21 U.S.C. § 379d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379d: Automation of Food and Drug Administration
Automation of Food and Drug Administration
Status: in_force

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this chapter.

(b) Authorization of appropriations

There are authorized to be appropriated each fiscal year such sums as are necessary to carry out this section.

(June 25, 1938, ch. 675, §711, formerly §712, as added Pub. L. 101–635, title IV, §401, Nov. 28, 1990, 104 Stat. 4585; renumbered §711, Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498.)

Editorial Notes

Prior Provisions

A prior section 711 of act June 25, 1938, was renumbered section 731 by Pub. L. 102–571 and is classified to section 379f of this title.
21 U.S.C. § 387l (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387l: Judicial review
Judicial review
Status: in_force

(a) Right to review

(1) In general

Not later than 30 days after—

(A) the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or

(B) a denial of an application under section 387j(c) of this title,

any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.

(2) Requirements

(A) Copy of petition

A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary.

(B) Record of proceedings

On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—

(i) the record of the proceedings on which the regulation or order was based; and

(ii) a statement of the reasons for the issuance of such a regulation or order.

(C) Definition of record

In this section, the term "record" means—

(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;

(ii) all information submitted to the Secretary with respect to such regulation or order;

(iii) proceedings of any panel or advisory committee with respect to such regulation or order;

(iv) any hearing held with respect to such regulation or order; and

(v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.

(b) Standard of review

Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with section 706(2)(A) of title 5.

(c) Finality of judgment

The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28.

(d) Other remedies

The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law.

(e) Regulations and orders must recite basis in record

To facilitate judicial review, a regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p of this title shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.

(June 25, 1938, ch. 675, §912, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1819.)
21 U.S.C. § 467d (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 467d: Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts
Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts
Status: in_force

For the efficient administration and enforcement of this chapter, the provision (including penalties) of sections 46, 48, 49 and 50 of title 15 (except paragraphs (c) through (h) of section 46 and the last paragraph of section 49 1 of title 15), and the provisions of section 409(l) 1 of title 47, are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15 on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 467c of this title.

(Pub. L. 85–172, §22, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807.)

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. § 364h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364h: Small businesses
Small businesses
Status: in_force

(a) In general

Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.

(b) Requirements applicable to all manufacturers and processors of cosmetics

The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:

(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.

(2) Cosmetic products that are injected.

(3) Cosmetic products that are intended for internal use.

(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

(June 25, 1938, ch. 675, §612, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 364d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364d: Safety substantiation
Safety substantiation
Status: in_force

(a) Substantiation of safety

A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.

(b) Coal-tar hair dye

Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title. A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.

(c) Definitions

For purposes of this section:

(1) Adequate substantiation of safety

The term "adequate substantiation of safety" means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.

(2) Safe

The term "safe" means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.

(June 25, 1938, ch. 675, §608, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

Talc-Containing Cosmetics

Pub. L. 117–328, div. FF, title III, §3505, Dec. 29, 2022, 136 Stat. 5859, provided that:

"The Secretary of Health and Human Services—

"(1) not later than one year after the date of enactment of this Act [Dec. 29, 2022], shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and

"(2) not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations."
21 U.S.C. § 2012 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter II: NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE / Section 2012: Establishment of clearinghouse and advisory council
Establishment of clearinghouse and advisory council
Status: in_force

(a) Clearinghouse

There is established, under the supervision of the Attorney General of the United States, an information clearinghouse to be known as the National Methamphetamine Information Clearinghouse.

(b) Advisory council

(1) In general

There is established an advisory council to be known as the National Methamphetamine Advisory Council.

(2) Membership

The Council shall consist of 10 members appointed by the Attorney General—

(A) not fewer than 3 of whom shall be representatives of law enforcement agencies;

(B) not fewer than 4 of whom shall be representatives of nongovernmental and nonprofit organizations providing services or training and implementing programs or strategies related to methamphetamines; and

(C) 1 of whom shall be a representative of the Department of Health and Human Services.

(3) Period of appointment; vacancies

Members shall be appointed for 3 years. Any vacancy in the Council shall not affect its powers, but shall be filled in the same manner as the original appointment.

(4) Personnel matters

(A) Travel expenses

The members of the Council shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5, while away from their homes or regular places of business in the performance of services for the Council.

(B) No compensation

The members of the Council shall not receive compensation for the performance of the duties of a member of the Council.

(Pub. L. 109–469, title X, §1003, Dec. 29, 2006, 120 Stat. 3538.)
21 U.S.C. § 99 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter I: EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Section 99: Repealed. July 28, 1953, ch. 251, title I, §101, 67 Stat. 208
Repealed. July 28, 1953, ch. 251, title I, §101, 67 Stat. 208
Status: repealed

Section, act Aug. 31, 1951, ch. 374, title I, §101, 65 Stat. 229, related to reimbursement for excess expenses of meat inspection.
21 U.S.C. § 675 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 675: Assaulting, resisting, or impeding certain persons; murder; protection of such persons
Assaulting, resisting, or impeding certain persons; murder; protection of such persons
Status: in_force

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.

(Mar. 4, 1907, ch. 2907, title IV, §405, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599.)
21 U.S.C. § 2351 (2024) — Title 21: FOOD AND DRUGS / Chapter 28A: FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL / Subchapter I: SANCTIONS IN RESPONSE TO NATIONAL EMERGENCY RELATING TO FENTANYL TRAFFICKING / Section 2351: Finding; policy
Finding; policy
Status: in_force

(a) Finding

Congress finds that international trafficking of fentanyl, fentanyl precursors, or other related opioids constitutes an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States, and is a national emergency.

(b) Policy

It shall be the policy of the United States to apply economic and other financial sanctions to those who engage in the international trafficking of fentanyl, fentanyl precursors, or other related opioids to protect the national security, foreign policy, and economy of the United States.

(Pub. L. 118–50, div. E, title I, §3101, Apr. 24, 2024, 138 Stat. 936.)
21 U.S.C. § 1907 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1907: Definitions
Definitions
Status: in_force

As used in this chapter:

(1) Entity

The term "entity" means a partnership, joint venture, association, corporation, organization, network, group, or subgroup, or any form of business collaboration.

(2) Foreign person

The term "foreign person" means any citizen or national of a foreign state or any entity not organized under the laws of the United States, but does not include a foreign state.

(3) Narcotics trafficking

The term "narcotics trafficking" means any illicit activity to cultivate, produce, manufacture, distribute, sell, finance, or transport narcotic drugs, controlled substances, or listed chemicals, or otherwise endeavor or attempt to do so, or to assist, abet, conspire, or collude with others to do so.

(4) Narcotic drug; controlled substance; listed chemical

The terms "narcotic drug", "controlled substance", and "listed chemical" have the meanings given those terms in section 802 of this title.

(5) Person

The term "person" means an individual or entity.

(6) United States person

The term "United States person" means any United States citizen or national, permanent resident alien, an entity organized under the laws of the United States (including its foreign branches), or any person within the United States.

(7) Significant foreign narcotics trafficker

The term "significant foreign narcotics trafficker" means any foreign person that plays a significant role in international narcotics trafficking, that the President has determined to be appropriate for sanctions pursuant to this chapter, and that the President has publicly identified in the report required under subsection (b) or (h)(1) of section 1903 of this title.

(Pub. L. 106–120, title VIII, §808, Dec. 3, 1999, 113 Stat. 1632.)
21 U.S.C. § 2102 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2102: Ensuring the safety of pet food
Ensuring the safety of pet food
Status: in_force

(a) Processing and ingredient standards

Not later than 2 years after September 27, 2007, the Secretary of Health and Human Services (referred to in this chapter as the "Secretary"), in consultation with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by regulation establish—

(1) processing standards for pet food; and

(2) updated standards for the labeling of pet food that include nutritional and ingredient information.

(b) Early warning surveillance systems and notification during pet food recalls

Not later than 1 year after September 27, 2007, the Secretary shall establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food. In establishing such system, the Secretary shall—

(1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of the Food and Drug Administration and the Department of Agriculture, and the National Animal Health Laboratory Network of the Department of Agriculture;

(2) consult with relevant professional associations and private sector veterinary hospitals;

(3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other notification networks as appropriate to inform veterinarians and relevant stakeholders during any recall of pet food; and

(4) use such information and conduct such other activities as the Secretary deems appropriate.

(Pub. L. 110–85, title X, §1002, Sept. 27, 2007, 121 Stat. 963; Pub. L. 115–234, title III, §306(b), Aug. 14, 2018, 132 Stat. 2441.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this title", meaning title X of Pub. L. 110–85, Sept. 27, 2007, 121 Stat. 962, which enacted this chapter and section 350f of this title, amended sections 321 and 331 of this title, and enacted provisions set out as notes under sections 350f and 2110 of this title. For complete classification of title X to the Code, see Tables.

Amendments

2018—Subsec. (a). Pub. L. 115–234 redesignated pars. (2) and (3) as (1) and (2), respectively, and struck out former par. (1) which read as follows: "ingredient standards and definitions with respect to pet food;".
21 U.S.C. § 154a (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 154a: Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria
Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria
Status: in_force

In order to meet an emergency condition, limited market or local situation, or other special circumstance (including production solely for intrastate use under a State-operated program), the Secretary may issue a special license under an expedited procedure on such conditions as are necessary to assure purity, safety, and a reasonable expectation of efficacy. The Secretary shall exempt by regulation from the requirement of preparation pursuant to an unsuspended and unrevoked license any virus, serum, toxin, or analogous product prepared by any person, firm, or corporation—

(1) solely for administration to animals of such person, firm, or corporation;

(2) solely for administration to animals under a veterinarian-client-patient relationship in the course of the State licensed professional practice of veterinary medicine by such person, firm, or corporation; or

(3) solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Secretary to meet criteria under which the State—

(A) may license virus, serum, toxin, and analogous products and establishments that produce such products;

(B) may review the purity, safety, potency, and efficacy of such products prior to licensure;

(C) may review product test results to assure compliance with applicable standards for purity, safety, and potency, prior to release to the market;

(D) may deal effectively with violations of State law regulating virus, serum, toxin, and analogous products; and

(E) exercises the authority referred to in subclauses (A) through (D) consistent with the intent of this chapter of prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous products.

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

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Statutory Notes and Related Subsidiaries

Effective Date

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

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. § 2312 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter I: SANCTIONS WITH RESPECT TO FOREIGN OPIOID TRAFFICKERS / Section 2312: Imposition of sanctions
Imposition of sanctions
Status: in_force

The President shall impose five or more of the sanctions described in section 2313 of this title with respect to each foreign person that is an entity, and four or more of such sanctions with respect to each foreign person that is an individual, that—

(1) is identified as a foreign opioid trafficker in a report submitted under section 2311(a) of this title; or

(2) the President determines is owned, controlled, directed by, knowingly supplying or sourcing precursors for, or knowingly acting for or on behalf of, such a foreign opioid trafficker.

(Pub. L. 116–92, div. F, title LXXII, §7212, Dec. 20, 2019, 133 Stat. 2265.)

Executive Documents

Delegation of Functions

Functions and authorities of President under this section delegated to Secretary of the Treasury, in consultation with the Secretary of State, by section 1(d)(v) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.
21 U.S.C. § 2014 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter II: NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE / Section 2014: Authorization of appropriations
Authorization of appropriations
Status: in_force

There are authorized to be appropriated—

(1) for fiscal year 2007—

(A) $500,000 to establish the NMIC and Council; and

(B) such sums as are necessary for the operation of the NMIC and Council; and

(2) for each of fiscal years 2008 and 2009, such sums as are necessary for the operation of the NMIC and Council.

(Pub. L. 109–469, title X, §1005, Dec. 29, 2006, 120 Stat. 3539.)
21 U.S.C. § 614 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 614: Repealed. Pub. L. 107-171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508
Repealed. Pub. L. 107-171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508
Status: repealed

Section, acts Mar. 4, 1907, ch. 2907, title I, §14, formerly 12th par., 34 Stat. 1263; renumbered §14 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, prohibited clearance to vessel carrying animals for export without inspector's certificate. Section was formerly classified to section 82 of this title.
21 U.S.C. § 399b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399b: Office of Women's Health
Office of Women's Health
Status: in_force

(a) Establishment

There is established within the Office of the Commissioner, an office to be known as the Office of Women's Health (referred to in this section as the "Office"). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.

(b) Purpose

The Director of the Office shall—

(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the "Administration") levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;

(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women's health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;

(3) provide information to women and health care providers on those areas in which differences between men and women exist;

(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women's issues, consumer organizations, and women's health professionals on Administration policy with regard to women;

(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and

(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 237a(b)(4) of title 42).

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.

(June 25, 1938, ch. 675, §1011, as added Pub. L. 111–148, title III, §3509(g), Mar. 23, 2010, 124 Stat. 536.)

Editorial Notes

Codification

Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, §209(a), Jan. 4, 2011, 124 Stat. 3945, and subsequently renumbered section 1012 by Pub. L. 114–255, div. A, title III, §3073(b)(2), Dec. 13, 2016, 130 Stat. 1137, and is classified to section 399c of this title.
21 U.S.C. § 397 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 397: Contracts for expert review
Contracts for expert review
Status: in_force

(a) In general

(1) Authority

The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of information.

(2) Increased efficiency and expertise through contracts

The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.

(b) Review of expert review

(1) In general

Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.

(2) Limitation

A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.).

