21 U.S.C. § 959 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 959: Possession, manufacture, or distribution of controlled substance
Possession, manufacture, or distribution of controlled substance
Status: in_force

(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 a listed chemical intending, knowing, or having reasonable cause to believe 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) Manufacture or distribution of listed chemical for purpose of manufacture or unlawful importation of controlled substance

It shall be unlawful for any person to manufacture or distribute a listed chemical—

(1) intending or knowing that the listed chemical will be used to manufacture a controlled substance; and

(2) intending, knowing, or having reasonable cause to believe that the controlled substance will be unlawfully imported into the United States.

(c) 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.

(d) Acts committed outside territorial jurisdiction of United States

This section is intended to reach acts of manufacture or distribution committed outside the territorial jurisdiction of the United States.

(Pub. L. 91–513, title III, §1009, Oct. 27, 1970, 84 Stat. 1289; Pub. L. 99–570, title III, §3161(a), Oct. 27, 1986, 100 Stat. 3207–94; Pub. L. 104–237, title I, §102(a), (b), Oct. 3, 1996, 110 Stat. 3100; Pub. L. 104–305, §2(b)(2)(A), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 114–154, §2, May 16, 2016, 130 Stat. 387; Pub. L. 115–91, div. A, title X, §1012(b), Dec. 12, 2017, 131 Stat. 1546.)

Editorial Notes

References in Text

Schedules I and II, referred to in subsec. (a), are set out in section 812(c) of this title.

Amendments

2017—Subsec. (d). Pub. L. 115–91 struck out "; venue" after "United States" in heading and "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." after "United States." in text.

2016—Subsec. (a). Pub. L. 114–154, §2(2), substituted "It shall be unlawful for any person to manufacture or distribute a controlled substance in schedule I or II or flunitrazepam or a listed chemical intending, knowing, or having reasonable cause to believe 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." for "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."

Subsecs. (b) to (d). Pub. L. 114–154 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

1996—Subsec. (a). Pub. L. 104–305 inserted "or flunitrazepam" after "schedule I or II" in introductory provisions.

Pub. L. 104–237, §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, §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).

Statutory Notes and Related Subsidiaries

Effective Date

Section 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 a under section 951 of this title.
21 U.S.C. § 379r (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379r: National uniformity for nonprescription drugs
National uniformity for nonprescription drugs
Status: in_force

(a) In general

Except as provided in subsection (b), (c)(1), (d), (e), or (f), 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), 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), 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) 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 order under section 355h of this title by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) 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 or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); 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.

(June 25, 1938, ch. 675, §751, as added Pub. L. 105–115, title IV, §412(a), Nov. 21, 1997, 111 Stat. 2373; amended Pub. L. 116–136, div. A, title III, §3851(c), Mar. 27, 2020, 134 Stat. 454.)

Editorial Notes

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, which is classified principally to chapter 39A (§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, which is classified generally to chapter 39 (§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.

Amendments

2020—Subsec. (d)(1). Pub. L. 116–136, §3851(c)(1), in introductory provisions, substituted "final order under section 355h of this title" for "final regulation promulgated" and struck out "and not misbranded" after "safe and effective".

Subsec. (d)(1)(A). Pub. L. 116–136, §3851(c)(2), substituted "regulation or order in effect" for "regulation in effect".

Statutory Notes and Related Subsidiaries

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.
21 U.S.C. § 694 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter V: MISCELLANEOUS PROVISIONS / Section 694: Authorization of appropriations
Authorization of appropriations
Status: in_force

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.

(June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756, §2, 48 Stat. 1225.)

Editorial Notes

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.

Codification

Act June 26, 1934, ch. 756, §2(a), 48 Stat. 1225, which was classified to section 725a of former Title 31, Money and Finance, provided for the repeal, effective July 1, 1935, of the permanent appropriations under the appropriations titles listed in section 2(b) of such Act, and further provided that such portions of any Acts as made permanent appropriations to be expended under such accounts were 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 were provided by the laws providing such permanent appropriations. The text of section 2(b)(3) of such Act provides as follows: "Meat inspection, Bureau of Animal Industry (fiscal year) (3–114)." Section 2(a) of such Act also authorized to be appropriated such other sums as necessary in the enforcement of the meat inspection laws. See 1934 Amendment note below.

