21 U.S.C. § 208 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 208: Certain preparations and sales excepted
Certain preparations and sales excepted
Status: in_force

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

(Mar. 3, 1915, ch. 74, §6, 38 Stat. 819.)

Editorial Notes

Codification

Section is comprised of section 6 of act Mar. 3, 1915. Remainder of such section 6 is classified to section 207 of this title.
21 U.S.C. § 847 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 847: Additional penalties
Additional penalties
Status: in_force

Any penalty imposed for violation of this subchapter shall be in addition to, and not in lieu of, any civil or administrative penalty or sanction authorized by law.

(Pub. L. 91–513, title II, §407, Oct. 27, 1970, 84 Stat. 1265.)

Statutory Notes and Related Subsidiaries

Effective Date

Section 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 a note under section 801 of this title.
21 U.S.C. § 171 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 171: Repealed. Pub. L. 91-513, title III, §1101(a)(2), (4), Oct. 27, 1970, 84 Stat. 1291
Repealed. Pub. L. 91-513, title III, §1101(a)(2), (4), Oct. 27, 1970, 84 Stat. 1291
Status: repealed

Section 171, acts Feb. 9, 1909, ch. 100, §1, 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 14, 1930, ch. 488, §3, 46 Stat. 586; July 1, 1944, ch. 377, §8, 58 Stat. 721; Mar. 8, 1946, ch. 81, §7, 60 Stat. 39; Aug. 8, 1953, ch. 394, §8, 67 Stat. 506, defined "narcotic drug", "United States", and "person". See section 801 et seq. of this title.

Section 172, acts Feb. 9, 1909, ch. 100, §2(a), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; June 7, 1924, ch. 352, 43 Stat. 657, established a Federal Narcotics Control Board. Act May 26, 1922, ch. 202, §1, 42 Stat. 596, also classified to this section, was repealed by Pub. L. 89–554, §8(a), Sept. 6, 1966, 80 Stat. 645.

Section 173, acts Feb. 9, 1909, ch. 100, §2(b), (d), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; June 14, 1930, ch. 488, §3, 46 Stat. 586, prohibited importation of narcotic drugs. See section 801 et seq. of this title.

Section 173a, act June 14, 1930, ch. 488, §6, 46 Stat. 587, provided for importation of additional amounts of coca leaves.

Section 174, acts Feb. 9, 1909, ch. 100, §2(c), (f), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; Nov. 2, 1951, ch. 666, §§1, 5(1), 65 Stat. 767; July 18, 1956, ch. 629, title I, §105, 70 Stat. 570, set penalties for bringing narcotic drugs into the United States contrary to law. See chapter 13 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

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

Savings Provision

Pub. L. 91–513, title III, §1103, Oct. 27, 1970, 84 Stat. 1294, provided that:

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

"(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of section 1101 [the first day of the seventh calendar month that begins after Oct. 26, 1970] shall not be affected by the repeals or amendments made by such section or section 1102, or abated by reason thereof."
21 U.S.C. § 904 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 904: Payment of tort claims
Payment of tort claims
Status: in_force

Notwithstanding section 2680(k) of title 28, the Attorney General, in carrying out the functions of the Department of Justice under this subchapter, is authorized to pay tort claims in the manner authorized by section 2672 of title 28, when such claims arise in a foreign country in connection with the operations of the Drug Enforcement Administration abroad.

(Pub. L. 91–513, title II, §709, Oct. 27, 1970, 84 Stat. 1284; Pub. L. 93–481, §1, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 95–137, §1(a), Oct. 18, 1977, 91 Stat. 1169; Pub. L. 96–132, §§13, 15, Nov. 30, 1979, 93 Stat. 1048; Pub. L. 97–414, §9(g)(1), Jan. 4, 1983, 96 Stat. 2064.)

Editorial Notes

Amendments

1983—Pub. L. 97–414 struck out subsecs. (a) and (b) which had provided, respectively, that (a) there were authorized to be appropriated $105,000,000 for the fiscal year ending June 30, 1975, $175,000,000 for the fiscal year ending June 30, 1976, $200,000,000 for the fiscal year ending September 30, 1977, $188,000,000 for the fiscal year ending September 30, 1978, $215,000,000 for the fiscal year ending September 30, 1979, and $198,336,000 for the fiscal year ending September 30, 1980, for the expenses of the Department of Justice in carrying out its functions under this subchapter, and that (b) no funds appropriated under any other provision of this chapter could be used for the expenses of the Department of Justice for which funds were authorized to be appropriated by former subsection (a) of this section, and removed the subsection designator (c) before "Notwithstanding".

1979—Subsec. (a). Pub. L. 96–132, §15, inserted provisions authorizing appropriations of $198,336,000 for the fiscal year ending Sept. 30, 1980.

Subsec. (c). Pub. L. 96–132, §13, added subsec. (c).

1977—Subsec. (a). Pub. L. 95–137 substituted "September 30, 1977, $188,000,000 for the fiscal year ending September 30, 1978, and $215,000,000 for the fiscal year ending September 30, 1979," for "June 30, 1977," and struck out "(other than its expenses incurred in connection with carrying out section 803(a) of this title)".

1974—Pub. L. 93–481 designated existing provisions as subsec. (a), substituted authorization of appropriations for fiscal years ending June 30, 1975, June 30, 1976, and June 30, 1977, for authorization of appropriations for fiscal years ending June 30, 1972, June 30, 1973, and June 30, 1974, and added subsec. (b).
21 U.S.C. § 197 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 197: Repealed. Pub. L. 91-513, title III, §1101(a)(4), Oct. 27, 1970, 84 Stat. 1291
Repealed. Pub. L. 91-513, title III, §1101(a)(4), Oct. 27, 1970, 84 Stat. 1291
Status: repealed

Section 197, act June 14, 1930, ch. 488, §7, 46 Stat. 587, directed Secretary of the Treasury to cooperate with Secretary of State in discharge of international obligations of United States concerning traffic in narcotic drugs.

Section 198, acts June 14, 1930, ch. 488, §8, 46 Stat. 587; July 18, 1956, ch. 629, title III, §302, 70 Stat. 575, directed Secretary of the Treasury to cooperate with the several States in suppression of abuse of narcotic drugs in their respective jurisdictions.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

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

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.
21 U.S.C. § 1046 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1046: Imports
Imports
Status: in_force

(a) Authorization for importation of restricted eggs; prerequisites for importation of egg products; treatment as domestic articles subject to this chapter; marking and labeling exemption for personal consumption

(1) No restricted eggs capable of use as human food shall be imported into the United States except as authorized by regulations of the Secretary.

(2) No egg products capable of use as human food shall be imported into the United States unless they were processed under an approved continuous inspection system of the government of the foreign country of origin or subdivision thereof and are labeled and packaged in accordance with, and otherwise comply with the standards of this chapter and regulations issued thereunder applicable to such articles within the United States.

(3) No eggs packed into a container that is destined for the ultimate consumer shall be imported into the United States unless the eggs are accompanied by a certification that the eggs have at all times after packaging been stored and transported under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit, as required by sections 1034(e) and 1037(c) of this title.

(4) All such imported articles shall upon entry into the United States be deemed and treated as domestic articles subject to the other provisions of this chapter: Provided, That they shall be labeled as required by such regulations for imported articles: Provided further, That nothing in this section shall apply to eggs or egg products purchased outside the United States by any individual for consumption by him and members of his household and his nonpaying guests and employees.

(b) Terms and conditions for destruction

The Secretary may prescribe the terms and conditions for the destruction of all such articles which are imported contrary to this section, unless (1) they are exported by the consignee within the time fixed therefor by the Secretary or (2) in the case of articles which are not in compliance solely because of misbranding, such articles are brought into compliance with this chapter under supervision of authorized representatives of the Secretary.

(c) Payment of storage, cartage, and labor charges by owner or consignee; liens

All charges for storage, cartage, and labor with respect to any article which is imported contrary to this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against such article and any other article thereafter imported under this chapter by or for such owner or consignee.

(d) Prohibition

The importation of any article contrary to this section is prohibited.

(Pub. L. 91–597, §17, Dec. 29, 1970, 84 Stat. 1630; Pub. L. 102–237, title X, §1012(f), Dec. 13, 1991, 105 Stat. 1901.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (a) to (c), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsec. (a). Pub. L. 102–237 designated first sentence as par. (1) and second sentence as par. (2), added par. (3), and designated third sentence as par. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 1522 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1522: Purposes
Purposes
Status: in_force

The purposes of this subchapter are—

(1) to reduce substance use and misuse among youth in communities throughout the United States, and over time, to reduce substance use and misuse among adults;

(2) to strengthen collaboration among communities, the Federal Government, and State, local, and tribal governments;

(3) to enhance intergovernmental cooperation and coordination on the issue of substance use and misuse among youth;

(4) to serve as a catalyst for increased citizen participation and greater collaboration among all sectors and organizations of a community that first demonstrates a long-term commitment to reducing substance use and misuse among youth;

(5) to rechannel resources from the fiscal year 1998 Federal drug control budget to provide technical assistance, guidance, and financial support to communities that demonstrate a long-term commitment in reducing substance use and misuse among youth;

(6) to disseminate to communities timely information regarding the state-of-the-art practices and initiatives that have proven to be effective in reducing substance use and misuse among youth;

(7) to enhance, not supplant, local community initiatives for reducing substance use and misuse among youth; and

(8) to encourage the creation of and support for community anti-drug coalitions throughout the United States.

(Pub. L. 100–690, title I, §1022, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 225; amended Pub. L. 115–271, title VIII, §8203(b)(1), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(1). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(1), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse" wherever appearing.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Pub. L. 116–74, §2(c)(2), Nov. 27, 2019, 133 Stat. 1158, provided that: "The amendments made by this subsection [amending this section, sections 1506, 1523, 1524, 1531 to 1533, 1535, 1541 to 1548, and 1705 of this title, and provisions set out as notes under sections 1521, 1524, and 1532 of this title] shall take effect as if included in the enactment of the Substance Abuse Prevention Act of 2018 (subtitle K of title VIII of Public Law 115–271) [see Tables for classification]."
21 U.S.C. § 671 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 671: Inspection services; refusal or withdrawal; hearing; business unfitness based upon certain convictions; other provisions for withdrawal of services unaffected; responsible connection with business; finality of Secretary's actions; judicial review; record
Inspection services; refusal or withdrawal; hearing; business unfitness based upon certain convictions; other provisions for withdrawal of services unaffected; responsible connection with business; finality of Secretary's actions; judicial review; record
Status: in_force

The Secretary may (for such period, or indefinitely, as he deems necessary to effectuate the purposes of this chapter) refuse to provide, or withdraw, inspection service under subchapter I of this chapter with respect to any establishment if he determines, after opportunity for a hearing is accorded to the applicant for, or recipient of, such service, that such applicant or recipient is unfit to engage in any business requiring inspection under subchapter I because the applicant or recipient, or anyone responsibly connected with the applicant or recipient, has been convicted, in any Federal or State court, of (1) any felony, or (2) more than one violation of any law, other than a felony, based upon the acquiring, handling, or distributing of unwholesome, mislabeled, or deceptively packaged food or upon fraud in connection with transactions in food. This section shall not affect in any way other provisions of this chapter for withdrawal of inspection services under subchapter I from establishments failing to maintain sanitary conditions or to destroy condemned carcasses, parts, meat or meat food products.

For the purpose of this section a person shall be deemed to be responsibly connected with the business if he was a partner, officer, director, holder, or owner of 10 per centum or more of its voting stock or employee in a managerial or executive capacity.

The determination and order of the Secretary with respect thereto under this section shall be final and conclusive unless the affected applicant for, or recipient of, inspection service files application for judicial review within thirty days after the effective date of such order in the appropriate court as provided in section 674 of this title. Judicial review of any such order shall be upon the record upon which the determination and order are based.

(Mar. 4, 1907, ch. 2907, title IV, §401, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 597; amended Pub. L. 99–641, title IV, §403(b), Nov. 10, 1986, 100 Stat. 3568.)

Editorial Notes

Amendments

1986—Subsec. (a). Pub. L. 99–641, §403(b)(1), (2)(B), (C), temporarily designated provisions which related to authority to refuse or withdraw inspection service as subsec. (a), struck out "any felony, or (2)" after "of (1)", and inserted "or (2) any felony" after "transactions in food". See Effective and Termination Dates of 1986 Amendment note below.

Pub. L. 99–641, §403(b)(2)(A), which directed that subsec. (a) be amended by substituting "applicant for" for "applicant, for", could not be executed because "applicant, for" does not appear.

Subsecs. (b) to (e). Pub. L. 99–641, §403(b)(6), temporarily added subsecs. (b) to (e). See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (f). Pub. L. 99–641, §403(b)(3), temporarily designated provisions which related to other provisions for withdrawal of inspection services as subsec. (f). See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (g). Pub. L. 99–641, §403(b)(4), temporarily designated provisions which related to responsible connection with business as subsec. (g). See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (h). Pub. L. 99–641, §403(b)(5), temporarily designated provisions which related to finality of determination by Secretary and to judicial review as subsec. (h), substituted "Except as provided in subsection (e)(2) of this section, the determination" for "The determination" and "subsection (e) of this section" for "this section". See Effective and Termination Dates of 1986 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(b), Nov. 10, 1986, 100 Stat. 3568, provided that the amendment made by that section is effective only during the 6-year period beginning Nov. 10, 1986.

Effective Date

Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title.

Construction and Effect of Amendments by Pub. L. 99–641

For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled "Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program" and "Savings Provision", respectively, under section 609 of this title.
21 U.S.C. § 1905 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1905: Authorities
Authorities
Status: in_force

(a) In general

To carry out the purposes of this chapter, the Secretary of the Treasury may, under such regulations as he may prescribe, by means of instructions, licenses, or otherwise—

(1) investigate, regulate, or prohibit—

(A) any transactions in foreign exchange, currency, or securities; and

(B) transfers of credit or payments between, by, through, or to any banking institution, to the extent that such transfers or payments involve any interests of any foreign country or a national thereof; and

(2) investigate, block during the pendency of an investigation, regulate, direct and compel, nullify, void, prevent, or prohibit any acquisition, holding, withholding, use, transfer, withdrawal, transportation, placement into foreign or domestic commerce of, or dealing in, or exercising any right, power, or privilege with respect to, or transactions involving, any property in which any foreign country or a national thereof has any interest,

by any person, or with respect to any property, subject to the jurisdiction of the United States.

