21 U.S.C. § 360kk (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360kk: Performance standards for electronic products
Performance standards for electronic products
Status: in_force

(a) Promulgation of regulations

(1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product radiation from such products if he determines that such standards are necessary for the protection of the public health and safety. Such standards may include provisions for the testing of such products and the measurement of their electronic product radiation emissions, may require the attachment of warning signs and labels, and may require the provision of instructions for the installation, operation, and use of such products. Such standards may be prescribed from time to time whenever such determinations are made, but the first of such standards shall be prescribed prior to January 1, 1970. In the development of such standards, the Secretary shall consult with Federal and State departments and agencies having related responsibilities or interests and with appropriate professional organizations and interested persons, including representatives of industries and labor organizations which would be affected by such standards, and shall give consideration to—

(A) the latest available scientific and medical data in the field of electronic product radiation;

(B) the standards currently recommended by (i) other Federal agencies having responsibilities relating to the control and measurement of electronic product radiation, and (ii) public or private groups having an expertise in the field of electronic product radiation;

(C) the reasonableness and technical feasibility of such standards as applied to a particular electronic product;

(D) the adaptability of such standards to the need for uniformity and reliability of testing and measuring procedures and equipment; and

(E) in the case of a component, or accessory described in paragraph (2)(B) of section 360hh of this title, the performance of such article in the manufactured or assembled product for which it is designed.

(2) The Secretary may prescribe different and individual performance standards, to the extent appropriate and feasible, for different electronic products so as to recognize their different operating characteristics and uses.

(3) The performance standards prescribed under this section shall not apply to any electronic product which is intended solely for export if (A) such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export, and (B) such product meets all the applicable requirements of the country to which such product is intended for export.

(4) The Secretary may by regulation amend or revoke any performance standard prescribed under this section.

(5) The Secretary may exempt from the provisions of this section any electronic product intended for use by departments or agencies of the United States provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the United States.

(b) Administrative procedure

The provisions of subchapter II of chapter 5 of title 5 (relating to the administrative procedure for rulemaking), and of chapter 7 of title 5 (relating to judicial review), shall apply with respect to any regulation prescribing, amending, or revoking any standard prescribed under this section.

(c) Publication in Federal Register

Each regulation prescribing, amending, or revoking a standard shall specify the date on which it shall take effect which, in the case of any regulation prescribing, or amending any standard, may not be sooner than one year or not later than two years after the date on which such regulation is issued, unless the Secretary finds, for good cause shown, that an earlier or later effective date is in the public interest and publishes in the Federal Register his reason for such finding, in which case such earlier or later date shall apply.

(d) Judicial review

(1) In a case of actual controversy as to the validity of any regulation issued under this section prescribing, amending, or revoking a performance standard, any person who will be adversely affected by such regulation when it is effective may at any time prior to the sixtieth day after such regulation is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such regulation. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based the regulation, as provided in section 2112 of title 28.

(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendations, if any, for the modification or setting aside of his original regulation, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to review the regulation in accordance with chapter 7 of title 5 and to grant appropriate relief as provided in such chapter.

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

(5) Any action instituted under this subsection shall survive, notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.

(e) Availability of record

A certified copy of the transcript of the record and administrative proceedings under this section shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, exclusion of imports, or other proceeding arising under or in respect of this part irrespective of whether proceedings with respect to the regulation have previously been initiated or become final under this section.

(f) Technical Electronic Product Radiation Safety Standards Committee

(1)(A) The Secretary shall establish a Technical Electronic Product Radiation Safety Standards Committee (hereafter in this part referred to as the "Committee") which he shall consult before prescribing any standard under this section. The Committee shall be appointed by the Secretary, after consultation with public and private agencies concerned with the technical aspect of electronic product radiation safety, and shall be composed of fifteen members each of whom shall be technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation safety, as follows:

(i) Five members shall be selected from governmental agencies, including State and Federal Governments;

(ii) Five members shall be selected from the affected industries after consultation with industry representatives; and

(iii) Five members shall be selected from the general public, of which at least one shall be a representative of organized labor.

(B) The Committee may propose electronic product radiation safety standards to the Secretary for his consideration. All proceedings of the Committee shall be recorded and the record of each such proceeding shall be available for public inspection.

(2) Payments to members of the Committee who are not officers or employees of the United States pursuant to subsection (c) of section 210 of title 42 shall not render members of the Committee officers or employees of the United States for any purpose.

(g) Review and evaluation

The Secretary shall review and evaluate on a continuing basis testing programs carried out by industry to assure the adequacy of safeguards against hazardous electronic product radiation and to assure that electronic products comply with standards prescribed under this section.

(h) Product certification

Every manufacturer of an electronic product to which is applicable a standard in effect under this section shall furnish to the distributor or dealer at the time of delivery of such product, in the form of a label or tag permanently affixed to such product or in such manner as approved by the Secretary, the certification that such product conforms to all applicable standards under this section. Such certification shall be based upon a test, in accordance with such standard, of the individual article to which it is attached or upon a testing program which is in accord with good manufacturing practice and which has not been disapproved by the Secretary (in such manner as he shall prescribe by regulation) on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this section.

(June 25, 1938, ch. 675, §534, formerly act July 1, 1944, ch. 373, title III, §534, formerly §358, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91–515, title VI, §601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311; renumbered §534 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §§3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.)

Editorial Notes

Codification

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

Amendments

1993—Pub. L. 103–80, §4(a)(2), amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263f of Title 42, The Public Health and Welfare, as this section.

Subsec. (f)(2). Pub. L. 103–80, §3(w), made technical amendment to reference to section 210 of title 42 to reflect correction of corresponding provision of original act.

1990—Subsec. (a)(1)(E). Pub. L. 101–629, §19(a)(2)(B), substituted "section 360hh" for "section 263c".

Subsecs. (e), (f)(1)(A). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

1970—Subsec. (f)(2). Pub. L. 91–515 struck out provisions related to payment of compensation and travel expenses of members of the Committee who are not officers or employees of the United States, and substituted "to members of the Committee who are not officers or employees of the United States pursuant to subsection (c) of section 210 of title 42" for "under this subsection".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 861 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 861: Employment or use of persons under 18 years of age in drug operations
Employment or use of persons under 18 years of age in drug operations
Status: in_force

(a) Unlawful acts

It shall be unlawful for any person at least eighteen years of age to knowingly and intentionally—

(1) employ, hire, use, persuade, induce, entice, or coerce, a person under eighteen years of age to violate any provision of this subchapter or subchapter II;

(2) employ, hire, use, persuade, induce, entice, or coerce, a person under eighteen years of age to assist in avoiding detection or apprehension for any offense of this subchapter or subchapter II by any Federal, State, or local law enforcement official; or

(3) receive a controlled substance from a person under 18 years of age, other than an immediate family member, in violation of this subchapter or subchapter II.

(b) Penalty for first offense

Any person who violates subsection (a) is subject to twice the maximum punishment otherwise authorized and at least twice any term of supervised release otherwise authorized for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year.

(c) Penalty for subsequent offenses

Any person who violates subsection (a) after a prior conviction under subsection (a) of this section has become final, is subject to three times the maximum punishment otherwise authorized and at least three times any term of supervised release otherwise authorized for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year. Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title.

(d) Penalty for providing or distributing controlled substance to underage person

Any person who violates subsection (a)(1) or (2) 1

(1) by knowingly providing or distributing a controlled substance or a controlled substance analogue to any person under eighteen years of age; or

(2) if the person employed, hired, or used is fourteen years of age or younger,

shall be subject to a term of imprisonment for not more than five years or a fine of not more than $50,000, or both, in addition to any other punishment authorized by this section.

(e) Suspension of sentence; probation; parole

In any case of any sentence imposed under this section, imposition or execution of such sentence shall not be suspended and probation shall not be granted. An individual convicted under this section of an offense for which a mandatory minimum term of imprisonment is applicable shall not be eligible for parole under section 4202 of title 18 2 until the individual has served the mandatory term of imprisonment as enhanced by this section.

(f) Distribution of controlled substance to pregnant individual

Except as authorized by this subchapter, it shall be unlawful for any person to knowingly or intentionally provide or distribute any controlled substance to a pregnant individual in violation of any provision of this subchapter. Any person who violates this subsection shall be subject to the provisions of subsections (b), (c), and (e).

(Pub. L. 91–513, title II, §420, formerly §405B, as added Pub. L. 99–570, title I, §1102, Oct. 27, 1986, 100 Stat. 3207–10; amended Pub. L. 100–690, title VI, §§6452(b)(1), 6459, 6470(d), Nov. 18, 1988, 102 Stat. 4371, 4373, 4378; renumbered §420 and amended Pub. L. 101–647, title X, §§1002(c), 1003(c), title XXXV, §3599L, Nov. 29, 1990, 104 Stat. 4827, 4829, 4932.)

Editorial Notes

References in Text

Section 4202 of title 18, referred to in subsec. (e), which, as originally enacted in Title 18, Crimes and Criminal Procedure, related to eligibility of prisoners for parole, was repealed and a new section 4202 enacted as part of the repeal and enactment of a new chapter 311 (§4201 et seq.) of Title 18, by Pub. L. 94–233, §2, Mar. 15, 1976, 90 Stat. 219. For provisions relating to the eligibility of prisoners for parole, see section 4205 of Title 18. Pub. L. 98–473, title II, §§218(a)(5), 235(a)(1), (b)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, 2032, as amended, provided that, effective on the first day of the first calendar month beginning 36 months after Oct. 12, 1984 (Nov. 1, 1987), chapter 311 of Title 18 is repealed, subject to remaining effective for five years after Nov. 1, 1987, in certain circumstances. See Effective Date note set out under section 3551 of Title 18.

Codification

Section was classified to section 845b of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Subsec. (b). Pub. L. 101–647, §1003(c)(1), which directed the substitution of "is subject to twice the maximum punishment otherwise authorized" for "is punishable by a term of imprisonment up to twice that authorized, or up to twice the fine authorized, or both," was executed by making the substitution for "is punishable by a term of imprisonment up to twice that otherwise authorized, or up to twice the fine otherwise authorized, or both," to reflect the probable intent of Congress.

Subsec. (c). Pub. L. 101–647, §3599L, substituted "has become final" for "have become final".

Pub. L. 101–647, §1003(c)(2), which directed the substitution of "is subject to three times the maximum punishment otherwise authorized" for "is punishable by a term of imprisonment up to three times that authorized, or up to three times the fine authorized, or both," was executed by making the substitution for "is punishable by a term of imprisonment up to three times that otherwise authorized, or up to three times the fine otherwise authorized, or both," to reflect the probable intent of Congress.

1988—Subsec. (a)(3). Pub. L. 100–690, §6459, added par. (3).

Subsec. (c). Pub. L. 100–690, §6452(b)(1), struck out "or convictions" after "a prior conviction" and inserted at end "Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title."

Subsec. (e). Pub. L. 100–690, §6470(d), struck out "required by section 841(b) of this title" after "mandatory term of imprisonment".

1 So in original. Probably should be followed by a dash.

2 See References in Text note below.
21 U.S.C. § 605 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 605: Examination of carcasses brought into slaughtering or packing establishments, and of meat food products issued from and returned thereto; conditions for entry
Examination of carcasses brought into slaughtering or packing establishments, and of meat food products issued from and returned thereto; conditions for entry
Status: in_force

The foregoing provisions shall apply to all carcasses or parts of carcasses of amenable species or the meat or meat products thereof which may be brought into any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and such examination and inspection shall be had before the said carcasses or parts thereof shall be allowed to enter into any department wherein the same are to be treated and prepared for meat food products; and the foregoing provisions shall also apply to all such products, which, after having been issued from any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, shall be returned to the same or to any similar establishment where such inspection is maintained. The Secretary may limit the entry of carcasses, parts of carcasses, meat and meat food products, and other materials into any establishment at which inspection under this subchapter is maintained, under such conditions as he may prescribe to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this chapter.

(Mar. 4, 1907, ch. 2907, title I, §5, formerly 3rd par., 34 Stat. 1261; renumbered §5 and amended Pub. L. 90–201, §§1, 5, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 73 of this title.

Amendments

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

1967—Pub. L. 90–201, §§5, 12(a), limited entry of articles into establishments under such prescribed conditions as would be consistent with the purpose of this chapter and included horses, mules, and other equines in the list of animals, respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

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

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 360f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360f: Banned devices
Banned devices
Status: in_force

(a) General rule

Whenever the Secretary finds, on the basis of all available data and information, that—

(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury for one or more intended uses; and

(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;

he may initiate a proceeding to promulgate a regulation to make such device a banned device or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 396 of this title when intended for such use or uses.

(b) Special effective date

The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and (2) before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, and either affirm, modify, or revoke such proposed regulation.

(June 25, 1938, ch. 675, §516, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, §18(d), Nov. 28, 1990, 104 Stat. 4529; Pub. L. 117–328, div. FF, title III, §3306(a), Dec. 29, 2022, 136 Stat. 5834.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3306(a)(2), inserted "or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 396 of this title when intended for such use or uses" after "banned device" in concluding provisions.

Subsec. (a)(1). Pub. L. 117–328, §3306(a)(1), inserted "for one or more intended uses" before semicolon at end.

1990—Subsec. (a). Pub. L. 101–629 struck out "and after consultation with the appropriate panel or panels under section 360c of this title" after "data and information" in introductory provisions and struck out at end "The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection."

Statutory Notes and Related Subsidiaries

Construction of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3306(b), Dec. 29, 2022, 136 Stat. 5834, provided that: "Nothing in this section [amending this section] shall be construed to limit the authority of the Secretary [of Health and Human Services] to amend, in accordance with section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f), as amended by this section, and chapter 5 of title 5, United States Code, regulations promulgated pursuant to such section 516, as amended by this section."
21 U.S.C. § 346 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 346: Tolerances for poisonous or deleterious substances in food; regulations
Tolerances for poisonous or deleterious substances in food; regulations
Status: in_force

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 342(a) of this title. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

(June 25, 1938, ch. 675, §406, 52 Stat. 1049; Pub. L. 85–929, §3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86–618, title I, §103(a)(1), July 12, 1960, 74 Stat. 398.)

Editorial Notes

Amendments

1960—Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors.

1958—Subsec. (a). Pub. L. 85–929 substituted "clause (2)(A)" for "clause (2)" in first sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1960 Amendment

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

Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959

Effective date of subsec. (a) as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73 Stat. 288.

Effective Date of 1958 Amendment

For effective date of amendment by Pub. L. 85–929, see section 6(b), (c) of Pub. L. 85–929, set out as a note under section 342 of this title.

Executive Documents

Transfer of Functions

Functions vested in Secretary of Health, Education, and Welfare [now Health and Human Services] in establishing tolerances for pesticide chemicals under this section together with authority to monitor compliance with tolerances and effectiveness of surveillance and enforcement and to provide technical assistance to States and conduct research under this chapter and section 201 et seq. of Title 42, The Public Health and Welfare, transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970, §2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government Organization and Employees.