Section was not enacted as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Section was formerly classified to section 95 of this title.

Amendments

1934—Act June 26, 1934, substituted "Annual appropriations of the sum of $3,000,000 from the general fund of the Treasury are authorized" for "There is permanently appropriated, out of any money in the Treasury not otherwise appropriated, the sum of $3,000,000," and inserted before period at end ", and in addition there is authorized to be appropriated such other sums as may be necessary in the enforcement of the meat inspection laws".

Statutory Notes and Related Subsidiaries

Effective Date of 1934 Amendment

Act June 26, 1934, ch. 756, §2(a), 48 Stat. 1225, provided that the permanent appropriations under the appropriations titles listed in section 2(b) of such Act were repealed, effective July 1, 1935.
21 U.S.C. § 321 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter II: DEFINITIONS / Section 321: Definitions; generally
Definitions; generally
Status: in_force

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,1 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)(1) 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—

(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B) 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

(C) 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. The term "device" does not include software functions excluded pursuant to section 360j(o) of this title.

(2) The term "counterfeit device" means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.

(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) 2 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.3

Except for purposes of paragraph (g) and section 350f of this title, 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, soybeans, and sesame.

(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.

(rr)(1) The term "tobacco product" means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

(2) The term "tobacco product" does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353(g) of this title.

(3) The products described in paragraph (2) shall be subject to subchapter V of this chapter.

(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this chapter (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).

(5) The term "tobacco product" does not mean an article that is a food under paragraph (f), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.

(ss) The term "critical food" means a food that is—

(1) an infant formula; or

(2) a medical food, as defined in section 360ee(b)(3) of this title.

(June 25, 1938, ch. 675, §201, 52 Stat. 1040; July 22, 1954, ch. 559, §1, 68 Stat. 511; Pub. L. 85–929, §2, Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–618, title I, §101, July 12, 1960, 74 Stat. 397; Pub. L. 87–781, title I, §102(a), title III, §307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89–74, §§3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90–399, §102, July 13, 1968, 82 Stat. 351; Pub. L. 90–639, §§1, 4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91–513, title II, §701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92–516, §3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94–278, title V, §502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94–295, §3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95–203, §4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96–359, §3, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100–670, title I, §107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101–535, §5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101–629, §16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–282, §6, May 13, 1992, 106 Stat. 161; Pub. L. 102–300, §6(a), (b), June 16, 1992, 106 Stat. 240; Pub. L. 102–571, title I, §107(1), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§3(b), (dd)(1), 4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103–417, §§3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104–170, title IV, §402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105–115, title I, §§121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111 Stat. 2320, 2325, 2327; Pub. L. 105–324, §2(a), (c), Oct. 30, 1998, 112 Stat. 3035, 3037; Pub. L. 107–109, §5(b)(1), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–250, title III, §302(d), Oct. 26, 2002, 116 Stat. 1619; Pub. L. 108–282, title I, §102(b)(1), (5)(A), (B), title II, §203(c)(1), Aug. 2, 2004, 118 Stat. 891, 902, 908; Pub. L. 110–85, title X, §1005(c), Sept. 27, 2007, 121 Stat. 968; Pub. L. 111–31, div. A, title I, §101(a), June 22, 2009, 123 Stat. 1783; Pub. L. 114–255, div. A, title III, §3060(d), Dec. 13, 2016, 130 Stat. 1133; Pub. L. 116–304, §2(b), Jan. 5, 2021, 134 Stat. 4916; Pub. L. 117–11, §2(a), Apr. 23, 2021, 135 Stat. 262; Pub. L. 117–103, div. P, title I, §111(a), Mar. 15, 2022, 136 Stat. 789; Pub. L. 117–328, div. FF, title III, §3401(a)(2), Dec. 29, 2022, 136 Stat. 5838.)

Editorial Notes

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, which was classified to subchapter I (§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, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, 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 (§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, which is classified generally to chapter 10 (§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 (§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.

Amendments

2022—Par. (rr)(1). Pub. L. 117–103, §111(a)(1), inserted ", or containing nicotine from any source," after "from tobacco".

Par. (rr)(5). Pub. L. 117–103, §111(a)(2), added subpar. (5).