(b) Recordkeeping

Pursuant to subsection (a), the Secretary of the Treasury may require recordkeeping, reporting, and production of documents to carry out the purposes of this chapter.

(c) Defenses

(1) Full and actual compliance with any regulation, order, license, instruction, or direction issued under this chapter shall be a defense in any proceeding alleging a violation of any of the provisions of this chapter.

(2) No person shall be held liable in any court for or with respect to anything done or omitted in good faith in connection with the administration of, or pursuant to, and in reliance on this chapter, or any regulation, instruction, or direction issued under this chapter.

(d) Rulemaking

The Secretary of the Treasury may issue such other regulations or orders, including regulations prescribing recordkeeping, reporting, and production of documents, definitions, licenses, instructions, or directions, as may be necessary for the exercise of the authorities granted by this chapter.

(Pub. L. 106–120, title VIII, §806, Dec. 3, 1999, 113 Stat. 1631.)
21 U.S.C. § 677 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 677: Other Federal laws applicable for administration and enforcement of chapter; location of inquiries; jurisdiction of Federal courts
Other Federal laws applicable for administration and enforcement of chapter; location of inquiries; jurisdiction of Federal courts
Status: in_force

For the efficient administration and enforcement of this chapter, the provisions (including penalties) of sections 46, 48, 49 and 50 of title 15 (except paragraphs (c) through (h) of section 46 and the last paragraph of section 49 1 of title 15), and the provisions of section 409(l) 1 of title 47; are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person, firm, or corporation with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15 on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 674 of this title.

(Mar. 4, 1907, ch. 2907, title IV, §407, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599.)

Editorial Notes

References in Text

The last paragraph of section 49 of title 15, and the provisions of section 409(l) of title 47, referred to in text, which related to immunity of witnesses, were repealed by sections 211 and 242, respectively, of Pub. L. 91–452, Oct. 15, 1970, title II, 84 Stat. 929, 930. For provisions relating to immunity of witnesses, see section 6001 et seq. of Title 18, Crimes and Criminal Procedure.

1 See References in Text note below.
21 U.S.C. § 1901 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1901: Findings and policy
Findings and policy
Status: in_force

(a) Findings

Congress makes the following findings:

(1) Presidential Decision Directive 42, issued on October 21, 1995, ordered agencies of the executive branch of the United States Government to, inter alia, increase the priority and resources devoted to the direct and immediate threat international crime presents to national security, work more closely with other governments to develop a global response to this threat, and use aggressively and creatively all legal means available to combat international crime.

(2) Executive Order No. 12978 of October 21, 1995, provides for the use of the authorities in the International Emergency Economic Powers Act (IEEPA) (50 U.S.C. 1701 et seq.) to target and apply sanctions to four international narcotics traffickers and their organizations that operate from Colombia.

(3) IEEPA was successfully applied to international narcotics traffickers in Colombia and based on that successful case study, Congress believes similar authorities should be applied worldwide.

(4) There is a national emergency resulting from the activities of international narcotics traffickers and their organizations that threatens the national security, foreign policy, and economy of the United States.

(b) Policy

It shall be the policy of the United States to apply economic and other financial sanctions to significant foreign narcotics traffickers and their organizations worldwide to protect the national security, foreign policy, and economy of the United States from the threat described in subsection (a)(4).

(Pub. L. 106–120, title VIII, §802, Dec. 3, 1999, 113 Stat. 1626.)

Editorial Notes

References in Text

Executive Order No. 12978, referred to in subsec. (a)(2), is Ex. Ord. No. 12978, Oct. 21, 1995, 60 F.R. 54579, which is listed in a table under section 1701 of Title 50, War and National Defense.

The International Emergency Economic Powers Act, referred to in subsec. (a)(2), is title II of Pub. L. 95–223, Dec. 28, 1977, 91 Stat. 1626, which is classified generally to chapter 35 (§1701 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Short Title note set out under section 1701 of Title 50 and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 106–120, title VIII, §811, Dec. 3, 1999, 113 Stat. 1636, provided that: "This title [see Short Title note set out below] shall take effect on the date of the enactment of this Act [Dec. 3, 1999]."

Short Title

Pub. L. 106–120, title VIII, §801, Dec. 3, 1999, 113 Stat. 1626, provided that: "This title [enacting this chapter and amending section 1182 of Title 8, Aliens and Nationality] may be cited as the 'Foreign Narcotics Kingpin Designation Act'."
21 U.S.C. § 379c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379c: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, act June 25, 1938, ch. 675, §711, as added Nov. 28, 1990, Pub. L. 101–635, title II, §201, 104 Stat. 4584, which related to recovery and retention of fees for freedom of information requests, was renumbered section 731 of act June 25, 1938, by Pub. L. 102–571, title I, §106(6), Oct. 29, 1992, 106 Stat. 4499, and transferred to section 379f of this title.
21 U.S.C. § 1541 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1541: Repealed. Pub. L. 115-271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116-74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157
Repealed. Pub. L. 115-271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116-74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157
Status: repealed

Section 1541, Pub. L. 100–690, title I, §1041, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 231, established Advisory Commission on Drug-Free Communities.

Section 1542, Pub. L. 100–690, title I, §1042, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 231, related to duties of the Commission.

Section 1543, Pub. L. 100–690, title I, §1043, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 232, related to membership of the Commission.

Section 1544, Pub. L. 100–690, title I, §1044, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 232, related to compensation.

Section 1545, Pub. L. 100–690, title I, §1045, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 233, related to terms of office.

Section 1546, Pub. L. 100–690, title I, §1046, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 233, related to Commission meetings.

Section 1547, Pub. L. 100–690, title I, §1047, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 233, related to Commission staff.

Section 1548, Pub. L. 100–690, title I, §1048, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 234; amended Pub. L. 107–82, §3, Dec. 14, 2001, 115 Stat. 820, terminated the Commission at the end of fiscal year 2007.

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out a note under section 1522 of this title.
21 U.S.C. § 676 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 676: Violations
Violations
Status: in_force

(a) Misdemeanors; felonies: intent to defraud and distribution of adulterated articles; good faith

Any person, firm, or corporation who violates any provision of this chapter for which no other criminal penalty is provided by this chapter shall upon conviction be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine; but if such violation involves intent to defraud, or any distribution or attempted distribution of an article that is adulterated (except as defined in section 601(m)(8) of this title), such person, firm, or corporation shall be subject to imprisonment for not more than three years or a fine of not more than $10,000, or both: Provided, That no person, firm, or corporation, shall be subject to penalties under this section for receiving for transportation any article or animal in violation of this chapter if such receipt was made in good faith, unless such person, firm, or corporation refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such article or animal, and copies of all documents, if any there be, pertaining to the delivery of the article or animal to him.

(b) Minor violations; written notice of warning of criminal and civil proceedings

Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice of warning.

(Mar. 4, 1907, ch. 2907, title IV, §406, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599; amended Pub. L. 99–641, title IV, §403(c), Nov. 10, 1986, 100 Stat. 3570.)

Editorial Notes

Amendments

1986—Subsec. (b). Pub. L. 99–641, §403(c)(1), temporarily inserted provisions which related to factors required to be considered by Secretary in determining whether public interest is served by written notice of warning. See Effective and Termination Dates of 1986 Amendment note below.

Subsec. (c). Pub. L. 99–641, §403(c)(2), temporarily added subsec. (c). See Effective and Termination Dates of 1986 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(c), Nov. 10, 1986, 100 Stat. 3570, provided that the amendment made by that section is effective only during the 6-year period beginning Nov. 10, 1986.

Construction and Effect of Amendments by Pub. L. 99–641

For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled "Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program" and "Savings Provision", respectively, under section 609 of this title.
21 U.S.C. § 610 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 610: Prohibited acts
Prohibited acts
Status: in_force

No person, firm, or corporation shall, with respect to any cattle, sheep, swine, goats, horses, mules, or other equines, or any carcasses, parts of carcasses, meat or meat food products of any such animals—

(a) Slaughtering animals or preparation of articles capable of use as human food

slaughter any such animals or prepare any such articles which are capable of use as human food at any establishment preparing any such articles for commerce, except in compliance with the requirements of this chapter;

(b) Humane methods of slaughter

slaughter or handle in connection with slaughter any such animals in any manner not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906);

(c) Sales, transportation, and other transactions

sell, transport, offer for sale or transportation, or receive for transportation, in commerce, (1) any such articles which (A) are capable of use as human food and (B) are adulterated or misbranded at the time of such sale, transportation, offer for sale or transportation, or receipt for transportation; or (2) any articles required to be inspected under this subchapter unless they have been so inspected and passed;

(d) Adulteration or misbranding

do, with respect to any such articles which are capable of use as human food, any act while they are being transported in commerce or held for sale after such transportation, which is intended to cause or has the effect of causing such articles to be adulterated or misbranded.

(Mar. 4, 1907, ch. 2907, title I, §10, formerly 8th par., 34 Stat. 1262; renumbered §10 and amended Pub. L. 90–201, §§1, 7, Dec. 15, 1967, 81 Stat. 584, 589; Pub. L. 95–445, §3, Oct. 10, 1978, 92 Stat. 1069.)

Editorial Notes

References in Text

Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classified generally to chapter 48 (§1901 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Tables.

Sections 1903 and 1905 of Title 7, included within reference to Act of August 27, 1958, were repealed by Pub. L. 95–445, §5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title.

Codification

Section was formerly classified to section 78 of this title.

Amendments

1978—Subsecs. (b) to (d). Pub. L. 95–445 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

1967—Pub. L. 90–201, §7, included the list of animals and prohibited, except in compliance with requirements of this chapter, slaughtering animals or preparation of articles capable of use as human food, sales, transportation, and other transactions, and acts of adulteration or misbranding, incorporating in subsec. (b)(2) existing prohibition on distributions in interstate or foreign commerce of noninspected articles.

Statutory Notes and Related Subsidiaries

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–445 effective one year after Oct. 10, 1978, and an additional eighteen month period thereafter in hardship cases, see section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that subsecs. (b)(1) and (c) of this section effective upon expiration of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 1 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter I: FEDERAL FOOD AND DRUGS ACT OF 1906 / Section 1: Repealed. 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
Repealed. 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
Status: repealed

Section 1, act June 30, 1906, ch. 3915, §1, 34 Stat. 768, made it unlawful to manufacture adulterated or misbranded foods or drugs in Territories or District of Columbia and provided penalty for violations. See sections 331 and 333 of this title.

Section 2, act June 30, 1906, ch. 3915, §2, 34 Stat. 768, prohibited introduction, shipment, delivery or sale of adulterated or misbranded foods or drugs in interstate or foreign commerce, provided penalty for violations and exempted exports conforming to specifications of foreign purchaser and not in conflict with laws of foreign country importing the same. See sections 331, 333 and 381 of this title.

Section 3, acts June 30, 1906, ch. 3915, §3, 34 Stat. 768; Mar. 4, 1913, ch. 141, §1, 37 Stat. 736, authorized Secretaries of the Treasury, Agriculture, and Commerce to make uniform rules and regulations for enforcement of food and drug laws, including collection and examination of specimens. See section 371 of this title.

Section 4, act June 30, 1906, ch. 3915, §12, 34 Stat. 772, provided that act or omission of officer, agent, and so forth, of corporation, shall be deemed act or omission of corporation.

Section 5, act June 30, 1906, ch. 3915, §12, 34 Stat. 772, defined "territory" and "person". See section 321 of this title and section 1 of Title 1, General Provisions.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

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, which repealed sections 1 to 5, 7 to 14, and 15 of this title, provided that the repeal of those sections should take effect upon the effective date of act June 25, 1938, which was to take effect twelve months after the date of its enactment. Act June 23, 1939, ch. 242, §2(b), 53 Stat. 854, provided that: "The provisions of such act of June 30, 1906, as amended, to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this title], shall remain in force until January 1, 1940."
21 U.S.C. § 61 (2024) — Title 21: FOOD AND DRUGS / Chapter 3: FILLED MILK / Section 61: Definitions
Definitions
Status: in_force

Whenever used in this chapter—

(a) The term "person" includes an individual, partnership, corporation, or association;

(b) The term "interstate or foreign commerce" means commerce (1) between any State, Territory, or possession, or the District of Columbia, and any place outside thereof; (2) between points within the same State, Territory, or possession, or within the District of Columbia, but through any place outside thereof; or (3) within any Territory or possession, or within the District of Columbia; and

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

(Mar. 4, 1923, ch. 262, §1, 42 Stat. 1486.)

Statutory Notes and Related Subsidiaries

Short Title

Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in part that act Mar. 4, 1923, which enacted this chapter, may be cited as the "Filled Milk Act".
21 U.S.C. § 374a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 374a: Inspections relating to food allergens
Inspections relating to food allergens
Status: in_force

The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 374 of this title of facilities in which foods are manufactured, processed, packed, or held—

(1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and

(2) to ensure that major food allergens are properly labeled on foods.

(Pub. L. 108–282, title II, §205, Aug. 2, 2004, 118 Stat. 909.)

Editorial Notes

Codification

Section was enacted as a part of the Food Allergen Labeling and Consumer Protection Act of 2004, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 461 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 461: Offenses and punishment
Offenses and punishment
Status: in_force

(a) Violations; liability of agents, employees, and employers

Any person who violates the provisions of section 458, 459, 460, 463, or 466 of this title shall be fined not more than $1,000 or imprisoned not more than one year, or both; but if such violation involves intent to defraud, or any distribution or attempted distribution of an article that is adulterated (except as defined in section 453(g)(8) of this title), such person shall be fined not more than $10,000 or imprisoned not more than three years, or both. When construing or enforcing the provisions of said sections the act, omission, or failure of any person acting for or employed by any individual, partnership, corporation, or association within the scope of his employment or office shall in every case be deemed the act, omission, or failure of such individual, partnership, corporation, or association, as well as of such person.

(b) Liability of carrier

No carrier shall be subject to the penalties of this chapter, other than the penalties for violation of section 460 of this title, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier, of poultry or poultry products, owned by another person unless the carrier has knowledge, or is in possession of facts which would cause a reasonable person to believe that such poultry or poultry products were not inspected or marked in accordance with the provisions of this chapter or were otherwise not eligible for transportation under this chapter or unless the carrier refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such poultry or poultry products, and copies of all documents, if any there be, pertaining to the delivery of the poultry or poultry products to such carrier.

