21 U.S.C. § 801a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 801a: Congressional findings and declarations: psychotropic substances
Congressional findings and declarations: psychotropic substances
Status: in_force

The Congress makes the following findings and declarations:

(1) The Congress has long recognized the danger involved in the manufacture, distribution, and use of certain psychotropic substances for nonscientific and nonmedical purposes, and has provided strong and effective legislation to control illicit trafficking and to regulate legitimate uses of psychotropic substances in this country. Abuse of psychotropic substances has become a phenomenon common to many countries, however, and is not confined to national borders. It is, therefore, essential that the United States cooperate with other nations in establishing effective controls over international traffic in such substances.

(2) The United States has joined with other countries in executing an international treaty, entitled the Convention on Psychotropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to establish suitable controls over the manufacture, distribution, transfer, and use of certain psychotropic substances. The Convention is not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate legislation. It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose.

(3) In implementing the Convention on Psychotropic Substances, the Congress intends that, consistent with the obligations of the United States under the Convention, control of psychotropic substances in the United States should be accomplished within the framework of the procedures and criteria for classification of substances provided in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.]. This will insure that (A) the availability of psychotropic substances to manufacturers, distributors, dispensers, and researchers for useful and legitimate medical and scientific purposes will not be unduly restricted; (B) nothing in the Convention will interfere with bona fide research activities; and (C) nothing in the Convention will interfere with ethical medical practice in this country as determined by the Secretary of Health and Human Services on the basis of a consensus of the views of the American medical and scientific community.

(Pub. L. 95–633, title I, §101, Nov. 10, 1978, 92 Stat. 3768; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

This Act, referred to in par. (2), is Pub. L. 95–633, Nov. 10, 1978, 92 Stat. 2768, as amended, known as the Psychotropic Substances Act of 1978, which enacted sections 801a, 830, and 852 of this title, amended sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, repealed section 830 of this title effective Jan. 1, 1981, and enacted provisions set out as notes under sections 801, 801a, 812, and 830 of this title. For complete classification of this Act to the Code, see Short Title of 1978 Amendment note set out under section 801 of this title and Tables.

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (3), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to this chapter [§801 et seq.]. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Codification

Section was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in par. (3) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date

Pub. L. 95–633, title I, §112, Nov. 10, 1978, 92 Stat. 3774, provided that: "This title [enacting this section and section 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title and section 242a of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 801 and 812 of this title] and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States." [The Convention entered into force in respect to the United States on July 15, 1980.]
21 U.S.C. § 609 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 609: Examination of animals and food products thereof, slaughtered and prepared during nighttime
Examination of animals and food products thereof, slaughtered and prepared during nighttime
Status: in_force

The Secretary shall cause an examination and inspection of all amenable species, and the food products thereof, slaughtered and prepared in the establishments hereinbefore described for the purposes of commerce to be made during the nighttime as well as during the daytime when the slaughtering of said amenable species, or the preparation of said food products is conducted during the nighttime.

(Mar. 4, 1907, ch. 2907, title I, §9, formerly 7th par., 34 Stat. 1262; renumbered §9 and amended Pub. L. 90–201, §§1, 3, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99–641, title IV, §403(d)(1), 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 77 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.

1986—Pub. L. 99–641 temporarily inserted ", except as provided in section 606 of this title," after first reference to "other equines, and". See Effective and Termination Dates of 1986 Amendment note below.

1967—Pub. L. 90–201, §§3, 12(a), struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary" and included horses, mules, and other equines in the list of animals, respectively.

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)(1), Nov. 10, 1986, 100 Stat. 3570, provided that the amendment made by that section is effective only during the 6-year period beginning Nov. 10, 1986.

Pub. L. 99–641, title IV, §408, Nov. 10, 1986, 100 Stat. 3571, provided that:

"(a) General Effective Date.—Except as provided in subsection (b) of this section, this title and the amendments made by this title [amending this section and sections 606, 621, 671, and 676 of this title and enacting provisions set out as notes under this section and sections 606, 621, 671, and 676 of this title] shall become effective on the date of the enactment of this Act [Nov. 10, 1986].

"(b) Temporary Application of Existing Law.—Sections 6, 9, and 21 of the Federal Meat Inspection Act (21 U.S.C. 606, 609, and 621), as in effect immediately before the date of the enactment of this Act [Nov. 10, 1986], shall apply with respect to establishments until the Secretary of Agriculture first issues rules and regulations to implement the amendments made by section 403(a) [amending section 606 of this title]."

Effective Date of 1967 Amendment

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

Savings Provision

Pub. L. 99–641, title IV, §404, Nov. 10, 1986, 100 Stat. 3571, provided that: "The expiration date provisions of section 403 [enacting provisions set out as notes under this section and sections 606, 621, 671, and 676 of this title] shall not have the effect of releasing or extinguishing any penalty, forfeiture, or liability incurred under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), as amended by section 403 [amending this section and sections 606, 621, 671, and 676 of this title], or under the rules or regulations issued under such Act."

Inspection Services for Establishments Not Participating in Total Plant Quality-Control Program

Pub. L. 99–641, title IV, §403(e), Nov. 10, 1986, 100 Stat. 3570, provided that: "The amendments made by this section [amending this section and sections 606, 621, 671, and 676 of this title] shall not be construed to authorize the Secretary of Agriculture to refuse to provide inspection under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) at an establishment solely because such establishment does not participate in a total plant quality-control program."
21 U.S.C. § 1535 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1535: Supplemental grants for coalition mentoring activities
Supplemental grants for coalition mentoring activities
Status: in_force

(a) Authority to make grants

As part of the program established under section 1531 of this title, the Director may award an initial grant under this subsection, and renewal grants under subsection (f), to any coalition awarded a grant under section 1532 of this title that meets the criteria specified in subsection (d) in order to fund coalition mentoring activities by such coalition in support of the program.

(b) Treatment with other grants

(1) Supplement

A grant awarded to a coalition under this section is in addition to any grant awarded to the coalition under section 1532 of this title.

(2) Requirement for basic grant

A coalition may not be awarded a grant under this section for a fiscal year unless the coalition was awarded a grant or renewal grant under section 1532(b) of this title for that fiscal year.

(c) Application

A coalition seeking a grant under this section shall submit to the Administrator an application for the grant in such form and manner as the Administrator may require.

(d) Criteria

A coalition meets the criteria specified in this subsection if the coalition—

(1) has been in existence for at least 5 years;

(2) has achieved, by or through its own efforts, measurable results in the prevention and treatment of substance use and misuse among youth;

(3) has staff or members willing to serve as mentors for persons seeking to start or expand the activities of other coalitions in the prevention and treatment of substance use and misuse;

(4) has demonstrable support from some members of the community in which the coalition mentoring activities to be supported by the grant under this section are to be carried out; and

(5) submits to the Administrator a detailed plan for the coalition mentoring activities to be supported by the grant under this section.

(e) Use of grant funds

A coalition awarded a grant under this section shall use the grant amount for mentoring activities to support and encourage the development of new, self-supporting community coalitions that are focused on the prevention and treatment of substance use and misuse in such new coalitions' communities. The mentoring coalition shall encourage such development in accordance with the plan submitted by the mentoring coalition under subsection (d)(5).

(f) Renewal grants

The Administrator may make a renewal grant to any coalition awarded a grant under subsection (a), or a previous renewal grant under this subsection, if the coalition, at the time of application for such renewal grant—

(1) continues to meet the criteria specified in subsection (d); and

(2) has made demonstrable progress in the development of one or more new, self-supporting community coalitions that are focused on the prevention and treatment of substance use and misuse.

(g) Grant amounts

(1) In general

Subject to paragraphs (2) and (3), the total amount of grants awarded to a coalition under this section for a fiscal year may not exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year. Funds appropriated for the substance use and misuse activities of a coalition that includes a representative of the Bureau of Indian Affairs, the Indian Health Service, or a tribal government agency with expertise in the field of substance use and misuse may be counted as non-Federal funds raised by the coalition.

(2) Initial grants

The amount of the initial grant awarded to a coalition under subsection (a) may not exceed $75,000.

(3) Renewal grants

The total amount of renewal grants awarded to a coalition under subsection (f) for any fiscal year may not exceed $75,000.

(h) Fiscal year limitation on amount available for grants

The total amount available for grants under this section, including renewal grants under subsection (f), in any fiscal year may not exceed the amount equal to five percent of the amount authorized to be appropriated by section 1524(a) of this title for that fiscal year.

(i) Priority in awarding initial grants

In awarding initial grants under this section, priority shall be given to a coalition that expressly proposes to provide mentorship to a coalition or aspiring coalition serving economically disadvantaged areas.

(Pub. L. 100–690, title I, §1035, as added Pub. L. 107–82, §2, Dec. 14, 2001, 115 Stat. 819; 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

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—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" wherever appearing.

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. § 2341 (2024) — Title 21: FOOD AND DRUGS / Chapter 28A: FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL / Section 2341: Definitions
Definitions
Status: in_force

In this chapter:

(1) Appropriate congressional committees

The term "appropriate congressional committees" means—

(A) the Committee on Banking, Housing, and Urban Affairs of the Senate;

(B) the Committee on Foreign Relations of the Senate;

(C) the Committee on Financial Services of the House of Representatives; and

(D) the Committee on Foreign Affairs of the House of Representatives.

(2) Foreign person

The term "foreign person"—

(A) means—

(i) any citizen or national of a foreign country; or

(ii) any entity not organized under the laws of the United States or a jurisdiction within the United States; and

(B) does not include the government of a foreign country.

(3) Knowingly

The term "knowingly", with respect to conduct, a circumstance, or a result, means that a person has actual knowledge, or should have known, of the conduct, the circumstance, or the result.

(4) Trafficking

The term "trafficking", with respect to fentanyl, fentanyl precursors, or other related opioids, has the meaning given the term "opioid trafficking" in section 2302(8) of this title.

(5) Transnational criminal organization

The term "transnational criminal organization" includes—

(A) any organization designated as a significant transnational criminal organization under part 590 of title 31, Code of Federal Regulations;

(B) any of the organizations known as—

(i) the Sinaloa Cartel;

(ii) the Jalisco New Generation Cartel;

(iii) the Gulf Cartel;

(iv) the Los Zetas Cartel;

(v) the Juarez Cartel;

(vi) the Tijuana Cartel;

(vii) the Beltran-Leyva Cartel; or

(viii) La Familia Michoacana; or

(C) any successor organization to an organization described in subparagraph (B) or as otherwise determined by the President.

(6) United States person

The term "United States person" means—

(A) a United States citizen or an alien lawfully admitted for permanent residence to the United States;

(B) an entity organized under the laws of the United States or of any jurisdiction within the United States, including a foreign branch of such an entity; or

(C) any person in the United States.

(Pub. L. 118–50, div. E, §3003, Apr. 24, 2024, 138 Stat. 935.)

Editorial Notes

References in Text

This chapter, referred to in introductory provisions, was in the original "this division", meaning div. E of Pub. L. 118–50, Apr. 24, 2024, 138 Stat. 934, known as the Fentanyl Eradication and Narcotics Deterrence Off Fentanyl or the FEND Off Fentanyl Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out below and Tables.

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 118–50, div. E, §3001, Apr. 24, 2024, 138 Stat. 934, provided that: "This division [enacting this chapter and section 2313a of this title and amending sections 1701 and 4315 of Title 50, War and National Defense] may be cited as the 'Fentanyl Eradication and Narcotics Deterrence Off Fentanyl' [sic; probably should be followed by "Act"] or the 'FEND Off Fentanyl Act'."
21 U.S.C. § 387n (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387n: Jurisdiction of and coordination with the Federal Trade Commission
Jurisdiction of and coordination with the Federal Trade Commission
Status: in_force

(a) Jurisdiction

(1) In general

Except where expressly provided in this subchapter, nothing in this subchapter shall be construed as limiting or diminishing the authority of the Federal Trade Commission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products.

(2) Enforcement

Any advertising that violates this subchapter or a provision of the regulations referred to in section 387a–1 of this title, is an unfair or deceptive act or practice under section 45(a) of title 15 and shall be considered a violation of a rule promulgated under section 57a of title 15.

(b) Coordination

With respect to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act [15 U.S.C. 1333] and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 [15 U.S.C. 4402]—

(1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and

(2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections.

(June 25, 1938, ch. 675, §914, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1820.)

Editorial Notes

References in Text

The Federal Cigarette Labeling and Advertising Act, referred to in subsec. (b), is Pub. L. 89–92, July 27, 1965, 79 Stat. 282, which is classified generally to chapter 36 (§1331 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1331 of Title 15 and Tables.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, referred to in subsec. (b), is Pub. L. 99–252, Feb. 27, 1986, 100 Stat. 30, which is classified principally to chapter 70 (§4401 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 4401 of Title 15 and Tables.
21 U.S.C. § 1194 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter V: NATIONAL INSTITUTE ON DRUG ABUSE / Section 1194: 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 V, §504, as added Pub. L. 95–461, §6(b)(1), Oct. 14, 1978, 92 Stat. 1270, related to review by the Secretary of programs and activities. See section 290aa–5 of Title 42, The Public Health and Welfare.
21 U.S.C. § 387t (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387t: Labeling, recordkeeping, records inspection
Labeling, recordkeeping, records inspection
Status: in_force

(a) Origin labeling

(1) Requirement

Beginning 1 year after June 22, 2009, the label, packaging, and shipping containers of tobacco products other than cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement "sale only allowed in the United States". Beginning 15 months after the issuance of the regulations required by section 1333(d) of title 15, as amended by section 201 of Family 1 Smoking Prevention and Tobacco Control Act, the label, packaging, and shipping containers of cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement "Sale only allowed in the United States".