Par. (ss). Pub. L. 117–328 added par. (ss).

2021—Par. (h). Pub. L. 116–304 redesignated introductory provisions as subpar. (1) and former subpars. (1) to (3) as cls. (A) to (C), respectively, of subpar. (1) and added subpar. (2).

Par. (qq)(1). Pub. L. 117–11 substituted "soybeans, and sesame" for "and soybeans".

2016—Par. (h). Pub. L. 114–255 inserted at end of concluding provisions "The term 'device' does not include software functions excluded pursuant to section 360j(o) of this title."

2009—Par. (rr). Pub. L. 111–31 added par. (rr).

2007—Par. (ff). Pub. L. 110–85 substituted "paragraph (g) and section 350f of this title" for "paragraph (g)" in concluding provisions.

2004–Par. (u). Pub. L. 108–282, §102(b)(5)(A), substituted "360b, 360ccc" for "360b".

Par. (v). Pub. L. 108–282, §102(b)(5)(B), inserted concluding provisions.

Pars. (nn) to (pp). Pub. L. 108–282, §102(b)(1), added pars. (nn) to (pp).

Par. (qq). Pub. L. 108–282, §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, §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, §2(c), substituted "subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in introductory provisions.

1997—Par. (aa). Pub. L. 105–115, §125(b)(2)(A), struck out "or 357" after "section 355(j)".

Par. (dd). Pub. L. 105–115, §125(b)(2)(A), struck out "357," after "section 355,".

Par. (ff)(3)(A). Pub. L. 105–115, §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, §121(a), added par. (ii).

Par. (jj). Pub. L. 105–115, §125(e), added par. (jj).

1996—Par. (q). Pub. L. 104–170, §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, §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, §402(c), added pars. (gg) and (hh).

1994—Par. (g)(1). Pub. L. 103–417, §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, §3(b), added subpar. (6).

Par. (ff). Pub. L. 103–417, §3(a), added par. (ff).

1993—Pars. (c), (d). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture".

Par. (h). Pub. L. 103–80, §4(b), amended directory language of Pub. L. 102–300, §6(a)(1). See 1992 amendment note below.

Pars. (v) to (ff). Pub. L. 103–80, §3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively.

1992—Pars. (c), (d). Pub. L. 102–300, §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, §6(a)(1), as amended by Pub. L. 103–80, §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, §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, §6(a)(2), added par. (ff).

1990—Par. (g)(1). Pub. L. 101–629, §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, §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, §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, §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, §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, §701(a), struck out par. (v) which defined "depressant or stimulant drug".

1968—Par. (a)(2). Pub. L. 90–639, §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, §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, §102(c), added subpar. (5).

Par. (u). Pub. L. 90–399, §102(d), inserted reference to section 360b of this title.

Par. (v)(3). Pub. L. 90–639, §1, inserted reference to lysergic acid diethylamide.

Pars. (w), (x). Pub. L. 90–399, §102(e), added pars. (w) and (x).

1965—Par. (g). Pub. L. 89–74, §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, §3(a), added par. (v).

1962—Par. (a). Pub. L. 87–781, §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, §102(a)(1), inserted "and effectiveness" after "to evaluate the safety", and "and effective" after "as safe".

Par. (p)(2). Pub. L. 87–781, §102(a)(2), inserted "and effectiveness" after "safety".

1960—Par. (s). Pub. L. 86–618, §101(a), excluded color additives from definition of "food additive".

Par. (t). Pub. L. 86–618, §101(c), added par. (t). Former par. (t) redesignated (u).

Par. (u). Pub. L. 86–618, §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).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–103, div. P, title I, §111(c), Mar. 15, 2022, 136 Stat. 789, provided that: "The amendments made by subsections (a) and (b) [amending this section and section 387a of this title] shall take effect 30 days after the date of enactment of this Act [Mar. 15, 2022]."

Effective Date of 2021 Amendment

Pub. L. 117–11, §2(b), Apr. 23, 2021, 135 Stat. 262, provided that: "The amendment made by subsection (a) [amending this section] shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023."