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 618 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 618: Delivery of inspectors' certificates, and of copies
Delivery of inspectors' certificates, and of copies
Status: in_force

The inspectors provided for under this subchapter shall be authorized to give official certificates of the condition of the carcasses and products of amenable species; and one copy of every certificate granted under the provisions of this chapter shall be filed in the Department of Agriculture, another copy shall be delivered to the owner or shipper, and when the amenable species, or their carcasses and products are sent abroad, a third copy shall be delivered to the chief officer of the vessel on which the shipment shall be made.

(Mar. 4, 1907, ch. 2907, title I, §18, formerly 16th par., 34 Stat. 1263; renumbered §18 and amended Pub. L. 90–201, §§1, 12(a), (h), Dec. 15, 1967, 81 Stat. 584, 592; Pub. L. 107–171, title X, §10418(b)(4), May 13, 2002, 116 Stat. 508; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

"Provided for under this subchapter" was in the original "provided for herein".

Section was formerly classified to section 86 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.

2002—Pub. L. 107–171 substituted "of the carcasses and products of cattle, sheep, swine, goats, horses, mules, and other equines" for "of the cattle, sheep, swine, goats, horses, mules, and other equines, their carcasses and products as described in this subchapter".

1967—Pub. L. 90–201, §12(a), (h), included horses, mules, and other equines in the list of animals and struck out "sound and wholesome" before "conditions", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

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

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 360nn (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360nn: Inspection, records, and reports
Inspection, records, and reports
Status: in_force

(a) Inspection of premises

If the Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety in a particular factory, warehouse, or establishment in which electronic products are manufactured or held, may not be adequate or reliable, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are thereafter authorized (1) to enter, at reasonable times, any area in such factory, warehouse, or establishment in which the manufacturer's tests (or testing programs) required by section 360kk(h) of this title are carried out, and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, the facilities and procedures within such area which are related to electronic product radiation safety. Each such inspection shall be commenced and completed with reasonable promptness. In addition to other grounds upon which good cause may be found for purposes of this subsection, good cause will be considered to exist in any case where the manufacturer has introduced into commerce any electronic product which does not comply with an applicable standard prescribed under this part and with respect to which no exemption from the notification requirements has been granted by the Secretary under section 360ll(a)(2) or 360ll(e) of this title.

(b) Record keeping

Every manufacturer of electronic products shall establish and maintain such records (including testing records), make such reports, and provide such information, as the Secretary may reasonably require to enable him to determine whether such manufacturer has acted or is acting in compliance with this part and standards prescribed pursuant to this part and shall, upon request of an officer or employee duly designated by the Secretary, permit such officer or employee to inspect appropriate books, papers, records, and documents relevant to determining whether such manufacturer has acted or is acting in compliance with standards prescribed pursuant to this part.

(c) Disclosure of technical data

Every manufacturer of electronic products shall provide to the Secretary such performance data and other technical data related to safety as may be required to carry out the purposes of this part. The Secretary is authorized to require the manufacturer to give such notification of such performance and technical data at the time of original purchase to the ultimate purchaser of the electronic product, as he determines necessary to carry out the purposes of this part after consulting with the affected industry.

(d) Public nature of reports

Accident and investigation reports made under this part by any officer, employee, or agent of the Secretary shall be available for use in any civil, criminal, or other judicial proceeding arising out of such accident. Any such officer, employee, or agent may be required to testify in such proceedings as to the facts developed in such investigations. Any such report shall be made available to the public in a manner which need not identify individuals. All reports on research projects, demonstration projects, and other related activities shall be public information.

(e) Trade secrets

The Secretary or his representative shall not disclose any information reported to or otherwise obtained by him, pursuant to subsection (a) or (b) of this section, which concerns any information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18, except that such information may be disclosed to other officers or employees of the Department and of other agencies concerned with carrying out this part or when relevant in any proceeding under this part. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress.

(f) Information required to identify and locate first purchasers of electronic products

The Secretary may by regulation (1) require dealers and distributors of electronic products, to which there are applicable standards prescribed under this part and the retail prices of which is not less than $50, to furnish manufacturers of such products such information as may be necessary to identify and locate, for purposes of section 360ll of this title, the first purchasers of such products for purposes other than resale, and (2) require manufacturers to preserve such information. Any regulation establishing a requirement pursuant to clause (1) of the preceding sentence shall (A) authorize such dealers and distributors to elect, in lieu of immediately furnishing such information to the manufacturer, to hold and preserve such information until advised by the manufacturer or Secretary that such information is needed by the manufacturer for purposes of section 360ll of this title, and (B) provide that the dealer or distributor shall, upon making such election, give prompt notice of such election (together with information identifying the notifier and the product) to the manufacturer and shall, when advised by the manufacturer or Secretary, of the need therefor for the purposes of section 360ll of this title, immediately furnish the manufacturer with the required information. If a dealer or distributor discontinues the dealing in or distribution of electronic products, he shall turn the information over to the manufacturer. Any manufacturer receiving information pursuant to this subsection concerning first purchasers of products for purposes other than resale shall treat it as confidential and may use it only if necessary for the purpose of notifying persons pursuant to section 360ll(a) of this title.

(June 25, 1938, ch. 675, §537, formerly act July 1, 1944, ch. 373, title III, §537, formerly §360A, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered §537 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(E), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

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

Amendments

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

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

Subsecs. (b) to (e). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" wherever appearing.

Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), (2)(E)(ii), substituted "this part" for "this subpart", "section 360ll" for "section 263g" in three places, and "section 360ll(a)" for "section 263g(a)".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 360bb (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360bb: Designation of drugs for rare diseases or conditions
Designation of drugs for rare diseases or conditions
Status: in_force

(a) Request by sponsor; preconditions; "rare disease or condition" defined

(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—

(A) if an application for such drug is approved under section 355 of this title, or

(B) if a license for such drug is issued under section 262 of title 42,

the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) 1 respecting the designation of the drug.

(2) For purposes of paragraph (1), the term "rare disease or condition" means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made.

(b) Notification of discontinuance of drug or application as condition

A designation of a drug under subsection (a) shall be subject to the condition that—

(1) if an application was approved for the drug under section 355(b) of this title or a license was issued for the drug under section 262 of title 42, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and

(2) if an application has not been approved for the drug under section 355(b) of this title or a license has not been issued for the drug under section 262 of title 42 and if preclinical investigations or investigations under section 355(i) of this title are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 355(b) of this title or approval of a license under section 262 of title 42.

(c) Notice to public

Notice respecting the designation of a drug under subsection (a) shall be made available to the public.

(d) Regulations

The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

(June 25, 1938, ch. 675, §526, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–551, §4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99–91, §3(a)(2), Aug. 15, 1985, 99 Stat. 387; Pub. L. 100–290, §2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 105–115, title I, §125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 2326.)

Editorial Notes

References in Text

Subsection (b), referred to in subsec. (a)(1), was redesignated as subsec. (c) of this section by Pub. L. 100–290, §2(b), Apr. 18, 1988, 102 Stat. 90.

Amendments

1997—Subsec. (a)(1). Pub. L. 105–115, §125(b)(2)(H), struck out "the submission of an application for certification of the drug under section 357 of this title," before "or the submission of an application for licensing of the drug" in introductory provisions, inserted "or" at end of subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: "if a certification for such drug is issued under section 357 of this title, or".

Subsec. (b)(1). Pub. L. 105–115, §125(b)(2)(I)(i), struck out ", a certificate was issued for the drug under section 357 of this title," before "or a license was issued".

Subsec. (b)(2). Pub. L. 105–115, §125(b)(2)(I)(ii), struck out ", a certificate has not been issued for the drug under section 357 of this title," before "or a license has not been issued" and ", approval of an application for certification under section 357 of this title," before "or approval of a license".

1988—Subsec. (a)(1). Pub. L. 100–290, §2(a), inserted after first sentence "A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, the submission of an application for certification of the drug under section 357 of this title, or the submission of an application for licensing of the drug under section 262 of title 42."

Subsecs. (b) to (d). Pub. L. 100–290, §2(b), added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

1985—Subsec. (a)(1). Pub. L. 99–91 struck out "or" at end of subpar. (A), struck out subpar. (B) and substituted subpars. (B) and (C), and inserted ", certification," after "approval".

1984—Subsec. (a)(2). Pub. L. 98–551 substituted "which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which" for "which occurs so infrequently in the United States that".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

1 See References in Text note below.
21 U.S.C. § 612 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 612: Notification
Notification
Status: in_force

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

(Mar. 4, 1907, ch. 2907, title I, §12, as added Pub. L. 110–234, title XI, §11017(a), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, §4(a), title XI, §11017(a), June 18, 2008, 122 Stat. 1664, 2132.)

Editorial Notes

Codification

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

Prior Provisions

A prior section 612, acts Mar. 4, 1907, ch. 2907, title I, §12, formerly 10th par., 34 Stat. 1263; renumbered §12 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, related to inspection of animals for export, prior to repeal by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508. Section was formerly classified to section 80 of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.
21 U.S.C. § 2013 (2024) — Title 21: FOOD AND DRUGS / Chapter 25: MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS / Subchapter II: NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE / Section 2013: NMIC requirements and review
NMIC requirements and review
Status: in_force

(a) In general

The NMIC shall promote sharing information regarding successful law enforcement, treatment, environmental, prevention, social services, and other programs related to the production, use, or effects of methamphetamine and grants available for such programs.

(b) Components

The NMIC shall include—

(1) a toll-free number; and

(2) a website that provides a searchable database, which—

(A) provides information on the short-term and long-term effects of methamphetamine use;

(B) provides information regarding methamphetamine treatment and prevention programs and strategies and programs for drug endangered children, including descriptions of successful programs and strategies and contact information for such programs and strategies;

(C) provides information regarding grants for methamphetamine-related programs, including contact information and links to websites;

(D) allows a qualified entity to submit items to be posted on the website regarding successful public or private programs or other useful information related to the production, use, or effects of methamphetamine;

(E) includes a restricted section that may only be accessed by a law enforcement organization that contains successful strategies, training techniques, and other information that the Council determines helpful to law enforcement agency efforts to identify or combat the production, use, or effects of methamphetamine;

(F) allows public access to all information not in a restricted section; and

(G) contains any additional information the Council determines may be useful in identifying or combating the production, use, or effects of methamphetamine.

Thirty days after the website in paragraph (2) is operational, no funds shall be expended to continue the website methresources.gov.

(c) Review of posted information

(1) In general

Not later than 30 days after the date of submission of an item by a qualified entity, the Council shall review an item submitted for posting on the website described in subsection (b)(2)—

(A) to evaluate and determine whether the item, as submitted or as modified, meets the requirements for posting; and

(B) in consultation with the Attorney General, to determine whether the item should be posted in a restricted section of the website.

(2) Determination

Not later than 45 days after the date of submission of an item, the Council shall—

(A) post the item on the website described in subsection (b)(2); or

(B) notify the qualified entity that submitted the item regarding the reason such item shall not be posted and modifications, if any, that the qualified entity may make to allow the item to be posted.

(Pub. L. 109–469, title X, §1004, Dec. 29, 2006, 120 Stat. 3538.)
21 U.S.C. § 971 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 971: Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals
Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals
Status: in_force

(a) Notification prior to transaction

Each regulated person who imports or exports a listed chemical shall notify the Attorney General of the importation or exportation not later than 15 days before the transaction is to take place.

(b) Regular customers or importers

(1) The Attorney General shall provide by regulation for circumstances in which the requirement of subsection (a) does not apply to a transaction between a regulated person and a regular customer or to a transaction that is an importation by a regular importer. At the time of any importation or exportation constituting a transaction referred to in the preceding sentence, the regulated person shall notify the Attorney General of the transaction.

(2) The regulations under this subsection shall provide that the initial notification under subsection (a) with respect to a customer of a regulated person or to an importer shall, upon the expiration of the 15-day period, qualify the customer as a regular customer or the importer as a regular importer, unless the Attorney General otherwise notifies the regulated person in writing.

(c) Suspension of importation or exportation; disqualification of regular customers or importers; hearing

(1) The Attorney General may order the suspension of any importation or exportation of a listed chemical (other than a regulated transaction to which the requirement of subsection (a) does not apply by reason of subsection (b)) or may disqualify any regular customer or regular importer on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred). From and after the time when the Attorney General provides written notice of the order (including a statement of the legal and factual basis for the order) to the regulated person, the regulated person may not carry out the transaction.

(2) Upon written request to the Attorney General, a regulated person to whom an order applies under paragraph (1) is entitled to an agency hearing on the record in accordance with subchapter II of chapter 5 of title 5. The hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time, if so requested by the regulated person.

(d) Information required in notice; updated notice for change in circumstances

(1)(A) Information provided in a notice under subsection (a) or (b) shall include the name of the person to whom the importer or exporter involved intends to transfer the listed chemical involved, and the quantity of such chemical to be transferred.

(B) In the case of a notice under subsection (b) submitted by a regular importer, if the transferee identified in the notice is not a regular customer, such importer may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the notice is submitted to the Attorney General.

(C) After a notice under subsection (a) or (b) is submitted to the Attorney General, if circumstances change and the importer or exporter will not be transferring the listed chemical to the transferee identified in the notice, or will be transferring a greater quantity of the chemical than specified in the notice, the importer or exporter shall update the notice to identify the most recent prospective transferee or the most recent quantity or both (as the case may be) and may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the update is submitted to the Attorney General, except that such 15-day restriction does not apply if the prospective transferee identified in the update is a regular customer. The preceding sentence applies with respect to changing circumstances regarding a transferee or quantity identified in an update to the same extent and in the same manner as such sentence applies with respect to changing circumstances regarding a transferee or quantity identified in the original notice under subsection (a) or (b).

(D) In the case of a transfer of a listed chemical that is subject to a 15-day restriction under subparagraph (B) or (C), the transferee involved shall, upon the expiration of the 15-day period, be considered to qualify as a regular customer, unless the Attorney General otherwise notifies the importer or exporter involved in writing.

(2) With respect to a transfer of a listed chemical with which a notice or update referred to in paragraph (1) is concerned:

(A) The Attorney General, in accordance with the same procedures as apply under subsection (c)(2)—

(i) may order the suspension of the transfer of the listed chemical by the importer or exporter involved, except for a transfer to a regular customer, on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred), subject to the Attorney General ordering such suspension before the expiration of the 15-day period referred to in paragraph (1) with respect to the importation or exportation (in any case in which such a period applies); and

(ii) may, for purposes of clause (i) and paragraph (1), disqualify a regular customer on such ground.

(B) From and after the time when the Attorney General provides written notice of the order under subparagraph (A) (including a statement of the legal and factual basis for the order) to the importer or exporter, the importer or exporter may not carry out the transfer.

(3) For purposes of this subsection:

(A) The terms "importer" and "exporter" mean a regulated person who imports or exports a listed chemical, respectively.

(B) The term "transfer", with respect to a listed chemical, includes the sale of the chemical.

(C) The term "transferee" means a person to whom an importer or exporter transfers a listed chemical.

