that either - 
          (A) did not constitute the product described in the contract
        between the biomaterials supplier and the person who contracted
        for the supplying of the product; or
          (B) failed to meet any specifications that were - 
            (i) accepted, pursuant to applicable law, by the
          biomaterials supplier;
            (ii) published by the biomaterials supplier;
            (iii) provided by the biomaterials supplier to the person
          who contracted for such product;
            (iv) contained in a master file that was submitted by the
          biomaterials supplier to the Secretary and that is currently
          maintained by the biomaterials supplier for purposes of
          premarket approval of medical devices; or
            (v) included in the submissions for purposes of premarket
          approval or review by the Secretary under section 360, 360c,
          360e, or 360j of this title, and received clearance from the
          Secretary if such specifications were accepted, pursuant to
          applicable law, by the biomaterials supplier; and

        (2) such failure to meet applicable contractual requirements or
      specifications was an actual and proximate cause of the harm to
      the claimant.

-SOURCE-
    (Pub. L. 105-230, Sec. 5, Aug. 13, 1998, 112 Stat. 1524.)

-End-



-CITE-
    21 USC Sec. 1605                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
    Sec. 1605. Procedures for dismissal of civil actions against
      biomaterials suppliers

-STATUTE-
    (a) Motion to dismiss
      A defendant may, at any time during which a motion to dismiss may
    be filed under applicable law, move to dismiss an action against it
    on the grounds that the defendant is a biomaterials supplier and
    one or more of the following:
        (1) The defendant is not liable as a manufacturer, as provided
      in section 1604(b) of this title.
        (2) The defendant is not liable as a seller, as provided in
      section 1604(c) of this title.
        (3) The defendant is not liable for furnishing raw materials or
      component parts for the implant that failed to meet applicable
      contractual requirements or specifications, as provided in
      section 1604(d) of this title.
        (4) The claimant did not name the manufacturer as a party to
      the action, as provided in subsection (b) of this section.
    (b) Manufacturer of implant shall be named a party
      In any civil action covered by this chapter, the claimant shall
    be required to name the manufacturer of the implant as a party to
    the action, unless - 
        (1) the manufacturer is subject to service of process solely in
      a jurisdiction in which the biomaterials supplier is not
      domiciled or subject to a service of process; or
        (2) a claim against the manufacturer is barred by applicable
      law or rule of practice.
    (c) Proceeding on motion to dismiss
      The following rules shall apply to any proceeding on a motion to
    dismiss filed by a defendant under this section:
      (1) Effect of motion to dismiss on discovery
        (A) In general
          Except as provided in subparagraph (B), if a defendant files
        a motion to dismiss under subsection (a) of this section, no
        discovery shall be permitted in connection with the action that
        is the subject of the motion, other than discovery necessary to
        determine a motion to dismiss for lack of jurisdiction, until
        such time as the court rules on the motion to dismiss.
        (B) Discovery
          If a defendant files a motion to dismiss under subsection
        (a)(3) of this section on the grounds that it did not furnish
        raw materials or component parts for the implant that failed to
        meet applicable contractual requirements or specifications, the
        court may permit discovery limited to issues that are directly
        relevant to - 
            (i) the pending motion to dismiss; or
            (ii) the jurisdiction of the court.
      (2) Affidavits
        (A) Defendant
          A defendant may submit affidavits supporting the grounds for
        dismissal contained in its motion to dismiss under subsection
        (a) of this section. If the motion is made under subsection
        (a)(1) of this section, the defendant may submit an affidavit
        demonstrating that the defendant has not included the implant
        on a list, if any, filed with the Secretary pursuant to section
        360(j) of this title.
        (B) Claimant
          In response to a motion to dismiss, the claimant may submit
        affidavits demonstrating that - 
            (i) the Secretary has, with respect to the defendant and
          the implant that allegedly caused harm to the claimant,
          issued a declaration pursuant to section 1604(b)(2)(B) of
          this title; or
            (ii) the defendant is a seller of the implant who is liable
          under section 1604(c) of this title.
      (3) Basis of ruling on motion to dismiss
        The court shall rule on a motion to dismiss filed under
      subsection (a) of this section solely on the basis of the
      pleadings and affidavits of the parties made pursuant to this
      subsection. The court shall grant a motion to dismiss filed under
      subsection (a) of this section - 
          (A) unless the claimant submits a valid affidavit that
        demonstrates that the defendant is not a biomaterials supplier;
          (B) unless the court determines, to the extent raised in the
        pleadings and affidavits, that one or more of the following
        apply:
            (i) the defendant may be liable as a manufacturer, as
          provided in section 1604(b) of this title;
            (ii) the defendant may be liable as a seller, as provided
          in section 1604(c) of this title; or
            (iii) the defendant may be liable for furnishing raw
          materials or component parts for the implant that failed to
          meet applicable contractual requirements or specifications,
          as provided in section 1604(d) of this title; or

          (C) if the claimant did not name the manufacturer as a party
        to the action, as provided in subsection (b) of this section.
      (4) Treatment of motion as motion for summary judgment
        The court may treat a motion to dismiss as a motion for summary
      judgment subject to subsection (d) of this section in order to
      determine whether the pleadings and affidavits, in connection
      with such action, raise genuine issues of material fact
      concerning whether the defendant furnished raw materials or
      component parts of the implant that failed to meet applicable
      contractual requirements or specifications as provided in section
      1604(d) of this title.
    (d) Summary judgment
      (1) In general
        (A) Basis for entry of judgment
          If a motion to dismiss of a biomaterials supplier is to be
        treated as a motion for summary judgment under subsection
        (c)(4) of this section or if a biomaterials supplier moves for
        summary judgment, the biomaterials supplier shall be entitled
        to entry of judgment without trial if the court finds there is
        no genuine issue of material fact for each applicable element
        set forth in paragraphs (1) and (2) of section 1604(d) of this
        title.
        (B) Issues of material fact
          With respect to a finding made under subparagraph (A), the
        court shall consider a genuine issue of material fact to exist
        only if the evidence submitted by the claimant would be
        sufficient to allow a reasonable jury to reach a verdict for
        the claimant if the jury found the evidence to be credible.
      (2) Discovery made prior to a ruling on a motion for summary
        judgment
        If, under applicable rules, the court permits discovery prior
      to a ruling on a motion for summary judgment governed by section
      1604(d) of this title, such discovery shall be limited solely to
      establishing whether a genuine issue of material fact exists as
      to the applicable elements set forth in paragraphs (1) and (2) of
      section 1604(d) of this title.
      (3) Discovery with respect to a biomaterials supplier
        A biomaterials supplier shall be subject to discovery in
      connection with a motion seeking dismissal or summary judgment on
      the basis of the inapplicability of section 1604(d) of this title
      or the failure to establish the applicable elements of section
      1604(d) of this title solely to the extent permitted by the
      applicable Federal or State rules for discovery against
      nonparties.
    (e) Dismissal with prejudice
      An order granting a motion to dismiss or for summary judgment
    pursuant to this section shall be entered with prejudice, except
    insofar as the moving defendant may be rejoined to the action as
    provided in section 1606 of this title.
    (f) Manufacturer conduct of litigation
      The manufacturer of an implant that is the subject of an action
    covered under this chapter shall be permitted to conduct litigation
    on any motion for summary judgment or dismissal filed by a
    biomaterials supplier who is a defendant under this section on
    behalf of such supplier if the manufacturer and any other defendant
    in such action enter into a valid and applicable contractual
    agreement under which the manufacturer agrees to bear the cost of
    such litigation or to conduct such litigation.

-SOURCE-
    (Pub. L. 105-230, Sec. 6, Aug. 13, 1998, 112 Stat. 1526.)

-End-



-CITE-
    21 USC Sec. 1606                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-
    Sec. 1606. Subsequent impleader of dismissed biomaterials supplier

-STATUTE-
    (a) Impleading of dismissed defendant
      A court, upon motion by a manufacturer or a claimant within 90
    days after entry of a final judgment in an action by the claimant
    against a manufacturer, and notwithstanding any otherwise
    applicable statute of limitations, may implead a biomaterials
    supplier who has been dismissed from the action pursuant to this
    chapter if - 
        (1) the manufacturer has made an assertion, either in a motion
      or other pleading filed with the court or in an opening or
      closing statement at trial, or as part of a claim for
      contribution or indemnification, and the court finds based on the
      court's independent review of the evidence contained in the
      record of the action, that under applicable law - 
          (A) the negligence or intentionally tortious conduct of the
        dismissed supplier was an actual and proximate cause of the
        harm to the claimant; and
          (B) the manufacturer's liability for damages should be
        reduced in whole or in part because of such negligence or
        intentionally tortious conduct; or

        (2) the claimant has moved to implead the supplier and the
      court finds, based on the court's independent review of the
      evidence contained in the record of the action, that under
      applicable law - 
          (A) the negligence or intentionally tortious conduct of the
        dismissed supplier was an actual and proximate cause of the
        harm to the claimant; and
          (B) the claimant is unlikely to be able to recover the full
        amount of its damages from the remaining defendants.
    (b) Standard of liability
      Notwithstanding any preliminary finding under subsection (a) of
    this section, a biomaterials supplier who has been impleaded into
    an action covered by this chapter, as provided for in this section -
     
        (1) may, prior to entry of judgment on the claim against it,
      supplement the record of the proceeding that was developed prior
      to the grant of the motion for impleader under subsection (a) of
      this section; and
        (2) may be found liable to a manufacturer or a claimant only to
      the extent required and permitted by any applicable State or
      Federal law other than this chapter.
    (c) Discovery
      Nothing in this section shall give a claimant or any other party
    the right to obtain discovery from a biomaterials supplier at any
    time prior to grant of a motion for impleader beyond that allowed
    under section 1605 of this title.

-SOURCE-
    (Pub. L. 105-230, Sec. 7, Aug. 13, 1998, 112 Stat. 1528.)

-End-


-CITE-
    21 USC CHAPTER 22 - NATIONAL DRUG CONTROL POLICY            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
                 CHAPTER 22 - NATIONAL DRUG CONTROL POLICY             

-MISC1-
    Sec.                                                     
    1701.       Definitions.                                          
    1702.       Office of National Drug Control Policy.               
    1703.       Appointment and duties of Director and Deputy
                 Directors.                                           
    1704.       Coordination with National Drug Control Program
                 agencies in demand reduction, supply reduction, and
                 State and local affairs.                             
    1705.       Development, submission, implementation, and
                 assessment of National Drug Control Strategy.        
    1706.       High Intensity Drug Trafficking Areas Program.        
    1707.       Counter-Drug Technology Assessment Center.            
    1708.       National youth anti-drug media campaign.              
    1708a.      Annual report requirement.                            
    1709.       Repealed.                                             
    1710.       Drug Interdiction Coordinator and Committee.          
    1710a.      Requirement for disclosure of Federal sponsorship of
                 all Federal advertising or other communication
                 materials.                                           
    1711.       Authorization of appropriations.                      
    1712.       Termination of Office of National Drug Control Policy.
    1713.       Authorization of use of environmentally-approved
                 herbicides to eliminate illicit narcotics crops.     
    1714.       Awards for demonstration programs by local
                 partnerships to coerce abstinence in chronic
                 hard-drug users under community supervision through
                 the use of drug testing and sanctions.               

-End-



-CITE-
    21 USC Sec. 1701                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1701. Definitions

-STATUTE-
      In this chapter:
      (1) Demand reduction
        The term "demand reduction" means any activity conducted by a
      National Drug Control Program agency, other than an enforcement
      activity, that is intended to reduce the use of drugs, including -
       
          (A) drug abuse education;
          (B) drug abuse prevention;
          (C) drug abuse treatment;
          (D) drug abuse research;
          (E) drug abuse rehabilitation;
          (F) drug-free workplace programs;
          (G) drug testing, including the testing of employees;
          (H) interventions for drug abuse and dependence;
          (I) international drug control coordination and cooperation
        with respect to activities described in this paragraph; and
          (J) international drug abuse education, prevention,
        treatment, research, rehabilitation activities, and
        interventions for drug abuse and dependence.
      (2) Director
        The term "Director" means the Director of National Drug Control
      Policy.
      (3) Drug
        The term "drug" has the meaning given the term "controlled
      substance" in section 802(6) of this title.
      (4) Drug control
        The term "drug control" means any activity conducted by a
      National Drug Control Program agency involving supply reduction
      or demand reduction.
      (5) Fund
        The term "Fund" means the fund established under section
      1702(d) of this title.
      (6) National Drug Control Program
        The term "National Drug Control Program" means programs,
      policies, and activities undertaken by National Drug Control
      Program agencies pursuant to the responsibilities of such
      agencies under the National Drug Control Strategy, including any
      activities involving supply reduction, demand reduction, or
      State, local, and tribal affairs.
      (7) National Drug Control Program agency
        The term "National Drug Control Program agency" means any
      agency that is responsible for implementing any aspect of the
      National Drug Control Strategy, including any agency that
      receives Federal funds to implement any aspect of the National
      Drug Control Strategy, but does not include any agency that
      receives funds for drug control activity solely under the
      National Intelligence Program, the Joint Military Intelligence
      Program or Tactical Intelligence and Related Activities, or (for
      purposes of section 1703(d) of this title) an agency that is
      described in section 530C(a) of title 28, unless such agency has
      been designated - 
          (A) by the President; or
          (B) jointly by the Director and the head of the agency.
      (8) National Drug Control Strategy
        The term "National Drug Control Strategy" means the strategy
      developed and submitted to Congress under section 1705 of this
      title.
      (9) Office
        Unless the context clearly indicates otherwise, the term
      "Office" means the Office of National Drug Control Policy
      established under section 1702(a) of this title.
      (10) State, local, and tribal affairs
        The term "State, local, and tribal affairs" means domestic
      activities conducted by a National Drug Control Program agency
      that are intended to reduce the availability and use of illegal
      drugs, including - 
          (A) coordination and enhancement of Federal, State, local,
        and tribal law enforcement drug control efforts;
          (B) coordination and enhancement of efforts among National
        Drug Control Program agencies and State, local, and tribal
        demand reduction and supply reduction agencies;
          (C) coordination and enhancement of Federal, State, local,
        and tribal law enforcement initiatives to gather, analyze, and
        disseminate information and law enforcement intelligence
        relating to drug control among domestic law enforcement
        agencies; and
          (D) other coordinated and joint initiatives among Federal,
        State, local, and tribal agencies to promote comprehensive drug
        control strategies designed to reduce the demand for, and the
        availability of, illegal drugs.
      (11) Supply reduction
        The term "supply reduction" means any activity or program
      conducted by a National Drug Control Program agency that is
      intended to reduce the availability or use of illegal drugs in
      the United States or abroad, including - 
          (A) law enforcement outside the United States;
          (B) source country programs, including economic development
        programs primarily intended to reduce the production or
        trafficking of illicit drugs;
          (C) activities to control international trafficking in, and
        availability of, illegal drugs, including - 
            (i) accurate assessment and monitoring of international
          drug production and interdiction programs and policies; and
            (ii) coordination and promotion of compliance with
          international treaties relating to the production,
          transportation, or interdiction of illegal drugs;

          (D) activities to conduct and promote international law
        enforcement programs and policies to reduce the supply of
        drugs; and
          (E) activities to facilitate and enhance the sharing of
        domestic and foreign intelligence information among National
        Drug Control Program agencies, relating to the production and
        trafficking of drugs in the United States and in foreign
        countries.
      (12) Appropriate congressional committees
        Except where otherwise provided, the term "appropriate
      congressional committees" means the Committee on the Judiciary,
      the Committee on Appropriations, and the Caucus on International
      Narcotics Control of the Senate and the Committee on Government
      Reform, the Committee on the Judiciary, and the Committee on
      Appropriations of the House of Representatives.
      (13) Law enforcement
        The term "law enforcement" or "drug law enforcement" means all
      efforts by a Federal, State, local, or tribal government agency
      to enforce the drug laws of the United States or any State,
      including investigation, arrest, prosecution, and incarceration
      or other punishments or penalties.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 702, Oct. 21, 1998, 112
    Stat. 2681-670; Pub. L. 109-469, title I, Sec. 101, Dec. 29, 2006,
    120 Stat. 3503.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    title", meaning title VII of div. C of Pub. L. 105-277, Oct. 21,
    1998, 112 Stat. 2681-670, which is classified principally to this
    chapter. For complete classification of title VII to the Code, see
    Short Title note set out below and Tables.

-COD-
                               CODIFICATION                           
      The repeal of this chapter and of the amendments made by this
    chapter, effective Sept. 30, 2003, by section 1712 of this title,
    as in effect on Sept. 30, 2003, has not been given effect in the
    Code, to reflect the probable intent of Congress, because of the
    amendment to section 1712 of this title by Pub. L. 109-469 which
    substituted "September 30, 2010" for "September 30, 2003" as the
    effective date of the repeal.


-MISC1-
                                AMENDMENTS                            
      2006 - (1)(G). Pub. L. 109-469, Sec. 101(a)(2), substituted ",
    including the testing of employees;" for period at end.
      Par. (1)(H) to (J). Pub. L. 109-469, Sec. 101(a)(1), (3), added
    subpars. (H) to (J).
      Par. (6). Pub. L. 109-469, Sec. 101(b), inserted ", including any
    activities involving supply reduction, demand reduction, or State,
    local, and tribal affairs" before period at end.
      Par. (7). Pub. L. 109-469, Sec. 101(c), in introductory
    provisions, substituted "National Intelligence Program," for
    "National Foreign Intelligence Program," and inserted "or (for
    purposes of section 1703(d) of this title) an agency that is
    described in section 530C(a) of title 28," after "Related
    Activities,".
      Par. (9). Pub. L. 109-469, Sec. 101(d), substituted "indicates"
    for "implicates".
      Par. (10). Pub. L. 109-469, Sec. 101(e), amended par. (10)
    generally. Prior to amendment, text defined the term "State and
    local affairs".
      Par. (11). Pub. L. 109-469, Sec. 101(f), amended par. (11)
    generally. Prior to amendment, text defined the term "supply
    reduction".
      Pars. (12), (13). Pub. L. 109-469, Sec. 101(g), added pars. (12)
    and (13).

                       SHORT TITLE OF 2006 AMENDMENT                   
      Pub. L. 109-469, Sec. 1(a), Dec. 29, 2006, 120 Stat. 3502,
    provided that: "This Act [enacting sections 1708a, 1714, 2001 to
    2003, and 2011 to 2014 of this title, amending this section,
    sections 823, 1524, 1532, 1702 to 1708, 1710 to 1712 of this title,
    and section 458 of Title 6, Domestic Security, repealing sections
    1509, 1709, and 1801 to 1804 of this title, enacting provisions set
    out as notes under this section, sections 1532, 1705, 1706, and
    2001 of this title, and section 112 of Title 32, National Guard,
    amending provisions set out as a note under section 1521 of this
    title, and repealing provisions set out as a note under section
    1801 of this title] may be cited as the 'Office of National Drug
    Control Policy Reauthorization Act of 2006'."
      Pub. L. 109-469, title III, Sec. 302(a), Dec. 29, 2006, 120 Stat.
    3524, provided that: "This section [amending section 1706 of this
    title and enacting provisions set out as a note under section 1706
    of this title] may be cited as the 'Dawson Family Community
    Protection Act'."

                                SHORT TITLE                            
      Pub. L. 105-277, div. C, title VII, Sec. 701, Oct. 21, 1998, 112
    Stat. 2681-670, provided that: "This title [enacting this chapter,
    amending section 1509 of this title, sections 5312 to 5314 of Title
    5, Government Organization and Employees, section 1105 of Title 31,
    Money and Finance, and section 402 of Title 50, War and National
    Defense] may be cited as the 'Office of National Drug Control
    Policy Reauthorization Act of 1998'."

                                MODEL ACTS                            
      Pub. L. 109-469, title XI, Sec. 1105, Dec. 29, 2006, 120 Stat.
    3541, provided that:
      "(a) In General. - The Director of the Office of National Drug
    Control Policy shall provide for or shall enter into an agreement
    with a non-profit corporation that is described in section
    501(c)(3) of the Internal Revenue Code of 1986 [26 U.S.C.
    501(c)(3)] and exempt from tax under section 501(a) of such Code to
    - 
        "(1) advise States on establishing laws and policies to address
      alcohol and other drug issues, based on the model State drug laws
      developed by the President's Commission on Model State Drug Laws
      in 1993; and
        "(2) revise such model State drug laws and draft supplementary
      model State laws to take into consideration changes in the
      alcohol and drug abuse problems in the State involved.
      "(b) Authorization of Appropriations. - There is authorized to be
    appropriated to carry out this subsection [probably should be
    "section"] $1,500,000 for each of fiscal years 2007 through 2011."


-EXEC-
     EX. ORD. NO. 13165. WHITE HOUSE TASK FORCE ON DRUG USE IN SPORTS
        AND UNITED STATES REPRESENTATIVE ON THE BOARD OF THE WORLD
                            ANTI-DOPING AGENCY
      Ex. Ord. No. 13165, Aug. 9, 2000, 65 F.R. 49469, as amended by
    Ex. Ord. No. 13286, Sec. 11, Feb. 28, 2003, 68 F.R. 10622,
    provided:
      By the authority vested in me as President by the Constitution
    and the laws of the United States of America, including the Office
    of National Drug Control [Policy] Reauthorization Act of 1998, (21
    U.S.C. 1701 et seq.), and in order to develop recommendations for
    Federal agency actions to address the use of drugs in sports, in
    particular among young people, it is hereby ordered as follows:
      Section 1. Policy. The use of drugs in sports has reached a level
    that endangers not just the legitimacy of athletic competition but
    also the lives and health of athletes - from the elite ranks to
    youth leagues. The National Household Survey on Drug Abuse issued
    in 1999 found that in just 1 year's time the rate of steroid use
    among young people rose roughly 50 percent among both sexes and
    across all age groups. It is the policy of my Administration to
    take the steps needed to help eliminate illicit or otherwise banned
    drug use and doping in sports at the State, national, and
    international level.
      Sec. 2. Establishment of a White House Task Force on Drug Use in
    Sports. (a) There is established a White House Task Force on Drug
    Use in Sports (Task Force). The Task Force shall comprise the co-
    vice chairs of the White House Olympic Task Force (the "Olympic
    Task Force Vice Chairs"), and representatives designated by the
    Office of National Drug Control Policy, the Department of Health
    and Human Services, the Department of Labor, the President's
    Council on Physical Fitness and Sports, the Office of Management
    and Budget, the National Security Council, the Department of State,
    the Department of the Treasury, the Department of Education, the
    Department of Justice, the Department of Transportation, the
    Department of Homeland Security, the National Institute on Drug
    Abuse, and the Substance Abuse and Mental Health Services
    Administration.
      (b) The Task Force shall develop recommendations for the
    President on further executive and legislative actions that can be
    undertaken to address the problem of doping and drug use in sports.
    In developing the recommendations, the Task Force shall consider,
    among other things: (i) the health and safety of America's
    athletes, in particular our Nation's young people; (ii) the
    integrity of honest athletic competition; and (iii) the views and
    recommendations of State and local governments, the private sector,
    citizens, community groups, and nonprofit organizations, on actions
    to address this threat. The Task Force, through its Chairs, shall
    submit its recommendations to the President.
      (c) The Director of the Office of National Drug Control Policy
    (the Director), the Secretary of the Department of Health and Human
    Services, and the Olympic Task Force Vice Chairs or their designees
    shall serve as the Task Force Chairs.
      (d) To the extent permitted by law and at the request of the
    Chairs, agencies shall cooperate with and provide information to
    the Task Force.
      Sec. 3. Participation in the World Anti-Doping Agency. (a) As
    part of my Administration's efforts to address the problem of drug
    use in sports, the United States has played a leading role in the
    formation of a World Anti-Doping Agency (WADA) by the Olympic and
    sports community and the nations of the world. Through these
    efforts, the United States has been selected to serve as a
    governmental representative on the board of the WADA. This order
    will authorize the Director to serve as the United States
    Government's representative on the WADA board.
      (b) Pursuant to 21 U.S.C. 1701 et seq., the Director, or in his
    absence his designee, is hereby authorized to take all necessary
    and proper actions to execute his responsibilities as United States
    representative to the WADA.
      (c) To assist the Director in carrying out these responsibilities
    as the United States Government representative to the WADA and to
    the extent permitted by law, Federal employees may serve in their
    official capacity, inter alia, on WADA Committees or WADA advisory
    committees, serving as experts to the WADA.