Effective Date of 2004 Amendment

Pub. L. 108–282, title II, §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

Pub. L. 105–115, title V, §501, Nov. 21, 1997, 111 Stat. 2380, 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

Pub. L. 90–639, §6, Oct. 24, 1968, 82 Stat. 1362, 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

Pub. L. 89–74, §11, July 15, 1965, 79 Stat. 235, 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

Pub. L. 87–781, title I, §107, Oct. 10, 1962, 76 Stat. 788, 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

Pub. L. 91–513, title II, §702, Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 93–481, §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."

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, §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.

Regulation of Tobacco

Pub. L. 117–103, div. P, title I, §111(e), Mar. 15, 2022, 136 Stat. 790, provided that: "Effective 30 days after the date of enactment of this Act [Mar. 15, 2022], with respect to any regulation promulgated or related guidance issued, in whole or part, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) before the date that is 30 days after such date of enactment, the term 'tobacco product' shall have the meaning of, and shall be deemed amended to reflect the meaning of, such term as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)), as amended by subsection (a). Products that are tobacco products under such section 201(rr), as so amended, shall be subject to all requirements of regulations for tobacco products. The Secretary of Health and Human Services shall publish a notice in the Federal Register to update the Code of Federal Regulations to reflect such deemed amendment to existing regulations and guidance."

Pub. L. 105–115, title IV, §422, Nov. 21, 1997, 111 Stat. 2380, 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

Pub. L. 103–417, §2, Oct. 25, 1994, 108 Stat. 4325, 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

Pub. L. 90–639, §5, Oct. 24, 1968, 82 Stat. 1362, 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

Pub. L. 89–74, §2, July 15, 1965, 79 Stat. 226, 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

Pub. L. 89–74, §10, July 15, 1965, 79 Stat. 235, 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

Pub. L. 87–781, title II, §202, Oct. 10, 1962, 76 Stat. 793, 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."

Definitions

Pub. L. 105–115, §2, Nov. 21, 1997, 111 Stat. 2297, 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)."

Executive Documents

Transfer of Functions

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.

1 So in original. Probably should be "Pharmacopeia,".

2 So in original. Probably should be paragraph "(v)".

3 So in original. Provision probably should be set flush with subpar. (B).
21 U.S.C. § 1703 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1703: Appointment and duties of Director and Deputy Directors
Appointment and duties of Director and Deputy Directors
Status: in_force

(a) Appointment

(1) In general

(A) Director

(i) In general

There shall be at the head of the Office a Director who shall hold the same rank and status as the head of an executive department listed in section 101 of title 5.

(ii) Appointment

The Director shall be appointed by the President, by and with the advice and consent of the Senate, and shall serve at the pleasure of the President.

(B) Deputy Director

There shall be a Deputy Director who shall report directly to the Director, and who shall be appointed by the President, and shall serve at the pleasure of the President.

(C) Coordinators

The following coordinators shall be appointed by the Director:

(i) Performance Budget Coordinator, as described in subsection (c)(5).

(ii) Interdiction Coordinator, as described in section 1710 of this title.

(iii) Emerging and Continuing Threats Coordinator, as described in section 1708 of this title.

(iv) State, Local, and Tribal Affairs Coordinator, to carry out the activities described in subsection (j).

(v) Demand Reduction Coordinator, as described in subparagraph (D).

(D) Demand Reduction Coordinator

The Director shall designate or appoint a United States Demand Reduction Coordinator to be responsible for the activities described in section 1701(3) of this title. For purposes of carrying out the previous sentence, the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(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 officer or employee is not prohibited by this paragraph from making contributions to individual candidates.

(6) Prohibition on the use of funds for ballot initiatives

No funds authorized under this chapter may be obligated for the purpose of expressly advocating the passage or defeat of a State or local ballot initiative.

(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) 1 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) Repealed. Pub. L. 115–271, title VIII, §8221(b)(1)(A), Oct. 24, 2018, 132 Stat. 4142.

(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 section 1705(g)(2) of this title; 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) 2 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) Repealed. Pub. L. 115–271, title VIII, §8221(b)(1)(A), Oct. 24, 2018, 132 Stat. 4142.