(e) Broker or trader for international transaction in listed chemical

A person located in the United States who is a broker or trader for an international transaction in a listed chemical that is a regulated transaction solely because of that person's involvement as a broker or trader shall, with respect to that transaction, be subject to all of the notification, reporting, recordkeeping, and other requirements placed upon exporters of listed chemicals by this subchapter and subchapter I.

(f) Application of notification requirement to exports of listed chemical; waiver

(1) The Attorney General may by regulation require that the 15-day notification requirement of subsection (a) apply to all exports of a listed chemical to a specified country, regardless of the status of certain customers in such country as regular customers, if the Attorney General finds that such notification is necessary to support effective chemical diversion control programs or is required by treaty or other international agreement to which the United States is a party.

(2) The Attorney General may by regulation waive the 15-day notification requirement for exports of a listed chemical to a specified country if the Attorney General determines that such notification is not required for effective chemical diversion control. If the notification requirement is waived, exporters of the listed chemical shall be required to submit to the Attorney General reports of individual exportations or periodic reports of such exportation of the listed chemical, at such time or times and containing such information as the Attorney General shall establish by regulation.

(3) The Attorney General may by regulation waive the 15-day notification requirement for the importation of a listed chemical if the Attorney General determines that such notification is not necessary for effective chemical diversion control. If the notification requirement is waived, importers of the listed chemical shall be required to submit to the Attorney General reports of individual importations or periodic reports of the importation of the listed chemical, at such time or times and containing such information as the Attorney General shall establish by regulation.

(g) Return declaration

Within 30 days after a transaction covered by this section is completed, the importer or exporter shall send the Attorney General a return declaration containing particulars of the transaction, including the date, quantity, chemical, container, name of transferees, and such other information as the Attorney General may specify in regulations. For importers, a single return declaration may include the particulars of both the importation and distribution. If the importer has not distributed all chemicals imported by the end of the initial 30-day period, the importer shall file supplemental return declarations no later than 30 days from the date of any further distribution, until the distribution or other disposition of all chemicals imported pursuant to the import notification or any update are accounted for.

(h) Importation and distribution of ephedrine, pseudoephedrine, or phenylpropanolamine

(1) With respect to a regulated person importing ephedrine, pseudoephedrine, or phenylpropanolamine (referred to in this section as an "importer"), a notice of importation under subsection (a) or (b) shall include all information known to the importer on the chain of distribution of such chemical from the manufacturer to the importer.

(2) For the purpose of preventing or responding to the diversion of ephedrine, pseudoephedrine, or phenylpropanolamine for use in the illicit production of methamphetamine, the Attorney General may, in the case of any person who is a manufacturer or distributor of such chemical in the chain of distribution referred to in paragraph (1) (which person is referred to in this subsection as a "foreign-chain distributor"), request that such distributor provide to the Attorney General information known to the distributor on the distribution of the chemical, including sales.

(3) If the Attorney General determines that a foreign-chain distributor is refusing to cooperate with the Attorney General in obtaining the information referred to in paragraph (2), the Attorney General may, in accordance with procedures that apply under subsection (c), issue an order prohibiting the importation of ephedrine, pseudoephedrine, or phenylpropanolamine in any case in which such distributor is part of the chain of distribution for such chemical. Not later than 60 days prior to issuing the order, the Attorney General shall publish in the Federal Register a notice of intent to issue the order. During such 60-day period, imports of the chemical with respect to such distributor may not be restricted under this paragraph.

(Pub. L. 91–513, title III, §1018, as added Pub. L. 100–690, title VI, §6053(a), Nov. 18, 1988, 102 Stat. 4314; amended Pub. L. 103–200, §§4(a), 5(a), 9(b), Dec. 17, 1993, 107 Stat. 2338–2340; Pub. L. 103–322, title XXXIII, §330024(c), Sept. 13, 1994, 108 Stat. 2150; Pub. L. 109–177, title VII, §§716(a), (b)(1)(B), 721, Mar. 9, 2006, 120 Stat. 265, 267.)

Editorial Notes

Amendments

2006—Subsec. (b)(1). Pub. L. 109–177, §716(a)(1), substituted "or to a transaction that is an importation by a regular importer" for "or to an importation by a regular importer".

Subsec. (c)(1). Pub. L. 109–177, §716(b)(1)(B), inserted "(without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred)" after "manufacture of a controlled substance".

Subsecs. (d) to (f). Pub. L. 109–177, §716(a)(2), (3), added subsec. (d) and redesignated former subsecs. (d) and (e) as (e) and (f), respectively.

Subsec. (g). Pub. L. 109–177, §716(a)(4), added subsec. (g).

Subsec. (h). Pub. L. 109–177, §721, added subsec. (h).

1994—Subsecs. (b)(1), (2), (c)(1). Pub. L. 103–322, §330024(c)(2), made technical amendment to directory language of Pub. L. 103–200, §9(b). See 1993 Amendment notes below.

Subsec. (e). Pub. L. 103–322, §330024(c)(1), made technical amendment to directory language of Pub. L. 103–200, §5(a). See 1993 Amendment note below.

1993—Subsec. (b)(1). Pub. L. 103–200, §9(b)(1)(A), as amended by Pub. L. 103–322, §330024(c)(2), substituted "to an importation by a regular importer" for "regular supplier of the regulated person".

Subsec. (b)(2). Pub. L. 103–200, §9(b)(1)(B), as amended by Pub. L. 103–322, §330024(c)(2), substituted "a customer of a regulated person or to an importer" for "a customer or supplier of a regulated person" and "the importer as a regular importer" for "regular supplier".

Subsec. (c)(1). Pub. L. 103–200, §9(b)(2), as amended by Pub. L. 103–322, §330024(c)(2), substituted "regular importer" for "regular supplier".

Subsec. (d). Pub. L. 103–200, §4(a), added subsec. (d).

Subsec. (e). Pub. L. 103–200, §5(a), as amended by Pub. L. 103–322, §330024(c)(1), added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

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

Effective Date

Pub. L. 100–690, title VI, §6053(b), Nov. 18, 1988, 102 Stat. 4315, provided that:

"(1) Not later than 45 days after the date of the enactment of this Act [Nov. 18, 1988], the Attorney General shall forward to the Director of the Office of Management and Budget proposed regulations required by the amendment made by subsection (a) [enacting this section].

"(2) Not later than 55 days after the date of the enactment of this Act, the Director of the Office of Management and Budget shall—

"(A) review such proposed regulations of the Attorney General; and

"(B) forward any comments and recommendations for modifications to the Attorney General.

"(3) Not later than 60 days after the date of the enactment of this Act, the Attorney General shall publish the proposed final regulations required by the amendment made by subsection (a).

"(4) Not later than 120 days after the date of the enactment of this Act, the Attorney General shall promulgate final regulations required by the amendment made by subsection (a).

"(5) Subsection (a) of section 1018 of the Controlled Substances Import and Export Act [subsection (a) of this section], as added by subsection (a) of this section, shall take effect 90 days after the promulgation of the final regulations under paragraph (4).

"(6) Each regulated person shall provide to the Attorney General the identity of any regular customer or regular supplier of the regulated person not later than 30 days after the promulgation of the final regulations under paragraph (4). Not later than 60 days after the end of such 30-day period, each regular customer and regular supplier so identified shall be a regular customer or regular supplier for purposes of any applicable exception from the requirement of subsection (a) of such section 1018, unless the the [sic] Attorney General otherwise notifies the regulated person in writing."

Section effective 120 days after Nov. 18, 1988 [except subsec. (a), see above], see section 6061 of Pub. L. 100–690, set out as an Effective Date of 1988 Amendment note under section 802 of this title.

Exception for Iodine to Importation and Exportation Requirements for Listed Chemicals

Pub. L. 104–237, title II, §204(b), Oct. 3, 1996, 110 Stat. 3102, provided that:

"(1) Iodine shall not be subject to the requirements for listed chemicals provided in section 1018 of the Controlled Substances Import and Export Act (21 U.S.C. 971).

"(2) Effect of Exception.—The exception made by paragraph (1) shall not limit the authority of the Attorney General to impose the requirements for listed chemicals provided in section 1018 of the Controlled Substances Import and Export Act (21 U.S.C. 971)."
21 U.S.C. § 360cc (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360cc: Protection for drugs for rare diseases or conditions
Protection for drugs for rare diseases or conditions
Status: in_force

(a) Exclusive approval, certification, or license

Except as provided in subsection (b), if the Secretary—

(1) approves an application filed pursuant to section 355 of this title, or

(2) issues a license under section 262 of title 42

for a drug designated under section 360bb of this title for a rare disease or condition, the Secretary may not approve another application under section 355 of this title or issue another license under section 262 of title 42 for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2) 1 of this title does not apply to the refusal to approve an application under the preceding sentence.

(b) Exceptions

During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if—

(1) the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or

(2) the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.

(c) Condition of clinical superiority

(1) In general

If a sponsor of a drug that is designated under section 360bb of this title and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.

(2) Definition

For purposes of paragraph (1), the term "clinically superior" with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.

(3) Applicability

This subsection applies to any drug designated under section 360bb of this title for which an application was approved under section 355 of this title or licensed under section 262 of title 42 after August 18, 2017, regardless of the date on which such drug was designated under section 360bb of this title.

(d) Regulations

The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on August 18, 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.

(e) Demonstration of clinical superiority standard

To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—

(1) upon the designation of any drug under section 360bb of this title, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and

(2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.

(June 25, 1938, ch. 675, §527, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–417, title I, §102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99–91, §§2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103–80, §3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title I, §125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107–281, §4, Nov. 6, 2002, 116 Stat. 1993; Pub. L. 115–52, title VI, §607(a), Aug. 18, 2017, 131 Stat. 1049; Pub. L. 116–260, div. BB, title III, §323, Dec. 27, 2020, 134 Stat. 2933.)

Editorial Notes

References in Text

Section 355(c)(2) of this title, referred to in subsec. (a), was redesignated as section 355(c)(1)(B) of this title by Pub. L. 98–417, title I, §102(a)(2), Sept. 24, 1984, 98 Stat. 1592.

This section, as amended by such Act, referred to in subsec. (d), means this section as amended by the FDA Reauthorization Act of 2017, Pub. L. 115–52.

Amendments

2020—Subsec. (c)(3). Pub. L. 116–260 added par. (3).

2017—Subsec. (a). Pub. L. 115–52, §607(a)(1), substituted "the same drug for the same disease or condition" for "such drug for such disease or condition" in concluding provisions.

Subsec. (b). Pub. L. 115–52, §607(a)(2)(A), in introductory provisions, substituted "During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if" for "If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if".

Subsec. (b)(1). Pub. L. 115–52, §607(a)(2)(B), substituted "of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure" for "notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure".

Subsec. (b)(2). Pub. L. 115–52, §607(a)(2)(C), substituted "the holder provides" for "such holder provides".

Subsecs. (c) to (e). Pub. L. 115–52, §607(a)(3), added subsecs. (c) to (e).

2002—Subsec. (a). Pub. L. 107–281, in concluding provisions, struck out ", of such certification," after "such approved application" and ", the issuance of the certification," after "approval of the approved application".

1997—Subsec. (a). Pub. L. 105–115, §125(b)(2)(J), struck out ", issue another certification under section 357 of this title," before "or issue another license" in closing provisions, inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: "issues a certification under section 357 of this title, or".

Subsec. (b). Pub. L. 105–115, §125(b)(2)(K), in introductory provisions, struck out ", if a certification is issued under section 357 of this title for such a drug," after "rare disease or condition", ", of the issuance of the certification under section 357 of this title," after "application approval", ", issue another certification under section 357 of this title," after "application under section 355 of this title", and ", of such certification," after "approved application".

Subsec. (b)(1). Pub. L. 105–115, §125(b)(2)(K), struck out ", of the certification," after "holder of the approved application".

Subsec. (b)(2). Pub. L. 105–115, §125(b)(2)(K), struck out ", issuance of other certifications," after "approval of other applications".

1993—Subsec. (b). Pub. L. 103–80 struck out extraneous comma before "or issue a license under section 262" in introductory provisions and substituted "the" for "The" at beginning of par. (1).

1985—Pub. L. 99–91, §2(3), struck out "unpatented" before "drugs" in section catchline.

Subsec. (a). Pub. L. 99–91, §§2(1), 3(a)(3)(A)–(D), struck out "or" at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out "and for which a United States Letter of Patent may not be issued" after "rare disease or condition", inserted in first sentence ", issue another certification under section 357 of this title," after "section 355 of this title" the second time it appeared, inserted ", of such certification," after "holder of such approved application", and inserted ", the issuance of the certification," after "approval of the approved application".

Subsec. (b). Pub. L. 99–91, §§2(2), 3(a)(3)(E)–(K), struck out "and if a United States Letter of Patent may not be issued for the drug" after "such a drug", substituted ", if a certification is issued under section 357 of this title for such a drug, or if a license" for "or a license", inserted ", of the issuance of the certification under section 357 of this title," after "application approval", struck out ", if the drug is a biological product," before "issue a license", inserted ", issue another certification under section 357 of this title," after "section 355 of this title", inserted ", of such certification," after "holder of such approved application", inserted ", of such certification," after "application" in par. (1), and inserted ", issuance of other certifications," after "other applications" in par. (2).

1984—Subsecs. (a), (b). Pub. L. 98–417 substituted "section 355" for "section 355(b)" wherever appearing.

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

Construction

Pub. L. 115–52, title VI, §607(b), Aug. 18, 2017, 131 Stat. 1050, provided that: "Nothing in the amendments made by subsection (a) [amending this section] shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017 [Aug. 18, 2017]."

1 See References in Text note below.
21 U.S.C. § 2109 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2109: Publication of annual reports
Publication of annual reports
Status: in_force

(a) In general

The Commissioner of Food and Drugs shall annually submit to Congress and publish on the Internet Web site of the Food and Drug Administration, a report concerning the results of the Administration's pesticide residue monitoring program, that includes—

(1) information and analysis similar to that contained in the report entitled "Food and Drug Administration Pesticide Program Residue Monitoring 2003" as released in June of 2005;

(2) based on an analysis of previous samples, an identification of products or countries (for imports) that require special attention and additional study based on a comparison with equivalent products manufactured, distributed, or sold in the United States (including details on the plans for such additional studies), including in the initial report (and subsequent reports as determined necessary) the results and analysis of the Ginseng Dietary Supplements Special Survey as described on page 13 of the report entitled "Food and Drug Administration Pesticide Program Residue Monitoring 2003";

(3) information on the relative number of interstate and imported shipments of each tested commodity that were sampled, including recommendations on whether sampling is statistically significant, provides confidence intervals or other related statistical information, and whether the number of samples should be increased and the details of any plans to provide for such increase; and

(4) a description of whether certain commodities are being improperly imported as another commodity, including a description of additional steps that are being planned to prevent such smuggling.

(b) Initial reports

Annual reports under subsection (a) for fiscal years 2004 through 2006 may be combined into a single report, by not later than June 1, 2008, for purposes of publication under subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data collected for the year that was 2-years prior to the year in which the report is published.