(c) Assaulting, resisting, or impeding certain persons; murder; punishments

Any person who forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person while engaged in or on account of the performance of his official duties under this chapter shall be fined not more than $5,000 or imprisoned not more than three years, or both. Whoever, in the commission of any such acts, uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. Whoever kills any person while engaged in or on account of the performance of his official duties under this chapter shall be punished as provided under sections 1111 and 1114 of title 18.

(Pub. L. 85–172, §12, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, §12, Aug. 18, 1968, 82 Stat. 802.)

Editorial Notes

Amendments

1968—Par. (a). Pub. L. 90–492, §12(a), inserted reference to violations of section 463 of this title, and substituted provisions that violators of the enumerated sections shall be fined not more than $1,000 or imprisoned not more than one year, or both, but that in cases involving intent to defraud, or any distribution or attempt to distribute adulterated articles, except as defined in section 453(g) of this title, the violators shall be fined not more than $10,000 or imprisoned not more than three years, or both, for provisions that violators shall be guilty of a misdemeanor and subject to imprisonment for not more than six months or a fine of not more than $3,000, or both, with increased fines and imprisonment for any subsequent violations.

Par. (b). Pub. L. 90–492, §12(b), substituted "of poultry" for "of slaughtered poultry", "such poultry" for "such slaughtered poultry", and "otherwise not eligible" for "not otherwise eligible", and inserted provision that no carrier shall be subject to punishment unless the carrier refuses to furnish the name and address of the person from whom he received such poultry or poultry products, and copies of any documents pertaining to the delivery of the poultry or poultry products to such carrier.

Par. (c). Pub. L. 90–492, §12(c), added par. (c).

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 2401 (2024) — Title 21: FOOD AND DRUGS / Chapter 29: INTERNATIONAL SPORTS DOPING / Section 2401: Definitions
Definitions
Status: in_force

(1) Anti-doping organization

The term "anti-doping organization" has the meaning given the term in Article 2 of the Convention.

(2) Athlete

The term "athlete" has the meaning given the term in Article 2 of the Convention.

(3) Code

The term "Code" means the World Anti-Doping Code most recently adopted by WADA on March 5, 2003.

(4) Convention

The term "Convention" means the United Nations Educational, Scientific, and Cultural Organization International Convention Against Doping in Sport done at Paris October 19, 2005, and ratified by the United States in 2008.

(5) Major international sport competition

The term "Major International Sport Competition"— 1

(A) means a competition—

(i) in which one or more United States athletes and three or more athletes from other countries participate;

(ii) that is governed by the anti-doping rules and principles of the Code; and

(iii) in which—

(I) the competition organizer or sanctioning body receives sponsorship or other financial support from an organization doing business in the United States; or

(II) the competition organizer or sanctioning body receives compensation for the right to broadcast the competition in the United States; and

(B) includes a competition that is a single event or a competition that consists of a series of events held at different times which, when combined, qualify an athlete or team for an award or other recognition.

(6) Person

The term "person" means any individual, partnership, corporation, association, or other entity.

(7) Prohibited method

The term "prohibited method" has the meaning given the term in Article 2 of the Convention.

(8) Prohibited substance

The term "prohibited substance" has the meaning given the term in Article 2 of the Convention.

(9) Scheme in commerce

The term "scheme in commerce" means any scheme effectuated in whole or in part through the use in interstate or foreign commerce of any facility for transportation or communication.

(10) USADA

The term "USADA" means the United States Anti-Doping Agency.

(11) WADA

The term "WADA" means the World Anti-Doping Agency.

(Pub. L. 116–206, §2, Dec. 4, 2020, 134 Stat. 998.)

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 116–206, §1, Dec. 4, 2020, 134 Stat. 998, provided that: "This Act [enacting this chapter and amending section 3663A of Title 18, Crimes and Criminal Procedure] may be cited as the 'Rodchenkov Anti-Doping Act of 2019'."

1 So in original. Term is not capitalized as used in this chapter.
21 U.S.C. § 2201 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter I: IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS / Section 2201: Performance standards
Performance standards
Status: in_force

(a) In general

The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants.

(b) Guidance documents and regulations

Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 342 of this title or to prevent the spread by food of communicable disease under section 264 of title 42, the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations—

(1) shall apply to products or product classes;

(2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and

(3) shall not be written to be facility-specific.

(c) No duplication of efforts

The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants.

(d) Review

The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.

(Pub. L. 111–353, title I, §104, Jan. 4, 2011, 124 Stat. 3899.)

Editorial Notes

References in Text

The Secretary, referred to in text, probably means the Secretary of Health and Human Services.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 111–353, §1(a), Jan. 4, 2011, 124 Stat. 3885, provided that: "This Act [enacting this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amending sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacting provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title] may be cited as the 'FDA Food Safety Modernization Act'."
21 U.S.C. § 106 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter II: IMPORTATION OF CATTLE AND QUARANTINE / Section 106: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Sections, acts Aug. 10, 1917, ch. 52, §9, 40 Stat. 275; Nov. 21, 1918, ch. 212, §3, 40 Stat. 1048, related to slaughter of tick-infested cattle. Section 12 of act Aug. 10, 1917, provided that the act should cease to be in effect when the national emergency resulting from World War I had passed.
21 U.S.C. § 864 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 864: Anhydrous ammonia
Anhydrous ammonia
Status: in_force

(a) It is unlawful for any person—

(1) to steal anhydrous ammonia, or

(2) to transport stolen anhydrous ammonia across State lines,

knowing, intending, or having reasonable cause to believe that such anhydrous ammonia will be used to manufacture a controlled substance in violation of this part.

(b) Any person who violates subsection (a) shall be imprisoned or fined, or both, in accordance with section 843(d) of this title as if such violation were a violation of a provision of section 843 of this title.

(Pub. L. 91–513, title II, §423, as added Pub. L. 106–310, div. B, title XXXVI, §3653(a), Oct. 17, 2000, 114 Stat. 1240.)
21 U.S.C. § 321d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter II: DEFINITIONS / Section 321d: Market names for catfish and ginseng
Market names for catfish and ginseng
Status: in_force

(a) Catfish labeling

(1) In general

Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)—

(A) the term "catfish" may only be considered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae; and

(B) only labeling or advertising for fish classified within that family may include the term "catfish".

(2) Omitted

(b) Ginseng labeling

(1) In general

Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)—

(A) the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax; and

(B) only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term "ginseng".

(2) Omitted

(Pub. L. 107–171, title X, §10806, May 13, 2002, 116 Stat. 526.)

Editorial Notes

References in Text

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

Codification

Section is comprised of section 10806 of Pub. L. 107–171. Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107–171 amended section 343 of this title.

Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as part of Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 679a (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 679a: Safe Meat and Poultry Inspection Panel
Safe Meat and Poultry Inspection Panel
Status: in_force

(a) Establishment

There is established in the Department of Agriculture a permanent advisory panel to be known as the "Safe Meat and Poultry Inspection Panel" (referred to in this section as the "panel").

(b) Duties

(1) Review and evaluation

The panel shall review and evaluate, as the panel considers necessary, the adequacy, necessity, safety, cost-effectiveness, and scientific merit of—

(A) inspection procedures of, and work rules and worker relations involving Federal employees employed in, plants inspected under this chapter;

(B) informal petitions or proposals for changes in inspection procedures, processes, and techniques of plants inspected under this chapter;

(C) formal changes in meat inspection regulations promulgated under this chapter, whether in notice, proposed, or final form; and

(D) such other matters as may be referred to the panel by the Secretary regarding the quality or effectiveness of a safe and cost-effective meat inspection system under this chapter.

(2) Reports

(A) In general

The panel shall submit to the Secretary a report on the results of each review and evaluation carried out under paragraph (1), including such recommendations as the panel considers appropriate.

(B) Reports on formal changes

In the case of a report concerning a formal change in meat inspection regulations, the report shall be made within the time limits prescribed for formal comments on such changes.

(C) Publication in Federal Register

Each report of the panel to the Secretary shall be published in the Federal Register.

(c) Secretarial response

Not later than 90 days after the publication of a panel report under subsection (b)(2)(C), the Secretary shall publish in the Federal Register any response required of the Secretary to the report.

(d) Composition of panel

The panel shall be composed of 7 members, not fewer than 5 of whom shall be from the food science, meat science, or poultry science profession, appointed to staggered terms not to exceed 3 years by the Secretary from nominations received from the National Institutes of Health and the Federation of American Societies of Food Animal Science and based on the professional qualifications of the nominees.

(e) Nominations

(1) Initial panel

In constituting the initial panel, the Secretary shall solicit 6 nominees from the National Institutes of Health and 6 nominees from the Federation of American Societies of Food Animal Science for membership on the panel.

(2) Vacancies

Any subsequent vacancy on the panel shall be filled by the Secretary after soliciting 2 nominees from the National Institutes of Health and 2 nominees from the Federation of American Societies of Food Animal Science.

(3) Requirements for nominees

(A) In general

Each nominee provided under paragraph (1) or (2) shall have a background in public health issues and a scientific expertise in food, meat, or poultry science or in veterinary science.

(B) Submission of information

The Secretary may require nominees to submit such information as the Secretary considers necessary prior to completing the selection process.

(4) Additional nominees

If any list of nominees provided under paragraph (1) or (2) is unsatisfactory to the Secretary, the Secretary may request the nominating entities to submit an additional list of nominees.

(f) Travel expenses

While away from the home or regular place of business of a member of the panel in the performance of services for the panel, the member shall be allowed travel expenses, including per diem in lieu of subsistence, at the same rate as a person employed intermittently in the Government service would be allowed under section 5703 of title 5.

(g) Conflicts of interest

The Secretary shall promulgate regulations regarding conflicts of interest with respect to the members of the panel.

(h) Exemption

Chapter 10 of title 5 and title XVIII of the Food and Agriculture Act of 1977 (7 U.S.C. 2281 et seq.) shall not apply to the panel.

(i) Funding

From funds available to the Secretary to carry out this chapter and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), the Secretary shall allocate such sums as may be necessary to carry out this section.

(Mar. 4, 1907, ch. 2907, title IV, §410, as added Pub. L. 104–127, title IX, §918(a)(1)(B), Apr. 4, 1996, 110 Stat. 1188; amended Pub. L. 117–286, §4(a)(161), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

References in Text

The Food and Agriculture Act of 1977, referred to in subsec. (h), is Pub. L. 95–113, Sept. 29, 1977, 91 Stat. 913. Title XVIII of the Act is classified generally to chapter 55A (§2281 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title of 1977 Amendment note set out under section 1281 of Title 7 and Tables.

The Poultry Products Inspection Act, referred to in subsec. (i), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, 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.

Prior Provisions

A prior section 410 of act Mar. 4, 1907, was renumbered section 411, and is classified to section 680 of this title.

Amendments

2022—Subsec. (h). Pub. L. 117–286 substituted "Chapter 10 of title 5" for "The Federal Advisory Committee Act (5 U.S.C. App.)".

Statutory Notes and Related Subsidiaries

Use of Appropriated Funds

For prohibition of use of funds appropriated by div. A of Pub. L. 113–235 or any other Act to carry out this section, see section 741 Pub. L. 113–235, set out as a note under section 471 of this title.
21 U.S.C. § 214 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 214: Previous laws unaffected
Previous laws unaffected
Status: in_force

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

(Mar. 3, 1915, ch. 74, §13, 38 Stat. 822.)

Editorial Notes

References in Text

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

1 See References in Text note below.
21 U.S.C. § 347b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 347b: Contravention of State laws
Contravention of State laws
Status: in_force

Nothing in this Act shall be construed as authorizing the possession, sale, or serving of colored oleomargarine or colored margarine in any State or Territory in contravention of the laws of such State or Territory.

(Mar. 16, 1950, ch. 61, §6, 64 Stat. 22.)

Editorial Notes

References in Text

This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64 Stat. 20, which is classified to sections 331, 342, 347 to 347b of this title, and sections 45 and 55 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Tables.

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as a note under section 347 of this title.
21 U.S.C. § 680 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 680: Authorization of appropriations
Authorization of appropriations
Status: in_force

There are hereby authorized to be appropriated such sums as may be necessary to carry out the provisions of this chapter.

(Mar. 4, 1907, ch. 2907, title IV, §411, formerly §410, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 600; renumbered §411, Pub. L. 104–127, title IX, §918(a)(1)(A), Apr. 4, 1996, 110 Stat. 1188.)
21 U.S.C. § 966 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 966: Authority of Secretary of the Treasury
Authority of Secretary of the Treasury
Status: in_force

Nothing in this chapter shall derogate from the authority of the Secretary of the Treasury under the customs and related laws.

(Pub. L. 91–513, title III, §1016, Oct. 27, 1970, 84 Stat. 1291.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.
21 U.S.C. § 360mm (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360mm: Imports
Imports
Status: in_force

(a) Refusal of admission to noncomplying electronic products

Any electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under this part, or to which is not affixed a certification in the form of a label or tag in conformity with section 360kk(h) of this title shall be refused admission into the United States. The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon the latter's request, samples of electronic products which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may have a hearing before the Secretary of Health and Human Services. If it appears from an examination of such samples or otherwise that any electronic product fails to comply with applicable standards prescribed pursuant to section 360kk of this title, then, unless subsection (b) of this section applies and is complied with, (1) such electronic product shall be refused admission, and (2) the Secretary of the Treasury shall cause the destruction of such electronic product unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days after the date of notice of refusal of admission or within such additional time as may be permitted by such regulations.

(b) Bond

If it appears to the Secretary of Health and Human Services that any electronic product refused admission pursuant to subsection (a) of this section can be brought into compliance with applicable standards prescribed pursuant to section 360kk of this title, final determination as to admission of such electronic product may be deferred upon filing of timely written application by the owner or consignee and the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as the Secretary of Health and Human Services may by regulation prescribe. If such application is filed and such bond is executed the Secretary of Health and Human Services may, in accordance with rules prescribed by him, permit the applicant to perform such operations with respect to such electronic product as may be specified in the notice of permission.

(c) Liability of owner or consignee for expenses connected with refusal of admission

All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of operations provided for in subsection (b) of this section, and all expenses in connection with the storage, cartage, or labor with respect to any electronic product refused admission pursuant to subsection (a) of this section, shall be paid by the owner or consignee, and, in event of default, shall constitute a lien against any future importations made by such owner or consignee.

