§ 301. Short title
8,387 words·~38 min read·
/usc/title-21/section-301A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
(June 25, 1938, ch. 675, § 1, 52 Stat. 1040.)
Connections1,892 cite this · traces to 94
Cited by 1,892 sections · top 60
U.S. Code
- § 4321Congressional declaration of purpose
- § 321Definitions; generally
- § 355New drugs
- § 262Regulation of biological products
- § 802Definitions
- § 136Definitions
- § 351Adulterated drugs and devices
- § 360Registration of producers of drugs or devices
- § 331Prohibited acts
- § 360bNew animal drugs
- § 156Extension of patent term
- § 601Definitions
- § 1786Special supplemental nutrition program for women, infants, and children
- § 352Misbranded drugs and devices
- § 343Misbranded food
- § 811Authority and criteria for classification of substances
- § 371Regulations and hearings
- § 1701Definitions
- § 342Adulterated food
- § 509Functions of the Attorney General
- § 381Imports and exports
- § 353Exemptions and consideration for certain drugs, devices, and biological products
- § 374Inspection
- § 282Director of National Institutes of Health
- § 333Penalties
- § 829Prescriptions
- § 170Charitable, etc., contributions and gifts
- § 360ffPriority review to encourage treatments for rare pediatric diseases
- § 825Labeling and packaging
- § 2291Policy, general authorities, coordination, foreign police actions, definitions, and other provisions
- § 256bLimitation on prices of drugs purchased by covered entities
- § 42Importation or shipment of injurious mammals, birds, fish (including mollusks and crustacea), amphibia, and reptiles; permits, specimens for museums; regulations
- § 356Expedited approval of drugs for serious or life-threatening diseases or conditions
- § 379hAuthority to assess and use drug fees
- § 1261Definitions
- § 5925High-priority research and extension initiatives
- § 5341Establishment of dietary guidelines
- § 361Adulterated cosmetics
- § 379gDefinitions
- § 1382aIncome; earned and unearned income defined; exclusions from income
- § 453Definitions
- § 387Definitions
- § 830Regulation of listed chemicals and certain machines
- § 379iDefinitions
- § 262aEnhanced control of dangerous biological agents and toxins
- § 355cResearch into pediatric uses for drugs and biological products
- § 356cDiscontinuance or interruption in the production of life-saving drugs
- § 387eAnnual registration
- § 387sUser fees
- § 387aFDA authority over tobacco products
- § 136vAuthority of States
- § 1333Labeling
- § 1074gPharmacy benefits program
- § 6519Recordkeeping, investigations, and enforcement
- § 8401Regulation of certain biological agents and toxins
- § 360eeGrants and contracts for development of drugs for rare diseases and conditions
- § 2079Transfers of functions
- § 983General rules for civil forfeiture proceedings
Traces to 94 documents
U.S. Code
- Misbranded food§ 343
- Regulations and hearings§ 371
- Definitions and standards for food§ 341
- Adulterated cosmetics§ 361
- “Butter” defined§ 321a
- “Package” defined§ 321b
- Transferred§ 372a
- Establishment and functions of the Foundation§ 379dd
- Establishment and duties of Foundation§ 290b
- Grants and contracts for development of drugs for rare diseases and conditions§ 360ee
- Children’s asthma treatment grants program§ 280g
- Definitions; generally§ 321
- New drugs§ 355
- Prohibited acts§ 331
- Restricting entrance of illicit drugs§ 384g
- Expanded access to unapproved therapies and diagnostics§ 360bbb
- Definitions§ 379i
- Priority review to encourage treatments for rare pediatric diseases§ 360ff
- Priority review to encourage treatments for tropical diseases§ 360n
- Extension of patent term§ 156
- Regulation of biological products§ 262
- Definitions§ 360fff
- Authority to assess and use device fees§ 379j
- Automation of Food and Drug Administration§ 379d
- Exemption of meats and meat food products§ 392
- Public health emergencies§ 247d
- Director of National Institutes of Health§ 282
- Program for pediatric studies of drugs§ 284m
- Premarket approval§ 360e
