CHAPTER 9 — Federal Food, Drug, and Cosmetic Act
309 sections.
SUBCHAPTER I — SHORT TITLE 1 sections
SUBCHAPTER II — DEFINITIONS 5 sections
SUBCHAPTER III — PROHIBITED ACTS AND PENALTIES 12 sections
- § 331. — Prohibited acts
- § 332. — Injunction proceedings
- § 333. — Penalties
- § 333a. — Repealed. Pub. L. 101–647, title XIX, § 1905, Nov. 29, 1990, 104 Stat. 4853
- § 334. — Seizure
- § 335. — Hearing before report of criminal violation
- § 335a. — Debarment, temporary denial of approval, and suspension
- § 335b. — Civil penalties
- § 335c. — Authority to withdraw approval of abbreviated drug applications
- § 336. — Report of minor violations
- § 337. — Proceedings in name of United States; provision as to subpoenas
- § 337a. — Extraterritorial jurisdiction
SUBCHAPTER IV — FOOD 33 sections
- § 341. — Definitions and standards for food
- § 342. — Adulterated food
- § 343. — Misbranded food
- § 343–1. — National uniform nutrition labeling
- § 343–2. — Dietary supplement labeling exemptions
- § 343–3. — Disclosure
- § 343a. — Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
- § 344. — Emergency permit control
- § 345. — Regulations making exemptions
- § 346. — Tolerances for poisonous or deleterious substances in food; regulations
- § 346a. — Tolerances and exemptions for pesticide chemical residues
- § 346b. — Authorization of appropriations
- § 347. — Intrastate sales of colored oleomargarine
- § 347a. — Congressional declaration of policy regarding oleomargarine sales
- § 347b. — Contravention of State laws
- § 348. — Food additives
- § 349. — Bottled drinking water standards; publication in Federal Register
- § 350. — Vitamins and minerals
- § 350a. — Infant formulas
- § 350a–1. — Protecting infants and improving formula supply
- § 350b. — New dietary ingredients
- § 350c. — Maintenance and inspection of records
- § 350d. — Registration of food facilities
- § 350e. — Sanitary transportation practices
- § 350f. — Reportable food registry
- § 350g. — Hazard analysis and risk-based preventive controls
- § 350h. — Standards for produce safety
- § 350i. — Protection against intentional adulteration
- § 350j. — Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
- § 350k. — Laboratory accreditation for analyses of foods
- § 350l. — Mandatory recall authority
- § 350l–1. — Annual report to Congress
- § 350m. — Requirements for critical food
SUBCHAPTER V — DRUGS AND DEVICES 129 sections
Part A — Drugs and Devices 67 sections
- § 351. — Adulterated drugs and devices
- § 352. — Misbranded drugs and devices
- § 353. — Exemptions and consideration for certain drugs, devices, and biological products
- § 353a. — Pharmacy compounding
- § 353a–1. — Enhanced communication
- § 353b. — Outsourcing facilities
- § 353c. — Prereview of television advertisements
- § 353d. — Process to update labeling for certain generic drugs
- § 354. — Veterinary feed directive drugs
- § 355. — New drugs
- § 355–1. — Risk evaluation and mitigation strategies
- § 355–2. — Actions for delays of generic drugs and biosimilar biological products
- § 355a. — Pediatric studies of drugs
- § 355b. — Adverse-event reporting
- § 355c. — Research into pediatric uses for drugs and biological products
- § 355c–1. — Report
- § 355d. — Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
- § 355e. — Pharmaceutical security
- § 355f. — Extension of exclusivity period for new qualified infectious disease products
- § 355g. — Utilizing real world evidence
- § 355h. — Regulation of certain nonprescription drugs that are marketed without an approved drug application
- § 356. — Expedited approval of drugs for serious or life-threatening diseases or conditions
- § 356–1. — Accelerated approval of priority countermeasures
- § 356–2. — Accelerated approval Council
- § 356a. — Manufacturing changes
- § 356b. — Reports of postmarketing studies
- § 356c. — Discontinuance or interruption in the production of life-saving drugs
- § 356c–1. — Annual reporting on drug shortages
- § 356d. — Coordination; task force and strategic plan
- § 356e. — Drug shortage list
- § 356f. — Hospital repackaging of drugs in shortage
- § 356g. — Standards for regenerative medicine and regenerative advanced therapies
- § 356h. — Competitive generic therapies
- § 356i. — Prompt reports of marketing status
- § 356j. — Discontinuance or interruption in the production of medical devices
- § 356k. — Platform technologies
- § 356l. — Advanced manufacturing technologies designation program
- § 357. — Qualification of drug development tools
- § 358. — Authority to designate official names
- § 359. — Nonapplicability of subchapter to cosmetics
- § 360. — Registration of producers of drugs or devices
- § 360a. — Clinical trial guidance for antibiotic drugs
- § 360a–1. — Clinical trials
- § 360a–2. — Susceptibility test interpretive criteria for microorganisms
- § 360b. — New animal drugs