(June 25, 1938, ch. 675, §1007, formerly §907, as added Pub. L. 105–115, title IV, §415, Nov. 21, 1997, 111 Stat. 2377; renumbered §1007, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

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. § 2101 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2101: Findings
Findings
Status: in_force

Congress finds that—

(1) the safety and integrity of the United States food supply are vital to public health, to public confidence in the food supply, and to the success of the food sector of the Nation's economy;

(2) illnesses and deaths of individuals and companion animals caused by contaminated food—

(A) have contributed to a loss of public confidence in food safety; and

(B) have caused significant economic losses to manufacturers and producers not responsible for contaminated food items;

(3) the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to—

(A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;

(B) an increasing volume of imported food from a wide variety of countries; and

(C) a shortage of adequate resources for monitoring and inspection;

(4) according to the Economic Research Service of the Department of Agriculture, the United States is increasing the amount of food that it imports such that—

(A) from 2003 to 2007, the value of food imports has increased from $45,600,000,000 to $64,000,000,000; and

(B) imported food accounts for 13 percent of the average American diet including 31 percent of fruits, juices, and nuts, 9.5 percent of red meat, and 78.6 percent of fish and shellfish; and

(5) the number of full-time equivalent Food and Drug Administration employees conducting inspections has decreased from 2003 to 2007.

(Pub. L. 110–85, title X, §1001, Sept. 27, 2007, 121 Stat. 962.)
21 U.S.C. § 459 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 459: Compliance by all establishments
Compliance by all establishments
Status: in_force

(a) In general

No establishment processing poultry or poultry products for commerce otherwise subject to this chapter shall process any poultry or poultry product except in compliance with the requirements of this chapter.

(b) Notification

Any establishment subject to inspection under this chapter that believes, or has reason to believe, that an adulterated or misbranded poultry or poultry product received by or originating from the establishment has entered into commerce shall promptly notify the Secretary with regard to the type, amount, origin, and destination of the poultry or poultry product.

(c) Plans and reassessments

The Secretary shall require that each establishment subject to inspection under this chapter shall, at a minimum—

(1) prepare and maintain current procedures for the recall of all poultry or poultry products produced and shipped by the establishment;

(2) document each reassessment of the process control plans of the establishment; and

(3) upon request, make the procedures and reassessed process control plans available to inspectors appointed by the Secretary for review and copying.

(Pub. L. 85–172, §10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, §10, Aug. 18, 1968, 82 Stat. 801; Pub. L. 110–234, title XI, §11017(b), May 22, 2008, 122 Stat. 1370; Pub. L. 110–246, §4(a), title XI, §11017(b), June 18, 2008, 122 Stat. 1664, 2132.)

Editorial Notes

Codification

Pub. L. 110–234 and Pub. L. 110–246 made identical amendments to this section. The amendments by Pub. L. 110–234 were repealed by section 4(a) of Pub. L. 110–246.

Amendments

2008—Pub. L. 110–246, §11017(b), inserted section catchline, designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

1968—Pub. L. 90–492 substituted "otherwise subject to this chapter" for "in or for marketing in a designated major consuming area".

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture.

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. § 202 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 202: Certain classes of persons and corporations excepted; insecticides
Certain classes of persons and corporations excepted; insecticides
Status: in_force

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

(Mar. 3, 1915, ch. 74, §1, 38 Stat. 818.)

Editorial Notes

Codification

Section is comprised of part of section 1 of act Mar. 3, 1915. Remainder of such section 1 is classified to section 201 of this title.
21 U.S.C. § 617 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 617: Clearance prohibited to vessel carrying meat for export without inspector's certificate
Clearance prohibited to vessel carrying meat for export without inspector's certificate
Status: in_force

No clearance shall be given to any vessel having on board any fresh, salted, canned, corned, or packed beef, mutton, pork, goat or equine meat for export to and sale in a foreign country from any port in the United States, until the owner or shipper thereof shall obtain from an inspector appointed under the provisions of this chapter a certificate that the said amenable species were sound and healthy at the time of inspection, and that their meat is sound and wholesome, unless the Secretary shall have waived the requirements of such certificate for the country to which said amenable species or meats are to be exported.

(Mar. 4, 1907, ch. 2907, title I, §17, formerly 15th par., 34 Stat. 1263; renumbered §17 and amended Pub. L. 90–201, §§1, 3(b), 12(a), (g), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 85 of this title.

Amendments

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

1967—Pub. L. 90–201, §§3(b), 12(a), (g), struck out "of Agriculture" after "Secretary", included horses, mules, and other equines in the list of animals, and substituted "goat or equine meat" for "or goat meat, being the meat of animals killed after March 4, 1907, or except as hereinbefore provided", respectively.

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 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.
21 U.S.C. § 347a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 347a: Congressional declaration of policy regarding oleomargarine sales
Congressional declaration of policy regarding oleomargarine sales
Status: in_force

The Congress hereby finds and declares that the sale, or the serving in public eating places, of colored oleomargarine or colored margarine without clear identification as such or which is otherwise adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] depresses the market in interstate commerce for butter and for oleomargarine or margarine clearly identified and neither adulterated nor misbranded, and constitutes a burden on interstate commerce in such articles. Such burden exists, irrespective of whether such oleomargarine or margarine originates from an interstate source or from the State in which it is sold.

(Mar. 16, 1950, ch. 61, §3(a), 64 Stat. 20.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, 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 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. § 2003 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter I: ANTI-DOPING AGENCY / Section 2003: Authorization of appropriations
Authorization of appropriations
Status: in_force

There are authorized to be appropriated to the United States Anti-Doping Agency—

(1) for fiscal year 2023, $15,500,000;

(2) for fiscal year 2024, $16,200,000;

(3) for fiscal year 2025, $16,900,000;

(4) for fiscal year 2026, $17,700,000;

(5) for fiscal year 2027, $18,500,000;

(6) for fiscal year 2028, $19,800,000;

(7) for fiscal year 2029, $22,100,000;

(8) for fiscal year 2030, $24,900,000; and

(9) for fiscal year 2031, $23,700,000.

(Pub. L. 109–469, title VII, §703, Dec. 29, 2006, 120 Stat. 3534; Pub. L. 113–280, §3, Dec. 18, 2014, 128 Stat. 3020; Pub. L. 117–103, div. Q, title III, §304, Mar. 15, 2022, 136 Stat. 817.)

Editorial Notes

Amendments

2022—Pub. L. 117–103 amended section generally. Prior to amendment, section related to appropriations for fiscal years 2014 to 2020.

2014—Pub. L. 113–280 amended section generally. Prior to amendment, section related to authorization of appropriations for fiscal years 2007 to 2011.
21 U.S.C. § 1055 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1055: Authorization of appropriations
Authorization of appropriations
Status: in_force

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

(Pub. L. 91–597, §27, Dec. 29, 1970, 84 Stat. 1635.)

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. § 1045 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1045: Limitation on entry of eggs and egg products and other materials into official plants
Limitation on entry of eggs and egg products and other materials into official plants
Status: in_force

The Secretary may limit the entry of eggs and egg products and other materials into official plants under such conditions as he may prescribe to assure that allowing the entry of such articles into such plants will be consistent with the purposes of this chapter.

(Pub. L. 91–597, §16, Dec. 29, 1970, 84 Stat. 1630.)

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. § 356f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356f: Hospital repackaging of drugs in shortage
Hospital repackaging of drugs in shortage
Status: in_force

(a) Definitions

In this section:

(1) Drug

The term "drug" excludes any controlled substance (as such term is defined in section 802 of this title).

(2) Health system

The term "health system" means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients.

(3) Repackage

For the purposes of this section only, the term "repackage", with respect to a drug, means to divide the volume of a drug into smaller amounts in order to—

(A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under section 356e of this title; and

(B) facilitate access to the drug by hospitals within the same health system.

(b) Exclusion from registration

Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under section 360 of this title solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)—

(1) during any period in which the drug is listed on the drug shortage list under section 356e of this title; or

(2) during the 60-day period following any period described in paragraph (1).

(c) Conditions

Subsection (b) shall only apply to a hospital, with respect to the repackaging of a drug for transfer to another hospital within the same health system, if the following conditions are met:

(1) Drug for intrasystem use only

In no case may a drug that has been repackaged in accordance with this section be sold or otherwise distributed by the health system or a hospital within the system to an entity or individual that is not a hospital within such health system.

(2) Compliance with State rules

Repackaging of a drug under this section shall be done in compliance with applicable State requirements of each State in which the drug is repackaged and received.

(d) Termination

This section shall not apply on or after the date on which the Secretary issues final guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs to other hospitals within the same health system during a drug shortage.

(June 25, 1938, ch. 675, §506F, as added Pub. L. 112–144, title X, §1007, July 9, 2012, 126 Stat. 1106.)
21 U.S.C. § 1038 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1038: Cooperation with appropriate State and other governmental agencies; utilization of employees; reimbursement
Cooperation with appropriate State and other governmental agencies; utilization of employees; reimbursement
Status: in_force

The Secretary shall, whenever he determines that it would effectuate the purposes of this chapter, cooperate with appropriate State and other governmental agencies, in carrying out any provisions of this chapter. In carrying out the provisions of this chapter, the Secretary may conduct such examinations, investigations, and inspections as he determines practicable through any officer or employee of any such agency commissioned by him for such purpose. The Secretary shall reimburse the States and other agencies for the costs incurred by them in such cooperative programs.

(Pub. L. 91–597, §9, Dec. 29, 1970, 84 Stat. 1627.)

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. § 849 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 849: Transportation safety offenses
Transportation safety offenses
Status: in_force

(a) Definitions

In this section—

"safety rest area" means a roadside facility with parking facilities for the rest or other needs of motorists.

"truck stop" means a facility (including any parking lot appurtenant thereto) that—

(A) has the capacity to provide fuel or service, or both, to any commercial motor vehicle (as defined in section 31301 of title 49), operating in commerce (as defined in that section); and

(B) is located within 2,500 feet of the National System of Interstate and Defense Highways or the Federal-Aid Primary System.

(b) First offense

A person who violates section 841(a)(1) of this title or section 856 of this title by distributing or possessing with intent to distribute a controlled substance in or on, or within 1,000 feet of, a truck stop or safety rest area is (except as provided in subsection (b)) 1 subject to—

(1) twice the maximum punishment authorized by section 841(b) of this title; and

(2) twice any term of supervised release authorized by section 841(b) of this title for a first offense.

(c) Subsequent offense

A person who violates section 841(a)(1) of this title or section 856 of this title by distributing or possessing with intent to distribute a controlled substance in or on, or within 1,000 feet of, a truck stop or a safety rest area after a prior conviction or convictions under subsection (a) 2 have become final is subject to—

(1) 3 times the maximum punishment authorized by section 841(b) of this title; and

(2) 3 times any term of supervised release authorized by section 841(b) of this title for a first offense.

(Pub. L. 91–513, title II, §409, as added Pub. L. 103–322, title XVIII, §180201(b)(1), Sept. 13, 1994, 108 Stat. 2046.)

Editorial Notes

Prior Provisions

A prior section 849, Pub. L. 91–513, title II, §409, Oct. 27, 1970, 84 Stat. 1266; Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, related to dangerous special drug offender sentencing, prior to repeal by Pub. L. 98–473, title II, §§219(a), 235(a)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, eff. Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such repeal.

1 So in original. Probably should refer to subsection (c).

2 So in original. Probably should refer to subsection (b).
21 U.S.C. § 188 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 188: Repealed. Pub. L. 91-513, title III, §1101(a)(7), Oct. 27, 1970, 84 Stat. 1292
Repealed. Pub. L. 91-513, title III, §1101(a)(7), Oct. 27, 1970, 84 Stat. 1292
Status: repealed

Sections, acts Dec. 11, 1942, ch. 720, 56 Stat. 1045; June 25, 1959, Pub. L. 86–70, §20, 73 Stat. 145; July 12, 1960, Pub. L. 86–624, §16, 74 Stat. 415, known as the "Opium Poppy Control Act of 1942", provided for the domestic control of production and distribution of the opium poppy. Sections 1 to 17 of said Act of Dec. 11, 1942, were classified, respectively, to sections 188, 188 notes, and 188a to 188n of this title.

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 section 171 of this title.
21 U.S.C. § 387r (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387r: Drug products used to treat tobacco dependence
Drug products used to treat tobacco dependence
Status: in_force

(a) In general

The Secretary shall—

(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title;

(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and

(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

(b) Report on innovative products

(1) In general

Not later than 3 years after June 22, 2009, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health—

(A) total abstinence from tobacco use;

(B) reductions in consumption of tobacco; and

(C) reductions in the harm associated with continued tobacco use.

(2) Recommendations

The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.

(June 25, 1938, ch. 675, §918, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1825.)

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.
21 U.S.C. § 356l (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356l: Advanced manufacturing technologies designation program
Advanced manufacturing technologies designation program
Status: in_force

(a) In general

Not later than 1 year after December 29, 2022, the Secretary shall initiate a program under which persons may request designation of an advanced manufacturing technology as described in subsection (b).

(b) Designation process

The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by—

(1) reducing development time for a drug using the designated manufacturing method; or

(2) increasing or maintaining the supply of—

(A) a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or

(B) a drug that is on the drug shortage list under section 356e of this title.

(c) Evaluation and designation of an advanced manufacturing technology

(1) Submission

A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by—

(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and

(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.

(2) Evaluation and designation

Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).

(d) Review of advanced manufacturing technologies

If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—

(1) expedite the development and review of an application submitted under section 355 of this title or section 262 of title 42, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and

(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 355 of this title or section 262 of title 42, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.

(e) Implementation and evaluation of advanced manufacturing technologies program

(1) Public meeting

The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after December 29, 2022, to discuss, and obtain input and recommendations from relevant stakeholders regarding—

(A) the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and

(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.

(2) Program guidance

(A) In general

The Secretary shall—

(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the program under this section; and

(ii) not later than 2 years after December 29, 2022, issue final guidance regarding the implementation of such program.