-End-



-CITE-
    21 USC Sec. 1702                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1702. Office of National Drug Control Policy

-STATUTE-
    (a) Establishment of Office
      There is established in the Executive Office of the President an
    Office of National Drug Control Policy, which shall - 
        (1) develop national drug control policy;
        (2) coordinate and oversee the implementation of the national
      drug control policy;
        (3) assess and certify the adequacy of National Drug Control
      Programs and the budget for those programs; and
        (4) evaluate the effectiveness of the national drug control
      policy and the National Drug Control Program agencies' programs,
      by developing and applying specific goals and performance
      measurements.

    When developing the national drug control policy, any policy of the
    Director relating to syringe exchange programs for intravenous drug
    users shall be based on the best available medical and scientific
    evidence regarding their effectiveness in promoting individual
    health and preventing the spread of infectious disease, and their
    impact on drug addiction and use. In making any policy relating to
    syringe exchange programs, the Director shall consult with the
    National Institutes of Health and the National Academy of Sciences.
    (b) Director of National Drug Control Policy and Deputy Directors
      (1) Director
        There shall be a Director of National Drug Control Policy who
      shall head the Office (referred to in this chapter as the
      "Director") and shall hold the same rank and status as the head
      of an executive department listed in section 101 of title 5.
      (2) Deputy Director
        There shall be a Deputy Director of National Drug Control
      Policy who shall report directly to the Director (referred to in
      this chapter as the "Deputy Director").
      (3) Other Deputy Directors
        (A) In general
          There shall be a Deputy Director for Demand Reduction, a
        Deputy Director for Supply Reduction, and a Deputy Director for
        State, Local, and Tribal Affairs.
        (B) Reporting
          The Deputy Director for Demand Reduction, the Deputy Director
        for Supply Reduction, and the Deputy Director for State, Local,
        and Tribal Affairs shall report directly to the Deputy Director
        of the Office of National Drug Control Policy.
        (C) Deputy Director for Demand Reduction
          The Deputy Director for Demand Reduction shall be responsible
        for the activities in subparagraphs (A) through (H) of section
        1701(1) (!1) of this title.

        (D) Deputy Director for Supply Reduction
          The Deputy Director for Supply Reduction shall - 
            (i) have substantial experience and expertise in drug
          interdiction and other supply reduction activities; and
            (ii) be responsible for the activities in subparagraphs (A)
          through (C) in section 1701(11) of this title.
        (E) Deputy Director for State, Local, and Tribal Affairs
          The Deputy Director for State, Local, and Tribal Affairs
        shall be responsible for the activities - 
            (i) in subparagraphs (A) through (D) of section 1701(10) of
          this title;
            (ii) in section 1706 of this title, the High Intensity Drug
          Trafficking Areas Program; and
            (iii) in section 1707 of this title, the Counterdrug
          Technology Assessment Center.
    (c) Access by Congress
      The location of the Office in the Executive Office of the
    President shall not be construed as affecting access by Congress,
    or any committee of the House of Representatives or the Senate, to
    any - 
        (1) information, document, or study in the possession of, or
      conducted by or at the direction of the Director; or
        (2) personnel of the Office.
    (d) Office of National Drug Control Policy Gift Fund
      (1) Establishment
        There is established in the Treasury of the United States a
      fund for the receipt of gifts, both real and personal, for the
      purpose of aiding or facilitating the work of the Office under
      section 1703(c) of this title.
      (2) Contributions
        The Office may accept, hold, and administer contributions to
      the Fund.
      (3) Use of amounts deposited
        Amounts deposited in the Fund are authorized to be
      appropriated, to remain available until expended for authorized
      purposes at the discretion of the Director.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 703, Oct. 21, 1998, 112
    Stat. 2681-672; Pub. L. 109-469, title I, Sec. 102, title XI, Sec.
    1120, Dec. 29, 2006, 120 Stat. 3505, 3548.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in subsec. (b)(1), (2), was in the
    original "this Act" and was translated as reading "this title",
    meaning title VII of Pub. L. 105-277, div. C, Oct. 21, 1998, 112
    Stat. 2681-670, which is classified principally to this chapter, to
    reflect the probable intent of Congress. For complete
    classification of title VII to the Code, see Short Title note set
    out under section 1701 of this title and Tables.
      Section 1701(1) of this title, referred to in subsec. (b)(3)(C),
    was in the original "section 702(l)", and was translated as reading
    "section 702(1)", meaning section 702(1) of Pub. L. 105-277, to
    reflect the probable intent of Congress, because section 702 of
    Pub. L. 105-277 does not contain a subsec. (l).


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a). Pub. L. 109-469, Sec. 1120, inserted
    concluding provisions.
      Pub. L. 109-469, Sec. 102(a), amended subsec. (a) generally.
    Prior to amendment, subsec. (a) related to establishment of Office
    of National Drug Control Policy.
      Subsec. (b). Pub. L. 109-469, Sec. 102(b), amended subsec. (b)
    generally. Prior to amendment, subsec. (b) related to Director and
    Deputy Directors of National Drug Control Policy.

              GIFTS TO OFFICE OF NATIONAL DRUG CONTROL POLICY          
      Pub. L. 109-115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475,
    provided in part: "That the Office [of National Drug Control
    Policy] is authorized to accept, hold, administer, and utilize
    gifts, both real and personal, public and private, without fiscal
    year limitation, for the purpose of aiding or facilitating the work
    of the Office."
      Similar provisions were contained in the following prior
    appropriation acts:
      Pub. L. 108-447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249.
      Pub. L. 108-199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.
      Pub. L. 108-7, div. J, title III, Feb. 20, 2003, 117 Stat. 446.
      Pub. L. 107-67, title III, Nov. 12, 2001, 115 Stat. 530.
      Pub. L. 106-554, Sec. 1(a)(3) [title III], Dec. 21, 2000, 114
    Stat. 2763, 2763A-139.
      Pub. L. 106-58, title III, Sept. 29, 1999, 113 Stat. 447.
      Pub. L. 105-277, div. A, Sec. 101(h) [title III], Oct. 21, 1998,
    112 Stat. 2681-480, 2681-496.
      Pub. L. 105-61, title III, Oct. 10, 1997, 111 Stat. 1293.
      Pub. L. 104-208, div. A, title I, Sec. 101(f) [title III], Sept.
    30, 1996, 110 Stat. 3009-314, 3009-329.
      Pub. L. 104-52, title III, Nov. 19, 1995, 109 Stat. 479.
      Pub. L. 103-329, title III, Sept. 30, 1994, 108 Stat. 2394.
      Pub. L. 103-123, title III, Oct. 28, 1993, 107 Stat. 1237.
      Pub. L. 102-393, title III, Oct. 6, 1992, 106 Stat. 1741.
      Pub. L. 102-141, title III, Oct. 28, 1991, 105 Stat. 847.
      Pub. L. 101-509, title III, Nov. 5, 1990, 104 Stat. 1402.
      Pub. L. 101-136, title III, Nov. 3, 1989, 103 Stat. 793.


-EXEC-
    EX. ORD. NO. 12911. SEAL FOR OFFICE OF NATIONAL DRUG CONTROL POLICY
      Ex. Ord. No. 12911, Apr. 25, 1994, 59 F.R. 21121 [22121],
    provided:
      By the authority vested in me as President by the Constitution
    and the laws of the United States of America, it is hereby ordered
    as follows:
      Section 1. There is approved for the Office of National Drug
    Control Policy in the Executive Office of the President an official
    seal described as follows:
      On a blue disc the Arms of the United States proper above a
    curved gold scroll inscribed "OFFICE OF NATIONAL DRUG CONTROL
    POLICY" in blue letters, all within a white border edged in gold
    and inscribed "EXECUTIVE OFFICE OF THE PRESIDENT OF THE UNITED
    STATES" in blue letters.
      This design is appropriate for the Office of National Drug
    Control Policy. The dark blue in this seal is suggested by the Seal
    of the President and denotes the direct organizational link of the
    Office of National Drug Control Policy with the Presidential
    office. The Arms of the United States refer to the entire Nation
    and represent the involvement in drug control policies that are
    necessary to assist the President in his role as Chief Executive of
    the United States.
      Sec. 2. The seal shall be of the design that is attached hereto
    and made a part of this order.
                                                     William J. Clinton.

<p><img src="http://uscode.house.gov/images/code06/t211702.gif" width=576 height=579 alt="Image of item"><p>


-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 1703                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1703. Appointment and duties of Director and Deputy Directors

-STATUTE-
    (a) Appointment
      (1) In general
        The Director, the Deputy Director of National Drug Control
      Policy, the Deputy Director for Demand Reduction, the Deputy
      Director for Supply Reduction, and the Deputy Director for State
      and Local Affairs, shall each be appointed by the President, by
      and with the advice and consent of the Senate, and shall serve at
      the pleasure of the President. In appointing the Deputy Director
      for Demand Reduction under this paragraph, the President shall
      take into consideration the scientific, educational or
      professional background of the individual, and whether the
      individual has experience in the fields of substance abuse
      prevention, education, or treatment.
      (2) Duties of Deputy Director of National Drug Control Policy
        The Deputy Director of National Drug Control Policy shall - 
          (A) carry out the duties and powers prescribed by the
        Director; and
          (B) serve as the Director in the absence of the Director or
        during any period in which the office of the Director is
        vacant.
      (3) Acting Director
        If the Director dies, resigns, or is otherwise unable to
      perform the functions and duties of the office, the Deputy
      Director shall perform the functions and duties of the Director
      temporarily in an acting capacity pursuant to subchapter III of
      chapter 33 of title 5.
      (4) Prohibition
        No person shall serve as Director or a Deputy Director while
      serving in any other position in the Federal Government.
      (5) Prohibition on political campaigning
        Any officer or employee of the Office who is appointed to that
      position by the President, by and with the advice and consent of
      the Senate, may not participate in Federal election campaign
      activities, except that such official is not prohibited by this
      paragraph from making contributions to individual candidates.
    (b) Responsibilities
      The Director - 
        (1) shall assist the President in the establishment of
      policies, goals, objectives, and priorities for the National Drug
      Control Program;
        (2) shall promulgate the National Drug Control Strategy under
      section 1705(a) of this title and each report under section
      1705(b) of this title in accordance with section 1705 of this
      title;
        (3) shall coordinate and oversee the implementation by the
      National Drug Control Program agencies of the policies, goals,
      objectives, and priorities established under paragraph (1) and
      the fulfillment of the responsibilities of such agencies under
      the National Drug Control Strategy and make recommendations to
      National Drug Control Program agency heads with respect to
      implementation of Federal counter-drug programs;
        (4) shall make such recommendations to the President as the
      Director determines are appropriate regarding changes in the
      organization, management, and budgets of National Drug Control
      Program agencies, and changes in the allocation of personnel to
      and within those departments and agencies, to implement the
      policies, goals, priorities, and objectives established under
      paragraph (1) and the National Drug Control Strategy;
        (5) shall consult with and assist State and local governments
      with respect to the formulation and implementation of National
      Drug Control Policy and their relations with the National Drug
      Control Program agencies;
        (6) shall appear before duly constituted committees and
      subcommittees of the House of Representatives and of the Senate
      to represent the drug policies of the executive branch;
        (7) shall notify any National Drug Control Program agency if
      its policies are not in compliance with the responsibilities of
      the agency under the National Drug Control Strategy, transmit a
      copy of each such notification to the President and the
      appropriate congressional committees, and maintain a copy of each
      such notification;
        (8) shall provide, by July 1 of each year, budget
      recommendations, including requests for specific initiatives that
      are consistent with the priorities of the President under the
      National Drug Control Strategy, to the heads of departments and
      agencies with responsibilities under the National Drug Control
      Program, which recommendations shall - 
          (A) apply to the next budget year scheduled for formulation
        under chapter 11 of title 31, and each of the 4 subsequent
        fiscal years; and
          (B) address funding priorities developed in the National Drug
        Control Strategy;

        (9) may serve as representative of the President in appearing
      before Congress on all issues relating to the National Drug
      Control Program;
        (10) shall, in any matter affecting national security
      interests, work in conjunction with the Assistant to the
      President for National Security Affairs;
        (11) may serve as spokesperson of the Administration on drug
      issues;
        (12) shall ensure that no Federal funds appropriated to the
      Office of National Drug Control Policy shall be expended for any
      study or contract relating to the legalization (for a medical use
      or any other use) of a substance listed in schedule I of section
      812 of this title and take such actions as necessary to oppose
      any attempt to legalize the use of a substance (in any form) that
      - 
          (A) is listed in schedule I of section 812 of this title; and
          (B) has not been approved for use for medical purposes by the
        Food and Drug Administration;

        (13) shall require each National Drug Control Program agency to
      submit to the Director on an annual basis an evaluation of
      progress by the agency with respect to drug control program goals
      using the performance measures for the agency developed under
      section 1705(c) of this title, including progress with respect to
      - 
          (A) success in reducing domestic and foreign sources of
        illegal drugs;
          (B) success in protecting the borders of the United States
        (and in particular the Southwestern border of the United
        States) from penetration by illegal narcotics;
          (C) success in reducing violent crime associated with drug
        use in the United States;
          (D) success in reducing the negative health and social
        consequences of drug use in the United States; and
          (E) implementation of drug treatment and prevention programs
        in the United States and improvements in the adequacy and
        effectiveness of such programs;

        (14) shall submit to the appropriate congressional committees
      on an annual basis, not later than 60 days after the date of the
      last day of the applicable period, a summary of - 
          (A) each of the evaluations received by the Director under
        paragraph (13); and
          (B) the progress of each National Drug Control Program agency
        toward the drug control program goals of the agency using the
        performance measures for the agency developed under section
        1705(c) of this title;

        (15) shall ensure that drug prevention and drug treatment
      research and information is effectively disseminated by National
      Drug Control Program agencies to State and local governments and
      nongovernmental entities involved in demand reduction by - 
          (A) encouraging formal consultation between any such agency
        that conducts or sponsors research, and any such agency that
        disseminates information in developing research and information
        product development agendas;
          (B) encouraging such agencies (as appropriate) to develop and
        implement dissemination plans that specifically target State
        and local governments and nongovernmental entities involved in
        demand reduction; and
          (C) supporting the substance abuse information clearinghouse
        administered by the Administrator of the Substance Abuse and
        Mental Health Services Administration and established in
        section 290aa(d)(16) of title 42 by - 
            (i) encouraging all National Drug Control Program agencies
          to provide all appropriate and relevant information; and
            (ii) supporting the dissemination of information to all
          interested entities;

        (16) shall coordinate with the private sector to promote
      private research and development of medications to treat
      addiction;
        (17) shall seek the support and commitment of State, local, and
      tribal officials in the formulation and implementation of the
      National Drug Control Strategy;
        (18) shall monitor and evaluate the allocation of resources
      among Federal law enforcement agencies in response to significant
      local and regional drug trafficking and production threats;
        (19) shall submit an annual report to Congress detailing how
      the Office of National Drug Control Policy has consulted with and
      assisted State, local, and tribal governments with respect to the
      formulation and implementation of the National Drug Control
      Strategy and other relevant issues; and
        (20) shall, within 1 year after December 29, 2006, report to
      Congress on the impact of each Federal drug reduction strategy
      upon the availability, addiction rate, use rate, and other harms
      of illegal drugs.
    (c) National Drug Control Program budget
      (1) Responsibilities of National Drug Control Program agencies
        (A) In general
          For each fiscal year, the head of each department, agency, or
        program of the Federal Government with responsibilities under
        the National Drug Control Program Strategy shall transmit to
        the Director a copy of the proposed drug control budget request
        of the department, agency, or program at the same time as that
        budget request is submitted to their superiors (and before
        submission to the Office of Management and Budget) in the
        preparation of the budget of the President submitted to
        Congress under section 1105(a) of title 31.
        (B) Submission of drug control budget requests
          The head of each National Drug Control Program agency shall
        ensure timely development and submission to the Director of
        each proposed drug control budget request transmitted pursuant
        to this paragraph, in such format as may be designated by the
        Director with the concurrence of the Director of the Office of
        Management and Budget.
        (C) Content of drug control budget requests
          A drug control budget request submitted by a department,
        agency, or program under this paragraph shall include all
        requests for funds for any drug control activity undertaken by
        that department, agency, or program, including demand
        reduction, supply reduction, and State, local, and tribal
        affairs, including any drug law enforcement activities. If an
        activity has both drug control and nondrug control purposes or
        applications, the department, agency, or program shall estimate
        by a documented calculation the total funds requested for that
        activity that would be used for drug control, and shall set
        forth in its request the basis and method for making the
        estimate.
      (2) National Drug Control Program budget proposal
        For each fiscal year, following the transmission of proposed
      drug control budget requests to the Director under paragraph (1),
      the Director shall, in consultation with the head of each
      National Drug Control Program agency and the head of each major
      national organization that represents law enforcement officers,
      agencies, or associations - 
          (A) develop a consolidated National Drug Control Program
        budget proposal designed to implement the National Drug Control
        Strategy and to inform Congress and the public about the total
        amount proposed to be spent on all supply reduction, demand
        reduction, State, local, and tribal affairs, including any drug
        law enforcement, and other drug control activities by the
        Federal Government, which shall conform to the content
        requirements set forth in paragraph (1)(C);
          (B) submit the consolidated budget proposal to the President;
        and
          (C) after submission under subparagraph (B), submit the
        consolidated budget proposal to Congress.
      (3) Review and certification of budget requests and budget
        submissions of National Drug Control Program agencies
        (A) In general
          The Director shall review each drug control budget request
        submitted to the Director under paragraph (1).
        (B) Review of budget requests
          (i) Inadequate requests
            If the Director concludes that a budget request submitted
          under paragraph (1) is inadequate, in whole or in part, to
          implement the objectives of the National Drug Control
          Strategy with respect to the department, agency, or program
          at issue for the year for which the request is submitted, the
          Director shall submit to the head of the applicable National
          Drug Control Program agency a written description of funding
          levels and specific initiatives that would, in the
          determination of the Director, make the request adequate to
          implement those objectives.
          (ii) Adequate requests
            If the Director concludes that a budget request submitted
          under paragraph (1) is adequate to implement the objectives
          of the National Drug Control Strategy with respect to the
          department, agency, or program at issue for the year for
          which the request is submitted, the Director shall submit to
          the head of the applicable National Drug Control Program
          agency a written statement confirming the adequacy of the
          request.
          (iii) Record
            The Director shall maintain a record of each description
          submitted under clause (i) and each statement submitted under
          clause (ii).
        (C) Specific requests
          The Director shall not confirm the adequacy of any budget
        request that - 
            (i) requests funding for Federal law enforcement activities
          that do not adequately compensate for transfers of drug
          enforcement resources and personnel to law enforcement and
          investigation activities;
            (ii) requests funding for law enforcement activities on the
          borders of the United States that do not adequately direct
          resources to drug interdiction and enforcement;
            (iii) requests funding for drug treatment activities that
          do not provide adequate results and accountability measures;
            (iv) requests funding for any activities of the Safe and
          Drug-Free Schools Program that do not include a clear anti-
          drug message or purpose intended to reduce drug use;
            (v) requests funding for drug treatment activities that do
          not adequately support and enhance Federal drug treatment
          programs and capacity;
            (vi) requests funding for fiscal year 2007 for activities
          of the Department of Education, unless it is accompanied by a
          report setting forth a plan for providing expedited
          consideration of student loan applications for all
          individuals who submitted an application for any Federal
          grant, loan, or work assistance that was rejected or denied
          pursuant to 1091(r)(1) (!1) of title 20 by reason of a
          conviction for a drug-related offense not occurring during a
          period of enrollment for which the individual was receiving
          any Federal grant, loan, or work assistance; and

            (vii) requests funding for the operations and management of
          the Department of Homeland Security that does not include a
          specific request for funds for the Office of Counternarcotics
          Enforcement to carry out its responsibilities under section
          458 of title 6.
        (D) Agency response
          (i) In general
            The head of a National Drug Control Program agency that
          receives a description under subparagraph (B)(i) shall
          include the funding levels and initiatives described by the
          Director in the budget submission for that agency to the
          Office of Management and Budget.
          (ii) Impact statement
            The head of a National Drug Control Program agency that has
          altered its budget submission under this subparagraph shall
          include as an appendix to the budget submission for that
          agency to the Office of Management and Budget an impact
          statement that summarizes - 
              (I) the changes made to the budget under this
            subparagraph; and
              (II) the impact of those changes on the ability of that
            agency to perform its other responsibilities, including any
            impact on specific missions or programs of the agency.
          (iii) Congressional notification
            The head of a National Drug Control Program agency shall
          submit a copy of any impact statement under clause (ii) to
          the Senate and the House of Representatives and the
          appropriate congressional committees, at the time the budget
          for that agency is submitted to Congress under section
          1105(a) of title 31.
        (E) Certification of budget submissions
          (i) In general
            At the time a National Drug Control Program agency submits
          its budget request to the Office of Management and Budget,
          the head of the National Drug Control Program agency shall
          submit a copy of the budget request to the Director.
          (ii) Certification
            The Director - 
              (I) shall review each budget submission submitted under
            clause (i); and
              (II) based on the review under subclause (I), if the
            Director concludes that the budget submission of a National
            Drug Control Program agency does not include the funding
            levels and initiatives described under subparagraph (B) - 
                (aa) may issue a written decertification of that
              agency's budget; and
                (bb) in the case of a decertification issued under item
              (aa), shall submit to the Senate and the House of
              Representatives and the appropriate congressional
              committees, a copy of - 
                  (aaa) the decertification issued under item (aa);
                  (bbb) the description made under subparagraph (B);
                and
                  (ccc) the budget recommendations made under
                subsection (b)(8) of this section.
      (4) Reprogramming and transfer requests
        (A) In general
          No National Drug Control Program agency shall submit to
        Congress a reprogramming or transfer request with respect to
        any amount of appropriated funds in an amount exceeding
        $1,000,000 that is included in the National Drug Control
        Program budget unless the request has been approved by the
        Director. If the Director has not responded to a request for
        reprogramming subject to this subparagraph within 30 days after
        receiving notice of the request having been made, the request
        shall be deemed approved by the Director under this
        subparagraph and forwarded to Congress.
        (B) Appeal
          The head of any National Drug Control Program agency may
        appeal to the President any disapproval by the Director of a
        reprogramming or transfer request under this paragraph.
    (d) Powers of the Director
      In carrying out subsection (b) of this section, the Director may -
     