- § 360b–1. — Priority zoonotic animal drugs
- § 360c. — Classification of devices intended for human use
- § 360c–1. — Reporting
- § 360d. — Performance standards
- § 360e. — Premarket approval
- § 360e–1. — Pediatric uses of devices
- § 360e–3. — Breakthrough devices
- § 360e–4. — Predetermined change control plans for devices
- § 360f. — Banned devices
- § 360g. — Judicial review
- § 360g–1. — Agency documentation and review of significant decisions regarding devices
- § 360g–2. — Third party data transparency
- § 360h. — Notification and other remedies
- § 360h–1. — Program to improve the device recall system
- § 360i. — Records and reports on devices
- § 360j. — General provisions respecting control of devices intended for human use
- § 360k. — State and local requirements respecting devices
- § 360l. — Postmarket surveillance
- § 360m. — Accredited persons
- § 360n. — Priority review to encourage treatments for tropical diseases
- § 360n–1. — Priority review for qualified infectious disease products
- § 360n–2. — Ensuring cybersecurity of devices
Part B — Drugs for Rare Diseases or Conditions 8 sections
- § 360aa. — Recommendations for investigations of drugs for rare diseases or conditions
- § 360bb. — Designation of drugs for rare diseases or conditions
- § 360cc. — Protection for drugs for rare diseases or conditions
- § 360dd. — Open protocols for investigations of drugs for rare diseases or conditions
- § 360ee. — Grants and contracts for development of drugs for rare diseases and conditions
- § 360ee–1. — FDA rare neurodegenerative disease grant program
- § 360ff. — Priority review to encourage treatments for rare pediatric diseases
- § 360ff–1. — Targeted drugs for rare diseases
Part C — Electronic Product Radiation Control 12 sections
- § 360hh. — Definitions
- § 360ii. — Program of control
- § 360jj. — Studies by Secretary
- § 360kk. — Performance standards for electronic products
- § 360ll. — Notification of defects in and repair or replacement of electronic products
- § 360mm. — Imports
- § 360nn. — Inspection, records, and reports
- § 360oo. — Prohibited acts
- § 360pp. — Enforcement
- § 360qq. — Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
- § 360rr. — Federal-State cooperation
- § 360ss. — State standards
Part D — Dissemination of Treatment Information 1 sections
Part E — General Provisions Relating to Drugs and Devices 21 sections
- § 360bbb. — Expanded access to unapproved therapies and diagnostics
- § 360bbb–0. — Expanded access policy required for investigational drugs
- § 360bbb–0a. — Investigational drugs for use by eligible patients
- § 360bbb–1. — Dispute resolution
- § 360bbb–2. — Classification of products
- § 360bbb–3. — Authorization for medical products for use in emergencies
- § 360bbb–3a. — Emergency use of medical products
- § 360bbb–3b. — Products held for emergency use
- § 360bbb–3c. — Expedited development and review of medical products for emergency uses
- § 360bbb–4. — Countermeasure development, review, and technical assistance
- § 360bbb–4a. — Priority review to encourage treatments for agents that present national security threats
- § 360bbb–4b. — Medical countermeasure master files
- § 360bbb–5. — Critical Path Public-Private Partnerships
- § 360bbb–5a. — Emerging technology program
- § 360bbb–6. — Risk communication
- § 360bbb–7. — Notification
- § 360bbb–8. — Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
- § 360bbb–8a. — Optimizing global clinical trials
- § 360bbb–8b. — Use of clinical investigation data from outside the United States
- § 360bbb–8c. — Patient participation in medical product discussion
- § 360bbb–8d. — Notification, nondistribution, and recall of controlled substances
Part F — New Animal Drugs for Minor Use and Minor Species 3 sections
Part G — Medical Gases 3 sections
Part H — Pharmaceutical Distribution Supply Chain 5 sections
Part I — Nonprescription Sunscreen and Other Active Ingredients 9 sections
- § 360fff. — Definitions
- § 360fff–1. — Submission of requests
- § 360fff–2. — Eligibility determinations; data submission; filing
- § 360fff–3. — GRASE determination
- § 360fff–4. — Guidance; other provisions
- § 360fff–5. — Repealed. Pub. L. 116–136, div. A, title III, § 3854(b)(5), Mar. 27, 2020, 134 Stat. 456
- § 360fff–6. — Non-sunscreen time and extent applications
- § 360fff–7. — Report
- § 360fff–8. — Sunset
SUBCHAPTER VI — COSMETICS 14 sections
- § 361. — Adulterated cosmetics
- § 362. — Misbranded cosmetics
- § 363. — Regulations making exemptions
- § 364. — Definitions
- § 364a. — Adverse events
- § 364b. — Good manufacturing practice
- § 364c. — Registration and product listing
- § 364d. — Safety substantiation
- § 364e. — Labeling
- § 364f. — Records
- § 364g. — Mandatory recall authority
- § 364h. — Small businesses
- § 364i. — Exemption for certain products and facilities
- § 364j. — Preemption
SUBCHAPTER VII — GENERAL AUTHORITY 60 sections