(2) Effective date

The effective date specified in paragraph (1) shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with such paragraph.

(b) Regulations concerning recordkeeping for tracking and tracing

(1) In general

The Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products.

(2) Inspection

In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the point of manufacture through distribution to retail outlets to assist in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products.

(3) Codes

The Secretary may require codes on the labels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system.

(4) Size of business

The Secretary shall take into account the size of a business in promulgating regulations under this section.

(5) Recordkeeping by retailers

The Secretary shall not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption.

(c) Records inspection

If the Secretary has a reasonable belief that a tobacco product is part of an illicit trade or smuggling or is a counterfeit product, each person who manufactures, processes, transports, distributes, receives, holds, packages, exports, or imports tobacco products shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times and within reasonable limits and in a reasonable manner, upon the presentation of appropriate credentials and a written notice to such person, to have access to and copy all records (including financial records) relating to such article that are needed to assist the Secretary in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products. The Secretary shall not authorize an officer or employee of the government of any of the several States to exercise authority under the preceding sentence on Indian country without the express written consent of the Indian tribe involved.

(d) Knowledge of illegal transaction

(1) Notification

If the manufacturer or distributor of a tobacco product has knowledge which reasonably supports the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the control of such person may be or has been—

(A) imported, exported, distributed, or offered for sale in interstate commerce by a person without paying duties or taxes required by law; or

(B) imported, exported, distributed, or diverted for possible illicit marketing,

the manufacturer or distributor shall promptly notify the Attorney General and the Secretary of the Treasury of such knowledge.

(2) Knowledge defined

For purposes of this subsection, the term "knowledge" as applied to a manufacturer or distributor means—

(A) the actual knowledge that the manufacturer or distributor had; or

(B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.

(e) Consultation

In carrying out this section, the Secretary shall consult with the Attorney General of the United States and the Secretary of the Treasury, as appropriate.

(June 25, 1938, ch. 675, §920, as added Pub. L. 111–31, div. A, title III, §301, June 22, 2009, 123 Stat. 1850.)

Editorial Notes

References in Text

Section 201 of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(1), is section 201 of div. A of Pub. L. 111–31.

1 So in original. Probably should be "the Family".
21 U.S.C. § 623 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 623: Exemptions from inspection requirements
Exemptions from inspection requirements
Status: in_force

(a) Personal slaughtering and custom slaughtering for personal, household, guest, and employee uses

The provisions of this subchapter requiring inspection of the slaughter of animals and the preparation of the carcasses, parts thereof, meat and meat food products at establishments conducting such operations for commerce shall not apply to the slaughtering by any person of animals of his own raising, and the preparation by him and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such animals exclusively for use by him and members of his household and his nonpaying guests and employees; nor to the custom slaughter by any person, firm, or corporation of cattle, sheep, swine or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such animals, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person, firm, or corporation of carcasses, parts thereof, meat or meat food products, derived from the slaughter by any person of cattle, sheep, swine, or goats of his own raising, or from game animals, delivered by the owner thereof for such custom preparation, and transportation in commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That in cases where such person, firm, or corporation engages in such custom operations at an establishment at which inspection under this subchapter is maintained, the Secretary may exempt from such inspection at such establishment any animals slaughtered or any meat or meat food products otherwise prepared on such custom basis: Provided further, That custom operations at any establishment shall be exempt from inspection requirements as provided by this section only if the establishment complies with regulations which the Secretary is hereby authorized to promulgate to assure that any carcasses, parts thereof, meat or meat food products wherever handled on a custom basis, or any containers or packages containing such articles, are separated at all times from carcasses, parts thereof, meat or meat food products prepared for sale, and that all such articles prepared on a custom basis, or any containers or packages containing such articles, are plainly marked "Not for Sale" immediately after being prepared and kept so identified until delivered to the owner and that the establishment conducting the custom operation is maintained and operated in a sanitary manner.

(b) Territorial exemption; refusal, withdrawal, or modification

The Secretary may, under such sanitary conditions as he may by regulations prescribe, exempt from the inspection requirements of this subchapter the slaughter of animals, and the preparation of carcasses, parts thereof, meat and meat food products, by any person, firm, or corporation in any Territory not organized with a legislative body solely for distribution within such Territory when the Secretary determines that it is impracticable to provide such inspection within the limits of funds appropriated for administration of this chapter and that such exemption will otherwise facilitate enforcement of this chapter. The Secretary may refuse, withdraw, or modify any exemption under this subsection in his discretion whenever he determines such action is necessary to effectuate the purposes of this chapter.

(c) Pizzas containing meat food products

(1) Under such terms and conditions as the Secretary shall prescribe through rules and regulations issued under section 624 of this title that may be necessary to ensure food safety and protect public health such as special handling procedures, the Secretary shall exempt pizzas containing a meat food product from the inspection requirements of this chapter if—

(A) the meat food product components of the pizzas have been prepared, inspected, and passed in a cured or cooked form as ready-to-eat in compliance with the requirements of this chapter; and

(B) the pizzas are to be served in public or private nonprofit institutions.

(2) The Secretary may withdraw or modify any exemption under this subsection whenever the Secretary determines such action is necessary to ensure food safety and to protect public health. The Secretary may reinstate or further modify any exemption withdrawn or modified under this subsection.

(d) Adulteration and misbranding provisions applicable to inspection-free articles

The adulteration and misbranding provisions of this subchapter, other than the requirement of the inspection legend, shall apply to articles which are exempted from inspection or not required to be inspected under this section.

(Mar. 4, 1907, ch. 2907, title I, §23, formerly 21st, 22nd pars., 34 Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235; renumbered §23 and amended Pub. L. 90–201, §§1, 11, Dec. 15, 1967, 81 Stat. 584, 591; Pub. L. 91–342, July 18, 1970, 84 Stat. 438; Pub. L. 102–237, title X, §1016(a), Dec. 13, 1991, 105 Stat. 1902.)

Editorial Notes

Codification

Section was formerly classified to sections 91 and 92 of this title.

Amendments

1991—Subsecs. (c), (d). Pub. L. 102–237 added subsec. (c) and redesignated former subsec. (c) as (d).

1970—Subsec. (a). Pub. L. 91–342 changed proviso so as to permit custom slaughterers to conduct a separate inspected meat business, continued the exemption for owners to slaughter and process their own animals for their own use, authorized the Secretary to exempt custom slaughtering and processing performed by an inspected establishment, and required that custom slaughtered articles be clearly marked "not for sale".

1967—Pub. L. 90–201, §11, substituted provisions for personal, custom, and territorial slaughtering exemptions and for application of adulteration and misbranding provisions to inspection-free articles for farmer definition and retail butcher and retail dealer exemption provisions.

1938—Act June 29, 1948, amended section generally.

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective upon expiration of sixty days after Dec. 15, 1967, see section 20(c) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.

Regulations

Secretary to issue final rules no later than Aug. 1, 1992, to implement exemption authorized by subsec. (c) of this section, see section 1016(c) of Pub. L. 102–237, set out as a note under section 464 of this title.
21 U.S.C. § 2103 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2103: Ensuring efficient and effective communications during a recall
Ensuring efficient and effective communications during a recall
Status: in_force

The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—

(1) work with companies, relevant professional associations, and other organizations to collect and aggregate information pertaining to the recall;

(2) use existing networks of communication, including electronic forms of information dissemination, to enhance the quality and speed of communication with the public; and

(3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug Administration in a single location, which shall include a searchable database of recalled human foods and a searchable database of recalled pet foods, that is easily accessed and understood by the public.

(Pub. L. 110–85, title X, §1003, Sept. 27, 2007, 121 Stat. 963.)
21 U.S.C. § 960a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 960a: Foreign terrorist organizations, terrorist persons and groups
Foreign terrorist organizations, terrorist persons and groups
Status: in_force

(a) Prohibited acts

Whoever engages in conduct that would be punishable under section 841(a) 1 of this title if committed within the jurisdiction of the United States, or attempts or conspires to do so, knowing or intending to provide, directly or indirectly, anything of pecuniary value to any person or organization that has engaged or engages in terrorist activity (as defined in section 1182(a)(3)(B) of title 8) or terrorism (as defined in section 2656f(d)(2) of title 22), shall be sentenced to a term of imprisonment of not less than twice the minimum punishment under section 841(b)(1),1 and not more than life, a fine in accordance with the provisions of title 18, or both. Notwithstanding section 3583 of title 18, any sentence imposed under this subsection shall include a term of supervised release of at least 5 years in addition to such term of imprisonment.

(b) Jurisdiction

There is jurisdiction over an offense under this section if—

(1) the prohibited drug activity or the terrorist offense is in violation of the criminal laws of the United States;

(2) the offense, the prohibited drug activity, or the terrorist offense occurs in or affects interstate or foreign commerce;

(3) an offender provides anything of pecuniary value for a terrorist offense that causes or is designed to cause death or serious bodily injury to a national of the United States while that national is outside the United States, or substantial damage to the property of a legal entity organized under the laws of the United States (including any of its States, districts, commonwealths, territories, or possessions) while that property is outside of the United States;

(4) the offense or the prohibited drug activity occurs in whole or in part outside of the United States (including on the high seas), and a perpetrator of the offense or the prohibited drug activity is a national of the United States or a legal entity organized under the laws of the United States (including any of its States, districts, commonwealths, territories, or possessions); or

(5) after the conduct required for the offense occurs an offender is brought into or found in the United States, even if the conduct required for the offense occurs outside the United States.

(c) Proof requirements

To violate subsection (a), a person must have knowledge that the person or organization has engaged or engages in terrorist activity (as defined in section 1182(a)(3)(B) of title 8) or terrorism (as defined in section 2656f(d)(2) of title 22).

(d) Definition

As used in this section, the term "anything of pecuniary value" has the meaning given the term in section 1958(b)(1) of title 18.

(Pub. L. 91–513, title III, §1010A, as added Pub. L. 109–177, title I, §122, Mar. 9, 2006, 120 Stat. 225.)

Editorial Notes

References in Text

Section 841, referred to in the original in subsec. (a), probably should have been a reference to section 401 of Pub. L. 91–513, which is classified to section 841 of this title. Pub. L. 91–513 does not contain a section 841.

1 See References in Text note below.
21 U.S.C. § 672 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 672: Administrative detention; duration; pending judicial proceedings; notification of governmental authorities; release
Administrative detention; duration; pending judicial proceedings; notification of governmental authorities; release
Status: in_force

Whenever any carcass, part of a carcass, meat or meat food product of cattle, sheep, swine, goats, horses, mules, or other equines, or any product exempted from the definition of a meat food product, or any dead, dying, disabled, or diseased cattle, sheep, swine, goat, or equine is found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in, commerce or otherwise subject to subchapter I or II of this chapter, and there is reason to believe that any such article is adulterated or misbranded and is capable of use as human food, or that it has not been inspected, in violation of the provisions of subchapter I of this chapter or of any other Federal law or the laws of any State or Territory, or the District of Columbia, or that such article or animal has been or is intended to be, distributed in violation of any such provisions, it may be detained by such representative for a period not to exceed twenty days, pending action under section 673 of this title or notification of any Federal, State, or other governmental authorities having jurisdiction over such article or animal, and shall not be moved by any person, firm, or corporation from the place at which it is located when so detained, until released by such representative. All official marks may be required by such representative to be removed from such article or animal before it is released unless it appears to the satisfaction of the Secretary that the article or animal is eligible to retain such marks.

(Mar. 4, 1907, ch. 2907, title IV, §402, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 598.)
21 U.S.C. § 356g (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356g: Standards for regenerative medicine and regenerative advanced therapies
Standards for regenerative medicine and regenerative advanced therapies
Status: in_force

(a) In general

Not later than 2 years after December 13, 2016, the Secretary, in consultation with the National Institute of Standards and Technology and stakeholders (including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, regenerative medicine and advanced therapies industry organizations, and standard setting organizations), shall facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products.

(b) Activities

(1) In general

In carrying out this section, the Secretary shall continue to—

(A) identify opportunities to help advance the development of regenerative medicine therapies and regenerative advanced therapies;

(B) identify opportunities for the development of laboratory regulatory science research and documentary standards that the Secretary determines would help support the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability; and

(C) work with stakeholders, such as those described in subsection (a), as appropriate, in the development of such standards.

(2) Regulations and guidance

Not later than 1 year after the development of standards as described in subsection (a), the Secretary shall review relevant regulations and guidance and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

(c) Definitions

For purposes of this section, the terms "regenerative medicine therapy" and "regenerative advanced therapy" have the meanings given such terms in section 356(g) of this title.

(June 25, 1938, ch. 675, §506G, as added Pub. L. 114–255, div. A, title III, §3036, Dec. 13, 2016, 130 Stat. 1104; amended Pub. L. 115–52, title IX, §901(b), Aug. 18, 2017, 131 Stat. 1076.)

Editorial Notes

Amendments

2017—Subsec. (b)(1)(A). Pub. L. 115–52 substituted "identify" for "identity".