        (1) select, appoint, employ, and fix compensation of such
      officers and employees of the Office as may be necessary to carry
      out the functions of the Office under this chapter;
        (2) subject to subsection (e)(3) of this section, request the
      head of a department or agency, or program of the Federal
      Government to place department, agency, or program personnel who
      are engaged in drug control activities on temporary detail to
      another department, agency, or program in order to implement the
      National Drug Control Strategy, and the head of the department or
      agency shall comply with such a request;
        (3) use for administrative purposes, on a reimbursable basis,
      the available services, equipment, personnel, and facilities of
      Federal, State, and local agencies;
        (4) procure the services of experts and consultants in
      accordance with section 3109 of title 5, relating to appointments
      in the Federal Service, at rates of compensation for individuals
      not to exceed the daily equivalent of the rate of pay payable
      under level IV of the Executive Schedule under section 5311 of
      title 5;
        (5) accept and use gifts and donations of property from
      Federal, State, and local government agencies, and from the
      private sector, as authorized in section 1702(d) of this title;
        (6) use the mails in the same manner as any other department or
      agency of the executive branch;
        (7) monitor implementation of the National Drug Control
      Program, including - 
          (A) conducting program and performance audits and
        evaluations; and
          (B) requesting assistance from the Inspector General of the
        relevant agency in such audits and evaluations;

        (8) transfer funds made available to a National Drug Control
      Program agency for National Drug Control Strategy programs and
      activities to another account within such agency or to another
      National Drug Control Program agency for National Drug Control
      Strategy programs and activities, except that - 
          (A) the authority under this paragraph may be limited in an
        annual appropriations Act or other provision of Federal law;
          (B) the Director may exercise the authority under this
        paragraph only with the concurrence of the head of each
        affected agency;
          (C) in the case of an interagency transfer, the total amount
        of transfers under this paragraph may not exceed 3 percent of
        the total amount of funds made available for National Drug
        Control Strategy programs and activities to the agency from
        which those funds are to be transferred;
          (D) funds transferred to an agency under this paragraph may
        only be used to increase the funding for programs or activities
        authorized by law; and
          (E) the Director shall - 
            (i) submit to Congress, including to the Committees on
          Appropriations of the Senate and the House of
          Representatives, the authorizing committees for the Office,
          and any other applicable committees of jurisdiction, a
          reprogramming or transfer request in advance of any transfer
          under this paragraph in accordance with the regulations of
          the affected agency or agencies; and
            (ii) annually submit to Congress a report describing the
          effect of all transfers of funds made pursuant to this
          paragraph or subsection (c)(4) of this section during the 12-
          month period preceding the date on which the report is
          submitted;

        (9) issue to the head of a National Drug Control Program agency
      a fund control notice described in subsection (f) of this section
      to ensure compliance with the National Drug Control Program
      Strategy and notify the appropriate congressional committees of
      any fund control notice issued in accordance with subsection
      (f)(5);
        (10) participate in the drug certification process pursuant to
      section 2291j of title 22 and section 2291j-1 of title 22.
    (e) Personnel detailed to Office
      (1) Evaluations
        Notwithstanding any provision of chapter 43 of title 5, the
      Director shall perform the evaluation of the performance of any
      employee detailed to the Office for purposes of the applicable
      performance appraisal system established under such chapter for
      any rating period, or part thereof, that such employee is
      detailed to such office.
      (2) Compensation
        (A) Bonus payments
          Notwithstanding any other provision of law, the Director may
        provide periodic bonus payments to any employee detailed to the
        Office.
        (B) Restrictions
          An amount paid under this paragraph to an employee for any
        period - 
            (i) shall not be greater than 20 percent of the basic pay
          paid or payable to such employee for such period; and
            (ii) shall be in addition to the basic pay of such
          employee.
        (C) Aggregate amount
          The aggregate amount paid during any fiscal year to an
        employee detailed to the Office as basic pay, awards, bonuses,
        and other compensation shall not exceed the annual rate payable
        at the end of such fiscal year for positions at level III of
        the Executive Schedule.
      (3) Maximum number of detailees
        The maximum number of personnel who may be detailed to another
      department or agency (including the Office) under subsection
      (d)(2) of this section during any fiscal year is - 
          (A) for the Department of Defense, 50; and
          (B) for any other department or agency, 10.
    (f) Fund control notices
      (1) In general
        A fund control notice may direct that all or part of an amount
      appropriated to the National Drug Control Program agency account
      be obligated by - 
          (A) months, fiscal year quarters, or other time periods; and
          (B) activities, functions, projects, or object classes.
      (2) Unauthorized obligation or expenditure prohibited
        An officer or employee of a National Drug Control Program
      agency shall not make or authorize an expenditure or obligation
      contrary to a fund control notice issued by the Director.
      (3) Disciplinary action for violation
        In the case of a violation of paragraph (2) by an officer or
      employee of a National Drug Control Program agency, the head of
      the agency, upon the request of and in consultation with the
      Director, may subject the officer or employee to appropriate
      administrative discipline, including, when circumstances warrant,
      suspension from duty without pay or removal from office.
      (4) (!2) Congressional notice

        A copy of each fund control notice shall be transmitted to the
      appropriate congressional committees.
      (5) (!3) Restrictions

        The Director shall not issue a fund control notice to direct
      that all or part of an amount appropriated to the National Drug
      Control Program agency account be obligated, modified, or altered
      in any manner - 
          (A) contrary, in whole or in part, to a specific
        appropriation; or
          (B) contrary, in whole or in part, to the expressed intent of
        Congress.
      (4) (!2) Congressional notice. - 
        A copy of each fund control notice shall be transmitted to the
      appropriate congressional committees.
      (5) (!3) Restrictions
        The Director shall not issue a fund control notice to direct
      that all or part of an amount appropriated to the National Drug
      Control Program agency account be obligated, modified, or altered
      in any manner contrary, in whole or in part, to a specific
      appropriation or statute.
    (g) Inapplicability to certain programs
      The provisions of this section shall not apply to the National
    Intelligence Program, the Joint Military Intelligence Program, and
    Tactical and Related Activities, unless such program or an element
    of such program is designated as a National Drug Control Program - 
        (1) by the President; or
        (2) jointly by - 
          (A) in the case of the National Intelligence Program, the
        Director and the Director of National Intelligence; or
          (B) in the case of the Joint Military Intelligence Program
        and Tactical and Related Activities, the Director, the Director
        of National Intelligence, and the Secretary of Defense.
    (h) Construction
      Nothing in this chapter shall be construed as derogating the
    authorities and responsibilities of the Director of National
    Intelligence or the Director of the Central Intelligence Agency
    contained in the National Security Act of 1947 (50 U.S.C. 401 et
    seq.), the Central Intelligence Agency Act of 1949 (50 U.S.C. 403a
    et seq.), or any other law.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 704, Oct. 21, 1998, 112
    Stat. 2681-672; Pub. L. 109-469, title I, Secs. 103(a)-(e), (f)(3),
    105, Dec. 29, 2006, 120 Stat. 3506, 3507, 3510, 3511.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      Levels III and IV of the Executive Schedule, referred to in
    subsecs. (d)(4) and (e)(2)(C), are set out in sections 5314 and
    5315, respectively, of Title 5, Government Organization and
    Employees.
      This chapter, referred to in subsec. (h), was in the original
    "this Act" and was translated as reading "this title", meaning
    title VII of Pub. L. 105-277, div. C, Oct. 21, 1998, 112 Stat. 2681-
    670, which is classified principally to this chapter, to reflect
    the probable intent of Congress. For complete classification of
    title VII to the Code, see Short Title note set out under section
    1701 of this title and Tables.
      The National Security Act of 1947, referred to in subsec. (h), is
    act July 26, 1947, ch. 343, 61 Stat. 495, as amended. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 401 of Title 50, War and National Defense, and
    Tables.
      The Central Intelligence Agency Act of 1949, referred to in
    subsec. (h), is act June 20, 1949, ch. 227, 63 Stat. 208, as
    amended, which is classified generally to section 403a et seq. of
    Title 50, War and National Defense. For complete classification of
    this Act to the Code, see Short Title note set out under section
    403a of Title 50 and Tables.

-COD-
                               CODIFICATION                           
      In subsec. (b)(8)(A), "chapter 11 of title 31" substituted for
    "the Budget and Accounting Act of 1921" on authority of Pub. L. 97-
    258, Sec. 4(b), Sept. 13, 1982, 96 Stat. 1067, the first section
    of which enacted Title 31, Money and Finance.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a)(3). Pub. L. 109-469, Sec. 103(a), amended par.
    (3) generally. Prior to amendment, text read as follows: "In the
    absence of the Deputy Director, or if the Office of the Deputy
    Director is vacant, the Director shall designate such other
    permanent employee of the Office to serve as the Director, if the
    Director is absent or unable to serve."
      Subsec. (b)(4). Pub. L. 109-469, Sec. 103(b)(1), substituted
    "National Drug Control Program agencies" for "Federal departments
    and agencies engaged in drug enforcement".
      Subsec. (b)(7). Pub. L. 109-469, Sec. 103(b)(2), inserted "and
    the appropriate congressional committees" after "President".
      Subsec. (b)(13). Pub. L. 109-469, Sec. 103(b)(3), struck out
    "(beginning in 1999)" after "basis" in introductory provisions.
      Subsec. (b)(14). Pub. L. 109-469, Sec. 103(b)(4), added par. (14)
    and struck out former par. (14) which read as follows: "shall
    submit to the Appropriations committees and the authorizing
    committees of jurisdiction of the House of Representatives and the
    Senate on an annual basis, not later than 60 days after the date of
    the last day of the applicable period, a summary of - 
        "(A) each of the evaluations received by the Director under
      paragraph (13); and
        "(B) the progress of each National Drug Control Program agency
      toward the drug control program goals of the agency using the
      performance measures for the agency developed under section
      1705(c) of this title; and".
      Subsec. (b)(15)(C). Pub. L. 109-469, Sec. 103(b)(5), added
    subpar. (C) and struck out former subpar. (C) which read as
    follows: "developing a single interagency clearinghouse for the
    dissemination of research and information by such agencies to State
    and local governments and nongovernmental agencies involved in
    demand reduction."
      Subsec. (b)(16) to (20). Pub. L. 109-469, Sec. 103(b)(6), added
    pars. (16) to (20).
      Subsec. (c)(1)(C). Pub. L. 109-469, Sec. 105(a), added subpar.
    (C).
      Subsec. (c)(2). Pub. L. 109-469, Sec. 105(b)(1), inserted "and
    the head of each major national organization that represents law
    enforcement officers, agencies, or associations" after "agency" in
    introductory provisions.
      Subsec. (c)(2)(A). Pub. L. 109-469, Sec. 105(b)(2), inserted "and
    to inform Congress and the public about the total amount proposed
    to be spent on all supply reduction, demand reduction, State,
    local, and tribal affairs, including any drug law enforcement, and
    other drug control activities by the Federal Government, which
    shall conform to the content requirements set forth in paragraph
    (1)(C)" before semicolon at end.
      Subsec. (c)(3)(C). Pub. L. 109-469, Sec. 105(c)(2), added subpar.
    (C). Former subpar. (C) redesignated (D).
      Subsec. (c)(3)(C)(iii). Pub. L. 109-469, Sec. 103(c)(1), inserted
    "and the appropriate congressional committees," after "House of
    Representatives".
      Subsec. (c)(3)(D). Pub. L. 109-469, Sec. 105(c)(1), redesignated
    subpar. (C) as (D). Former subpar. (D) redesignated (E).
      Subsec. (c)(3)(D)(ii)(II)(bb). Pub. L. 109-469, Sec. 103(c)(2),
    inserted "and the appropriate congressional committees," after
    "House of Representatives".
      Subsec. (c)(3)(D)(iii). Pub. L. 109-469, Sec. 105(c)(3), which
    directed amendment of cl. (iii) by inserting "and the appropriate
    congressional committees," after "House of Representatives", was
    not executed in view of the identical amendment made by Pub. L. 109-
    469, Sec. 103(c)(1) to subpar. (C)(iii) prior to its redesignation
    as (D)(iii). See above.
      Subsec. (c)(3)(E). Pub. L. 109-469, Sec. 105(c)(1), redesignated
    subpar. (D) as (E).
      Subsec. (c)(3)(E)(ii)(II)(bb). Pub. L. 109-469, Sec. 105(c)(4),
    which directed amendment of item (bb) by inserting "and the
    appropriate congressional committees," after "House of
    Representatives", was not executed in view of the identical
    amendment made by Pub. L. 109-469, Sec. 103(c)(2) to subpar.
    (D)(ii)(II)(bb) prior to its redesignation as (E)(ii)(II)(bb). See
    above.
      Subsec. (c)(4)(A). Pub. L. 109-469, Sec. 105(d), substituted
    "$1,000,000" for "$5,000,000" and inserted at end "If the Director
    has not responded to a request for reprogramming subject to this
    subparagraph within 30 days after receiving notice of the request
    having been made, the request shall be deemed approved by the
    Director under this subparagraph and forwarded to Congress."
      Subsec. (d)(8)(D). Pub. L. 109-469, Sec. 105(e)(1), substituted
    "authorized by law;" for "have been authorized by Congress;".
      Subsec. (d)(9). Pub. L. 109-469, Sec. 105(e)(2), which directed
    the substitution of "Strategy and notify the appropriate
    congressional committees of any fund control notice issued; and"
    for "Strategy; and", could not be executed because the words
    "Strategy; and" did not appear subsequent to amendment by Pub. L.
    109-469, Sec. 103(d)(1). See below.
      Pub. L. 109-469, Sec. 103(d)(1), substituted "Strategy and notify
    the appropriate congressional committees of any fund control notice
    issued in accordance with subsection (f)(5);" for "Strategy; and".
      Subsec. (d)(10). Pub. L. 109-469, Secs. 103(d)(2) and 105(e)(3),
    made identical amendments, inserting "and section 2291j-1 of title
    22" before period at end.
      Subsec. (f)(4), (5). Pub. L. 109-469, Sec. 105(f), added pars.
    (4) and (5) set out second.
      Pub. L. 109-469, Sec. 103(e), added pars. (4) and (5) set out
    first.
      Subsec. (g). Pub. L. 109-469, Sec. 103(f)(3)(A), amended subsec.
    (g) generally. Prior to amendment, text read as follows: "The
    provisions of this section shall not apply to the National Foreign
    Intelligence Program, the Joint Military Intelligence Program and
    Tactical Intelligence and Related Activities unless the agency that
    carries out such program is designated as a National Drug Control
    Program agency by the President or jointly by the Director and the
    head of the agency."
      Subsec. (h). Pub. L. 109-469, Sec. 103(f)(3)(B), amended subsec.
    (h) generally. Prior to amendment, text read as follows: "Nothing
    in this chapter shall be construed as derogating the authorities
    and responsibilities of the Director of Central Intelligence
    contained in sections 403-4 and 414 of title 50 or any other law."

      REPORT ON STREAMLINING FEDERAL PREVENTION AND TREATMENT EFFORTS  
      Pub. L. 105-277, div. D, title II, Sec. 221, Oct. 21, 1998, 112
    Stat. 2681-758, expressed sense of Congress that efforts of the
    Federal Government to reduce demand for illegal drugs in United
    States are frustrated by fragmentation of those efforts across
    multiple departments and agencies, and improvement of those efforts
    can best be achieved through consolidation and coordination, and
    further provided that not later than 18 months after Oct. 21, 1998,
    Director of the Office of National Drug Control Policy was to
    prepare and submit to Congress a report evaluating options for
    increasing efficacy of drug prevention and treatment programs,
    including a thorough review of activities and potential
    consolidation of existing Federal drug information clearinghouses.


-EXEC-
             EX. ORD. NO. 12880. NATIONAL DRUG CONTROL PROGRAM         
      Ex. Ord. No. 12880, Nov. 16, 1993, 58 F.R. 60989, as amended by
    Ex. Ord. No. 13008, June 3, 1996, 61 F.R. 28721, provided:
      The Office of National Drug Control Policy has the lead
    responsibility within the Executive Office of the President to
    establish policies, priorities, and objectives for the Nation's
    drug control program, with the goal of reducing the production,
    availability, and use of illegal drugs. All lawful and reasonable
    means must be used to ensure that the United States has a
    comprehensive and effective National Drug Control Strategy.
      Therefore, by the authority vested in me as President by the
    Constitution and the laws of the United States of America,
    including the National Narcotics Leadership Act of 1988, as amended
    (former 21 U.S.C. 1501 et seq.), and in order to provide for the
    effective management of the drug abuse policies of the United
    States, it is hereby ordered as follows:
      Section 1. General Provisions. (a) Because the United States
    considers the operations of international criminal narcotics
    syndicates as a national security threat requiring an extraordinary
    and coordinated response by civilian and military agencies involved
    in national security, the Director of the Office of National Drug
    Control Policy (Director), in his role as the principal adviser to
    the National Security Council on national drug control policy (50
    U.S.C. 402(f)), shall provide drug policy guidance and direction in
    the development of related national security programs.
      (b) The Director shall provide oversight and direction for all
    international counternarcotics policy development and
    implementation, in coordination with other concerned Cabinet
    members, as appropriate.
      (c) An Interagency Working Group (IWG) on international
    counternarcotics policy, chaired by the Office of National Drug
    Control Policy, shall develop and ensure coordinated implementation
    of an international counternarcotics policy. The IWG shall report
    its activities and differences of views among agencies to the
    Director for review, mediation, and resolution with concerned
    Cabinet members, and if necessary, by the President.
      (d) A coordinator for drug interdiction shall be designated by
    the Director to ensure that assets dedicated by Federal drug
    program agencies for interdiction are sufficient and that their use
    is properly integrated and optimized. The coordinator shall ensure
    that interdiction efforts and priorities are consistent with
    overall U.S. international counternarcotics policy.
      (e) The Director shall examine the number and structure of
    command/control and drug intelligence centers operated by drug
    control program agencies involved in international counter-
    narcotics and suggest improvements to the current structure for
    consideration by the President and concerned members of the
    Cabinet.
      (f) The Director, utilizing the services of the Drugs and Crime
    Data Center and Department of Justice Clearinghouse, shall assist
    in coordinating and enhancing the dissemination of statistics and
    studies relating to anti-drug abuse policy.
      (g) The Director shall provide advice to agencies regarding ways
    to achieve efficiencies in spending and improvements to interagency
    cooperation that could enhance the delivery of drug control
    treatment and prevention services to the public. The Director may
    request agencies to provide studies, information, and analyses in
    support of this order.
      Sec. 2. Goals, Direction, Duties and Responsibilities with
    Respect to the National Drug Control Program. (a) Budget Matters.
    (1) In addition to the budgetary authorities and responsibilities
    provided to the Director by statute, [former] 21 U.S.C. 1502, for
    those agency budget requests that are not certified as adequate to
    implement the objectives of the National Drug Control Strategy, the
    Director shall include in such certifications initiatives or
    funding levels that would make such requests adequate.
      (2) The Director shall provide, by July 1 of each year, budget
    recommendations to the heads of departments and agencies with
    responsibilities under the National Drug Control Program. The
    recommendations shall apply to the second following fiscal year and
    address funding priorities developed in the annual National Drug
    Control Strategy.
      (b) Measurement of National Drug Control Strategy Outcomes. (1)
    The National Drug Control Strategy shall include long-range goals
    for reducing drug use and the consequences of drug use in the
    United States, including burdens on hospital emergency rooms, drug
    use among arrestees, the extent of drug-related crime, high school
    dropout rates, the number of infants exposed annually to illicit
    drugs in utero, national drug abuse treatment capacity, and the
    annual national health care costs of drug use.
      (2) The National Drug Control Strategy shall also include an
    assessment of the quality of techniques and instruments to measure
    current drug use and supply and demand reduction activities, and
    the adequacy of the coverage of existing national drug use
    instruments and techniques to measure the total illicit drug user
    population and groups at-risk for drug use.
      (3) The Director shall coordinate an effort among the relevant
    drug control program agencies to assess the quality, access,
    management, effectiveness, and standards of accountability of drug
    abuse treatment, prevention, education, and other demand reduction
    activities.
      (c) Provision of Reports. To the extent permitted by law, heads
    of departments and agencies with responsibilities under the
    National Drug Control Program shall make available to the Office of
    National Drug Control Policy, appropriate statistics, studies, and
    reports, pertaining to Federal drug abuse control.
                                                     William J. Clinton.

-FOOTNOTE-
    (!1) So in original. Probably should be preceded by "section".

    (!2) So in original. Two pars. (4) have been enacted.

    (!3) So in original. Two pars. (5) have been enacted.


-End-



-CITE-
    21 USC Sec. 1704                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1704. Coordination with National Drug Control Program agencies
      in demand reduction, supply reduction, and State and local
      affairs

-STATUTE-
    (a) Access to information
      (1) In general
        Upon the request of the Director, the head of any National Drug
      Control Program agency shall cooperate with and provide to the
      Director any statistics, studies, reports, and other information
      prepared or collected by the agency concerning the
      responsibilities of the agency under the National Drug Control
      Strategy that relate to - 
          (A) drug control; or
          (B) the manner in which amounts made available to that agency
        for drug control are being used by that agency.
      (2) Protection of intelligence information
        (A) In general
          The authorities conferred on the Office and the Director by
        this chapter shall be exercised in a manner consistent with
        provisions of the National Security Act of 1947 (50 U.S.C. 401
        et seq.). The Director of National Intelligence shall prescribe
        such regulations as may be necessary to protect information
        provided pursuant to this chapter regarding intelligence
        sources and methods.
        (B) Duties of Director
          The Director of National Intelligence and the Director of the
        Central Intelligence Agency shall, to the maximum extent
        practicable in accordance with subparagraph (A), render full
        assistance and support to the Office and the Director.
      (3) Required reports
        (A) Secretaries of the Interior and Agriculture
          Not later than July 1 of each year, the Secretaries of
        Agriculture and the Interior shall jointly submit to the
        Director and the appropriate congressional committees an
        assessment of the quantity of illegal drug cultivation and
        manufacturing in the United States on lands owned or under the
        jurisdiction of the Federal Government for the preceding year.
        (B) Secretary of Homeland Security
          Not later than July 1 of each year, the Secretary of Homeland
        Security shall submit to the Director and the appropriate
        congressional committees information for the preceding year
        regarding - 
            (i) the number and type of seizures of drugs by each
          component of the Department of Homeland Security seizing
          drugs, as well as statistical information on the geographic
          areas of such seizures; and
            (ii) the number of air and maritime patrol hours primarily
          dedicated to drug supply reduction missions undertaken by
          each component of the Department of Homeland Security.
        (C) Secretary of Defense
          The Secretary of Defense shall, by July 1 of each year,
        submit to the Director and the appropriate congressional
        committees information for the preceding year regarding the
        number of air and maritime patrol hours primarily dedicated to
        drug supply reduction missions undertaken by each component of
        the Department of Defense.
        (D) Attorney General
          The Attorney General shall, by July 1 of each year, submit to
        the Director and the appropriate congressional committees
        information for the preceding year regarding the number and
        type of - 
            (i) arrests for drug violations;
            (ii) prosecutions for drug violations by United States
          Attorneys; and
            (iii) seizures of drugs by each component of the Department
          of Justice seizing drugs, as well as statistical information
          on the geographic areas of such seizures.
    (b) Certification of policy changes to Director
      (1) In general
        Subject to paragraph (2), the head of a National Drug Control
      Program agency shall, unless exigent circumstances require
      otherwise, notify the Director in writing regarding any proposed
      change in policies relating to the activities of that agency
      under the National Drug Control Program prior to implementation
      of such change. The Director shall promptly review such proposed
      change and certify to the head of that agency in writing whether
      such change is consistent with the National Drug Control
      Strategy.
      (2) Exception
        If prior notice of a proposed change under paragraph (1) is not
      practicable - 
          (A) the head of the National Drug Control Program agency
        shall notify the Director of the proposed change as soon as
        practicable; and
          (B) upon such notification, the Director shall review the
        change and certify to the head of that agency in writing
        whether the change is consistent with the National Drug Control
        Strategy.
    (c) General Services Administration
      The Administrator of General Services shall provide to the
    Director, on a reimbursable basis, such administrative support
    services as the Director may request.
    (d) Accounting of funds expended
      The Director shall - 
        (A) require the National Drug Control Program agencies to
      submit to the Director not later than February 1 of each year a
      detailed accounting of all funds expended by the agencies for
      National Drug Control Program activities during the previous
      fiscal year, and require such accounting to be authenticated by
      the Inspector General for each agency prior to submission to the
      Director; and
        (B) submit to Congress not later than April 1 of each year the
      information submitted to the Director under subparagraph (A).