(B) Content

The guidance described in subparagraph (A) shall address—

(i) the process by which a person may request a designation under subsection (b);

(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions;

(iii) the process to expedite the development and review of applications under subsection (d); and

(iv) the criteria described in subsection (b) for eligibility for such a designation.

(3) Report

Not later than 3 years after December 29, 2022, and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing a description and evaluation of the program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:

(A) The number of persons that have requested designations and that have been granted designations.

(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.

(C) The average number of calendar days for completion of evaluations under subsection (c)(2).

(D) An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection (c)(2).

(E) The number of applications received under section 355 of this title or section 262 of title 42, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.

(f) Sunset

The Secretary—

(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2032; and

(2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (b) prior to such date, if the Secretary determines such activities are in the interest of the public health.

(June 25, 1938, ch. 675, §506L, as added Pub. L. 117–328, div. FF, title III, §3213, Dec. 29, 2022, 136 Stat. 5826.)
21 U.S.C. § 2011 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter II: NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE / Section 2011: Definitions
Definitions
Status: in_force

In this subchapter—

(1) the term "Council" means the National Methamphetamine Advisory Council established under section 2012(b)(1) of this title;

(2) the term "drug endangered children" means children whose physical, mental, or emotional health are at risk because of the production, use, or other effects of methamphetamine production or use by another person;

(3) the term "National Methamphetamine Information Clearinghouse" or "NMIC" means the information clearinghouse established under section 2012(a) of this title; and

(4) the term "qualified entity" means a State, local, or tribal government, school board, or public health, law enforcement, nonprofit, community anti-drug coalition, or other nongovernmental organization providing services related to methamphetamines.

(Pub. L. 109–469, title X, §1002, Dec. 29, 2006, 120 Stat. 3537.)
21 U.S.C. § 350e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350e: Sanitary transportation practices
Sanitary transportation practices
Status: in_force

(a) Definitions

In this section:

(1) Bulk vehicle

The term "bulk vehicle" includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.

(2) Transportation

The term "transportation" means any movement in commerce by motor vehicle or rail vehicle.

(b) Regulations

The Secretary shall by regulation require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.

(c) Contents

The regulations under subsection (b) shall—

(1) prescribe such practices as the Secretary determines to be appropriate relating to—

(A) sanitation;

(B) packaging, isolation, and other protective measures;

(C) limitations on the use of vehicles;

(D) information to be disclosed—

(i) to a carrier by a person arranging for the transport of food; and

(ii) to a manufacturer or other person that—

(I) arranges for the transportation of food by a carrier; or

(II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and

(E) recordkeeping; and

(2) include—

(A) a list of nonfood products that the Secretary determines may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and

(B) a list of nonfood products that the Secretary determines may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle.

(d) Waivers

(1) In general

The Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the waiver—

(A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and

(B) will not be contrary to the public interest.

(2) Publication

The Secretary shall publish in the Federal Register any waiver and the reasons for the waiver.

(e) Preemption

(1) In general

A requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if—

(A) complying with a requirement of the State or political subdivision and a requirement of this section, or a regulation prescribed under this section, is not possible; or

(B) the requirement of the State or political subdivision as applied or enforced is an obstacle to accomplishing and carrying out this section or a regulation prescribed under this section.

(2) Applicability

This subsection applies to transportation that occurs on or after the effective date of the regulations promulgated under subsection (b).

(f) Assistance of other agencies

The Secretary of Transportation, the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, and the heads of other Federal agencies, as appropriate, shall provide assistance on request, to the extent resources are available, to the Secretary for the purposes of carrying out this section.

(June 25, 1938, ch. 675, §416, as added Pub. L. 109–59, title VII, §7202(b), Aug. 10, 2005, 119 Stat. 1911.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as an Effective Date of 2005 Amendment note under section 331 of this title.

Regulations

Pub. L. 111–353, title I, §111(a), Jan. 4, 2011, 124 Stat. 3916, provided that: "Not later than 18 months after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b))."
21 U.S.C. § 145 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 145: Penalties
Penalties
Status: in_force

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

(Feb. 15, 1927, ch. 155, §5, 44 Stat. 1103.)
21 U.S.C. § 1301 (2024) — Title 21: FOOD AND DRUGS / Chapter 18: PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE PREVENTION / Section 1301: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Section 1301, Pub. L. 99–570, title VIII, §8002, Oct. 27, 1986, 100 Stat. 3207–161 related to the establishment of the President's Media Commission on Alcohol and Drug Abuse Prevention.

Section 1302, Pub. L. 99–570, title VIII, §8003, Oct. 27, 1986, 100 Stat. 3207–161, related to duties of the Commission.

Section 1303, Pub. L. 99–570, title VIII, §8004, Oct. 27, 1986, 100 Stat. 3207–162, required appointment of members of the Commission within 30 days after Oct. 27, 1986.

Section 1304, Pub. L. 99–570, title VIII, §8005, Oct. 27, 1986, 100 Stat. 3207–162, related to meetings.

Section 1305, Pub. L. 99–570, title VIII, §8006, Oct. 27, 1986, 100 Stat. 3207–163, related to employment of Director and staff and the procurement of the services of experts and consultants.

Section 1306, Pub. L. 99–570, title VIII, §8007, Oct. 27, 1986, 100 Stat. 3207–163, related to the powers of the Commission.

Section 1307, Pub. L. 99–570, title VIII, §8008, Oct. 27, 1986, 100 Stat. 3207–163, related to an annual report to Congress.

Section 1308, Pub. L. 99–570, title VIII, §8009, Oct. 27, 1986, 100 Stat. 3207–163, related to termination of Commission three years after the date on which members of the Commission were first appointed unless the President extended the authority of the Commission by Executive order.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 99–570, title VIII, §8001, Oct. 27, 1986, 100 Stat. 3207–161, provided that title VIII of Pub. L. 99–570, which enacted this chapter, was to be cited as the "President's Media Commission on Alcohol and Drug Abuse Prevention Act".
21 U.S.C. § 175 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 175: Repealed. June 27, 1952, ch. 477, title IV, §403(a)(10), 66 Stat. 279
Repealed. June 27, 1952, ch. 477, title IV, §403(a)(10), 66 Stat. 279
Status: repealed

Section, acts Feb. 9, 1909, ch. 100, §2(e), 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, related to deportation of convicted aliens. See section 1251 et seq. of Title 8, Aliens and Nationality.
21 U.S.C. § 321b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter II: DEFINITIONS / Section 321b: "Package" defined
"Package" defined
Status: in_force

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

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

Editorial Notes

References in Text

An act approved March 3, 1913, referred to in text, is act Mar. 3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this title. For complete classification of this Act to the Code, see Tables.

"An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes", referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.

Codification

Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to the last sentence of paragraph third of section 10 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that this section should remain in force and effect and be applicable to the provisions of this chapter.
21 U.S.C. § 142 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 142: Milk or cream when unfit for importation
Milk or cream when unfit for importation
Status: in_force

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

(Feb. 15, 1927, ch. 155, §2, 44 Stat. 1101.)

Statutory Notes and Related Subsidiaries

Transfer of Functions

Agricultural Research Service became the successor to functions of Bureau of Dairy Industry under Secretary of Agriculture's Memorandum 1320, Supplement 4, Nov. 2, 1953.
21 U.S.C. § 15 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter I: FEDERAL FOOD AND DRUGS ACT OF 1906 / Section 15: 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, act June 30, 1906, ch. 3915, §11, 34 Stat. 772, provided for examination of samples of imports, refusal of admission and delivery to consignee, delivery to consignee pending examination and decision on bond and charges for storage and lien therefor. See section 381 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

For effective date of repeal, see section 1002(a) of act June 25, 1938, set out as a note under sections 1 to 5 of this title.
21 U.S.C. § 887 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 887: Coordination and consolidation of post-seizure administration
Coordination and consolidation of post-seizure administration
Status: in_force

The Attorney General and the Secretary of the Treasury shall take such action as may be necessary to develop and maintain a joint plan to coordinate and consolidate post-seizure administration of property seized under this subchapter, subchapter II, or provisions of the customs laws relating to controlled substances.

(Pub. L. 91–513, title II, §517, as added Pub. L. 100–690, title VI, §6078(a), Nov. 18, 1988, 102 Stat. 4325.)
21 U.S.C. § 1502a (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter I: OFFICE OF NATIONAL DRUG CONTROL POLICY / Section 1502a: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, Pub. L. 100–690, title I, §1003A, as added Pub. L. 101–510, div. A, title X, §1011, Nov. 5, 1990, 104 Stat. 1633, and amended, which related to the Counter-Drug Technology Assessment Center, was renumbered section 1008 of Pub. L. 100–690 by Pub. L. 103–322, title IX, §90204(c)(2), (3), Sept. 13, 1994, 108 Stat. 1994, and transferred to former section 1505 of this title.
21 U.S.C. § 643 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter II: MEAT PROCESSORS AND RELATED INDUSTRIES / Section 643: Registration of business, name of person, and trade names
Registration of business, name of person, and trade names
Status: in_force

No person, firm, or corporation shall engage in business, in or for commerce, as a meat broker, renderer, or animal food manufacturer, or engage in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, of any cattle, sheep, swine, goats, horses, mules, or other equines, whether intended for human food or other purposes, or engage in business as a public warehouseman storing any such articles in or for commerce, or engage in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased animals of the specified kinds, or parts of the carcasses of any such animals that died otherwise than by slaughter, unless, when required by regulations of the Secretary, he has registered with the Secretary his name, and the address of each place of business at which, and all trade names under which, he conducts such business.

(Mar. 4, 1907, ch. 2907, title II, §203, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 594.)
21 U.S.C. § 2335 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter II: OTHER MATTERS / Section 2335: Exception relating to importation of goods
Exception relating to importation of goods
Status: in_force

(a) In general

The authorities and requirements to impose sanctions under this chapter shall not include the authority or a requirement to impose sanctions on the importation of goods.

(b) Good defined

In this section, the term "good" means any article, natural or manmade substance, material, supply, or manufactured product, including inspection and test equipment, and excluding technical data.

(Pub. L. 116–92, div. F, title LXXII, §7235, Dec. 20, 2019, 133 Stat. 2275.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 2301 of this title and Tables.
21 U.S.C. § 154 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 154: Regulations for preparation and sale; licenses
Regulations for preparation and sale; licenses
Status: in_force

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

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832; Pub. L. 99–198, title XVII, §1768(b), Dec. 23, 1985, 99 Stat. 1654.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Amendments

1985—Pub. L. 99–198 inserted "or otherwise to carry out this chapter," after "domestic animals,".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

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

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. § 691 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter V: MISCELLANEOUS PROVISIONS / Section 691: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Section, Pub. L. 90–201, §17, Dec. 15, 1967, 81 Stat. 600; Pub. L. 103–437, §8(3), Nov. 2, 1994, 108 Stat. 4588, which required the Secretary of Agriculture to report annually to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate on the slaughter of animals and the processing and distribution of carcasses and products, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 46 of House Document No. 103–7.
21 U.S.C. § 674 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 674: Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations of section 607(e) of this title
Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations of section 607(e) of this title
Status: in_force

The United States district courts, the District Court of Guam, the District Court of the Virgin Islands, the highest court of American Samoa, and the United States courts of the other Territories, are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of, this chapter, and shall have jurisdiction in all other kinds of cases arising under this chapter, except as provided in section 607(e) of this title.

(Mar. 4, 1907, ch. 2907, title IV, §404, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 599.)
21 U.S.C. § 1051 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1051: Other Federal laws applicable for administration and enforcement of chapter; prosecution of inquiries; exercise of jurisdiction
Other Federal laws applicable for administration and enforcement of chapter; prosecution of inquiries; exercise of jurisdiction
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 with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15, on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 1050 of this title.

(Pub. L. 91–597, §22, Dec. 29, 1970, 84 Stat. 1632.)

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 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.

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.

1 See References in Text note below.
21 U.S.C. § 613 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 613: Plans and reassessments
Plans and reassessments
Status: in_force

The Secretary shall require that each establishment subject to inspection under this chapter shall, at a minimum—

(1) prepare and maintain current procedures for the recall of all meat or meat food products produced and shipped by the establishment;

(2) document each reassessment of the process control plans of the establishment; and

(3) upon request, make the procedures and reassessed process control plans available to inspectors appointed by the Secretary for review and copying.

(Mar. 4, 1907, ch. 2907, title I, §13, as added Pub. L. 110–234, title XI, §11017(a), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, §4(a), title XI, §11017(a), June 18, 2008, 122 Stat. 1664, 2132.)

Editorial Notes

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Prior Provisions

A prior section 613, acts Mar. 4, 1907, ch. 2907, title I, §13, formerly 11th par., 34 Stat. 1263; renumbered §13 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, related to inspectors of animals for export and certificates of condition, prior to repeal by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508. Section was formerly classified to section 81 of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.
21 U.S.C. § 463 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 463: Rules and regulations
Rules and regulations
Status: in_force

(a) Storage and handling of poultry products; violation of regulations

The Secretary may by regulations prescribe conditions under which poultry products capable of use as human food, shall be stored or otherwise handled by any person engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, or importing, such articles, whenever the Secretary deems such action necessary to assure that such articles will not be adulterated or misbranded when delivered to the consumer. Violation of any such regulation is prohibited.

(b) Other necessary rules and regulations

The Secretary shall promulgate such other rules and regulations as are necessary to carry out the provisions of this chapter.

(c) Oral presentation of views

In applying the provisions of section 553(c) of title 5 to proposed rule making under this chapter, an opportunity for the oral presentation of views shall be accorded all interested persons.