Statutory Notes and Related Subsidiaries

Guidance Regarding Devices Used in the Recovery, Isolation, or Delivery of Regenerative Advanced Therapies

Pub. L. 114–255, div. A, title III, §3034, Dec. 13, 2016, 130 Stat. 1103, provided that:

"(a) Draft Guidance.—Not later than 1 year after the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. In doing so, the Secretary shall specifically address—

"(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products;

"(2) what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device;

"(3) when the Food and Drug Administration considers it is necessary, if ever, for the intended use of a device to be limited to a specific intended use with only one particular type of cell; and

"(4) application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

"(b) Final Guidance.—Not later than 12 months after the close of the period for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall finalize such guidance."
21 U.S.C. § 2002 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter I: ANTI-DOPING AGENCY / Section 2002: Records, audit, and report
Records, audit, and report
Status: in_force

(a) Records

The United States Anti-Doping Agency shall keep correct and complete records of account.

(b) Report

The United States Anti-Doping Agency shall submit an annual report to Congress which shall include—

(1) an audit conducted and submitted in accordance with section 10101 of title 36; and

(2) a description of the activities of the agency.

(Pub. L. 109–469, title VII, §702, Dec. 29, 2006, 120 Stat. 3534.)
21 U.S.C. § 862b (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 862b: Sanctioning for testing positive for controlled substances
Sanctioning for testing positive for controlled substances
Status: in_force

Notwithstanding any other provision of law, States shall not be prohibited by the Federal Government from testing welfare recipients for use of controlled substances nor from sanctioning welfare recipients who test positive for use of controlled substances.

(Pub. L. 104–193, title IX, §902, Aug. 22, 1996, 110 Stat. 2347.)

Editorial Notes

Codification

Section was enacted as part of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, and not as part of the Controlled Substances Act which comprises this subchapter.
21 U.S.C. § 384e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII: IMPORTS AND EXPORTS / Section 384e: Recognition of foreign government inspections
Recognition of foreign government inspections
Status: in_force

(a) Inspection

The Secretary—

(1) may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under section 360(i) of this title in order to facilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of section 360(h) of this title;

(2) may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conducting inspections that meet the applicable requirements of this chapter; and

(3) shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter.

(b) Results of inspection

The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—

(1) evidence of compliance with section 351(a)(2)(B) of this title or section 381(r) of this title; and

(2) for any other purposes as determined appropriate by the Secretary.

(c) Periodic review

(1) In general

Beginning not later than 1 year after December 29, 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate.

(2) Reports to Congress

Beginning not later than 4 years after December 29, 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1).

(June 25, 1938, ch. 675, §809, as added Pub. L. 112–144, title VII, §712, July 9, 2012, 126 Stat. 1072; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(X), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title VII, §701(b), Aug. 18, 2017, 131 Stat. 1055; Pub. L. 117–328, div. FF, title III, §3613(c), Dec. 29, 2022, 136 Stat. 5872.)

Editorial Notes

Amendments

2022—Subsec. (a)(1). Pub. L. 117–328, §3613(c)(1), inserted "preapproval or" before "risk-based inspections".

Subsec. (c). Pub. L. 117–328, §3613(c)(2), added subsec. (c).

2017—Subsec. (a)(1). Pub. L. 115–52 substituted "paragraph (2) or (3) of section 360(h)" for "section 360(h)(3)".

2016—Subsec. (a)(2). Pub. L. 114–255 substituted "conducting" for "conduction".
21 U.S.C. § 399f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399f: Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
Status: in_force

(a) Communication plan

The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall review and modify, as necessary, the Food and Drug Administration's communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.

(b) Content

The communication plan described under subsection (a)—

(1) shall take into account—

(A) the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the Department of Health and Human Services;

(B) the nature of the medical product; and

(C) health and disease information available from other agencies within such Department, as well as any new means of communicating health and safety benefits and risks related to medical products;

(2) taking into account the nature of the medical product, shall address the best strategy for communicating safety alerts, labeled indications for the medical products, changes to the label or labeling of medical products (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and

(3) shall include a process for implementation of any improvements or other modifications determined to be necessary.

(c) Issuance and posting of communication plan

(1) Communication plan

Not later than 1 year after July 9, 2012, the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section.

(2) Posting of communication plan on the office of minority health web site

The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan.

(Pub. L. 112–144, title XI, §1138, July 9, 2012, 126 Stat. 1125.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 152 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 152: Importation regulated and prohibited
Importation regulated and prohibited
Status: in_force

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

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

Amendment of Section

For termination of amendment by section 501(c) of Pub. L. 100–449, see Effective and Termination Dates of 1988 Amendment note below.

Editorial Notes

Codification

See note set out under section 151 of this title.

Amendments

1988—Pub. L. 100–449 temporarily amended section generally. Prior to amendment, section read as follows: "The importation into the United States, without a permit from the Secretary of Agriculture, of any virus, serum, toxin, or analogous product for use in the treatment of domestic animals, and the importation of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, are prohibited." See Effective and Termination Dates of 1988 Amendment note below.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1988 Amendment

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

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. § 207 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 207: Restrictions on sales; written orders or prescriptions
Restrictions on sales; written orders or prescriptions
Status: in_force

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

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

Editorial Notes

Codification

Section is comprised of part of section 6 of act Mar. 3, 1915. Remainder of such section 6 is classified to section 208 of this title.
21 U.S.C. § 221 (2024) — Title 21: FOOD AND DRUGS / Chapter 8: NARCOTIC FARMS / Section 221: Repealed. July 1, 1944, ch. 373, title XIII, §1313, 58 Stat. 714
Repealed. July 1, 1944, ch. 373, title XIII, §1313, 58 Stat. 714
Status: repealed

Section 221, act Jan. 19, 1929, ch. 82, §1, 45 Stat. 1085, defined "habit-forming narcotic drug", "narcotic", and "addict". See section 201 of Title 42, The Public Health and Welfare.

Section 222, act Jan. 19, 1929, ch. 82, §2, 45 Stat. 1085, provided for narcotic farms.

Section 222a, act June 23, 1935, ch. 725, §1, 49 Stat. 1840, provided name for narcotic farm at Lexington, Ky.

Section 222b, act Mar. 28, 1938, ch. 55, §1, 52 Stat. 134, provided name for narcotic farm at Fort Worth, Texas.

Section 223, act Jan. 19, 1929, ch. 82, §3, 45 Stat. 1085; 1939 Reorg. Plan No. I, §205(b), eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1425, provided for an annual estimate of expenses of maintenance of narcotic farms.

Section 224, act Jan. 19, 1929, ch. 82, §4, 45 Stat. 1086, provided for construction of buildings for two of the narcotic farms.

Section 225, acts Jan. 19, 1929, ch. 82, §5, 45 Stat. 1086; June 14, 1930, ch. 488, §4(a), 46 Stat. 586; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, provided for control and management of narcotic farms.

Section 226, act Jan. 19, 1929, ch. 82, §6, 45 Stat. 1086; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for care and treatment of addicts.

Section 227, act Jan. 19, 1929, ch. 82, §7, 45 Stat. 1086, provided for transfer to and from farms of addicts who are prisoners.

Section 228, act Jan. 19, 1929, ch. 82, §8, 45 Stat. 1087, provided that it was the duty of prosecuting officers to report convicted persons believed to be addicts.

Section 229, act Jan. 19, 1929, ch. 82, §9, 45 Stat. 1087; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for employment of addicts.

Section 230, act Jan. 19, 1929, ch. 82, §10, 45 Stat. 1087, provided for parole of inmates.

Section 231, act Jan. 19, 1929, ch. 82, §11, 45 Stat. 1087; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for discharge of addicts.

Section 232, act Jan. 19, 1929, ch. 82, §12, 45 Stat. 1088; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for admission of voluntary patients.

Section 233, act Jan. 19, 1929, ch. 82, §13, 45 Stat. 1088; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for furnishing of gratuities and transportation to discharged convicts.

Section 234, act. Jan. 19, 1929, ch. 82, §14, 45 Stat. 1089; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided penalties for introduction of narcotic drugs into a narcotic farm.

Section 235, act Jan. 19, 1929, ch. 82, §15, 45 Stat. 1089, provided penalties for escape of inmates.

Section 236, act Jan. 19, 1929, ch. 82, §16, 45 Stat. 1089, provided penalties for procuring of escape by inmates.

Section 237, act Jan. 19, 1929, ch. 82, §17, 45 Stat. 1089, provided for deportation of alien inmates who are entitled to a discharge from narcotic farms.

Editorial Notes

Renumbering of Repealing Act

Title XIII, §1313, formerly title VI, §611, of act July 1, 1944, which repealed these sections, was renumbered title VII, §711, by act Aug. 13, 1946, ch. 958, §5, 60 Stat. 1049; §713, by act Feb. 28, 1948, ch. 83, §9(b), 62 Stat. 47; title VIII, §813, by act July 30, 1956, ch. 779, §3(b), 70 Stat. 721; title IX, §913, by Pub. L. 88–581, §4(b), Sept. 4, 1964, 78 Stat. 919; title X, §1013, by Pub. L. 89–239, §3(b), Oct. 6, 1965, 79 Stat. 931; title XI, §1113, by Pub. L. 91–572, §6(b), Dec. 24, 1970, 84 Stat. 1506; title XII, §1213, by Pub. L. 92–294, §3(b), May 16, 1972, 86 Stat. 137; title XIII, §1313, by Pub. L. 93–154, §2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed by Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936.
21 U.S.C. § 2313 (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 2313: Description of sanctions
Description of sanctions
Status: in_force

(a) In general

The sanctions that may be imposed with respect to a foreign person under section 2312 of this title are the following:

(1) Loans from United States financial institutions

The United States Government may prohibit any United States financial institution from making loans or providing credits to the foreign person.

(2) Prohibitions on financial institutions

The following prohibitions may be imposed with respect to a foreign person that is a financial institution:

(A) Prohibition on designation as primary dealer

Neither the Board of Governors of the Federal Reserve System nor the Federal Reserve Bank of New York may designate, or permit the continuation of any prior designation of, the financial institution as a primary dealer in United States Government debt instruments.

(B) Prohibition on service as a repository of Government funds

The financial institution may not serve as agent of the United States Government or serve as repository for United States Government funds.

The imposition of either sanction under subparagraph (A) or (B) shall be treated as one sanction for purposes of section 2312 of this title, and the imposition of both such sanctions shall be treated as 2 sanctions for purposes of that section.

(3) Procurement ban

The United States Government may not procure, or enter into any contract for the procurement of, any goods or services from the foreign person.

(4) Foreign exchange

The President may, pursuant to such regulations as the President may prescribe, prohibit any transactions in foreign exchange that are subject to the jurisdiction of the United States and in which the foreign person has any interest.

(5) Banking transactions

The President may, pursuant to such regulations as the President may prescribe, prohibit any transfers of credit or payments between financial institutions or by, through, or to any financial institution, to the extent that such transfers or payments are subject to the jurisdiction of the United States and involve any interest of the foreign person.

(6) Property transactions

The President may, pursuant to such regulations as the President may prescribe, prohibit any person from—

(A) acquiring, holding, withholding, using, transferring, withdrawing, or transporting any property that is subject to the jurisdiction of the United States and with respect to which the foreign person has any interest;

(B) dealing in or exercising any right, power, or privilege with respect to such property; or

(C) conducting any transaction involving such property.

(7) Ban on investment in equity or debt of sanctioned person

The President may, pursuant to such regulations or guidelines as the President may prescribe, prohibit any United States person from investing in or purchasing significant amounts of equity or debt instruments of the foreign person.

(8) Exclusion of corporate officers

The President may direct the Secretary of State to deny a visa to, and the Secretary of Homeland Security to exclude from the United States, any alien that the President determines is a corporate officer or principal of, or a shareholder with a controlling interest in, the foreign person.

(9) Sanctions on principal executive officers

The President may impose on the principal executive officer or officers of the foreign person, or on individuals performing similar functions and with similar authorities as such officer or officers, any of the sanctions described in paragraphs (1) through (8) that are applicable.

(b) Penalties

A person that violates, attempts to violate, conspires to violate, or causes a violation of any regulation, license, or order issued to carry out subsection (a) shall be subject to the penalties set forth in subsections (b) and (c) of section 1705 of title 50 to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

(c) Exceptions

(1) Intelligence and law enforcement activities

Sanctions under this section shall not apply with respect to—

(A) any activity subject to the reporting requirements under title V of the National Security Act of 1947 (50 U.S.C. 3091 et seq.); or

(B) any authorized intelligence or law enforcement activities of the United States.

(2) Exception to comply with United Nations headquarters agreement

Sanctions under subsection (a)(8) shall not apply to an alien if admitting the alien into the United States is necessary to permit the United States to comply with the Agreement regarding the Headquarters of the United Nations, signed at Lake Success June 26, 1947, and entered into force November 21, 1947, between the United Nations and the United States, the Convention on Consular Relations, done at Vienna April 24, 1963, and entered into force March 19, 1967, or other applicable international obligations.

(d) Implementation

The President may exercise all authorities provided under sections 1702 and 1704 of title 50 to carry out this section.

(Pub. L. 116–92, div. F, title LXXII, §7213, Dec. 20, 2019, 133 Stat. 2266.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (c)(1)(A), is act July 26, 1947, ch. 343, 61 Stat. 495. Title V of the Act is classified generally to subchapter III (§3091 et seq.) of chapter 44 of Title 50, War and National Defense. For complete classification of this Act to the Code, see Tables.