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 705, Oct. 21, 1998, 112
    Stat. 2681-680; Pub. L. 109-469, title I, Sec. 104, Dec. 29, 2006,
    120 Stat. 3510.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      The National Security Act of 1947, referred to in subsec.
    (a)(2)(A), is act July 26, 1947, ch. 343, 61 Stat. 495, as amended.
    For complete classification of this Act to the Code, see Short
    Title note set out under section 401 of Title 50, War and National
    Defense, and Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a)(1)(A). Pub. L. 109-469, Sec. 104(1), struck
    out "abuse" after "drug".
      Subsec. (a)(2)(A). Pub. L. 109-469, Sec. 104(2), substituted
    "Director of National Intelligence" for "Director of Central
    Intelligence".
      Subsec. (a)(2)(B). Pub. L. 109-469, Sec. 104(3), substituted
    "Director of National Intelligence and the Director of the Central
    Intelligence Agency" for "Director of Central Intelligence".
      Subsec. (a)(3). Pub. L. 109-469, Sec. 104(4), amended par. (3)
    generally. Prior to amendment, text read as follows: "The Secretary
    of Agriculture shall annually submit to the Director an assessment
    of the acreage of illegal drug cultivation in the United States."
      Subsec. (b)(2)(B). Pub. L. 109-469, Sec. 104(5), substituted
    "Strategy" for "Program".
      Subsec. (c). Pub. L. 109-469, Sec. 104(6), substituted "on" for
    "in".

-End-



-CITE-
    21 USC Sec. 1705                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1705. Development, submission, implementation, and assessment
      of National Drug Control Strategy

-STATUTE-
    (a) Timing, contents, and process for development and submission of
      National Drug Control Strategy
      (1) Timing
        Not later than February 1 of each year, the President shall
      submit to Congress a National Drug Control Strategy, which shall
      set forth a comprehensive plan for the year to reduce illicit
      drug use and the consequences of such illicit drug use in the
      United States by limiting the availability of, and reducing the
      demand for, illegal drugs.
      (2) Contents
        (A) In general
          The National Drug Control Strategy submitted under paragraph
        (1) shall include the following:
            (i) Comprehensive, research-based, long-range, quantifiable
          goals for reducing illicit drug use and the consequences of
          illicit drug use in the United States.
            (ii) Annual quantifiable and measurable objectives and
          specific targets to accomplish long-term quantifiable goals
          that the Director determines may be achieved during each year
          beginning on the date on which the National Drug Control
          Strategy is submitted.
            (iii) A 5-year projection for program and budget
          priorities.
            (iv) A review of international, State, local, and private
          sector drug control activities to ensure that the United
          States pursues coordinated and effective drug control at all
          levels of government.
            (v) An assessment of current illicit drug use (including
          inhalants and steroids) and availability, impact of illicit
          drug use, and treatment availability, which assessment shall
          include - 
              (I) estimates of drug prevalence and frequency of use as
            measured by national, State, and local surveys of illicit
            drug use and by other special studies of nondependent and
            dependent illicit drug use;
              (II) illicit drug use in the workplace and the
            productivity lost by such use; and
              (III) illicit drug use by arrestees, probationers, and
            parolees.

            (vi) An assessment of the reduction of illicit drug
          availability, as measured by - 
              (I) the quantities of cocaine, heroin, marijuana,
            methamphetamine, ecstasy, and other drugs available for
            consumption in the United States;
              (II) the amount of marijuana, cocaine, heroin,
            methamphetamine, ecstasy, and precursor chemicals and other
            drugs entering the United States;
              (III) the number of illicit drug manufacturing
            laboratories seized and destroyed and the number of
            hectares of marijuana, poppy, and coca cultivated and
            destroyed domestically and in other countries;
              (IV) the number of metric tons of marijuana, heroin,
            cocaine, and methamphetamine seized and other drugs; and
              (V) changes in the price and purity of heroin,
            methamphetamine, and cocaine, changes in the price of
            ecstasy, and changes in tetrahydrocannabinol level of
            marijuana and other drugs.

            (vii) An assessment of the reduction of the consequences of
          illicit drug use and availability, which shall include - 
              (I) the burden illicit drug users placed on hospital
            emergency departments in the United States, such as the
            quantity of illicit drug-related services provided;
              (II) the annual national health care cost of illicit drug
            use; and
              (III) the extent of illicit drug-related crime and
            criminal activity.

            (viii) A determination of the status of drug treatment in
          the United States, by assessing - 
              (I) public and private treatment utilization; and
              (II) the number of illicit drug users the Director
            estimates meet diagnostic criteria for treatment.

            (ix) A review of the research agenda of the Counterdrug
          Technology Assessment Center to reduce the availability and
          abuse of drugs.
            (x) A summary of the efforts made to coordinate with
          private sector entities to conduct private research and
          development of medications to treat addiction by - 
              (I) screening chemicals for potential therapeutic value;
              (II) developing promising compounds;
              (III) conducting clinical trials;
              (IV) seeking Food and Drug Administration approval for
            drugs to treat addiction;
              (V) marketing the drug for the treatment of addiction;
              (VI) urging physicians to use the drug in the treatment
            of addiction; and
              (VII) encouraging insurance companies to reimburse the
            cost of the drug for the treatment of addiction.

            (xi) An assessment of Federal effectiveness in achieving
          the National Drug Control Strategy for the previous year,
          including a specific evaluation of whether the objectives and
          targets for reducing illicit drug use for the previous year
          were met and reasons for the success or failure of the
          previous year's Strategy.
            (xii) A general review of the status of, and trends in,
          demand reduction activities by private sector entities and
          community-based organizations, including faith-based
          organizations, to determine their effectiveness and the
          extent of cooperation, coordination, and mutual support
          between such entities and organizations and Federal, State,
          local, and tribal government agencies.
            (xiii) Such additional statistical data and information as
          the Director considers appropriate to demonstrate and assess
          trends relating to illicit drug use, the effects and
          consequences of illicit drug use (including the effects on
          children of substance abusers), supply reduction, demand
          reduction, drug-related law enforcement, and the
          implementation of the National Drug Control Strategy.
            (xiv) A supplement reviewing the activities of each
          individual National Drug Control Program agency during the
          previous year with respect to the National Drug Control
          Strategy and the Director's assessment of the progress of
          each National Drug Control Program agency in meeting its
          responsibilities under the National Drug Control Strategy.
        (B) Classified information
          Any contents of the National Drug Control Strategy that
        involve information properly classified under criteria
        established by an Executive order shall be presented to
        Congress separately from the rest of the National Drug Control
        Strategy.
        (C) Selection of data and information
          In selecting data and information for inclusion under
        subparagraph (A), the Director shall ensure - 
            (i) the inclusion of data and information that will permit
          analysis of current trends against previously compiled data
          and information where the Director believes such analysis
          enhances long-term assessment of the National Drug Control
          Strategy; and
            (ii) the inclusion of data and information to permit a
          standardized and uniform assessment of the effectiveness of
          drug treatment programs in the United States.
      (3) Process for development and submission
        In developing and effectively implementing the National Drug
      Control Strategy, the Director - 
          (A) shall consult with - 
            (i) the heads of the National Drug Control Program
          agencies;
            (ii) Congress;
            (iii) State, local, and tribal officials;
            (iv) private citizens and organizations, including
          community and faith-based organizations with experience and
          expertise in demand reduction;
            (v) private citizens and organizations with experience and
          expertise in supply reduction; and
            (vi) appropriate representatives of foreign governments;

          (B) in satisfying the requirements of subparagraph (A), shall
        ensure, to the maximum extent possible, that State, local, and
        tribal officials and relevant private organizations commit to
        support and take steps to achieve the goals and objectives of
        the National Drug Control Strategy;
          (C) with the concurrence of the Attorney General, may require
        the El Paso Intelligence Center to undertake specific tasks or
        projects to support or implement the National Drug Control
        Strategy; and
          (D) with the concurrence of the Director of National
        Intelligence and the Attorney General, may request that the
        National Drug Intelligence Center undertake specific tasks or
        projects to support or implement the National Drug Control
        Strategy.
    (b) Submission of revised strategy
      The President may submit to Congress a revised National Drug
    Control Strategy that meets the requirements of this section - 
        (1) at any time, upon a determination of the President, in
      consultation with the Director, that the National Drug Control
      Strategy in effect is not sufficiently effective; or
        (2) if a new President or Director takes office.
    (c) Performance measurement system
      Not later than February 1 of each year, the Director shall submit
    to Congress as part of the National Drug Control Strategy, a
    description of a national drug control performance measurement
    system, that - 
        (1) develops 2-year and 5-year performance measures and targets
      for each National Drug Control Strategy goal and objective
      established for reducing drug use, availability, and the
      consequences of drug use;
        (2) describes the sources of information and data that will be
      used for each performance measure incorporated into the
      performance measurement system;
        (3) identifies major programs and activities of the National
      Drug Control Program agencies that support the goals and annual
      objectives of the National Drug Control Strategy;
        (4) evaluates the contribution of demand reduction and supply
      reduction activities as defined in section 1701 of this title
      implemented by each National Drug Control Program agency in
      support of the National Drug Control Strategy;
        (5) monitors consistency between the drug-related goals and
      objectives of the National Drug Control Program agencies and
      ensures that each agency's goals and budgets support and are
      fully consistent with the National Drug Control Strategy; and
        (6) coordinates the development and implementation of national
      drug control data collection and reporting systems to support
      policy formulation and performance measurement, including an
      assessment of - 
          (A) the quality of current drug use measurement instruments
        and techniques to measure supply reduction and demand reduction
        activities;
          (B) the adequacy of the coverage of existing national drug
        use measurement instruments and techniques to measure the
        illicit drug user population, and groups that are at risk for
        illicit drug use;
          (C) the adequacy of the coverage of existing national
        treatment outcome monitoring systems to measure the
        effectiveness of drug abuse treatment in reducing illicit drug
        use and criminal behavior during and after the completion of
        substance abuse treatment; and
          (D) the actions the Director shall take to correct any
        deficiencies and limitations identified pursuant to
        subparagraphs (A) and (B) of this subsection.
    (d) Modifications
      A description of any modifications made during the preceding year
    to the national drug performance measurement system described in
    subsection (c) shall be included in each report submitted under
    subsection (b).

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 706, Oct. 21, 1998, 112
    Stat. 2681-681; Pub. L. 109-469, title II, Secs. 201, 202, Dec. 29,
    2006, 120 Stat. 3513, 3517.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.


-MISC1-
                                AMENDMENTS                            
      2006 - Pub. L. 109-469, Sec. 201, amended section generally.
    Prior to amendment, section related to development, submission,
    implementation, and assessment of National Drug Control Strategy.
      Subsecs. (c), (d). Pub. L. 109-469, Sec. 202, added subsecs. (c)
    and (d).

        REQUIREMENT FOR SOUTHWEST BORDER COUNTERNARCOTICS STRATEGY    
      Pub. L. 109-469, title XI, Sec. 1110, Dec. 29, 2006, 120 Stat.
    3543, provided that:
      "(a) In General. - Not later than 120 days after the date of
    enactment of this Act [Dec. 29, 2006], and every 2 years
    thereafter, the Director of National Drug Control Policy shall
    submit to the Congress a Southwest Border Counternarcotics
    Strategy.
      "(b) Purposes. - The Southwest Border Counternarcotics Strategy
    shall - 
        "(1) set forth the Government's strategy for preventing the
      illegal trafficking of drugs across the international border
      between the United States and Mexico, including through ports of
      entry and between ports of entry on that border;
        "(2) state the specific roles and responsibilities of the
      relevant National Drug Control Program agencies (as defined in
      section 702 of the Office of National Drug Control Policy
      Reauthorization Act of 1998 (21 U.S.C. 1701)) for implementing
      that strategy; and
        "(3) identify the specific resources required to enable the
      relevant National Drug Control Program agencies to implement that
      strategy.
      "(c) Specific Content Related to Drug Tunnels Between the United
    States and Mexico. - The Southwest Border Counternarcotics Strategy
    shall include - 
        "(1) a strategy to end the construction and use of tunnels and
      subterranean passages that cross the international border between
      the United States and Mexico for the purpose of illegal
      trafficking of drugs across such border; and
        "(2) recommendations for criminal penalties for persons who
      construct or use such a tunnel or subterranean passage for such a
      purpose.
      "(d) Consultation With Other Agencies. - The Director shall issue
    the Southwest Border Counternarcotics Strategy in consultation with
    the heads of the relevant National Drug Control Program agencies.
      "(e) Limitation. - The Southwest Border Counternarcotics Strategy
    shall not change existing agency authorities or the laws governing
    interagency relationships, but may include recommendations about
    changes to such authorities or laws.
      "(f) Report to Congress. - The Director shall provide a copy of
    the Southwest Border Counternarcotics Strategy to the appropriate
    congressional committees (as defined in section 702 of the Office
    of National Drug Control Policy Reauthorization Act of 1998 (21
    U.S.C. 1701)), and to the Committee on Armed Services and the
    Committee on Homeland Security of the House of Representatives, and
    the Committee on Homeland Security and Governmental Affairs and the
    Committee on Armed Services of the Senate.
      "(g) Treatment of Classified or Law Enforcement Sensitive
    Information. - Any content of the Southwest Border Counternarcotics
    Strategy that involves information classified under criteria
    established by an Executive order, or whose public disclosure, as
    determined by the Director or the head of any relevant National
    Drug Control Program agency, would be detrimental to the law
    enforcement or national security activities of any Federal, State,
    local, or tribal agency, shall be presented to Congress separately
    from the rest of the strategy."

-End-



-CITE-
    21 USC Sec. 1706                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1706. High Intensity Drug Trafficking Areas Program

-STATUTE-
    (a) Establishment
      (1) In general
        There is established in the Office a program to be known as the
      High Intensity Drug Trafficking Areas Program (in this section
      referred to as the "Program").
      (2) Purpose
        The purpose of the Program is to reduce drug trafficking and
      drug production in the United States by - 
          (A) facilitating cooperation among Federal, State, local, and
        tribal law enforcement agencies to share information and
        implement coordinated enforcement activities;
          (B) enhancing law enforcement intelligence sharing among
        Federal, State, local, and tribal law enforcement agencies;
          (C) providing reliable law enforcement intelligence to law
        enforcement agencies needed to design effective enforcement
        strategies and operations; and
          (D) supporting coordinated law enforcement strategies which
        maximize use of available resources to reduce the supply of
        illegal drugs in designated areas and in the United States as a
        whole.
    (b) Designation
      (1) In general
        The Director, in consultation with the Attorney General, the
      Secretary of the Treasury, the Secretary of Homeland Security,
      heads of the National Drug Control Program agencies, and the
      Governor of each applicable State, may designate any specified
      area of the United States as a high intensity drug trafficking
      area.
      (2) Activities
        After making a designation under paragraph (1) and in order to
      provide Federal assistance to the area so designated, the
      Director may - 
          (A) obligate such sums as are appropriated for the Program;
          (B) direct the temporary reassignment of Federal personnel to
        such area, subject to the approval of the head of the
        department or agency that employs such personnel;
          (C) take any other action authorized under section 1703 of
        this title to provide increased Federal assistance to those
        areas; and
          (D) coordinate activities under this section (specifically
        administrative, recordkeeping, and funds management activities)
        with State, local, and tribal officials.
    (c) Petitions for designation
      The Director shall establish regulations under which a coalition
    of interested law enforcement agencies from an area may petition
    for designation as a high intensity drug trafficking area. Such
    regulations shall provide for a regular review by the Director of
    the petition, including a recommendation regarding the merit of the
    petition to the Director by a panel of qualified, independent
    experts.
    (d) Factors for consideration
      In considering whether to designate an area under this section as
    a high intensity drug trafficking area, the Director shall
    consider, in addition to such other criteria as the Director
    considers to be appropriate, the extent to which - 
        (1) the area is a significant center of illegal drug
      production, manufacturing, importation, or distribution;
        (2) State, local, and tribal law enforcement agencies have
      committed resources to respond to the drug trafficking problem in
      the area, thereby indicating a determination to respond
      aggressively to the problem;
        (3) drug-related activities in the area are having a
      significant harmful impact in the area, and in other areas of the
      country; and
        (4) a significant increase in allocation of Federal resources
      is necessary to respond adequately to drug-related activities in
      the area.
    (e) Organization of high intensity drug trafficking areas
      (1) Executive Board and officers
        To be eligible for funds appropriated under this section, each
      high intensity drug trafficking area shall be governed by an
      Executive Board. The Executive Board shall designate a chairman,
      vice chairman, and any other officers to the Executive Board that
      it determines are necessary.
      (2) Responsibilities
        The Executive Board of a high intensity drug trafficking area
      shall be responsible for - 
          (A) providing direction and oversight in establishing and
        achieving the goals of the high intensity drug trafficking
        area;
          (B) managing the funds of the high intensity drug trafficking
        area;
          (C) reviewing and approving all funding proposals consistent
        with the overall objective of the high intensity drug
        trafficking area; and
          (D) reviewing and approving all reports to the Director on
        the activities of the high intensity drug trafficking area.
      (3) Board representation
        None of the funds appropriated under this section may be
      expended for any high intensity drug trafficking area, or for a
      partnership or region of a high intensity drug trafficking area,
      if the Executive Board for such area, region, or partnership,
      does not apportion an equal number of votes between
      representatives of participating Federal agencies and
      representatives of participating State, local, and tribal
      agencies. Where it is impractical for an equal number of
      representatives of Federal agencies and State, local, and tribal
      agencies to attend a meeting of an Executive Board in person, the
      Executive Board may use a system of proxy votes or weighted votes
      to achieve the voting balance required by this paragraph.
      (4) No agency relationship
        The eligibility requirements of this section are intended to
      ensure the responsible use of Federal funds. Nothing in this
      section is intended to create an agency relationship between
      individual high intensity drug trafficking areas and the Federal
      Government.
    (f) Use of funds
      The Director shall ensure that no Federal funds appropriated for
    the Program are expended for the establishment or expansion of drug
    treatment programs, and shall ensure that not more than 5 percent
    of the Federal funds appropriated for the Program are expended for
    the establishment of drug prevention programs.
    (g) Counterterrorism activities
      (1) Assistance authorized
        The Director may authorize use of resources available for the
      Program to assist Federal, State, local, and tribal law
      enforcement agencies in investigations and activities related to
      terrorism and prevention of terrorism, especially but not
      exclusively with respect to such investigations and activities
      that are also related to drug trafficking.
      (2) Limitation
        The Director shall ensure - 
          (A) that assistance provided under paragraph (1) remains
        incidental to the purpose of the Program to reduce drug
        availability and carry out drug-related law enforcement
        activities; and
          (B) that significant resources of the Program are not
        redirected to activities exclusively related to terrorism,
        except on a temporary basis under extraordinary circumstances,
        as determined by the Director.
    (h) Role of Drug Enforcement Administration
      The Director, in consultation with the Attorney General, shall
    ensure that a representative of the Drug Enforcement Administration
    is included in the Intelligence Support Center for each high
    intensity drug trafficking area.
    (i) Annual HIDTA Program budget submissions
      As part of the documentation that supports the President's annual
    budget request for the Office, the Director shall submit to
    Congress a budget justification that includes - 
        (1) the amount proposed for each high intensity drug
      trafficking area, conditional upon a review by the Office of the
      request submitted by the HIDTA and the performance of the HIDTA,
      with supporting narrative descriptions and rationale for each
      request;
        (2) a detailed justification that explains - 
          (A) the reasons for the proposed funding level; how such
        funding level was determined based on a current assessment of
        the drug trafficking threat in each high intensity drug
        trafficking area;
          (B) how such funding will ensure that the goals and
        objectives of each such area will be achieved; and
          (C) how such funding supports the National Drug Control
        Strategy; and

        (3) the amount of HIDTA funds used to investigate and prosecute
      organizations and individuals trafficking in methamphetamine in
      the prior calendar year, and a description of how those funds
      were used.
    (j) Emerging threat response fund
      (1) In general
        Subject to the availability of appropriations, the Director may
      expend up to 10 percent of the amounts appropriated under this
      section on a discretionary basis, to respond to any emerging drug
      trafficking threat in an existing high intensity drug trafficking
      area, or to establish a new high intensity drug trafficking area
      or expand an existing high intensity drug trafficking area, in
      accordance with the criteria established under paragraph (2).
      (2) Consideration of impact
        In allocating funds under this subsection, the Director shall
      consider - 
          (A) the impact of activities funded on reducing overall drug
        traffic in the United States, or minimizing the probability
        that an emerging drug trafficking threat will spread to other
        areas of the United States; and
          (B) such other criteria as the Director considers
        appropriate.
    (k) Evaluation
      (1) Initial report
        Not later than 90 days after December 29, 2006, the Director
      shall, after consulting with the Executive Boards of each
      designated high intensity drug trafficking area, submit a report
      to Congress that describes, for each designated high intensity
      drug trafficking area - 
          (A) the specific purposes for the high intensity drug
        trafficking area;
          (B) the specific long-term and short-term goals and
        objectives for the high intensity drug trafficking area;
          (C) the measurements that will be used to evaluate the
        performance of the high intensity drug trafficking area in
        achieving the long-term and short-term goals; and
          (D) the reporting requirements needed to evaluate the
        performance of the high intensity drug trafficking area in
        achieving the long-term and short-term goals.
      (2) Evaluation of HIDTA Program as part of National Drug Control
        Strategy
        For each designated high intensity drug trafficking area, the
      Director shall submit, as part of the annual National Drug
      Control Strategy report, a report that - 
          (A) describes - 
            (i) the specific purposes for the high intensity drug
          trafficking area; and
            (ii) the specific long-term and short-term goals and
          objectives for the high intensity drug trafficking area; and