(c) Memorandum of understanding

The Commissioner of Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a) relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing Service on meat, poultry, eggs, and certain raw agricultural products, respectively.

(Pub. L. 110–85, title X, §1010, Sept. 27, 2007, 121 Stat. 970.)
21 U.S.C. § 379l (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379l: Education
Education
Status: in_force

(a) In general

The Secretary shall conduct training and education programs for the employees of the Food and Drug Administration relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under section 374 of this title;

(3) training to achieve product specialization in such inspections; and

(4) training in administrative process and procedure and integrity issues.

(b) Intramural fellowships and other training programs

The Secretary, acting through the Commissioner, may, through fellowships and other training programs, conduct and support intramural research training for predoctoral and postdoctoral scientists and physicians. Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.

(June 25, 1938, ch. 675, §746, formerly §742, as added Pub. L. 105–115, title IV, §408(a), Nov. 21, 1997, 111 Stat. 2371; amended Pub. L. 110–85, title VI, §601(c), Sept. 27, 2007, 121 Stat. 897; renumbered §746, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Editorial Notes

Prior Provisions

A prior section 746 of act June 25, 1938, was renumbered section 749 and is classified to section 379o of this title.

Amendments

2007—Subsec. (b). Pub. L. 110–85 inserted at end "Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services."

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.
21 U.S.C. § 364f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364f: Records
Records
Status: in_force

(a) In general

If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).

(b) Rule of construction

Nothing in this section shall be construed to limit the authority of the Secretary to inspect records or require establishment and maintenance of records under any other provision of this chapter, including section 364a or 364b of this title.

(June 25, 1938, ch. 675, §610, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5855.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 321a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter II: DEFINITIONS / Section 321a: "Butter" defined
"Butter" defined
Status: in_force

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

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

Editorial Notes

References in Text

The Food and Drug Act of June 30, 1906, referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.

Codification

Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to section 6 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that this section should remain in force and effect and be applicable to the provisions of this chapter.
21 U.S.C. § 301 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter I: SHORT TITLE / Section 301: Short title
Short title
Status: in_force

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

(June 25, 1938, ch. 675, §1, 52 Stat. 1040.)

Statutory Notes and Related Subsidiaries

Effective Date; Postponement in Certain Cases

Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:

"[Sec. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title].

"(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the effective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of this title] of such Act with respect to lithographed labeling which was manufactured prior to February 1, 1939, and to containers bearing labeling which, prior to February 1, 1939, was lithographed, etched, stamped, pressed, printed, fused or blown on or in such containers, where compliance with such provisions would be unduly burdensome by reason of causing the loss of valuable stocks of such labeling or containers, and where such postponement would not prevent the public interest being adequately served: Provided, That in no case shall such regulations apply to labeling which would not have complied with the requirements of the Food and Drugs Act of June 30, 1906, as amended.

"Sec. 2. (a) The provisions of section 8 [section 10 of this title], paragraph fifth, under the heading 'In the case of food:', of the Food and Drugs Act of June 30, 1906, as amended, and regulations promulgated thereunder, and all other provisions of such Act to the extent that they may relate to the enforcement of such section 8 [section 10 of this title] and of such regulations, shall remain in force until January 1, 1940.

"(b) The provisions of such Act of June 30, 1906, as amended, [sections 1 to 5, 7 to 15, and 372a of this title] to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this title], shall remain in force until January 1, 1940.

"(c) Notwithstanding the provisions of section 1 of this Act, such section shall not apply—

"(1) to the provisions of section 502(d) and (e) of the Federal Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar as such provisions relate to any substance named in section 8 [section 10 of this title], paragraph second, under the heading 'In the case of drugs:', of the Food and Drugs Act of June 30, 1906, as amended, or a derivative of any such substance; or

"(2) to the provisions of section 502(b), (d), (e), (f), (g), and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d) to (h) of this title], insofar as such provisions relate to drugs to which section 505 [355 of this title] of such Act applies."

Effective Date

Act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, provided that: "This Act [enacting this chapter and repealing sections 1 to 5 and 7 to 15 of this title], shall take effect twelve months after the date of its enactment [June 25, 1938]. The Federal Food and Drugs Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1–15), shall remain in force until such effective date, and, except as otherwise provided in this subsection, is hereby repealed effective upon such date: Provided, That the provisions of section 701 [section 371 of this title] shall become effective on the enactment of this Act, and thereafter the Secretary is authorized hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or after the effective date of this Act as the Secretary shall direct, and (2) designate prior to the effective date of this Act food having common or usual names and exempt such food from the requirements of clause (2) of section 403(i) [section 343(i) of this title] for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401 [section 341 of this title]: Provided further, That sections 502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively of this title], and all other provisions of this Act to the extent that they may relate to the enforcement of such sections, shall take effect on the date of the enactment of this Act, except that in the case of a cosmetic to which the proviso of section 601(a) [section 361(a) of this title], relates, such cosmetic shall not, prior to the ninetieth day after such date of enactment, be deemed adulterated by reason of the failure of its label to bear the legend prescribed in such proviso: Provided further, That the Act of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section 321a of this title]; 42 Stat. 1500, ch. 268), defining butter and providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1934 ed., title 21, sec. 10 [section 321b of this title]; 41 Stat. 271, ch. 26], defining wrapped meats as in package form; and the amendment to the Food and Drugs Act, section 10A, approved August 27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [section 372a of this title]) shall remain in force and effect and be applicable to the provisions of this Act."

Short Title of 2023 Amendment

Pub. L. 118–15, div. B, title III, §2301(a), Sept. 30, 2023, 137 Stat. 86, provided that: "This chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending sections 379j–11 to 379j–13 of this title, enacting provisions set out as notes under sections 379j–11 to 379j–13 of this title, and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2023'."

Pub. L. 118–15, div. B, title III, §2311(a), Sept. 30, 2023, 137 Stat. 90, provided that: "This chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending sections 379j–21 and 379j–22 of this title, enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Amendments of 2023'."

Short Title of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3001, Dec. 29, 2022, 136 Stat. 5807, provided that: "This title [see Tables for classification] may be cited as the 'Food and Drug Omnibus Reform Act of 2022'."

Pub. L. 117–328, div. FF, title III, §3501, Dec. 29, 2022, 136 Stat. 5847, provided that: "This subtitle [subtitle E (§§3501–3508), enacting sections 364 to 364j of this title, amending sections 331, 361, 362, 374, and 381 of this title, and enacting provisions set out as notes under sections 331, 364, 364d, and 364e of this title] may be cited as the 'Modernization of Cosmetics Regulation Act of 2022'."

Pub. L. 117–180, div. F, §1, Sept. 30, 2022, 136 Stat. 2139, provided that: "This division [see Tables for classification] may be cited as the 'FDA User Fee Reauthorization Act of 2022'."

Pub. L. 117–180, div. F, title I, §1001(a), Sept. 30, 2022, 136 Stat. 2140, provided that: "This title [amending sections 379g, 379h, and 379h–2 of this title, enacting notes set out under sections 379g and 379h–2 of this title, and repealing notes set out under sections 379g and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2022'."

Pub. L. 117–180, div. F, title II, §2001(a), Sept. 30, 2022, 136 Stat. 2147, provided that: "This title [amending sections 360d, 360m, and 379i to 379j–1 of this title, enacting notes set out under sections 360d, 379i, and 379j–1 of this title, and repealing provisions set out as notes under sections 379i and 379j–1 of this title] may be cited as the 'Medical Device User Fee Amendments of 2022'."

Pub. L. 117–180, div. F, title III, §3001(a), Sept. 30, 2022, 136 Stat. 2155, provided that: "This title [amending sections 379j–42 and 379j–43 of this title, enacting provisions set out as notes under sections 379j–41 and 379j–43 of this title, and repealing provisions set out as notes under sections 379j–41 and 379j–43 of this title] may be cited as the 'Generic Drug User Fee Amendments of 2022'."

Pub. L. 117–180, div. F, title IV, §4001(a), Sept. 30, 2022, 136 Stat. 2160, provided that: "This title [amending sections 379j–51 to 379j–53 of this title, enacting provisions set out as notes under sections 379j–51 and 379j–53 of this title, and repealing provisions set out as notes under sections 379j–51 and 379j–53 of this title] may be cited as the 'Biosimilar User Fee Amendments of 2022'."

Pub. L. 117–101, §1, Mar. 15, 2022, 136 Stat. 47, provided that: "This Act [amending section 379dd of this title and section 290b of Title 42, The Public Health and Welfare] may be cited as the 'Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act'."

Short Title of 2021 Amendment

Pub. L. 117–79, §1, Dec. 23, 2021, 135 Stat. 1533, provided that: "This Act [enacting section 360ee–1 of this title, section 280g–7b of Title 42, The Public Health and Welfare, and provisions set out as notes under sections 360aa and 360ee of this title] may be cited as the 'Accelerating Access to Critical Therapies for ALS Act'."

Pub. L. 117–11, §1, Apr. 23, 2021, 135 Stat. 262, provided that: "This Act [amending section 321 of this title and enacting provisions set out as a note under section 321 of this title] may be cited as the 'Food Allergy Safety, Treatment, Education, and Research Act of 2021' or the 'FASTER Act of 2021'."

Pub. L. 116–304, §1, Jan. 5, 2021, 134 Stat. 4915, provided that: "This Act [amending sections 321 and 381 of this title] may be cited as the 'Safeguarding Therapeutics Act'."

Pub. L. 116–290, §1, Jan. 5, 2021, 134 Stat. 4889, provided that: "This Act [amending section 355 of this title and enacting provisions set out as a note under section 355 of this title] may be cited as the 'Orange Book Transparency Act of 2020'."

Short Title of 2018 Amendment

Pub. L. 115–271, §1(a), Oct. 24, 2018, 132 Stat. 3894, provided that: "This Act [see Tables for classification] may be cited as the 'Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act' or the 'SUPPORT for Patients and Communities Act'."

Pub. L. 115–271, title III, §3011, Oct. 24, 2018, 132 Stat. 3935, provided that: "This chapter [chapter 2 (§§3011–3014) of subtitle A of title III of Pub. L. 115–271, enacting sections 360bbb–8d and 384f of this title, amending sections 331 and 381 of this title, and enacting provisions set out as a note under section 331 of this title] may be cited as the 'Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act' or the 'SCREEN Act'."

Pub. L. 115–271, title III, §3021, Oct. 24, 2018, 132 Stat. 3938, provided that: "This chapter [chapter 3 (§§3021, 3022) of subtitle A of title III of Pub. L. 115–271, enacting section 384g of this title and amending sections 331, 335a, and 381 of this title] may be cited as the 'Stop Illicit Drug Importation Act of 2018'."

Pub. L. 115–271, title III, §3031, Oct. 24, 2018, 132 Stat. 3940, provided that: "This chapter [chapter 4 (§§3031, 3032) of subtitle A of title III of Pub. L. 115–271, amending section 355–1 of this title] may be cited as the 'Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018' or the 'SOUND Disposal and Packaging Act'."

Pub. L. 115–234, §1, Aug. 14, 2018, 132 Stat. 2427, provided that: "This Act [amending sections 348, 352, 360b, 360ccc, 360ccc–1, 379j–11 to 379j–13, 379–21, 379j–22, and 2102 of this title, enacting provisions set out as notes under this section and sections 348, 352, 360b, 360ccc–1, 379j–11 to 379j–13, 379j–21, and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–12, 379j–13, 379j–21, and 379j–22 of this title] may be cited as the 'Animal Drug and Animal Generic Drug User Fee Amendments of 2018'."

Pub. L. 115–234, title I, §101(a), Aug. 14, 2018, 132 Stat. 2428, provided that: "This title [amending sections 379j–11 to 379j–13 of this title, enacting provisions set out as notes under sections 379j–11 to 379j–13 of this title, and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2018'."

Pub. L. 115–234, title II, §201(a), Aug. 14, 2018, 132 Stat. 2432, provided that: "This title [amending sections 379j–21 and 379j–22 of this title, enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Amendments of 2018'."

Pub. L. 115–176, §1, May 30, 2018, 132 Stat. 1372, provided that: "This Act [enacting section 360bbb–0a of this title and provisions set out as a note under section 360bbb–0a of this title] may be cited as the 'Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017'."

Short Title of 2017 Amendment

Pub. L. 115–52, §1, Aug. 18, 2017, 131 Stat. 1005, provided that: "This Act [see Tables for classification] may be cited as the 'FDA Reauthorization Act of 2017'."

Pub. L. 115–52, title I, §101(a), Aug. 18, 2017, 131 Stat. 1006, provided that: "This title [amending sections 379h, 379h–2, and 379j–12 of this title, enacting provisions set out as notes under sections 379g and 379h–2 of this title, and repealing provisions set out as notes under sections 379g and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2017'."

Pub. L. 115–52, title II, §201(a), Aug. 18, 2017, 131 Stat. 1013, provided that: "This title [amending sections 360d, 360e, 360m, 379d–3, 379i, 379j, 379j–1, and 379k–1 of this title, enacting provisions set out as notes under sections 379i and 379j–1 of this title, and repealing provisions set out as a note under section 379i of this title] may be cited as the 'Medical Device User Fee Amendments of 2017'."

Pub. L. 115–52, title III, §301(a), Aug. 18, 2017, 131 Stat. 1020, provided that: "This title [amending sections 379j–41 to 379j–43 of this title, enacting provisions set out as notes under sections 379j–41 and 379j–43 of this title, and repealing provisions set out as notes under sections 379j–41 and 379j–43 of this title] may be cited as the 'Generic Drug User Fee Amendments of 2017'."

Pub. L. 115–52, title IV, §401(a), Aug. 18, 2017, 131 Stat. 1028, provided that: "This title [amending sections 379j–51 to 379j–53 of this title, enacting provisions set out as notes under sections 379j–51 and 379j–53 of this title, and repealing provisions set out as notes under sections 379j–51 and 379j–53 of this title] may be cited as the 'Biosimilar User Fee Amendments of 2017'."

Short Title of 2016 Amendment

Pub. L. 114–229, §1, Sept. 30, 2016, 130 Stat. 943, provided that: "This Act [amending section 360ff of this title and enacting provisions set out as a note under section 360ff of this title] may be cited as the 'Advancing Hope Act of 2016'."

Pub. L. 114–146, §1, Apr. 19, 2016, 130 Stat. 357, provided that: "This Act [amending section 360n of this title] may be cited as the 'Adding Zika Virus to the FDA Priority Review Voucher Program Act'."

Short Title of 2015 Amendment

Pub. L. 114–114, §1, Dec. 28, 2015, 129 Stat. 3129, provided that: "This Act [amending section 331 of this title and enacting provisions set out as notes under section 331 of this title] may be cited as the 'Microbead-Free Waters Act of 2015'."

