Title 21 — Food and Drugs

Every section of Title 21 of the United States Code, food and drugs — 743 sections, full text, with the cases that cite each one.

• 21 U.S.C. § 360bbb-6 — Risk communication
• 21 U.S.C. § 360bbb-7 — Notification
• 21 U.S.C. § 360bbb-8 — Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
• 21 U.S.C. § 360bbb-8a — Optimizing global clinical trials
• 21 U.S.C. § 360bbb-8b — Use of clinical investigation data from outside the United States
• 21 U.S.C. § 360bbb-8c — Patient participation in medical product discussion
• 21 U.S.C. § 360bbb-8d — Notification, nondistribution, and recall of controlled substances
• 21 U.S.C. § 360c — Classification of devices intended for human use
• 21 U.S.C. § 360c-1 — Reporting
• 21 U.S.C. § 360cc — Protection for drugs for rare diseases or conditions
• 21 U.S.C. § 360ccc — Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
• 21 U.S.C. § 360ccc-1 — Index of legally marketed unapproved new animal drugs for minor species
• 21 U.S.C. § 360ccc-2 — Designated new animal drugs for minor use or minor species
• 21 U.S.C. § 360d — Performance standards
• 21 U.S.C. § 360dd — Open protocols for investigations of drugs for rare diseases or conditions
• 21 U.S.C. § 360ddd — Definitions
• 21 U.S.C. § 360ddd-1 — Regulation of medical gases
• 21 U.S.C. § 360ddd-2 — Inapplicability of drug fees to designated medical gases
• 21 U.S.C. § 360e — Premarket approval
• 21 U.S.C. § 360e-1 — Pediatric uses of devices
• 21 U.S.C. § 360e-3 — Breakthrough devices
• 21 U.S.C. § 360e-4 — Predetermined change control plans for devices
• 21 U.S.C. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• 21 U.S.C. § 360ee-1 — FDA rare neurodegenerative disease grant program
• 21 U.S.C. § 360eee — Definitions
• 21 U.S.C. § 360eee-1 — Requirements
• 21 U.S.C. § 360eee-2 — National standards for prescription drug wholesale distributors
• 21 U.S.C. § 360eee-3 — National standards for third-party logistics providers
• 21 U.S.C. § 360eee-4 — Uniform national policy
• 21 U.S.C. § 360f — Banned devices
• 21 U.S.C. § 360ff — Priority review to encourage treatments for rare pediatric diseases
• 21 U.S.C. § 360ff-1 — Targeted drugs for rare diseases
• 21 U.S.C. § 360fff — Definitions
• 21 U.S.C. § 360fff-1 — Submission of requests
• 21 U.S.C. § 360fff-2 — Eligibility determinations; data submission; filing
• 21 U.S.C. § 360fff-3 — GRASE determination
• 21 U.S.C. § 360fff-4 — Guidance; other provisions
• 21 U.S.C. § 360fff-5 — Repealed. Pub. L. 116–136, div. A, title III, §3854(b)(5), Mar. 27, 2020, 134 Stat. 456
• 21 U.S.C. § 360fff-6 — Non-sunscreen time and extent applications
• 21 U.S.C. § 360fff-7 — Report
• 21 U.S.C. § 360fff-8 — Sunset
• 21 U.S.C. § 360g — Judicial review
• 21 U.S.C. § 360g-1 — Agency documentation and review of significant decisions regarding devices
• 21 U.S.C. § 360g-2 — Third party data transparency
• 21 U.S.C. § 360h — Notification and other remedies
• 21 U.S.C. § 360h-1 — Program to improve the device recall system
• 21 U.S.C. § 360hh — Definitions
• 21 U.S.C. § 360i — Records and reports on devices
• 21 U.S.C. § 360ii — Program of control
• 21 U.S.C. § 360j — General provisions respecting control of devices intended for human use
• 21 U.S.C. § 360jj — Studies by Secretary
• 21 U.S.C. § 360k — State and local requirements respecting devices
• 21 U.S.C. § 360kk — Performance standards for electronic products
• 21 U.S.C. § 360l — Postmarket surveillance
• 21 U.S.C. § 360ll — Notification of defects in and repair or replacement of electronic products
• 21 U.S.C. § 360m — Accredited persons
• 21 U.S.C. § 360mm — Imports
• 21 U.S.C. § 360n — Priority review to encourage treatments for tropical diseases
• 21 U.S.C. § 360n-1 — Priority review for qualified infectious disease products
• 21 U.S.C. § 360n-2 — Ensuring cybersecurity of devices
• 21 U.S.C. § 360nn — Inspection, records, and reports
• 21 U.S.C. § 360oo — Prohibited acts