          (B) includes an evaluation of the performance of the high
        intensity drug trafficking area in accomplishing the specific
        long-term and short-term goals and objectives identified under
        paragraph (1)(B).
    (l) Assessment of drug enforcement task forces in high intensity
      drug trafficking areas
      Not later than 1 year after December 29, 2006, and as part of
    each subsequent annual National Drug Control Strategy report, the
    Director shall submit to Congress a report - 
        (1) assessing the number and operation of all federally funded
      drug enforcement task forces within each high intensity drug
      trafficking area; and
        (2) describing - 
          (A) each Federal, State, local, and tribal drug enforcement
        task force operating in the high intensity drug trafficking
        area;
          (B) how such task forces coordinate with each other, with any
        high intensity drug trafficking area task force, and with
        investigations receiving funds from the Organized Crime and
        Drug Enforcement Task Force;
          (C) what steps, if any, each such task force takes to share
        information regarding drug trafficking and drug production with
        other federally funded drug enforcement task forces in the high
        intensity drug trafficking area;
          (D) the role of the high intensity drug trafficking area in
        coordinating the sharing of such information among task forces;
          (E) the nature and extent of cooperation by each Federal,
        State, local, and tribal participant in ensuring that such
        information is shared among law enforcement agencies and with
        the high intensity drug trafficking area;
          (F) the nature and extent to which information sharing and
        enforcement activities are coordinated with joint terrorism
        task forces in the high intensity drug trafficking area; and
          (G) any recommendations for measures needed to ensure that
        task force resources are utilized efficiently and effectively
        to reduce the availability of illegal drugs in the high
        intensity drug trafficking areas.
    (m) Assessment of law enforcement intelligence sharing in High
      Intensity Drug Trafficking Areas Program
      Not later than 180 days after December 29, 2006, and as part of
    each subsequent annual National Drug Control Strategy report, the
    Director, in consultation with the Director of National
    Intelligence, shall submit to Congress a report - 
        (1) evaluating existing and planned law enforcement
      intelligence systems supported by each high intensity drug
      trafficking area, or utilized by task forces receiving any
      funding under the Program, including the extent to which such
      systems ensure access and availability of law enforcement
      intelligence to Federal, State, local, and tribal law enforcement
      agencies within the high intensity drug trafficking area and
      outside of it;
        (2) the extent to which Federal, State, local, and tribal law
      enforcement agencies participating in each high intensity drug
      trafficking area are sharing law enforcement intelligence
      information to assess current drug trafficking threats and design
      appropriate enforcement strategies; and
        (3) the measures needed to improve effective sharing of
      information and law enforcement intelligence regarding drug
      trafficking and drug production among Federal, State, local, and
      tribal law enforcement participating in a high intensity drug
      trafficking area, and between such agencies and similar agencies
      outside the high intensity drug trafficking area.
    (n) Coordination of Law enforcement intelligence sharing with
      Organized Crime Drug Enforcement Task Force program
      The Director, in consultation with the Attorney General, shall
    ensure that any drug enforcement intelligence obtained by the
    Intelligence Support Center for each high intensity drug
    trafficking area is shared, on a timely basis, with the drug
    intelligence fusion center operated by the Organized Crime Drug
    Enforcement Task Force of the Department of Justice.
    (o) Use of funds to combat methamphetamine trafficking
      (1) Requirement
        As part of the documentation that supports the President's
      annual budget request for the Office, the Director shall submit
      to Congress a report describing the use of HIDTA funds to
      investigate and prosecute organizations and individuals
      trafficking in methamphetamine in the prior calendar year.
      (2) Contents
        The report shall include - 
          (A) the number of methamphetamine manufacturing facilities
        discovered through HIDTA-funded initiatives in the previous
        fiscal year;
          (B) the amounts of methamphetamine or listed chemicals (as
        that term is defined in section 802(33) of this title (!1)
        seized by HIDTA-funded initiatives in the area during the
        previous year; and

          (C) law enforcement intelligence and predictive data from the
        Drug Enforcement Administration showing patterns and trends in
        abuse, trafficking, and transportation in methamphetamine and
        listed chemicals.
      (3) Certification
        Before the Director awards any funds to a high intensity drug
      trafficking area, the Director shall certify that the law
      enforcement entities participating in that HIDTA are providing
      laboratory seizure data to the national clandestine laboratory
      database at the El Paso Intelligence Center.
    (p) Authorization of appropriations
      There is authorized to be appropriated to the Office of National
    Drug Control Policy to carry out this section - 
        (1) $240,000,000 for fiscal year 2007;
        (2) $250,000,000 for fiscal year 2008;
        (3) $260,000,000 for fiscal year 2009;
        (4) $270,000,000 for fiscal year 2010; and
        (5) $280,000,000 for each of (!2) fiscal year 2011.

    (q) Specific purposes
      (1) In general
        The Director shall ensure that, of the amounts appropriated for
      a fiscal year for the Program, at least $7,000,000 is used in
      high intensity drug trafficking areas with severe neighborhood
      safety and illegal drug distribution problems.
      (2) Required uses
        The funds used under paragraph (1) shall be used - 
          (A) to ensure the safety of neighborhoods and the protection
        of communities, including the prevention of the intimidation of
        potential witnesses of illegal drug distribution and related
        activities; and
          (B) to combat illegal drug trafficking through such methods
        as the Director considers appropriate, such as establishing or
        operating (or both) a toll-free telephone hotline for use by
        the public to provide information about illegal drug-related
        activities.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 707, Oct. 21, 1998, 112
    Stat. 2681-686; Pub. L. 109-469, title III, Secs. 301, Sec. 302(c),
    Dec. 29, 2006, 120 Stat. 3518, 3525.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      December 29, 2006, referred to in subsecs. (k)(1), (l), and (m)
    was in the original "the date of the enactment of this section",
    which was translated as meaning the date of enactment of Pub. L.
    109-469, which amended this section generally, to reflect the
    probable intent of Congress.


-MISC1-
                                AMENDMENTS                            
      2006 - Pub. L. 109-469, Sec. 301, amended section generally.
    Prior to amendment, section related to the High Intensity Drug
    Trafficking Areas Program.
      Subsec. (q). Pub. L. 109-469, Sec. 302(c), added subsec. (q).

                                 FINDINGS                             
      Pub. L. 109-469, title III, Sec. 302(b), Dec. 29, 2006, 120 Stat.
    3524, provided that: "Congress finds the following:
        "(1) In the early morning hours of October 16, 2002, the home
      of Carnell and Angela Dawson was firebombed in apparent
      retaliation for Mrs. Dawson's notification to police about
      persistent drug distribution activity in their East Baltimore
      City neighborhood.
        "(2) The arson claimed the lives of Mr. and Mrs. Dawson and
      their 5 young children, aged 9 to 14.
        "(3) The horrific murder of the Dawson family is a stark
      example of domestic narco-terrorism.
        "(4) In all phases of counternarcotics law enforcement - from
      prevention to investigation to prosecution to reentry - the
      voluntary cooperation of ordinary citizens is a critical
      component.
        "(5) Voluntary cooperation is difficult for law enforcement
      officials to obtain when citizens feel that cooperation carries
      the risk of violent retaliation by illegal drug trafficking
      organizations and their affiliates.
        "(6) Public confidence that law enforcement is doing all it can
      to make communities safe is a prerequisite for voluntary
      cooperation among people who may be subject to intimidation or
      reprisal (or both).
        "(7) Witness protection programs are insufficient on their own
      to provide security because many individuals and families who
      strive every day to make distressed neighborhoods livable for
      their children, other relatives, and neighbors will resist or
      refuse offers of relocation by local, State, and Federal
      prosecutorial agencies and because, moreover, the continued
      presence of strong individuals and families is critical to
      preserving and strengthening the social fabric in such
      communities.
        "(8) Where (as in certain sections of Baltimore City)
      interstate trafficking of illegal drugs has severe ancillary
      local consequences within areas designated as high intensity drug
      trafficking areas, it is important that supplementary High
      Intensity Drug Trafficking Areas Program funds be committed to
      support initiatives aimed at making the affected communities safe
      for the residents of those communities and encouraging their
      cooperation with tribal, local, State, and Federal law
      enforcement efforts to combat illegal drug trafficking."

     COMBATING METHAMPHETAMINE AND AMPHETAMINE IN HIGH INTENSITY DRUG
                             TRAFFICKING AREAS
      Pub. L. 106-310, div. B, title XXXVI, Sec. 3624, Oct. 17, 2000,
    114 Stat. 1232, provided that:
      "(a) In General. - 
        "(1) In general. - The Director of National Drug Control Policy
      shall use amounts available under this section to combat the
      trafficking of methamphetamine and amphetamine in areas
      designated by the Director as high intensity drug trafficking
      areas.
        "(2) Activities. - In meeting the requirement in paragraph (1),
      the Director shall transfer funds to appropriate Federal, State,
      and local governmental agencies for employing additional Federal
      law enforcement personnel, or facilitating the employment of
      additional State and local law enforcement personnel, including
      agents, investigators, prosecutors, laboratory technicians,
      chemists, investigative assistants, and drug-prevention
      specialists.
      "(b) Authorization of Appropriations. - There is authorized to be
    appropriated to carry out this section - 
        "(1) $15,000,000 for fiscal year 2000; and
        "(2) such sums as may be necessary for each of fiscal years
      2001 through 2004.
      "(c) Apportionment of Funds. - 
        "(1) Factors in apportionment. - The Director shall apportion
      amounts appropriated for a fiscal year pursuant to the
      authorization of appropriations in subsection (b) for activities
      under subsection (a) among and within areas designated by the
      Director as high intensity drug trafficking areas based on the
      following factors:
          "(A) The number of methamphetamine manufacturing facilities
        and amphetamine manufacturing facilities discovered by Federal,
        State, or local law enforcement officials in the previous
        fiscal year.
          "(B) The number of methamphetamine prosecutions and
        amphetamine prosecutions in Federal, State, or local courts in
        the previous fiscal year.
          "(C) The number of methamphetamine arrests and amphetamine
        arrests by Federal, State, or local law enforcement officials
        in the previous fiscal year.
          "(D) The amounts of methamphetamine, amphetamine, or listed
        chemicals (as that term is defined in section 102(33) of the
        Controlled Substances Act (21 U.S.C. 802(33)) seized by
        Federal, State, or local law enforcement officials in the
        previous fiscal year.
          "(E) Intelligence and predictive data from the Drug
        Enforcement Administration and the Department of Health and
        Human Services showing patterns and trends in abuse,
        trafficking, and transportation in methamphetamine,
        amphetamine, and listed chemicals (as that term is so defined).
        "(2) Certification. - Before the Director apportions any funds
      under this subsection to a high intensity drug trafficking area,
      the Director shall certify that the law enforcement entities
      responsible for clandestine methamphetamine and amphetamine
      laboratory seizures in that area are providing laboratory seizure
      data to the national clandestine laboratory database at the El
      Paso Intelligence Center.
      "(d) Limitation on Administrative Costs. - Not more than 5
    percent of the amount appropriated in a fiscal year pursuant to the
    authorization of appropriations for that fiscal year in subsection
    (b) may be available in that fiscal year for administrative costs
    associated with activities under subsection (a)."

         FUNDING FOR HIGH INTENSITY DRUG TRAFFICKING AREAS PROGRAM     
      Pub. L. 106-58, title III, Sept. 29, 1999, 113 Stat. 448,
    provided in part: "That, hereafter, of the amount appropriated for
    fiscal year 2000 or any succeeding fiscal year for the High
    Intensity Drug Trafficking Areas Program, the funds to be obligated
    or expended during such fiscal year for programs addressing the
    treatment or prevention of drug use as part of the approved
    strategy for a designated High Intensity Drug Trafficking Area
    (HIDTA) shall not be less than the funds obligated or expended for
    such programs during fiscal year 1999 for each designated HIDTA
    without the prior approval of the Committees on Appropriations".

-FOOTNOTE-
    (!1) So in original. There probably should be a closing parenthesis.

    (!2) So in original.


-End-



-CITE-
    21 USC Sec. 1707                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1707. Counter-Drug Technology Assessment Center

-STATUTE-
    (a) Establishment
      There is established within the Office the Counter-Drug
    Technology Assessment Center (referred to in this section as the
    "Center"). The Center shall operate under the authority of the
    Director of National Drug Control Policy and shall serve as the
    central counter-drug technology research and development
    organization of the United States Government.
    (b) Chief Scientist
      There shall be at the head of the Center the Chief Scientist, who
    shall be appointed by the Director from among individuals qualified
    and distinguished in the area of science, medicine, engineering, or
    technology.
    (c) Research and development responsibilities
      The Director, acting through the Chief Scientist, shall - 
        (1) identify and define the short-, medium-, and long-term
      scientific and technological needs of Federal, State, local, and
      tribal drug supply reduction agencies, including - 
          (A) advanced surveillance, tracking, and radar imaging;
          (B) electronic support measures;
          (C) communications;
          (D) data fusion, advanced computer systems, and artificial
        intelligence; and
          (E) chemical, biological, radiological (including neutron and
        electron), and other means of detection;

        (2) identify demand reduction basic and applied research needs
      and initiatives, in consultation with affected National Drug
      Control Program agencies, including - 
          (A) improving treatment through neuroscientific advances;
          (B) improving the transfer of biomedical research to the
        clinical setting; and
          (C) in consultation with the National Institute of Drug Abuse
        and the Substance Abuse and Mental Health Services
        Administration, and through interagency agreements or grants,
        examining addiction and rehabilitation research and the
        application of technology to expanding the effectiveness and
        availability of drug treatment;

        (3) make a priority ranking of such needs identified in
      paragraphs (1) and (2) according to fiscal and technological
      feasibility, as part of a National Counterdrug Research and
      Development Program;
        (4) oversee and coordinate counterdrug technology initiatives
      with related activities of other Federal civilian and military
      departments;
        (5) provide support to the development and implementation of
      the national drug control performance measurement system
      established under subsection (c) of section 1705 of this title;
      and
        (6) pursuant to the authority of the Director of National Drug
      Control Policy under section 1703 of this title, submit requests
      to Congress for the reprogramming or transfer of funds
      appropriated for counterdrug technology research and development.
    (d) Limitation on authority
      The authority granted to the Director under this section shall
    not extend to the awarding of contracts, management of individual
    projects, or other operational activities.
    (e) Assistance and support to the Office of National Drug Control
      Policy
      The Secretary of Defense, the Secretary of Homeland Security, and
    the Secretary of Health and Human Services shall, to the maximum
    extent practicable, render assistance and support to the Office and
    to the Director in the conduct of counterdrug technology
    assessment.
    (f) Technology transfer program
      (1) Program
        The Chief Scientist, with the advice and counsel of experts
      from State, local, and tribal law enforcement agencies, shall be
      responsible to the Director for coordination and implementation
      of a counterdrug technology transfer program.
      (2) Purpose
        The purpose of the Technology Transfer Program shall be for the
      Counterdrug Technology Assessment Center to transfer technology
      and associated training directly to State, local, and tribal law
      enforcement agencies.
      (3) Priority of receipts
        Transfers shall be made in priority order based on - 
          (A) the need of potential recipients for such technology;
          (B) the effectiveness of the technology to enhance current
        counterdrug activities of potential recipients; and
          (C) the ability and willingness of potential recipients to
        evaluate transferred technology.
      (4) Agreement authority
        The Director may enter into an agreement with the Secretary of
      Homeland Security to transfer technology with both counterdrug
      and homeland security applications to State, local, and tribal
      law enforcement agencies on a reimbursable basis.
      (5) Report
        On or before July 1 of each year, the Director shall submit a
      report to the appropriate congressional committees that addresses
      the following:
          (A) The number of requests received during the previous 12
        months, including the identity of each requesting agency and
        the type of technology requested.
          (B) The number of requests fulfilled during the previous 12
        months, including the identity of each recipient agency and the
        type of technology transferred.
          (C) A summary of the criteria used in making the
        determination on what requests were funded and what requests
        were not funded, except that such summary shall not include
        specific information on any individual requests.
          (D) A general assessment of the future needs of the program,
        based on expected changes in threats, expected technologies,
        and likely need from potential recipients.
          (E) An assessment of the effectiveness of the technologies
        transferred, based in part on the evaluations provided by the
        recipients, with a recommendation whether the technology should
        continue to be offered through the program.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 708, Oct. 21, 1998, 112
    Stat. 2681-687; Pub. L. 109-469, title IV, Sec. 401, Dec. 29, 2006,
    120 Stat. 3525.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (b). Pub. L. 109-469, Sec. 401(a), amended subsec.
    (b) generally. Prior to amendment, text read as follows: "There
    shall be at the head of the Center the Director of Technology, who
    shall be appointed by the Director of National Drug Control Policy
    from among individuals qualified and distinguished in the area of
    science, medicine, engineering, or technology."
      Subsec. (c). Pub. L. 109-469, Sec. 401(b)(1)(B), added subsec.
    (c) and struck out former subsec. (c) which related to additional
    responsibilities of the Director of National Drug Control Policy.
      Subsec. (d). Pub. L. 109-469, Sec. 401(c), which directed
    insertion of ", the Secretary of Homeland Security," after "The
    Secretary of Defense", could not be executed because the words "The
    Secretary of Defense" did not appear subsequent to amendment by
    Pub. L. 109-469, Sec. 401(b)(1). See below.
      Pub. L. 109-469, Sec. 401(b)(1)(B), added subsec. (d). Former
    subsec. (d) redesignated (e).
      Subsec. (e). Pub. L. 109-469, Sec. 401(b)(2), amended subsec. (e)
    generally. Prior to amendment, text read as follows: "The Secretary
    of Defense and the Secretary of Health and Human Services shall, to
    the maximum extent practicable, render assistance and support to
    the Office and to the Director in the conduct of counter-drug
    technology assessment."
      Pub. L. 109-469, Sec. 401(b)(1)(A), redesignated subsec. (d) as
    (e).
      Subsec. (f). Pub. L. 109-469, Sec. 401(b)(3), added subsec. (f).

-End-



-CITE-
    21 USC Sec. 1708                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1708. National youth anti-drug media campaign

-STATUTE-
    (a) In general
      The Director shall conduct a national youth anti-drug media
    campaign (referred to in this chapter (!1) as the "national media
    campaign") in accordance with this section for the purposes of - 

        (1) preventing drug abuse among young people in the United
      States;
        (2) increasing awareness of adults of the impact of drug abuse
      on young people; and
        (3) encouraging parents and other interested adults to discuss
      with young people the dangers of illegal drug use.
    (b) Use of funds
      (1) In general
        Amounts made available to carry out this section for the
      national media campaign may only be used for the following:
          (A) The purchase of media time and space, including the
        strategic planning for, and accounting of, such purchases.
          (B) Creative and talent costs, consistent with paragraph
        (2)(A).
          (C) Advertising production costs.
          (D) Testing and evaluation of advertising.
          (E) Evaluation of the effectiveness of the national media
        campaign.
          (F) The negotiated fees for the winning bidder on requests
        for proposals issued either by the Office or its designee to
        enter into contracts to carry out activities authorized by this
        section.
          (G) Partnerships with professional and civic groups,
        community-based organizations, including faith-based
        organizations, and government organizations related to the
        national media campaign.
          (H) Entertainment industry outreach, interactive outreach,
        media projects and activities, public information, news media
        outreach, and corporate sponsorship and participation.
          (I) Operational and management expenses.
      (2) Specific requirements
        (A) Creative services
          (i) In using amounts for creative and talent costs under
        paragraph (1)(B), the Director shall use creative services
        donated at no cost to the Government (including creative
        services provided by the Partnership for a Drug-Free America)
        wherever feasible and may only procure creative services for
        advertising - 
            (I) responding to high-priority or emergent campaign needs
          that cannot timely be obtained at no cost; or
            (II) intended to reach a minority, ethnic, or other special
          audience that cannot reasonably be obtained at no cost; or
            (III) the Director determines that the Partnership for a
          Drug-Free America is unable to provide, pursuant to
          subsection (d)(2)(B).

          (ii) Subject to the availability of appropriations, no more
        than $1,500,000 may be expended under this section each fiscal
        year on creative services, except that the Director may expend
        up to $2,000,000 in a fiscal year on creative services to meet
        urgent needs of the national media campaign with advance
        approval from the Committee on Appropriations of the Senate and
        of the House of Representatives upon a showing of the
        circumstances causing such urgent needs of the national media
        campaign.
        (B) Testing and evaluation of advertising
          In using amounts for testing and evaluation of advertising
        under paragraph (1)(D), the Director shall test all
        advertisements prior to use in the national media campaign to
        ensure that the advertisements are effective and meet industry-
        accepted standards. The Director may waive this requirement
        for advertisements using no more than 10 percent of the
        purchase of advertising time purchased under this section in a
        fiscal year and no more than 10 percent of the advertising
        space purchased under this section in a fiscal year, if the
        advertisements respond to emergent and time-sensitive campaign
        needs or the advertisements will not be widely utilized in the
        national media campaign.
        (C) Evaluation of effectiveness of media campaign
          In using amounts for the evaluation of the effectiveness of
        the national media campaign under paragraph (1)(E), the
        Director shall - 
            (i) designate an independent entity to evaluate by April 20
          of each year the effectiveness of the national media campaign
          based on data from - 
              (I) the Monitoring the Future Study published by the
            Department of Health and Human Services;
              (II) the Attitude Tracking Study published by the
            Partnership for a Drug-Free America;
              (III) the National Household Survey on Drug Abuse; and
              (IV) other relevant studies or publications, as
            determined by the Director, including tracking and
            evaluation data collected according to marketing and
            advertising industry standards; and

            (ii) ensure that the effectiveness of the national media
          campaign is evaluated in a manner that enables consideration
          of whether the national media campaign has contributed to
          reduction of illicit drug use among youth and such other
          measures of evaluation as the Director determines are
          appropriate.
      (3) Purchase of advertising time and space
        Subject to the availability of appropriations, for each fiscal
      year, not less than 77 percent of the amounts appropriated under
      this section shall be used for the purchase of advertising time
      and space for the national media campaign, subject to the
      following exceptions:
          (A) In any fiscal year for which less than $125,000,000 is
        appropriated for the national media campaign, not less than 72
        percent of the amounts appropriated under this section shall be
        used for the purchase of advertising time and space for the
        national media campaign.
          (B) In any fiscal year for which more than $195,000,000 is
        appropriated under this section, not less than 82 percent shall
        be used for advertising production costs and the purchase of
        advertising time and space for the national media campaign.
    (c) Advertising
      In carrying out this section, the Director shall ensure that
    sufficient funds are allocated to meet the stated goals of the
    national media campaign.
    (d) Division of responsibilities and functions under the program
      (1) In general
        The Director, in consultation with the Partnership for a Drug-
      Free America, shall determine the overall purposes and strategy
      of the national media campaign.
      (2) Responsibilities
        (A) Director
          The Director shall be responsible for implementing a focused
        national media campaign to meet the purposes set forth in
        subsection (a), and shall approve - 
            (i) the strategy of the national media campaign;
            (ii) all advertising and promotional material used in the
          national media campaign; and
            (iii) the plan for the purchase of advertising time and
          space for the national media campaign.
        (B) The Partnership for a Drug-Free America
          The Director shall request that the Partnership for a Drug-
        Free America - 
            (i) develop and recommend strategies to achieve the goals
          of the national media campaign, including addressing national
          and local drug threats in specific regions or States, such as
          methamphetamine and ecstasy;
            (ii) create all advertising to be used in the national
          media campaign, except advertisements that are - 
              (I) provided by other nonprofit entities pursuant to
            subsection (f);
              (II) intended to respond to high-priority or emergent
            campaign needs that cannot timely be obtained at no cost
            (not including production costs and talent reuse payments),
            provided that any such advertising material is reviewed by
            the Partnership for a Drug-Free America;
              (III) intended to reach a minority, ethnic, or other
            special audience that cannot be obtained at no cost (not
            including production costs and talent reuse payments),
            provided that any such advertising material is reviewed by
            the Partnership for a Drug-Free America; or
              (IV) any other advertisements that the Director
            determines that the Partnership for a Drug-Free America is
            unable to provide or if the Director determines that
            another entity is more appropriate, subject to the
            requirements of subsection (b)(2)(A).