Executive Documents

Delegation of Functions

Functions and authorities of President under subsections (a)(4) to (9) and (d) of this section delegated to Secretary of the Treasury, in consultation with the Secretary of State, by section 1(d)(vi) and (vii) 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. § 353d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 353d: Process to update labeling for certain generic drugs
Process to update labeling for certain generic drugs
Status: in_force

(a) Definitions

For purposes of this section:

(1) The term "covered drug" means a drug approved under section 355(c) of this title—

(A) for which there are no unexpired patents included in the list under section 355(j)(7) of this title and no unexpired period of exclusivity;

(B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and

(C) for which—

(i)(I) there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling;

(II) the approved labeling does not reflect current legal and regulatory requirements for content or format; or

(III) there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and

(ii) updating the approved labeling would benefit the public health.

(2) The term "period of exclusivity", with respect to a drug approved under section 355(c) of this title, means any period of exclusivity under clause (ii), (iii), or (iv) of section 355(c)(3)(E) of this title, clause (ii), (iii), or (iv) of section 355(j)(5)(F) of this title, or section 355a, 355f, or 360cc of this title.

(3) The term "generic version" means a drug approved under section 355(j) of this title whose reference listed drug is a covered drug.

(4) The term "relevant accepted use" means a use for a drug in clinical practice that is supported by scientific evidence that appears to the Secretary to meet the standards for approval under section 355 of this title.

(5) The term "selected drug" means a covered drug for which the Secretary has determined through the process under subsection (c) that the labeling should be changed.

(b) Identification of covered drugs

The Secretary may identify covered drugs for which labeling updates would provide a public health benefit. To assist in identifying covered drugs, the Secretary may do one or both of the following:

(1) Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs.

(2) Seek public input concerning such drugs, including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug, by—

(A) holding one or more public meetings;

(B) opening a public docket for the submission of public comments; or

(C) other means, as the Secretary determines appropriate.

(c) Selection of drugs for updating

If the Secretary determines, with respect to a covered drug, that the available scientific evidence meets the standards under section 355 of this title for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug, the Secretary may initiate the process under subsection (d).

(d) Initiation of the process of updating

If the Secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection (c), the Secretary shall provide notice to the holders of approved applications for a generic version of such drug that—

(1) summarizes the findings supporting the determination of the Secretary that the available scientific evidence meets the standards under section 355 of this title for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection (c);

(2) provides a clear statement regarding the additional, modified, or supplemental information for such labeling, according to the determination by the Secretary (including, as applicable, modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug); and

(3) states whether the statement under paragraph (2) applies to the selected drug as a class of covered drugs or only to a specific drug product.

(e) Response to notification

Within 30 days of receipt of notification provided by the Secretary pursuant to subsection (d), the holder of an approved application for a generic version of the selected drug shall—

(1) agree to change the approved labeling to reflect the additional, modified, or supplemental information the Secretary has determined to be appropriate; or

(2) notify the Secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted.

(f) Review of application holder's response

(1) In general

Upon receipt of the application holder's response, the Secretary shall promptly review each statement received under subsection (e)(2) and determine which labeling changes pursuant to the Secretary's notice under subsection (d) are appropriate, if any. If the Secretary disagrees with the reasons why such labeling changes are not warranted, the Secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect available scientific evidence, and if so, the content of such labeling changes.

(2) Changes to labeling

After considering all responses from the holder of an approved application under paragraph (1) or (2) of subsection (e), and any discussion under paragraph (1), the Secretary may order such holder to make the labeling changes the Secretary determines are appropriate. Such holder of an approved application shall—

(A) update its paper labeling for the drug at the next printing of that labeling;

(B) update any electronic labeling for the drug within 30 days of such order; and

(C) submit the revised labeling through the form, "Supplement—Changes Being Effected".

(g) Violation

If the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection (f)(2), such generic version of the selected drug shall be deemed to be misbranded under section 352 of this title.

(h) Limitations; generic drugs

(1) In general

With respect to any labeling change required under this section, the generic version shall be deemed to have the same conditions of use and the same labeling as its reference listed drug for purposes of clauses (i) and (v) of section 355(j)(2)(A) of this title. Any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug.

(2) Supplemental applications

Changes to labeling made in accordance with this section shall not be eligible for an exclusivity period under this chapter.

(3) Selection of drugs

The Secretary shall not identify a drug as a covered drug or select a drug label for updating under subsection (b) or (c) solely based on the availability of new safety information. Upon identification of a drug as a covered drug under subsection (b), the Secretary may then consider the availability of new safety information (as defined in section 355–1(b) of this title) in determining whether the drug is a selected drug and in determining what labeling changes are appropriate.

(i) Rules of construction

(1) Approval standards

This section shall not be construed as altering the applicability of the standards for approval of an application under section 355 of this title. No order shall be issued under this subsection unless the scientific evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section 355 of this title.

(2) Removal of information

Nothing in this section shall be construed to give the Secretary additional authority to remove approved indications for drugs, other than the authority described in this section.

(3) Secretary authority

Nothing in this section shall be construed to limit the authority of the Secretary to require labeling changes under section 355(o) of this title.

(4) Maintenance of labeling

Nothing in this section shall be construed to affect the responsibility of the holder of an approved application under section 355(j) of this title to maintain its labeling in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 314.97 of title 21, Code of Federal Regulations (or any successor regulations).

(j) Reports

Not later than 4 years after December 27, 2020, and every 4 years thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that—

(1) describes the actions of the Secretary under this section, including—

(A) the number of covered drugs and description of the types of drugs the Secretary has selected for labeling changes and the rationale for such recommended changes; and

(B) the number of times the Secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change, if any; and

(2) includes any recommendations of the Secretary for modifying the program under this section.

(June 25, 1938, ch. 675, §503D, as added Pub. L. 116–260, div. BB, title III, §324, Dec. 27, 2020, 134 Stat. 2933.)
21 U.S.C. § 347 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 347: Intrastate sales of colored oleomargarine
Intrastate sales of colored oleomargarine
Status: in_force

(a) Law governing

Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this chapter as if it had been introduced in interstate commerce.

(b) Labeling and packaging requirements

No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—

(1) such oleomargarine or margarine is packaged,

(2) the net weight of the contents of any package sold in a retail establishment is one pound or less,

(3) there appears on the label of the package (A) the word "oleomargarine" or "margarine" in type or lettering at least as large as any other type or lettering on such label, and (B) a full and accurate statement of all the ingredients contained in such oleomargarine or margarine, and

(4) each part of the contents of the package is contained in a wrapper which bears the word "oleomargarine" or "margarine" in type or lettering not smaller than 20-point type.

The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this chapter.

(c) Sales in public eating places

No person shall possess in a form ready for serving colored oleomargarine or colored margarine at a public eating place unless a notice that oleomargarine or margarine is served is displayed prominently and conspicuously in such place and in such manner as to render it likely to be read and understood by the ordinary individual being served in such eating place or is printed or is otherwise set forth on the menu in type or lettering not smaller than that normally used to designate the serving of other food items. No person shall serve colored oleomargarine or colored margarine at a public eating place, whether or not any charge is made therefor, unless (1) each separate serving bears or is accompanied by labeling identifying it as oleomargarine or margarine, or (2) each separate serving thereof is triangular in shape.

(d) Exemption from labeling requirements

Colored oleomargarine or colored margarine when served with meals at a public eating place shall at the time of such service be exempt from the labeling requirements of section 343 of this title (except paragraphs (a) and (f)) if it complies with the requirements of subsection (b) of this section.

(e) Color content of oleomargarine

For the purpose of this section colored oleomargarine or colored margarine is oleomargarine or margarine having a tint or shade containing more than one and six-tenths degrees of yellow, or of yellow and red collectively, but with an excess of yellow over red, measured in terms of Lovibond tintometer scale or its equivalent.

(June 25, 1938, ch. 675, §407, as added Mar. 16, 1950, ch. 61, §3(c), 64 Stat. 20.)

Statutory Notes and Related Subsidiaries

Effective Date

Act Mar. 16, 1950, ch. 61, §7, 64 Stat. 22, provided that: "This Act [enacting this section and sections 347a and 347b of this title and amending sections 331 and 342 of this title and sections 45 and 55 of Title 15, Commerce and Trade] shall become effective on July 1, 1950."

Transfer of Appropriations

Act Mar. 16, 1950, ch. 61, §5, 64 Stat. 22, provided that: "So much of the unexpended balances of appropriations, allocations, or other funds (including funds available for the fiscal year ending June 30, 1950) for the use of the Bureau of Internal Revenue of the Treasury Department in the exercise of functions under the Oleomargarine Tax Act (26 U.S.C., §2300, subchapter A) [now section 4591 et seq. of Title 26, Internal Revenue Code], as the Director of the Bureau of the Budget [now Director of the Office of Management and Budget] may determine, shall be transferred to the Federal Security Agency (Food and Drug Administration) [now the Department of Health and Human Services] for use in the enforcement of this Act [see Effective Date note above]."
21 U.S.C. § 387e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387e: Annual registration
Annual registration
Status: in_force

(a) Definitions

In this section:

(1) Manufacture, preparation, compounding, or processing

The term "manufacture, preparation, compounding, or processing" shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.

(2) Name

The term "name" shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.

(b) Registration by owners and operators

On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person. If enactment of the Family Smoking Prevention and Tobacco Control Act occurs in the second half of the calendar year, the Secretary shall designate a date no later than 6 months into the subsequent calendar year by which registration pursuant to this subsection shall occur.

(c) Registration by new owners and operators

Every person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person's name, place of business, and such establishment.

(d) Registration of added establishments

Every person required to register under subsection (b) or (c) shall immediately register with the Secretary any additional establishment which that person owns or operates in any State and in which that person begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products.

(e) Uniform product identification system

The Secretary may by regulation prescribe a uniform system for the identification of tobacco products and may require that persons who are required to list such tobacco products under subsection (i) shall list such tobacco products in accordance with such system.

(f) Public access to registration information

The Secretary shall make available for inspection, to any person so requesting, any registration filed under this section.

(g) Biennial inspection of registered establishments

Every establishment registered with the Secretary under this section shall be subject to inspection under section 374 of this title or subsection (h), and every such establishment engaged in the manufacture, compounding, or processing of a tobacco product or tobacco products shall be so inspected by 1 or more officers or employees duly designated by the Secretary at least once in the 2-year period beginning with the date of registration of such establishment under this section and at least once in every successive 2-year period thereafter.

(h) Registration by foreign establishments

Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (i) and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether tobacco products manufactured, prepared, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.

(i) Registration information

(1) Product list

Every person who registers with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by—

(A) in the case of a tobacco product contained in the applicable list with respect to which a tobacco product standard has been established under section 387g of this title or which is subject to section 387j of this title, a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product;

(B) in the case of any other tobacco product contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and

(C) if the registrant filing a list has determined that a tobacco product contained in such list is not subject to a tobacco product standard established under section 387g of this title, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product.

(2) Consultation with respect to forms

The Secretary shall consult with the Secretary of the Treasury in developing the forms to be used for registration under this section to minimize the burden on those persons required to register with both the Secretary and the Tax and Trade Bureau of the Department of the Treasury.

(3) Biannual report of any change in product list

Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following:

(A) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established name and shall be accompanied by the other information required by paragraph (1).

(B) If since the date the registrant last made a report under this paragraph that person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.

(C) If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.

(D) Any material change in any information previously submitted under this paragraph or paragraph (1).

(j) Report preceding introduction of certain substantially equivalent products into interstate commerce

(1) In general

Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—

(A) the basis for such person's determination that—

(i) the tobacco product is substantially equivalent, within the meaning of section 387j of this title, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 387j of this title, is substantially equivalent and that is in compliance with the requirements of this chapter; or

(ii) the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemptions granted by the Secretary pursuant to paragraph (3); and

(B) action taken by such person to comply with the requirements under section 387g of this title that are applicable to the tobacco product.

(2) Application to certain post–February 15, 2007, products

A report under this subsection for a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009, shall be submitted to the Secretary not later than 21 months after June 22, 2009.

(3) Exemptions

(A) In general

The Secretary may exempt from the requirements of this subsection relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 387j of this title, tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines that—

(i) such modification would be a minor modification of a tobacco product that can be sold under this chapter;

(ii) a report under this subsection is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and

(iii) an exemption is otherwise appropriate.

(B) Regulations

Not later than 15 months after June 22, 2009, the Secretary shall issue regulations to implement this paragraph.

(June 25, 1938, ch. 675, §905, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1792.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Prior Provisions

A prior section 905 of act June 25, 1938, was renumbered section 1005 and is classified to section 395 of this title.

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. § 360qq (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360qq: Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
Status: repealed

Section, act June 25, 1938, ch. 675, §540, formerly act July 1, 1944, ch. 373, title III, §540, formerly §360D, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1185; renumbered §540 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, related to annual report on administration of electronic product radiation control program.
21 U.S.C. § 355b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 355b: Adverse-event reporting
Adverse-event reporting
Status: in_force

(a) Toll-free number in labeling

Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (regardless of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule:

(1) The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience.

(2) In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession.

(3) The rule shall take effect not later than 60 days after the date on which the rule is promulgated.

(b) Drugs with pediatric market exclusivity

(1) In general

During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A 1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report of an adverse event regarding the drug that the Secretary of Health and Human Services receives shall be referred to the Office of Pediatric Therapeutics established under section 393a of this title. In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such subcommittee 2 regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.

(2) Rule of construction

Paragraph (1) may not be construed as restricting the authority of the Secretary of Health and Human Services to continue carrying out the activities described in such paragraph regarding a drug after the one-year period described in such paragraph regarding the drug has expired.

(Pub. L. 107–109, §17, Jan. 4, 2002, 115 Stat. 1422; Pub. L. 108–155, §3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, 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 enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2003—Subsec. (b)(1). Pub. L. 108–155 struck out "Advisory Subcommittee of the Anti-Infective Drugs" before "Advisory Committee".