(Pub. L. 85–172, §14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, §13, Aug. 18, 1968, 82 Stat. 803.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 designated existing provisions as par. (b), added pars. (a) and (c), and in par. (b), as so designated, substituted "such other rules" for "such rules".

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. § 2403 (2024) — Title 21: FOOD AND DRUGS / Chapter 29: INTERNATIONAL SPORTS DOPING / Section 2403: Criminal penalties and statute of limitations
Criminal penalties and statute of limitations
Status: in_force

(a) In general

(1) Criminal penalty

Whoever violates section 2402 of this title shall be sentenced to a term of imprisonment for not more than 10 years, fined $250,000 if the person is an individual or $1,000,000 if the defendant is other than an individual, or both.

(2) Forfeiture

Any property real or personal, tangible or intangible, may be seized and criminally forfeited to the United States if that property—

(A) is used or intended to be used, in any manner, to commit or facilitate a violation of section 2402 of this title; or

(B) constitutes or is traceable to the proceeds taken, obtained, or retained in connection with or as a result of a violation of section 2402 of this title.

(b) Limitation on prosecution

(1) In general

No person shall be prosecuted, tried, or punished for violation of section 2402 of this title unless the indictment is returned or the information is filed within 10 years after the date on which the offense was completed.

(2) Tolling

Upon application in the United States, filed before a return of an indictment, indicating that evidence of an offense under this chapter is in a foreign country, the district court before which a grand jury is impaneled to investigate the offense shall suspend the running of this statute of limitation for the offense if the court finds by a preponderance of the evidence that an official request has been made for such evidence and that it reasonably appears, or reasonably appeared at the time the request was made, that such evidence is, or was, in such foreign country.

(Pub. L. 116–206, §4, Dec. 4, 2020, 134 Stat. 999.)
21 U.S.C. § 129a (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 129a: Repealed. Pub. L. 107-171, title X, §10418(a)(1), (8), (16), May 13, 2002, 116 Stat. 507, 508
Repealed. Pub. L. 107-171, title X, §10418(a)(1), (8), (16), May 13, 2002, 116 Stat. 507, 508
Status: repealed

Section 129a, Pub. L. 97–46, §1, Sept. 25, 1981, 95 Stat. 953; Pub. L. 106–224, title IV, §438(b), June 20, 2000, 114 Stat. 454, related to transfer of funds for emergency arrest of animal or poultry diseases. Section was formerly classified to section 147b of Title 7, Agriculture.

Section 130, act May 29, 1884, ch. 60, §8, 23 Stat. 33; 1967 Reorg. Plan No. 3, §402(430), eff. Aug. 11, 1967, 32 F.R. 11669, 81 Stat. 948; Pub. L. 93–198, title IV, §401, Dec. 24, 1973, 87 Stat. 793, related to pleuropneumonia in District of Columbia and duties of Council of the District of Columbia.

Section 131, act May 26, 1910, ch. 256, 36 Stat. 440, related to fences along international boundary lines to keep out diseased animals.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 97–46, §2, Sept. 25, 1981, 95 Stat. 953, provided that section 129a of this title was to become effective Sept. 25, 1981, prior to repeal by Pub. L. 107–171, title X, §10418(a)(1), May 13, 2002, 116 Stat. 507.
21 U.S.C. § 360rr (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360rr: Federal-State cooperation
Federal-State cooperation
Status: in_force

The Secretary is authorized (1) to accept from State and local authorities engaged in activities related to health or safety or consumer protection, on a reimbursable basis or otherwise, any assistance in the administration and enforcement of this part which he may request and which they may be able and willing to provide and, if so agreed, may pay in advance or otherwise for the reasonable cost of such assistance, and (2) he may, for the purpose of conducting examinations, investigations, and inspections, commission any officer or employee of any such authority as an officer of the Department.

(June 25, 1938, ch. 675, §541, formerly act July 1, 1944, ch. 373, title III, §541, formerly §360E, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered §541 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 263m 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 263m 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".

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. § 345 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 345: Regulations making exemptions
Regulations making exemptions
Status: in_force

The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.

(June 25, 1938, ch. 675, §405, 52 Stat. 1049; Pub. L. 101–535, §5(a), Nov. 8, 1990, 104 Stat. 2362.)

Editorial Notes

Amendments

1990—Pub. L. 101–535 inserted at end "This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title."

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

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

Construction of Amendments by Pub. L. 101–535

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

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 158 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 158: Offenses; punishment
Offenses; punishment
Status: in_force

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

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

Editorial Notes

References in Text

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

Codification

See note set out under section 151 of this title.
21 U.S.C. § 467f (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 467f: Federal Food, Drug, and Cosmetic Act applications
Federal Food, Drug, and Cosmetic Act applications
Status: in_force

(a) Exemptions; authorities under food, drug, and cosmetic provisions unaffected

Poultry and poultry products shall be exempt from the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] to the extent of the application or extension thereto of the provisions of this chapter, except that the provisions of this chapter shall not derogate from any authority conferred by the Federal Food, Drug, and Cosmetic Act prior to August 18, 1968.

(b) Enforcement proceedings; detainer authority of representatives of Secretary of Health and Human Services

The detainer authority conferred by section 467a of this title shall apply to any authorized representative of the Secretary of Health and Human Services for purposes of the enforcement of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with respect to any poultry carcass, or part or product thereof, that is outside any official establishment, and for such purposes the first reference to the Secretary in section 467a of this title shall be deemed to refer to the Secretary of Health and Human Services.

(Pub. L. 85–172, §24, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807; amended 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 text, 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

"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.
21 U.S.C. § 890 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 890: Review of Federal sales of chemicals usable to manufacture controlled substances
Review of Federal sales of chemicals usable to manufacture controlled substances
Status: in_force

A Federal department or agency may not sell from the stocks of the department or agency any chemical which, as determined by the Administrator of the Drug Enforcement Administration, could be used in the manufacture of a controlled substance unless the Administrator certifies in writing to the head of the department or agency that there is no reasonable cause to believe that the sale of the chemical would result in the illegal manufacture of a controlled substance.

(Pub. L. 91–513, title II, §520, as added Pub. L. 104–201, div. A, title X, §1034(a), Sept. 23, 1996, 110 Stat. 2640.)
21 U.S.C. § 1048 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1048: Administrative detention of violative articles; duration; release; removal of official marks
Administrative detention of violative articles; duration; release; removal of official marks
Status: in_force

Whenever any eggs or egg products subject to this chapter, are found by any authorized representative of the Secretary upon any premises and there is reason to believe that they are or have been processed, bought, sold, possessed, used, transported, or offered or received for sale or transportation in violation of this chapter or that they are in any other way in violation of this chapter, or whenever any restricted eggs capable of use as human food are found by such a representative in the possession of any person not authorized to acquire such eggs under the regulations of the Secretary, such articles may be detained by such representative for a reasonable period but not to exceed twenty days, pending action under section 1049 of this title or notification of any Federal, State, or other governmental authorities having jurisdiction over such articles and shall not be moved by any person from the place at which they are located when so detained until released by such representative. All official marks may be required by such representative to be removed from such articles before they are released unless it appears to the satisfaction of the Secretary that the articles are eligible to retain such marks.

(Pub. L. 91–597, §19, 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.

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. § 206 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 206: Revocation of license
Revocation of license
Status: in_force

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

(Mar. 3, 1915, ch. 74, §4, 38 Stat. 819.)
21 U.S.C. § 1531 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1531: Establishment of drug-free communities support program
Establishment of drug-free communities support program
Status: in_force

(a) Establishment

The Director shall establish a program to support communities in the development and implementation of comprehensive, long-term plans and programs to prevent and treat substance use and misuse among youth.

(b) Program

In carrying out the Program, the Director shall—

(1) make and track grants to grant recipients;

(2) provide for technical assistance and training, data collection, and dissemination of information on state-of-the-art practices that the Director determines to be effective in reducing substance use and misuse; and

(3) provide for the general administration of the Program.

(c) Administration

Not later than 30 days after receiving recommendations from the Advisory Commission under section 1542(a)(1) 1 of this title, the Director shall appoint an Administrator to carry out the Program.

(d) Contracting

The Director may employ any necessary staff and may enter into contracts or agreements with national drug control agencies, including interagency agreements to delegate authority for the execution of grants and for such other activities necessary to carry out this subchapter.

(Pub. L. 100–690, title I, §1031, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 226; amended Pub. L. 115–271, title VIII, §8203(b)(4)(A), 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 1542(a)(1) of this title, referred to in subsec. (c), was repealed by Pub. L. 115–271, title VIII, §8203(b)(5), Oct. 24, 2018, 132 Stat. 4112.

Amendments

2019—Subsecs. (a), (b)(2). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(4)(A). See 2018 Amendment note below.

2018—Subsecs. (a), (b)(2). Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "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.
21 U.S.C. § 129 (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 129: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

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

Prior Provisions

Provisions similar to those in this section were contained in the following prior appropriation acts:

Pub. L. 106–387, §1(a) [title I], Oct. 28, 2000, 114 Stat. 1549, 1549A–9, repealed by Pub. L. 107–171, title X, §10418(a)(15), May 13, 2002, 116 Stat. 508.

Pub. L. 106–78, title I, Oct. 22, 1999, 113 Stat. 1143.

Pub. L. 105–277, div. A, §101(a) [title I], Oct. 21, 1998, 112 Stat. 2681, 2681–8.

Pub. L. 105–86, title I, Nov. 18, 1997, 111 Stat. 2086.

Pub. L. 104–180, title I, Aug. 6, 1996, 110 Stat. 1576.

Pub. L. 104–37, title I, Oct. 21, 1995, 109 Stat. 307.

Pub. L. 103–330, title I, Sept. 30, 1994, 108 Stat. 2443.

Pub. L. 103–111, title I, Oct. 21, 1993, 107 Stat. 1054.

Pub. L. 102–341, title I, Aug. 14, 1992, 106 Stat. 882.

Pub. L. 102–142, title I, Oct. 28, 1991, 105 Stat. 886.

Pub. L. 101–506, title I, Nov. 5, 1990, 104 Stat. 1323.

Pub. L. 101–161, title I, Nov. 21, 1989, 103 Stat. 959.

Pub. L. 100–460, title I, Oct. 1, 1988, 102 Stat. 2237.

Pub. L. 100–202, §101(k) [title I], Dec. 22, 1987, 101 Stat. 1329–322, 1329–331.

Pub. L. 99–500, §101(a) [title I], Oct. 18, 1986, 100 Stat. 1783, 1783–8, and Pub. L. 99–591, §101(a) [title I], Oct. 30, 1986, 100 Stat. 3341, 3341–8.

Pub. L. 99–190, §101(a) [H.R. 3037, title I], Dec. 19, 1985, 99 Stat. 1185; Pub. L. 100–202, §106, Dec. 22, 1987, 101 Stat. 1329–433.

Pub. L. 97–370, title I, Dec. 18, 1982, 96 Stat. 1792.

Pub. L. 97–103, title I, Dec. 23, 1981, 95 Stat. 1472.

Pub. L. 96–528, title I, Dec. 15, 1980, 94 Stat. 3099.

Pub. L. 96–108, title I, Nov. 9, 1979, 93 Stat. 826.

Pub. L. 95–448, title I, Oct. 11, 1978, 92 Stat. 1076.

Pub. L. 95–97, title I, Aug. 12, 1977, 91 Stat. 813.

Pub. L. 94–351, title I, July 12, 1976, 90 Stat. 854.

Pub. L. 94–122, title I, Oct. 21, 1975, 89 Stat. 645.

Pub. L. 93–563, title I, Dec. 31, 1974, 88 Stat. 1824.

Pub. L. 93–135, title I, Oct. 24, 1973, 87 Stat. 472.

Pub. L. 92–399, title I, Aug. 22, 1972, 86 Stat. 594.

Pub. L. 92–73, title I, Aug. 10, 1971, 85 Stat. 185.

Pub. L. 91–566, title I, Dec. 22, 1970, 84 Stat. 1482.

Pub. L. 91–127, title I, Nov. 26, 1969, 83 Stat. 246.

Pub. L. 90–463, title I, Aug. 8, 1968, 82 Stat. 640.

Pub. L. 90–113, title I, Oct. 24, 1967, 81 Stat. 321.

Pub. L. 89–556, title I, Sept. 7, 1966, 80 Stat. 690.

Pub. L. 89–316, title I, Nov. 2, 1965, 79 Stat. 1166.

Pub. L. 88–573, title I, Sept. 2, 1964, 78 Stat. 863.

Pub. L. 88–250, title I, Dec. 30, 1963, 77 Stat. 821.

Pub. L. 87–879, title I, Oct. 24, 1962, 76 Stat. 1204.

Pub. L. 87–112, title I, July 26, 1961, 75 Stat. 228.

Pub. L. 86–532, title I, June 29, 1960, 74 Stat. 233.

Pub. L. 86–80, title I, July 8, 1959, 73 Stat. 168.

Pub. L. 85–459, title I, June 13, 1958, 72 Stat. 189.

Pub. L. 85–118, title I, Aug. 2, 1957, 71 Stat. 330.

June 4, 1956, ch. 355, title I, 70 Stat. 230.

May 23, 1955, ch. 43, title I, 69 Stat. 52.

June 29, 1954, ch. 409, title I, 68 Stat. 305.

July 28, 1953, ch. 251, title III, 67 Stat. 223.

July 5, 1952, ch. 574, title III, 66 Stat. 354.

Aug. 31, 1951, ch. 374, title II, 65 Stat. 243.

Sept. 6, 1950, ch. 896, Ch. VI, title I, 64 Stat. 661.

June 29, 1949, ch. 280, title I, 63 Stat. 332.

June 19, 1948, ch. 543, 62 Stat. 515.