        If the Director determines that another entity is more
        appropriate under clause (ii)(IV), the Director shall notify
        Congress, through the committees of jurisdiction in the House
        and Senate, in writing, not less than 30 days prior to
        contracting with a party other than the Partnership for a Drug-
        Free America.
        (C) Media buying contractor
          The Director shall enter into a contract with a media buying
        contractor to plan and purchase advertising time and space for
        the national media campaign. The media buying contractor shall
        not provide any other service or material, or conduct any other
        function or activity which the Director determines should be
        provided by the Partnership for a Drug-Free America.
    (e) Prohibitions
      None of the amounts made available under subsection (b) may be
    obligated or expended for any of the following:
        (1) To supplant current anti-drug community-based coalitions.
        (2) To supplant pro bono public service time donated by
      national and local broadcasting networks for other public service
      campaigns.
        (3) For partisan political purposes, or express advocacy in
      support of or to defeat any clearly identified candidate, clearly
      identified ballot initiative, or clearly identified legislative
      or regulatory proposal.
        (4) To fund advertising that features any elected officials,
      persons seeking elected office, cabinet level officials, or other
      Federal officials employed pursuant to section 213 of Schedule C
      of title 5, Code of Federal Regulations.
        (5) To fund advertising that does not contain a primary message
      intended to reduce or prevent illicit drug use.
        (6) To fund advertising containing a primary message intended
      to promote support for the media campaign or private sector
      contributions to the media campaign.
    (f) Matching requirement
      (1) In general
        Amounts made available under subsection (b) for media time and
      space shall be matched by an equal amount of non-Federal funds
      for the national media campaign, or be matched with in-kind
      contributions of the same value.
      (2) No-cost match advertising direct relationship requirement
        The Director shall ensure that at least 70 percent of no-cost
      match advertising provided directly relates to substance abuse
      prevention consistent with the specific purposes of the national
      media campaign, except that in any fiscal year in which less than
      $125,000,000 is appropriated to the national media campaign, the
      Director shall ensure that at least 85 percent of no-cost match
      advertising directly relates to substance abuse prevention
      consistent with the specific purposes of the national media
      campaign.
      (3) No-cost match advertising not directly related
        The Director shall ensure that no-cost match advertising that
      does not directly relate to substance abuse prevention consistent
      with the purposes of the national media campaign includes a clear
      anti-drug message. Such message is not required to be the primary
      message of the match advertising.
    (g) Financial and performance accountability
      The Director shall cause to be performed - 
        (1) audits and reviews of costs of the national media campaign
      pursuant to section 254d of title 41; and
        (2) an audit to determine whether the costs of the national
      media campaign are allowable under section 256 of title 41.
    (h) Report to Congress
      The Director shall submit on an annual basis a report to Congress
    that describes - 
        (1) the strategy of the national media campaign and whether
      specific objectives of the media campaign were accomplished;
        (2) steps taken to ensure that the national media campaign
      operates in an effective and efficient manner consistent with the
      overall strategy and focus of the national media campaign;
        (3) plans to purchase advertising time and space;
        (4) policies and practices implemented to ensure that Federal
      funds are used responsibly to purchase advertising time and space
      and eliminate the potential for waste, fraud, and abuse; and
        (5) all contracts entered into with a corporation, partnership,
      or individual working on behalf of the national media campaign.
    (i) Local target requirement
      The Director shall, to the maximum extent feasible, use amounts
    made available under this section for media that focuses on, or
    includes specific information on, prevention or treatment resources
    for consumers within specific local areas.
    (j) Prevention of marijuana use
      (1) Findings
        The Congress finds the following:
          (A) 60 percent of adolescent admissions for drug treatment
        are based on marijuana use.
          (B) Potency levels of contemporary marijuana, particularly
        hydroponically grown marijuana, are significantly higher than
        in the past, rising from under 1 percent of THC in the mid-
        1970s to as high as 30 percent today.
          (C) Contemporary research has demonstrated that youths
        smoking marijuana early in life may be up to 5 times more
        likely to use hard drugs.
          (D) Contemporary research has demonstrated clear detrimental
        effects in adolescent educational achievement resulting from
        marijuana use.
          (E) Contemporary research has demonstrated clear detrimental
        effects in adolescent brain development resulting from
        marijuana use.
          (F) An estimated 9,000,000 Americans a year drive while under
        the influence of illegal drugs, including marijuana.
          (G) Marijuana smoke contains 50 to 70 percent more of certain
        cancer causing chemicals than tobacco smoke.
          (H) Teens who use marijuana are up to 4 times more likely to
        have a teen pregnancy than teens who have not.
          (I) Federal law enforcement agencies have identified clear
        links suggesting that trade in hydroponic marijuana facilitates
        trade by criminal organizations in hard drugs, including
        heroin.
          (J) Federal law enforcement agencies have identified possible
        links between trade in cannabis products and financing for
        terrorist organizations.
      (2) Emphasis on prevention of youth marijuana use
        In conducting advertising and activities otherwise authorized
      under this section, the Director may emphasize prevention of
      youth marijuana use.
    (k) Prevention of methamphetamine abuse and other emerging drug
      abuse threats
      (1) Requirement to use 10 percent of funds for methamphetamine
        abuse prevention
        The Director shall ensure that, of the amounts appropriated
      under this section for the national media campaign for a fiscal
      year, not less than 10 percent shall be expended solely for the
      activities described in subsection (b)(1) with respect to
      advertisements specifically intended to reduce the use of
      methamphetamine.
      (2) Authority to use funds for other drug abuse upon
        certification that methamphetamine abuse fell during fiscal
        year 2007
        With respect to fiscal year 2008 and any fiscal year
      thereafter, if the Director certifies in writing to Congress that
      domestic methamphetamine laboratory seizures (as reported to the
      El Paso Intelligence Center of the Drug Enforcement
      Administration) decreased to at least 75 percent of the 2006
      level, or the Director has documented a highly, statistically
      significant increase in a specific drug, from a baseline
      determined by locally collected data, that can be defined as a
      local drug crisis, the Director may apply paragraph (1)(A) for
      that fiscal year with respect to advertisements specifically
      intended to reduce the use of such other drugs.
    (l) Authorization of appropriations
      There is authorized to be appropriated to the Office to carry out
    this section, $195,000,000 for each of fiscal years 2007 and 2008
    and $210,000,000 for each of fiscal years 2009 through 2011.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 709, Oct. 21, 1998, 112
    Stat. 2681-688; Pub. L. 109-469, title V, Sec. 501(a), Dec. 29,
    2006, 120 Stat. 3527.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in subsec. (a), was in the original
    "this subtitle" and was translated as reading "this title", meaning
    title VII of Pub. L. 105-277, div. C, Oct. 21, 1998, 112 Stat. 2681-
    670, which is classified principally to this chapter, to reflect
    the probable intent of Congress. Title VII does not contain
    subtitles. For complete classification of title VII to the Code,
    see Short Title note set out under section 1701 of this title and
    Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Pub. L. 109-469 amended section catchline and text
    generally. Prior to amendment, section related to the President's
    Council on Counter-Narcotics.


-EXEC-
       EX. ORD. NO. 12992. PRESIDENT'S COUNCIL ON COUNTER-NARCOTICS   
      Ex. Ord. No. 12992, Mar. 15, 1996, 61 F.R. 11287, as amended by
    Ex. Ord. No. 13023, Secs. 2, 3, Nov. 6, 1996, 61 F.R. 57767; Ex.
    Ord. No. 13284, Sec. 8, Jan. 23, 2003, 68 F.R. 4076, provided:
      By the authority vested in me as President by the Constitution
    and the laws of the United States of America, including section 301
    of title 3, United States Code, it is hereby ordered as follows:
      Section 1. Establishment. There is established the President's
    Drug Policy Council ("Council").
      Sec. 2. Membership. The Council shall comprise the:
      (a) President, who shall serve as Chairman of the Council;
      (b) Vice President;
      (c) Secretary of State;
      (d) Secretary of the Treasury;
      (e) Secretary of Defense;
      (f) Attorney General;
      (g) Secretary of the Interior;
      (h) Secretary of Agriculture;
      (i) Secretary of Health and Human Services;
      (j) Secretary of Housing and Urban Development;
      (k) Secretary of Transportation;
      (l) Secretary of Education;
      (m) Secretary of Veterans Affairs;
      (n) Secretary of Homeland Security;
      (o) Representative of the United States of America to the United
    Nations;
      (p) Director of the Office of Management and Budget;
      (q) Chief of Staff to the President;
      (r) Director of National Drug Control Policy;
      (s) Director of Central Intelligence;
      (t) Assistant to the President for National Security Affairs;
      (u) Counsel to the President;
      (v) Chairman, Joint Chiefs of Staff;
      (w) National Security Advisor to the Vice President; and
      (x) Assistant to the President for Domestic Policy.
      As applicable, the Council shall also comprise such other
    officials of the departments and agencies as the President may,
    from time to time, designate.
      Sec. 3. Meetings of the Council. The President, or upon his
    direction, the Vice President, may convene meetings of the Council.
    The President shall preside over meetings of the Council, provided
    that in his absence, the Vice President will preside. The Council
    will meet at least quarterly.
      Sec. 4. Functions. (a) The functions of the Council are to advise
    and assist the President in: (1) providing direction and oversight
    for the national drug control strategy, including relating drug
    control policy to other national security interests and
    establishing priorities; and (2) ensuring coordination among
    departments and agencies concerning implementation of the
    President's national drug control strategy.
      (b) The Director of National Drug Control Policy will continue to
    be the senior drug control policy official in the executive branch
    and the President's chief drug control policy spokesman.
      (c) In matters affecting national security interests, the
    Director of National Drug Control Policy shall work in conjunction
    with the Assistant to the President for National Security Affairs.
      Sec. 5. Administration. (a) The Council may utilize established
    or ad hoc committees, task forces, or interagency groups chaired by
    the Director of National Drug Control Policy or his representative,
    in carrying out its functions under this order.
      (b) The staff of the Office of National Drug Control Policy, in
    coordination with the staffs of the Vice President and the
    Assistant to the President for National Security Affairs, shall act
    as staff for the Council.
      (c) All executive departments and agencies shall cooperate with
    the Council and provide such assistance, information, and advice as
    the Council may request, to the extent permitted by law.

      EX. ORD. NO. 13023. EXPANDING AND CHANGING NAME OF PRESIDENT'S
                       COUNCIL ON COUNTER-NARCOTICS
      Ex. Ord. No. 13023, Nov. 6, 1996, 61 F.R. 57767, provided:
      By the authority vested in me as President by the Constitution
    and the laws of the United States of America, including section 301
    of title 3, United States Code, and in order to change the name of
    the "President's Council on Counter-Narcotics" to the "President's
    Drug Policy Council" and to make the Secretaries of the Interior,
    Agriculture, Health and Human Services, Housing and Urban
    Development, Education, Veterans Affairs, and the Assistant to the
    President for Domestic Policy, permanent members of the Council, it
    is hereby ordered as follows:
      Section 1. The Council established by Executive Order 12992 [set
    out above] shall henceforth be called the "President's Drug Policy
    Council."
      [Secs. 2, 3. Amended Ex. Ord. No. 12992, set out above.]
                                                     William J. Clinton.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 1708a                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1708a. Annual report requirement

-STATUTE-
    (a) In general
      On or before February 1 of each year, the Director shall submit a
    report to Congress that describes - 
        (1) the strategy of the national media campaign and whether
      specific objectives of the campaign were accomplished;
        (2) steps taken to ensure that the national media campaign
      operates in an effective and efficient manner consistent with the
      overall strategy and focus of the campaign;
        (3) plans to purchase advertising time and space;
        (4) policies and practices implemented to ensure that Federal
      funds are used responsibly to purchase advertising time and space
      and eliminate the potential for waste, fraud, and abuse;
        (5) all contracts entered into with a corporation, partnership,
      or individual working on behalf of the national media campaign;
        (6) specific policies and steps implemented to ensure
      compliance with title IV of this Act;
        (7) steps taken to ensure that the national media campaign will
      secure, to the maximum extent possible, no cost matches of
      advertising time and space or in-kind contributions that are
      directly related to the campaign in accordance with title IV of
      this Act; and
        (8) a review and evaluation of the effectiveness of the
      national media campaign strategy for the past year.
    (b) Audit
      The Government Accountability Office shall, at a frequency of not
    less than once per year - 
        (1) conduct and supervise an audit and investigation relating
      to the programs and operations of the - 
          (A) Office; or
          (B) certain programs within the Office, including - 
            (i) the High Intensity Drug Trafficking Areas Program;
            (ii) the Counterdrug Technology Assessment Center; or
            (iii) the National Youth Anti-drug Media Campaign; and

        (2) provide the Director and the appropriate congressional
      committees with a report containing an evaluation of and
      recommendations on the - 
          (A) policies and activities of the programs and operations
        subject to the audit and investigation;
          (B) economy, efficiency, and effectiveness in the
        administration of the reviewed programs and operations; and
          (C) policy or management changes needed to prevent and detect
        fraud and abuse in such programs and operations.

-SOURCE-
    (Pub. L. 109-469, title II, Sec. 203, Dec. 29, 2006, 120 Stat.
    3517.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Title IV of this Act, referred to in subsec. (a)(6), (7), is
    title IV of Pub. L. 109-469, Dec. 29, 2006, 120 Stat. 3525, which
    amended section 1707 of this title.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Office of National Drug
    Control Policy Reauthorization Act of 2006, and not as part of the
    Office of National Drug Control Policy Reauthorization Act of 1998
    which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 1709                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1709. Repealed.

-MISC1-
    Sec. 1709. Repealed. Pub. L. 109-469, title XI, Sec. 1101(a), Dec.
      29, 2006, 120 Stat. 3539.
      Section, Pub. L. 105-277, div. C, title VII, Sec. 710, Oct. 21,
    1998, 112 Stat. 2681-689, related to Parents Advisory Council on
    Youth Drug Abuse.

-End-



-CITE-
    21 USC Sec. 1710                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1710. Drug Interdiction Coordinator and Committee

-STATUTE-
    (a) United States Interdiction Coordinator
      (1) In general
        The United States Interdiction Coordinator shall perform the
      duties of that position described in paragraph (2) and such other
      duties as may be determined by the Director with respect to
      coordination of efforts to interdict illicit drugs from entering
      the United States.
      (2) Responsibilities
        The United States Interdiction Coordinator shall be responsible
      to the Director for - 
          (A) coordinating the interdiction activities of the National
        Drug Control Program agencies to ensure consistency with the
        National Drug Control Strategy;
          (B) on behalf of the Director, developing and issuing, on or
        before March 1 of each year and in accordance with paragraph
        (3), a National Interdiction Command and Control Plan to ensure
        the coordination and consistency described in subparagraph (A);
          (C) assessing the sufficiency of assets committed to illicit
        drug interdiction by the relevant National Drug Control Program
        agencies; and
          (D) advising the Director on the efforts of each National
        Drug Control Program agency to implement the National
        Interdiction Command and Control Plan.
      (3) Staff
        The Director shall assign such permanent staff of the Office as
      he considers appropriate to assist the United States Interdiction
      Coordinator to carry out the responsibilities described in
      paragraph (2), and may also, at his discretion, request that
      appropriate National Drug Control Program agencies detail or
      assign staff to the Office of Supply Reduction for that purpose.
      (4) National Interdiction Command and Control Plan
        (A) Purposes
          The National Interdiction Command and Control Plan shall - 
            (i) set forth the Government's strategy for drug
          interdiction;
            (ii) state the specific roles and responsibilities of the
          relevant National Drug Control Program agencies for
          implementing that strategy; and
            (iii) identify the specific resources required to enable
          the relevant National Drug Control Program agencies to
          implement that strategy.
        (B) Consultation with other agencies
          The United States Interdiction Coordinator shall issue the
        National Interdiction Command and Control Plan in consultation
        with the other members of the Interdiction Committee described
        in subsection (b).
        (C) Limitation
          The National Interdiction Command and Control Plan shall not
        change existing agency authorities or the laws governing
        interagency relationships, but may include recommendations
        about changes to such authorities or laws.
        (D) Report to Congress
          On or before March 1 of each year, the United States
        Interdiction Coordinator shall provide a report on behalf of
        the Director to the appropriate congressional committees, to
        the Committee on Armed Services and the Committee on Homeland
        Security of the House of Representatives, and to the Committee
        on Homeland Security and Governmental Affairs and the Committee
        on Armed Services of the Senate, which shall include - 
            (i) a copy of that year's National Interdiction Command and
          Control Plan;
            (ii) information for the previous 10 years regarding the
          number and type of seizures of drugs by each National Drug
          Control Program agency conducting drug interdiction
          activities, as well as statistical information on the
          geographic areas of such seizures; and
            (iii) information for the previous 10 years regarding the
          number of air and maritime patrol hours undertaken by each
          National Drug Control Program agency conducting drug
          interdiction activities, as well as statistical information
          on the geographic areas in which such patrol hours took
          place.
        (E) Treatment of classified or law enforcement sensitive
          information
          Any content of the report described in subparagraph (D) that
        involves information classified under criteria established by
        an Executive order, or the public disclosure of which, as
        determined by the Director, the Director of National
        Intelligence, or the head of any Federal Government agency the
        activities of which are described in the plan, would be
        detrimental to the law enforcement or national security
        activities of any Federal, State, or local agency, shall be
        presented to Congress separately from the rest of the report.
    (b) Interdiction Committee
      (1) In general
        The Interdiction Committee shall meet to - 
          (A) discuss and resolve issues related to the coordination,
        oversight and integration of international, border, and
        domestic drug interdiction efforts in support of the National
        Drug Control Strategy;
          (B) review the annual National Interdiction Command and
        Control Plan, and provide advice to the Director and the United
        States Interdiction Coordinator concerning that plan; and
          (C) provide such other advice to the Director concerning drug
        interdiction strategy and policies as the committee determines
        is appropriate.
      (2) Chairman
        The Director shall designate one of the members of the
      Interdiction Committee to serve as chairman.
      (3) Meetings
        The members of the Interdiction Committee shall meet, in person
      and not through any delegate or representative, at least once per
      calendar year, prior to March 1. At the call of either the
      Director or the current chairman, the Interdiction Committee may
      hold additional meetings, which shall be attended by the members
      either in person, or through such delegates or representatives as
      they may choose.
      (4) Report
        Not later than September 30 of each year, the chairman of the
      Interdiction Committee shall submit a report to the Director and
      to the appropriate congressional committees describing the
      results of the meetings and any significant findings of the
      Committee during the previous 12 months. Any content of such a
      report that involves information classified under criteria
      established by an Executive order, or whose public disclosure, as
      determined by the Director, the chairman, or any member, would be
      detrimental to the law enforcement or national security
      activities of any Federal, State, local, or tribal agency, shall
      be presented to Congress separately from the rest of the report.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 711, Oct. 21, 1998, 112
    Stat. 2681-691; Pub. L. 109-469, title I, Sec. 103(f)(1), Dec. 29,
    2006, 120 Stat. 3507.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.


-MISC1-
                                AMENDMENTS                            
      2006 - Pub. L. 109-469, which directed that section 711 of Office
    of National Drug Control Policy Reauthorization Act of 1998 (Pub.
    L. 105-277, div. C, title VII) be amended by "adding at the end" a
    new section 711, was executed by substituting the new section 711
    for this section which was the existing section 711 of the Act, to
    reflect the probable intent of Congress. Prior to amendment, this
    section related to drug interdiction.

-End-



-CITE-
    21 USC Sec. 1710a                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1710a. Requirement for disclosure of Federal sponsorship of
      all Federal advertising or other communication materials

-STATUTE-
    (a) Requirement
      Each advertisement or other communication paid for by the Office,
    either directly or through a contract awarded by the Office, shall
    include a prominent notice informing the target audience that the
    advertisement or other communication is paid for by the Office.
    (b) Advertisement or other communication
      In this section, the term "advertisement or other communication"
    includes - 
        (1) an advertisement disseminated in any form, including print
      or by any electronic means; and
        (2) a communication by an individual in any form, including
      speech, print, or by any electronic means.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 712, as added Pub. L. 109-
    469, title XI, Sec. 1118, Dec. 29, 2006, 120 Stat. 3546.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-COD-
                               CODIFICATION                           
      Another section 712 of title VII of div. C of Pub. L. 105-277
    amended former section 1509 of this title.

-End-



-CITE-
    21 USC Sec. 1711                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1711. Authorization of appropriations

-STATUTE-
      There are authorized to be appropriated to carry out this chapter
    except activities otherwise specified, to remain available until
    expended, such sums as may be necessary for each of fiscal years
    2006 through 2010.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 714, Oct. 21, 1998, 112
    Stat. 2681-693; Pub. L. 109-469, title VI, Sec. 601, Dec. 29, 2006,
    120 Stat. 3533.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    title", meaning title VII of Pub. L. 105-277, div. C, Oct. 21,
    1998, 112 Stat. 2681-670, which is classified principally to this
    chapter. For complete classification of title VII to the Code, see
    Short Title note set out under section 1701 of this title and
    Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Pub. L. 109-469 substituted "chapter except activities
    otherwise specified," for "chapter," and "2006 through 2010" for
    "1999 through 2003".

                              APPROPRIATIONS                          
      Provisions appropriating funds to carry out activities authorized
    by the Office of National Drug Control Policy Reauthorization Act
    of 1998, which enacted this chapter, notwithstanding section 1712
    of this title, were contained in the following appropriation acts:
      Pub. L. 109-115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475.
      Pub. L. 108-447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249,
    3250.
      Pub. L. 108-199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.

-End-



-CITE-
    21 USC Sec. 1712                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1712. Termination of Office of National Drug Control Policy

-STATUTE-
    (a) In general
      Except as provided in subsection (b) of this section, effective
    on September 30, 2010, this chapter and the amendments made to this
    chapter are repealed.
    (b) Exception
      Subsection (a) of this section does not apply to section 713 or
    the amendments made by that section.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 715, Oct. 21, 1998, 112
    Stat. 2681-693; Pub. L. 109-469, title VI, Sec. 602, Dec. 29, 2006,
    120 Stat. 3533.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in subsec. (a), was in the original
    "this title", meaning title VII of Pub. L. 105-277, div. C, Oct.
    21, 1998, 112 Stat. 2681-670, which is classified principally to
    this chapter. For complete classification of title VII to the Code,
    see Short Title note set out under section 1701 of this title and
    Tables.
      Section 713, referred to in subsec. (b), is section 713 of Pub.
    L. 105-277, div. C, title VII, Oct. 21, 1998, 112 Stat. 2681-693,
    which amended sections 5312 to 5314 of Title 5, Government
    Organization and Employees, section 1105 of Title 31, Money and
    Finance, and section 402 of Title 50, War and National Defense.