Part A — General Administrative Provisions 22 sections
- § 371. — Regulations and hearings
- § 372. — Examinations and investigations
- § 372a. — Transferred
- § 373. — Records
- § 374. — Inspection
- § 374a. — Inspections relating to food allergens
- § 375. — Publicity
- § 376. — Examination of sea food on request of packer; marking food with results; fees; penalties
- § 377. — Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
- § 378. — Advertising of foods
- § 379. — Confidential information
- § 379a. — Presumption of existence of jurisdiction
- § 379b. — Consolidated administrative and laboratory facility
- § 379c. — Transferred
- § 379d. — Automation of Food and Drug Administration
- § 379d–1. — Conflicts of interest
- § 379d–2. — Policy on the review and clearance of scientific articles published by FDA employees
- § 379d–3. — Streamlined hiring authority
- § 379d–3a. — Hiring authority for scientific, technical, and professional personnel
- § 379d–3b. — Strategic Workforce Plan and report
- § 379d–4. — Reporting requirements
- § 379d–5. — Guidance document regarding product promotion using the Internet
Part B — Colors 1 sections
Part C — Fees 25 sections
subpart 1 — freedom of information fees 1 sections
subpart 2 — fees relating to drugs 4 sections
subpart 3 — fees relating to devices 3 sections
subpart 4 — fees relating to animal drugs 3 sections
subpart 5 — fees relating to generic new animal drugs 2 sections
subpart 6 — fees related to food 1 sections
subpart 7 — fees relating to generic drugs 3 sections
subpart 8 — fees relating to biosimilar biological products 3 sections
subpart 9 — fees relating to outsourcing facilities 2 sections
subpart 10 — fees relating to over-the-counter drugs 3 sections
Part D — Information and Education 3 sections
Part E — Environmental Impact Review 1 sections
Part F — National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics 2 sections
Part G — Safety Reports 1 sections
Part H — Serious Adverse Event Reports 2 sections
Part I — Reagan-Udall Foundation for the Food and Drug Administration 3 sections
SUBCHAPTER VIII — IMPORTS AND EXPORTS 11 sections
- § 381. — Imports and exports
- § 382. — Exports of certain unapproved products
- § 383. — Office of International Relations
- § 384. — Importation of prescription drugs
- § 384a. — Foreign supplier verification program
- § 384b. — Voluntary qualified importer program
- § 384c. — Inspection of foreign food facilities
- § 384d. — Accreditation of third-party auditors
- § 384e. — Recognition of foreign government inspections
- § 384f. — Strengthening FDA and CBP coordination and capacity
- § 384g. — Restricting entrance of illicit drugs
SUBCHAPTER IX — TOBACCO PRODUCTS 25 sections
- § 387. — Definitions
- § 387a. — FDA authority over tobacco products
- § 387a–1. — Final rule
- § 387b. — Adulterated tobacco products
- § 387c. — Misbranded tobacco products
- § 387d. — Submission of health information to the Secretary
- § 387e. — Annual registration
- § 387f. — General provisions respecting control of tobacco products
- § 387f–1. — Enforcement action plan for advertising and promotion restrictions
- § 387g. — Tobacco product standards
- § 387h. — Notification and other remedies
- § 387i. — Records and reports on tobacco products
- § 387j. — Application for review of certain tobacco products
- § 387k. — Modified risk tobacco products
- § 387l. — Judicial review
- § 387m. — Equal treatment of retail outlets
- § 387n. — Jurisdiction of and coordination with the Federal Trade Commission
- § 387o. — Regulation requirement
- § 387p. — Preservation of State and local authority
- § 387q. — Tobacco Products Scientific Advisory Committee
- § 387r. — Drug products used to treat tobacco dependence
- § 387s. — User fees
- § 387t. — Labeling, recordkeeping, records inspection
- § 387u. — Studies of progress and effectiveness
- § 387v. — Reporting on tobacco regulation activities
SUBCHAPTER X — MISCELLANEOUS 19 sections
- § 391. — Separability clause
- § 392. — Exemption of meats and meat food products
- § 393. — Food and Drug Administration
- § 393a. — Office of Pediatric Therapeutics
- § 394. — Scientific review groups
- § 395. — Loan repayment program
- § 396. — Practice of medicine
- § 397. — Contracts for expert review
- § 398. — Notices to States regarding imported food
- § 399. — Grants to enhance food safety
- § 399a. — Office of the Chief Scientist
- § 399b. — Office of Women’s Health
- § 399c. — Improving the training of State, local, territorial, and tribal food safety officials
- § 399d. — Employee protections
- § 399e. — Nanotechnology
- § 399f. — Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
- § 399g. — Food and Drug Administration Intercenter Institutes
- § 399h. — National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
- § 399i. — Food and Drug Administration Working Capital Fund