July 30, 1947, ch. 356, title I, 61 Stat. 532.

June 22, 1946, ch. 445, 60 Stat. 278.

May 5, 1945, ch. 109, 59 Stat. 144.

June 28, 1944, ch. 296, 58 Stat. 434.

July 12, 1943, ch. 215, 57 Stat. 403.

July 22, 1942, ch. 516, 56 Stat. 676.

July 1, 1941, ch. 267, 55 Stat. 418.

June 25, 1940, ch. 421, 54 Stat. 542.

June 30, 1939, ch. 253, title I, 53 Stat. 951.

June 16, 1938, ch. 464, title I, 52 Stat. 722.

June 29, 1937, ch. 404, 50 Stat. 406.

June 4, 1936, ch. 489, 49 Stat. 1432.

May 17, 1935, ch. 131, title I, 49 Stat. 257.

Mar. 26, 1934, ch. 89, 48 Stat. 477.

Mar. 3, 1933, ch. 203, 47 Stat. 1442.

July 7, 1932, ch. 443, 47 Stat. 620.

Feb. 23, 1931, ch. 278, 46 Stat. 1252.

May 27, 1930, ch. 341, 46 Stat. 403.

Feb. 16, 1929, ch. 227, 45 Stat. 1198.

May 16, 1928, ch. 572, 45 Stat. 548.

Jan. 18, 1927, ch. 39, 44 Stat. 1005.

May 11, 1926, ch. 286, 44 Stat. 529.

Feb. 10, 1925, ch. 200, 43 Stat. 851.

Dec. 5, 1924, ch. 4, 43 Stat. 683.

June 5, 1924, ch. 266, 43 Stat. 458.

Apr. 2, 1924, ch. 81, 43 Stat. 40.

Feb. 26, 1923, ch. 119, 42 Stat. 1318.

May 11, 1922, ch. 185, 42 Stat. 536.

Mar. 4, 1917, ch. 179, 39 Stat. 1167.
21 U.S.C. § 955a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 955a: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Sections, Pub. L. 96–350, §§1–4, Sept. 15, 1980, 94 Stat. 1159, 1160, relating to maritime drug law enforcement, were transferred to sections 1901 to 1904 of the former Appendix to Title 46, Shipping. Sections 1901 to 1904 of the former Appendix to Title 46 were repealed and restated in chapter 705 of Title 46, Shipping, by Pub. L. 109–304, §§10(2), 19, Oct. 6, 2006, 120 Stat. 1683, 1710. For disposition of sections of the former Appendix to Title 46, see Disposition Table preceding section 101 of Title 46.
21 U.S.C. § 2105 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2105: Enhanced aquaculture and seafood inspection
Enhanced aquaculture and seafood inspection
Status: in_force

(a) Findings

Congress finds the following:

(1) In 2007, there has been an overwhelming increase in the volume of aquaculture and seafood that has been found to contain substances that are not approved for use in food in the United States.

(2) As of May 2007, inspection programs are not able to satisfactorily accomplish the goals of ensuring the food safety of the United States.

(3) To protect the health and safety of consumers in the United States, the ability of the Secretary to perform inspection functions must be enhanced.

(b) Heightened inspections

The Secretary is authorized to enhance, as necessary, the inspection regime of the Food and Drug Administration for aquaculture and seafood, consistent with obligations of the United States under international agreements and United States law.

(c) Report to Congress

Not later than 180 days after September 27, 2007, the Secretary shall submit to Congress a report that—

(1) describes the specifics of the aquaculture and seafood inspection program;

(2) describes the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products; and

(3) provides for an assessment of the risks associated with particular contaminants and banned substances.

(d) Partnerships with States

Upon the request by any State, the Secretary may enter into partnership agreements, as soon as practicable after the request is made, to implement inspection programs to Federal standards regarding the importation of aquaculture and seafood.

(Pub. L. 110–85, title X, §1006, Sept. 27, 2007, 121 Stat. 969.)

Statutory Notes and Related Subsidiaries

Regulation of Export of Shrimp to the United States

Pub. L. 116–260, div. A, title VII, §787, Dec. 27, 2020, 134 Stat. 1230, provided that:

"(a) The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (Commissioner), shall develop and, if it determines feasible, implement a number of options for regulating the export of shrimp to the United States from other countries, including the three largest exporting countries by volume to the United States over the last three calendar years, such as sampling of products prior to export to the United States, increasing foreign inspections of export facilities, increased seafood importer inspections, foreign surveillance inspections at overseas manufacturing sites, enhanced import screening, higher rates of examination and sampling, use of third-party audits, and formal seafood arrangements with foreign competent authorities.

"(b) The Commissioner shall especially give priority consideration to the following with the funds appropriated—

"(1) that appropriate controls are applied to shrimp feed and production ponds, processing plants, and facilities throughout the chain of distribution to determine compliance with seafood safety requirements;

"(2) dedicate its inspectional effort to determine compliance with seafood arrangements, once established, from any dedicated funds;

"(3) provide an annual report to the Committee before the end of fiscal years 2021, 2022, and 2023 with the reporting requirement goal being to provide the Committee information related to FDA's oversight of the safety of shrimp products imported into the United States."
21 U.S.C. § 1533 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1533: Information collection and dissemination with respect to grant recipients
Information collection and dissemination with respect to grant recipients
Status: in_force

(a) Coalition information

(1) General auditing authority

For the purpose of audit and examination, the Administrator—

(A) shall have access to any books, documents, papers, and records that are pertinent to any grant or grant renewal request under this subchapter; and

(B) may periodically request information from a grant recipient to ensure that the grant recipient meets the applicable criteria under section 1532(a) of this title.

(2) Application process

The Administrator shall issue a request for proposal regarding, with respect to the grants awarded under section 1532 of this title, the application process, grant renewal, and suspension or withholding of renewal grants. Each application under this paragraph shall be in writing and shall be subject to review by the Administrator.

(3) Reporting

The Administrator shall, to the maximum extent practicable and in a manner consistent with applicable law, minimize reporting requirements by a grant recipient and expedite any application for a renewal grant made under this part.

(b) Data collection and dissemination

(1) In general

The Administrator may collect data from—

(A) national substance use and misuse organizations that work with eligible coalitions, community anti-drug coalitions, departments or agencies of the Federal Government, or State or local governments and the governing bodies of Indian tribes; and

(B) any other entity or organization that carries out activities that relate to the purposes of the Program.

(2) Activities of Administrator

The Administrator may—

(A) evaluate the utility of specific initiatives relating to the purposes of the Program;

(B) conduct an evaluation of the Program; and

(C) disseminate information described in this subsection to—

(i) eligible coalitions and other substance use and misuse organizations; and

(ii) the general public.

(3) Consultation

The Administrator shall carry out activities under this subsection in consultation with the Advisory Commission and the National Community Antidrug Coalition Institute.

(4) Limitation on use of certain funds for evaluation of Program

Amounts for activities under paragraph (2)(B) may not be derived from amounts under section 1524(a) of this title except for amounts that are available under section 1524(b) of this title for administrative costs.

(Pub. L. 100–690, title I, §1033, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 230; amended Pub. L. 107–82, §1(e), (f), Dec. 14, 2001, 115 Stat. 818; Pub. L. 115–271, title VIII, §8203(b)(4)(A), 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)(4)(A). See 2018 Amendment note below.

2018—Subsec. (b)(1)(A), (2)(C)(i). Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse".

2001—Subsec. (b)(3). Pub. L. 107–82, §1(e), added par. (3).

Subsec. (b)(4). Pub. L. 107–82, §1(f), added par. (4).

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.
21 U.S.C. § 391 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 391: Separability clause
Separability clause
Status: in_force

If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.

(June 25, 1938, ch. 675, §1001, formerly §901, 52 Stat. 1059; renumbered §1001, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 871 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 871: Attorney General
Attorney General
Status: in_force

(a) Delegation of functions

The Attorney General may delegate any of his functions under this subchapter to any officer or employee of the Department of Justice.

(b) Rules and regulations

The Attorney General may promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter.

(c) Acceptance of devises, bequests, gifts, and donations

The Attorney General may accept in the name of the Department of Justice any form of devise, bequest, gift, or donation where the donor intends to donate property for the purpose of preventing or controlling the abuse of controlled substances. He may take all appropriate steps to secure possession of such property and may sell, assign, transfer, or convey any such property other than moneys.

(Pub. L. 91–513, title II, §501, Oct. 27, 1970, 84 Stat. 1270.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a) and (b), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, 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.
21 U.S.C. § 1178 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1178: Records and audit
Records and audit
Status: in_force

(a) Assistance records; contents

Each recipient of assistance under section 1177 of this title pursuant to grants or contracts entered into under other than competitive bidding procedures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant or contract, the total cost of the project or undertaking in connection with which such grant or contract is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(b) Access to pertinent information for audit and examination

The Secretary and Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of such recipients that are pertinent to such grants or contracts.

(Pub. L. 92–255, title IV, §411, Mar. 21, 1972, 86 Stat. 83; Pub. L. 97–35, title IX, §971, Aug. 13, 1981, 95 Stat. 597.)

Editorial Notes

Amendments

1981—Subsec. (a). Pub. L. 97–35 struck out reference to section 1176 of this title.
21 U.S.C. § 62 (2024) — Title 21: FOOD AND DRUGS / Chapter 3: FILLED MILK / Section 62: Manufacture, shipment, or delivery for shipment in interstate or foreign commerce prohibited
Manufacture, shipment, or delivery for shipment in interstate or foreign commerce prohibited
Status: in_force

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

(Mar. 4, 1923, ch. 262, §2, 42 Stat. 1487.)
21 U.S.C. § 360aaa (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360aaa: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Sections 360aaa to 360aaa–6 ceased to be effective pursuant to section 401(e) of Pub. L. 105–115, set out as an Effective and Termination Dates note below.

Section 360aaa, act June 25, 1938, ch. 675, §551, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2356, related to requirements for dissemination of treatment information on drugs or devices.

Section 360aaa–1, act June 25, 1938, ch. 675, §552, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2358, related to information authorized to be disseminated under section 360aaa.

Section 360aaa–2, act June 25, 1938, ch. 675, §553, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2359, related to establishment of list of articles and publications disseminated and list of providers that received articles and reference publications.

Section 360aaa–3, act June 25, 1938, ch. 675, §554, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2359, related to requirement regarding submission of supplemental application for new use and an exemption from that requirement.

Section 360aaa–4, act June 25, 1938, ch. 675, §555, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2361, related to corrective actions and cessation of dissemination.

Section 360aaa–5, act June 25, 1938, ch. 675, §556, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2362, related to definitions.

Section 360aaa–6, act June 25, 1938, ch. 675, §557, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2363, related to rules of construction.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates

Pub. L. 105–115, title IV, §401(d), Nov. 21, 1997, 111 Stat. 2364, provided that: "The amendments made by this section [enacting this part and amending section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Nov. 21, 1997], or upon the Secretary's issuance of final regulations pursuant to subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is sooner."

Pub. L. 105–115, title IV, §401(e), Nov. 21, 1997, 111 Stat. 2364, provided that: "The amendments made by this section [enacting this part and amending section 331 of this title] cease to be effective September 30, 2006, or 7 years after the date on which the Secretary promulgates the regulations described in subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is later."

Regulations

Pub. L. 105–115, title IV, §401(c), Nov. 21, 1997, 111 Stat. 2364, provided that: "Not later than 1 year after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall promulgate regulations to implement the amendments made by this section [enacting this part and amending section 331 of this title]."
21 U.S.C. § 1506 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter I: OFFICE OF NATIONAL DRUG CONTROL POLICY / Section 1506: Repealed. Pub. L. 100-690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, §2(b), June 27, 1997, 111 Stat. 234; Pub. L. 115-271, title VIII, §8203(a)(3), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116-74, §2(c)(1)(A)(i)(III), Nov. 27, 2019, 133 Stat. 1157
Repealed. Pub. L. 100-690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, §2(b), June 27, 1997, 111 Stat. 234; Pub. L. 115-271, title VIII, §8203(a)(3), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116-74, §2(c)(1)(A)(i)(III), Nov. 27, 2019, 133 Stat. 1157
Status: repealed

Section 1506, Pub. L. 100–690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188; Pub. L. 103–322, title IX, §90208(a), Sept. 13, 1994, 108 Stat. 1995; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234; Pub. L. 115–271, title VIII, §8203(a)(3), Oct. 24, 2018, 132 Stat. 4111; Pub. L. 116–74, §2(c)(1)(A)(i)(III), Nov. 27, 2019, 133 Stat. 1157, repealed this subchapter, and the amendments made by this subchapter, except for section 1007, effective Sept. 30, 1997. Amendment by Pub. L. 115–271, which added another exception for sections 1021 to 1035 of Pub. L. 100–690 (21 U.S.C. 1521 to 1535), and which was not given effect because those sections had not been treated as repealed in light of Pub. L. 105–20, §2(b), was subsequently repealed by Pub. L. 116–74.

Section 1507, Pub. L. 100–690, title I, §1010, Nov. 18, 1988, 102 Stat. 4188; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, defined terms for purposes of this subchapter. See section 1701 of this title.

Section 1508, Pub. L. 100–690, title I, §1011, Nov. 18, 1988, 102 Stat. 4189; Pub. L. 103–322, title IX, §90206, Sept. 13, 1994, 108 Stat. 1995; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, authorized appropriations to carry out this subchapter. See section 1711 of this title.

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.