(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;

(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; and

(21) in order to formulate the national drug control policies, goals, objectives, and priorities—

(A) shall consult with and assist—

(i) State and local governments;

(ii) National Drug Control Program agencies;

(iii) each committee, working group, council, or other entity established under this chapter, as appropriate;

(iv) the public;

(v) appropriate congressional committees; and

(vi) any other person in the discretion of the Director; and

(B) may—

(i) establish advisory councils;

(ii) acquire data from agencies; and

(iii) request data from any other entity.

(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) and include—

(i) the funding level for each National Drug Control Program agency; and

(ii) alternative funding structures that could improve progress on achieving the goals of the National Drug Control Strategy; and

(B) submit the consolidated budget proposal to the President and 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 requests a level of funding that will not enable achievement of the goals of the National Drug Control Strategy, including—

(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 substance use disorder prevention and treatment activities that do not provide adequate results and accountability measures; and

(iv) requests funding for drug treatment activities that do not adequately support and enhance Federal drug treatment programs and capacity.

(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 shall—

(I) review each budget submission submitted under clause (i);

(II) based on the review under subclause (I), make a determination as to whether the budget submission of a National Drug Control Program agency includes the funding levels and initiatives described in subparagraph (B); and

(III) submit to the appropriate congressional committees—

(aa) a written statement that either—

(AA) certifies that the budget submission includes sufficient funding; or

(BB) decertifies the budget submission as not including sufficient funding;

(bb) a copy of the description made under subparagraph (B); and

(cc) the budget recommendations made under subsection (b)(8).

(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 $5,000,000 or 10 percent of a specific program or account 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.

(5) Performance-Budget Coordinator

(A) Designation

The Director shall designate or appoint a United States Performance-Budget Coordinator to—

(i) ensure the Director has sufficient information necessary to analyze the performance of each National Drug Control Program agency, the impact Federal funding has had on the goals in the Strategy, and the likely contributions to the goals of the Strategy based on funding levels of each National Drug Control Program agency, to make an independent assessment of the budget request of each agency under this subsection;

(ii) advise the Director on agency budgets, performance measures and targets, and additional data and research needed to make informed policy decisions under this section and section 1705 of this title; and

(iii) other duties as may be determined by the Director with respect to measuring or assessing performance or agency budgets.

(B) Determination of position

For purposes of carrying out subparagraph (A), the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(6) Budget estimate or request submission to Congress

Whenever the Director submits any budget estimate or request to the President or the Office of Management and Budget, the Director shall concurrently transmit to the appropriate congressional committees a detailed statement of the budgetary needs of the Office to execute its mission based on the good-faith assessment of the Director.

(d) Powers of the Director

In carrying out subsection (b), 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), 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;

(E) the Director shall—

(i) submit to the appropriate congressional committees 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; and

(ii) annually submit to the appropriate congressional committees a report describing the effect of all transfers of funds made pursuant to this paragraph or subsection (c)(4) during the 12-month period preceding the date on which the report is submitted; and

(F) funds may only be used for—

(i) expansion of demand reduction activities;

(ii) interdiction of illicit drugs on the high seas, in United States territorial waters, and at United States ports of entry by officers and employees of National Drug Control Program agencies and domestic and foreign law enforcement officers;

(iii) accurate assessment and monitoring of international drug production and interdiction programs and policies;

(iv) activities to facilitate and enhance the sharing of domestic and foreign intelligence information among National Drug Control Program agencies related to the production and trafficking of drugs in the United States and foreign countries; and

(v) research related to any of these activities;

(9) issue to the head of a National Drug Control Program agency a fund control notice described in subsection (f) 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); and

(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

Subject to the availability of appropriations, 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) 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) Congressional notice

A copy of each fund control notice shall be transmitted to the appropriate congressional committees.

(5) 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. 3001 et seq.], the Central Intelligence Agency Act of 1949 [50 U.S.C. 3501 et seq.], or any other law.

(i) Model acts program

(1) In general

The Director shall provide for or shall enter into an agreement with a nonprofit organization to—

(A) advise States on establishing laws and policies to address illicit drug use issues; and

(B) revise such model State drug laws and draft supplementary model State laws to take into consideration changes in illicit drug use issues in the State involved.

(2) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $1,250,000 for each of fiscal years 2018 through 2023.

