Title 21 — Food and DrugsRelease 119-73
§301 Short title
Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER I— - SHORT TITLE › § 301
Full Legal Text
Title 21, §301
Food and Drugs — Source: USLM XML via OLRC
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Legislative History
Notes & Related Subsidiaries
Statutory Notes and Related Subsidiaries
Effective Date
Postponement in Certain CasesAct 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: section 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 section 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 section 502(j), 505, and 601(a) [section 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 2025 Amendment Pub. L. 119–37, div. F, title V, § 6501, Nov. 12, 2025, 139 Stat. 637, provided that: “This title [amending section 355, 355h, 379j–71, 379j–72, and 379j–73 of this title and enacting provisions set out as notes under section 355, 360fff–3, 379j–71, and 379j–73 of this title] may be cited as the ‘Over-the-Counter Monograph Drug User Fee
Amendments
’.”
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 section 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 section 379j–21 and 379j–22 of this title, enacting provisions set out as notes under section 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under section 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 section 331, 361, 362, 374, and 381 of this title, and enacting provisions set out as notes under section 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 section 379g, 379h, and 379h–2 of this title, enacting notes set out under section 379g and 379h–2 of this title, and repealing notes set out under section 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 section 360d, 360m, and 379i to 379j–1 of this title, enacting notes set out under section 360d, 379i, and 379j–1 of this title, and repealing provisions set out as notes under section 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 section 379j–42 and 379j–43 of this title, enacting provisions set out as notes under section 379j–41 and 379j–43 of this title, and repealing provisions set out as notes under section 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 section 379j–51 and 379j–53 of this title, and repealing provisions set out as notes under section 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 section 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 section 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 section 360bbb–8d and 384f of this title, amending section 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 section 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 section 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 section 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 section 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 section 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 section 379j–21 and 379j–22 of this title, enacting provisions set out as notes under section 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under section 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 section 379h, 379h–2, and 379j–12 of this title, enacting provisions set out as notes under section 379g and 379h–2 of this title, and repealing provisions set out as notes under section 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 section 360d, 360e, 360m, 379d–3, 379i, 379j, 379j–1, and 379k–1 of this title, enacting provisions set out as notes under section 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 section 379j–41 and 379j–43 of this title, and repealing provisions set out as notes under section 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 section 379j–51 and 379j–53 of this title, and repealing provisions set out as notes under section 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 section 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 section 353a–1 and 353b of this title, amending section 331, 333, 352 to 353a, 353b, 353c, and 360eee–1 of this title, and enacting provisions set out as notes under this section and section 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 section 353a–1 and 353b of this title, amending section 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 section 331, 333, 352, 353, and 360eee–1 of this title, and enacting provisions set out as notes under section 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 section 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 section 379j–21 and 379j–22 of this title, enacting provisions set out as notes under section 379j–21 and 379j–22 of this title, and repealing provisions set out as notes under section 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 section 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 section 379g, 379h, and 379h–2 of this title, enacting provisions set out as notes under section 379g and 379h–2 of this title, and repealing provisions set out as notes under section 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 section 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 section 379d–4 and 379j–41 to 379j–43 of this title, amending section 352 and 379d–3 of this title, and enacting provisions set out as notes under section 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 section 379d–4 and 379g of this title, and enacting provisions set out as notes under section 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 section 321, 331, 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 391 to 393, 394 to 399a, and 679 of this title and section 1333, 1334, 4402, 4406, and 4408 of Title 15, Commerce and Trade, enacting provisions set out as notes under section 331, 333, 387, and 387c of this title and section 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 section 360b, 379j–11, and 379j–12 of this title, and enacting provisions set out as notes under section 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 section 379j–21 and 379j–22 of this title, amending section 379k, 379l, and 379o of this title, and enacting provisions set out as notes under section 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, section 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 section 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 section 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 section 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 section 379h–1 and 379h–2 of this title, amending section 379g, 379h, and 379j–11 of this title, and enacting provisions set out as notes under section 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 section 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 section 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 section 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 section 379aa and 379aa–1 of this title, amending section 331, 343, 352, and 381 of this title, and enacting provisions set out as notes under section 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 section 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 section 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 section 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 section 321, 331, 352, 353, 354, and 360b of this title, enacting provisions set out as notes under section 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 section 321, 343, and 343–1 of this title, and enacting provisions set out as notes under section 321 and 343 of this title and section 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 section 331, 352, 360, 360e, 374, 379i, and 379j of this title and provisions set out as notes under section 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 section 355, 355a, and 355b of this title and section 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 section 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 section 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 section 379i and 379j of this title and section 289g–3 of Title 42, The Public Health and Welfare, amending section 321, 331, 333, 335a, 352, 353, 360, 360c, 360e, 360m, and 374 of this title, and enacting provisions set out as notes under section 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 section 356b, 379g, and 379h of this title and enacting provisions set out as notes under section 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 section 355b and 393a of this title and section 284m of Title 42, The Public Health and Welfare, amending section 321, 355, 355a, and 379h of this title and section 282, 284k, 284l, 285a–2, and 290b of Title 42, and enacting provisions set out as notes under section 355 and 355a of this title and section 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 section 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 section 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 section 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 section 247b–8 and 299a–3 of Title 42, The Public Health and Welfare, amending section 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 section 262, 263a, and 282 of Title 42, repealing section 356 and 357 of this title, and enacting provisions set out as notes under section 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l, 360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and section 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 section 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 section 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 section 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 section 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and Welfare, amending section 321, 331, 342, 343, and 350 of this title and section 281 of Title 42, and enacting provisions set out as notes under section 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 section 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 section 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 section 379g and 379h of this title, transferring section 372a, 376, and 379c of this title to section 376, 379e and 379f, respectively, of this title, amending section 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 section 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 section 343 and 393 of this title and amending provisions set out as notes under section 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 section 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 section 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 section 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 section 360l and 383 of this title, amending section 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 section 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 section 321, 337, 343, 345, and 371 of this title, and enacting provisions set out as notes under section 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 section 321, 353, and 360b of this title, section 2201 of Title 28, Judiciary and Judicial Procedure, and section 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 section 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 section 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 section 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 section 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 section 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 section 355 and 360cc of this title, section 68b, 68c, and 70b of Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary and Judicial Procedure, and section 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 section 236, 255, and 298b–4 of Title 42, The Public Health and Welfare, amending section 1274, 1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and Trade, section 904 of this title, section 280C and 6096 of Title 26, and section 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 section 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 section 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 section 321 and 343 of this title, enacting provisions set out as notes under section 343 and 348 of this title, and amending provisions set out as notes under section 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 section 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 section 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 section 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 section 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 section 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 section 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 section 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 section 321, 331, 333, 342, 346, 351, 352, 361, 362, 371, and 379e of this title, repealing section 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 section 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 section 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 SubstancesFederal 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.
Reference
Citations & Metadata
Citation
21 U.S.C. § 301
Title 21 — Food and Drugs
Last Updated
Apr 6, 2026
Release point: 119-73