(d) Designation of agent for purposes of service

It shall be the duty of every manufacturer offering an electronic product for importation into the United States to designate in writing an agent upon whom service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made for and on behalf of said manufacturer, and to file such designation with the Secretary, which designation may from time to time be changed by like writing, similarly filed. Service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made upon said manufacturer by service upon such designated agent at his office or usual place of residence with like effect as if made personally upon said manufacturer, and in default of such designation of such agent, service of process, notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial proceeding for enforcement of this part or any standards prescribed pursuant to this part may be made by posting such process, notice, order, requirement, or decision in the Office of the Secretary or in a place designated by him by regulation.

(June 25, 1938, ch. 675, §536, formerly act July 1, 1944, ch. 373, title III, §536, formerly §360, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered §536 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(D), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263h of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263h of Title 42, The Public Health and Welfare, as this section.

1992—Subsecs. (a), (b). Pub. L. 102–300 substituted "Health and Human Services" for "Health, Education, and Welfare" wherever appearing.

1990—Subsec. (a). Pub. L. 101–629, §19(a)(1)(B), (2)(D), substituted "this part" for "this subpart", "section 360kk(h)" for "section 263f(h)", and "section 360kk" for "section 263f".

Subsec. (b). Pub. L. 101–629, §19(a)(2)(D), substituted "section 360kk" for "section 263f".

Subsec. (d). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in two places.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 144 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 144: Unlawful receiving of imported milk or cream
Unlawful receiving of imported milk or cream
Status: in_force

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

(Feb. 15, 1927, ch. 155, §4, 44 Stat. 1103.)
21 U.S.C. § 379f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379f: Recovery and retention of fees for freedom of information requests
Recovery and retention of fees for freedom of information requests
Status: in_force

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs, may—

(1) set and charge fees, in accordance with section 552(a)(4)(A) of title 5, to recover all reasonable costs incurred in processing requests made under section 552 of title 5 for records obtained or created under this chapter or any other Federal law for which responsibility for administration has been delegated to the Commissioner by the Secretary;

(2) retain all fees charged for such requests; and

(3) establish an accounting system and procedures to control receipts and expenditures of fees received under this section.

(b) Use of fees

The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provisions of this chapter.

(c) Waiver of fees

Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5.

(June 25, 1938, ch. 675, §731, formerly §711, as added Pub. L. 101–635, title II, §201, Nov. 28, 1990, 104 Stat. 4584; renumbered §731, Pub. L. 102–571, title I, §106(6), Oct. 29, 1992, 106 Stat. 4499.)

Editorial Notes

Codification

Section was formerly classified to section 379c of this title prior to renumbering by Pub. L. 102–571.
21 U.S.C. § 355e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 355e: Pharmaceutical security
Pharmaceutical security
Status: in_force

(a) In general

The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.

(b) Standards development

(1) In general

The Secretary shall, in consultation with the agencies specified in paragraph (4), manufacturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.

(2) Standardized numeral identifier

Not later than 30 months after September 27, 2007, the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.

(3) Promising technologies

The standards developed under this subsection shall address promising technologies, which may include—

(A) radio frequency identification technology;

(B) nanotechnology;

(C) encryption technologies; and

(D) other track-and-trace or authentication technologies.

(4) Interagency collaboration

In carrying out this subsection, the Secretary shall consult with Federal health and security agencies, including—

(A) the Department of Justice;

(B) the Department of Homeland Security;

(C) the Department of Commerce; and

(D) other appropriate Federal and State agencies.

(c) Inspection and enforcement

(1) In general

The Secretary shall expand and enhance the resources and facilities of agency components of the Food and Drug Administration involved with regulatory and criminal enforcement of this chapter to secure the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs including biological products and active pharmaceutical ingredients from domestic and foreign sources.

(2) Activities

The Secretary shall undertake enhanced and joint enforcement activities with other Federal and State agencies, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug supply chain.

(d) Definition

In this section, the term "prescription drug" means a drug subject to section 353(b)(1) of this title.

(June 25, 1938, ch. 675, §505D, as added Pub. L. 110–85, title IX, §913, Sept. 27, 2007, 121 Stat. 952.)
21 U.S.C. § 360k (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360k: State and local requirements respecting devices
State and local requirements respecting devices
Status: in_force

(a) General rule

Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

(b) Exempt requirements

Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—

(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or

(2) the requirement—

(A) is required by compelling local conditions, and

(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.

(June 25, 1938, ch. 675, §521, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 574.)
21 U.S.C. § 822a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 822a: Prescription drug take back expansion
Prescription drug take back expansion
Status: in_force

(a) Definition of covered entity

In this section, the term "covered entity" means—

(1) a State, local, or tribal law enforcement agency;

(2) a manufacturer, distributor, or reverse distributor of prescription medications;

(3) a retail pharmacy;

(4) a registered narcotic treatment program;

(5) a hospital or clinic with an onsite pharmacy;

(6) an eligible long-term care facility; or

(7) any other entity authorized by the Drug Enforcement Administration to dispose of prescription medications.

(b) Program authorized

The Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, shall coordinate with covered entities in expanding or making available disposal sites for unwanted prescription medications.

(Pub. L. 114–198, title II, §203, July 22, 2016, 130 Stat. 717.)

Editorial Notes

Codification

Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Access to Increased Drug Disposal

Pub. L. 115–271, title III, subtitle B, ch. 6, Oct. 24, 2018, 132 Stat. 3950, provided that:

"SEC. 3251. SHORT TITLE.

"This chapter may be cited as the 'Access to Increased Drug Disposal Act of 2018'.

"SEC. 3252. DEFINITIONS.

"In this chapter—

"(1) the term 'Attorney General' means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs;

"(2) the term 'authorized collector' means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation);

"(3) the term 'covered grant' means a grant awarded under section 3003 [probably means section 3253; no section 3003 of Pub. L. 115–271 has been enacted]; and

"(4) the term 'eligible collector' means a person who is eligible to be an authorized collector.

"SEC. 3253. AUTHORITY TO MAKE GRANTS.

"The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors.

"SEC. 3254. APPLICATION.

"A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum—

"(1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant;

"(2) details a plan to increase participation rates of eligible collectors as authorized collectors; and

"(3) describes how the State will select eligible collectors to be served under the grant.

"SEC. 3255. USE OF GRANT FUNDS.

"A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors.

"SEC. 3256. ELIGIBILITY FOR GRANT.

"The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General.

"SEC. 3257. DURATION OF GRANTS.

"The Attorney General shall determine the period of years for which a covered grant is made to a State.

"SEC. 3258. ACCOUNTABILITY AND OVERSIGHT.

"A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that—

"(1) lists the ultimate recipients of the grant amounts;

"(2) describes the activities undertaken by the State using the grant amounts; and

"(3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors.

"SEC. 3259. DURATION OF PROGRAM.

"The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act [Oct. 24, 2018].

"SEC. 3260. AUTHORIZATION OF APPROPRIATIONS.

"There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter."
21 U.S.C. § 333a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 333a: Repealed. Pub. L. 101-647, title XIX, §1905, Nov. 29, 1990, 104 Stat. 4853
Repealed. Pub. L. 101-647, title XIX, §1905, Nov. 29, 1990, 104 Stat. 4853
Status: repealed

Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and illegal trafficking in steroids or human growth hormones.
21 U.S.C. § 360oo (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360oo: Prohibited acts
Prohibited acts
Status: in_force

(a) It shall be unlawful—

(1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any electronic product which does not comply with an applicable standard prescribed pursuant to section 360kk of this title;

(2) for any person to fail to furnish any notification or other material or information required by section 360ll or 360nn of this title; or to fail to comply with the requirements of section 360ll(f) of this title;

(3) for any person to fail or to refuse to establish or maintain records required by this part or to permit access by the Secretary or any of his duly authorized representatives to, or the copying of, such records, or to permit entry or inspection, as required by or pursuant to section 360nn of this title;

(4) for any person to fail or to refuse to make any report required pursuant to section 360nn(b) of this title or to furnish or preserve any information required pursuant to section 360nn(f) of this title; or

(5) for any person (A) to fail to issue a certification as required by section 360kk(h) of this title, or (B) to issue such a certification when such certification is not based upon a test or testing program meeting the requirements of section 360kk(h) of this title or when the issuer, in the exercise of due care, would have reason to know that such certification is false or misleading in a material respect.

(b) The Secretary may exempt any electronic product, or class thereof, from all or part of subsection (a), upon such conditions as he may find necessary to protect the public health or welfare, for the purpose of research, investigations, studies, demonstrations, or training, or for reasons of national security.

(June 25, 1938, ch. 675, §538, formerly act July 1, 1944, ch. 373, title III, §538, formerly §360B, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered §538 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(F), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263j of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263j of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1). Pub. L. 101–629, §19(a)(2)(F)(i), substituted "section 360kk" for "section 263f".

Subsec. (a)(2). Pub. L. 101–629, §19(a)(2)(F)(ii), (iii), substituted "section 360ll or 360nn" for "section 263g or 263i" and "section 360ll(f)" for "section 263g(f)".

Subsec. (a)(3). Pub. L. 101–629, §19(a)(1)(B), (2)(F)(iii), substituted "this part" for "this subpart" and "section 360nn" for "section 263i".

Subsec. (a)(4). Pub. L. 101–629, §19(a)(2)(F)(iii), substituted "section 360nn(b)" for "section 263i(b)" and "section 360nn(f)" for "section 263i(f)".

Subsec. (a)(5). Pub. L. 101–629, §19(a)(2)(F)(i), substituted "section 360kk(h)" for "section 263f(h)" in two places.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 1604 (2024) — Title 21: FOOD AND DRUGS / Chapter 21: BIOMATERIALS ACCESS ASSURANCE / Section 1604: Liability of biomaterials suppliers
Liability of biomaterials suppliers
Status: in_force

(a) In general

Except as provided in section 1606 of this title, a biomaterials supplier shall not be liable for harm to a claimant caused by an implant unless such supplier is liable—

(1) as a manufacturer of the implant, as provided in subsection (b);

(2) as a seller of the implant, as provided in subsection (c); or

(3) for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in subsection (d).

(b) Liability as manufacturer

(1) In general

A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the biomaterials supplier is the manufacturer of the implant.

(2) Grounds for liability

The biomaterials supplier may be considered the manufacturer of the implant that allegedly caused harm to a claimant only if the biomaterials supplier—

(A)(i) registered or was required to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii) included or was required to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section;

(B) is the subject of a declaration issued by the Secretary pursuant to paragraph (3) that states that the supplier, with respect to the implant that allegedly caused harm to the claimant, was required to—

(i) register with the Secretary under section 360 of this title, and the regulations issued under such section, but failed to do so; or

(ii) include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section, but failed to do so; or

(C) is related by common ownership or control to a person meeting all the requirements described in subparagraph (A) or (B), if the court deciding a motion to dismiss in accordance with section 1605(c)(3)(B)(i) of this title finds, on the basis of affidavits submitted in accordance with section 1605 of this title, that it is necessary to impose liability on the biomaterials supplier as a manufacturer because the related manufacturer meeting the requirements of subparagraph (A) or (B) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the claimant prevail.

(3) Administrative procedures

(A) In general

The Secretary may issue a declaration described in paragraph (2)(B) on the motion of the Secretary or on petition by any person, after providing—

(i) notice to the affected persons; and

(ii) an opportunity for an informal hearing.

(B) Docketing and final decision

Immediately upon receipt of a petition filed pursuant to this paragraph, the Secretary shall docket the petition. Not later than 120 days after the petition is filed, the Secretary shall issue a final decision on the petition.

(C) Applicability of statute of limitations

Any applicable statute of limitations shall toll during the period from the time a claimant files a petition with the Secretary under this paragraph until such time as either (i) the Secretary issues a final decision on the petition, or (ii) the petition is withdrawn.

(D) Stay pending petition for declaration

If a claimant has filed a petition for a declaration with respect to a defendant, and the Secretary has not issued a final decision on the petition, the court shall stay all proceedings with respect to that defendant until such time as the Secretary has issued a final decision on the petition.

(c) Liability as seller

A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable as a seller for harm to a claimant caused by an implant only if—

(1) the biomaterials supplier—

(A) held title to the implant and then acted as a seller of the implant after its initial sale by the manufacturer; or

(B) acted under contract as a seller to arrange for the transfer of the implant directly to the claimant after the initial sale by the manufacturer of the implant; or

(2) the biomaterials supplier is related by common ownership or control to a person meeting all the requirements described in paragraph (1), if a court deciding a motion to dismiss in accordance with section 1605(c)(3)(B)(ii) of this title finds, on the basis of affidavits submitted in accordance with section 1605 of this title, that it is necessary to impose liability on the biomaterials supplier as a seller because the related seller meeting the requirements of paragraph (1) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the claimant prevail.

(d) Liability for failure to meet applicable contractual requirements or specifications

A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the claimant in an action shows, by a preponderance of the evidence, that—

(1) the biomaterials supplier supplied raw materials or component parts for use in the implant that either—

(A) did not constitute the product described in the contract between the biomaterials supplier and the person who contracted for the supplying of the product; or

(B) failed to meet any specifications that were—

(i) accepted, pursuant to applicable law, by the biomaterials supplier;

(ii) published by the biomaterials supplier;

(iii) provided by the biomaterials supplier to the person who contracted for such product;

(iv) contained in a master file that was submitted by the biomaterials supplier to the Secretary and that is currently maintained by the biomaterials supplier for purposes of premarket approval of medical devices; or

(v) included in the submissions for purposes of premarket approval or review by the Secretary under section 360, 360c, 360e, or 360j of this title, and received clearance from the Secretary if such specifications were accepted, pursuant to applicable law, by the biomaterials supplier; and

(2) such failure to meet applicable contractual requirements or specifications was an actual and proximate cause of the harm to the claimant.

(Pub. L. 105–230, §5, Aug. 13, 1998, 112 Stat. 1524.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.
21 U.S.C. § 956 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 956: Exemption authority
Exemption authority
Status: in_force

(a) Individual possessing controlled substance

(1) Subject to paragraph (2), the Attorney General may by regulation exempt from sections 952(a) and (b), 953, 954, and 955 of this title any individual who has a controlled substance (except a substance in schedule I) in his possession for his personal medical use, or for administration to an animal accompanying him, if he lawfully obtained such substance and he makes such declaration (or gives such other notification) as the Attorney General may by regulation require.