• 21 U.S.C. § 360pp — Enforcement
• 21 U.S.C. § 360qq — Repealed. Pub. L. 105–362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
• 21 U.S.C. § 360rr — Federal-State cooperation
• 21 U.S.C. § 360ss — State standards
• 21 U.S.C. § 361 — Adulterated cosmetics
• 21 U.S.C. § 362 — Misbranded cosmetics
• 21 U.S.C. § 363 — Regulations making exemptions
• 21 U.S.C. § 364 — Definitions
• 21 U.S.C. § 364a — Adverse events
• 21 U.S.C. § 364b — Good manufacturing practice
• 21 U.S.C. § 364c — Registration and product listing
• 21 U.S.C. § 364d — Safety substantiation
• 21 U.S.C. § 364e — Labeling
• 21 U.S.C. § 364f — Records
• 21 U.S.C. § 364g — Mandatory recall authority
• 21 U.S.C. § 364h — Small businesses
• 21 U.S.C. § 364i — Exemption for certain products and facilities
• 21 U.S.C. § 364j — Preemption
• 21 U.S.C. § 371 — Regulations and hearings
• 21 U.S.C. § 372 — Examinations and investigations
• 21 U.S.C. § 372a — Transferred
• 21 U.S.C. § 373 — Records
• 21 U.S.C. § 374 — Inspection
• 21 U.S.C. § 374a — Inspections relating to food allergens
• 21 U.S.C. § 375 — Publicity
• 21 U.S.C. § 376 — Examination of sea food on request of packer; marking food with results; fees; penalties
• 21 U.S.C. § 377 — Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
• 21 U.S.C. § 378 — Advertising of foods
• 21 U.S.C. § 379 — Confidential information
• 21 U.S.C. § 379a — Presumption of existence of jurisdiction
• 21 U.S.C. § 379aa — Serious adverse event reporting for nonprescription drugs
• 21 U.S.C. § 379aa-1 — Serious adverse event reporting for dietary supplements
• 21 U.S.C. § 379b — Consolidated administrative and laboratory facility
• 21 U.S.C. § 379c — Transferred
• 21 U.S.C. § 379d — Automation of Food and Drug Administration
• 21 U.S.C. § 379d-1 — Conflicts of interest
• 21 U.S.C. § 379d-2 — Policy on the review and clearance of scientific articles published by FDA employees
• 21 U.S.C. § 379d-3 — Streamlined hiring authority
• 21 U.S.C. § 379d-3a — Hiring authority for scientific, technical, and professional personnel
• 21 U.S.C. § 379d-3b — Strategic Workforce Plan and report
• 21 U.S.C. § 379d-4 — Reporting requirements
• 21 U.S.C. § 379d-5 — Guidance document regarding product promotion using the Internet
• 21 U.S.C. § 379dd — Establishment and functions of the Foundation
• 21 U.S.C. § 379dd-1 — Location of Foundation
• 21 U.S.C. § 379dd-2 — Activities of the Food and Drug Administration
• 21 U.S.C. § 379e — Listing and certification of color additives for foods, drugs, devices, and cosmetics
• 21 U.S.C. § 379f — Recovery and retention of fees for freedom of information requests
• 21 U.S.C. § 379g — Definitions
• 21 U.S.C. § 379h — Authority to assess and use drug fees
• 21 U.S.C. § 379h-1 — Fees relating to advisory review of prescription-drug television advertising
• 21 U.S.C. § 379h-2 — Reauthorization; reporting requirements
• 21 U.S.C. § 379i — Definitions
• 21 U.S.C. § 379j — Authority to assess and use device fees
• 21 U.S.C. § 379j-1 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j-11 — Definitions
• 21 U.S.C. § 379j-12 — Authority to assess and use animal drug fees
• 21 U.S.C. § 379j-13 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j-21 — Authority to assess and use generic new animal drug fees
• 21 U.S.C. § 379j-22 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j-31 — Authority to collect and use fees
• 21 U.S.C. § 379j-41 — Definitions
• 21 U.S.C. § 379j-42 — Authority to assess and use human generic drug fees
• 21 U.S.C. § 379j-43 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j-51 — Definitions
• 21 U.S.C. § 379j-52 — Authority to assess and use biosimilar biological product fees
• 21 U.S.C. § 379j-53 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j-61 — Definitions
• 21 U.S.C. § 379j-62 — Authority to assess and use outsourcing facility fees
• 21 U.S.C. § 379j-71 — Definitions