Effective Date of Repeal

Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100–690, which was formerly classified to section 1506 of this title.
21 U.S.C. § 1707 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1707: Repealed. Pub. L. 115-271, title VIII, §8222(3), Oct. 24, 2018, 132 Stat. 4143
Repealed. Pub. L. 115-271, title VIII, §8222(3), Oct. 24, 2018, 132 Stat. 4143
Status: repealed

Section, Pub. L. 105–277, div. C, title VII, §§708, 715, Oct. 21, 1998, 112 Stat. 2681–687, 2681–693; Pub. L. 109–469, title IV, §401, title VI, §602, Dec. 29, 2006, 120 Stat. 3525, 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110, related to Counter-Drug Technology Assessment Center.
21 U.S.C. § 468 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 468: Cost of inspection; overtime
Cost of inspection; overtime
Status: in_force

The cost of inspection rendered under the requirements of this chapter, shall be borne by the United States, except the cost of overtime and holiday pay paid pursuant to the 1 section 2219a of title 7.

(Pub. L. 85–172, §25, formerly §19, Aug. 28, 1957, 71 Stat. 448, renumbered Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805; Pub. L. 107–171, title X, §10703(c)(1), May 13, 2002, 116 Stat. 517.)

Editorial Notes

References in Text

Section 2219a of title 7, referred to in text, was in the original "section 10703 of the Farm Security and Rural Investment Act of 2002", meaning section 10703 of Pub. L. 107–171, which enacted section 2219a of Title 7, Agriculture, amended this section, section 695 of this title, and section 5549 of Title 5, Government Organization and Employees, and repealed section 394 of Title 7.

Amendments

2002—Pub. L. 107–171 substituted "except the cost of overtime and holiday pay paid pursuant to the section 2219a of title 7." for "except that the cost of overtime and holiday work performed in establishments subject to the provisions of this chapter at such rates as the Secretary may determine shall be borne by such establishments. Sums received by the Secretary in reimbursement for sums paid out by him for such premium pay work shall be available without fiscal year limitation to carry out the purposes of this section."

1 So in original. The word "the" probably should not appear.
21 U.S.C. § 877 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 877: Judicial review
Judicial review
Status: in_force

All final determinations, findings, and conclusions of the Attorney General under this subchapter shall be final and conclusive decisions of the matters involved, except that any person aggrieved by a final decision of the Attorney General may obtain review of the decision in the United States Court of Appeals for the District of Columbia or for the circuit in which his principal place of business is located upon petition filed with the court and delivered to the Attorney General within thirty days after notice of the decision. Findings of fact by the Attorney General, if supported by substantial evidence, shall be conclusive.

(Pub. L. 91–513, title II, §507, Oct. 27, 1970, 84 Stat. 1273.)
21 U.S.C. § 200 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 200: Repealed. Nov. 2, 1951, ch. 666, §5(2), 65 Stat. 769
Repealed. Nov. 2, 1951, ch. 666, §5(2), 65 Stat. 769
Status: repealed

Sections, acts Aug. 12, 1937, ch. 598, §§1–3, 50 Stat. 627; July 1, 1944, ch. 377, §9, 58 Stat. 721; Mar. 8, 1946, ch. 81, §8, 60 Stat. 39, related to punishment for offenses after first offense. See section 801 et seq. of this title.

Statutory Notes and Related Subsidiaries

Savings Provision

Act Nov. 2, 1951, ch. 666, §6, 65 Stat. 769, provided that any rights or liabilities now existing under former sections 200 to 200b of this title should not be affected by their repeal.
21 U.S.C. § 615 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 615: Inspection of carcasses, meat of which is intended for export
Inspection of carcasses, meat of which is intended for export
Status: in_force

The Secretary shall also cause to be made a careful inspection of the carcasses and parts thereof of all amenable species, the meat of which, fresh, salted, canned, corned, packed, cured, or otherwise prepared, is intended and offered for export to any foreign country, at such times and places and in such manner as he may deem proper.

(Mar. 4, 1907, ch. 2907, title I, §15, formerly 13th par., 34 Stat. 1263; renumbered §15 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 83 of this title.

Amendments

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

1967—Pub. L. 90–201, §§3(b), 12(a), struck out "of Agriculture" after "Secretary" and included horses, mules, and other equines in the list of animals, 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 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.
21 U.S.C. § 1043 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1043: Rules and regulations; administration and enforcement
Rules and regulations; administration and enforcement
Status: in_force

The Secretary shall promulgate such rules and regulations as he deems necessary to carry out the purposes or provisions of this chapter, and shall be responsible for the administration and enforcement of this chapter except as otherwise provided in section 1034(d) of this title.

(Pub. L. 91–597, §14, Dec. 29, 1970, 84 Stat. 1629.)

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. § 191 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 191: Repealed. Pub. L. 91-513, title III, §1101(a)(1), Oct. 27, 1970, 84 Stat. 1291
Repealed. Pub. L. 91-513, title III, §1101(a)(1), Oct. 27, 1970, 84 Stat. 1291
Status: repealed

Sections, acts Feb. 23, 1887, ch. 210, 24 Stat. 409; June 25, 1948, ch. 646, §§5, 39, 62 Stat. 986, 992, prohibited importation of opium by Chinese subjects and the trafficking in, in China, of opium by United States citizens. Sections 1 to 3 of said Act of Feb. 23, 1887, were classified to sections 191 to 193, respectively, of this title.

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 Savings Provision note under section 171 of this title.
21 U.S.C. § 961 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 961: Prohibited acts B
Prohibited acts B
Status: in_force

Any person who violates section 954 of this title or fails to notify the Attorney General of an importation or exportation under section 971 of this title shall be subject to the following penalties:

(1) Except as provided in paragraph (2), any such person shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. Sections 842(c)(1) and (c)(3) of this title shall apply to any civil penalty assessed under this paragraph.

(2) If such a violation is prosecuted by an information or indictment which alleges that the violation was committed knowingly or intentionally and the trier of fact specifically finds that the violation was so committed, such person shall be sentenced to imprisonment for not more than one year or a fine of not more than $25,000 or both.

(Pub. L. 91–513, title III, §1011, Oct. 27, 1970, 84 Stat. 1290; Pub. L. 100–690, title VI, §6053(d), Nov. 18, 1988, 102 Stat. 4316.)

Editorial Notes

Amendments

1988—Pub. L. 100–690 inserted "or fails to notify the Attorney General of an importation or exportation under section 971 of this title".

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date

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. § 1176 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1176: Repealed. Pub. L. 97-35, title IX, §969(a), Aug. 13, 1981, 95 Stat. 595
Repealed. Pub. L. 97-35, title IX, §969(a), Aug. 13, 1981, 95 Stat. 595
Status: repealed

Section, Pub. L. 92–255, title IV, §409, Mar. 21, 1972, 86 Stat. 80; Pub. L. 94–237, §§7, 8(a), 9(a)(1), (b)(1), Mar. 19, 1976, 90 Stat. 245–247; Pub. L. 94–371, §10(a)(1), (b)(1), July 26, 1976, 90 Stat. 1040; Pub. L. 95–83, title III, §311(a)(3), Aug. 1, 1977, 91 Stat. 397; Pub. L. 95–461, §§2(a), 4, Oct. 14, 1978, 92 Stat. 1268, 1269; Pub. L. 96–79, title I, §115(j)(2), Oct. 4, 1979, 93 Stat. 610; Pub. L. 96–181, §6, Jan. 2, 1980, 93 Stat. 1311, provided for creation and funding through the fiscal year ending Sept. 30, 1981, of a program of formula grants to States to operate State plans for the establishment, conduct, and coordination of projects for the development of more effective drug abuse prevention functions in the States and for the evaluation of such programs.
21 U.S.C. § 621 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 621: Inspectors to make examinations provided for; appointment; duties; regulations
Inspectors to make examinations provided for; appointment; duties; regulations
Status: in_force

The Secretary shall appoint from time to time inspectors to make examination and inspection of all amenable species, inspection of which is hereby provided for and of all carcasses and parts thereof, and of all meats and meat food products thereof, and of the sanitary conditions of all establishments in which such meat and meat food products hereinbefore described are prepared; and said inspectors shall refuse to stamp, mark, tag, or label any carcass or any part thereof, or meat food product therefrom, prepared in any establishment hereinbefore mentioned, until the same shall have actually been inspected and found to be not adulterated; and shall perform such other duties as are provided by this chapter and by the rules and regulations to be prescribed by said Secretary; and said Secretary shall, from time to time, make such rules and regulations as are necessary for the efficient execution of the provisions of this chapter, and all inspections and examinations made under this chapter, shall be such and made in such manner as described in the rules and regulations prescribed by said Secretary not inconsistent with provisions of this chapter.

(Mar. 4, 1907, ch. 2907, title I, §21, formerly 19th par., 34 Stat. 1264; renumbered §21 and amended Pub. L. 90–201, §§1, 3(b), 12(a), (i), Dec. 15, 1967, 81 Stat. 584, 588, 592, 593; Pub. L. 99–641, title IV, §403(d)(2), Nov. 10, 1986, 100 Stat. 3570; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 89 of this title.

Amendments

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

1986—Pub. L. 99–641 temporarily substituted "thereof, and of meat food products" for "and meat food products", which substitution was made for the first such reference as the probable intent of Congress. See Effective and Termination Dates of 1986 Amendment note below.

1967—Pub. L. 90–201, §§3(b), 12(a), (i), struck out "of Agriculture" after "Secretary" in four places, included horses, mules, and other equines in the list of animals, and substituted "not adulterated" for "sound, healthful, wholesome, and fit for human food, and to contain no dyes, chemicals, preservatives, or ingredients which render such meat food product unsound, unhealthful, unwholesome, or unfit for human food; and to have been prepared under proper sanitary conditions, hereinbefore provided for", respectively.

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 and Termination Dates of 1986 Amendment

Pub. L. 99–641, title IV, §403(d)(2), Nov. 10, 1986, 100 Stat. 3570, provided that the amendment made by that section is effective only during the 6-year period beginning on Nov. 10, 1986.

Amendment by Pub. L. 99–641 effective Nov. 10, 1986, except that this section as in effect immediately before Nov. 10, 1986, applies with respect to establishments until the Secretary of Agriculture first issues rules and regulations to implement the amendments made by section 403(a) of Pub. L. 99–641 to section 606 of this title, see section 408 of Pub. L. 99–641, set out as a note under section 609 of this title.

Effective Date of 1967 Amendment

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

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

For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled "Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program" and "Savings Provision", respectively, under section 609 of this title.
21 U.S.C. § 692 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter V: MISCELLANEOUS PROVISIONS / Section 692: Inspection extended to reindeer
Inspection extended to reindeer
Status: in_force

The provisions of the meat-inspection law may be extended to the inspection of reindeer.

(June 30, 1914, ch. 131, 38 Stat. 420.)

Editorial Notes

Codification

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

Section was formerly classified to section 94 of this title.
21 U.S.C. § 1708a (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1708a: Repealed. Pub. L. 116-74, §2(b)(1), Nov. 27, 2019, 133 Stat. 1157
Repealed. Pub. L. 116-74, §2(b)(1), Nov. 27, 2019, 133 Stat. 1157
Status: repealed

Section, Pub. L. 109–469, title II, §203, Dec. 29, 2006, 120 Stat. 3517; Pub. L. 112–234, §2(c), Dec. 28, 2012, 126 Stat. 1624; Pub. L. 115–271, title VIII, §8218(b), Oct. 24, 2018, 132 Stat. 4132, required the Government Accountability Office to conduct and supervise an audit and investigation and prepare and report every 3 years.
21 U.S.C. § 212 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 212: Offenses; punishment; duty to enforce provisions
Offenses; punishment; duty to enforce provisions
Status: in_force

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

(Mar. 3, 1915, ch. 74, §11, 38 Stat. 821.)
21 U.S.C. § 6 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter I: FEDERAL FOOD AND DRUGS ACT OF 1906 / Section 6: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, act Mar. 4, 1923, ch. 268, 42 Stat. 1500, was transferred to section 321a of this title.
21 U.S.C. § 470 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 470: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Section, Pub. L. 85–172, §27, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 807; amended Pub. L. 103–437, §8(1), Nov. 2, 1994, 108 Stat. 4588, which required the Secretary of Agriculture to report annually to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate on the slaughter of poultry and the processing and distribution of poultry parts and products, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 46 of House Document No. 103–7.
21 U.S.C. § 1709 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1709: Repealed. Pub. L. 109-469, title XI, §1101(a), Dec. 29, 2006, 120 Stat. 3539
Repealed. Pub. L. 109-469, title XI, §1101(a), Dec. 29, 2006, 120 Stat. 3539
Status: repealed

Section, Pub. L. 105–277, div. C, title VII, §710, Oct. 21, 1998, 112 Stat. 2681–689, related to Parents Advisory Council on Youth Drug Abuse.
21 U.S.C. § 26 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 26: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Section, which was from the appropriation acts of Jan. 18, 1927, ch. 39, 44 Stat. 984; May 16, 1928, ch. 572, 45 Stat. 548; Feb. 16, 1929, ch. 227, 45 Stat. 1198; May 27, 1930, ch. 341, 46 Stat. 424, and subsequent Department of Agriculture Appropriation Acts to and including act June 28, 1944, ch. 296, §4, 58 Stat. 461, and related to inspection of food and other products, is covered by section 2256 of Title 7, Agriculture.
21 U.S.C. § 394 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 394: Scientific review groups
Scientific review groups
Status: in_force

Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—

(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and

(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(June 25, 1938, ch. 675, §1004, formerly §903, as added Pub. L. 101–635, title III, §301, Nov. 28, 1990, 104 Stat. 4584; renumbered §904, Pub. L. 103–43, title XX, §2006(1), June 10, 1993, 107 Stat. 209; renumbered §1004, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 1505a (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter I: OFFICE OF NATIONAL DRUG CONTROL POLICY / Section 1505a: Annual report on development and deployment of narcotics detection technologies
Annual report on development and deployment of narcotics detection technologies
Status: in_force

(a) Report requirement

Not later than December 1st of each year, the Director of the Office of National Drug Control Policy shall submit to Congress and the President a report on the development and deployment of narcotics detection technologies by Federal agencies. Each such report shall be prepared in consultation with the Secretary of Defense, the Secretary of State, the Secretary of Homeland Security, and the Secretary of the Treasury.