(2) Notwithstanding any exemption under paragraph (1), a United States resident who enters the United States through an international land border with a controlled substance (except a substance in schedule I) for which the individual does not possess a valid prescription issued by a practitioner (as defined in section 802 of this title) in accordance with applicable Federal and State law (or documentation that verifies the issuance of such a prescription to that individual) may not import the controlled substance into the United States in an amount that exceeds 50 dosage units of the controlled substance.

(b) Compound, mixture, or preparation

The Attorney General may by regulation except any compound, mixture, or preparation containing any depressant or stimulant substance listed in paragraph (a) or (b) of schedule III or in schedule IV or V from the application of all or any part of this subchapter if (1) the compound, mixture, or preparation contains one or more active medicinal ingredients not having a depressant or stimulant effect on the central nervous system, and (2) such ingredients are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse of the substances which do have a depressant or stimulant effect on the central nervous system.

(Pub. L. 91–513, title III, §1006, Oct. 27, 1970, 84 Stat. 1288; Pub. L. 105–277, div. C, title VIII, §872(a), Oct. 21, 1998, 112 Stat. 2681–707; Pub. L. 105–357, §2(a), Nov. 10, 1998, 112 Stat. 3271.)

Editorial Notes

References in Text

Schedules I, III, IV, and V, referred to in text, are set out in section 812(c) of this title.

Amendments

1998—Subsec. (a). Pub. L. 105–277 and Pub. L. 105–357 amended subsec. (a) identically, designating existing provisions as par. (1), substituting "Subject to paragraph (2), the Attorney General" for "The Attorney General", and adding par. (2).

Statutory Notes and Related Subsidiaries

Federal Minimum Requirement

Pub. L. 105–357, §2(b), Nov. 10, 1998, 112 Stat. 3271, provided that: "Section 1006(a)(2) of the Controlled Substances Import and Export Act [21 U.S.C. 956(a)(2)], as added by this section, is a minimum Federal requirement and shall not be construed to limit a State from imposing any additional requirement."

Pub. L. 105–277, div. C, title VIII, §872(b), Oct. 21, 1998, 112 Stat. 2681–707, enacted a provision substantially identical to that enacted by Pub. L. 105–357, §2(b), set out above.

Jurisdiction of Secretary of Health and Human Services

Pub. L. 105–277, div. C, title VIII, §872(c), Oct. 21, 1998, 112 Stat. 2681–707, and Pub. L. 105–357, §2(c), Nov. 10, 1998, 112 Stat. 3271, provided that: "The amendment made by subsection (a) [amending this section] shall not be construed to affect the jurisdiction of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.)."
21 U.S.C. § 886 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 886: Payments and advances
Payments and advances
Status: in_force

(a) Payment to informers

The Attorney General is authorized to pay any person, from funds appropriated for the Drug Enforcement Administration, for information concerning a violation of this subchapter, such sum or sums of money as he may deem appropriate, without reference to any moieties or rewards to which such person may otherwise be entitled by law.

(b) Reimbursement for purchase of controlled substances

Moneys expended from appropriations of the Drug Enforcement Administration for purchase of controlled substances and subsequently recovered shall be reimbursed to the current appropriation for the Administration.1

(c) Advance of funds for enforcement purposes

The Attorney General is authorized to direct the advance of funds by the Treasury Department in connection with the enforcement of this subchapter.

(d) Drug Pollution Fund

(1) There is established in the Treasury a trust fund to be known as the "Drug Pollution Fund" (hereinafter referred to in this subsection as the "Fund"), consisting of amounts appropriated or credited to such Fund under section 841(b)(6) of this title.

(2) There are hereby appropriated to the Fund amounts equivalent to the fines imposed under section 841(b)(6) of this title.

(3) Amounts in the Fund shall be available, as provided in appropriations Acts, for the purpose of making payments in accordance with paragraph (4) for the clean up of certain pollution resulting from the actions referred to in section 841(b)(6) of this title.

(4)(A) The Secretary of the Treasury, after consultation with the Attorney General, shall make payments under paragraph (3), in such amounts as the Secretary determines appropriate, to the heads of executive agencies or departments that meet the requirements of subparagraph (B).

(B) In order to receive a payment under paragraph (3), the head of an executive agency or department shall submit an application in such form and containing such information as the Secretary of the Treasury shall by regulation require. Such application shall contain a description of the fine imposed under section 841(b)(6) of this title, the circumstances surrounding the imposition of such fine, and the type and severity of pollution that resulted from the actions to which such fine applies.

(5) For purposes of subchapter B of chapter 98 of title 26, the Fund established under this paragraph shall be treated in the same manner as a trust fund established under subchapter A of such chapter.

(Pub. L. 91–513, title II, §516, Oct. 27, 1970, 84 Stat. 1279; Pub. L. 96–132, §16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 100–690, title VI, §6254(i), Nov. 18, 1988, 102 Stat. 4367.)

Editorial Notes

Codification

In subsec. (b), "Administration" substituted for "Bureau" as the probable intent of Congress in view of amendment by Pub. L. 96–132, which substituted references to the Drug Enforcement Administration for references to the Bureau of Narcotics and Dangerous Drugs wherever appearing in text.

Amendments

1988—Subsec. (d). Pub. L. 100–690 added subsec. (d).

1979—Subsecs. (a), (b). Pub. L. 96–132 substituted "Drug Enforcement Administration" for "Bureau of Narcotics and Dangerous Drugs".

Statutory Notes and Related Subsidiaries

Reimbursement by Drug Enforcement Administration of Expenses Incurred To Remediate Methamphetamine Laboratories

Pub. L. 106–310, div. B, title XXXVI, §3672, Oct. 17, 2000, 114 Stat. 1246, provided that:

"(a) Reimbursement Authorized.—The Attorney General, acting through the Administrator of the Drug Enforcement Administration, may reimburse States, units of local government, Indian tribal governments, other public entities, and multi-jurisdictional or regional consortia thereof for expenses incurred to clean up and safely dispose of substances associated with clandestine methamphetamine laboratories which may present a danger to public health or the environment.

"(b) Additional DEA Personnel.—From amounts appropriated or otherwise made available to carry out this section, the Attorney General may hire not more than five additional Drug Enforcement Administration personnel to administer this section.

"(c) Authorization of Appropriations.—There is authorized to be appropriated to the Attorney General to carry out this section $20,000,000 for fiscal year 2001."

1 See Codification note below.
21 U.S.C. § 360hh (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360hh: Definitions
Definitions
Status: in_force

As used in this part—

(1) the term "electronic product radiation" means—

(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or

(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;

(2) the term "electronic product" means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;

(3) the term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products;

(4) the term "commerce" means (A) commerce between any place in any State and any place outside thereof; and (B) commerce wholly within the District of Columbia; and

(5) the term "State" includes the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, and American Samoa.

(June 25, 1938, ch. 675, §531, formerly act July 1, 1944, ch. 373, title III, §531, formerly §355, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L. 94–484, title IX, §905(b)(1), Oct. 12, 1976, 90 Stat. 2325; renumbered §531 and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263c of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263c of Title 42, The Public Health and Welfare, as this section.

1990—Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in introductory provisions.

1976—Par. (5). Pub. L. 94–484 defined "State" to include Northern Mariana Islands.

Statutory Notes and Related Subsidiaries

Short Title

For short title of Pub. L. 90–602, which enacted provisions now comprising this part (§§360hh to 360ss), as the "Radiation Control for Health and Safety Act of 1968", see section 1 of Pub. L. 90–602, set out as a Short Title of 1968 Amendments note under section 301 of this title.

Transfer of Subpart; Construction

Pub. L. 101–629, §19(c), Nov. 28, 1990, 104 Stat. 4530, provided that: "The transfer of subpart 3 of part F of title III of the Public Health Service Act [42 U.S.C. 263b et seq.] to the Federal Food, Drug, and Cosmetic Act [this chapter] does not change the application of the requirements of such subpart and such Act to electronic products which were in effect on the date of the enactment of this Act [Nov. 28, 1990]."

Definition of "Secretary" and "Department"

Pub. L. 90–602, §3, Oct. 18, 1968, 82 Stat. 1186, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "As used in the amendments made by section 2 of this Act [enacting provisions now comprising sections 360hh to 360ss of this title], except when otherwise specified, the term 'Secretary' means the Secretary of Health and Human Services, and the term 'Department' means the Department of Health and Human Services."

Noninterference With Other Federal Agencies

Pub. L. 90–602, §4, Oct. 18, 1968, 82 Stat. 1187, provided that: "The amendments made by section 2 of this Act [enacting provisions now comprising sections 360hh to 360ss of this title] shall not be construed as superseding or limiting the functions, under any other provision of law, of any officer or agency of the United States."
21 U.S.C. § 350m (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350m: Requirements for critical food
Requirements for critical food
Status: in_force

(a) Notification of meaningful disruption for critical food

(1) In general

A manufacturer of a critical food (as defined in section 321(ss) of this title) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.

(2) Distribution of information

Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.

(3) Confidentiality

Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(4) Meaningful disruption

In this subsection, the term "meaningful disruption"—

(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and

(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

(b) Risk management plans

Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection—

(1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment;

(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and

(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 374 of this title.

(c) Failure to meet requirements

(1) In general

If a person fails to submit information required under, and in accordance with, subsection (a)—

(A) the Secretary shall issue a letter to such person informing such person of such failure; and

(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)—

(i) the letter issued under subparagraph (A); and

(ii) at the request of such person, any response to such letter such person submitted to the Secretary.

(2) Exception

If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply.

(June 25, 1938, ch. 675, §424, as added Pub. L. 117–328, div. FF, title III, §3401(k), Dec. 29, 2022, 136 Stat. 5844.)
21 U.S.C. § 1402 (2024) — Title 21: FOOD AND DRUGS / Chapter 19: PESTICIDE MONITORING IMPROVEMENTS / Section 1402: Foreign pesticide information
Foreign pesticide information
Status: in_force

(a) Cooperative agreements

The Secretary of Health and Human Services shall enter into cooperative agreements with the governments of the countries which are the major sources of food imports into the United States subject to pesticide residue monitoring by the Food and Drug Administration for the purpose of improving the ability of the Food and Drug Administration to assure compliance with the pesticide tolerance requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with regard to imported food.

(b) Information activities

(1) The cooperative agreements entered into under subsection (a) with governments of foreign countries shall specify the action to be taken by the parties to the agreements to accomplish the purpose described in subsection (a), including the means by which the governments of the foreign countries will provide to the Secretary of Health and Human Services current information identifying each of the pesticides used in the production, transportation, and storage of food products imported from production regions of such countries into the United States.

(2) In the case of a foreign country with which the Secretary is unable to enter into an agreement under subsection (a) or for which the information provided under paragraph (1) is insufficient to assure an effective pesticide monitoring program, the Secretary shall, to the extent practicable, obtain the information described in paragraph (1) with respect to such country from other Federal or international agencies or private sources.

(3) The Secretary of Health and Human Services shall assure that appropriate offices of the Food and Drug Administration which are engaged in the monitoring of imported food for pesticide residues receive the information obtained under paragraph (1) or (2).

(4) The Secretary of Health and Human Services shall make available any information obtained under paragraph (1) or (2) to State agencies engaged in the monitoring of imported food for pesticide residues other than information obtained from private sources the disclosure of which to such agencies is restricted.

(c) Coordination with other agencies

The Secretary of Health and Human Services shall—

(1) notify in writing the Department of Agriculture, the Environmental Protection Agency, and the Department of State at the initiation of negotiations with a foreign country to develop a cooperative agreement under subsection (a); and

(2) coordinate the activities of the Department of Health and Human Services with the activities of those departments and agencies, as appropriate, during the course of such negotiations.

(d) Report

Not later than one year after August 23, 1988, the Secretary of Health and Human Services shall report to the Committee on Agriculture, Nutrition, and Forestry and the Committee on Labor and Human Resources of the Senate and the House of Representatives on the activities undertaken by the Secretary to implement this section. The report shall be made available to appropriate Federal and State agencies and to interested persons.

(Pub. L. 100–418, title IV, §4703, Aug. 23, 1988, 102 Stat. 1413.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
21 U.S.C. § 21 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 21: Branding grades on barrels of apples
Branding grades on barrels of apples
Status: in_force

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

(Aug. 3, 1912, ch. 273, §3, 37 Stat. 251.)
21 U.S.C. § 114e (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter III: PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION / Section 114e: Repealed. Pub. L. 107-171, title X, §10418(a)(10), (11), May 13, 2002, 116 Stat. 508
Repealed. Pub. L. 107-171, title X, §10418(a)(10), (11), May 13, 2002, 116 Stat. 508
Status: repealed

Section 114e, act June 16, 1948, ch. 477, §1, 62 Stat. 458, related to research and investigations into the control and eradication of cattle grubs.

Section 114f, act June 16, 1948, ch. 477, §2, 62 Stat. 458, defined the term "State" and authorized appropriations.

Section 114g, Pub. L. 87–209, §1, Sept. 6, 1961, 75 Stat. 481, related to hog cholera eradication program.

Section 114h, Pub. L. 87–209, §2, Sept. 6, 1961, 75 Stat. 481, related to advisory committee.
21 U.S.C. § 359 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 359: Nonapplicability of subchapter to cosmetics
Nonapplicability of subchapter to cosmetics
Status: in_force

This subchapter, as amended by the Drug Amendments of 1962, shall not apply to any cosmetic unless such cosmetic is also a drug or device or component thereof.

(June 25, 1938, ch. 675, §509, as added Pub. L. 87–781, title I, §113, Oct. 10, 1962, 76 Stat. 791.)

Editorial Notes

References in Text

This subchapter, as amended by the Drug Amendments of 1962, referred to in text, means the amendment of this subchapter by Pub. L. 87–781 which enacted sections 358 to 360 of this title, amended sections 351 to 353, 355, and 357 of this title, and enacted provisions set out as notes under sections 352, 355, 358, and 360 of this title.

The Drug Amendments of 1962, referred to in text, is Pub. L. 87–781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete classification of this Act to the Code, see Short Title of 1962 Amendment note set out under section 301 of this title and Tables.
21 U.S.C. § 679c (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 679c: Expansion of Food Safety Inspection Service activities
Expansion of Food Safety Inspection Service activities
Status: in_force

(a) In general

The Secretary of Agriculture may utilize existing authorities to give high priority to enhancing and expanding the capacity of the Food Safety Inspection Service to conduct activities to—

(1) enhance the ability of the Service to inspect and ensure the safety and wholesomeness of meat and poultry products;

(2) improve the capacity of the Service to inspect international meat and meat products, poultry and poultry products, and egg products at points of origin and at ports of entry;

(3) strengthen the ability of the Service to collaborate with relevant agencies within the Department of Agriculture and with other entities in the Federal Government, the States, and Indian tribes (as defined in section 5304(e) of title 25) through the sharing of information and technology; and

(4) otherwise expand the capacity of the Service to protect against the threat of bioterrorism.