• 21 U.S.C. § 379j-72 — Authority to assess and use OTC monograph fees
• 21 U.S.C. § 379j-73 — Reauthorization; reporting requirements
• 21 U.S.C. § 379k — Information system
• 21 U.S.C. § 379k-1 — Electronic format for submissions
• 21 U.S.C. § 379l — Education
• 21 U.S.C. § 379o — Environmental impact
• 21 U.S.C. § 379r — National uniformity for nonprescription drugs
• 21 U.S.C. § 379s — Preemption for labeling or packaging of cosmetics
• 21 U.S.C. § 379v — Safety report disclaimers
• 21 U.S.C. § 381 — Imports and exports
• 21 U.S.C. § 382 — Exports of certain unapproved products
• 21 U.S.C. § 383 — Office of International Relations
• 21 U.S.C. § 384 — Importation of prescription drugs
• 21 U.S.C. § 384a — Foreign supplier verification program
• 21 U.S.C. § 384b — Voluntary qualified importer program
• 21 U.S.C. § 384c — Inspection of foreign food facilities
• 21 U.S.C. § 384d — Accreditation of third-party auditors
• 21 U.S.C. § 384e — Recognition of foreign government inspections
• 21 U.S.C. § 384f — Strengthening FDA and CBP coordination and capacity
• 21 U.S.C. § 384g — Restricting entrance of illicit drugs
• 21 U.S.C. § 387 — Definitions
• 21 U.S.C. § 387a — FDA authority over tobacco products
• 21 U.S.C. § 387a-1 — Final rule
• 21 U.S.C. § 387b — Adulterated tobacco products
• 21 U.S.C. § 387c — Misbranded tobacco products
• 21 U.S.C. § 387d — Submission of health information to the Secretary
• 21 U.S.C. § 387e — Annual registration
• 21 U.S.C. § 387f — General provisions respecting control of tobacco products
• 21 U.S.C. § 387f-1 — Enforcement action plan for advertising and promotion restrictions
• 21 U.S.C. § 387g — Tobacco product standards
• 21 U.S.C. § 387h — Notification and other remedies
• 21 U.S.C. § 387i — Records and reports on tobacco products
• 21 U.S.C. § 387j — Application for review of certain tobacco products
• 21 U.S.C. § 387k — Modified risk tobacco products
• 21 U.S.C. § 387l — Judicial review
• 21 U.S.C. § 387m — Equal treatment of retail outlets
• 21 U.S.C. § 387n — Jurisdiction of and coordination with the Federal Trade Commission
• 21 U.S.C. § 387o — Regulation requirement
• 21 U.S.C. § 387p — Preservation of State and local authority
• 21 U.S.C. § 387q — Tobacco Products Scientific Advisory Committee
• 21 U.S.C. § 387r — Drug products used to treat tobacco dependence
• 21 U.S.C. § 387s — User fees
• 21 U.S.C. § 387t — Labeling, recordkeeping, records inspection
• 21 U.S.C. § 387u — Studies of progress and effectiveness
• 21 U.S.C. § 387v — Reporting on tobacco regulation activities
• 21 U.S.C. § 391 — Separability clause
• 21 U.S.C. § 392 — Exemption of meats and meat food products
• 21 U.S.C. § 393 — Food and Drug Administration
• 21 U.S.C. § 393a — Office of Pediatric Therapeutics
• 21 U.S.C. § 394 — Scientific review groups
• 21 U.S.C. § 395 — Loan repayment program
• 21 U.S.C. § 396 — Practice of medicine
• 21 U.S.C. § 397 — Contracts for expert review
• 21 U.S.C. § 398 — Notices to States regarding imported food
• 21 U.S.C. § 399 — Grants to enhance food safety
• 21 U.S.C. § 399a — Office of the Chief Scientist
• 21 U.S.C. § 399b — Office of Women's Health
• 21 U.S.C. § 399c — Improving the training of State, local, territorial, and tribal food safety officials
• 21 U.S.C. § 399d — Employee protections
• 21 U.S.C. § 399e — Nanotechnology
• 21 U.S.C. § 399f — Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
• 21 U.S.C. § 399g — Food and Drug Administration Intercenter Institutes
• 21 U.S.C. § 399h — National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
• 21 U.S.C. § 399i — Food and Drug Administration Working Capital Fund
• 21 U.S.C. § 451 — Congressional statement of findings
• 21 U.S.C. § 452 — Congressional declaration of policy
• 21 U.S.C. § 453 — Definitions
• 21 U.S.C. § 454 — Federal and State cooperation in development and administration of State poultry product inspection programs
• 21 U.S.C. § 455 — Inspection in official establishments