Statutory Notes and Related Subsidiaries

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title.

1 So in original. Probably should be preceded by "section".

2 So in original. Probably should be "Committee".
21 U.S.C. § 18 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 18: Suspension of importation of adulterated articles
Suspension of importation of adulterated articles
Status: in_force

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

(Aug. 30, 1890, ch. 839, §4, 26 Stat. 415.)
21 U.S.C. § 355f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 355f: Extension of exclusivity period for new qualified infectious disease products
Extension of exclusivity period for new qualified infectious disease products
Status: in_force

(a) Extension

If the Secretary approves an application pursuant to section 355 of this title for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 355 of this title, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 355 of this title, or the 7-year period described in section 360cc of this title, as applicable, shall be extended by 5 years.

(b) Relation to pediatric exclusivity

Any extension under subsection (a) of a period shall be in addition to any extension of the period under section 355a of this title with respect to the drug.

(c) Limitations

Subsection (a) does not apply to the approval of—

(1) a supplement to an application under section 355(b) of this title for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired;

(2) a subsequent application filed with respect to a product approved under section 355 of this title for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength;

(3) a product that does not meet the definition of a qualified infectious disease product under subsection (g) based upon its approved uses; or

(4) an application pursuant to section 262(a) of title 42.

(d) Designation

(1) In general

The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product at any time before the submission of an application under section 355(b) of this title or section 262(a) of title 42 for such drug. The Secretary shall, not later than 60 days after the submission of such a request, determine whether the drug is a qualified infectious disease product.

(2) Limitation

Except as provided in paragraph (3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under subsection (f)(2)(C).

(3) Revocation of designation

The Secretary may revoke a designation of a drug as a qualified infectious disease product if the Secretary finds that the request for such designation contained an untrue statement of material fact.

(e) Regulations

(1) In general

Not later than 2 years after July 9, 2012, the Secretary shall adopt final regulations implementing this section, including developing the list of qualifying pathogens described in subsection (f).

(2) Procedure

In promulgating a regulation implementing this section, the Secretary shall—

(A) issue a notice of proposed rulemaking that includes the proposed regulation;

(B) provide a period of not less than 60 days for comments on the proposed regulation; and

(C) publish the final regulation not less than 30 days before the effective date of the regulation.

(3) Restrictions

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2), except that the Secretary may issue interim guidance for sponsors seeking designation under subsection (d) prior to the promulgation of such regulations.

(4) Designation prior to regulations

The Secretary shall designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection, if such drugs meet the definition of a qualified infectious disease product described in subsection (g).

(f) Qualifying pathogen

(1) Definition

In this section, the term "qualifying pathogen" means a pathogen identified and listed by the Secretary under paragraph (2) that has the potential to pose a serious threat to public health, such as—

(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;

(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;

(C) multi-drug resistant tuberculosis; and

(D) Clostridium difficile.

(2) List of qualifying pathogens

(A) In general

The Secretary shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list.

(B) Considerations

In establishing and maintaining the list of pathogens described under this section, the Secretary shall—

(i) consider—

(I) the impact on the public health due to drug-resistant organisms in humans;

(II) the rate of growth of drug-resistant organisms in humans;

(III) the increase in resistance rates in humans; and

(IV) the morbidity and mortality in humans; and

(ii) consult with experts in infectious diseases and antibiotic resistance, including the Centers for Disease Control and Prevention, the Food and Drug Administration, medical professionals, and the clinical research community.

(C) Review

Every 5 years, or more often as needed, the Secretary shall review, provide modifications to, and publish the list of qualifying pathogens under subparagraph (A) and shall by regulation revise the list as necessary, in accordance with subsection (e).

(g) Qualified infectious disease product

The term "qualified infectious disease product" means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—

(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and

(2) is intended to treat a serious or life-threatening infection, including such an infection caused by—

(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

(B) qualifying pathogens listed by the Secretary under subsection (f).

(June 25, 1938, ch. 675, §505E, as added Pub. L. 112–144, title VIII, §801(a), July 9, 2012, 126 Stat. 1077; amended Pub. L. 117–328, div. FF, title III, §3212(a), Dec. 29, 2022, 136 Stat. 5826.)

Editorial Notes

Amendments

2022—Subsec. (c)(4). Pub. L. 117–328, §3212(a)(1), added par. (4).

Subsec. (d)(1). Pub. L. 117–328, §3212(a)(2), inserted "or section 262(a) of title 42" after "section 355(b) of this title".

Subsec. (g). Pub. L. 117–328, §3212(a)(3), amended subsec. (g) generally. Prior to amendment, text read as follows: "The term 'qualified infectious disease product' means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—

"(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

"(2) qualifying pathogens listed by the Secretary under subsection (f)."

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 112–144, title VIII, §801(b), July 9, 2012, 126 Stat. 1079, provided that: "Section 505E of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f], as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act [July 9, 2012]."
21 U.S.C. § 387q (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387q: Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Status: in_force

(a) Establishment

Not later than 6 months after June 22, 2009, the Secretary shall establish a 12-member advisory committee, to be known as the Tobacco Products Scientific Advisory Committee (in this section referred to as the "Advisory Committee").

(b) Membership

(1) In general

(A) Members

The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of—

(i) 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;

(ii) 1 individual who is an officer or employee of a State or local government or of the Federal Government;

(iii) 1 individual as a representative of the general public;

(iv) 1 individual as a representative of the interests of the tobacco manufacturing industry;

(v) 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee; and

(vi) 1 individual as a representative of the interests of the tobacco growers.

(B) Nonvoting members

The members of the committee appointed under clauses (iv), (v), and (vi) of subparagraph (A) shall serve as consultants to those described in clauses (i) through (iii) of subparagraph (A) and shall be nonvoting representatives.

(C) Conflicts of interest

No members of the committee, other than members appointed pursuant to clauses (iv), (v), and (vi) of subparagraph (A) shall, during the member's tenure on the committee or for the 18-month period prior to becoming such a member, receive any salary, grants, or other payments or support from any business that manufactures, distributes, markets, or sells cigarettes or other tobacco products.

(2) Limitation

The Secretary may not appoint to the Advisory Committee any individual who is in the regular full-time employ of the Food and Drug Administration or any agency responsible for the enforcement of this chapter. The Secretary may appoint Federal officials as ex officio members.

(3) Chairperson

The Secretary shall designate 1 of the members appointed under clauses (i), (ii), and (iii) of paragraph (1)(A) to serve as chairperson.

(c) Duties

The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to the Secretary—

(1) as provided in this subchapter;

(2) on the effects of the alteration of the nicotine yields from tobacco products;

(3) on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and

(4) on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary.

(d) Compensation; support; chapter 10 of title 5

(1) Compensation and travel

Members of the Advisory Committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which may not exceed the daily equivalent of the rate in effect under the Senior Executive Schedule under section 5382 of title 5, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently.

(2) Administrative support

The Secretary shall furnish the Advisory Committee clerical and other assistance.

(3) Nonapplication of chapter 10 of title 5

Section 1013 of title 5 does not apply to the Advisory Committee.

(e) Proceedings of advisory panels and committees

The Advisory Committee shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made under this subsection information which is exempt from disclosure under section 552(b) of title 5.

(June 25, 1938, ch. 675, §917, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1824; amended Pub. L. 117–286, §4(a)(160), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

Amendments

2022—Subsec. (d). Pub. L. 117–286, §4(a)(160)(A), substituted "chapter 10 of title 5" for "FACA" in heading.

Subsec. (d)(3). Pub. L. 117–286, §4(a)(160)(B), substituted "chapter 10 of title 5" for "FACA" in heading and "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in text.

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. § 852 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 852: Application of treaties and other international agreements
Application of treaties and other international agreements
Status: in_force

Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit the provision of treatment, education, or rehabilitation as alternatives to conviction or criminal penalty for offenses involving any drug or other substance subject to control under any such treaty or agreement.

(Pub. L. 91–513, title II, §412, as added Pub. L. 95–633, title I, §107(a), Nov. 10, 1978, 92 Stat. 3773.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as a note under section 801a of this title.
21 U.S.C. § 360a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360a: Clinical trial guidance for antibiotic drugs
Clinical trial guidance for antibiotic drugs
Status: in_force

(a) In general

Not later than 1 year after September 27, 2007, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.

(b) Review

Not later than 5 years after September 27, 2007, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.

(June 25, 1938, ch. 675, §511, as added Pub. L. 110–85, title IX, §911, Sept. 27, 2007, 121 Stat. 951.)

Editorial Notes

Prior Provisions

A prior section 360a, act June 25, 1938, ch. 675, §511, as added July 15, 1965, Pub. L. 89–74, §3(b), 79 Stat. 227; amended Oct. 24, 1968, Pub. L. 90–639, §2(a), 82 Stat. 1361, regulated the manufacture, compounding, and processing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activities connected therewith, prior to repeal by Pub. L. 91–513, title II, §§701(a), 704, Oct. 27, 1970, 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after Oct. 26, 1970.
21 U.S.C. § 98 (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 98: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, act June 5, 1948, ch. 423, 62 Stat. 344, which related to payment of cost of meat inspection, was transferred to section 695 of this title.
21 U.S.C. § 199 (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 199: Repealed. Pub. L. 91-513, title III, §1101(a)(5), Oct. 27, 1970, 84 Stat. 1292
Repealed. Pub. L. 91-513, title III, §1101(a)(5), Oct. 27, 1970, 84 Stat. 1292
Status: repealed

Section, act July 3, 1930, ch. 829, 46 Stat. 850, authorized payment to persons giving information concerning violations of narcotics laws. See section 886(a) of this title.

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 this section by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under section 171 of this title.
21 U.S.C. § 1713 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1713: Authorization of use of environmentally-approved herbicides to eliminate illicit narcotics crops
Authorization of use of environmentally-approved herbicides to eliminate illicit narcotics crops
Status: in_force

The Secretary of State, the Attorney General, the Secretary of Agriculture, the Secretary of Defense, the Director of the Office of National Drug Control Policy, and the Administrator of the Environmental Protection Agency are authorized to support the development and use of environmentally-approved herbicides to eliminate illicit narcotics crops, including coca, cannabis, and opium poppy, both in the United States and in foreign countries.

(Pub. L. 105–277, div. C, title VIII, §834, Oct. 21, 1998, 112 Stat. 2681–702.)

Editorial Notes

Codification

Section was enacted as part of the Western Hemisphere Drug Elimination Act, and not as part of the Office of National Drug Control Policy Reauthorization Act of 1998 which comprises this chapter.
21 U.S.C. § 1524 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1524: Authorization of appropriations
Authorization of appropriations
Status: in_force

(a) In general

There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this subchapter $99,000,000 for each of fiscal years 2018 through 2023.

(b) Administrative costs

Not more than 8 percent of the funds appropriated to carry out this subchapter may be used by the Office of National Drug Control Policy to pay administrative costs associated with the responsibilities of the Office under this subchapter.

(Pub. L. 100–690, title I, §1024, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 226; amended Pub. L. 107–82, §1(b), (c), Dec. 14, 2001, 115 Stat. 817; Pub. L. 109–469, title VIII, §801, Dec. 29, 2006, 120 Stat. 3535; Pub. L. 115–271, title VIII, §8203(a)(3)(A), (b)(3), formerly §8203(a)(4)(A), (b)(3), Oct. 24, 2018, 132 Stat. 4111, renumbered Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157; Pub. L. 116–74, §2(c)(1)(A)(i)(V), (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)(3). See 2018 Amendment note below.

Pub. L. 116–74, §2(c)(1)(A)(i)(V), made technical amendment to directory language of Pub. L. 115–271, §8203(a)(3)(A). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(3), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), added subsecs. (a) and (b) and struck out former subsecs. (a) and (b), which related to authorization of appropriations and administrative costs, respectively.

Pub. L. 115–271, §8203(a)(3)(A), formerly §8203(a)(4)(A), as renumbered and amended by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), (V), amended directory language of Pub. L. 109–469, §801. See 2006 Amendment notes below.

2006—Subsec. (a)(11) to (15). Pub. L. 109–469, §801(a), as amended by Pub. L. 115–271, §8203(a)(3)(A), added pars. (11) to (15).

Subsec. (b). Pub. L. 109–469, §801(b), as amended by Pub. L. 115–271, §8203(a)(3)(A), amended subsec. (b) generally. Prior to amendment, text read as follows: "Not more than the following percentages of the amounts authorized under subsection (a) of this section may be used to pay administrative costs:

"(1) 10 percent for fiscal year 1998.

"(2) 6 percent for fiscal year 1999.

"(3) 4 percent for fiscal year 2000.

"(4) 3 percent for fiscal year 2001.

"(5) 6 percent for each of fiscal years 2002 through 2007."

2001—Subsec. (a)(5) to (10). Pub. L. 107–82, §1(b), added pars. (5) to (10) and struck out former par. (5) which read as follows: "$43,500,000 for fiscal year 2002."

Subsec. (b)(5). Pub. L. 107–82, §1(c), added par. (5) and struck out former par. (5) which read as follows: "3 percent for fiscal year 2002."

