US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 301

Short title

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

June 25, 1938, ch. 675, § 152 Stat. 1040(, .)

Statutory Notes and Related Subsidiaries

Effective Date; Postponement in Certain Cases

Act June 23, 1939, ch. 24253 Stat. 853

“[Sec. 1]
(a)
The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until : 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 [,] 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 , and to containers bearing labeling which, prior to , 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 , as amended.
“Sec. 2.
(a)
section 10 of this titlesection 10 of this title The provisions of section 8 [], paragraph fifth, under the heading ‘In the case of food:’, of the Food and Drugs Act of , 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 [] and of such regulations, shall remain in force until .
“(b)
section 343(k) of this title The provisions of such Act of , 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 [], shall remain in force until .
“(c)
Notwithstanding the provisions of section 1 of this Act, such section shall not apply—
“(1)
section 10 of this title 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 [], paragraph second, under the heading ‘In the case of drugs:’, of the Food and Drugs Act of , 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.”
, §§ 1, 2, , 854, provided that:

Effective Date

Act June 25, 1938, ch. 675, § 1002(a)52 Stat. 1059Pub. L. 111–31, div. A, title I, § 101(b)(2)123 Stat. 1784

Providedsection 371 of this titlesection 343(i) of this titlesection 341 of this titleProvided furthersection 361(a) of this titleProvided furthersection 321a of this title42 Stat. 1500section 321b of this title41 Stat. 271section 372a of this title“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 []. The Federal Food and Drugs Act of , 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: , That the provisions of section 701 [] 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) [] for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401 []: , 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) [], 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: , That the Act of (U.S.C., 1934 ed., title 21, sec. 6 []; , ch. 268), defining butter and providing a standard therefor; the Act of (U.S.C., 1934 ed., title 21, sec. 10 []; , ch. 26], defining wrapped meats as in package form; and the amendment to the Food and Drugs Act, section 10A, approved (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a []) shall remain in force and effect and be applicable to the provisions of this Act.”
, formerly § 902(a), ; renumbered § 1002(a), , , , provided that:

Short Title of 2025 Amendment

Pub. L. 119–37, div. F, title V, § 6501139 Stat. 637

“This title [amending sections 355, 355h, 379j–71, 379j–72, and 379j–73 of this title and enacting provisions set out as notes under sections 355, 360fff–3, 379j–71, and 379j–73 of this title] may be cited as the ‘Over-the-Counter Monograph Drug User Fee Amendments’.”
, , , provided that:

Short Title of 2023 Amendment

Pub. L. 118–15, div. B, title III, § 2301(a)137 Stat. 86

Pub. L. 118–15“This chapter [chapter 1 (§§ 2301–2307) of subtitle A of title III of div. B of , 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’.”
, , , provided that:

Pub. L. 118–15, div. B, title III, § 2311(a)137 Stat. 90

Pub. L. 118–15“This chapter [chapter 2 (§§ 2311–2316) of subtitle A of title III of div. B of , 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’.”
, , , provided that:

Short Title of 2022 Amendment

Pub. L. 117–328, div. FF, title III, § 3001136 Stat. 5807

“This title [see Tables for classification] may be cited as the ‘Food and Drug Omnibus Reform Act of 2022’.”
, , , provided that:

Pub. L. 117–328, div. FF, title III, § 3501136 Stat. 5847

“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’.”
, , , provided that:

Pub. L. 117–180, div. F, § 1136 Stat. 2139

“This division [see Tables for classification] may be cited as the ‘FDA User Fee Reauthorization Act of 2022’.”
, , , provided that:

Pub. L. 117–180, div. F, title I, § 1001(a)136 Stat. 2140

“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’.”
, , , provided that:

Pub. L. 117–180, div. F, title II, § 2001(a)136 Stat. 2147

“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’.”
, , , provided that:

Pub. L. 117–180, div. F, title III, § 3001(a)136 Stat. 2155

“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’.”
, , , provided that:

Pub. L. 117–180, div. F, title IV, § 4001(a)136 Stat. 2160

“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’.”
, , , provided that:

Pub. L. 117–101, § 1136 Stat. 47

section 379dd of this titlesection 290b of Title 42“This Act [amending and , 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’.”
, , , provided that:

Short Title of 2021 Amendment

Pub. L. 117–79, § 1135 Stat. 1533

section 360ee–1 of this titlesection 280g–7b of Title 42“This Act [enacting , , 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’.”
, , , provided that:

Pub. L. 117–11, § 1135 Stat. 262

section 321 of this titlesection 321 of this title“This Act [amending and enacting provisions set out as a note under ] may be cited as the ‘Food Allergy Safety, Treatment, Education, and Research Act of 2021’ or the ‘FASTER Act of 2021’.”
, , , provided that:

Pub. L. 116–304, § 1134 Stat. 4915

“This Act [amending sections 321 and 381 of this title] may be cited as the ‘Safeguarding Therapeutics Act’.”
, , , provided that:

Pub. L. 116–290, § 1134 Stat. 4889

section 355 of this titlesection 355 of this title“This Act [amending and enacting provisions set out as a note under ] may be cited as the ‘Orange Book Transparency Act of 2020’.”
, , , provided that:

Short Title of 2018 Amendment

Pub. L. 115–271, § 1(a)132 Stat. 3894

“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’.”
, , , provided that:

Pub. L. 115–271, title III, § 3011132 Stat. 3935

Pub. L. 115–271section 331 of this title“This chapter [chapter 2 (§§ 3011–3014) of subtitle A of title III of , 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 ] may be cited as the ‘Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act’ or the ‘SCREEN Act’.”
, , , provided that:

Pub. L. 115–271, title III, § 3021132 Stat. 3938

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

Pub. L. 115–271, title III, § 3031132 Stat. 3940

Pub. L. 115–271section 355–1 of this title“This chapter [chapter 4 (§§ 3031, 3032) of subtitle A of title III of , amending ] 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’.”
, , , provided that:

Pub. L. 115–234, § 1132 Stat. 2427

“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’.”
, , , provided that:

Pub. L. 115–234, title I, § 101(a)132 Stat. 2428

“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’.”
, , , provided that:

Pub. L. 115–234, title II, § 201(a)132 Stat. 2432

“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’.”
, , , provided that:

Pub. L. 115–176, § 1132 Stat. 1372

section 360bbb–0a of this titlesection 360bbb–0a of this title“This Act [enacting and provisions set out as a note under ] may be cited as the ‘Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017’.”
, , , provided that:

Short Title of 2017 Amendment

Pub. L. 115–52, § 1131 Stat. 1005

“This Act [see Tables for classification] may be cited as the ‘FDA Reauthorization Act of 2017’.”
, , , provided that:

Pub. L. 115–52, title I, § 101(a)131 Stat. 1006

“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’.”
, , , provided that:

Pub. L. 115–52, title II, § 201(a)131 Stat. 1013

section 379i of this title“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 ] may be cited as the ‘Medical Device User Fee Amendments of 2017’.”
, , , provided that:

Pub. L. 115–52, title III, § 301(a)131 Stat. 1020

“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’.”
, , , provided that:

Pub. L. 115–52, title IV, § 401(a)131 Stat. 1028

“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’.”
, , , provided that:

Short Title of 2016 Amendment

Pub. L. 114–229, § 1130 Stat. 943

section 360ff of this titlesection 360ff of this title“This Act [amending and enacting provisions set out as a note under ] may be cited as the ‘Advancing Hope Act of 2016’.”
, , , provided that:

Pub. L. 114–146, § 1130 Stat. 357

section 360n of this title“This Act [amending ] may be cited as the ‘Adding Zika Virus to the FDA Priority Review Voucher Program Act’.”
, , , provided that:

Short Title of 2015 Amendment

Pub. L. 114–114, § 1129 Stat. 3129

section 331 of this titlesection 331 of this title“This Act [amending and enacting provisions set out as notes under ] may be cited as the ‘Microbead-Free Waters Act of 2015’.”
, , , provided that:

Pub. L. 114–89, § 1129 Stat. 698

section 156 of Title 35section 262 of Title 42“This Act [amending sections 355, 360b, 360ccc to 360ccc–2, 811, 823, and 953 of this title, , Patents, and , The Public Health and Welfare] may be cited as the ‘Improving Regulatory Transparency for New Medical Therapies Act’.”
, , , provided that:

Short Title of 2014 Amendment

Pub. L. 113–233, § 1128 Stat. 2127

section 360n of this title“This Act [amending ] may be cited as the ‘Adding Ebola to the FDA Priority Review Voucher Program Act’.”
, , , provided that:

Pub. L. 113–195, § 1128 Stat. 2035

section 360fff of this title“This Act [enacting part I of subchapter V of this chapter and provisions set out as a note under ] may be cited as the ‘Sunscreen Innovation Act’.”
, , , provided that:

Short Title of 2013 Amendment

Pub. L. 113–54, § 1127 Stat. 587

“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’.”
, , , provided that:

Pub. L. 113–54, title I, § 101127 Stat. 587

section 331 of this title“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 ] may be cited as the ‘Compounding Quality Act’.”
, , , provided that:

Pub. L. 113–54, title II, § 201127 Stat. 599

“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’.”
, , , provided that:

Pub. L. 113–14, § 1127 Stat. 451

“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’.”
, , , provided that:

Pub. L. 113–14, title I, § 101(a)127 Stat. 451

section 379j–11 of this title“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 ] may be cited as the ‘Animal Drug User Fee Amendments of 2013’.”
, , , provided that:

Pub. L. 113–14, title II, § 201(a)127 Stat. 464

“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’.”
, , , provided that:

Short Title of 2012 Amendment

Pub. L. 112–193, § 1126 Stat. 1443

section 379j–42 of this title“This Act [amending sections 352, 379j, and 379j–42 of this title and enacting provisions set out as a note under ] may be cited as the ‘FDA User Fee Corrections Act of 2012’.”
, , , provided that:

Pub. L. 112–144, § 1126 Stat. 993

“This Act [see Tables for classification] may be cited as the ‘Food and Drug Administration Safety and Innovation Act’.”
, , , provided that:

Pub. L. 112–144, title I, § 101(a)126 Stat. 996

“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’.”
, , , provided that:

Pub. L. 112–144, title II, § 201(a)126 Stat. 1002

section 379d–3 of this titlesection 379i of this titlesection 379i of this title“This title [enacting , amending sections 360e, 379i, 379j, and 379j–1 of this title, enacting provisions set out as notes under , and repealing provisions set out as notes under ] may be cited as the ‘Medical Device User Fee Amendments of 2012’.”
, , , provided that:

Pub. L. 112–144, title III, § 301(a)126 Stat. 1008

“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’.”
, , , provided that:

Pub. L. 112–144, title IV, § 401(a)126 Stat. 1026

“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’.”
, , , provided that:

Short Title of 2009 Amendment

Pub. L. 111–31, div. A, § 1(a)123 Stat. 1776

section 392 of this title“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 ] may be cited as the ‘Family Smoking Prevention and Tobacco Control Act’.”
, , , provided that:

Short Title of 2008 Amendment

Pub. L. 110–316, title I, § 101(a)122 Stat. 3509

section 379j–13 of this title“This title [enacting , 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’.”
, , , provided that:

Pub. L. 110–316, title II, § 201(a)122 Stat. 3515

lo“This title [enacting sections 379j–21 and 379j–22 of this title, amending sections 379k, 379, and 379 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’.”
, , , provided that:

Short Title of 2007 Amendment

Pub. L. 110–85, § 1121 Stat. 823

section 247d–5a of Title 42llsection 282 of Title 42section 284m of Title 42“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 , The Public Health and Welfare, amending sections 321, 331, 333, 334, 352, 355, 355a, 355c, 360, 360e, 360i, 360j, 360, 360m, 360ee, 374, 379g, 379h, 379i, 379j, 379j–11, 379, 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 , and amending provisions set out as notes under ] may be cited as the ‘Food and Drug Administration Amendments Act of 2007’.”
, , , provided that:

Pub. L. 110–85, title I, § 101(a)121 Stat. 825

“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’.”
, , , provided that:

Pub. L. 110–85, title II, § 201(a)121 Stat. 842

section 379j–1 of this titlesection 379i of this title“This title [enacting , amending sections 333, 360, 360i, 360m, 374, 379i, and 379j of this title, and enacting provisions set out as notes under ] may be cited as the ‘Medical Device User Fee Amendments of 2007’.”
, , , provided that:

Pub. L. 110–85, title III, § 301121 Stat. 859

section 360e–1 of this titlelsection 282 of Title 42section 360j of this titlesection 282 of Title 42section 284m of Title 42“This title [enacting , amending sections 360j, 360, and 393a of this title and , The Public Health and Welfare, enacting provisions set out as notes under and , and amending provisions set out as a note under ] may be cited as the ‘Pediatric Medical Device Safety and Improvement Act of 2007’.”
, , , provided that:

Pub. L. 110–85, title IV, § 401121 Stat. 866

section 355d of this titlesection 355c of this titlesection 355c of this title“This title [enacting , amending , and enacting provisions set out as a note under ] may be cited as the ‘Pediatric Research Equity Act of 2007’.”
, , , provided that:

Pub. L. 110–85, title V, § 501121 Stat. 876

section 355a of this titlesection 355a of this titlesection 284m of Title 42“This title [amending 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 , and amending provisions set out as a note under ] may be cited as the ‘Best Pharmaceuticals for Children Act of 2007’.”
, , , provided that:

Short Title of 2006 Amendment

Pub. L. 109–462, § 1120 Stat. 3469

“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’.”
, , , provided that:

Short Title of 2005 Amendments

Pub. L. 109–59, title VII, § 7201119 Stat. 1911

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

Pub. L. 109–43, § 1119 Stat. 439

section 352 of this title“This Act [amending sections 352 and 379j of this title, enacting provisions set out as a note under , 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’.”
, , , provided that:

Short Title of 2004 Amendments

Pub. L. 108–282, title I, § 101118 Stat. 891

section 360b of this title“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 ] may be cited as the ‘Minor Use and Minor Species Animal Health Act of 2004’.”
, , , provided that:

Pub. L. 108–282, title II, § 201118 Stat. 905

section 374a of this titlesection 242r of Title 42“This title [enacting and , 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’.”
, , , provided that:

Pub. L. 108–214, § 1118 Stat. 572

l“This Act [amending sections 331, 352, 360, 360e, 374, 379i, and 379j of this title and provisions set out as notes under sections 352, 360, and 379j of this title] may be cited as the ‘Medical Devices Technical Corrections Act’.”
, , , provided that:

Short Title of 2003 Amendments

Pub. L. 108–155, § 1117 Stat. 1936

section 355c of this titlesection 355c of this titlesection 355a of this titlesection 284m of Title 42“This Act [enacting , 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 , and amending provisions set out as notes under and ] may be cited as the ‘Pediatric Research Equity Act of 2003’.”
, , , provided that:

Pub. L. 108–130, § 1117 Stat. 1361

section 379j–11 of this title“This Act [enacting sections 379j–11 and 379j–12 of this title and provisions set out as notes under ] may be cited as the ‘Animal Drug User Fee Act of 2003’.”
, , , provided that:

Short Title of 2002 Amendments

Pub. L. 107–281, § 1116 Stat. 1992

section 360ee of this title“This Act [amending sections 360cc and 360ee of this title and enacting provisions set out as a note under ] may be cited as the ‘Rare Diseases Orphan Product Development Act of 2002’.”
, , , provided that:

Pub. L. 107–250, § 1(a)116 Stat. 1588

section 289g–3 of Title 42lsection 289g–3 of Title 42“This Act [enacting sections 379i and 379j of this title and , 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, 360, 379i, and 379j of this title and ] may be cited as the ‘Medical Device User Fee and Modernization Act of 2002’.”
, , , provided that:

Pub. L. 107–188, title V, § 501116 Stat. 687

Pub. L. 107–188“This subtitle [subtitle A (§§ 501–509) of title V of , 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’.”
, , , provided that:

Pub. L. 107–109, § 1115 Stat. 1408

section 284m of Title 42l“This Act [enacting sections 355b and 393a of this title and , The Public Health and Welfare, amending sections 321, 355, 355a, and 379h of this title and sections 282, 284k, 284, 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’.”
, , , provided that:

Short Title of 2000 Amendment

Pub. L. 106–387, § 1(a) [title VII, § 745(a)]114 Stat. 1549

section 384 of this titlesection 384 of this title“This section [enacting , amending sections 331, 333, and 381 of this title, and enacting provisions set out as a note under ] may be cited as the ‘Medicine Equity and Drug Safety Act of 2000’.”
, , , 1549A–35, provided that:

Pub. L. 106–387, § 1(a) [title VII, § 746(a)]114 Stat. 1549

section 381 of this titlesection 381 of this title“This section [amending and enacting provisions set out as a note under ] may be cited as the ‘Prescription Drug Import Fairness Act of 2000’.”
, , , 1549A–40, provided that:

Short Title of 1998 Amendment

Pub. L. 105–324, § 1112 Stat. 3035

“This Act [amending sections 321 and 346a of this title] may be cited as the ‘Antimicrobial Regulation Technical Corrections Act of 1998’.”
, , , provided that:

Short Title of 1997 Amendment

Pub. L. 105–115, § 1(a)111 Stat. 2296

lolsection 45C of Title 26section 156 of Title 35section 8126 of Title 38l“This Act [enacting sections 343–3, 353a, 355a, 356 to 356c, 360m, 360aaa to 360aaa–6, 360bbb to 360bbb–2, 379k, 379, 379, 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, 360, 360aa to 360cc, 360ee, 371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title, , Internal Revenue Code, , Patents, , 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, 360, 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’.”
, , , provided that:

Short Title of 1996 Amendments

Pub. L. 104–250, § 1(a)110 Stat. 3151

section 354 of this titlesection 360b of this title“This Act [enacting , amending sections 331, 353, and 360b of this title, and enacting provisions set out as notes under ] may be cited as the ‘Animal Drug Availability Act of 1996’.”
, , , provided that:

Pub. L. 104–170, title IV, § 401(a)110 Stat. 1513

“This title [amending sections 321, 331, 333, 342, and 346a of this title] may be cited as the ‘Food Quality Protection Act of 1996’.”
, , , provided that:

Pub. L. 104–170, § 1110 Stat. 1489section 136 of Title 7[Another “Food Quality Protection Act of 1996”, was enacted by , , which is set out as a note under , Agriculture.]

Pub. L. 104–134, title II, § 2101(a)110 Stat. 1321–313

Pub. L. 104–134section 382 of this titlesection 262 of Title 42“This chapter [chapter 1A (§§ 2101–2105) of title II of , enacting and amending sections 331 and 381 of this title and , The Public Health and Welfare] may be cited as the ‘FDA Export Reform and Enhancement Act of 1996’.”
, , , provided that:

Short Title of 1994 Amendments

Pub. L. 103–417, § 1(a)108 Stat. 4325

section 287c–11 of Title 42section 281 of Title 42“This Act [enacting sections 343–2 and 350b of this title and , The Public Health and Welfare, amending sections 321, 331, 342, 343, and 350 of this title and , 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’.”
, , , provided that:

Pub. L. 103–396, § 1108 Stat. 4153

section 360b of this title“This Act [amending sections 331, 343–1, 360b, and 371 of this title and enacting provisions set out as notes under ] may be cited as the ‘Animal Medicinal Drug Use Clarification Act of 1994’.”
, , , provided that:

Short Title of 1993 Amendment

Pub. L. 103–80, § 1107 Stat. 773

section 263b of Title 42section 343 of this title“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 , The Public Health and Welfare, and enacting provisions set out as a note under ] may be cited as the ‘Nutrition Labeling and Education Act Amendments of 1993’.”
, , , provided that:

Short Title of 1992 Amendments

Pub. L. 102–571, title I, § 101(a)106 Stat. 4491

section 379g of this title“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 , 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’.”
, , , provided that:

Pub. L. 102–571, title II, § 201106 Stat. 4500

“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’.”
, , , provided that:

Pub. L. 102–353, § 1(a)106 Stat. 941

section 353 of this title“This Act [amending sections 333, 353, and 381 of this title and enacting provisions set out as a note under ] may be cited as the ‘Prescription Drug Amendments of 1992’.”
, , , provided that:

Pub. L. 102–300, § 1(a)106 Stat. 238

lsection 262 of Title 42section 360i of this title“This Act [amending sections 321, 331, 334, 346a, 352, 353, 356, 357, 360c, 360d, 360g to 360i, 360, 360mm, 371 to 372a, 376, and 381 of this title and , The Public Health and Welfare and enacting and amending provisions set out as notes under ] may be cited as the ‘Medical Device Amendments of 1992’.”
, , , provided that:

Pub. L. 102–282, § 1(a)106 Stat. 149

section 335a of this title“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 ] may be cited as the ‘Generic Drug Enforcement Act of 1992’.”
, , , provided that:

Short Title of 1990 Amendments

Pub. L. 101–635, § 1(a)104 Stat. 4583

“This Act [enacting sections 379b to 379d and 394 of this title] may be cited as the ‘Food and Drug Administration Revitalization Act’.”
, , , provided that:

Pub. L. 101–629, § 1(a)104 Stat. 4511

lsection 263b of Title 42“This Act [enacting sections 360 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 , 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’.”
, , , provided that:

Pub. L. 101–535, § 1(a)104 Stat. 2353

section 343–1 of this title“This Act [enacting , 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’.”
, , , provided that:

Short Title of 1988 Amendments

Pub. L. 100–670, § 1(a)102 Stat. 3971

section 2201 of Title 28section 360b of this title“This Act [amending sections 321, 353, and 360b of this title, , Judiciary and Judicial Procedure, and sections 156 and 271 of Title 35, Patents, and enacting provisions set out as notes under ] may be cited as the ‘Generic Animal Drug and Patent Term Restoration Act’.”
, , , provided that:

Pub. L. 100–607, title V, § 501102 Stat. 3120

section 393 of this titlesection 393 of this title“This title [enacting , amending sections 5315 and 5316 of Title 5, Government Organization and Employees, and enacting provisions set out as notes under ] may be cited as the ‘Food and Drug Administration Act of 1988’.”
, , , provided that:

Pub. L. 100–293, § 1(a)102 Stat. 95

section 353 of this title“This Act [amending sections 331, 333, 353, and 381 of this title and enacting provisions set out as notes under ] may be cited as the ‘Prescription Drug Marketing Act of 1987’.”
, , , provided that:

Pub. L. 100–290, § 1102 Stat. 90

section 360aa of this titlesection 236 of Title 42“This Act [amending sections 360bb and 360ee of this title, enacting provisions set out as a note under , and amending provisions set out as a note under , The Public Health and Welfare] may be cited as the ‘Orphan Drug Amendments of 1988’.”
, , , provided that:

Short Title of 1986 Amendment

Pub. L. 99–660, title I, § 101(a)100 Stat. 3743

section 382 of this titlesection 333 of this titlesection 262 of Title 42“This title [enacting , amending sections 241 and 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under and ] may be cited as the ‘Drug Export Amendments Act of 1986’.”
, , , provided that:

Short Title of 1985 Amendment

Pub. L. 99–91, § 199 Stat. 387

section 360aa of this titlesection 236 of Title 42“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 and ] may be cited as the ‘Orphan Drug Amendments of 1985’.”
, , , provided that:

Short Title of 1984 Amendment

Pub. L. 98–417, § 198 Stat. 1585

section 156 of Title 35section 2201 of Title 28section 355 of this titlesection 68b of Title 15“That this Act [enacting , Patents, amending sections 355 and 360cc of this title, sections 68b, 68c, and 70b of Title 15, Commerce and Trade, , Judiciary and Judicial Procedure, and sections 271 and 282 of Title 35, and enacting provisions set out as notes under and ] may be cited as the ‘Drug Price Competition and Patent Term Restoration Act of 1984’.”
, , , provided:

Short Title of 1983 Amendments

Pub. L. 98–22, § 197 Stat. 173

section 348 of this title“That this Act [amending provisions set out as a note under ] may be cited as the ‘Saccharin Study and Labeling Act Amendment of 1983’.”
, , , provided:

Pub. L. 97–414, § 1(a)96 Stat. 2049

section 44H of Title 26section 155 of Title 35section 904 of this titleosection 360aa of this titlesection 44H of Title 26section 300t–11 of Title 42“This Act [enacting part B of subchapter V of chapter 9 of this title, , Internal Revenue Code, , 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, , sections 280C and 6096 of Title 26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254, 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 , , and sections 241, 255, 287i, and 300x–1 of Title 42, and repealing provisions set out as a note under ] may be cited as the ‘Orphan Drug Act’.”
, , , provided that:

Short Title of 1981 Amendment

Pub. L. 97–42, § 195 Stat. 946

section 348 of this title“That this Act [amending provisions set out as a note under ] may be cited as the ‘Saccharin Study and Labeling Act Amendment of 1981’.”
, , , provided:

Short Title of 1980 Amendment

Pub. L. 96–359, § 194 Stat. 1190

section 350a of this titlesection 350a of this title“That this Act [enacting , amending sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and enacting a provision set out as a note under ] may be cited as the ‘Infant Formula Act of 1980’.”
, , , provided:

Short Title of 1977 Amendment

Pub. L. 95–203, § 191 Stat. 1451

section 343a of this titlel“This Act [enacting , 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 289–1 of Title 42, The Public Health and Welfare] may be cited as the ‘Saccharin Study and Labeling Act’.”
, , , provided that:

Short Title of 1976 Amendment

Pub. L. 94–295, § 1(a)90 Stat. 539

section 3512 of Title 42section 55 of Title 15“This Act [enacting sections 360c to 360k, 379, and 379a of this title and , The Public Health and Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 of this title and , Commerce and Trade] may be cited as the ‘Medical Device Amendments of 1976’.”
, , , provided that:

Short Title of 1972 Amendment

Pub. L. 92–387, § 186 Stat. 559

section 360 of this title“This Act [amending sections 331, 335, and 360 of this title and enacting provisions set out as notes under ] may be cited as the ‘Drug Listing Act of 1972’.”
, , , provided that:

Short Title of 1968 Amendments

Pub. L. 90–602, § 182 Stat. 1173

section 360hh of this title“This Act [enacting provisions now comprising part C (§§ 360hh–360ss) of subchapter III of this chapter and provisions set out as notes under ] may be cited as the ‘Radiation Control for Health and Safety Act of 1968’.”
, , , provided that:

Pub. L. 90–399, § 182 Stat. 342

section 360b of this titlesection 360b of this title“That this Act [enacting , amending sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title, and enacting provisions set out as a note under ] may be cited as the ‘Animal Drug Amendments of 1968’.”
, , , provided:

Short Title of 1965 Amendment

Pub. L. 89–74, § 179 Stat. 226

section 1114 of Title 18“That this Act [amending sections 321, 331, 333, 334, 360, and 372 of this title and , 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’.”
, , , provided:

Short Title of 1962 Amendment

Pub. L. 87–781, § 176 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, § 174 Stat. 397

“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’.”
, , , provided:

Short Title of 1958 Amendment

Pub. L. 85–929, § 172 Stat. 1784

section 210 of Title 42“That this Act [amending sections 321, 331, 342, 346, 348 of this title and , 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’.”
, , , provided:

Severability

Pub. L. 113–54, title I, § 106(b)127 Stat. 598

“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.”
, , , provided that:

Pub. L. 110–85, title XI, § 1105121 Stat. 975

“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.”
, , , provided that:

Hazardous Substances

Pub. L. 86–613, § 1874 Stat. 380section 1261 of Title 15Federal Hazardous Substances Act as not modifying this chapter, see , , , set out as an Effect Upon Federal and State Laws note under , Commerce and Trade.