Pub. L. 114–89, §1, Nov. 25, 2015, 129 Stat. 698, provided that: "This Act [amending sections 355, 360b, 360ccc to 360ccc–2, 811, 823, and 953 of this title, section 156 of Title 35, Patents, and section 262 of Title 42, The Public Health and Welfare] may be cited as the 'Improving Regulatory Transparency for New Medical Therapies Act'."

Short Title of 2014 Amendment

Pub. L. 113–233, §1, Dec. 16, 2014, 128 Stat. 2127, provided that: "This Act [amending section 360n of this title] may be cited as the 'Adding Ebola to the FDA Priority Review Voucher Program Act'."

Pub. L. 113–195, §1, Nov. 26, 2014, 128 Stat. 2035, provided that: "This Act [enacting part I of subchapter V of this chapter and provisions set out as a note under section 360fff of this title] may be cited as the 'Sunscreen Innovation Act'."

Short Title of 2013 Amendment

Pub. L. 113–54, §1, Nov. 27, 2013, 127 Stat. 587, provided that: "This Act [enacting part H of subchapter V and subpart 9 of part C of subchapter VII of this chapter and sections 353a–1 and 353b of this title, amending sections 331, 333, 352 to 353a, 353b, 353c, and 360eee–1 of this title, and enacting provisions set out as notes under this section and sections 331, 333, and 353 of this title] may be cited as the 'Drug Quality and Security Act'."

Pub. L. 113–54, title I, §101, Nov. 27, 2013, 127 Stat. 587, provided that: "This Act [probably means "This title", enacting subpart 9 of part C of subchapter VII of this chapter and sections 353a–1 and 353b of this title, amending sections 331, 352, 353a, 353b, and 353c of this title, and enacting provisions set out as notes under this section and section 331 of this title] may be cited as the 'Compounding Quality Act'."

Pub. L. 113–54, title II, §201, Nov. 27, 2013, 127 Stat. 599, provided that: "This title [enacting part H of subchapter V of this chapter, amending sections 331, 333, 352, 353, and 360eee–1 of this title, and enacting provisions set out as notes under sections 331, 333, and 353 of this title] may be cited as the 'Drug Supply Chain Security Act'."

Pub. L. 113–14, §1, June 13, 2013, 127 Stat. 451, provided that: "This Act [amending sections 379j–11 to 379j–13, 379j–21, and 379j–22 of this title, enacting provisions set out as notes under this section and sections 379j–11 to 379j–13, 379j–21, and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–11, 379j–21, and 379j–22 of this title] may be cited as the 'Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013'."

Pub. L. 113–14, title I, §101(a), June 13, 2013, 127 Stat. 451, provided that: "This title [amending sections 379j–11 to 379j–13 of this title, enacting provisions set out as notes under sections 379j–11 to 379j–13 of this title, and repealing provisions set out as notes under section 379j–11 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2013'."

Pub. L. 113–14, title II, §201(a), June 13, 2013, 127 Stat. 464, provided that: "This title [amending sections 379j–21 and 379j–22 of this title, enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Amendments of 2013'."

Short Title of 2012 Amendment

Pub. L. 112–193, §1, Oct. 5, 2012, 126 Stat. 1443, provided that: "This Act [amending sections 352, 379j, and 379j–42 of this title and enacting provisions set out as a note under section 379j–42 of this title] may be cited as the 'FDA User Fee Corrections Act of 2012'."

Pub. L. 112–144, §1, July 9, 2012, 126 Stat. 993, provided that: "This Act [see Tables for classification] may be cited as the 'Food and Drug Administration Safety and Innovation Act'."

Pub. L. 112–144, title I, §101(a), July 9, 2012, 126 Stat. 996, provided that: "This title [amending sections 379g, 379h, and 379h–2 of this title, enacting provisions set out as notes under sections 379g and 379h–2 of this title, and repealing provisions set out as notes under sections 379g and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2012'."

Pub. L. 112–144, title II, §201(a), July 9, 2012, 126 Stat. 1002, provided that: "This title [enacting section 379d–3 of this title, amending sections 360e, 379i, 379j, and 379j–1 of this title, enacting provisions set out as notes under section 379i of this title, and repealing provisions set out as notes under section 379i of this title] may be cited as the 'Medical Device User Fee Amendments of 2012'."

Pub. L. 112–144, title III, §301(a), July 9, 2012, 126 Stat. 1008, provided that: "This title [enacting sections 379d–4 and 379j–41 to 379j–43 of this title, amending sections 352 and 379d–3 of this title, and enacting provisions set out as notes under sections 379j–41 and 379j–43 of this title] may be cited as the 'Generic Drug User Fee Amendments of 2012'."

Pub. L. 112–144, title IV, §401(a), July 9, 2012, 126 Stat. 1026, provided that: "This title [enacting sections 379j–51 to 379j–53 of this title, amending sections 379d–4 and 379g of this title, and enacting provisions set out as notes under sections 379g, 379j–51, and 379j–53 of this title] may be cited as the 'Biosimilar User Fee Act of 2012'."

Short Title of 2009 Amendment

Pub. L. 111–31, div. A, §1(a), June 22, 2009, 123 Stat. 1776, provided that: "This division [enacting subchapter IX of this chapter, amending sections 321, 331, 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 391 to 393, 394 to 399a, and 679 of this title and sections 1333, 1334, 4402, 4406, and 4408 of Title 15, Commerce and Trade, enacting provisions set out as notes under sections 331, 333, 387, and 387c of this title and sections 1333 and 4402 of Title 15, and amending provisions set out as notes under this section and section 392 of this title] may be cited as the 'Family Smoking Prevention and Tobacco Control Act'."

Short Title of 2008 Amendment

Pub. L. 110–316, title I, §101(a), Aug. 14, 2008, 122 Stat. 3509, provided that: "This title [enacting section 379j–13 of this title, amending sections 360b, 379j–11, and 379j–12 of this title, and enacting provisions set out as notes under sections 360b and 379j–11 of this title] may be cited as the 'Animal Drug User Fee Amendments of 2008'."

Pub. L. 110–316, title II, §201(a), Aug. 14, 2008, 122 Stat. 3515, provided that: "This title [enacting sections 379j–21 and 379j–22 of this title, amending sections 379k, 379l, and 379o of this title, and enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title] may be cited as the 'Animal Generic Drug User Fee Act of 2008'."

Short Title of 2007 Amendment

Pub. L. 110–85, §1, Sept. 27, 2007, 121 Stat. 823, provided that: "This Act [enacting part I of subchapter VII of this chapter, chapter 26 of this title, sections 350f, 353b, 355–1, 355d, 355e, 360a, 360e–1, 360n, 360bbb–5, 360bbb–6, 379d–1, 379d–2, 379h–1, 379h–2, 379j–1, and 399a of this title, and section 247d–5a of Title 42, The Public Health and Welfare, amending sections 321, 331, 333, 334, 352, 355, 355a, 355c, 360, 360e, 360i, 360j, 360l, 360m, 360ee, 374, 379g, 379h, 379i, 379j, 379j–11, 379l, 381, and 393a of this title and sections 247d–3b, 262, 282, 283, 283a–2, 283a–3, 284m, 285g–10, 288–6, and 290b of Title 42, enacting provisions set out as notes under this section and sections 331, 350f, 352, 355, 355a, 355c, 360j, 379g, 379h, 379h–2, 379i, and 2110 of this title and section 282 of Title 42, and amending provisions set out as notes under section 284m of Title 42] may be cited as the 'Food and Drug Administration Amendments Act of 2007'."

Pub. L. 110–85, title I, §101(a), Sept. 27, 2007, 121 Stat. 825, provided that: "This title [enacting sections 379h–1 and 379h–2 of this title, amending sections 379g, 379h, and 379j–11 of this title, and enacting provisions set out as notes under sections 379g, 379h, and 379h–2 of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2007'."

Pub. L. 110–85, title II, §201(a), Sept. 27, 2007, 121 Stat. 842, provided that: "This title [enacting section 379j–1 of this title, amending sections 333, 360, 360i, 360m, 374, 379i, and 379j of this title, and enacting provisions set out as notes under section 379i of this title] may be cited as the 'Medical Device User Fee Amendments of 2007'."

Pub. L. 110–85, title III, §301, Sept. 27, 2007, 121 Stat. 859, provided that: "This title [enacting section 360e–1 of this title, amending sections 360j, 360l, and 393a of this title and section 282 of Title 42, The Public Health and Welfare, enacting provisions set out as notes under section 360j of this title and section 282 of Title 42, and amending provisions set out as a note under section 284m of Title 42] may be cited as the 'Pediatric Medical Device Safety and Improvement Act of 2007'."

Pub. L. 110–85, title IV, §401, Sept. 27, 2007, 121 Stat. 866, provided that: "This title [enacting section 355d of this title, amending section 355c of this title, and enacting provisions set out as a note under section 355c of this title] may be cited as the 'Pediatric Research Equity Act of 2007'."

Pub. L. 110–85, title V, §501, Sept. 27, 2007, 121 Stat. 876, provided that: "This title [amending section 355a of this title and sections 284m, 285g–10, 288–6, and 290b of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section 355a of this title, and amending provisions set out as a note under section 284m of Title 42] may be cited as the 'Best Pharmaceuticals for Children Act of 2007'."

Short Title of 2006 Amendment

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

Short Title of 2005 Amendments

Pub. L. 109–59, title VII, §7201, Aug. 10, 2005, 119 Stat. 1911, provided that: "This subtitle [subtitle B (§§7201–7204) of title VII of Pub. L. 109–59, enacting section 350e of this title, amending sections 331, 342, and 373 of this title and section 5701 of Title 49, Transportation, omitting sections 5702 to 5714 of Title 49, and enacting provisions set out as a note under section 331 of this title] may be cited as the 'Sanitary Food Transportation Act of 2005'."

Pub. L. 109–43, §1, Aug. 1, 2005, 119 Stat. 439, provided that: "This Act [amending sections 352 and 379j of this title, enacting provisions set out as a note under section 352 of this title, and amending provisions set out as notes under sections 352 and 379i of this title] may be cited as the 'Medical Device User Fee Stabilization Act of 2005'."

Short Title of 2004 Amendments

Pub. L. 108–282, title I, §101, Aug. 2, 2004, 118 Stat. 891, provided that: "This title [enacting sections 360ccc to 360ccc–2 of this title, amending sections 321, 331, 352, 353, 354, and 360b of this title, enacting provisions set out as notes under sections 360ccc and 393 of this title, and amending provisions set out as a note under section 360b of this title] may be cited as the 'Minor Use and Minor Species Animal Health Act of 2004'."

Pub. L. 108–282, title II, §201, Aug. 2, 2004, 118 Stat. 905, provided that: "This title [enacting section 374a of this title and section 242r of Title 42, The Public Health and Welfare, amending sections 321, 343, and 343–1 of this title, and enacting provisions set out as notes under sections 321 and 343 of this title and sections 243 and 300d–2 of Title 42] may be cited as the 'Food Allergen Labeling and Consumer Protection Act of 2004'."

Pub. L. 108–214, §1, Apr. 1, 2004, 118 Stat. 572, provided that: "This Act [amending sections 331, 352, 360, 360e, 374, 379i, and 379j of this title and provisions set out as notes under sections 352, 360l, and 379j of this title] may be cited as the 'Medical Devices Technical Corrections Act'."

Short Title of 2003 Amendments

Pub. L. 108–155, §1, Dec. 3, 2003, 117 Stat. 1936, provided that: "This Act [enacting section 355c of this title, amending sections 355, 355a, and 355b of this title and sections 262 and 284m of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section 355c of this title, and amending provisions set out as notes under section 355a of this title and section 284m of Title 42] may be cited as the 'Pediatric Research Equity Act of 2003'."

Pub. L. 108–130, §1, Nov. 18, 2003, 117 Stat. 1361, provided that: "This Act [enacting sections 379j–11 and 379j–12 of this title and provisions set out as notes under section 379j–11 of this title] may be cited as the 'Animal Drug User Fee Act of 2003'."

Short Title of 2002 Amendments

Pub. L. 107–281, §1, Nov. 6, 2002, 116 Stat. 1992, provided that: "This Act [amending sections 360cc and 360ee of this title and enacting provisions set out as a note under section 360ee of this title] may be cited as the 'Rare Diseases Orphan Product Development Act of 2002'."

Pub. L. 107–250, §1(a), Oct. 26, 2002, 116 Stat. 1588, provided that: "This Act [enacting sections 379i and 379j of this title and section 289g–3 of Title 42, The Public Health and Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360, 360c, 360e, 360m, and 374 of this title, and enacting provisions set out as notes under sections 352, 360e, 360j, 360l, 379i, and 379j of this title and section 289g–3 of Title 42] may be cited as the 'Medical Device User Fee and Modernization Act of 2002'."

Pub. L. 107–188, title V, §501, June 12, 2002, 116 Stat. 687, provided that: "This subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending sections 356b, 379g, and 379h of this title and enacting provisions set out as notes under sections 356b and 379g of this title] may be cited as the 'Prescription Drug User Fee Amendments of 2002'."

Pub. L. 107–109, §1, Jan. 4, 2002, 115 Stat. 1408, provided that: "This Act [enacting sections 355b and 393a of this title and section 284m of Title 42, The Public Health and Welfare, amending sections 321, 355, 355a, and 379h of this title and sections 282, 284k, 284l, 285a–2, and 290b of Title 42, and enacting provisions set out as notes under sections 355 and 355a of this title and sections 284m and 289 of Title 42] may be cited as the 'Best Pharmaceuticals for Children Act'."

Short Title of 2000 Amendment

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

Pub. L. 106–387, §1(a) [title VII, §746(a)], Oct. 28, 2000, 114 Stat. 1549, 1549A–40, provided that: "This section [amending section 381 of this title and enacting provisions set out as a note under section 381 of this title] may be cited as the 'Prescription Drug Import Fairness Act of 2000'."

Short Title of 1998 Amendment

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

Short Title of 1997 Amendment

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

Short Title of 1996 Amendments

Pub. L. 104–250, §1(a), Oct. 9, 1996, 110 Stat. 3151, provided that: "This Act [enacting section 354 of this title, amending sections 331, 353, and 360b of this title, and enacting provisions set out as notes under section 360b of this title] may be cited as the 'Animal Drug Availability Act of 1996'."

Pub. L. 104–170, title IV, §401(a), Aug. 3, 1996, 110 Stat. 1513, provided that: "This title [amending sections 321, 331, 333, 342, and 346a of this title] may be cited as the 'Food Quality Protection Act of 1996'."

[Another "Food Quality Protection Act of 1996", was enacted by Pub. L. 104–170, §1, 110 Stat. 1489, which is set out as a note under section 136 of Title 7, Agriculture.]

Pub. L. 104–134, title II, §2101(a), Apr. 26, 1996, 110 Stat. 1321–313, provided that: "This chapter [chapter 1A (§§2101–2105) of title II of Pub. L. 104–134, enacting section 382 of this title and amending sections 331 and 381 of this title and section 262 of Title 42, The Public Health and Welfare] may be cited as the 'FDA Export Reform and Enhancement Act of 1996'."