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 2018 Amendment

Pub. L. 115–271, title VIII, §8203(a)(3)(B), formerly §8203(a)(4)(B), Oct. 24, 2018, 132 Stat. 4111, as renumbered by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157, provided that: "The amendments made by subparagraph (A) [amending this section, section 1532 of this title, and provisions set out as a note under section 1532 of this title] shall take effect as though enacted as part of the Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469; 120 Stat. 3502)."
21 U.S.C. § 2333 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter II: OTHER MATTERS / Section 2333: Regulatory authority
Regulatory authority
Status: in_force

Not later than 90 days after December 20, 2019, the President shall issue such regulations as are necessary to carry out this chapter, including guidance with respect to what activities are included under the definition of "opioid trafficking" under section 2302(8) of this title.

(Pub. L. 116–92, div. F, title LXXII, §7233, Dec. 20, 2019, 133 Stat. 2275.)

Editorial Notes

 References in Text

This chapter, referred to in text, 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.

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)(ix) 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. § 831 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 831: Additional requirements relating to online pharmacies and telemedicine
Additional requirements relating to online pharmacies and telemedicine
Status: in_force

(a) In general

An online pharmacy shall display in a visible and clear manner on its homepage a statement that it complies with the requirements of this section with respect to the delivery or sale or offer for sale of controlled substances and shall at all times display on the homepage of its Internet site a declaration of compliance in accordance with this section.

(b) Licensure

Each online pharmacy shall comply with the requirements of State law concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to applicable licensure requirements, as determined by each such State.

(c) Internet pharmacy site disclosure information

Each online pharmacy shall post in a visible and clear manner on the homepage of each Internet site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, that website:

(1) The name and address of the pharmacy as it appears on the pharmacy's Drug Enforcement Administration certificate of registration.

(2) The pharmacy's telephone number and email address.

(3) The name, professional degree, and States of licensure of the pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge can be contacted.

(4) A list of the States in which the pharmacy is licensed to dispense controlled substances.

(5) A certification that the pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances.

(6) The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof.

(7) The following statement, unless revised by the Attorney General by regulation: "This online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309.".

(d) Notification

(1) In general

Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in such form and manner as the Attorney General shall determine, and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.

(2) Contents

The notification required under paragraph (1) shall include—

(A) the information required to be posted on the online pharmacy's Internet site under subsection (c) and shall notify the Attorney General and the applicable State boards of pharmacy, under penalty of perjury, that the information disclosed on its Internet site under subsection (c) is true and accurate;

(B) the online pharmacy's Internet site address and a certification that the online pharmacy shall notify the Attorney General of any change in the address at least 30 days in advance; and

(C) the Drug Enforcement Administration registration numbers of any pharmacies and practitioners referred to in subsection (c), as applicable.

(3) Existing online pharmacies

An online pharmacy that is already operational as of the effective date of this section, shall notify the Attorney General and applicable State boards of pharmacy in accordance with this subsection not later than 30 days after such date.

(e) Declaration of compliance

On and after the date on which it makes the notification under subsection (d), each online pharmacy shall display on the homepage of its Internet site, in such form as the Attorney General shall by regulation require, a declaration that it has made such notification to the Attorney General.

(f) Reports

Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part.

(g) Notice and designations concerning Indian tribes

(1) In general

For purposes of sections 802(52) and 882(c)(6)(B) of this title, the Secretary shall notify the Attorney General, at such times and in such manner as the Secretary and the Attorney General determine appropriate, of the Indian tribes or tribal organizations with which the Secretary has contracted or compacted under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.] for the tribes or tribal organizations to provide pharmacy services.

(2) Designations

(A) In general

The Secretary may designate a practitioner described in subparagraph (B) as an Internet Eligible Controlled Substances Provider. Such designations shall be made only in cases where the Secretary has found that there is a legitimate need for the practitioner to be so designated because the population served by the practitioner is in a sufficiently remote location that access to medical services is limited.

(B) Practitioners

A practitioner described in this subparagraph is a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.] with the Indian Health Service.

(h) Special registration for telemedicine

(1) In general

The Attorney General may issue to a practitioner a special registration to engage in the practice of telemedicine for purposes of section 802(54)(E) of this title if the practitioner, upon application for such special registration—

(A) demonstrates a legitimate need for the special registration; and

(B) is registered under section 823(g) of this title in the State in which the patient will be located when receiving the telemedicine treatment, unless the practitioner—

(i) is exempted from such registration in all States under section 822(d) of this title; or

(ii) is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract and is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title.

(2) Regulations

Not later than 1 year after October 24, 2018, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—

(A) the limited circumstances in which a special registration under this subsection may be issued; and

(B) the procedure for obtaining a special registration under this subsection.

(3) Denials

Proceedings to deny an application for registration under this subsection shall be conducted in accordance with section 824(c) of this title.

(i) Reporting of telemedicine by VHA during medical emergency situations

(1) In general

Any practitioner issuing a prescription for a controlled substance under the authorization to conduct telemedicine during a medical emergency situation described in section 802(54)(F) of this title shall report to the Secretary of Veterans Affairs the authorization of that emergency prescription, in accordance with such requirements as the Secretary of Veterans Affairs shall, by regulation, establish.

(2) To Attorney General

Not later than 30 days after the date that a prescription described in subparagraph (A) is issued, the Secretary of Veterans Affairs shall report to the Attorney General the authorization of that emergency prescription.

(j) Clarification concerning prescription transfers

Any transfer between pharmacies of information relating to a prescription for a controlled substance shall meet the applicable requirements under regulations promulgated by the Attorney General under this chapter.

(Pub. L. 91–513, title II, §311, as added Pub. L. 110–425, §3(d)(1), Oct. 15, 2008, 122 Stat. 4825; amended Pub. L. 115–271, title III, §3232, Oct. 24, 2018, 132 Stat. 3950; Pub. L. 117–215, title I, §103(b)(1)(F), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

Section 309, referred to in subsec. (c)(7), is section 309 of Pub. L. 91–513, which is classified to section 829 of this title.

For effective date of this section, referred to in subsec. (d)(3), see Effective Date note below.

The Indian Self-Determination and Education Assistance Act, referred to in subsec. (g)(1), (2)(B), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

This chapter, referred to in subsec. (j), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Amendments

2022—Subsec. (h)(1)(B). Pub. L. 117–215 substituted "823(g)" for "823(f)" wherever appearing.

2018—Subsec. (h)(2). Pub. L. 115–271 amended par. (2) generally. Prior to amendment, text read as follows: "The Attorney General shall, with the concurrence of the Secretary, promulgate regulations specifying the limited circumstances in which a special registration under this subsection may be issued and the procedures for obtaining such a special registration."

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as an Effective Date of 2008 Amendment note under section 802 of this title.
21 U.S.C. § 149 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 149: Definitions
Definitions
Status: in_force

When used in this subchapter—

(a) The term "person" means an individual, partnership, association, or corporation.

(b) The term "United States" means the fifty States and the District of Columbia.

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

Editorial Notes

Amendments

1960—Subsec. (b). Pub. L. 86–624 substituted "means the fifty States and the District of Columbia" for "means continental United States, including Alaska".

1959—Subsec. (b). Pub. L. 86–70 inserted ", including Alaska" after "continental United States".
21 U.S.C. § 876 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 876: Subpenas
Subpenas
Status: in_force

(a) Authorization of use by Attorney General

In any investigation relating to his functions under this subchapter with respect to controlled substances, listed chemicals, tableting machines, or encapsulating machines, the Attorney General may subpena witnesses, compel the attendance and testimony of witnesses, and require the production of any records (including books, papers, documents, and other tangible things which constitute or contain evidence) which the Attorney General finds relevant or material to the investigation. The attendance of witnesses and the production of records may be required from any place in any State or in any territory or other place subject to the jurisdiction of the United States at any designated place of hearing; except that a witness shall not be required to appear at any hearing more than 500 miles distant from the place where he was served with a subpena. Witnesses summoned under this section shall be paid the same fees and mileage that are paid witnesses in the courts of the United States.

(b) Service

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

(c) Enforcement

In the case of contumacy by or refusal to obey a subpena issued to any person, the Attorney General may invoke the aid of any court of the United States within the jurisdiction of which the investigation is carried on or of which the subpenaed person is an inhabitant, or in which he carries on business or may be found, to compel compliance with the subpena. The court may issue an order requiring the subpenaed person to appear before the Attorney General to produce records, if so ordered, or to give testimony touching the matter under investigation. Any failure to obey the order of the court may be punished by the court as a contempt thereof. All process in any such case may be served in any judicial district in which such person may be found.

(Pub. L. 91–513, title II, §506, Oct. 27, 1970, 84 Stat. 1272; Pub. L. 100–690, title VI, §6058, Nov. 18, 1988, 102 Stat. 4319.)

Editorial Notes

Amendments

1988—Subsec. (a). Pub. L. 100–690 inserted "listed chemicals, tableting machines, or encapsulating machines," after "with respect to controlled substances,".

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.
21 U.S.C. § 399a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399a: Office of the Chief Scientist
Office of the Chief Scientist
Status: in_force

(a) Establishment; appointment

The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.

(b) Duties of the Office

The Office of the Chief Scientist shall—

(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;

(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;

(3) develop and advocate for a budget to support intramural research;

(4) develop a peer review process by which intramural research can be evaluated;

(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—

(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and

(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

(June 25, 1938, ch. 675, §1010, formerly §910, as added Pub. L. 110–85, title VI, §602, Sept. 27, 2007, 121 Stat. 898; renumbered §1010, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 467b (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 467b: Seizure and condemnation
Seizure and condemnation
Status: in_force

(a) Proceedings in rem; libel of information; jurisdiction; disposal by destruction or sale; proceeds into the Treasury; sales restrictions; bonds; court costs and fees, storage, and other expenses against claimants; jury trial; United States as plaintiff

(1) Any poultry product, or any dead, dying, disabled, or diseased poultry, that is being transported in commerce or otherwise subject to this chapter, or is held for sale in the United States after such transportation, and that (A) is or has been processed, sold, transported, or otherwise distributed or offered or received for distribution in violation of this chapter, or (B) is capable of use as human food and is adulterated or misbranded, or (C) in any other way is in violation of this chapter, shall be liable to be proceeded against and seized and condemned, at any time, on a libel of information in any United States district court or other proper court as provided in section 467c of this title within the jurisdiction of which the article or poultry is found.

(2) If the article or poultry is condemned it shall, after entry of the decree, (A) be distributed in accordance with paragraph (5), or (B) be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the article or poultry shall not be sold contrary to the provisions of this chapter, or the laws of the jurisdiction in which it is sold: Provided, That upon the execution and delivery of a good and sufficient bond conditioned that the article or poultry shall not be sold or otherwise disposed of contrary to the provisions of this chapter, or the laws of the jurisdiction in which disposal is made, the court may direct that such article or poultry be delivered to the owner thereof subject to such supervision by authorized representatives of the Secretary as is necessary to insure compliance with the applicable laws.

(3) When a decree of condemnation is entered against the article or poultry and it is released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant of the article or poultry.

(4) The proceedings in such libel cases shall conform, as nearly as may be, to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States.

(5)(A) An article that is condemned under paragraph (1) may as the court may direct, after entry of the decree, be distributed without charge to nonprofit, private entities or to Federal, State, or local government entities engaged in the distribution of food without charge to individuals, if such article—

(i) is capable of use as a human food;

(ii) has been inspected under this chapter and found to be wholesome and not to be adulterated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination is made at the time of the entry of the decree that such article is wholesome and not so adulterated; and

(iii) is plainly marked "Not for Sale" on such article or its container.

(B) The United States may not be held legally responsible for any article that is distributed under subparagraph (A) to a nonprofit, private entity or to a Federal, State, or local government entity, if such article—

(i) was found after inspection under this chapter to be wholesome and not adulterated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination was made at the time of the entry of the decree that such article was wholesome and not so adulterated; and

(ii) was plainly marked "Not for Sale" on such article or its container.

(C) The person from whom such article was seized and condemned may not be held legally responsible for such article, if such article—

(i) was found after inspection under this chapter to be wholesome and not adulterated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination was made at the time of entry of the decree that such article was wholesome and not so adulterated; and

(ii) was plainly marked "Not for Sale" on such article or its container.

(b) Condemnation or seizure under other provisions unaffected

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

(Pub. L. 85–172, §20, as added Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 806; amended Pub. L. 101–205, §2, Dec. 7, 1989, 103 Stat. 1830.)

Editorial Notes

Amendments

1989—Subsec. (a). Pub. L. 101–205 designated first sentence as par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C), respectively, designated second sentence as par. (2) and inserted "(A) be distributed in accordance with paragraph (5), or (B)" after "entry of the decree,", designated third and fourth sentences as pars. (3) and (4), respectively, and added par. (5).
21 U.S.C. § 41 (2024) — Title 21: FOOD AND DRUGS / Chapter 2: TEAS / Section 41: Repealed. Pub. L. 104-128, §2, Apr. 9, 1996, 110 Stat. 1198
Repealed. Pub. L. 104-128, §2, Apr. 9, 1996, 110 Stat. 1198
Status: repealed

Section 41, acts Mar. 2, 1897, ch. 358, §1, 29 Stat. 604; May 16, 1908, ch. 170, 35 Stat. 163; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; May 24, 1962, Pub. L. 87–456, title III, §303(a), 76 Stat. 77; Aug. 23, 1988, Pub. L. 100–418, title I, §1214(l), 102 Stat. 1158, prohibited unlawful importation of substandard tea.

Section 42, acts Mar. 2, 1897, ch. 358, §2, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, related to establishment and composition of board of experts in teas.

Section 43, acts Mar. 2, 1897, ch. 358, §3, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, authorized establishment of purity standards.

Section 44, acts Mar. 2, 1897, ch. 358, §4, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, related to bonds of importers, examination of imported teas, and importation at ports without examiners.