-COD-
                               CODIFICATION                           
      The repeal of this chapter and of the amendments made by this
    chapter, effective Sept. 30, 2003, by this section, as in effect on
    Sept. 30, 2003, has not been given effect in the Code, to reflect
    the probable intent of Congress, because of the amendment to this
    section by Pub. L. 109-469 which substituted "September 30, 2010"
    for "September 30, 2003" as the effective date of the repeal. See
    2006 Amendment note below.


-MISC1-
                                AMENDMENTS                            
      2006 - Pub. L. 109-469 substituted "September 30, 2010, this
    chapter and the amendments made to this chapter" for "September 30,
    2003, this chapter and the amendments made by this chapter".

-End-



-CITE-
    21 USC Sec. 1713                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1713. Authorization of use of environmentally-approved
      herbicides to eliminate illicit narcotics crops

-STATUTE-
      The Secretary of State, the Attorney General, the Secretary of
    Agriculture, the Secretary of Defense, the Director of the Office
    of National Drug Control Policy, and the Administrator of the
    Environmental Protection Agency are authorized to support the
    development and use of environmentally-approved herbicides to
    eliminate illicit narcotics crops, including coca, cannabis, and
    opium poppy, both in the United States and in foreign countries.

-SOURCE-
    (Pub. L. 105-277, div. C, title VIII, Sec. 834, Oct. 21, 1998, 112
    Stat. 2681-702.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Western Hemisphere Drug
    Elimination Act, and not as part of the Office of National Drug
    Control Policy Reauthorization Act of 1998 which comprises this
    chapter.

-End-



-CITE-
    21 USC Sec. 1714                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 22 - NATIONAL DRUG CONTROL POLICY

-HEAD-
    Sec. 1714. Awards for demonstration programs by local partnerships
      to coerce abstinence in chronic hard-drug users under community
      supervision through the use of drug testing and sanctions

-STATUTE-
    (a) Awards required
      The Director shall make competitive awards to fund demonstration
    programs by eligible partnerships for the purpose of reducing the
    use of illicit drugs by chronic hard-drug users living in the
    community while under the supervision of the criminal justice
    system.
    (b) Use of award amounts
      Award amounts received under this section shall be used - 
        (1) to support the efforts of the agencies, organizations, and
      researchers included in the eligible partnership;
        (2) to develop and field a drug testing and graduated sanctions
      program for chronic hard-drug users living in the community under
      criminal justice supervision; and
        (3) to assist individuals described in subsection (a) by
      strengthening rehabilitation efforts through such means as job
      training, drug treatment, or other services.
    (c) Eligible partnership defined
      In this section, the term "eligible partnership" means a working
    group whose application to the Director - 
        (1) identifies the roles played, and certifies the involvement
      of, two or more agencies or organizations, which may include - 
          (A) State, local, or tribal agencies (such as those carrying
        out police, probation, prosecution, courts, corrections,
        parole, or treatment functions);
          (B) Federal agencies (such as the Drug Enforcement Agency,
        the Bureau of Alcohol, Tobacco, Firearms, and Explosives, and
        United States Attorney offices); and
          (C) community-based organizations;

        (2) includes a qualified researcher;
        (3) includes a plan for using judicial or other criminal
      justice authority to administer drug tests to individuals
      described in subsection (a) at least twice a week, and to swiftly
      and certainly impose a known set of graduated sanctions for non-
      compliance with community-release provisions relating to drug
      abstinence (whether imposed as a pre-trial, probation, or parole
      condition or otherwise);
        (4) includes a strategy for responding to a range of substance
      use and abuse problems and a range of criminal histories;
        (5) includes a plan for integrating data infrastructure among
      the agencies and organizations included in the eligible
      partnership to enable seamless, real-time tracking of individuals
      described in subsection (a);
        (6) includes a plan to monitor and measure the progress toward
      reducing the percentage of the population of individuals
      described in subsection (a) who, upon being summoned for a drug
      test, either fail to show up or who test positive for drugs.
    (d) Reports to Congress
      (1) Interim report
        Not later than June 1, 2009, the Director shall submit to
      Congress a report that identifies the best practices in reducing
      the use of illicit drugs by chronic hard-drug users, including
      the best practices identified through the activities funded under
      this section.
      (2) Final report
        Not later than June 1, 2010, the Director shall submit to
      Congress a report on the demonstration programs funded under this
      section, including on the matters specified in paragraph (1).
    (e) Authorization of appropriations
      There is authorized to be appropriated to carry out this section
    $4,900,000 for each of fiscal years 2007 through 2009.

-SOURCE-
    (Pub. L. 105-277, div. C, title VII, Sec. 716, as added Pub. L. 109-
    469, title XI, Sec. 1119, Dec. 29, 2006, 120 Stat. 3547.)


-STATAMEND-
                             REPEAL OF SECTION                         
      For repeal of section on Sept. 30, 2010, see section 1712 of this
    title.

-End-


-CITE-
    21 USC CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA
           CAMPAIGN                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN

-HEAD-
           CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN       

-End-



-CITE-
    21 USC Secs. 1801 to 1804                                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN

-HEAD-
    Secs. 1801 to 1804. Repealed.

-MISC1-
    Secs. 1801 to 1804. Repealed. Pub. L. 109-469, title V, Sec.
      501(b), Dec. 29, 2006, 120 Stat. 3533.
      Section 1801, Pub. L. 105-277, div. D, title I, Sec. 102, Oct.
    21, 1998, 112 Stat. 2681-752, related to requirement to conduct
    national media campaign.
      Section 1802, Pub. L. 105-277, div. D, title I, Sec. 103, Oct.
    21, 1998, 112 Stat. 2681-752, related to use of funds.
      Section 1803, Pub. L. 105-277, div. D, title I, Sec. 104, Oct.
    21, 1998, 112 Stat. 2681-753, related to reports to Congress.
      Section 1804, Pub. L. 105-277, div. D, title I, Sec. 105, Oct.
    21, 1998, 112 Stat. 2681-753, related to authorization of
    appropriations.

                                SHORT TITLE                            
      Pub. L. 105-277, div. D, Sec. 1(a), Oct. 21, 1998, 112 Stat. 2681-
    751, provided that: "This division [enacting this chapter and
    section 7144 of Title 20, Education, and enacting provisions set
    out as notes under this section, section 1703 of this title,
    section 6301 of Title 20, and section 3751 of Title 42, The Public
    Health and Welfare] may be cited as the 'Drug Demand Reduction
    Act'."
      Pub. L. 105-277, div. D, title I, Sec. 101, Oct. 21, 1998, 112
    Stat. 2681-752, which provided that subtitle A (Secs. 101-105) of
    title I of div. D of Pub. L. 105-277, enacting this chapter, was to
    be cited as the "Drug-Free Media Campaign Act of 1998", was
    repealed by Pub. L. 109-469, title V, Sec. 501(b), Dec. 29, 2006,
    120 Stat. 3533.

-End-


-CITE-
    21 USC CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
             CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING         

-MISC1-
    Sec.                                                     
    1901.       Findings and policy.                                  
    1902.       Purpose.                                              
    1903.       Public identification of significant foreign narcotics
                 traffickers and required reports.                    
    1904.       Blocking assets and prohibiting transactions.         
    1905.       Authorities.                                          
    1906.       Enforcement.                                          
    1907.       Definitions.                                          
    1908.       Judicial Review Commission on Foreign Asset Control.  

-End-



-CITE-
    21 USC Sec. 1901                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1901. Findings and policy

-STATUTE-
    (a) Findings
      Congress makes the following findings:
        (1) Presidential Decision Directive 42, issued on October 21,
      1995, ordered agencies of the executive branch of the United
      States Government to, inter alia, increase the priority and
      resources devoted to the direct and immediate threat
      international crime presents to national security, work more
      closely with other governments to develop a global response to
      this threat, and use aggressively and creatively all legal means
      available to combat international crime.
        (2) Executive Order No. 12978 of October 21, 1995, provides for
      the use of the authorities in the International Emergency
      Economic Powers Act (IEEPA) (50 U.S.C. 1701 et seq.) to target
      and apply sanctions to four international narcotics traffickers
      and their organizations that operate from Colombia.
        (3) IEEPA was successfully applied to international narcotics
      traffickers in Colombia and based on that successful case study,
      Congress believes similar authorities should be applied
      worldwide.
        (4) There is a national emergency resulting from the activities
      of international narcotics traffickers and their organizations
      that threatens the national security, foreign policy, and economy
      of the United States.
    (b) Policy
      It shall be the policy of the United States to apply economic and
    other financial sanctions to significant foreign narcotics
    traffickers and their organizations worldwide to protect the
    national security, foreign policy, and economy of the United States
    from the threat described in subsection (a)(4) of this section.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 802, Dec. 3, 1999, 113 Stat.
    1626.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Executive Order No. 12978, referred to in subsec. (a)(2), is Ex.
    Ord. No. 12978, Oct. 21, 1995, 60 F.R. 54579, which is listed in a
    table under section 1701 of Title 50, War and National Defense.
      The International Emergency Economic Powers Act, referred to in
    subsec. (a)(2), is title II of Pub. L. 95-223, Dec. 28, 1977, 91
    Stat. 1626, as amended, which is classified generally to chapter 35
    (Sec. 1701 et seq.) of Title 50, War and National Defense. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 1701 of Title 50 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Pub. L. 106-120, title VIII, Sec. 811, Dec. 3, 1999, 113 Stat.
    1636, provided that: "This title [see Short Title note set out
    below] shall take effect on the date of the enactment of this Act
    [Dec. 3, 1999]."

                                SHORT TITLE                            
      Pub. L. 106-120, title VIII, Sec. 801, Dec. 3, 1999, 113 Stat.
    1626, provided that: "This title [enacting this chapter and
    amending section 1182 of Title 8, Aliens and Nationality] may be
    cited as the 'Foreign Narcotics Kingpin Designation Act'."

-End-



-CITE-
    21 USC Sec. 1902                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1902. Purpose

-STATUTE-
      The purpose of this chapter is to provide authority for the
    identification of, and application of sanctions on a worldwide
    basis to, significant foreign narcotics traffickers, their
    organizations, and the foreign persons who provide support to those
    significant foreign narcotics traffickers and their organizations,
    whose activities threaten the national security, foreign policy,
    and economy of the United States.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 803, Dec. 3, 1999, 113 Stat.
    1626.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This chapter, referred to in text, was in the original "this
    title", meaning title VIII of Pub. L. 106-120, Dec. 3, 1999, 113
    Stat. 1626, which is classified generally to this chapter. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 1901 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 1903                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1903. Public identification of significant foreign narcotics
      traffickers and required reports

-STATUTE-
    (a) Provision of information to the President
      The Secretary of the Treasury, the Attorney General, the
    Secretary of Defense, the Secretary of State, and the Director of
    Central Intelligence shall consult among themselves and provide the
    appropriate and necessary information to enable the President to
    submit the report under subsection (b) of this section. This
    information shall also be provided to the Director of the Office of
    National Drug Control Policy.
    (b) Public identification and sanctioning of significant foreign
      narcotics traffickers
      Not later than June 1, 2000, and not later than June 1 of each
    year thereafter, the President shall submit a report to the
    Permanent Select Committee on Intelligence, and the Committees on
    the Judiciary, International Relations, Armed Services, and Ways
    and Means of the House of Representatives; and to the Select
    Committee on Intelligence, and the Committees on the Judiciary,
    Foreign Relations, Armed Services, and Finance of the Senate - 
        (1) identifying publicly the foreign persons that the President
      determines are appropriate for sanctions pursuant to this
      chapter; and
        (2) detailing publicly the President's intent to impose
      sanctions upon these significant foreign narcotics traffickers
      pursuant to this chapter.

    The report required in this subsection shall not include
    information on persons upon which United States sanctions imposed
    under this chapter, or otherwise on account of narcotics
    trafficking, are already in effect.
    (c) Unclassified report required
      The report required by subsection (b) of this section shall be
    submitted in unclassified form and made available to the public.
    (d) Classified report
      (1) Not later than July 1, 2000, and not later than July 1 of
    each year thereafter, the President shall provide the Permanent
    Select Committee on Intelligence of the House of Representatives
    and the Select Committee on Intelligence of the Senate with a
    report in classified form describing in detail the status of the
    sanctions imposed under this chapter, including the personnel and
    resources directed towards the imposition of such sanctions during
    the preceding fiscal year, and providing background information
    with respect to newly-identified significant foreign narcotics
    traffickers and their activities.
      (2) Such classified report shall describe actions the President
    intends to undertake or has undertaken with respect to such
    significant foreign narcotics traffickers.
      (3) The report required under this subsection is in addition to
    the President's obligations to keep the intelligence committees of
    Congress fully and currently informed pursuant to the provisions of
    the National Security Act of 1947.
    (e) Exclusion of certain information
      (1) Intelligence
        Notwithstanding any other provision of this section, the
      reports described in subsections (b) and (d) of this section
      shall not disclose the identity of any person, if the Director of
      Central Intelligence determines that such disclosure could
      compromise an intelligence operation, activity, source, or method
      of the United States.
      (2) Law enforcement
        Notwithstanding any other provision of this section, the
      reports described in subsections (b) and (d) of this section
      shall not disclose the name of any person if the Attorney
      General, in coordination as appropriate with the Director of the
      Federal Bureau of Investigation, the Administrator of the Drug
      Enforcement Administration, and the Secretary of the Treasury,
      determines that such disclosure could reasonably be expected to -
      
          (A) compromise the identity of a confidential source,
        including a State, local, or foreign agency or authority or any
        private institution that furnished information on a
        confidential basis;
          (B) jeopardize the integrity or success of an ongoing
        criminal investigation or prosecution;
          (C) endanger the life or physical safety of any person; or
          (D) cause substantial harm to physical property.
    (f) Notification required
      (1) Whenever either the Director of Central Intelligence or the
    Attorney General makes a determination under subsection (e) of this
    section, the Director of Central Intelligence or the Attorney
    General shall notify the Permanent Select Committee on Intelligence
    of the House of Representatives and the Select Committee on
    Intelligence of the Senate, and explain the reasons for such
    determination.
      (2) The notification required under this subsection shall be
    submitted to the Permanent Select Committee on Intelligence of the
    House of Representatives and the Select Committee on Intelligence
    of the Senate not later than July 1, 2000, and on an annual basis
    thereafter.
    (g) Determinations not to apply sanctions
      (1) The President may waive the application to a significant
    foreign narcotics trafficker of any sanction authorized by this
    chapter if the President determines that the application of
    sanctions under this chapter would significantly harm the national
    security of the United States.
      (2) When the President determines not to apply sanctions that are
    authorized by this chapter to any significant foreign narcotics
    trafficker, the President shall notify the Permanent Select
    Committee on Intelligence, and the Committees on the Judiciary,
    International Relations, Armed Services, and Ways and Means of the
    House of Representatives, and the Select Committee on Intelligence,
    and the Committees on the Judiciary, Foreign Relations, Armed
    Services, and Finance of the Senate not later than 21 days after
    making such determination.
    (h) Changes in determinations to impose sanctions
      (1) Additional determinations
        (A) If at any time after the report required under subsection
      (b) of this section the President finds that a foreign person is
      a significant foreign narcotics trafficker and such foreign
      person has not been publicly identified in a report required
      under subsection (b) of this section, the President shall submit
      an additional public report containing the information described
      in subsection (b) of this section with respect to such foreign
      person to the Permanent Select Committee on Intelligence, and the
      Committees on the Judiciary, International Relations, Armed
      Services, and Ways and Means of the House of Representatives, and
      the Select Committee on Intelligence, and the Committees on the
      Judiciary, Foreign Relations, Armed Services, and Finance of the
      Senate.
        (B) The President may apply sanctions authorized under this
      chapter to the significant foreign narcotics trafficker
      identified in the report submitted under subparagraph (A) as if
      the trafficker were originally included in the report submitted
      pursuant to subsection (b) of this section.
        (C) The President shall notify the Secretary of the Treasury of
      any determination made under this paragraph.
      (2) Revocation of determination
        (A) Whenever the President finds that a foreign person that has
      been publicly identified as a significant foreign narcotics
      trafficker in the report required under subsection (b) of this
      section or this subsection no longer engages in those activities
      for which sanctions under this chapter may be applied, the
      President shall issue public notice of such a finding.
        (B) Not later than the date of the public notice issued
      pursuant to subparagraph (A), the President shall notify, in
      writing and in classified or unclassified form, the Permanent
      Select Committee on Intelligence, and the Committees on the
      Judiciary, International Relations, Armed Services, and Ways and
      Means of the House of Representatives, and the Select Committee
      on Intelligence, and the Committees on the Judiciary, Foreign
      Relations, Armed Services, and Finance of the Senate of actions
      taken under this paragraph and a description of the basis for
      such actions.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 804, Dec. 3, 1999, 113 Stat.
    1626.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The National Security Act of 1947, referred to in subsec. (d)(3),
    is act July 26, 1947, ch. 343, 61 Stat. 495, as amended. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 401 of Title 50, War and National
    Defense, and Tables.

-CHANGE-
                              CHANGE OF NAME                          
      Reference to the Director of Central Intelligence or the Director
    of the Central Intelligence Agency in the Director's capacity as
    the head of the intelligence community deemed to be a reference to
    the Director of National Intelligence. Reference to the Director of
    Central Intelligence or the Director of the Central Intelligence
    Agency in the Director's capacity as the head of the Central
    Intelligence Agency deemed to be a reference to the Director of the
    Central Intelligence Agency. See section 1081(a), (b) of Pub. L.
    108-458, set out as a note under section 401 of Title 50, War and
    National Defense.


-TRANS-
                          DELEGATION OF FUNCTIONS                      
      For delegation of Congressional reporting functions of President
    under subsec. (d) of this section, see section 1 of Ex. Ord. No.
    13313, July 31, 2003, 68 F.R. 46075, set out as a note under
    section 301 of Title 3, The President.

-End-



-CITE-
    21 USC Sec. 1904                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1904. Blocking assets and prohibiting transactions

-STATUTE-
    (a) Applicability of sanctions
      A significant foreign narcotics trafficker publicly identified in
    the report required under subsection (b) or (h)(1) of section 1903
    of this title and foreign persons designated by the Secretary of
    the Treasury pursuant to subsection (b) of this section shall be
    subject to any and all sanctions as authorized by this chapter. The
    application of sanctions on any foreign person pursuant to
    subsection (b) or (h)(1) of section 1903 of this title or
    subsection (b) of this section shall remain in effect until revoked
    pursuant to section 1903(h)(2) of this title or subsection
    (e)(1)(A) of this section or waived pursuant to section 1903(g)(1)
    of this title.
    (b) Blocking of assets
      Except to the extent provided in regulations, orders,
    instructions, licenses, or directives issued pursuant to this
    chapter, and notwithstanding any contract entered into or any
    license or permit granted prior to the date on which the President
    submits the report required under subsection (b) or (h)(1) of
    section 1903 of this title, there are blocked as of such date, and
    any date thereafter, all such property and interests in property
    within the United States, or within the possession or control of
    any United States person, which are owned or controlled by - 
        (1) any significant foreign narcotics trafficker publicly
      identified by the President in the report required under
      subsection (b) or (h)(1) of section 1903 of this title;
        (2) any foreign person that the Secretary of the Treasury, in
      consultation with the Attorney General, the Director of Central
      Intelligence, the Director of the Federal Bureau of
      Investigation, the Administrator of the Drug Enforcement
      Administration, the Secretary of Defense, and the Secretary of
      State, designates as materially assisting in, or providing
      financial or technological support for or to, or providing goods
      or services in support of, the international narcotics
      trafficking activities of a significant foreign narcotics
      trafficker so identified in the report required under subsection
      (b) or (h)(1) of section 1903 of this title, or foreign persons
      designated by the Secretary of the Treasury pursuant to this
      subsection;
        (3) any foreign person that the Secretary of the Treasury, in
      consultation with the Attorney General, the Director of Central
      Intelligence, the Director of the Federal Bureau of
      Investigation, the Administrator of the Drug Enforcement
      Administration, the Secretary of Defense, and the Secretary of
      State, designates as owned, controlled, or directed by, or acting
      for or on behalf of, a significant foreign narcotics trafficker
      so identified in the report required under subsection (b) or
      (h)(1) of section 1903 of this title, or foreign persons
      designated by the Secretary of the Treasury pursuant to this
      subsection; and
        (4) any foreign person that the Secretary of the Treasury, in
      consultation with the Attorney General, the Director of Central
      Intelligence, the Director of the Federal Bureau of
      Investigation, the Administrator of the Drug Enforcement
      Administration, the Secretary of Defense, and the Secretary of
      State, designates as playing a significant role in international
      narcotics trafficking.
    (c) Prohibited transactions
      Except to the extent provided in regulations, orders,
    instructions, licenses, or directives issued pursuant to this
    chapter, and notwithstanding any contract entered into or any
    license or permit granted prior to the date on which the President
    submits the report required under subsection (b) or (h)(1) of
    section 1903 of this title, the following transactions are
    prohibited:
        (1) Any transaction or dealing by a United States person, or
      within the United States, in property or interests in property of
      any significant foreign narcotics trafficker so identified in the
      report required pursuant to subsection (b) or (h)(1) of section
      1903 of this title, and foreign persons designated by the
      Secretary of the Treasury pursuant to subsection (b) of this
      section.
        (2) Any transaction or dealing by a United States person, or
      within the United States, that evades or avoids, or has the
      effect of evading or avoiding, and any endeavor, attempt, or
      conspiracy to violate, any of the prohibitions contained in this
      chapter.
    (d) Law enforcement and intelligence activities not affected
      Nothing in this chapter prohibits or otherwise limits the
    authorized law enforcement or intelligence activities of the United
    States, or the law enforcement activities of any State or
    subdivision thereof.
    (e) Implementation
      (1) The Secretary of the Treasury, in consultation with the
    Attorney General, the Director of Central Intelligence, the
    Director of the Federal Bureau of Investigation, the Administrator
    of the Drug Enforcement Administration, the Secretary of Defense,
    and the Secretary of State, is authorized to take such actions as
    may be necessary to carry out this chapter, including - 
        (A) making those designations authorized by paragraphs (2),
      (3), and (4) of subsection (b) of this section and revocation
      thereof;
        (B) promulgating rules and regulations permitted under this
      chapter; and
        (C) employing all powers conferred on the Secretary of the
      Treasury under this chapter.

      (2) Each agency of the United States shall take all appropriate
    measures within its authority to carry out the provisions of this
    chapter.
      (3) Section 552(a)(3) of title 5 shall not apply to any record or
    information obtained or created in the implementation of this
    chapter.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 805, Dec. 3, 1999, 113 Stat.
    1629; Pub. L. 107-108, title III, Sec. 307, Dec. 28, 2001, 115
    Stat. 1399.)


-MISC1-
                                AMENDMENTS                            
      2001 - Subsec. (f). Pub. L. 107-108 struck out heading and text
    of subsec. (f). Text read as follows: "The determinations,
    identifications, findings, and designations made pursuant to
    section 1903 of this title and subsection (b) of this section shall
    not be subject to judicial review."