- General provisions respecting control of devices intended for human use§ 360j
- Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers§ 355d
- Research into pediatric uses for drugs and biological products§ 355c
- Pediatric studies of drugs§ 355a
- Sanitary transportation practices§ 350e
- Food transportation safety inspections§ 5701
- Misbranded drugs and devices§ 352
- New animal drugs§ 360b
- Inspections relating to food allergens§ 374a
- Improvement and publication of data on food-related allergic responses§ 242r
- Fetal research§ 289g
- Importation of prescription drugs§ 384
- Imports and exports§ 381
- Clinical testing expenses for certain drugs for rare diseases or conditions§ 45C
- Limitation on prices of drugs procured by Department and certain other Federal agencies§ 8126
- Veterinary feed directive drugs§ 354
- Definitions§ 136
- Exports of certain unapproved products§ 382
- Transferred§ 287c
- Organization of National Institutes of Health§ 281
- Certification of mammography facilities§ 263b
- Definitions§ 379g
- Exemptions and consideration for certain drugs, devices, and biological products§ 353
- Records and reports on devices§ 360i
- Debarment, temporary denial of approval, and suspension§ 335a
- Creation of remedy§ 2201
- Food and Drug Administration§ 393
- Recommendations for investigations of drugs for rare diseases or conditions§ 360aa
- Orphan Products Board§ 236
- Penalties§ 333
- Misbranded wool products§ 68b
- Food additives§ 348
- Renumbered § 45C]§ 44H
- Payment of tort claims§ 904
- Development grants for health systems agencies§ 300t
- Infant formulas§ 350a
- Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73§ 343a
- Office to assist small manufacturers of medical devices; establishment§ 3512
- Additional definitions§ 55
- Registration of producers of drugs or devices§ 360
- Definitions§ 360hh
- Protection of officers and employees of the United States§ 1114
- Pay and allowances§ 210
- Definitions§ 1261
public-private-law
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- Food Allergy Safety, Treatment, Education, and Research Act of 2021Public Law 117-11
- Safeguarding Therapeutics ActPublic Law 116-304
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- Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities ActPublic Law 115-271
- Animal Drug and Animal Generic Drug User Fee Amendments of 2018Public Law 115-234
- Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017Public Law 115-176
- FDA Reauthorization Act of 2017Public Law 115-52
- Advancing Hope Act of 2016Public Law 114-229
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- Microbead-Free Waters Act of 2015Public Law 114-114
- Improving Regulatory Transparency for New Medical Therapies ActPublic Law 114-89
- Adding Ebola to the FDA Priority Review Voucher Program ActPublic Law 113-233
- Sunscreen Innovation ActPublic Law 113-195
- Drug Quality and Security ActPublic Law 113-54
- Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013Public Law 113-14
189 references not yet in our index
- June 25, 1938, ch. 675, § 1
- 52 Stat. 1040
- Act June 23, 1939, ch. 242
- 53 Stat. 853
- section 10 of this title
- Act June 25, 1938, ch. 675, § 1002(a)
- 52 Stat. 1059
- Pub. L. 111–31, div. A, title I, § 101(b)(2)
- 123 Stat. 1784
- 42 Stat. 1500
- 41 Stat. 271
- 139 Stat. 637
- 137 Stat. 86
- 137 Stat. 90
- 136 Stat. 5807
- 136 Stat. 5847
- 136 Stat. 2139
- 136 Stat. 2140
- 136 Stat. 2147
- 136 Stat. 2155
- 136 Stat. 2160
- 136 Stat. 47
- 135 Stat. 1533
- 135 Stat. 262
- 134 Stat. 4915
- 134 Stat. 4889
- 132 Stat. 3894
- 132 Stat. 3935
- 132 Stat. 3938
- 132 Stat. 3940
- 132 Stat. 2427
- 132 Stat. 2428
- 132 Stat. 2432
- 132 Stat. 1372
- 131 Stat. 1005
- 131 Stat. 1006
- 131 Stat. 1013
- 131 Stat. 1020
- 131 Stat. 1028
- 130 Stat. 943
+ 149 more
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§ 301
Short title
Bills×586
Fed. Reg.×582
U.S.C.×306
Stat.×229
Stat. Comp.×89
Pub. L.×81
C.F.R.×19
ActJune 25, 1938, ch. 675, § 1
Stat.52 Stat. 1040
ActAct June 23, 1939, ch. 242
Cites 283 · showing 12Cited by 1,892 across 7 sources