(b) Authorization of appropriations

There is authorized to be appropriated to carry out this section, $15,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

(Pub. L. 107–188, title III, §332, June 12, 2002, 116 Stat. 679.)

Editorial Notes

Codification

Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.
21 U.S.C. § 335c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 335c: Authority to withdraw approval of abbreviated drug applications
Authority to withdraw approval of abbreviated drug applications
Status: in_force

(a) In general

The Secretary—

(1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement, and

(2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing practice set forth in the abbreviated drug application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce.

(b) Procedure

The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(c) Applicability

Subsection (a) shall apply with respect to offenses or acts regardless of when such offenses or acts occurred.

(d) Judicial review

Any person that is the subject of an adverse decision under subsection (a) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside.

(June 25, 1938, ch. 675, §308, as added Pub. L. 102–282, §4, May 13, 1992, 106 Stat. 160.)

Statutory Notes and Related Subsidiaries

Construction

This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
21 U.S.C. § 2004 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter I: ANTI-DOPING AGENCY / Section 2004: Information sharing
Information sharing
Status: in_force

Except as otherwise prohibited by law and except in cases in which the integrity of a criminal investigation would be affected, pursuant to the obligation of the United States under Article 7 of the United Nations Educational, Scientific, and Cultural Organization International Convention Against Doping in Sport done at Paris October 19, 2005, and ratified by the United States in 2008, the Attorney General, the Secretary of Homeland Security, and the Commissioner of Food and Drugs shall provide to the United States Anti-Doping Agency any relevant information relating to the prevention of the use of performance-enhancing drugs or the prohibition of performance-enhancing methods.

(Pub. L. 117–103, div. Q, title III, §305, Mar. 15, 2022, 136 Stat. 817.)

Editorial Notes

Codification

Section was enacted as part of the United States Anti-Doping Agency Reauthorization Act of 2022 and also as part of the Consolidated Appropriations Act, 2022, and not as part of title VII of Pub. L. 109–469 which comprises this chapter.
21 U.S.C. § 156 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 156: Licenses conditioned on permitting inspection; suspension of licenses
Licenses conditioned on permitting inspection; suspension of licenses
Status: in_force

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

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning act Mar. 4, 1913, ch. 145, 37 Stat. 828, which enacted this chapter, sections 155 and 393 of Title 7, Agriculture, section 316 of Title 15, Commerce and Trade, sections 501, 502, 512, 558, and 560 of Title 16, Conservation, and section 630 of former Title 31, Money and Finance, and amended section 83 of former Title 5, Executive Departments and Government Officers and Employees, and sections 518 and 673 of Title 16.

Section 316 of Title 15 was omitted from the Code as superseded by section 5701 et seq. of Title 5, Government Organization and Employees. Section 630 of former Title 31 was repealed by act Sept. 12, 1950, ch. 946, title III, §301(64), 64 Stat. 842. Section 83 of former Title 5 was repealed and reenacted as section 5946 of Title 5 by Pub. L. 89–554, Sept. 6, 1966, 80 Stat. 514. For complete classification of act Mar. 4, 1913, to the Code, see Tables.

Codification

See note set out under section 151 of this title.

Statutory Notes and Related Subsidiaries

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.
21 U.S.C. § 886a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 886a: Diversion Control Fee Account
Diversion Control Fee Account
Status: in_force

(1) In general

There is established in the general fund of the Treasury a separate account which shall be known as the Diversion Control Fee Account. For fiscal year 1993 and thereafter:

(A) There shall be deposited as offsetting receipts into that account all fees collected by the Drug Enforcement Administration, in excess of $15,000,000, for the operation of its diversion control program.

(B) Such amounts as are deposited into the Diversion Control Fee Account shall remain available until expended and shall be refunded out of that account by the Secretary of the Treasury, at least on a quarterly basis, to reimburse the Drug Enforcement Administration for expenses incurred in the operation of the diversion control program. Such reimbursements shall be made without distinguishing between expenses related to controlled substance activities and expenses related to chemical activities.

(C) Fees charged by the Drug Enforcement Administration under its diversion control program shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that program.

(D) The amount required to be refunded from the Diversion Control Fee Account for fiscal year 1994 and thereafter shall be refunded in accordance with estimates made in the budget request of the Attorney General for those fiscal years. Any proposed changes in the amounts designated in said budget requests shall only be made after notification to the Committees on Appropriations of the House of Representatives and the Senate fifteen days in advance.

(2) Definitions

In this section:

(A) Diversion control program

The term "diversion control program" means the controlled substance and chemical diversion control activities of the Drug Enforcement Administration.

(B) Controlled substance and chemical diversion control activities

The term "controlled substance and chemical diversion control activities" means those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals.

(Pub. L. 102–395, title I, §111(b), Oct. 6, 1992, 106 Stat. 1843; Pub. L. 105–362, title X, §1001(b), Nov. 10, 1998, 112 Stat. 3291; Pub. L. 108–447, div. B, title VI, §633(a), Dec. 8, 2004, 118 Stat. 2921.)

Editorial Notes

Codification

Section was enacted as part of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1993, and not as part of the Controlled Substances Act which comprises this subchapter.

Amendments

2004—Pub. L. 108–447, §633(a)(2) to (4), designated existing provisions as par. (1) and inserted heading, substituted "program. Such reimbursements shall be made without distinguishing between expenses related to controlled substance activities and expenses related to chemical activities" for "program" in par. (1)(B), and added par. (2).

Pub. L. 108–447, §633(a)(1), which directed redesignation of pars. (1) to (5) as subpars. (A) to (E) and adjustment of margins, was executed by redesignating pars. (1) to (4) as (A) to (D), respectively, to reflect the probable intent of Congress, because Pub. L. 105–362 struck out par. (5). See 1998 Amendment note below.

1998—Par. (5). Pub. L. 105–362 struck out par. (5) which read as follows: "The Attorney General shall prepare and submit annually to the Congress, statements of financial condition of the account, including the beginning balance, receipts, refunds to appropriations, transfers to the general fund, and the ending balance."
21 U.S.C. § 1049 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1049: Seizure and condemnation proceedings
Seizure and condemnation proceedings
Status: in_force

(a) Jurisdiction; disposal of condemned articles; court costs and fees; conformity to supplemental rules for admiralty and maritime claims; jury trial; United States as plaintiff

Any eggs or egg products that are or have been processed, bought, sold, possessed, used, transported, or offered or received for sale or transportation, in violation of this chapter, or in any other way are in violation of this chapter; and any restricted eggs, capable of use as human food, in the possession of any person not authorized to acquire such eggs under the regulations of the Secretary shall be liable to be proceeded against and seized and condemned, at any time, on a complaint in any United States district court or other proper court as provided in section 1050 of this title within the jurisdiction of which the articles are found. If the articles are condemned they shall, after entry of the decree, be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the articles shall not be sold contrary to the provision of this chapter, the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.], or the laws of the jurisdiction in which they are sold: Provided, That upon the execution and delivery of a good and sufficient bond conditioned that the articles shall not be sold or otherwise disposed of contrary to the provisions of this chapter, the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, or the laws of the jurisdiction in which disposal is made, the court may direct that they be delivered to the owner thereof subject to such supervision by authorized representatives of the Secretary as is necessary to insure compliance with the applicable laws. When a decree of condemnation is entered against the articles and they are released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant thereof. The proceedings in such cases shall conform, as nearly as may be, to the supplemental rules for certain admiralty and maritime claims, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States.

(b) Condemnation or seizure under other provisions unaffected

The provisions of this section shall in no way derogate from authority for condemnation or seizure conferred by other provisions of this chapter, or other laws.

(Pub. L. 91–597, §20, Dec. 29, 1970, 84 Stat. 1631.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, 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.

The supplemental rules for certain admiralty and maritime claims, referred to in subsec. (a), were renamed the Supplemental Rules for Admiralty or Maritime Claims and Asset Forfeiture Actions and are set out as part of the Federal Rules of Civil Procedure in the Appendix to Title 28, Judiciary and Judicial Procedure.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 603 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 603: Examination of animals prior to slaughter; use of humane methods
Examination of animals prior to slaughter; use of humane methods
Status: in_force

(a) Examination of animals before slaughtering; diseased animals slaughtered separately and carcasses examined

For the purpose of preventing the use in commerce of meat and meat food products which are adulterated, the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all amenable species before they shall be allowed to enter into any slaughtering, packing, meat-canning, rendering, or similar establishment, in which they are to be slaughtered and the meat and meat food products thereof are to be used in commerce; and all amenable species found on such inspection to show symptoms of disease shall be set apart and slaughtered separately from all other cattle, sheep, swine, goats, horses, mules, or other equines, and when so slaughtered the carcasses of said cattle, sheep, swine, goats, horses, mules, or other equines shall be subject to a careful examination and inspection, all as provided by the rules and regulations to be prescribed by the Secretary, as provided for in this subchapter.

(b) Humane methods of slaughter

For the purpose of preventing the inhumane slaughtering of livestock, the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of the method by which amenable species are slaughtered and handled in connection with slaughter in the slaughtering establishments inspected under this chapter. The Secretary may refuse to provide inspection to a new slaughtering establishment or may cause inspection to be temporarily suspended at a slaughtering establishment if the Secretary finds that any cattle, sheep, swine, goats, horses, mules, or other equines have been slaughtered or handled in connection with slaughter at such establishment by any method not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906) until the establishment furnishes assurances satisfactory to the Secretary that all slaughtering and handling in connection with slaughter of livestock shall be in accordance with such a method.

(Mar. 4, 1907, ch. 2907, title I, §3, formerly 1st par., 34 Stat. 1260; renumbered §3 and amended Pub. L. 90–201, §§1, 3, 12(a), (b), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 95–445, §2, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

References in Text

Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classified generally to chapter 48 (§1901 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Tables.

Sections 1903 and 1905 of Title 7, included within reference to Act of August 27, 1958, were repealed by Pub. L. 95–445, §5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note below.

Codification

Section was formerly classified to section 71 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines" wherever appearing.

1978—Pub. L. 95–445 designated existing provisions as subsec. (a) and added subsec. (b).

1967—Pub. L. 90–201, §§3, 12(a), (b), struck out "interstate or foreign" before "commerce" in two places, substituted "Secretary shall" for "Secretary, at his discretion, may", and struck out "of Agriculture" after "Secretary", included horses, mules, and other equines, and horses, mules, or other equines in the list of animals, and substituted "adulterated" for "unsound, unhealthful, unwholesome, or otherwise unfit for human food", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1978 Amendment

Pub. L. 95–445, §7, Oct. 10, 1978, 92 Stat. 1070, provided that: "The provisions of this Act [see Short Title of 1978 Amendment note set out under section 601 of this title] shall become effective one year after the date of enactment [Oct. 10, 1978]. However, such provisions shall not apply to a person, firm, or corporation for such additional period of time, not to exceed eighteen months, as may be determined by the Secretary, if the Secretary, upon application, finds that compliance with the provisions of this Act on its effective date would cause undue hardship on such person, firm, or corporation."

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

Religious Freedom; Ritual Slaughter

Pub. L. 95–445, §6, Oct. 10, 1978, 92 Stat. 1070, provided that: "Nothing in this Act [see Short Title of 1978 Amendment note set out under section 601 of this title] shall be construed to prohibit, abridge, or in any way hinder the religious freedom of any person or group. Notwithstanding any other provision of this Act, in order to protect freedom of religion, ritual slaughter and the handling or other preparation of livestock for ritual slaughter are exempted from the terms of this Act. For the purposes of this section the term 'ritual slaughter' means slaughter in accordance with section 2(b) of the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1902(b))."
21 U.S.C. § 885 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 885: Burden of proof; liabilities
Burden of proof; liabilities
Status: in_force

(a) Exemptions and exceptions; presumption in simple possession offenses

(1) It shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceeding under this subchapter, and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.

(2) In the case of a person charged under section 844(a) of this title with the possession of a controlled substance, any label identifying such substance for purposes of section 353(b)(2) of this title shall be admissible in evidence and shall be prima facie evidence that such substance was obtained pursuant to a valid prescription from a practitioner while acting in the course of his professional practice.

(b) Registration and order forms

In the absence of proof that a person is the duly authorized holder of an appropriate registration or order form issued under this subchapter, he shall be presumed not to be the holder of such registration or form, and the burden of going forward with the evidence with respect to such registration or form shall be upon him.

(c) Use of vehicles, vessels, and aircraft

The burden of going forward with the evidence to establish that a vehicle, vessel, or aircraft used in connection with controlled substances in schedule I was used in accordance with the provisions of this subchapter shall be on the persons engaged in such use.

(d) Immunity of Federal, State, local and other officials

Except as provided in sections 2234 and 2235 of title 18, no civil or criminal liability shall be imposed by virtue of this subchapter upon any duly authorized Federal officer lawfully engaged in the enforcement of this subchapter, or upon any duly authorized officer of any State, territory, political subdivision thereof, the District of Columbia, or any possession of the United States, who shall be lawfully engaged in the enforcement of any law or municipal ordinance relating to controlled substances.

(Pub. L. 91–513, title II, §515, Oct. 27, 1970, 84 Stat. 1279.)

Editorial Notes

References in Text

Schedule I, referred to in subsec. (c), is set out in section 812(c) of this title.
21 U.S.C. § 379o (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379o: Environmental impact
Environmental impact
Status: in_force

Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the regulations published in part 25 of title 21, Code of Federal Regulations (as in effect on August 31, 1997) in connection with an action carried out under (or a recommendation or report relating to) this chapter, shall be considered to meet the requirements for a detailed statement under section 4332(2)(C) of title 42.

(June 25, 1938, ch. 675, §749, formerly §746, as added Pub. L. 105–115, title IV, §411, Nov. 21, 1997, 111 Stat. 2373; renumbered §749, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

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. § 1121 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter II: DRUG ABUSE POLICY COORDINATION / Section 1121: Repealed. Pub. L. 92-255, title I, §104, Mar. 21, 1972, 86 Stat. 67
Repealed. Pub. L. 92-255, title I, §104, Mar. 21, 1972, 86 Stat. 67
Status: repealed

Section 1121, Pub. L. 92–255, title II, §211, Mar. 21, 1972, 86 Stat. 69, provided for appointment of an acting Director until position was initially filled.