Section 45, act Mar. 2, 1897, ch. 358, §5, 29 Stat. 605, related to delivery permits and reexamination and retention of substandard teas.

Section 46, acts Mar. 2, 1897, ch. 358, §7, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, 713, related to examiners and examination according to usages of trade.

Section 46a, acts Mar. 2, 1897, ch. 358, §13, formerly act July 1, 1941, ch. 269, title II, 55 Stat. 478; renumbered §13 of act Mar. 2, 1897, and amended Aug. 10, 1993, Pub. L. 103–66, title IV, §4401, 107 Stat. 378, related to deposit of fee prior to examination.

Section 47, acts Mar. 2, 1897, ch. 358, §6, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, 713; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, required referral of disputes to United States Board of Tea Appeals and authorized board to permit delivery or order destruction or exportation of substandard teas.

Section 48, acts Mar. 2, 1897, ch. 358, §8, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, related to reexaminations, including findings by examiner and assistance of experts.

Section 49, acts Mar. 2, 1897, ch. 358, §9, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, related to reimporting rejected teas and forfeitures for violation of provisions.

Section 50, acts Mar. 2, 1897, ch. 358, §10, 29 Stat. 607; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695, authorized issuance of regulations.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Pub. L. 104–128, §3, Apr. 9, 1996, 110 Stat. 1198, provided that: "This Act [repealing this chapter] shall take effect on the date of enactment of this Act [Apr. 9, 1996]."

Short Title of Repeal

Pub. L. 104–128, §1, Apr. 9, 1996, 110 Stat. 1198, provided that: "This Act [repealing this chapter] may be cited as the 'Federal Tea Tasters Repeal Act of 1996'."

Short Title

Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in part that act Mar. 2, 1897, which was classified generally to this chapter, could be cited as the Tea Importation Act.
21 U.S.C. § 1180 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1180: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, Pub. L. 92–255, title IV, §413, Mar. 21, 1972, 86 Stat. 84; Pub. L. 96–181, §8(a), (b)(1), Jan. 2, 1980, 93 Stat. 1313, 1314; Pub. L. 97–35, title IX, §973(e), Aug. 13, 1981, 95 Stat. 598, which related to drug abuse among government and other employees, was redesignated section 525 of the Public Health Service Act by Pub. L. 98–24, §2(b)(16)(A), Apr. 26, 1983, 97 Stat. 182, and is classified to section 290ee–1 of Title 42, The Public Health and Welfare.
21 U.S.C. § 2108 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2108: Annual report to Congress
Annual report to Congress
Status: in_force

The Secretary shall, on an annual basis, submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report that includes, with respect to the preceding 1-year period—

(1) the number and amount of food products regulated by the Food and Drug Administration imported into the United States, aggregated by country and type of food;

(2) a listing of the number of Food and Drug Administration inspectors of imported food products referenced in paragraph (1) and the number of Food and Drug Administration inspections performed on such products; and

(3) aggregated data on the findings of such inspections, including data related to violations of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and enforcement actions used to follow-up on such findings and violations.

(Pub. L. 110–85, title X, §1009, Sept. 27, 2007, 121 Stat. 970.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (3), 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.
21 U.S.C. § 349 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 349: Bottled drinking water standards; publication in Federal Register
Bottled drinking water standards; publication in Federal Register
Status: in_force

(a) Except as provided in subsection (b), whenever the Administrator of the Environmental Protection Agency prescribes interim or revised national primary drinking water regulations under section 1412 of the Public Health Service Act [42 U.S.C. 300g–1], the Secretary shall consult with the Administrator and within 180 days after the promulgation of such drinking water regulations either promulgate amendments to regulations under this chapter applicable to bottled drinking water or publish in the Federal Register his reasons for not making such amendments.

(b)(1) Not later than 180 days before the effective date of a national primary drinking water regulation promulgated by the Administrator of the Environmental Protection Agency for a contaminant under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the Secretary shall promulgate a standard of quality regulation under this subsection for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems (as defined under section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water used for bottled drinking water. The effective date for any such standard of quality regulation shall be the same as the effective date for such national primary drinking water regulation, except for any standard of quality of regulation promulgated by the Secretary before August 6, 1996, for which (as of August 6, 1996) an effective date had not been established. In the case of a standard of quality regulation to which such exception applies, the Secretary shall promulgate monitoring requirements for the contaminants covered by the regulation not later than 2 years after August 6, 1996.

(2) A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secretary determines appropriate for bottled water.

(3) A regulation issued by the Secretary as provided in this subsection shall require the following:

(A) In the case of contaminants for which a maximum contaminant level is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the regulation under this subsection shall establish a maximum contaminant level for the contaminant in bottled water which is no less stringent than the maximum contaminant level provided in the national primary drinking water regulation.

(B) In the case of contaminants for which a treatment technique is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the regulation under this subsection shall require that bottled water be subject to requirements no less protective of the public health than those applicable to water provided by public water systems using the treatment technique required by the national primary drinking water regulation.

(4)(A) If the Secretary does not promulgate a regulation under this subsection within the period described in paragraph (1), the national primary drinking water regulation referred to in paragraph (1) shall be considered, as of the date on which the Secretary is required to establish a regulation under paragraph (1), as the regulation applicable under this subsection to bottled water.

(B) In the case of a national primary drinking water regulation that pursuant to subparagraph (A) is considered to be a standard of quality regulation, the Secretary shall, not later than the applicable date referred to in such subparagraph, publish in the Federal Register a notice—

(i) specifying the contents of such regulation, including monitoring requirements; and

(ii) providing that for purposes of this paragraph the effective date for such regulation is the same as the effective date for the regulation for purposes of the Safe Drinking Water Act [42 U.S.C. 300f et seq.] (or, if the exception under paragraph (1) applies to the regulation, that the effective date for the regulation is not later than 2 years and 180 days after August 6, 1996).

(June 25, 1938, ch. 675, §410, as added Pub. L. 93–523, §4, Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104–182, title III, §305, Aug. 6, 1996, 110 Stat. 1684.)

Editorial Notes

References in Text

The Safe Drinking Water Act, referred to in subsec. (b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16, 1974, Pub. L. 93–523, §2(a), 88 Stat. 1660, as amended, which is classified generally to subchapter XII (§300f et seq.) of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

1996—Pub. L. 104–182 substituted "(a) Except as provided in subsection (b), whenever" for "Whenever" and added subsec. (b).

Statutory Notes and Related Subsidiaries

Bottled Water Study

Pub. L. 104–182, title I, §114(b), Aug. 6, 1996, 110 Stat. 1641, provided that not later than 18 months after Aug. 6, 1996, the Administrator of the Food and Drug Administration would publish for public notice and comment a draft study on the feasibility of appropriate methods, if any, of informing customers of the contents of bottled water, and publish a final study not later than 30 months after Aug. 6, 1996.
21 U.S.C. § 373 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 373: Records
Records
Status: in_force

(a) In general

For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, shall not be used in a criminal prosecution of the person from whom obtained, and except that carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b).

(b) Food transportation records

A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 350e of this title shall, on request of an officer or employee designated by the Secretary, permit the officer or employee, at reasonable times, to have access to and to copy all records that the Secretary requires to be kept under section 350e(c)(1)(E) of this title.

(June 25, 1938, ch. 675, §703, 52 Stat. 1057; Pub. L. 91–452, title II, §230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103–80, §3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109–59, title VII, §7202(c), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 111–31, div. A, title I, §103(h), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (a). Pub. L. 111–31 inserted "tobacco product," after "device," in two places and "tobacco products," after "devices," in two places.

2005—Pub. L. 109–59 struck out "of interstate shipment" after "Records" in section catchline, designated existing provisions as subsec. (a), inserted subsec. heading, substituted "carriers, except as provided in subsection (b)" for "carriers" before period at end, and added subsec. (b).

1993—Pub. L. 103–80 substituted ", except that" for ": Provided, That" and ", and except that" for ": Provided further, That".

1970—Pub. L. 91–452 inserted ", or any evidence which is directly or indirectly derived from such evidence," after "under this section".

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

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

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–452 effective on sixtieth day following Oct. 15, 1970, and not to affect any immunity to which any individual is entitled under this section by reason of any testimony given before sixtieth day following Oct. 15, 1970, see section 260 of Pub. L. 91–452, set out as an Effective Date; Savings Provision note under section 6001 of Title 18, Crimes and Criminal Procedure.

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. § 353a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 353a: Pharmacy compounding
Pharmacy compounding
Status: in_force

(a) In general

Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding—

(1) is by—

(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or

(B) a licensed physician,

on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or

(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and

(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between—

(i) the licensed pharmacist or licensed physician; and

(ii)(I) such individual patient for whom the prescription order will be provided; or

(II) the physician or other licensed practitioner who will write such prescription order.

(b) Compounded drug

(1) Licensed pharmacist and licensed physician

A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician—

(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—

(i) that—

(I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;

(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or

(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (c);

(ii) that are manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title); and

(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;

(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;

(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and

(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.

(2) Definition

For purposes of paragraph (1)(D), the term "essentially a copy of a commercially available drug product" does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.

(3) Drug product

A drug product may be compounded under subsection (a) only if—

(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and

(B) such drug product is compounded in a State—

(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or

(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).

(c) Regulations

(1) In general

The Secretary shall issue regulations to implement this section. Before issuing regulations to implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the Secretary.

(2) Limiting compounding

The Secretary, in consultation with the United States Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying drug substances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a monograph does not exist or which are not components of drug products approved by the Secretary. The Secretary shall include in the regulation the criteria for such substances, which shall include historical use, reports in peer reviewed medical literature, or other criteria the Secretary may identify.

(d) Application

This section shall not apply to—

(1) compounded positron emission tomography drugs as defined in section 321(ii) of this title; or

(2) radiopharmaceuticals.

(e) "Compounding" defined

As used in this section, the term "compounding" does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

(June 25, 1938, ch. 675, §503A, as added Pub. L. 105–115, title I, §127(a), Nov. 21, 1997, 111 Stat. 2328; amended Pub. L. 113–54, title I, §106(a), Nov. 27, 2013, 127 Stat. 598.)

Editorial Notes

Amendments

2013—Subsec. (a). Pub. L. 113–54, §106(a)(1), struck out "unsolicited" before "receipt of a valid prescription" in introductory provisions.

Subsec. (b)(1)(A)(i)(III). Pub. L. 113–54, §106(a)(4), substituted "subsection (c)" for "subsection (d)".

Subsecs. (c) to (f). Pub. L. 113–54, §106(a)(2), (3), redesignated subsecs. (d) to (f) as (c) to (e), respectively, and struck out former subsec. (c). Prior to amendment, subsec. (c) read as follows: "A drug may be compounded under subsection (a) of this section only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician."

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 105–115, title I, §127(b), Nov. 21, 1997, 111 Stat. 2330, provided that: "Section 503A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by subsection (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act [Nov. 21, 1997]."
21 U.S.C. § 111 (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 111: Repealed. Pub. L. 107-171, title X, §10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508
Repealed. Pub. L. 107-171, title X, §10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508
Status: repealed

Section 111, act Feb. 2, 1903, ch. 349, §2, 32 Stat. 792; July 22, 1954, ch. 558, §33, 68 Stat. 510; Jan. 28, 1956, ch. 12, §2, 70 Stat. 5, related to regulations to prevent contagious diseases.

Section 112, act May 29, 1884, ch. 60, §4, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to investigations as to pleuropneumonia and other diseases and regulations.

Statutory Notes and Related Subsidiaries

Short Title

Act Feb. 2, 1903, ch. 349, 32 Stat. 791, classified to former sections 112 and 120 to 122 of this title, is popularly known as the Cattle Contagious Diseases Act of 1903.

Act May 29, 1884, ch. 60, 23 Stat. 31, classified to former sections 112, 113 to 114a–1, 115, 116, 117 to 120, and 130 of this title and section 391 of Title 7, Agriculture, is popularly known as the Animal Industry Act.
21 U.S.C. § 620 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 620: Imports
Imports
Status: in_force

(a) Adulteration or misbranding prohibition; compliance with inspection, building construction standards, and other provisions; humane methods of slaughter; treatment as domestic articles subject to this chapter and food, drug, and cosmetic provisions; marking and labeling; personal consumption exemption

No carcasses, parts of carcasses, meat or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines which are capable of use as human food, shall be imported into the United States if such articles are adulterated or misbranded and unless they comply with all the inspection, building, construction standards, and all other provisions of this chapter and regulations issued thereunder applicable to such articles in commerce within the United States. No such carcasses, parts of carcasses, meat or meat food products shall be imported into the United States unless the livestock from which they were produced was slaughtered and handled in connection with slaughter in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906). All such imported articles shall, upon entry into the United States, be deemed and treated as domestic articles subject to the other provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]: Provided, That they shall be marked and labeled as required by such regulations for imported articles: Provided further, That nothing in this section shall apply to any individual who purchases meat or meat products outside the United States for his own consumption except that the total amount of such meat or meat products shall not exceed fifty pounds.

