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2022 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
| Publication Title | United States Code, 2018 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT |
| Contains | sections 301 to 399i |
| Date | 2022 |
| Laws In Effect As Of Date | January 5, 2023 |
| Positive Law | No |
| Disposition | standard |
- Table of Contents
- Front Matter
- + Subchapter I - Short Title (Section 301 - 301)
- + Subchapter II - Definitions (Section 321 - 321d)
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+
Subchapter III - Prohibited Acts and Penalties
(Section 331 - 337a)
- Sec. 331 - Prohibited acts
- Sec. 332 - Injunction proceedings
- Sec. 333 - Penalties
- Sec. 333a - Repealed. Pub. L. 101-647, title XIX, §1905, Nov. 29, 1990, 104 Stat. 4853
- Sec. 334 - Seizure
- Sec. 335 - Hearing before report of criminal violation
- Sec. 335a - Debarment, temporary denial of approval, and suspension
- Sec. 335b - Civil penalties
- Sec. 335c - Authority to withdraw approval of abbreviated drug applications
- Sec. 336 - Report of minor violations
- Sec. 337 - Proceedings in name of United States; provision as to subpoenas
- Sec. 337a - Extraterritorial jurisdiction
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+
Subchapter IV - Food
(Section 341 - 350m)
- Sec. 341 - Definitions and standards for food
- Sec. 342 - Adulterated food
- Sec. 343 - Misbranded food
- Sec. 343-1 - National uniform nutrition labeling
- Sec. 343-2 - Dietary supplement labeling exemptions
- Sec. 343-3 - Disclosure
- Sec. 343a - title V, §517
- Sec. 344 - Emergency permit control
- Sec. 345 - Regulations making exemptions
- Sec. 346 - Tolerances for poisonous or deleterious substances in food; regulations
- Sec. 346a - Tolerances and exemptions for pesticide chemical residues
- Sec. 346b - Authorization of appropriations
- Sec. 347 - Intrastate sales of colored oleomargarine
- Sec. 347a - Congressional declaration of policy regarding oleomargarine sales
- Sec. 347b - Contravention of State laws
- Sec. 348 - Food additives
- Sec. 349 - Bottled drinking water standards; publication in Federal Register
- Sec. 350 - Vitamins and minerals
- Sec. 350a - Infant formulas
- Sec. 350a-1 - Protecting infants and improving formula supply
- Sec. 350b - New dietary ingredients
- Sec. 350c - Maintenance and inspection of records
- Sec. 350d - Registration of food facilities
- Sec. 350e - Sanitary transportation practices
- Sec. 350f - Reportable food registry
- Sec. 350g - Hazard analysis and risk-based preventive controls
- Sec. 350h - Standards for produce safety
- Sec. 350i - Protection against intentional adulteration
- Sec. 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
- Sec. 350k - Laboratory accreditation for analyses of foods
- Sec. 350l - Mandatory recall authority
- Sec. 350l-1 - Annual report to Congress
- Sec. 350m - Requirements for critical food
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+
Subchapter V - Drugs and Devices
(Section 351 - 360fff-8)
- Part A - Drugs and Devices (Section 351 - 360n-2)
- Part B - Drugs for Rare Diseases or Conditions (Section 360aa - 360ff-1)
- Part C - Electronic Product Radiation Control (Section 360hh - 360ss)
- Part D - Dissemination of Treatment Information (Section 360aaa - 360aaa-6)
- Part E - General Provisions Relating to Drugs and Devices (Section 360bbb - 360bbb-8d)
- Part F - New Animal Drugs for Minor Use and Minor Species (Section 360ccc - 360ccc-2)
- Part G - Medical Gases (Section 360ddd - 360ddd-2)
- Part H - Pharmaceutical Distribution Supply Chain (Section 360eee - 360eee-4)
- Part I - Nonprescription Sunscreen and Other Active Ingredients (Section 360fff - 360fff-8)
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+
Subchapter VI - Cosmetics
(Section 361 - 364j)
- Sec. 361 - Adulterated cosmetics
- Sec. 362 - Misbranded cosmetics
- Sec. 363 - Regulations making exemptions
- Sec. 364 - Definitions
- Sec. 364a - Adverse events
- Sec. 364b - Good manufacturing practice
- Sec. 364c - Registration and product listing
- Sec. 364d - Safety substantiation
- Sec. 364e - Labeling