(j) State, Local, and Tribal Affairs Coordinator

The Director shall designate or appoint a United States State, Local, and Tribal Affairs Coordinator to perform the duties of the Office outlined in this section and section 1705 of this title and such other duties as may be determined by the Director with respect to coordination of drug control efforts between agencies and State, local, and Tribal governments. For purposes of carrying out the previous sentence, the Director shall designate or appoint an appointee in the Senior Executive Service or an appointee in a position at level 15 of the General Schedule (or equivalent).

(k) Harm reduction programs

When developing the national drug control policy, any policy of the Director, including policies relating to syringe exchange programs for intravenous drug users, shall be based on the best available medical and scientific evidence regarding the effectiveness of such policy in promoting individual health and preventing the spread of infectious disease and the impact of such policy on drug addiction and use. In making any policy relating to harm reduction programs, the Director shall consult with the National Institutes of Health and the National Academy of Sciences.

(Pub. L. 105–277, div. C, title VII, §§704, 715, Oct. 21, 1998, 112 Stat. 2681–672, 2681–693; Pub. L. 109–469, title I, §§103(a)–(e), (f)(3), 105, title VI, §602, Dec. 29, 2006, 120 Stat. 3506, 3507, 3510, 3511, 3533; Pub. L. 112–166, §2(t), Aug. 10, 2012, 126 Stat. 1288; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8217(c)–(f), 8221(b)(1), 8222(2), Oct. 24, 2018, 132 Stat. 4110, 4120–4122, 4142; Pub. L. 116–74, §2(a)(1), (2), (5), Nov. 27, 2019, 133 Stat. 1155.)

Editorial Notes

References in Text

Section 1705 of this title, referred to in subsec. (b)(2), (14)(B), was amended by Pub. L. 115–271, title VIII, §8221(a), Oct. 24, 2018, 132 Stat. 4134. Subsec. (b) of section 1705 no longer relates to reports for National Drug Control Program Agencies, but similar provisions can be found elsewhere in that section. Subsec. (c) of section 1705 was redesignated (h).

This chapter, referred to in subsec. (b)(21)(A)(iii), was in the original a reference to "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.

The General Schedule, referred to in subsecs. (c)(5)(B) and (j), is set out under section 5332 of Title 5, Government Organization and Employees.

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, which was formerly classified principally to chapter 15 (§401 et seq.) of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified principally to chapter 44 (§3001 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

The Central Intelligence Agency Act of 1949, referred to in subsec. (h), is act June 20, 1949, ch. 227, 63 Stat. 208, which was formerly classified generally to section 403a et seq. of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified generally to chapter 46 (§3501 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

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, §4(b), Sept. 13, 1982, 96 Stat. 1067, the first section of which enacted Title 31, Money and Finance.

Amendments

2019—Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies" wherever appearing.

Subsec. (a)(1)(C)(i). Pub. L. 116–74, §2(a)(5)(A)(i)(I), substituted "subsection (c)(5)" for "subsection (c)(4)".

Subsec. (a)(1)(C)(iv). Pub. L. 116–74, §2(a)(5)(A)(i)(II), made technical amendment to reference in original act which appears in text as reference to subsection (j).

Subsec. (a)(1)(D). Pub. L. 116–74, §2(a)(5)(A)(ii), substituted "For purposes of carrying out the previous sentence, the Director shall designate or appoint an" for "The Director shall determine whether the coordinator position is a noncareer" and "or an appointee" for "or a career appointee".

Subsec. (b)(21)(A)(iii). Pub. L. 116–74, §2(a)(5)(B), made technical amendment to reference in original act which appears in text as reference to this chapter.

Subsec. (c)(2)(A)(ii). Pub. L. 116–74, §2(a)(5)(C)(i), substituted "of" for "fo".

Subsec. (c)(3)(E)(ii)(I). Pub. L. 116–74, §2(a)(5)(C)(ii)(I), substituted "clause (i)" for "subparagraph (A)".

Subsec. (c)(3)(E)(ii)(II). Pub. L. 116–74, §2(a)(5)(C)(ii)(II), substituted "subclause (I)" for "clause (i)".

Subsec. (c)(5)(A)(i). Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" in two places.