-CHANGE-
                              CHANGE OF NAME                          
      Reference to the Director of Central Intelligence or the Director
    of the Central Intelligence Agency in the Director's capacity as
    the head of the intelligence community deemed to be a reference to
    the Director of National Intelligence. Reference to the Director of
    Central Intelligence or the Director of the Central Intelligence
    Agency in the Director's capacity as the head of the Central
    Intelligence Agency deemed to be a reference to the Director of the
    Central Intelligence Agency. See section 1081(a), (b) of Pub. L.
    108-458, set out as a note under section 401 of Title 50, War and
    National Defense.

-End-



-CITE-
    21 USC Sec. 1905                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1905. Authorities

-STATUTE-
    (a) In general
      To carry out the purposes of this chapter, the Secretary of the
    Treasury may, under such regulations as he may prescribe, by means
    of instructions, licenses, or otherwise - 
        (1) investigate, regulate, or prohibit - 
          (A) any transactions in foreign exchange, currency, or
        securities; and
          (B) transfers of credit or payments between, by, through, or
        to any banking institution, to the extent that such transfers
        or payments involve any interests of any foreign country or a
        national thereof; and

        (2) investigate, block during the pendency of an investigation,
      regulate, direct and compel, nullify, void, prevent, or prohibit
      any acquisition, holding, withholding, use, transfer, withdrawal,
      transportation, placement into foreign or domestic commerce of,
      or dealing in, or exercising any right, power, or privilege with
      respect to, or transactions involving, any property in which any
      foreign country or a national thereof has any interest,

    by any person, or with respect to any property, subject to the
    jurisdiction of the United States.
    (b) Recordkeeping
      Pursuant to subsection (a) of this section, the Secretary of the
    Treasury may require recordkeeping, reporting, and production of
    documents to carry out the purposes of this chapter.
    (c) Defenses
      (1) Full and actual compliance with any regulation, order,
    license, instruction, or direction issued under this chapter shall
    be a defense in any proceeding alleging a violation of any of the
    provisions of this chapter.
      (2) No person shall be held liable in any court for or with
    respect to anything done or omitted in good faith in connection
    with the administration of, or pursuant to, and in reliance on this
    chapter, or any regulation, instruction, or direction issued under
    this chapter.
    (d) Rulemaking
      The Secretary of the Treasury may issue such other regulations or
    orders, including regulations prescribing recordkeeping, reporting,
    and production of documents, definitions, licenses, instructions,
    or directions, as may be necessary for the exercise of the
    authorities granted by this chapter.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 806, Dec. 3, 1999, 113 Stat.
    1631.)

-End-



-CITE-
    21 USC Sec. 1906                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1906. Enforcement

-STATUTE-
    (a) Criminal penalties
      (1) Whoever willfully violates the provisions of this chapter, or
    any license rule, or regulation issued pursuant to this chapter, or
    willfully neglects or refuses to comply with any order of the
    President issued under this chapter shall be - 
        (A) imprisoned for not more than 10 years,
        (B) fined in the amount provided in title 18 or, in the case of
      an entity, fined not more than $10,000,000,

    or both.
      (2) Any officer, director, or agent of any entity who knowingly
    participates in a violation of the provisions of this chapter shall
    be imprisoned for not more than 30 years, fined not more than
    $5,000,000, or both.
    (b) Civil penalties
      A civil penalty not to exceed $1,000,000 may be imposed by the
    Secretary of the Treasury on any person who violates any license,
    order, rule, or regulation issued in compliance with the provisions
    of this chapter.
    (c) Judicial review of civil penalty
      Any penalty imposed under subsection (b) of this section shall be
    subject to judicial review only to the extent provided in section
    702 of title 5.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 807, Dec. 3, 1999, 113 Stat.
    1631.)

-End-



-CITE-
    21 USC Sec. 1907                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1907. Definitions

-STATUTE-
      As used in this chapter:
      (1) Entity
        The term "entity" means a partnership, joint venture,
      association, corporation, organization, network, group, or
      subgroup, or any form of business collaboration.
      (2) Foreign person
        The term "foreign person" means any citizen or national of a
      foreign state or any entity not organized under the laws of the
      United States, but does not include a foreign state.
      (3) Narcotics trafficking
        The term "narcotics trafficking" means any illicit activity to
      cultivate, produce, manufacture, distribute, sell, finance, or
      transport narcotic drugs, controlled substances, or listed
      chemicals, or otherwise endeavor or attempt to do so, or to
      assist, abet, conspire, or collude with others to do so.
      (4) Narcotic drug; controlled substance; listed chemical
        The terms "narcotic drug", "controlled substance", and "listed
      chemical" have the meanings given those terms in section 802 of
      this title.
      (5) Person
        The term "person" means an individual or entity.
      (6) United States person
        The term "United States person" means any United States citizen
      or national, permanent resident alien, an entity organized under
      the laws of the United States (including its foreign branches),
      or any person within the United States.
      (7) Significant foreign narcotics trafficker
        The term "significant foreign narcotics trafficker" means any
      foreign person that plays a significant role in international
      narcotics trafficking, that the President has determined to be
      appropriate for sanctions pursuant to this chapter, and that the
      President has publicly identified in the report required under
      subsection (b) or (h)(1) of section 1903 of this title.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 808, Dec. 3, 1999, 113 Stat.
    1632.)

-End-



-CITE-
    21 USC Sec. 1908                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING

-HEAD-
    Sec. 1908. Judicial Review Commission on Foreign Asset Control

-STATUTE-
    (a) Establishment
      There is established a commission to be known as the "Judicial
    Review Commission on Foreign Asset Control" (in this section
    referred to as the "Commission").
    (b) Membership and procedural matters
      (1) The Commission shall be composed of five members, as follows:
        (A) One member shall be appointed by the Chairman of the Select
      Committee on Intelligence of the Senate.
        (B) One member shall be appointed by the Vice Chairman of the
      Select Committee on Intelligence of the Senate.
        (C) One member shall be appointed by the Chairman of the
      Permanent Select Committee on Intelligence of the House of
      Representatives.
        (D) One member shall be appointed by the Ranking Minority
      Member of the Permanent Select Committee on Intelligence of the
      House of Representatives.
        (E) One member shall be appointed jointly by the members
      appointed under subparagraphs (A) through (D).

      (2) Each member of the Commission shall, for purposes of the
    activities of the Commission under this section, possess or obtain
    an appropriate security clearance in accordance with applicable
    laws and regulations regarding the handling of classified
    information.
      (3) The members of the Commission shall choose the chairman of
    the Commission from among the members of the Commission.
      (4) The members of the Commission shall establish rules governing
    the procedures and proceedings of the Commission.
    (c) Duties
      The Commission shall have as its duties the following:
        (1) To conduct a review of the current judicial, regulatory,
      and administrative authorities relating to the blocking of assets
      of foreign persons by the United States Government.
        (2) To conduct a detailed examination and evaluation of the
      remedies available to United States persons affected by the
      blocking of assets of foreign persons by the United States
      Government.
    (d) Powers
      (1) The Commission may hold such hearings, sit and act at such
    times and places, take such testimony, and receive such evidence as
    the Commission considers advisable to carry out the purposes of
    this section.
      (2) The Commission may secure directly from any executive
    department, agency, bureau, board, commission, office, independent
    establishment, or instrumentality of the Government information,
    suggestions, estimates, and statistics for the purposes of this
    section. Each such department, agency, bureau, board, commission,
    office, establishment, or instrumentality shall, to the extent
    authorized by law, furnish such information, suggestions,
    estimates, and statistics directly to the Commission, upon request
    of the chairman of the Commission. The Commission shall handle and
    protect all classified information provided to it under this
    section in accordance with applicable statutes and regulations.
      (3) The Attorney General and the Secretary of the Treasury shall
    provide to the Commission, on a nonreimbursable basis, such
    administrative services, funds, facilities, and other support
    services as are necessary for the performance of the Commission's
    duties under this section.
      (4) The Commission shall receive the full and timely cooperation
    of any official, department, or agency of the United States
    Government whose assistance is necessary for the fulfillment of the
    duties of the Commission under this section, including the
    provision of full and current briefings and analyses.
      (5) No department or agency of the Government may withhold
    information from the Commission on the grounds that providing the
    information to the Commission would constitute the unauthorized
    disclosure of classified information or information relating to
    intelligence sources or methods.
      (6) The Commission may use the United States mails in the same
    manner and under the same conditions as the departments and
    agencies of the United States.
    (e) Staff
      (1) Subject to paragraph (2), the chairman of the Commission, in
    accordance with rules agreed upon by the Commission, shall appoint
    and fix the compensation of a staff director and such other
    personnel as may be necessary to enable the Commission to carry out
    its duties, without regard to the provisions of title 5 governing
    appointments in the competitive service, and without regard to the
    provisions of chapter 51 and subchapter III or (!1) chapter 53 of
    such title relating to classification and General Schedule pay
    rates, except that no rate of pay fixed under this subsection may
    exceed the equivalent of that payable to a person occupying a
    position at level V of the Executive Schedule under section 5316 of
    such title.

      (2)(A) Any employee of a department or agency referred to in
    subparagraph (B) may be detailed to the Commission without
    reimbursement from the Commission, and such detailee shall retain
    the rights, status, and privileges of his or her regular employment
    without interruption.
      (B) The departments and agencies referred to in this subparagraph
    are as follows:
        (i) The Department of Justice.
        (ii) The Department of the Treasury.
        (iii) The Central Intelligence Agency.

      (3) All staff of the Commission shall possess a security
    clearance in accordance with applicable laws and regulations
    concerning the handling of classified information.
    (f) Compensation and travel expenses
      (1)(A) Except as provided in subparagraph (B), each member of the
    Commission may be compensated at not to exceed the daily equivalent
    of the annual rate of basic pay in effect for a position at level
    IV of the Executive Schedule under section 5315 of title 5 for each
    day during which that member is engaged in the actual performance
    of the duties of the Commission under this section.
      (B) Members of the Commission who are officers or employees of
    the United States shall receive no additional pay by reason of
    their service on the Commission.
      (2) While away from their homes or regular places of business in
    the performance of services for the Commission, members of the
    Commission may be allowed travel expenses, including per diem in
    lieu of subsistence, in the same manner as persons employed
    intermittently in the Government service are allowed expenses under
    section 5703(b) (!2) of title 5.

    (g) Report
      (1) Not later than 1 year after December 3, 1999, the Commissions
    (!3) shall submit to the committees of Congress referred to in
    paragraph (4) a report on the activities of the Commission under
    this section, including the findings, conclusions, and
    recommendations, if any, of the Commission as a result of the
    review under subsection (c)(1) of this section and the examination
    and evaluation under subsection (c)(2) of this section.

      (2) The report under paragraph (1) shall include any additional
    or dissenting views of a member of the Commission upon the request
    of the member.
      (3) The report under paragraph (1) shall be submitted in
    unclassified form, but may include a classified annex.
      (4) The committees of Congress referred to in this paragraph are
    the following:
        (A) The Select Committee on Intelligence and the Committees on
      Foreign Relations and the Judiciary of the Senate.
        (B) The Permanent Select Committee on Intelligence and the
      Committees on International Relations and the Judiciary of the
      House of Representatives.
    (h) Termination
      The Commission shall terminate at the end of the 60-day period
    beginning on the date on which the report required by subsection
    (g) of this section is submitted to the committees of Congress
    referred to in that subsection.
    (i) Inapplicability of certain administrative provisions
      (1) The provisions of the Federal Advisory Committee Act (5
    U.S.C. App.) shall not apply to the activities of the Commission
    under this section.
      (2) The provisions of section 552 of title 5 (commonly referred
    to as the Freedom of Information Act) shall not apply to the
    activities, records, and proceedings of the Commission under this
    chapter.
    (j) Funding
      The Attorney General shall, from amounts authorized to be
    appropriated to the Attorney General by this Act, make available to
    the Commission $1,000,000 for purposes of the activities of the
    Commission under this section. Amounts made available to the
    Commission under the preceding sentence shall remain available
    until expended.

-SOURCE-
    (Pub. L. 106-120, title VIII, Sec. 810, Dec. 3, 1999, 113 Stat.
    1633.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The provisions of title 5 governing appointments in the
    competitive service, referred to in subsec. (e)(1), are classified
    generally to section 3301 et seq. of Title 5, Government
    Organization and Employees.
      The Federal Advisory Committee Act, referred to in subsec. (i),
    is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is
    set out in the Appendix to Title 5, Government Organization and
    Employees.
      This Act, referred to in subsec. (j), is Pub. L. 106-120, Dec. 3,
    1999, 113 Stat. 1606, known as the Intelligence Authorization Act
    for Fiscal Year 2000. For complete classification of this Act to
    the Code, see Tables.

-FOOTNOTE-
    (!1) So in original. Probably should be "of".

    (!2) So in original. Section 5703 of title 5 does not contain a
         subsec. (b).

    (!3) So in original. Probably should be "Commission".


-End-


-CITE-
    21 USC CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE
           PROVISIONS                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS

-HEAD-
           CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS       


-MISC1-
                     SUBCHAPTER I - ANTI-DOPING AGENCY                 
    Sec.                                                     
    2001.       Designation of United States Anti-Doping Agency.      
    2002.       Records, audit, and report.                           
    2003.       Authorization of appropriations.                      

    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
    2011.       Definitions.                                          
    2012.       Establishment of clearinghouse and advisory council.  
    2013.       NMIC requirements and review.                         
    2014.       Authorization of appropriations.                      

-End-


-CITE-
    21 USC SUBCHAPTER I - ANTI-DOPING AGENCY                    01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER I - ANTI-DOPING AGENCY

-HEAD-
                     SUBCHAPTER I - ANTI-DOPING AGENCY                 

-End-



-CITE-
    21 USC Sec. 2001                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER I - ANTI-DOPING AGENCY

-HEAD-
    Sec. 2001. Designation of United States Anti-Doping Agency

-STATUTE-
    (a) Definitions
      In this subchapter:
      (1) United States Olympic Committee
        The term "United States Olympic Committee" means the
      organization established by the "Ted Stevens Olympic and Amateur
      Sports Act" (36 U.S.C. 220501 et seq.).
      (2) Amateur athletic competition
        The term "amateur athletic competition" means a contest, game,
      meet, match, tournament, regatta, or other event in which amateur
      athletes compete (36 U.S.C. 220501(b)(2)).
      (3) Amateur athlete
        The term "amateur athlete" means an athlete who meets the
      eligibility standards established by the national governing body
      or paralympic sports organization for the sport in which the
      athlete competes (36 U.S.C. 22501(b)(1)).(!1)

      (4) Gene doping
        The term "gene doping" means the nontherapeutic use of cells,
      genes, genetic elements, or of the modulation of gene expression,
      having the capacity to enhance athletic performance.
    (b) In general
      The United States Anti-Doping Agency shall - 
        (1) serve as the independent anti-doping organization for the
      amateur athletic competitions recognized by the United States
      Olympic Committee;
        (2) ensure that athletes participating in amateur athletic
      activities recognized by the United States Olympic Committee are
      prevented from using performance-enhancing drugs, or performance-
      enhancing genetic modifications accomplished through gene-
      doping;
        (3) implement anti-doping education, research, testing, and
      adjudication programs to prevent United States Amateur Athletes
      participating in any activity recognized by the United States
      Olympic Committee from using performance-enhancing drugs, or
      performance-enhancing genetic modifications accomplished through
      gene-doping;
        (4) serve as the United States representative responsible for
      coordination with other anti-doping organizations coordinating
      amateur athletic competitions recognized by the United States
      Olympic Committee to ensure the integrity of athletic
      competition, the health of the athletes and the prevention of use
      of performance-enhancing drugs, or performance-enhancing genetic
      modifications accomplished through gene-doping by United States
      amateur athletes; and
        (5) permanently include "gene doping" among any list of
      prohibited substances adopted by the Agency.

-SOURCE-
    (Pub. L. 109-469, title VII, Sec. 701, Dec. 29, 2006, 120 Stat.
    3533.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Ted Stevens Olympic and Amateur Sports Act, referred to in
    subsec. (a)(1), is chapter 2205 of Title 36, Patriotic and National
    Observances, Ceremonies, and Organizations.


-MISC1-
                                SHORT TITLE                            
      Pub. L. 109-469, title X, Sec. 1001, Dec. 29, 2006, 120 Stat.
    3537, provided that: "This title [enacting subchapter II of this
    chapter] may be cited as the 'National Methamphetamine Information
    Clearinghouse Act of 2006'."

-FOOTNOTE-               

    (!1) So in original. Probably should be "220501(b)(1))."


-End-



-CITE-
    21 USC Sec. 2002                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER I - ANTI-DOPING AGENCY

-HEAD-
    Sec. 2002. Records, audit, and report

-STATUTE-
    (a) Records
      The United States Anti-Doping Agency shall keep correct and
    complete records of account.
    (b) Report
      The United States Anti-Doping Agency shall submit an annual
    report to Congress which shall include - 
        (1) an audit conducted and submitted in accordance with section
      10101 of title 36; and
        (2) a description of the activities of the agency.

-SOURCE-
    (Pub. L. 109-469, title VII, Sec. 702, Dec. 29, 2006, 120 Stat.
    3534.)

-End-



-CITE-
    21 USC Sec. 2003                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER I - ANTI-DOPING AGENCY

-HEAD-
    Sec. 2003. Authorization of appropriations

-STATUTE-
      There are authorized to be appropriated to the United States Anti-
    Doping Agency - 
        (1) for fiscal year 2007, $9,700,000;
        (2) for fiscal year 2008, $10,300,000;
        (3) for fiscal year 2009, $10,600,000;
        (4) for fiscal year 2010, $11,000,000; and
        (5) for fiscal year 2011, $11,500,000.

-SOURCE-
    (Pub. L. 109-469, title VII, Sec. 703, Dec. 29, 2006, 120 Stat.
    3534.)

-End-


-CITE-
    21 USC SUBCHAPTER II - NATIONAL METHAMPHETAMINE
           INFORMATION CLEARINGHOUSE                       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

-HEAD-
    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

-End-



-CITE-
    21 USC Sec. 2011                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

-HEAD-
    Sec. 2011. Definitions

-STATUTE-
      In this subchapter - 
        (1) the term "Council" means the National Methamphetamine
      Advisory Council established under section 2012(b)(1) of this
      title;
        (2) the term "drug endangered children" means children whose
      physical, mental, or emotional health are at risk because of the
      production, use, or other effects of methamphetamine production
      or use by another person;
        (3) the term "National Methamphetamine Information
      Clearinghouse" or "NMIC" means the information clearinghouse
      established under section 2012(a) of this title; and
        (4) the term "qualified entity" means a State, local, or tribal
      government, school board, or public health, law enforcement,
      nonprofit, community anti-drug coalition, or other
      nongovernmental organization providing services related to
      methamphetamines.

-SOURCE-
    (Pub. L. 109-469, title X, Sec. 1002, Dec. 29, 2006, 120 Stat.
    3537.)

-End-



-CITE-
    21 USC Sec. 2012                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

-HEAD-
    Sec. 2012. Establishment of clearinghouse and advisory council

-STATUTE-
    (a) Clearinghouse
      There is established, under the supervision of the Attorney
    General of the United States, an information clearinghouse to be
    known as the National Methamphetamine Information Clearinghouse.
    (b) Advisory council
      (1) In general
        There is established an advisory council to be known as the
      National Methamphetamine Advisory Council.
      (2) Membership
        The Council shall consist of 10 members appointed by the
      Attorney General - 
          (A) not fewer than 3 of whom shall be representatives of law
        enforcement agencies;
          (B) not fewer than 4 of whom shall be representatives of
        nongovernmental and nonprofit organizations providing services
        or training and implementing programs or strategies related to
        methamphetamines; and
          (C) 1 of whom shall be a representative of the Department of
        Health and Human Services.
      (3) Period of appointment; vacancies
        Members shall be appointed for 3 years. Any vacancy in the
      Council shall not affect its powers, but shall be filled in the
      same manner as the original appointment.
      (4) Personnel matters
        (A) Travel expenses
          The members of the Council shall be allowed travel expenses,
        including per diem in lieu of subsistence, at rates authorized
        for employees of agencies under subchapter I of chapter 57 of
        title 5, while away from their homes or regular places of
        business in the performance of services for the Council.
        (B) No compensation
          The members of the Council shall not receive compensation for
        the performance of the duties of a member of the Council.

-SOURCE-
    (Pub. L. 109-469, title X, Sec. 1003, Dec. 29, 2006, 120 Stat.
    3538.)

-End-



-CITE-
    21 USC Sec. 2013                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

-HEAD-
    Sec. 2013. NMIC requirements and review

-STATUTE-
    (a) In general
      The NMIC shall promote sharing information regarding successful
    law enforcement, treatment, environmental, prevention, social
    services, and other programs related to the production, use, or
    effects of methamphetamine and grants available for such programs.
    (b) Components
      The NMIC shall include - 
        (1) a toll-free number; and
        (2) a website that provides a searchable database, which - 
          (A) provides information on the short-term and long-term
        effects of methamphetamine use;
          (B) provides information regarding methamphetamine treatment
        and prevention programs and strategies and programs for drug
        endangered children, including descriptions of successful
        programs and strategies and contact information for such
        programs and strategies;
          (C) provides information regarding grants for methamphetamine-
        related programs, including contact information and links to
        websites;
          (D) allows a qualified entity to submit items to be posted on
        the website regarding successful public or private programs or
        other useful information related to the production, use, or
        effects of methamphetamine;
          (E) includes a restricted section that may only be accessed
        by a law enforcement organization that contains successful
        strategies, training techniques, and other information that the
        Council determines helpful to law enforcement agency efforts to
        identify or combat the production, use, or effects of
        methamphetamine;
          (F) allows public access to all information not in a
        restricted section; and
          (G) contains any additional information the Council
        determines may be useful in identifying or combating the
        production, use, or effects of methamphetamine.

    Thirty days after the website in paragraph (2) is operational, no
    funds shall be expended to continue the website methresources.gov.
    (c) Review of posted information
      (1) In general
        Not later than 30 days after the date of submission of an item
      by a qualified entity, the Council shall review an item submitted
      for posting on the website described in subsection (b)(2) - 
          (A) to evaluate and determine whether the item, as submitted
        or as modified, meets the requirements for posting; and
          (B) in consultation with the Attorney General, to determine
        whether the item should be posted in a restricted section of
        the website.
      (2) Determination
        Not later than 45 days after the date of submission of an item,
      the Council shall - 
          (A) post the item on the website described in subsection
        (b)(2); or
          (B) notify the qualified entity that submitted the item
        regarding the reason such item shall not be posted and
        modifications, if any, that the qualified entity may make to
        allow the item to be posted.

-SOURCE-
    (Pub. L. 109-469, title X, Sec. 1004, Dec. 29, 2006, 120 Stat.
    3538.)

-End-



-CITE-
    21 USC Sec. 2014                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
    SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE

-HEAD-
    Sec. 2014. Authorization of appropriations

-STATUTE-
      There are authorized to be appropriated - 
        (1) for fiscal year 2007 - 
          (A) $500,000 to establish the NMIC and Council; and
          (B) such sums as are necessary for the operation of the NMIC
        and Council; and

        (2) for each of fiscal years 2008 and 2009, such sums as are
      necessary for the operation of the NMIC and Council.

-SOURCE-
    (Pub. L. 109-469, title X, Sec. 1005, Dec. 29, 2006, 120 Stat.
    3539.)

-End-