- Sec. 364f - Records
- Sec. 364g - Mandatory recall authority
- Sec. 364h - Small businesses
- Sec. 364i - Exemption for certain products and facilities
- Sec. 364j - Preemption
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+
Subchapter VII - General Authority
(Section 371 - 379dd-2)
- Part A - General Administrative Provisions (Section 371 - 379d-5)
- Part B - Colors (Section 379e - 379e)
- Part C - Fees (Section 379f - 379j-73)
- Part D - Information and Education (Section 379k - 379l)
- Part E - Environmental Impact Review (Section 379o - 379o)
- Part F - National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics (Section 379r - 379s)
- Part G - Safety Reports (Section 379v - 379v)
- Part H - Serious Adverse Event Reports (Section 379aa - 379aa-1)
- Part I - Reagan-Udall Foundation for the Food and Drug Administration (Section 379dd - 379dd-2)
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+
Subchapter VIII - Imports and Exports
(Section 381 - 384g)
- Sec. 381 - Imports and exports
- Sec. 382 - Exports of certain unapproved products
- Sec. 383 - Office of International Relations
- Sec. 384 - Importation of prescription drugs
- Sec. 384a - Foreign supplier verification program
- Sec. 384b - Voluntary qualified importer program
- Sec. 384c - Inspection of foreign food facilities
- Sec. 384d - Accreditation of third-party auditors
- Sec. 384e - Recognition of foreign government inspections
- Sec. 384f - Strengthening FDA and CBP coordination and capacity
- Sec. 384g - Restricting entrance of illicit drugs
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+
Subchapter IX - Tobacco Products
(Section 387 - 387v)
- Sec. 387 - Definitions
- Sec. 387a - FDA authority over tobacco products
- Sec. 387a-1 - Final rule
- Sec. 387b - Adulterated tobacco products
- Sec. 387c - Misbranded tobacco products
- Sec. 387d - Submission of health information to the Secretary
- Sec. 387e - Annual registration
- Sec. 387f - General provisions respecting control of tobacco products
- Sec. 387f-1 - Enforcement action plan for advertising and promotion restrictions
- Sec. 387g - Tobacco product standards
- Sec. 387h - Notification and other remedies
- Sec. 387i - Records and reports on tobacco products
- Sec. 387j - Application for review of certain tobacco products
- Sec. 387k - Modified risk tobacco products
- Sec. 387l - Judicial review
- Sec. 387m - Equal treatment of retail outlets
- Sec. 387n - Jurisdiction of and coordination with the Federal Trade Commission
- Sec. 387o - Regulation requirement
- Sec. 387p - Preservation of State and local authority
- Sec. 387q - Tobacco Products Scientific Advisory Committee
- Sec. 387r - Drug products used to treat tobacco dependence
- Sec. 387s - User fees
- Sec. 387t - Labeling, recordkeeping, records inspection
- Sec. 387u - Studies of progress and effectiveness
- Sec. 387v - Reporting on tobacco regulation activities
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+
Subchapter X - Miscellaneous
(Section 391 - 399i)
- Sec. 391 - Separability clause
- Sec. 392 - Exemption of meats and meat food products
- Sec. 393 - Food and Drug Administration
- Sec. 393a - Office of Pediatric Therapeutics
- Sec. 394 - Scientific review groups
- Sec. 395 - Loan repayment program
- Sec. 396 - Practice of medicine
- Sec. 397 - Contracts for expert review
- Sec. 398 - Notices to States regarding imported food
- Sec. 399 - Grants to enhance food safety
- Sec. 399a - Office of the Chief Scientist
- Sec. 399b - Office of Women's Health
- Sec. 399c - Improving the training of State, local, territorial, and tribal food safety officials
- Sec. 399d - Employee protections
- Sec. 399e - Nanotechnology
- Sec. 399f - Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
- Sec. 399g - Food and Drug Administration Intercenter Institutes
- Sec. 399h - National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
- Sec. 399i - Food and Drug Administration Working Capital Fund
Disclaimer: These codes may not be the most recent version. United States may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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