(b) Matters to be included

Each report under subsection (a) shall include—

(1) a description of each project implemented by a Federal agency relating to the development or deployment of narcotics detection technology;

(2) the agency responsible for each project described in paragraph (1);

(3) the amount of funds obligated or expended to carry out each project described in paragraph (1) during the fiscal year in which the report is submitted or during any fiscal year preceding the fiscal year in which the report is submitted;

(4) the amount of funds estimated to be obligated or expended for each project described in paragraph (1) during any fiscal year after the fiscal year in which the report is submitted to Congress; and

(5) a detailed timeline for implementation of each project described in paragraph (1).

(Pub. L. 105–85, div. A, title X, §1034, Nov. 18, 1997, 111 Stat. 1884; Pub. L. 107–296, title XVII, §1704(e)(10), Nov. 25, 2002, 116 Stat. 2315.)

Editorial Notes

Codification

Section was enacted as part of the National Defense Authorization Act for Fiscal Year 1998, and not as part of the National Narcotics Leadership Act of 1988 which comprises this chapter.

Amendments

2002—Subsec. (a). Pub. L. 107–296 substituted "of Homeland Security" for "of Transportation".

Statutory Notes and Related Subsidiaries

Effective Date of 2002 Amendment

Amendment by Pub. L. 107–296 effective on the date of transfer of the Coast Guard to the Department of Homeland Security, see section 1704(g) of Pub. L. 107–296, set out as a note under section 101 of Title 10, Armed Forces.
21 U.S.C. § 355d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 355d: Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Status: in_force

The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.

(June 25, 1938, ch. 675, §505C, as added Pub. L. 110–85, title IV, §403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, §509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, §505(f), Aug. 18, 2017, 131 Stat. 1047.)

Editorial Notes

Amendments

2017—Pub. L. 115–52 inserted "or pediatric rare diseases" after "psychiatry".

2012—Pub. L. 112–144 inserted "deferral extensions," after "deferrals," in section catchline and "neonatology," after "pediatric ethics," in text.
21 U.S.C. § 465 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 465: Limitations upon entry of poultry products and other materials into official establishments
Limitations upon entry of poultry products and other materials into official establishments
Status: in_force

The Secretary may limit the entry of poultry products and other materials into any official establishment, under such conditions as he may prescribe to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this chapter.

(Pub. L. 85–172, §16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90–492, §15, Aug. 18, 1968, 82 Stat. 805.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 substituted provisions authorizing the Secretary to limit the entry of poultry products and other materials into any official establishment for provisions that any person distributing unwholesome or adulterated exempted poultry or poultry products intended for human consumption shall be guilty of a misdemeanor and subject to penalties upon conviction thereof.

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. § 17 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 17: Penalty for sale or introduction of falsely labeled dairy or food products; venue
Penalty for sale or introduction of falsely labeled dairy or food products; venue
Status: in_force

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

(July 1, 1902, ch. 1357, §2, 32 Stat. 632.)
21 U.S.C. § 147 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 147: Repeal of inconsistent laws
Repeal of inconsistent laws
Status: in_force

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

(Feb. 15, 1927, ch. 155, §7, 44 Stat. 1103.)
21 U.S.C. § 456 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 456: Operation of premises, facilities and equipment
Operation of premises, facilities and equipment
Status: in_force

(a) Sanitary practices

Each official establishment slaughtering poultry or processing poultry products for commerce or otherwise subject to inspection under this chapter shall have such premises, facilities, and equipment, and be operated in accordance with such sanitary practices, as are required by regulations promulgated by the Secretary for the purpose of preventing the entry into or flow or movement in commerce or burdensome effect upon commerce, of poultry products which are adulterated.

(b) Refusal of inspection

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

(Pub. L. 85–172, §7, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90–492, §7, Aug. 18, 1968, 82 Stat. 799.)

Editorial Notes

Amendments

1968—Par. (a). Pub. L. 90–492 substituted "otherwise subject to inspection under this chapter" for "in or for marketing in a designated major consuming area", "burdensome effect upon commerce" for "in a designated major consuming area", and "which are adulterated" for "which are unwholesome or adulterated".

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. § 1172 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1172: Repealed. Pub. L. 98-24, §2(c)(2), Apr. 26, 1983, 97 Stat. 182
Repealed. Pub. L. 98-24, §2(c)(2), Apr. 26, 1983, 97 Stat. 182
Status: repealed

Section, Pub. L. 92–255, title IV, §405, Mar. 21, 1972, 86 Stat. 77; Pub. L. 95–461, §3(b), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 97–35, title IX, §973(c)(1), Aug. 13, 1981, 95 Stat. 598, required that the Secretary of Health and Human Services make periodic reports to the Congress and to the President on drug abuse in the United States. See section 290aa–4 of Title 42, The Public Health and Welfare.
21 U.S.C. § 94 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter I: EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Section 94: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section 94, act June 30, 1914, ch. 131, 38 Stat. 420, which related to inspection of reindeer, was transferred to section 692 of this title.

Section 94a, act May 23, 1908, ch. 192, 35 Stat. 254, which related to inspection of dairy products for export, was transferred to section 693 of this title.

Section 95, acts June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756, §2, 48 Stat. 1225, which related to authorization of appropriations for expenses of inspection, was transferred to section 694 of this title.
21 U.S.C. § 136 (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 136: Additional inspection services
Additional inspection services
Status: in_force

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

(Pub. L. 101–624, title XXV, §2508, Nov. 28, 1990, 104 Stat. 4069.)
21 U.S.C. § 132 (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 132: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, act May 23, 1908, ch. 192, 35 Stat. 254, which related to inspection of dairy products for export, was transferred to section 693 of this title.
21 U.S.C. § 7 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter I: FEDERAL FOOD AND DRUGS ACT OF 1906 / Section 7: 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 7, act June 30, 1906, ch. 3915, §6, 34 Stat. 769, defined "drug" and "food". See section 321 of this title.

Section 8, act June 30, 1906, ch. 3915, §7, 34 Stat. 769, deemed drugs to be adulterated when sold having a difference from recognized standards, except where there is an explanatory statement on or in container, and when sold below professed standard; confectioneries, when containing mineral substances, poisonous color or flavors, other deleterious ingredients, liquors or narcotics; food, when concerned with injurious mixtures, use of substitutes, abstraction of valuable constituents, concealment of damage or inferiority, deleterious ingredients, preservatives in shipment conditionally excepted, animal or vegetable substances unfit for food and products of animals diseased or having died otherwise than by slaughter. See sections 342 and 351 of this title.

Section 9, act June 30, 1906, ch. 3915, §8, 34 Stat. 771, defined "misbranded" and provided for its application to drugs and food. See sections 343 and 352 of this title.

Section 10, acts June 30, 1906, ch. 3915, §8, 34 Stat. 771; Aug. 23, 1912, ch. 352, 37 Stat. 416; Mar. 3, 1913, ch. 117, 37 Stat. 732; July 24, 1919, ch. 26, 41 Stat. 271; July 8, 1930, ch. 874, 46 Stat. 1019, deemed drugs to be misbranded when there is an imitation or use of name of other article, when there is removal and substitution of contents of package or failure to state on label quantity or proportion of narcotics therein, and when there is a false statement of curative or therapeutic effect; and food, when there is an imitation or use of name of other article, when there is a false label or brand removal and substitution of contents of package, or failure to state or label quantity or proportion of narcotics therein, when the packages are not marked with weight, with certain variations and exemptions permitted, when there are false or misleading statements on package or label as to ingredients or substances; and food, when mixtures or compounds under distinctive names, the articles are labeled, branded as compounds, imitations, or blends; construed the term "blend" and related to disclosure of trade formulas of proprietary foods, and canned food. See sections 321b, 341, 343 and 352 of this title.

Section 11, acts June 30, 1906, ch. 3915, §4, 34 Stat. 769; Jan. 18, 1927, ch. 39, 44 Stat. 1003, provided for examination of specimens, notice of adulteration or misbranding, hearing, certification of violations to United States district attorney and notice of judgment.

Section 12, act June 30, 1906, ch. 3915, §5, 34 Stat. 769, provided for prosecution by district attorneys for enforcement of penalties.

Section 13, act June 30, 1906, ch. 3915, §9, 34 Stat. 771, provided for a seller's guaranty as protection to dealer. See section 333 of this title.

Section 14, act June 30, 1906, ch. 3915, §10, 34 Stat. 771, provided for seizure of articles by libel for condemnation, at suit of and in name of United States, in United States district court where found, conforming to proceedings in admiralty, with right to trial by jury, destruction or sale of adulterated or misbranded articles, bond and payment of proceeds into Treasury of United States. See sections 332, 334 and 337 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

For effective date of repeal, see section 1002(a) of act June 25, 1938, set out as a note under sections 1 to 5 of this title.
21 U.S.C. § 387m (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387m: Equal treatment of retail outlets
Equal treatment of retail outlets
Status: in_force

The Secretary shall issue regulations to require that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restrictions applicable to retail establishments accessible to individuals under the age of 18.

(June 25, 1938, ch. 675, §913, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1820.)
21 U.S.C. § 970 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 970: Criminal forfeitures
Criminal forfeitures
Status: in_force

Section 853 of this title, relating to criminal forfeitures, shall apply in every respect to a violation of this subchapter punishable by imprisonment for more than one year.

(Pub. L. 91–513, title III, §1017, as added Pub. L. 98–473, title II, §307, Oct. 12, 1984, 98 Stat. 2051.)
21 U.S.C. § 1403 (2024) — Title 21: FOOD AND DRUGS / Chapter 19: PESTICIDE MONITORING IMPROVEMENTS / Section 1403: Pesticide analytical methods
Pesticide analytical methods
Status: in_force

The Secretary of Health and Human Services shall, in consultation with the Administrator of the Environmental Protection Agency—

(1) develop a detailed long-range plan and timetable for research that is necessary for the development of and validation of—

(A) new and improved analytical methods capable of detecting at one time the presence of multiple pesticide residues in food, and

(B) rapid pesticide analytical methods, and

(2) conduct a review to determine whether the use of rapid pesticide analytical methods by the Secretary would enable the Secretary to improve the cost-effectiveness of monitoring and enforcement activities under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], including increasing the number of pesticide residues which can be detected and the number of tests for pesticide residues which can be conducted in a cost-effective manner.

The Secretary shall report the plan developed under paragraph (1), the resources necessary to carry out the research described in such paragraph, recommendations for the implementation of such research, and the result of the review conducted under paragraph (2) not later than the expiration of 240 days after August 23, 1988, to the Committee on Agriculture, Nutrition, and Forestry and the Committee on Labor and Human Resources of the Senate and the House of Representatives.

(Pub. L. 100–418, title IV, §4704, Aug. 23, 1988, 102 Stat. 1414.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, 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. § 1501 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter I: OFFICE OF NATIONAL DRUG CONTROL POLICY / Section 1501: Repealed. Pub. L. 100-690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, §2(b), June 27, 1997, 111 Stat. 234
Repealed. Pub. L. 100-690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, §2(b), June 27, 1997, 111 Stat. 234
Status: repealed

Section 1501, Pub. L. 100–690, title I, §1002, Nov. 18, 1988, 102 Stat. 4181, established Office of National Drug Control Policy in Executive Office of President. See section 1702 of this title.

Section 1502, Pub. L. 100–690, title I, §1003, Nov. 18, 1988, 102 Stat. 4182; Pub. L. 103–322, title IX, §§90201, 90202, 90207, Sept. 13, 1994, 108 Stat. 1990, 1991, 1995, related to appointment and duties of Director, Deputy Directors, and Associate Director of Office of National Drug Control Policy. See section 1703 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100–690, as amended, which was formerly classified to section 1506 of this title.

Short Title of 1997 Amendment

Pub. L. 105–20, §1, June 27, 1997, 111 Stat. 224, provided that: "This Act [enacting subchapter II of this chapter and amending former sections 1504, 1506 to 1508 of this title, section 2291 of Title 22, Foreign Relations and Intercourse, and provisions set out as notes under this section] may be cited as the 'Drug-Free Communities Act of 1997'."

Short Title

Pub. L. 100–690, §1, Nov. 18, 1988, 102 Stat. 4181, provided that: "This Act [see Tables for classification] may be cited as the 'Anti-Drug Abuse Act of 1988'."

Pub. L. 100–690, title I, §1001, Nov. 18, 1988, 102 Stat. 4181, provided that: "This subtitle [subtitle A (§§1001–1048) of title I of Pub. L. 100–690, enacting this chapter, amending section 1115 of this title, sections 5312, 5314, and 5315 of Title 5, Government Organization and Employees, section 1105 of Title 31, Money and Finance, and section 402 of Title 50, War and National Defense, repealing sections 1103, 1111 to 1114, 1116, and 1201 to 1204 of this title, enacting provisions set out as notes under sections 1201 and 1501 of this title, and repealing provisions set out as notes under section 1201 of this title may be cited as the 'National Narcotics Leadership Act of 1988'."