Short Title of 1994 Amendments

Pub. L. 103–417, §1(a), Oct. 25, 1994, 108 Stat. 4325, provided that: "This Act [enacting sections 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and Welfare, amending sections 321, 331, 342, 343, and 350 of this title and section 281 of Title 42, and enacting provisions set out as notes under sections 321 and 343 of this title] may be cited as the 'Dietary Supplement Health and Education Act of 1994'."

Pub. L. 103–396, §1, Oct. 22, 1994, 108 Stat. 4153, provided that: "This Act [amending sections 331, 343–1, 360b, and 371 of this title and enacting provisions set out as notes under section 360b of this title] may be cited as the 'Animal Medicinal Drug Use Clarification Act of 1994'."

Short Title of 1993 Amendment

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

Short Title of 1992 Amendments

Pub. L. 102–571, title I, §101(a), Oct. 29, 1992, 106 Stat. 4491, provided that: "This title [enacting sections 379g and 379h of this title, transferring sections 372a, 376, and 379c of this title to sections 376, 379e and 379f, respectively, of this title, amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361, 362, 453, 601, and 1033 of this title, enacting provisions set out as notes under section 379g of this title, and amending provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the 'Prescription Drug User Fee Act of 1992'."

Pub. L. 102–571, title II, §201, Oct. 29, 1992, 106 Stat. 4500, provided that: "This title [enacting provisions set out as notes under sections 343 and 393 of this title and amending provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the 'Dietary Supplement Act of 1992'."

Pub. L. 102–353, §1(a), Aug. 26, 1992, 106 Stat. 941, provided that: "This Act [amending sections 333, 353, and 381 of this title and enacting provisions set out as a note under section 353 of this title] may be cited as the 'Prescription Drug Amendments of 1992'."

Pub. L. 102–300, §1(a), June 16, 1992, 106 Stat. 238, provided that: "This Act [amending sections 321, 331, 334, 346a, 352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to 372a, 376, and 381 of this title and section 262 of Title 42, The Public Health and Welfare and enacting and amending provisions set out as notes under section 360i of this title] may be cited as the 'Medical Device Amendments of 1992'."

Pub. L. 102–282, §1(a), May 13, 1992, 106 Stat. 149, provided that: "This Act [enacting sections 335a to 335c of this title, amending sections 321, 336, 337, and 355 of this title, and enacting provisions set out as notes under section 335a of this title] may be cited as the 'Generic Drug Enforcement Act of 1992'."

Short Title of 1990 Amendments

Pub. L. 101–635, §1(a), Nov. 28, 1990, 104 Stat. 4583, provided that: "This Act [enacting sections 379b to 379d and 394 of this title] may be cited as the 'Food and Drug Administration Revitalization Act'."

Pub. L. 101–629, §1(a), Nov. 28, 1990, 104 Stat. 4511, provided that: "This Act [enacting sections 360l and 383 of this title, amending sections 321, 333, 351, 353, and 360c to 360j of this title and sections 263b to 263n of Title 42, The Public Health and Welfare, redesignating sections 263b to 263n of Title 42 as sections 360gg to 360ss of this title, repealing section 263b of Title 42, and enacting provisions set out as notes under sections 333, 360c, 360i, 360j, 360hh and 383 of this title] may be cited as the 'Safe Medical Devices Act of 1990'."

Pub. L. 101–535, §1(a), Nov. 8, 1990, 104 Stat. 2353, provided that: "This Act [enacting section 343–1 of this title, amending sections 321, 337, 343, 345, and 371 of this title, and enacting provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the 'Nutrition Labeling and Education Act of 1990'."

Short Title of 1988 Amendments

Pub. L. 100–670, §1(a), Nov. 16, 1988, 102 Stat. 3971, provided that: "This Act [amending sections 321, 353, and 360b of this title, section 2201 of Title 28, Judiciary and Judicial Procedure, and sections 156 and 271 of Title 35, Patents, and enacting provisions set out as notes under section 360b of this title] may be cited as the 'Generic Animal Drug and Patent Term Restoration Act'."

Pub. L. 100–607, title V, §501, Nov. 4, 1988, 102 Stat. 3120, provided that: "This title [enacting section 393 of this title, amending sections 5315 and 5316 of Title 5, Government Organization and Employees, and enacting provisions set out as notes under section 393 of this title] may be cited as the 'Food and Drug Administration Act of 1988'."

Pub. L. 100–293, §1(a), Apr. 22, 1988, 102 Stat. 95, provided that: "This Act [amending sections 331, 333, 353, and 381 of this title and enacting provisions set out as notes under section 353 of this title] may be cited as the 'Prescription Drug Marketing Act of 1987'."

Pub. L. 100–290, §1, Apr. 18, 1988, 102 Stat. 90, provided that: "This Act [amending sections 360bb and 360ee of this title, enacting provisions set out as a note under section 360aa of this title, and amending provisions set out as a note under section 236 of Title 42, The Public Health and Welfare] may be cited as the 'Orphan Drug Amendments of 1988'."

Short Title of 1986 Amendment

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

Short Title of 1985 Amendment

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

Short Title of 1984 Amendment

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

Short Title of 1983 Amendments

Pub. L. 98–22, §1, Apr. 22, 1983, 97 Stat. 173, provided: "That this Act [amending provisions set out as a note under section 348 of this title] may be cited as the 'Saccharin Study and Labeling Act Amendment of 1983'."

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

Short Title of 1981 Amendment

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

Short Title of 1980 Amendment

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

Short Title of 1977 Amendment

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

Short Title of 1976 Amendment

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

Short Title of 1972 Amendment

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

Short Title of 1968 Amendments

Pub. L. 90–602, §1, Oct. 18, 1968, 82 Stat. 1173, provided that: "This Act [enacting provisions now comprising part C (§§360hh–360ss) of subchapter III of this chapter and provisions set out as notes under section 360hh of this title] may be cited as the 'Radiation Control for Health and Safety Act of 1968'."

Pub. L. 90–399, §1, July 13, 1968, 82 Stat. 342, provided: "That this Act [enacting section 360b of this title, amending sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title, and enacting provisions set out as a note under section 360b of this title] may be cited as the 'Animal Drug Amendments of 1968'."

Short Title of 1965 Amendment

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

Short Title of 1962 Amendment

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

Short Title of 1960 Amendment

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

Short Title of 1958 Amendment

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

Severability

Pub. L. 113–54, title I, §106(b), Nov. 27, 2013, 127 Stat. 598, provided that: "If any provision of this Act [see Short Title of 2013 Amendment note above] (including the amendments made by this Act) is declared unconstitutional, or the applicability of this Act (including the amendments made by this Act) to any person or circumstance is held invalid, the constitutionality of the remainder of this Act (including the amendments made by this Act) and the applicability thereof to other persons and circumstances shall not be affected."

Pub. L. 110–85, title XI, §1105, Sept. 27, 2007, 121 Stat. 975, provided that: "If any provision of this Act [see Short Title of 2007 Amendment note above], an amendment made [by] this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or circumstances shall not be affected thereby."

Hazardous Substances

Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86–613, §18, July 12, 1960, 74 Stat. 380, set out as an Effect Upon Federal and State Laws note under section 1261 of Title 15, Commerce and Trade.
21 U.S.C. § 379 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379: Confidential information
Confidential information
Status: in_force

(a) Contractors

The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in connection with an activity which is undertaken under contract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or employee of the Department) is not prohibited from using such information. The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may by regulation prescribe.

(b) Ability to receive and protect confidential information obtained from foreign governments

(1) In general

The Secretary shall not be required to disclose under section 552 of title 5 (commonly referred to as the "Freedom of Information Act"), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—

(A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;

(B) the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and

(C) the information is covered by, and subject to, a written agreement between the Secretary and the foreign government.

(2) Time limitations

The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.

(3) Disclosures not affected

Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.

(4) Relation to other law

For purposes of section 552 of title 5, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552.

(c) Authority to enter into memoranda of understanding for purposes of information exchange

The Secretary may enter into written agreements to provide information referenced in section 331(j) of this title to foreign governments subject to the following criteria:

(1) Certification

The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.

(2) Written agreement

The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 247d of title 42 that is relevant to the information.

(3) Information exchange

The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 331(j) of this title in only the following circumstances:

(A) Information concerning the inspection of a facility may be provided to a foreign government if—

(i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and

(ii) the written agreement executed under paragraph (2) limits the recipient's use of the information to the recipient's civil regulatory purposes.

(B) Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

(4) Effect of subsection

Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.

(June 25, 1938, ch. 675, §708, as added Pub. L. 94–295, §8, May 28, 1976, 90 Stat. 582; amended Pub. L. 112–144, title VII, §710, July 9, 2012, 126 Stat. 1070.)

Editorial Notes

Amendments

2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).
21 U.S.C. § 399 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399: Grants to enhance food safety
Grants to enhance food safety
Status: in_force

(a) In general

The Secretary is authorized to make grants to eligible entities to—

(1) undertake examinations, inspections, and investigations, and related food safety activities under section 372 of this title;

(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments;

(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases;

(4) build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application; and

(5) take appropriate action to protect the public health in response to—

(A) a notification under section 398 of this title, including planning and otherwise preparing to take such action; or

(B) a recall of food under this chapter.

(b) Eligible entities; application

(1) In general

In this section, the term "eligible entity" means an entity—

(A) that is—

(i) a State;

(ii) a locality;

(iii) a territory;

(iv) an Indian tribe (as defined in section 5304(e) of title 25); or

(v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and

(B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(2) Contents

Each application submitted under paragraph (1) shall include—

(A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a);

(B) a description of the types of activities to be funded by the grant;

(C) an itemization of how grant funds received under this section will be expended;

(D) a description of how grant activities will be monitored; and

(E) an agreement by the eligible entity to report information required by the Secretary to conduct evaluations under this section.

(c) Limitations

The funds provided under subsection (a) shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any grant under this section in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.

(d) Additional authority

The Secretary may—

(1) award a grant under this section in each subsequent fiscal year without reapplication for a period of not more than 3 years, provided the requirements of subsection (c) are met for the previous fiscal year; and

(2) award a grant under this section in a fiscal year for which the requirement of subsection (c) has not been met only if such requirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating circumstances that the Secretary may determine appropriate.

(e) Duration of awards

The Secretary may award grants to an individual grant recipient under this section for periods of not more than 3 years. In the event the Secretary conducts a program evaluation, funding in the second year or third year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

(f) Progress and evaluation

(1) In general

The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), including the grant program under this section. A recipient of a grant described in the preceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. To the extent practicable, the Secretary shall take the performance of such a grant recipient into account when determining whether to continue funding for such recipient.

(2) No duplication

In carrying out paragraph (1), the Secretary shall not duplicate the efforts of the Secretary under other provisions of this chapter or the FDA Food Safety Modernization Act that require measurement and review of the activities of grant recipients under either this chapter or such Act.

(g) Supplement not supplant

Grant funds received under this section shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this section.

(h) Authorization of appropriations

For the purpose of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015.

(June 25, 1938, ch. 675, §1009, formerly §909, as added Pub. L. 107–188, title III, §311, June 12, 2002, 116 Stat. 673; renumbered §1009 and amended Pub. L. 111–31, div. A, title I, §§101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, §210(a), Jan. 4, 2011, 124 Stat. 3948.)

Editorial Notes

References in Text

The FDA Food Safety Modernization Act, referred to in subsec. (f), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Amendments

2011—Pub. L. 111–353 amended section generally. Prior to amendment, section related to grants to States for inspections.

2009—Subsec. (b). Pub. L. 111–31, §103(n), made technical amendment to reference in original act which appears in text as reference to section 398 of this title.

Statutory Notes and Related Subsidiaries

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 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.
21 U.S.C. § 1714 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1714: Awards for demonstration programs by local partnerships to coerce abstinence in chronic hard-drug users under community supervision through the use of drug testing and sanctions
Awards for demonstration programs by local partnerships to coerce abstinence in chronic hard-drug users under community supervision through the use of drug testing and sanctions
Status: in_force

(a) Awards required

The Director shall make competitive awards to fund demonstration programs by eligible partnerships for the purpose of reducing the use of illicit drugs by chronic hard-drug users living in the community while under the supervision of the criminal justice system.

(b) Use of award amounts

Award amounts received under this section shall be used—

(1) to support the efforts of the agencies, organizations, and researchers included in the eligible partnership;

(2) to develop and field a drug testing and graduated sanctions program for chronic hard-drug users living in the community under criminal justice supervision; and

(3) to assist individuals described in subsection (a) by strengthening rehabilitation efforts through such means as job training, drug treatment, or other services.

(c) Eligible partnership defined

In this section, the term "eligible partnership" means a working group whose application to the Director—

(1) identifies the roles played, and certifies the involvement of, two or more agencies or organizations, which may include—

(A) State, local, or tribal agencies (such as those carrying out police, probation, prosecution, courts, corrections, parole, or treatment functions);

(B) Federal agencies (such as the Drug Enforcement Agency, the Bureau of Alcohol, Tobacco, Firearms, and Explosives, and United States Attorney offices); and

(C) community-based organizations;

(2) includes a qualified researcher;

(3) includes a plan for using judicial or other criminal justice authority to administer drug tests to individuals described in subsection (a) at least twice a week, and to swiftly and certainly impose a known set of graduated sanctions for non-compliance with community-release provisions relating to drug abstinence (whether imposed as a pre-trial, probation, or parole condition or otherwise);

(4) includes a strategy for responding to a range of substance use and abuse problems and a range of criminal histories;

(5) includes a plan for integrating data infrastructure among the agencies and organizations included in the eligible partnership to enable seamless, real-time tracking of individuals described in subsection (a);

(6) includes a plan to monitor and measure the progress toward reducing the percentage of the population of individuals described in subsection (a) who, upon being summoned for a drug test, either fail to show up or who test positive for drugs.

(d) Reports to Congress

(1) Interim report

Not later than June 1, 2009, the Director shall submit to Congress a report that identifies the best practices in reducing the use of illicit drugs by chronic hard-drug users, including the best practices identified through the activities funded under this section.

(2) Final report

Not later than June 1, 2010, the Director shall submit to Congress a report on the demonstration programs funded under this section, including on the matters specified in paragraph (1).

(e) Authorization of appropriations

There is authorized to be appropriated to carry out this section $4,900,000 for each of fiscal years 2007 through 2009.

(Pub. L. 105–277, div. C, title VII, §716, as added Pub. L. 109–469, title XI, §1119, Dec. 29, 2006, 120 Stat. 3547; amended Pub. L. 105–277, div. C. title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110.)

Editorial Notes

Amendments

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

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

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

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.
21 U.S.C. § 889 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 889: Production control of controlled substances
Production control of controlled substances
Status: in_force

(a) Definitions

As used in this section:

(1) The term "controlled substance" has the same meaning given such term in section 802(6) of this title.

(2) The term "Secretary" means the Secretary of Agriculture.

(3) The term "State" means each of the fifty States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands of the United States, American Samoa, the Commonwealth of the Northern Mariana Islands, or the Trust Territory of the Pacific Islands.

