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2020 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Publication Title | United States Code, 2018 Edition, Supplement 2, 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 473 |
Date | 2020 |
Laws In Effect As Of Date | January 13, 2021 |
Positive Law | No |
Disposition | standard |
- Table of Contents
- Front Matter
- + Subchapter I - Short Title (Sections 301 - 301)
- + Subchapter II - Definitions (Sections 321 - 321d)
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+
Subchapter III - Prohibited Acts and Penalties
(Sections 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- Sec. 333a - Repealed.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
(Sections 341 - 350l-1)
- 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. 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
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Subchapter V - Drugs and Devices
(Sections 351 - 360fff-8)
- Part A - Drugs and Devices (Sections 351 - 360n-1)
- Part B - Drugs for Rare Diseases or Conditions (Sections 360aa - 360ff-1)
- Part C - Electronic Product Radiation Control (Sections 360hh - 360ss)
- Part D - Dissemination of Treatment Information (Sections 360aaa - 360aaa-6)
- Part E - General Provisions Relating to Drugs and Devices (Sections 360bbb - 360bbb-8d)
- Part F - New Animal Drugs for Minor Use and Minor Species (Sections 360ccc - 360ccc-2)
- Part G - Medical Gases (Sections 360ddd - 360ddd-2)
- Part H - Pharmaceutical Distribution Supply Chain (Sections 360eee - 360eee-4)
- Part I - Nonprescription Sunscreen and Other Active Ingredients (Sections 360fff - 360fff-8)
- + Subchapter VI - Cosmetics (Sections 361 - 364)
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Subchapter VII - General Authority
(Sections 371 - 379dd-2)
- Part A - General Administrative Provisions (Sections 371 - 379d-5)
- Part B - Colors (Sections 379e - 379e)
- Part C - Fees (Sections 379f - 379j-73)
- Part D - Information and Education (Sections 379k - 379l)
- Part E - Environmental Impact Review (Sections 379o - 379o)
- Part F - National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics (Sections 379r - 379s)
- Part G - Safety Reports (Sections 379v - 379v)
- Part H - Serious Adverse Event Reports (Sections 379aa - 379aa-1)
- Part I - Reagan-Udall Foundation for the Food and Drug Administration (Sections 379dd - 379dd-2)
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Subchapter VIII - Imports and Exports
(Sections 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
(Sections 387 - 387u)
- 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
-
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Subchapter X - Miscellaneous
(Sections 391 - 473)
- 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 - Grants for studying continuous drug manufacturing
- Sec. 399i - Food and Drug Administration Working Capital Fund
- Sec. 451 - Congressional statement of findings
- Sec. 452 - Congressional declaration of policy
- Sec. 453 - Definitions
- Sec. 454 - Federal and State cooperation in development and administration of State poultry product inspection programs
- Sec. 455 - Inspection in official establishments
- Sec. 456 - Operation of premises, facilities and equipment
- Sec. 457 - Labeling and container standards
- Sec. 458 - Prohibited acts
- Sec. 459 - Compliance by all establishments
- Sec. 460 - Miscellaneous activities subject to regulation
- Sec. 461 - Offenses and punishment
- Sec. 462 - Reporting of violations; notice; opportunity to present views
- Sec. 463 - Rules and regulations
- Sec. 464 - Exemptions
- Sec. 465 - Limitations upon entry of poultry products and other materials into official establishments
- Sec. 466 - Imports
- Sec. 467 - Inspection services
- Sec. 467a - Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks
- Sec. 467b - Seizure and condemnation
- Sec. 467c - Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas
- Sec. 467d - Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts
- Sec. 467e - Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, packaging, and ingredients; recordkeeping and related requirements; concurrent jurisdiction over distribution for human food purposes of adulterated or misbranded and imported articles; other matters
- Sec. 467f - Federal Food, Drug, and Cosmetic Act applications
- Sec. 468 - Cost of inspection; overtime
- Sec. 469 - Authorization of appropriations
- Sec. 470 - Omitted
- Sec. 471 - Safe Meat and Poultry Inspection Panel
- Sec. 472 - Interstate shipment of poultry inspected by Federal and State agencies for certain small establishments
- Sec. 473 - Grants for improvements to meat and poultry facilities to allow for interstate shipment
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