References to Subtitle A of Pub. L. 100–690

Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, provided that: "Each reference in Federal law to subtitle A of the Anti-Drug Abuse Act of 1988 [see section 1001 of Pub. L. 100–690, set out above], with the exception of section 1001 of such subtitle, in any provision of law that is in effect on the day before the date of enactment of this Act [June 27, 1997] shall be deemed to be a reference to chapter 1 of the National Narcotics Leadership Act of 1988 [chapter 1 of subtitle A (§§1002–1012) of title I of Pub. L. 100–690, see Tables for classification] (as so designated by this section)."
21 U.S.C. § 860a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 860a: Consecutive sentence for manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine on premises where children are present or reside
Consecutive sentence for manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine on premises where children are present or reside
Status: in_force

Whoever violates section 841(a)(1) of this title by manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine or its salts, isomers or salts of isomers on premises in which an individual who is under the age of 18 years is present or resides, shall, in addition to any other sentence imposed, be imprisoned for a period of any term of years but not more than 20 years, subject to a fine, or both.

(Pub. L. 91–513, title II, §419a, as added Pub. L. 109–177, title VII, §734(a), Mar. 9, 2006, 120 Stat. 270.)
21 U.S.C. § 101 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter II: IMPORTATION OF CATTLE AND QUARANTINE / Section 101: Suspension of importation of all animals
Suspension of importation of all animals
Status: in_force

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

(Aug. 30, 1890, ch. 839, §9, 26 Stat. 416.)
21 U.S.C. § 1503 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter I: OFFICE OF NATIONAL DRUG CONTROL POLICY / Section 1503: Repealed. Pub. L. 100-690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, §2(b), June 27, 1997, 111 Stat. 234
Repealed. Pub. L. 100-690, title I, §1009, Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, §2(b), June 27, 1997, 111 Stat. 234
Status: repealed

Section 1503, Pub. L. 100–690, title I, §1004, Nov. 18, 1988, 102 Stat. 4184, related to coordination between Office of National Drug Control Policy and executive branch departments and agencies. See section 1704 of this title.

Section 1504, Pub. L. 100–690, title I, §1005, Nov. 18, 1988, 102 Stat. 4185; Pub. L. 103–322, title IX, §90203, Sept. 13, 1994, 108 Stat. 1991; Pub. L. 105–20, §2(b), June 27, 1997, 111 Stat. 234, related to annual development and submission of National Drug Control Strategy by President to Congress. See section 1705 of this title.

Section 1505, Pub. L. 100–690, title I, §1008, formerly §1003A, as added Pub. L. 101–510, div. A, title X, §1011, Nov. 5, 1990, 104 Stat. 1633; renumbered §1008 and amended Pub. L. 103–322, title IX, §90204(a), (b), (c)(2), (3), Sept. 13, 1994, 108 Stat. 1993, 1994, established Counter-Drug Technology Assessment Center within Office of National Drug Control Policy.

A prior section 1505, Pub. L. 100–690, title I, §1008, Nov. 18, 1988, 102 Stat. 4188, provided for an executive reorganization study and report to Congress and the President no later than Jan. 15, 1990, prior to repeal by Pub. L. 103–322, §90204(c)(1).

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100–690, as amended, which was formerly classified to section 1506 of this title.
21 U.S.C. § 821 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 821: Rules and regulations
Rules and regulations
Status: in_force

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.

(Pub. L. 91–513, title II, §301, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 103–200, §3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 108–447, div. B, title VI, §633(b), Dec. 8, 2004, 118 Stat. 2922.)

Editorial Notes

Amendments

2004—Pub. L. 108–447 substituted "listed chemicals" for "the registration and control of regulated persons and of regulated transactions".

1993—Pub. L. 103–200 inserted before period at end "and to the registration and control of regulated persons and of regulated transactions".

Statutory Notes and Related Subsidiaries

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date

Section 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. § 679b (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 679b: Pasteurization of meat and poultry
Pasteurization of meat and poultry
Status: in_force

(1) In general

Effective beginning not later than 30 days after May 13, 2002, the Secretary of Agriculture shall conduct an education program regarding the availability and safety of processes and treatments that eliminate or substantially reduce the level of pathogens on meat, meat food products, poultry, and poultry products.

(2) Authorization of appropriations

There is authorized to be appropriated such sums as are necessary to carry out this section.

(Pub. L. 107–171, title X, §10808(a), May 13, 2002, 116 Stat. 530.)

Editorial Notes

Codification

Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.
21 U.S.C. § 159 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 159: Enforcement; penalties applicable; Congressional findings
Enforcement; penalties applicable; Congressional findings
Status: in_force

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

(Mar. 4, 1913, ch. 145, §1 (part), as added Pub. L. 99–198, title XVII, §1768(e), Dec. 23, 1985, 99 Stat. 1655.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99–198, set out as an Effective Date of 1985 Amendment note under section 151 of this title.
21 U.S.C. § 965 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 965: Applicability of part E of subchapter I
Applicability of part E of subchapter I
Status: in_force

Part E of subchapter I shall apply with respect to functions of the Attorney General (and of officers and employees of the Bureau of Narcotics and Dangerous Drugs) under this subchapter, to administrative and judicial proceedings under this subchapter, and to violations of this subchapter, to the same extent that such part applies to functions of the Attorney General (and such officers and employees) under subchapter I, to such proceedings under subchapter I, and to violations of subchapter I. For purposes of the application of this section to section 880 or 881 of this title, any reference in such section 880 or 881 of this title to "this subchapter" shall be deemed to be a reference to this subchapter, any reference to section 823 of this title shall be deemed to be a reference to section 958 of this title, and any reference to section 822(d) of this title shall be deemed to be a reference to section 957(b)(2) of this title.

(Pub. L. 91–513, title III, §1015, Oct. 27, 1970, 84 Stat. 1291; Pub. L. 95–633, title III, §301(b), Nov. 10, 1978, 92 Stat. 3778.)

Editorial Notes

Amendments

1978—Pub. L. 95–633 inserted "or 881" after "880" wherever appearing.

Executive Documents

Transfer of Functions

For abolition of Bureau of Narcotics and Dangerous Drugs, including Office of Director thereof, and creation of a single comprehensive agency for enforcement of drug laws by Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, see note set out under section 881 of this title.
21 U.S.C. § 602 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 602: Congressional statement of findings
Congressional statement of findings
Status: in_force

Meat and meat food products are an important source of the Nation's total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that meat and meat food products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded meat or meat food products impair the effective regulation of meat and meat food products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged meat and meat food products, and result in sundry losses to livestock producers and processors of meat and meat food products, as well as injury to consumers. The unwholesome, adulterated, mislabeled, or deceptively packaged articles can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged articles, to the detriment of consumers and the public generally. It is hereby found that all articles and animals which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

(Mar. 4, 1907, ch. 2907, title I, §2, as added Pub. L. 90–201, §2, Dec. 15, 1967, 81 Stat. 587.)
21 U.S.C. § 379a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379a: Presumption of existence of jurisdiction
Presumption of existence of jurisdiction
Status: in_force

In any action to enforce the requirements of this chapter respecting a device, tobacco product, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.

(June 25, 1938, ch. 675, §709, as added Pub. L. 94–295, §8, May 28, 1976, 90 Stat. 583; amended Pub. L. 105–115, title IV, §419, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 111–31, div. A, title I, §103(k), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Pub. L. 111–31 inserted "tobacco product," after "device,".

1997—Pub. L. 105–115 substituted "a device, food, drug, or cosmetic" for "a device".

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.
21 U.S.C. § 462 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 462: Reporting of violations; notice; opportunity to present views
Reporting of violations; notice; opportunity to present views
Status: in_force

Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to present his views orally or in writing with regard to such contemplated proceeding. Nothing in this chapter shall be construed as requiring the Secretary to report for criminal prosecution violations of this chapter whenever he believes that the public interest will be adequately served and compliance with the chapter obtained by a suitable written notice or warning.

(Pub. L. 85–172, §13, Aug. 28, 1957, 71 Stat. 447.)
21 U.S.C. § 210 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 210: Pharmacist; unauthorized use of title
Pharmacist; unauthorized use of title
Status: in_force

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

(Mar. 3, 1915, ch. 74, §10, 38 Stat. 821.)
21 U.S.C. § 364e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364e: Labeling
Labeling
Status: in_force

(a) General requirement

Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.

(b) Fragrance allergens

The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.

(c) Cosmetic products for professional use

(1) Definition of professional

For purposes of this subsection, the term "professional" means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.

(2) Professional use labeling

A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—

(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and

(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15.

(June 25, 1938, ch. 675, §609, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854.)

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3503(b)(2), Dec. 29, 2022, 136 Stat. 5859, provided that: "Section 609(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 364e(a)], as added by section 802 [probably should be "section 3502"], shall take effect on the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022]."

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 855 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 855: Alternative fine
Alternative fine
Status: in_force

In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds.

(Pub. L. 91–513, title II, §415, as added Pub. L. 98–473, title II, §2302, Oct. 12, 1984, 98 Stat. 2193.)
21 U.S.C. § 2402 (2024) — Title 21: FOOD AND DRUGS / Chapter 29: INTERNATIONAL SPORTS DOPING / Section 2402: Major international doping fraud conspiracies
Major international doping fraud conspiracies
Status: in_force

(a) In general

It shall be unlawful for any person, other than an athlete, to knowingly carry into effect, attempt to carry into effect, or conspire with any other person to carry into effect a scheme in commerce to influence by use of a prohibited substance or prohibited method any major international sports competition.

(b) Extraterritorial jurisdiction

There is extraterritorial Federal jurisdiction over an offense under this section.

(Pub. L. 116–206, §3, Dec. 4, 2020, 134 Stat. 999.)
21 U.S.C. § 364i (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364i: Exemption for certain products and facilities
Exemption for certain products and facilities
Status: in_force

(a) In general

Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.

(b) Exception

A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.

(June 25, 1938, ch. 675, §613, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 853a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 853a: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, Pub. L. 100–690, title V, §5301, Nov. 18, 1988, 102 Stat. 4310, which related to denial of Federal benefits to drug traffickers and possessors, was renumbered section 421 of the Controlled Substances Act by Pub. L. 101–647, title X, §1002(d)(1), Nov. 29, 1990, 104 Stat. 4827, and is classified to section 862 of this title.
21 U.S.C. § 114i (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 114i: Pseudorabies eradication
Pseudorabies eradication
Status: in_force

(a) Findings

Congress finds that efforts to eradicate pseudorabies in United States swine populations by the Department of Agriculture in cooperation with State agencies and the pork industry have a high priority and should be continued until pseudorabies is completely eradicated in the United States.

(b) Establishment of program

The Secretary of Agriculture shall establish and carry out a program for the eradication of pseudorabies in United States swine populations.

(c) Use of funds for testing and control of pseudorabies

The Secretary shall ensure that not less than 65 percent of the funds appropriated for the program established under subsection (b) shall be used for testing and screening of animals and for other purposes directly related to the eradication or control of pseudorabies. This requirement on the use of appropriated funds for this program shall not be implemented in a manner that would adversely affect any other animal or plant disease or pest eradication or control program.

(d) Authorization of appropriations

There are authorized to be appropriated for each of the fiscal years 1991 through 2007 such sums as may be necessary for the purpose of carrying out the program established under subsection (b).

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

Editorial Notes

Amendments

2002—Subsec. (d). Pub. L. 107–171 substituted "2007" for "2002".

1996—Subsec. (d). Pub. L. 104–127 substituted "2002" for "1995".
21 U.S.C. § 1509 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter I: OFFICE OF NATIONAL DRUG CONTROL POLICY / Section 1509: Repealed. Pub. L. 109-469, title XI, §1101(b), Dec. 29, 2006, 120 Stat. 3539
Repealed. Pub. L. 109-469, title XI, §1101(b), Dec. 29, 2006, 120 Stat. 3539
Status: repealed

Section, Pub. L. 100–690, title VI, §6073, Nov. 18, 1988, 102 Stat. 4323; Pub. L. 101–647, title XX, §2001(b), Nov. 29, 1990, 104 Stat. 4854; Pub. L. 102–393, title VI, §638(c), Oct. 6, 1992, 106 Stat. 1788; Pub. L. 103–322, title IX, §90205(a), (d), Sept. 13, 1994, 108 Stat. 1994, 1995; Pub. L. 105–277, div. C, title VII, §712, Oct. 21, 1998, 112 Stat. 2681–692, related to establishment of Special Forfeiture Fund.
21 U.S.C. § 854 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 854: Investment of illicit drug profits
Investment of illicit drug profits
Status: in_force

(a) Prohibition

It shall be unlawful for any person who has received any income derived, directly or indirectly, from a violation of this subchapter or subchapter II punishable by imprisonment for more than one year in which such person has participated as a principal within the meaning of section 2 of title 18, to use or invest, directly or indirectly, any part of such income, or the proceeds of such income, in acquisition of any interest in, or the establishment or operation of, any enterprise which is engaged in, or the activities of which affect interstate or foreign commerce. A purchase of securities on the open market for purposes of investment, and without the intention of controlling or participating in the control of the issuer, or of assisting another to do so, shall not be unlawful under this section if the securities of the issuer held by the purchaser, the members of his immediate family, and his or their accomplices in any violation of this subchapter or subchapter II after such purchase do not amount in the aggregate to 1 per centum of the outstanding securities of any one class, and do not confer, either in law or in fact, the power to elect one or more directors of the issuer.

(b) Penalty

Whoever violates this section shall be fined not more than $50,000 or imprisoned not more than ten years, or both.

(c) "Enterprise" defined

As used in this section, the term "enterprise" includes any individual, partnership, corporation, association, or other legal entity, and any union or group of individuals associated in fact although not a legal entity.

(d) Construction

The provisions of this section shall be liberally construed to effectuate its remedial purposes.

(Pub. L. 91–513, title II, §414, as added Pub. L. 98–473, title II, §303, Oct. 12, 1984, 98 Stat. 2049.)