Section 1122, Pub. L. 92–255, title II, §213, Mar. 21, 1972, 86 Stat. 69, prohibited Director or any other Federal officer from waiving or disregarding any limitation or requirement prescribed by law with respect to any Federal program or activity.

Section 1123, Pub. L. 92–255, title II, §214, Mar. 21, 1972, 86 Stat. 70, provided for authorization of appropriations, and fiscal year availability of such appropriations.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Section 1104 of this title, prior to repeal by Pub. L. 94–237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244, provided for repeal of sections effective June 30, 1975.
21 U.S.C. § 155 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 155: Permits for importation
Permits for importation
Status: in_force

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

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Statutory Notes and Related Subsidiaries

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.
21 U.S.C. § 346b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 346b: Authorization of appropriations
Authorization of appropriations
Status: in_force

There are authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of sections 321(q), (r), 342(a)(2), and 346a of this title.

(July 22, 1954, ch. 559, §4, 68 Stat. 517.)

Editorial Notes

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 387b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387b: Adulterated tobacco products
Adulterated tobacco products
Status: in_force

A tobacco product shall be deemed to be adulterated if—

(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;

(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;

(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;

(5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;

(6)(A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or

(B) it is in violation of an order under section 387j(c)(1)(A) of this title;

(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or

(8) it is in violation of section 387k of this title.

(June 25, 1938, ch. 675, §902, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1787.)

Editorial Notes

Prior Provisions

A prior section 902 of act June 25, 1938, was renumbered section 1002. Subsec. (a) of section 1002 is set out as a note under section 301 of this title. Subsecs. (b) and (c) of section 1002 are classified to section 392 of this title. Subsec. (d) of section 1002 is set out as a note under section 392 of this title.
21 U.S.C. § 356b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356b: Reports of postmarketing studies
Reports of postmarketing studies
Status: in_force

(a) Submission

(1) In general

A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary.

(2) Accelerated approval

Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under section 356(c) of this title, including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.

(3) Agreements prior to effective date

Any agreement entered into between the Secretary and a sponsor of a drug, prior to November 21, 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).

(b) Consideration of information as public information

Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary—

(1) to identify the sponsor; and

(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study.

(c) Status of studies and reports

The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies—

(1) that sponsors have entered into agreements to conduct; and

(2) for which reports have been submitted under subsection (a)(1).

(d) Disclosure

If a sponsor fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the Internet site of the Food and Drug Administration stating that the study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement that such reasons were not satisfactory to the Secretary.

(e) Notification

With respect to studies of the type required under section 356(c)(2)(A) of this title or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under section 356(c)(2)(A) of this title or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.

(June 25, 1938, ch. 675, §506B, as added Pub. L. 105–115, title I, §130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107–188, title V, §506, June 12, 2002, 116 Stat. 693; Pub. L. 112–144, title IX, §902(c), July 9, 2012, 126 Stat. 1088; Pub. L. 117–328, div. FF, title III, §3210(b), Dec. 29, 2022, 136 Stat. 5823.)

Editorial Notes

References in Text

The effective date of this subsection, referred to in subsec. (e), is Oct. 1, 2002, see Effective Date of 2002 Amendment note set out below.

Amendments

2022—Subsec. (a)(2), (3). Pub. L. 117–328 added par. (2) and redesignated former par. (2) as (3).

2012—Subsec. (e). Pub. L. 112–144 substituted "section 356(c)(2)(A) of this title" for "section 356(b)(2)(A) of this title" in two places.

2002—Subsecs. (d), (e). Pub. L. 107–188 added subsecs. (d) and (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2002 Amendment

Pub. L. 107–188, title V, §508, June 12, 2002, 116 Stat. 694, provided that: "The amendments made by this subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending this section and sections 379g and 379h of this title] shall take effect October 1, 2002."

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Construction of 2022 Amendment

Nothing in amendment made by Pub. L. 117–328 to be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117–328, set out as a note under section 356 of this title.

Report to Congressional Committees

Pub. L. 105–115, title I, §130(b), Nov. 21, 1997, 111 Stat. 2331, provided that not later than Oct. 1, 2001, the Secretary was to submit to Congress a report containing a summary of the reports submitted under section 356b of this title and an evaluation and legislative recommendations relating to postmarketing studies of drugs.
21 U.S.C. § 356e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356e: Drug shortage list
Drug shortage list
Status: in_force

(a) Establishment

The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.

(b) Contents

For each drug on such list, the Secretary shall include the following information:

(1) The name of the drug in shortage, including the National Drug Code number for such drug.

(2) The name of each manufacturer of such drug.

(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:

(A) Requirements related to complying with good manufacturing practices.

(B) Regulatory delay.

(C) Shortage of an active ingredient.

(D) Shortage of an inactive ingredient component.

(E) Discontinuance of the manufacture of the drug.

(F) Delay in shipping of the drug.

(G) Demand increase for the drug.

(4) The estimated duration of the shortage as determined by the Secretary.

(c) Public availability

(1) In general

Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.

(2) Trade secrets and confidential information

Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.

(3) Public health exception

The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).

(d) Interagency notification

Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.

(June 25, 1938, ch. 675, §506E, as added Pub. L. 112–144, title X, §1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, §3112(c), Mar. 27, 2020, 134 Stat. 362.)

Editorial Notes

Amendments

2020—Subsec. (d). Pub. L. 116–136 added subsec. (d).

2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of "discontinuance" for "discontinuation", was executed by substituting "Discontinuance" for "Discontinuation" to reflect the probable intent of Congress.

Statutory Notes and Related Subsidiaries

Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.
21 U.S.C. § 644 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter II: MEAT PROCESSORS AND RELATED INDUSTRIES / Section 644: Regulation of transactions, transportation, or importation of 4-D animals to prevent use as human food
Regulation of transactions, transportation, or importation of 4-D animals to prevent use as human food
Status: in_force

No person, firm, or corporation engaged in the business of buying, selling, or transporting in commerce, or importing, dead, dying, disabled, or diseased animals, or any parts of the carcasses of any animals that died otherwise than by slaughter, shall buy, sell, transport, offer for sale or transportation, or receive for transportation, in commerce, or import, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter, unless such transaction, transportation or importation is made in accordance with such regulations as the Secretary may prescribe to assure that such animals, or the unwholesome parts or products thereof, will be prevented from being used for human food purposes.

(Mar. 4, 1907, ch. 2907, title II, §204, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 594.)
21 U.S.C. § 963 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 963: Attempt and conspiracy
Attempt and conspiracy
Status: in_force

Any person who attempts or conspires to commit any offense defined in this subchapter shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy.

(Pub. L. 91–513, title III, §1013, Oct. 27, 1970, 84 Stat. 1291; Pub. L. 100–690, title VI, §6470(a), Nov. 18, 1988, 102 Stat. 4377.)

Editorial Notes

Amendments

1988—Pub. L. 100–690 substituted "shall be subject to the same penalties as those prescribed for the offense" for "is punishable by imprisonment or fine or both which may not exceed the maximum punishment prescribed for the offense".

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. § 1715 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1715: GAO audit
GAO audit
Status: in_force

Not later than 4 years after October 24, 2018, and every 4 years thereafter, the Comptroller General of the United States shall—

(1) conduct an audit relating to the programs and operations of—

(A) the Office; 1 and

(B) certain programs within the Office,1 including—

(i) the High Intensity Drug Trafficking Areas Program;

(ii) the Drug-Free Communities Program; and

(iii) the campaign under section 1708(f) of this title; and

(2) submit to the Director 1 and the appropriate congressional committees 1 a report containing an evaluation of and recommendations on the—

(A) policies and activities of the programs and operations subject to the audit;

(B) economy, efficiency, and effectiveness in the administration of the reviewed programs and operations; and

(C) policy or management changes needed to prevent and detect fraud and abuse in such programs and operations.

(Pub. L. 115–271, title VIII, §8220, Oct. 24, 2018, 132 Stat. 4134.)

Editorial Notes

References in Text

The terms "Office", "Director", and "appropriate congressional committees", referred to in text, probably have the meanings given such terms in section 1701 of this title.

Codification

Section was enacted as part of the Substance Abuse Prevention Act of 2018, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Office of National Drug Control Policy Reauthorization Act of 1998 which comprises this chapter.

1 See References in Text note below.
21 U.S.C. § 968 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 968: Service of subpena; proof of service
Service of subpena; proof of service
Status: in_force

A subpena of the Secretary of the Treasury may be served by any person designated in the subpena to serve it. Service upon a natural person may be made by personal delivery of the subpena to him. Service may be made upon a domestic or foreign corporation or upon a partnership or other unincorporated association which is subject to suit under a common name, by delivering the subpena to an officer, a managing or general agent, or to any other agent authorized by appointment or by law to receive service of process. The affidavit of the person serving the subpena entered on a true copy thereof by the person serving it shall be proof of service.

(Aug. 11, 1955, ch. 800, §2, 69 Stat. 685.)

Editorial Notes

Codification

Section was not enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which comprises this chapter.

Section was formerly classified to section 1035 of Title 31 prior to the general revision and enactment of Title 31, Money and Finance, by Pub. L. 97–258, §1, Sept. 13, 1982, 96 Stat. 877.

Section was also formerly classified to section 198b of this title.
21 U.S.C. § 1035 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1035: Sanitary operating practices in official plants
Sanitary operating practices in official plants
Status: in_force

(a) Premises, facilities, and equipment

Each official plant shall be operated in accordance with such sanitary practices and shall have such premises, facilities, and equipment as are required by regulations promulgated by the Secretary to effectuate the purposes of this chapter, including requirements for segregation and disposition of restricted eggs.

(b) Refusal by Secretary to inspect nonconforming plants

The Secretary shall refuse to render inspection to any plant whose premises, facilities, or equipment, or the operation thereof, fail to meet the requirements of this section.

(Pub. L. 91–597, §6, Dec. 29, 1970, 84 Stat. 1625.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 825 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 825: Labeling and packaging
Labeling and packaging
Status: in_force

(a) Symbol

It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in section 321(k) of this title) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances.

(b) Unlawful distribution without identifying symbol

It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in section 321(m) of this title) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a).

(c) Warning on label

The Secretary shall prescribe regulations under section 353(b) of this title which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

(d) Containers to be securely sealed

It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General.

(e) False labeling of anabolic steroids

(1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).

(2)(A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(B) A product is described in this subparagraph if the product—

(i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (j)]; or

(ii) is exempt from the provisions of section 505 of such Act relating to new drugs because—

(I) it is intended solely for investigational use as described in section 505(i) of such Act; and

(II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.

(Pub. L. 91–513, title II, §305, Oct. 27, 1970, 84 Stat. 1256; Pub. L. 113–260, §3(a), Dec. 18, 2014, 128 Stat. 2931.)

Editorial Notes

References in Text

Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in section 812(c) of this title.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

2014—Subsec. (e). Pub. L. 113–260 added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.

Identification and Publication of List of Products Containing Anabolic Steroids

Pub. L. 113–260, §4, Dec. 18, 2014, 128 Stat. 2932, provided that:

"(a) In General.—The Attorney General may, in the Attorney General's discretion, collect data and analyze products to determine whether they contain anabolic steroids and are properly labeled in accordance with this Act [see section 1 of Pub. L. 113–260, set out as a Short Title of 2014 Amendment note under section 801 of this title] and the amendments made by this Act. The Attorney General may publish in the Federal Register or on the website of the Drug Enforcement Administration a list of products which the Attorney General has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in accordance with this Act and the amendments made by this Act.

"(b) Absence From List.—The absence of a product from the list referred to in subsection (a) shall not constitute evidence that the product does not contain an anabolic steroid."
21 U.S.C. § 1523 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1523: Definitions
Definitions
Status: in_force

In this subchapter:

(1) Administrator

The term "Administrator" means the Administrator appointed by the Director under section 1531(c) of this title.

(2) Advisory Commission

The term "Advisory Commission" means the Advisory Commission established under section 1541 1 of this title.

(3) Community

The term "community" shall have the meaning provided that term by the Administrator, in consultation with the Advisory Commission.

(4) Director

The term "Director" means the Director of the Office of National Drug Control Policy.

(5) Eligible coalition

The term "eligible coalition" means a coalition that meets the applicable criteria under section 1532(a) of this title.

(6) Grant recipient

The term "grant recipient" means the recipient of a grant award under section 1532 of this title.

(7) Nonprofit organization

The term "nonprofit organization" means an organization described under section 501(c)(3) of title 26 that is exempt from taxation under section 501(a) of title 26.

(8) Program

The term "Program" means the program established under section 1531(a) of this title.

(9) Substance use and misuse

The term "substance use and misuse" means—

(A) the illegal use or misuse of drugs, including substances for which a listing is effect 2 under any of schedules I through V under section 812 of this title;

(B) the misuse of inhalants or over-the-counter drugs; or

(C) the use of alcohol, tobacco, or other related product as such use is prohibited by State or local law.

(10) Youth

The term "youth" shall have the meaning provided that term by the Administrator, in consultation with the Advisory Commission.

(Pub. L. 100–690, title I, §1023, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 225; amended Pub. L. 115–271, title VIII, §8203(b)(2), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157.)

Editorial Notes

References in Text

Section 1541 of this title, referred to in par. (2), was repealed by Pub. L. 115–271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112.

Amendments

2019—Par. (9). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(2). See 2018 Amendment note below.

2018—Par. (9). Pub. L. 115–271, §8203(b)(2), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), added par. (9) and struck out former par. (9) which defined "substance abuse".

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

1 See References in Text note below.

2 So in original.
21 U.S.C. § 469 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 469: Authorization of appropriations
Authorization of appropriations
Status: in_force

There is authorized to be appropriated such sums as are necessary to carry out the provisions of this chapter.

(Pub. L. 85–172, §26, formerly §20, Aug. 28, 1957, 71 Stat. 449, renumbered Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805.)
21 U.S.C. § 1032 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1032: Congressional declaration of policy
Congressional declaration of policy
Status: in_force

It is hereby declared to be the policy of the Congress to provide for the inspection of certain egg products, restrictions upon the disposition of certain qualities of eggs, and uniformity of standards for eggs, and otherwise regulate the processing and distribution of eggs and egg products as hereinafter prescribed to prevent the movement or sale for human food, of eggs and egg products which are adulterated or misbranded or otherwise in violation of this chapter.