Subsec. (c)(5)(B). Pub. L. 116–74, §2(a)(5)(C)(iii), substituted "For purposes of carrying out subparagraph (A), the Director shall designate or appoint an" for 'The Director shall determine whether the coordinator position is a noncareer".

Subsec. (d)(8)(F). Pub. L. 116–74, §2(a)(5)(D)(i), redesignated subpar. (E)(iii) as subpar. (F), redesignated subcls. (I) to (V) of former subpar. (E)(iii) as cls. (i) to (v) of subpar. (F), respectively, realigned margins, and substituted "activities;" for "activities." in cl. (v).

Subsec. (d)(9). Pub. L. 116–74, §2(a)(5)(D)(ii), made technical amendment to reference in original act which appears in text as reference to subsection (f)(5), and inserted "and" at end.

Subsec. (j). Pub. L. 116–74, §2(a)(5)(E), substituted "For purposes of carrying out the previous sentence, the Director shall designate or appoint an" for "The Director shall determine whether the coordinator position is a noncareer" and "or an appointee" for "or a career appointee", and inserted "section" before "1705".

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (a)(1). Pub. L. 115–271, §8217(c)(1), added subpars. (A) to (D) and struck out former subpars. (A) to (C) which related to appointment of Director, Deputy Directors, and Deputy Director for Demand Reduction, respectively.

Subsec. (a)(5). Pub. L. 115–271, §8217(c)(2), substituted "such officer or employee" for "such official".

Subsec. (a)(6). Pub. L. 115–271, §8217(c)(3), added par. (6).

Subsec. (b)(13). Pub. L. 115–271, §8221(b)(1)(A), struck out par. (13) which required each National Drug Control Program agency to submit annual progress reports.

Subsec. (b)(14)(A). Pub. L. 115–271, §8221(b)(1)(B), substituted "section 1705(g)(2) of this title" for "paragraph (13)".

Subsec. (b)(17). Pub. L. 115–271, §8221(b)(1)(A), struck out par. (17) which read as follows: "shall seek the support and commitment of State, local, and tribal officials in the formulation and implementation of the National Drug Control Strategy;".

Subsec. (b)(21). Pub. L. 115–271, §8217(d), added par. (21).

Subsec. (c)(2)(A). Pub. L. 115–271, §8217(e)(1)(A), substituted "paragraph (1)(C) and include—" for "paragraph (1)(C);" and added cls. (i) and (ii).

Subsec. (c)(2)(B). Pub. L. 115–271, §8217(e)(1)(B), substituted "the President and Congress." for "the President; and".

Subsec. (c)(2)(C). Pub. L. 115–271, §8217(e)(1)(C), struck out subpar. (C) which read as follows: "after submission under subparagraph (B), submit the consolidated budget proposal to Congress."

Subsec. (c)(3)(C). Pub. L. 115–271, §8222(2)(A)(i)(I), inserted "requests a level of funding that will not enable achievement of the goals of the National Drug Control Strategy, including" after "request that" in introductory provisions.

Subsec. (c)(3)(C)(iii). Pub. L. 115–271, §8222(2)(A)(i)(II), substituted "substance use disorder prevention and treatment" for "drug treatment" and "; and" for semicolon at end.

Subsec. (c)(3)(C)(iv), (v). Pub. L. 115–271, §8222(2)(A)(i)(III)–(V), redesignated cl. (v) as (iv), substituted period for semicolon at end, and struck out former cl. (iv) which read as follows: "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;".

Subsec. (c)(3)(C)(vi), (vii). Pub. L. 115–271, §8222(2)(A)(i)(III), struck out cls. (vi) and (vii) which read as follows:

"(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) 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."

Subsec. (c)(3)(E)(ii). Pub. L. 115–271, §8217(e)(2), added cl. (ii) and struck out former cl. (ii) which related to certification by Director of National Drug Control Program agency budget submissions.

Subsec. (c)(4)(A). Pub. L. 115–271, §8222(2)(A)(ii), substituted "$5,000,000 or 10 percent of a specific program or account" for "$1,000,000".

Subsec. (c)(5), (6). Pub. L. 115–271, §8217(e)(3), added pars. (5) and (6).

Subsec. (d)(8)(D). Pub. L. 115–271, §8217(f)(1)(A), struck out "and" at end.