(b) Terms and conditions for destruction

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

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

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

(d) Prohibition

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

(e) Omitted

(f) Inspection and other standards; applicability, enforcement, etc.; certifications

Notwithstanding any other provision of law, all carcasses, parts of carcasses, meat, and meat food products of cattle, sheep, swine, goats, horses, mules, or other equines, capable of use as human food, offered for importation into the United States shall be subject to the inspection, sanitary, quality, species verification, and residue standards applied to products produced in the United States. Any such imported meat articles that do not meet such standards shall not be permitted entry in to the United States. The Secretary shall enforce this provision through (1) the imposition of random inspections for such species verification and for residues, and (2) random sampling and testing of internal organs and fat of the carcasses for residues at the point of slaughter by the exporting country in accordance with methods approved by the Secretary. Each foreign country from which such meat articles are offered for importation into the United States shall obtain a certification issued by the Secretary stating that the country maintains a program using reliable analytical methods to ensure compliance with the United States standards for residues in such meat articles. No such meat article shall be permitted entry into the United States from a country for which the Secretary has not issued such certification. The Secretary shall periodically review such certifications and shall revoke any certification if the Secretary determines that the country involved is not maintaining a program that uses reliable analytical methods to ensure compliance with United States standards for residues in such meat articles. The consideration of any application for a certification under this subsection and the review of any such certification, by the Secretary, shall include the inspection of individual establishments to ensure that the inspection program of the foreign country involved is meeting such United States standards.

(g) Administration of animal drugs or antibiotics; terms and conditions; entry order violations

The Secretary may prescribe terms and conditions under which amenable species that have been administered an animal drug or antibiotic banned for use in the United States may be imported for slaughter and human consumption. No person shall enter amenable species into the United States in violation of any order issued under this subsection by the Secretary.

(h) Reciprocal meat inspection requirement

(1) As used in this subsection:

(A) The term "meat articles" means carcasses, meat and meat food products of cattle, sheep, swine, goats, horses, mules, or other equines, that are capable of use as human food.

(B) The term "standards" means inspection, building construction, sanitary, quality, species verification, residue, and other standards that are applicable to meat articles.

(2) On request of the Committee on Agriculture or the Committee on Ways and Means of the House of Representatives or the Committee on Agriculture, Nutrition, and Forestry or the Committee on Finance of the Senate, or at the initiative of the Secretary, the Secretary shall, as soon as practicable, determine whether a particular foreign country applies standards for the importation of meat articles from the United States that are not related to public health concerns about end-product quality that can be substantiated by reliable analytical methods.

(3) If the Secretary determines that a foreign country applies standards described in paragraph (2)—

(A) the Secretary shall consult with the United States Trade Representative; and

(B) within 30 days after the determination of the Secretary under paragraph (2), the Secretary and the United States Trade Representative shall recommend to the President whether action should be taken under paragraph (4).

(4) Within 30 days after receiving a recommendation for action under paragraph (3), the President shall, if and for such time as the President considers appropriate, prohibit imports into the United States of any meat articles produced in such foreign country unless it is determined that the meat articles produced in that country meet the standards applicable to meat articles in commerce within the United States.

(5) The action authorized under paragraph (4) may be used instead of, or in addition to, any other action taken under any other law.

(Mar. 4, 1907, ch. 2907, title I, §20, formerly 18th par., 34 Stat. 1264; renumbered §20 and amended Pub. L. 90–201, §§1, 10, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 95–445, §4, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 97–98, title XI, §1122, Dec. 22, 1981, 95 Stat. 1273; Pub. L. 99–198, title XVII, §1702, Dec. 23, 1985, 99 Stat. 1634; Pub. L. 100–418, title IV, §4604, Aug. 23, 1988, 102 Stat. 1408; Pub. L. 103–182, title III, §361(f), Dec. 8, 1993, 107 Stat. 2124; Pub. L. 103–437, §8(2), Nov. 2, 1994, 108 Stat. 4588; Pub. L. 103–465, title IV, §431(l), Dec. 8, 1994, 108 Stat. 4970; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

References in Text

Act of August 27, 1958, referred to in subsec. (a), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classified generally to chapter 48 (§1901 et seq.) of Title 7, Agriculture. Sections 1903 and 1905 of Title 7, included within reference to Act of August 27, 1958, were repealed by Pub. L. 95–445, §5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title. For complete classification of this Act to the Code, see Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, 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.

Codification

Subsec. (e) of this section, which required the Secretary to submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a comprehensive and detailed written annual report on the administration of this section, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 46 of House Document No. 103–7.

Section was formerly classified to section 88 of this title.

Amendments

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

1994—Subsec. (e). Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry" in introductory provisions.

Subsec. (e)(1)(A), (B). Pub. L. 103–465, §431(l)(1), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) read as follows:

"(A) Subject to subparagraphs (B) and (C), a certification by the Secretary that foreign plants in Canada and Mexico that export carcasses or meat or meat products referred to in subsection (a) of this section have complied with paragraph (2) or with requirements that are equivalent to United States requirements with regard to all inspection and building construction standards, and all other provisions of this chapter and regulations issued under this chapter.

"(B) Subject to subparagraph (C), the Secretary may treat as equivalent to a United States requirement a requirement described in subparagraph (A) if the exporting country provides the Secretary with scientific evidence or other information, in accordance with risk assessment methodologies agreed to by the Secretary and the exporting country, to demonstrate that the requirement or standard of the exporting country achieves the level of protection that the Secretary considers appropriate."

Subsec. (e)(2) to (7). Pub. L. 103–465, §431(l)(2), (3), redesignated pars. (3) to (7) as (2) to (6), respectively, and struck out former par. (2) which read as follows: "A certification by the Secretary that, except as provided in paragraph (1), foreign plants that export carcasses or meat or meat products referred to in subsection (a) of this section have complied with requirements that are at least equal to all inspection and building construction standards and all other provisions of this chapter and regulations issued under this chapter."

1993—Subsec. (e). Pub. L. 103–182, §361(f)(1), substituted "not be limited to the following:" for "not be limited to—" in introductory provisions.

Subsec. (e)(1) to (7). Pub. L. 103–182, §361(f)(2)–(7), added pars. (1) and (2), struck out former par. (1), redesignated pars. (2) to (6) as (3) to (7), respectively, substituted "The" for "the" at beginning of each par., substituted period for semicolon at end of pars. (3) to (5), and substituted period for "; and" at end of par. (6). Prior to amendment, former par. (1) read as follows: "a certification by the Secretary that foreign plants exporting carcasses or meat or meat products referred to in subsection (a) of this section have complied with requirements at least equal to all the inspection, building construction standards, and all other provisions of this chapter and regulations issued thereunder;".

1988—Subsec. (e)(6). Pub. L. 100–418, §4604(b), added par. (6).

Subsec. (h). Pub. L. 100–418, §4604(a), added subsec. (h).

1985—Subsec. (f). Pub. L. 99–198, §1702(a), struck out provision which had made this subsection effective six months after Dec. 22, 1981, and inserted provisions requiring that each foreign country from which meat articles are offered for importation into the United States obtain a certification issued by the Secretary stating that the country maintains a program using reliable analytical methods to ensure compliance with the United States standards for residues in such meat articles, that no meat article be permitted entry into the United States from a country for which the Secretary has not issued such certification, that the Secretary periodically review such certifications and revoke any certification if the Secretary determines that the country involved is not maintaining a program that uses reliable analytical methods to ensure compliance with United States standards for residues in such meat articles, and that the consideration of any application for a certification under this subsection and the review of any such certification, by the Secretary, include the inspection of individual establishments to ensure that the inspection program of the foreign country involved is meeting such United States standards.

Subsec. (g). Pub. L. 99–198, §1702(b), added subsec. (g).

1981—Subsec. (f). Pub. L. 97–98 added subsec. (f).

1978—Subsec. (a). Pub. L. 95–445 prohibited imports which do not comply with humane methods of slaughter.

1967—Pub. L. 90–201, §10, substituted imported articles provisions for penalty provisions deeming offenses as misdemeanors and punishable by fine of $10,000 or imprisonment for two years or both. See section 676(a) of this title.

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 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States (Jan. 1, 1995), see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Effective Date of 1981 Amendment

Amendment by Pub. L. 97–98 effective Dec. 22, 1981, see section 1801 of Pub. L. 97–98, set out as an Effective Date note under section 4301 of Title 7, Agriculture.

Effective Date of 1978 Amendment

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

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective upon expiration of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 350j (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350j: Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
Status: in_force

(a) Identification and inspection of facilities

(1) Identification

The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:

(A) The known safety risks of the food manufactured, processed, packed, or held at the facility.

(B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

(C) The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls.

(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title.

(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 381(q) or 384b of this title, as appropriate.

(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(2) Inspections

(A) In general

Beginning on January 4, 2011, the Secretary shall increase the frequency of inspection of all facilities.

(B) Domestic high-risk facilities

The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected—

(i) not less often than once in the 5-year period following January 4, 2011; and

(ii) not less often than once every 3 years thereafter.

(C) Domestic non-high-risk facilities

The Secretary shall ensure that each domestic facility that is not identified under paragraph (1) as a high-risk facility is inspected—

(i) not less often than once in the 7-year period following January 4, 2011; and

(ii) not less often than once every 5 years thereafter.

(D) Foreign facilities

(i) Year 1

In the 1-year period following January 4, 2011, the Secretary shall inspect not fewer than 600 foreign facilities.

(ii) Subsequent years

In each of the 5 years following the 1-year period described in clause (i), the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year.

(E) Reliance on Federal, State, or local inspections

In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.

(b) Identification and inspection at ports of entry

The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors:

(1) The known safety risks of the food imported.

(2) The known safety risks of the countries or regions of origin and countries through which such article of food is transported.

(3) The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

(4) The rigor and effectiveness of the activities conducted by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under section 384a of this title.

(5) Whether the food importer participates in the voluntary qualified importer program under section 384b of this title.

(6) Whether the food meets the criteria for priority under section 381(h)(1) of this title.

(7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 381(q) or 384b of this title.

(8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(c) Interagency agreements with respect to seafood

(1) In general

The Secretary of Health and Human Services, the Secretary of Commerce, the Secretary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or appropriate to improve seafood safety.

(2) Scope of agreements

The agreements under paragraph (1) may include—

(A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement;

(B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected;

(C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination;

(D) coordination to detect and investigate violations under applicable Federal law;

(E) a process, including the use or modification of existing processes, by which officers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the Secretary to carry out seafood examinations and investigations under section 381 of this title or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004;

(F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States;

(G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; and

(H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements.

(d) Coordination

The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to target food inspection resources.

(e) Facility

For purposes of this section, the term "facility" means a domestic facility or a foreign facility that is required to register under section 350d of this title.

(June 25, 1938, ch. 675, §421, as added Pub. L. 111–353, title II, §201(a), Jan. 4, 2011, 124 Stat. 3923.)

Editorial Notes

References in Text

Section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004, referred to in subsec. (c)(2)(E), is section 203 of Pub. L. 108–282, Aug. 2, 2004, 118 Stat. 906, which amended sections 321, 343, and 343–1 of this title and enacted provisions set out as notes under sections 321 and 343 of this title.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Advisory Committee Consultation

Pub. L. 111–353, title II, §201(c), Jan. 4, 2011, 124 Stat. 3926, provided that: "In allocating inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450j] (as added by subsection (a)), the Secretary may, as appropriate, consult with any relevant advisory committee within the Department of Health and Human Services."
21 U.S.C. § 2334 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter II: OTHER MATTERS / Section 2334: Termination
Termination
Status: in_force

The provisions of this chapter, and any sanctions imposed pursuant to this chapter, shall terminate on the date that is 7 years after December 20, 2019.

(Pub. L. 116–92, div. F, title LXXII, §7234, Dec. 20, 2019, 133 Stat. 2275.)

Editorial Notes

References in Text

This chapter, referred to in text, 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. § 829a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 829a: Delivery of a controlled substance by a pharmacy to an administering practitioner
Delivery of a controlled substance by a pharmacy to an administering practitioner
Status: in_force

(a) In general

Notwithstanding section 802(10) of this title, a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this subchapter and the regulations issued by the Attorney General under this subchapter, for the purpose of administering the controlled substance by the practitioner if—

(1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner's certificate of registration issued under this subchapter;

(2) the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;

(3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;

(4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;

(5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practitioner; and

(6) notwithstanding any exceptions under section 827 of this title, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General.

(b) Modification of number of days before which controlled substance shall be administered

(1) Initial 2-year period

During the 2-year period beginning on October 24, 2018, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will—

(A) reduce the risk of diversion; or

(B) protect the public health.

(2) Modifications after submission of report

After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5).

(3) Minimum number of days

Any modification under this subsection shall be for a period of not less than 7 days.

(Pub. L. 91–513, title II, §309A, as added Pub. L. 115–271, title III, §3204(a), Oct. 24, 2018, 132 Stat. 3945; amended Pub. L. 117–215, title I, §103(b)(1)(E), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §§1262(b)(2), 1264, Dec. 29, 2022, 136 Stat. 5682, 5685.)

Editorial Notes

References in Text

Section 3204(b) of the SUPPORT for Patients and Communities Act, referred to in subsec. (b)(2), is section 3204(b) of Pub. L. 115–271, title III, Oct. 24, 2018, 132 Stat. 3946, which is not classified to the Code.

Amendments

2022—Subsec. (a)(2). Pub. L. 117–328, §1262(b)(2), which directed substitution of "the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;" for "the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(g)(2) and—"

"(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and

"(B) the controlled substance is to be administered by injection or implantation;"

was executed by making the substitution for "the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(h)(2) and—" and subpars. (A) and (B), to reflect the probable intent of Congress and the intervening amendment by Pub. L. 117–215. See Amendment note below.

Pub. L. 117–215 substituted "823(h)(2)" for "823(g)(2)" in introductory provisions.

Subsec. (a)(5). Pub. L. 117–328, §1264, substituted "45 days" for "14 days".