(Pub. L. 91–597, §3, Dec. 29, 1970, 84 Stat. 1621.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 828 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 828: Order forms
Order forms
Status: in_force

(a) Unlawful distribution of controlled substances

It shall be unlawful for any person to distribute a controlled substance in schedule I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section.

(b) Nonapplicability of provisions

Nothing in subsection (a) shall apply to—

(1) the exportation of such substances from the United States in conformity with subchapter II;

(2) the delivery of such a substance to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business; but where such carriage or storage is in connection with the distribution by the owner of the substance to a third person, this paragraph shall not relieve the distributor from compliance with subsection (a); or

(3) the delivery of such a substance for the purpose of disposal by an ultimate user, long-term care facility, or other person acting in accordance with section 822(g) of this title.

(c) Preservation and availability

(1) Every person who in pursuance of an order required under subsection (a) distributes a controlled substance shall preserve such order for a period of two years, and shall make such order available for inspection and copying by officers and employees of the United States duly authorized for that purpose by the Attorney General, and by officers or employees of States or their political subdivisions who are charged with the enforcement of State or local laws regulating the production, or regulating the distribution or dispensing, of controlled substances and who are authorized under such laws to inspect such orders.

(2) Every person who gives an order required under subsection (a) shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with subsection (d) and regulations prescribed by him pursuant to this section, and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying by the officers and employees mentioned in paragraph (1) of this subsection.

(d) Issuance

(1) The Attorney General shall issue forms pursuant to subsections (a) and (c)(2) only to persons validly registered under section 823 of this title (or exempted from registration under section 822(d) of this title). Whenever any such form is issued to a person, the Attorney General shall, before delivery thereof, insert therein the name of such person, and it shall be unlawful for any other person (A) to use such form for the purpose of obtaining controlled substances or (B) to furnish such form to any person with intent thereby to procure the distribution of such substances.

(2) The Attorney General may charge reasonable fees for the issuance of such forms in such amounts as he may prescribe for the purpose of covering the cost to the United States of issuing such forms, and other necessary activities in connection therewith.

(e) Unlawful acts

It shall be unlawful for any person to obtain by means of order forms issued under this section controlled substances for any purpose other than their use, distribution, dispensing, or administration in the conduct of a lawful business in such substances or in the course of his professional practice or research.

(Pub. L. 91–513, title II, §308, Oct. 27, 1970, 84 Stat. 1259; Pub. L. 111–273, §3(b), Oct. 12, 2010, 124 Stat. 2860.)

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

2010—Subsec. (b)(3). Pub. L. 111–273 added par. (3).

Statutory Notes and Related Subsidiaries

Effective Date

Section 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 a note under section 801 of this title.
21 U.S.C. § 457 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 457: Labeling and container standards
Labeling and container standards
Status: in_force

(a) Requirements for shipping containers and immediate containers; nonconsumer packaged carcasses

All poultry products inspected at any official establishment under the authority of this chapter and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, on their shipping containers and immediate containers as the Secretary may require, the information required under paragraph (h) of section 453 of this title. In addition, the Secretary whenever he determines such action is practicable and necessary for the protection of the public, may require nonconsumer packaged carcasses at the time they leave the establishment to bear directly thereon in distinctly legible form any information required under such paragraph (h).

(b) Labeling requirements; definitions and standards of identity or composition or articles and standards of fill of container; standards consistent with Federal Food, Drug, and Cosmetic Act; consistency between Federal and State standards

The Secretary, whenever he determines such action is necessary for the protection of the public, may prescribe: (1) the styles and sizes of type to be used with respect to material required to be incorporated in labeling to avoid false or misleading labeling in marking and labeling any articles or poultry subject to this chapter; (2) definitions and standards of identity or composition or articles subject to this chapter and standards of fill of container for such articles not inconsistent with any such standards established under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and there shall be consultation between the Secretary and the Secretary of Health and Human Services prior to the issuance of such standards under either Act relating to articles subject to this chapter to avoid inconsistency in such standards and possible impairment of the coordinated effective administration of this chapter and the Federal Food, Drug, and Cosmetic Act. There shall also be consultation between the Secretary and an appropriate advisory committee provided for in section 454 of this title, prior to the issuance of such standards under this chapter, to avoid, insofar as feasible, inconsistency between Federal and State standards.

(c) Use of trade names; false or misleading marking or labeling; misleading form or size of container

No article subject to this chapter shall be sold or offered for sale by any person in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted.

(d) Withholding use of false or misleading mark, label, or container size or form; modification; hearing; conclusiveness of determination; appeal

If the Secretary has reason to believe that any marking or labeling or the size or form of any container in use or proposed for use with respect to any article subject to this chapter is false or misleading in any particular, he may direct that such use be withheld unless the marking, labeling, or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person using or proposing to use the marking, labeling, or container does not accept the determination of the Secretary, such person may request a hearing, but the use of the marking, labeling, or container shall, if the Secretary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after receipt of notice of such final determination, the person adversely affected thereby appeals to the United States Court of Appeals for the circuit in which such person has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. The provisions of section 194 of title 7 shall be applicable to appeals taken under this section.

(Pub. L. 85–172, §8, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90–492, §8, Aug. 18, 1968, 82 Stat. 799; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (b), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

1968—Par. (a). Pub. L. 90–492 substituted provisions requiring shipping containers and immediate containers, as the Secretary may order, to bear the information required under section 453(h) of this title, and provisions, whenever the Secretary determines such action to be practicable and necessary, requiring nonconsumer packaged carcasses at the time they leave the official establishment to bear the information required under the aforementioned section, for provisions requiring shipping containers to bear the official mark and the approved plant number of the official establishment in which the contents were processed, provisions requiring immediate containers to bear the official inspection mark, the name of the product, a statement of ingredients, the net weight or other appropriate measure of the contents, the name and address of the processor, and the approved plant number of the official establishment in which the contents were processed, and provisions authorizing the Secretary to make reasonable variations and grant exemptions from the foregoing labeling requirements.

Par. (b). Pub. L. 90–492 added par. (b). Provisions of former par. (b) were redesignated as pars. (c) and (d).

Par. (c). Pub. L. 90–492 redesignated part of provisions of former par. (b) as (c) and made changes in phraseology.

Par. (d). Pub. L. 90–492 redesignated part of provisions of former par. (b) as (d) and extended the authority of the Secretary to withhold from use products which have false or misleading markings or containers.

Statutory Notes and Related Subsidiaries

Change of Name

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

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 1906 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1906: Enforcement
Enforcement
Status: in_force

(a) Criminal penalties

(1) Whoever willfully violates the provisions of this chapter, or any license rule, or regulation issued pursuant to this chapter, or willfully neglects or refuses to comply with any order of the President issued under this chapter shall be—

(A) imprisoned for not more than 10 years,

(B) fined in the amount provided in title 18 or, in the case of an entity, fined not more than $10,000,000,

or both.

(2) Any officer, director, or agent of any entity who knowingly participates in a violation of the provisions of this chapter shall be imprisoned for not more than 30 years, fined not more than $5,000,000, or both.

(b) Civil penalties

A civil penalty not to exceed $1,000,000 may be imposed by the Secretary of the Treasury on any person who violates any license, order, rule, or regulation issued in compliance with the provisions of this chapter.

(c) Judicial review of civil penalty

Any penalty imposed under subsection (b) shall be subject to judicial review only to the extent provided in section 702 of title 5.

(Pub. L. 106–120, title VIII, §807, Dec. 3, 1999, 113 Stat. 1631.)
21 U.S.C. § 1606 (2024) — Title 21: FOOD AND DRUGS / Chapter 21: BIOMATERIALS ACCESS ASSURANCE / Section 1606: Subsequent impleader of dismissed biomaterials supplier
Subsequent impleader of dismissed biomaterials supplier
Status: in_force

(a) Impleading of dismissed defendant

A court, upon motion by a manufacturer or a claimant within 90 days after entry of a final judgment in an action by the claimant against a manufacturer, and notwithstanding any otherwise applicable statute of limitations, may implead a biomaterials supplier who has been dismissed from the action pursuant to this chapter if—

(1) the manufacturer has made an assertion, either in a motion or other pleading filed with the court or in an opening or closing statement at trial, or as part of a claim for contribution or indemnification, and the court finds based on the court's independent review of the evidence contained in the record of the action, that under applicable law—

(A) the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the claimant; and

(B) the manufacturer's liability for damages should be reduced in whole or in part because of such negligence or intentionally tortious conduct; or

(2) the claimant has moved to implead the supplier and the court finds, based on the court's independent review of the evidence contained in the record of the action, that under applicable law—

(A) the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the claimant; and

(B) the claimant is unlikely to be able to recover the full amount of its damages from the remaining defendants.

(b) Standard of liability

Notwithstanding any preliminary finding under subsection (a), a biomaterials supplier who has been impleaded into an action covered by this chapter, as provided for in this section—

(1) may, prior to entry of judgment on the claim against it, supplement the record of the proceeding that was developed prior to the grant of the motion for impleader under subsection (a); and

(2) may be found liable to a manufacturer or a claimant only to the extent required and permitted by any applicable State or Federal law other than this chapter.

(c) Discovery

Nothing in this section shall give a claimant or any other party the right to obtain discovery from a biomaterials supplier at any time prior to grant of a motion for impleader beyond that allowed under section 1605 of this title.

(Pub. L. 105–230, §7, Aug. 13, 1998, 112 Stat. 1528.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.
21 U.S.C. § 176 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 176: Repealed. Pub. L. 91-513, title III, §1101(a)(2), (9), Oct. 27, 1970, 84 Stat. 1291, 1292
Repealed. Pub. L. 91-513, title III, §1101(a)(2), (9), Oct. 27, 1970, 84 Stat. 1291, 1292
Status: repealed

Section 176, acts Feb. 9, 1909, ch. 100, §2(g), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202 §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, covered liability of masters of vessels and persons in charge of railroad cars and other vehicles used to carry narcotic drugs.

Section 176a, act Feb. 9, 1909, ch. 100, §2(h), as added July 18, 1956, ch. 629, title I, §106, 70 Stat. 570, covered illegal importation of marihuana and set penalties for such illegal importation. See section 801 et seq. of this title.

Section 176b, act Feb. 9, 1909, ch. 100, §2(i), as added July 18, 1956, ch. 629, title I, §107, 70 Stat. 571, prohibited sale of heroin to juveniles and set penalties for such illegal sale. See section 801 et seq. of this title.

Section 177, acts Feb. 9, 1909, ch. 100, §2(a), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, vested administration of Narcotic Drugs Import and Export Act in Department of the Treasury.

Section 178, act Feb. 9, 1909, ch. 100, §4, as added Jan. 17, 1914, ch. 9, 38 Stat. 275, prohibited possession of smoking opium. See section 801 et seq. of this title.

Section 179, act Feb. 9, 1909, ch. 100, §4, as added Jan. 17, 1914, ch. 9, 38 Stat. 275, covered liability of masters of vessels and persons in charge of railroad cars or other vehicles for possession of smoking heroin. See section 801 et seq. of this title.

Section 180, act Feb. 9, 1909, ch. 100, §5, as added Jan. 17, 1914, ch. 9, 38 Stat. 275; amended May 26, 1922, ch. 202, §2, 42 Stat. 597; June 14, 1930, ch. 488, §3, 46 Stat. 586, prohibited admission of smoking opium even for transportation to another country or for transferal from one vessel to another.

Section 181, act Feb. 9, 1909, ch. 100, §3, as added Jan. 17, 1914, ch. 9, 38 Stat. 275, created a presumption of illegal importation based upon presence of smoking opium in United States.

Section 182, act Feb. 9, 1909, ch. 100, §6, as added Jan. 17, 1914, ch. 9, 348 Stat. 275; amended May 26, 1922, ch. 202, §2, 42 Stat. 597; June 14, 1930, ch. 488, §3, 46 Stat. 586; Apr. 22, 1960, Pub. L. 86–429, §15, 74 Stat. 66, forbade exportation of narcotic drugs. See section 801 et seq. of this title.

Section 183, act Feb. 9, 1909, ch. 100, §7, as added Jan. 17, 1914, ch. 9, 38 Stat. 277, set out penalties for illegal exportation of narcotic drugs.

Section 184, act Feb. 9, 1909, ch. 100, §8, as added Jan. 17, 1914, ch. 9, 38 Stat. 277; amended May 26, 1922, ch. 202, §3, 42 Stat. 598, provided for seizure and forfeiture of narcotic drugs found on vessels and not shown on manifest or landed from vessels without a permit.

Section 184a, acts July 11, 1941, ch. 289, §1, 55 Stat. 584; July 18, 1956, ch. 629, title I, §108, 70 Stat. 571, made illegal bringing on board a vessel of United States any narcotic drugs not constituting a part of the cargo.

Section 185, act Feb. 9, 1909, ch. 100, §9, as added May 26, 1922, ch. 202, §4, 42 Stat. 598, authorized the citation of act Feb. 9, 1909, ch. 100, as the "Narcotic Drugs Import and Export Act".

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

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

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.
21 U.S.C. § 353c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 353c: Prereview of television advertisements
Prereview of television advertisements
Status: in_force

(a) In general

The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.

(b) Review

In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug—

(1) on changes that are—

(A) necessary to protect the consumer good and well-being; or

(B) consistent with prescribing information for the product under review; and

(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.

(c) No authority to require changes

Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).

(d) Elderly populations, children, racially and ethnically diverse communities

In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.

(e) Specific disclosures

(1) Serious risk; safety protocol

In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.

(2) Date of approval

In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 355 of this title or section 262 of title 42, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.

(f) Rule of construction

Nothing in this section may be construed as having any effect on requirements under section 352(n) of this title or on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).

(June 25, 1938, ch. 675, §503C, formerly §503B, as added Pub. L. 110–85, title IX, §901(d)(2), Sept. 27, 2007, 121 Stat. 939, renumbered §503C, Pub. L. 113–54, title I, §102(a)(1), Nov. 27, 2013, 127 Stat. 587.)

Editorial Notes

Codification

Section was formerly classified to section 353b of this title prior to renumbering by Pub. L. 113–54.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 331 of this title.
21 U.S.C. § 903 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 903: Application of State law
Application of State law
Status: in_force

No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.

(Pub. L. 91–513, title II, §708, Oct. 27, 1970, 84 Stat. 1284.)

Editorial Notes

References in Text

This subchapter, referred to in text, was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.