Subsec. (d)(8)(E)(i). Pub. L. 115–271, §8217(f)(1)(B)(i), substituted "the appropriate congressional committees" for "Congress, including to the Committees on Appropriations of the Senate and the House of Representatives, the authorizing committees for the Office," and struck out "or agencies" after "affected agency".

Subsec. (d)(8)(E)(ii). Pub. L. 115–271, §8217(f)(1)(B)(ii), substituted "the appropriate congressional committees" for "Congress" and inserted "and" at end.

Subsec. (d)(8)(E)(iii). Pub. L. 115–271, §8217(f)(1)(B)(iii), added cl. (iii).

Subsec. (e)(2)(A). Pub. L. 115–271, §8217(f)(2), substituted "Subject to the availability of appropriations" for "Notwithstanding any other provision of law".

Subsec. (f)(4). Pub. L. 115–271, §8217(2)(B)(ii), which directed the amendment of subsec. (f) by striking "the second paragraph (4)", was executed by striking the par. (4) added by Pub. L. 109–469, §105(f), to reflect the probable intent of Congress. Text read as follows: "A copy of each fund control notice shall be transmitted to the appropriate congressional committees."

Subsec. (f)(5). Pub. L. 115–271, §8217(2)(B)(i), which directed the amendment of subsec. (f) by striking "the first paragraph (5)", was executed by striking the par. (5) added by Pub. L. 109–469, §103(e), to reflect the probable intent of Congress. Text read as follows: "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."

Subsecs. (i) to (k). Pub. L. 115–271, §8217(f)(3), added subsecs. (i) to (k).

2012—Subsec. (a)(1). Pub. L. 112–166 amended par. (1) generally. Prior to amendment, text read as follows: "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."

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Subsec. (a)(3). Pub. L. 109–469, §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, §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, §103(b)(2), inserted "and the appropriate congressional committees" after "President".

Subsec. (b)(13). Pub. L. 109–469, §103(b)(3), struck out "(beginning in 1999)" after "basis" in introductory provisions.

Subsec. (b)(14). Pub. L. 109–469, §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, §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, §103(b)(6), added pars. (16) to (20).

Subsec. (c)(1)(C). Pub. L. 109–469, §105(a), added subpar. (C).

Subsec. (c)(2). Pub. L. 109–469, §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, §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, §105(c)(2), added subpar. (C). Former subpar. (C) redesignated (D).

Subsec. (c)(3)(C)(iii). Pub. L. 109–469, §103(c)(1), inserted "and the appropriate congressional committees," after "House of Representatives".

Subsec. (c)(3)(D). Pub. L. 109–469, §105(c)(1), redesignated subpar. (C) as (D). Former subpar. (D) redesignated (E).

Subsec. (c)(3)(D)(ii)(II)(bb). Pub. L. 109–469, §103(c)(2), inserted "and the appropriate congressional committees," after "House of Representatives".

Subsec. (c)(3)(D)(iii). Pub. L. 109–469, §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, §103(c)(1) to subpar. (C)(iii) prior to its redesignation as (D)(iii). See above.

Subsec. (c)(3)(E). Pub. L. 109–469, §105(c)(1), redesignated subpar. (D) as (E).

Subsec. (c)(3)(E)(ii)(II)(bb). Pub. L. 109–469, §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, §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, §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, §105(e)(1), substituted "authorized by law;" for "have been authorized by Congress;".

Subsec. (d)(9). Pub. L. 109–469, §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, §103(d)(1). See below.

Pub. L. 109–469, §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, §§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, §105(f), added pars. (4) and (5) set out second.

Pub. L. 109–469, §103(e), added pars. (4) and (5) set out first.

Subsec. (g). Pub. L. 109–469, §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, §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."

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–166 effective 60 days after Aug. 10, 2012, and applicable to appointments made on and after that effective date, including any nomination pending in the Senate on that date, see section 6(a) of Pub. L. 112–166, set out as a note under section 113 of Title 6, Domestic Security.

Report on Streamlining Federal Prevention and Treatment Efforts

Pub. L. 105–277, div. D, title II, §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.

Executive Documents

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)) [now 50 U.S.C. 3021(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.      

1 See References in Text note below.

2 Probably should be "1705(h)".