(b) Persons ineligible for Federal agricultural program benefits

Notwithstanding any other provision of law, following December 23, 1985, any person who is convicted under Federal or State law of planting, cultivation, growing, producing, harvesting, or storing a controlled substance in any crop year shall be ineligible for—

(1) as to any commodity produced during that crop year, and the four succeeding crop years, by such person—

(A) any price support or payment made available under the Agricultural Act of 1949 (7 U.S.C. 1421 et seq.), the Commodity Credit Corporation Charter Act (15 U.S.C. 714 et seq.), or any other Act;

(B) a farm storage facility loan made under section 4(h) of the Commodity Credit Corporation Charter Act (15 U.S.C. 714b(h));

(C) crop insurance under the Federal Crop Insurance Act (7 U.S.C. 1501 et seq.);

(D) a disaster payment made under the Agricultural Act of 1949 (7 U.S.C. 1421 et seq.); or

(E) a loan made, insured or guaranteed under the Consolidated Farm and Rural Development Act (7 U.S.C. 1921 et seq.) or any other provision of law administered by the Farmers Home Administration; or

(2) a payment made under section 4 or 5 of the Commodity Credit Corporation Charter Act (15 U.S.C. 714b or 714c) for the storage of an agricultural commodity that is—

(A) produced during that crop year, or any of the four succeeding crop years, by such person; and

(B) acquired by the Commodity Credit Corporation.

(c) Regulations

Not later than 180 days after December 23, 1985, the Secretary shall issue such regulations as the Secretary determines are necessary to carry out this section, including regulations that—

(1) define the term "person";

(2) govern the determination of persons who shall be ineligible for program benefits under this section; and

(3) protect the interests of tenants and sharecroppers.

(Pub. L. 91–513, title II, §519, formerly Pub. L. 99–198, title XVII, §1764, Dec. 23, 1985, 99 Stat. 1652; renumbered §519 of Pub. L. 91–513, Pub. L. 101–647, title X, §1002(h)(2), Nov. 29, 1990, 104 Stat. 4828.)

Editorial Notes

References in Text

The Agricultural Act of 1949, referred to in subsec. (b)(1)(A), (D), is act Oct. 31, 1949, ch. 792, 63 Stat. 1051, which is classified principally to chapter 35A (§1421 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 1421 of Title 7 and Tables.

The Commodity Credit Corporation Charter Act, referred to in subsec. (b)(1)(A), is act June 29, 1948, ch. 704, 62 Stat. 1070, and is classified generally to subchapter II (§714 et seq.) of chapter 15 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 714 of Title 15 and Tables.

The Federal Crop Insurance Act, referred to in subsec. (b)(1)(C), is subtitle A of title V of act Feb. 16, 1938, ch. 30, 52 Stat. 72, which is classified generally to subchapter I (§1501 et seq.) of chapter 36 of Title 7, Agriculture. For complete classification of this Act to the Code, see section 1501 of Title 7 and Tables.

The Consolidated Farm and Rural Development Act, referred to in subsec. (b)(1)(E), is title III of Pub. L. 87–128, Aug. 8, 1961, 75 Stat. 307, which is classified principally to chapter 50 (§1921 et seq.) of Title 7. For complete classification of this Act to the Code, see Short Title note set out under section 1921 of Title 7 and Tables.

Codification

Section was classified to section 881a of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Pub. L. 101–647 renumbered section 881a of this title as this section.

Executive Documents

Termination of Trust Territory of the Pacific Islands

For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title 48, Territories and Insular Possessions.
21 U.S.C. § 858 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 858: Endangering human life while illegally manufacturing controlled substance
Endangering human life while illegally manufacturing controlled substance
Status: in_force

Whoever, while manufacturing a controlled substance in violation of this subchapter, or attempting to do so, or transporting or causing to be transported materials, including chemicals, to do so, creates a substantial risk of harm to human life shall be fined in accordance with title 18 or imprisoned not more than 10 years, or both.

(Pub. L. 91–513, title II, §417, as added Pub. L. 100–690, title VI, §6301(a), Nov. 18, 1988, 102 Stat. 4370.)
21 U.S.C. § 393a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 393a: Office of Pediatric Therapeutics
Office of Pediatric Therapeutics
Status: in_force

(a) Establishment

The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.

(b) Duties

The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.

(c) Staff

The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—

(1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population;

(2) subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under section 355a of this title or an assessment under section 355c of this title;

(3) one or more additional individuals with expertise in pediatric epidemiology; and

(4) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b).

(d) Neonatology expertise

At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.

(Pub. L. 107–109, §6, Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, §306(a), Sept. 27, 2007, 121 Stat. 864; Pub. L. 112–144, title V, §511, July 9, 2012, 126 Stat. 1050; Pub. L. 115–52, title V, §505(d)(1), Aug. 18, 2017, 131 Stat. 1047.)

Editorial Notes

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

2017—Subsec. (d). Pub. L. 115–52 substituted "At least" for "For the 5-year period beginning on July 9, 2012, at least".

2012—Subsec. (c)(2) to (4). Pub. L. 112–144, §511(1), added pars. (2) and (3) and redesignated former par. (2) as (4).

Subsec. (d). Pub. L. 112–144, §511(2), added subsec. (d).

2007—Subsec. (b). Pub. L. 110–85 inserted ", including increasing pediatric access to medical devices" before period at end.
21 U.S.C. § 395 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 395: Loan repayment program
Loan repayment program
Status: in_force

(a) In general

(1) Authority for program

Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.

(2) Limitation

The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—

(A) has a substantial amount of educational loans relative to income; and

(B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years.

(b) Applicability of certain provisions

With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act [42 U.S.C. 254l et seq.], the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.

(June 25, 1938, ch. 675, §1005, formerly §905, as added Pub. L. 103–43, title XX, §2006(2), June 10, 1993, 107 Stat. 210; renumbered §1005, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b), is act July 1, 1944, ch. 373, 58 Stat. 682. Subpart III of part D of title III of the Act is classified generally to subpart III [§254l et seq.] of part D of subchapter II of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
21 U.S.C. § 136a (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 136a: Collection of fees for inspection services
Collection of fees for inspection services
Status: in_force

(a) Quarantine and inspection fees

(1) Fees authorized

The Secretary of Agriculture may prescribe and collect fees sufficient—

(A) to cover the cost of providing agricultural quarantine and inspection services in connection with the arrival at a port in the customs territory of the United States, or the preclearance or preinspection at a site outside the customs territory of the United States, of an international passenger, commercial vessel, commercial aircraft, commercial truck, or railroad car;

(B) to cover the cost of administering this subsection; and

(C) through fiscal year 2002, to maintain a reasonable balance in the Agricultural Quarantine Inspection User Fee Account established under paragraph (5).

(2) Limitation

In setting the fees under paragraph (1), the Secretary shall ensure that the amount of the fees is commensurate with the costs of agricultural quarantine and inspection services with respect to the class of persons or entities paying the fees. The costs of the services with respect to passengers as a class includes the costs of related inspections of the aircraft or other vehicle.

(3) Status of fees

Fees collected under this subsection by any person on behalf of the Secretary are held in trust for the United States and shall be remitted to the Secretary in such manner and at such times as the Secretary may prescribe.

(4) Late payment penalties

If a person subject to a fee under this subsection fails to pay the fee when due, the Secretary shall assess a late payment penalty, and the overdue fees shall accrue interest, as required by section 3717 of title 31.

(5) Agricultural Quarantine Inspection User Fee Account

(A) Establishment

There is established in the Treasury of the United States a fund, to be known as the "Agricultural Quarantine Inspection User Fee Account", which shall contain all of the fees collected under this subsection and late payment penalties and interest charges collected under paragraph (4) through fiscal year 2002.

(B) Use of account

For each of fiscal years 1996 through 2002, funds in the Agricultural Quarantine Inspection User Fee Account shall be available, in such amounts as are provided in advance in appropriations Acts, to cover the costs associated with the provision of agricultural quarantine and inspection services and the administration of this subsection. Amounts made available under this subparagraph shall be available until expended.

(C) Excess fees

Fees and other amounts collected under this subsection in any of fiscal years 1996 through 2002 in excess of $100,000,000 shall be available for the purposes specified in subparagraph (B) until expended, without further appropriation.

(6) Use of amounts collected after fiscal year 2002

After September 30, 2002, the unobligated balance in the Agricultural Quarantine Inspection User Fee Account and fees and other amounts collected under this subsection shall be credited to the Department of Agriculture accounts that incur the costs associated with the provision of agricultural quarantine and inspection services and the administration of this subsection. The fees and other amounts shall remain available to the Secretary until expended without fiscal year limitation.

(7) Staff years

The number of full-time equivalent positions in the Department of Agriculture attributable to the provision of agricultural quarantine and inspection services and the administration of this subsection shall not be counted toward the limitation on the total number of full-time equivalent positions in all agencies specified in section 5(b) of the Federal Workforce Restructuring Act of 1994 (Public Law 103–226; 5 U.S.C. 3101 note) or other limitation on the total number of full-time equivalent positions.

(b) Omitted

(c) Animal inspection and veterinary diagnostics

(1) Animal inspection

The Secretary may prescribe and collect fees to reimburse the Secretary for the cost of carrying out the provisions of the Federal Animal Quarantine Laws that relate to the importation, entry, and exportation of animals, articles, or means of conveyance.

(2) Veterinary diagnostics

The Secretary may prescribe and collect fees to recover the costs of carrying out the provisions of the Animal Health Protection Act [7 U.S.C. 8301 et seq.] that relate to veterinary diagnostics.

(3) Fees

All fees collected pursuant to this subsection and any late payment penalties or accrued interest collected pursuant to this subsection shall be credited to the accounts that incur the cost and shall remain available until expended without fiscal year limitation.

(4) Liability

Any person for whom an activity related to the importation, entry, or exportation of an animal, article, or means of conveyance or relating to veterinary diagnostics, is performed pursuant to the section, shall be liable for payment of fees assessed. Upon failure to pay such fees when due, the Secretary shall assess a late payment penalty, and such overdue fees shall accrue interest, as required by section 3717 of title 31. All fees, late payment penalties, and accrued interest collected shall be credited to such accounts that incur the costs and shall remain available until expended without fiscal year limitation.

(5) Leins 1

(A) In general

The Secretary shall have a lien against the animal, article, means of conveyance, or facility for which services have been provided under this section for the fees, any late payment penalty, and any accrued interest assessed under this subsection.

(B) Other animals, etc.

In the case of any person who fails to make payment when due under this subsection, the Secretary shall have a lien against any animal, article, or means of conveyance thereafter imported, moved in interstate commerce, or attempted to be exported by the person after the date of such failure until the date on which such owner or operator make 2 full payment to the Secretary under this subsection.

(C) Sales of animals, etc.

(i) Authority

The Secretary may, if a person does not pay fees, late payment penalties, or accrued interest on such, after providing reasonable notice of default to such person, sell at public sale after reasonable public notice, or otherwise dispose of, any such animal, article, means of conveyance or facility on which the Secretary has a lien under this paragraph.

(ii) Excess proceeds

If the sale proceeds under clause (i) exceed the fees due, any late payment penalty assessed, any accrued interest on such, and the expenses associated with the sale, such excess shall be paid to the owner of the animal, article, means of conveyance, or facility if such owner submits an application for such excess together with proof of ownership not later than 6 months after the date of such sale. If no such application is made, such excess shall be credited to accounts that incur the costs associated with the fees collected and shall remain available until expended, without fiscal year limitation. The Secretary shall suspend performance of services to persons who have failed to pay fees, late payment penalty, or accrued interest under this section.

(d) Regulations

The Secretary may prescribe such regulations as the Secretary determines necessary to carry out the provisions of this section.

(e) Recovery of amounts owed

An action may be brought for the recovery of fees, late payment penalties, and accrued interest which have not been paid in accordance with this section against any person obligated for payment of such assessments under this section in any United States district court or other United States court for any territory or possession in any jurisdiction in which such person is found or resides or transacts business, and such court shall have jurisdiction to hear and decide such action.

(f) Definitions

(1) Animal quarantine laws

For purposes of this section, the term "animal quarantine laws" means—

(A) section 306 of the Tariff Act of 1930 3 (19 U.S.C. 1306);

(B) section 9 of the Act of August 30, 1890 (21 U.S.C. 101);

(C) the Animal Health Protection Act [7 U.S.C. 8301 et seq.]; or

(D) any other Act administered by the Secretary relating to plant or animal diseases or pests.

(2) Customs territory

For the purposes of subsection (a), the term "customs territory of the United States" means the 50 States, the District of Columbia, and Puerto Rico.

(3) Person

For the purposes of this section, the term "person" means an individual, corporation, partnership, trust, association, or any other public or private entity, or any officer, employee, or agent thereof.

(4) United States

For the purposes of subsection (b), the term "United States" means the several States of the United States, the District of Columbia, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

(5) Vessel

For the purposes of subsection (a), the term "vessel" does not include any ferry.

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

Editorial Notes

References in Text

The Animal Health Protection Act, referred to in subsecs. (c)(2), (f)(1)(C), is subtitle E (§§10401–10418) of title X of Pub. L. 107–171, May 13, 2002, 116 Stat. 494, which is classified principally to chapter 109 (§8301 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 8301 of Title 7 and Tables.

Section 306 of the Tariff Act of 1930 (19 U.S.C. 1306), referred to in subsec. (f)(1)(A), was repealed by Pub. L. 107–171, title X, §10418(a)(5), May 13, 2002, 116 Stat. 507.

Codification

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

Amendments

2002—Subsec. (c)(2). Pub. L. 107–171, §10418(b)(5)(A), added par. (2) relating to veterinary diagnostics.

Subsec. (f)(1)(B) to (O). Pub. L. 107–171, §10418(b)(5)(B), added subpars. (B) to (D) and struck out former subpars. (B) to (O), which read as follows:

"(B) sections 6 through 10 of the Act of August 30, 1890 (26 Stat. 416, chapter 839; 21 U.S.C. 101–105);

"(C) section 2 of the Act of February 2, 1903 (32 Stat. 792, chapter 349; 21 U.S.C. 111);

"(D) the Act of May 29, 1884 (23 Stat. 32, chapter 60; 21 U.S.C. 112 to 114a–1, 115, 117–119, and 130) (commonly known as the 'Animal Industry Act');

"(E) the Act of February 28, 1947 (61 Stat. 7, chapter 8; 21 U.S.C. 114b, 114c, and 114d–1);

"(F) the Act of June 16, 1948 (62 Stat. 458, chapter 477; 21 U.S.C. 114e and 114f);

"(G) Public Law 87–209 (21 U.S.C. 114g and 114h);

"(H) the Act of May 31, 1920 (41 Stat. 699, chapter 217; 21 U.S.C. 116);

"(I) the Act of February 2, 1903 (32 Stat. 791, chapter 349; 21 U.S.C. 112 and 120–122) (commonly known as the 'Cattle Contagious Diseases Act of 1903');

"(J) the Act of March 3, 1905 (33 Stat. 1264, chapter 1496; 21 U.S.C. 123–127) (commonly known as the 'Cattle Contagious Diseases Act of 1905');

"(K) the matter under the heading 'Bureau of Animal Industry' of the Act of June 30, 1914 (38 Stat. 419, chapter 131; 21 U.S.C. 128);

"(L) section 101 of Public Law 92–73 (21 U.S.C. 129);

"(M) the matter under the heading 'Miscellaneous' of the Act of May 26, 1910 (36 Stat. 440, chapter 256; 21 U.S.C. 131);

"(N) sections 1 through 6 and 11 through 13 of Public Law 87–518 (21 U.S.C. 134–134h); or

"(O) any other Act administered by the Secretary relating to plant or animal diseases or pests, other than the first section of Public Law 91–239 (21 U.S.C. 135)."

1996—Subsec. (a). Pub. L. 104–127 added subsec. (a) and struck out heading and text of former subsec. (a) which consisted of pars. (1) to (4) relating to quarantine, inspection, and transportation fees.

1991—Subsec. (a)(1). Pub. L. 102–237, §1015(1), designated existing provisions as subpar. (A), realigned margin, added heading, and added subpars. (B) to (D).

Subsec. (a)(3)(B)(ii). Pub. L. 102–237, §1015(2), added cl. (ii) and struck out former cl. (ii) which read as follows: "The Secretary of Treasury shall use the Account to provide reimbursements to any appropriations accounts that incur the costs associated with the services authorized in paragraph (1). Any such reimbursement shall be subject to appropriations under clause (v)."

Subsec. (a)(4). Pub. L. 102–237, §1015(3), substituted "Subject to the limits set forth in paragraph (1), the" for "The".

1990—Subsec. (a)(1). Pub. L. 101–508, §1203(1), substituted "an international passenger, commercial vessel, commercial aircraft, commercial truck, or railroad car." for "a commercial vessel, commercial aircraft, commercial truck, or railroad car,".

Subsec. (a)(3)(B)(ii). Pub. L. 101–508, §1203(2)(A), inserted at end "Any such reimbursement shall be subject to appropriations under clause (v)."

Subsec. (a)(3)(B)(v). Pub. L. 101–508, §1203(2)(B), added cl. (v).

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–508 effective Nov. 29, 1990, see section 1301 of Pub. L. 101–508, set out as an Effective Date note under section 1994 of Title 7, Agriculture.

Report on Agricultural Quarantine Inspection Fund

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

1 So in original. Probably should be "Liens".

2 So in original. Probably should be "makes".

3 See References in Text note below.
21 U.S.C. § 384c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII: IMPORTS AND EXPORTS / Section 384c: Inspection of foreign food facilities
Inspection of foreign food facilities
Status: in_force

(a) Inspection

The Secretary—

(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 350d of this title; and

(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.

(b) Effect of inability to inspect

Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the Secretary and the foreign factory, warehouse, or other establishment.

(June 25, 1938, ch. 675, §807, as added Pub. L. 111–353, title III, §306(a), Jan. 4, 2011, 124 Stat. 3958.)

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.
21 U.S.C. § 874 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 874: Advisory committees
Advisory committees
Status: in_force

The Attorney General may from time to time appoint committees to advise him with respect to preventing and controlling the abuse of controlled substances. Members of the committees may be entitled to receive compensation at the rate of $100 for each day (including traveltime) during which they are engaged in the actual performance of duties. While traveling on official business in the performance of duties for the committees, members of the committees shall be allowed expenses of travel, including per diem instead of subsistence, in accordance with subchapter I of chapter 57 of title 5.

(Pub. L. 91–513, title II, §504, Oct. 27, 1970, 84 Stat. 1272.)

Statutory Notes and Related Subsidiaries

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.
21 U.S.C. § 1704 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1704: Coordination with National Drug Control Program agencies in demand reduction, supply reduction, and State and local affairs
Coordination with National Drug Control Program agencies in demand reduction, supply reduction, and State and local affairs
Status: in_force

(a) Access to information

(1) In general

Upon the request of the Director, the head of any National Drug Control Program agency shall cooperate with and provide to the Director any statistics, studies, reports, and other information prepared or collected by the agency concerning the responsibilities of the agency under the National Drug Control Strategy that relate to—

(A) drug control; or

(B) the manner in which amounts made available to that agency for drug control are being used by that agency.

(2) Protection of intelligence information

(A) In general

The authorities conferred on the Office and the Director by this chapter shall be exercised in a manner consistent with provisions of the National Security Act of 1947 [50 U.S.C. 3001 et seq.]. The Director of National Intelligence shall prescribe such regulations as may be necessary to protect information provided pursuant to this chapter regarding intelligence sources and methods.

(B) Duties of Director

The Director of National Intelligence and the Director of the Central Intelligence Agency shall, to the maximum extent practicable in accordance with subparagraph (A), render full assistance and support to the Office and the Director.

(3) Required reports

(A) Secretaries of the Interior and Agriculture

Not later than July 1 of each year, the Secretaries of Agriculture and the Interior shall jointly submit to the Director and the appropriate congressional committees an assessment of the quantity of illegal drug cultivation and manufacturing in the United States on lands owned or under the jurisdiction of the Federal Government for the preceding year.

(B) Secretary of Homeland Security

Not later than July 1 of each year, the Secretary of Homeland Security shall submit to the Director and the appropriate congressional committees information for the preceding year regarding—

(i) the number and type of seizures of drugs by each component of the Department of Homeland Security seizing drugs, as well as statistical information on the geographic areas of such seizures; and

(ii) the number of air and maritime patrol hours primarily dedicated to drug supply reduction missions undertaken by each component of the Department of Homeland Security.

(C) Secretary of Defense

The Secretary of Defense shall, by July 1 of each year, submit to the Director and the appropriate congressional committees information for the preceding year regarding the number of air and maritime patrol hours primarily dedicated to drug supply reduction missions undertaken by each component of the Department of Defense.

(D) Attorney General

The Attorney General shall, by July 1 of each year, submit to the Director and the appropriate congressional committees information for the preceding year regarding the number and type of—

(i) arrests for drug violations;

(ii) prosecutions for drug violations by United States Attorneys; and

(iii) seizures of drugs by each component of the Department of Justice seizing drugs, as well as statistical information on the geographic areas of such seizures.

(b) Certification of policy changes to Director

(1) In general

Subject to paragraph (2), the head of a National Drug Control Program agency shall, unless exigent circumstances require otherwise, notify the Director in writing regarding any proposed change in policies relating to the activities of that agency under the National Drug Control Program prior to implementation of such change. The Director shall promptly review such proposed change and certify to the head of that agency in writing whether such change is consistent with the National Drug Control Strategy.

(2) Exception

If prior notice of a proposed change under paragraph (1) is not practicable—

(A) the head of the National Drug Control Program agency shall notify the Director of the proposed change as soon as practicable; and

(B) upon such notification, the Director shall review the change and certify to the head of that agency in writing whether the change is consistent with the National Drug Control Strategy.

(c) General Services Administration

The Administrator of General Services shall provide to the Director, on a reimbursable basis, such administrative support services as the Director may request.

(d) Accounting of funds expended

(1) In general

Not later than February 1 of each year, in accordance with guidance issued by the Director, the head of each National Drug Control Program agency shall submit to the Director a detailed accounting of all funds expended by the agency for National Drug Control Program activities during the previous fiscal year and shall ensure such detailed accounting is authenticated for the previous fiscal year by the Inspector General for such agency prior to the submission to the Director as frequently as determined by the Inspector General but not less frequently than every 3 years.

(2) Submission to Congress

The Director shall submit to Congress not later than April 1 of each year the information submitted to the Director under paragraph (1).

(e) Drug court training and technical assistance program

(1) Grants authorized

The Director may make a grant to a nonprofit organization for the purpose of providing training and technical assistance to drug courts.

(2) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2018 through 2023.

(f) Tracking system for federally funded grant programs

(1) Establishment

The Director, or the head of an agency designated by the Director, in coordination with the Secretary of Health and Human Services, shall track federally-funded grant programs to—

(A) ensure the public has electronic access to information identifying:

(i) all drug control grants and pertinent identifying information for each grant; and

(ii) any available performance metrics, evaluations, or other information indicating the effectiveness of such programs;

(B) facilitate efforts to identify duplication, overlap, or gaps in funding to provide increased accountability of Federally-funded grants for substance use disorder treatment, prevention, and enforcement; and

(C) identify barriers that may impede applicants in the grant application process.

(2) National Drug Control Program Agencies

The head of each National Drug Control Program agency shall provide to the Director a complete list of all drug control program grant programs and any other relevant information for inclusion in the system developed under paragraph (1) and annually update such list.

(3) Updating existing systems

The Director may meet the requirements of this subsection by utilizing, updating, or improving existing Federal information systems to ensure they meet the requirements of this subsection.

(4) Report

Not later than 3 years after October 24, 2018, the Comptroller General of the United States shall submit to Congress a report examining implementation of this subsection.

(Pub. L. 105–277, div. C, title VII, §§705, 715, Oct. 21, 1998, 112 Stat. 2681–680, 2681–693; Pub. L. 109–469, title I, §104, title VI, §602, Dec. 29, 2006, 120 Stat. 3510, 3533; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8207, 8217(g), Oct. 24, 2018, 132 Stat. 4110, 4113, 4124; Pub. L. 116–74, §2(a)(1), (6), Nov. 27, 2019, 133 Stat. 1155, 1156.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (a)(2)(A), is act July 26, 1947, ch. 343, 61 Stat. 495, which was formerly classified principally to chapter 15 (§401 et seq.) of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified principally to chapter 44 (§3001 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

Amendments

2019—Pub. L. 116–74, §2(a)(1), substituted "National Drug Control Program agency" for "National Drug Control Program Agency" wherever appearing.

Subsec. (d)(1). Pub. L. 116–74, §2(a)(6)(A), substituted "than every" for "that every".

Subsec. (f)(1)(A)(i). Pub. L. 116–74, §2(a)(6)(B)(i)(I), substituted "grant; and" for "grant;".

Subsec. (f)(1)(C). Pub. L. 116–74, §2(a)(6)(B)(i)(II), inserted "that may impede applicants" after "barriers" and struck out "impediments that applicants currently have in the grant application process with applicable agencies" before period at end.

Subsec. (f)(2). Pub. L. 116–74, §2(a)(6)(B)(ii), substituted "Drug Control Program" for "Drug Control" in heading.

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

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

Subsec. (d). Pub. L. 115–271, §8217(g)(1), amended subsec. (d) generally. Prior to amendment, text read as follows: "The Director shall—

"(A) require the National Drug Control Program agencies to submit to the Director not later than February 1 of each year a detailed accounting of all funds expended by the agencies for National Drug Control Program activities during the previous fiscal year, and require such accounting to be authenticated by the Inspector General for each agency prior to submission to the Director; and

"(B) submit to Congress not later than April 1 of each year the information submitted to the Director under subparagraph (A)."

Subsec. (e). Pub. L. 115–271, §8207, added subsec. (e).

Subsec. (f). Pub. L. 115–271, §8217(g)(2), added subsec. (f).

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

Subsec. (a)(1)(A). Pub. L. 109–469, §104(1), struck out "abuse" after "drug".

Subsec. (a)(2)(A). Pub. L. 109–469, §104(2), substituted "Director of National Intelligence" for "Director of Central Intelligence".

Subsec. (a)(2)(B). Pub. L. 109–469, §104(3), substituted "Director of National Intelligence and the Director of the Central Intelligence Agency" for "Director of Central Intelligence".

Subsec. (a)(3). Pub. L. 109–469, §104(4), amended par. (3) generally. Prior to amendment, text read as follows: "The Secretary of Agriculture shall annually submit to the Director an assessment of the acreage of illegal drug cultivation in the United States."

Subsec. (b)(2)(B). Pub. L. 109–469, §104(5), substituted "Strategy" for "Program".

Subsec. (c). Pub. L. 109–469, §104(6), substituted "on" for "in".

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.
21 U.S.C. § 19 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 19: Repealed. May 29, 1928, ch. 901, §1(100), 45 Stat. 993
Repealed. May 29, 1928, ch. 901, §1(100), 45 Stat. 993
Status: repealed

Section, act May 23, 1908, ch. 192, 35 Stat. 261, related to report to Congress of expenditures in enforcing food and drug laws.
21 U.S.C. § 1031 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1031: Congressional statement of findings
Congressional statement of findings
Status: in_force

Eggs and egg products are an important source of the Nation's total supply of food, and are used in food in various forms. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential, in the public interest, that the health and welfare of consumers be protected by the adoption of measures prescribed herein for assuring that eggs and egg products distributed to them and used in products consumed by them are wholesome, otherwise not adulterated, and properly labeled and packaged. Lack of effective regulation for the handling or disposition of unwholesome, otherwise adulterated, or improperly labeled or packaged egg products and certain qualities of eggs is injurious to the public welfare and destroys markets for wholesome, not adulterated, and properly labeled and packaged eggs and egg products and results in sundry losses to producers and processors, as well as injury to consumers. Unwholesome, otherwise adulterated, or improperly labeled or packaged products can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged products, to the detriment of consumers and the public generally. It is hereby found that all egg products and the qualities of eggs which are regulated under this chapter are either in interstate or foreign commerce, or substantially affect such commerce, and that regulation by the Secretary of Agriculture and the Secretary of Health and Human Services, and cooperation by the States and other jurisdictions, as contemplated by this chapter, are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

(Pub. L. 91–597, §2, Dec. 29, 1970, 84 Stat. 1620; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Editorial Notes

References in Text

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

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in text 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. 91–597, §29, Dec. 29, 1970, 84 Stat. 1635, provided that: "The provisions of this Act [enacting this chapter, amending sections 633 and 636 of Title 15, Commerce and Trade, and enacting provisions set out as notes under this section] with respect to egg products shall take effect six months after enactment [Dec. 29, 1970]. Otherwise, this Act shall take effect eighteen months after enactment."

Short Title

Pub. L. 91–597, §1, Dec. 29, 1970, 84 Stat. 1620, provided: "That this Act [enacting this chapter, amending sections 633 and 636 of Title 15, Commerce and Trade, and enacting provisions set as notes under this section] may be cited as the 'Egg Products Inspection Act'."

Maintenance of Eggs at Proper Temperature

Pub. L. 102–237, title X, §1012(a), Dec. 13, 1991, 105 Stat. 1899, provided that:

"(1) Findings.—Congress finds that—

"(A) food borne illness is a serious health problem;

"(B) its incidence can be reduced through proper handling of food; and

"(C) eggs are perishable and therefore are particularly susceptible to supporting microbial growth if proper temperature controls are not maintained.

"(2) Purposes.—It is the purpose of this section [amending sections 1034, 1037, 1041, 1042, 1046, and 1052 of this title and enacting provisions set out as a note under section 1034 of this title] to prescribe the temperature at which eggs are maintained in order to reduce the potential for harmful microbial growth to protect the health and welfare of consumers."