Title 21 — Food and Drugs

Every section of Title 21 of the United States Code, food and drugs — 789 sections, full text, with the cases that cite each one.

• 21 U.S.C. § 358 — Authority to designate official names
• 21 U.S.C. § 359 — Nonapplicability of subchapter to cosmetics
• 21 U.S.C. § 360 — Registration of producers of drugs or devices
• 21 U.S.C. § 360a — Clinical trial guidance for antibiotic drugs
• 21 U.S.C. § 360aa — Recommendations for investigations of drugs for rare diseases or conditions
• 21 U.S.C. § 360aaa...360aaa–6 — Omitted
• 21 U.S.C. § 360a–1 — Clinical trials
• 21 U.S.C. § 360a–2 — Susceptibility test interpretive criteria for microorganisms
• 21 U.S.C. § 360b — New animal drugs
• 21 U.S.C. § 360bb — Designation of drugs for rare diseases or conditions
• 21 U.S.C. § 360bbb — Expanded access to unapproved therapies and diagnostics
• 21 U.S.C. § 360bbb–0 — Expanded access policy required for investigational drugs
• 21 U.S.C. § 360bbb–0a — Investigational drugs for use by eligible patients
• 21 U.S.C. § 360bbb–1 — Dispute resolution
• 21 U.S.C. § 360bbb–2 — Classification of products
• 21 U.S.C. § 360bbb–3 — Authorization for medical products for use in emergencies
• 21 U.S.C. § 360bbb–3a — Emergency use of medical products
• 21 U.S.C. § 360bbb–3b — Products held for emergency use
• 21 U.S.C. § 360bbb–3c — Expedited development and review of medical products for emergency uses
• 21 U.S.C. § 360bbb–4 — Countermeasure development, review, and technical assistance
• 21 U.S.C. § 360bbb–4a — Priority review to encourage treatments for agents that present national security threats
• 21 U.S.C. § 360bbb–4b — Medical countermeasure master files
• 21 U.S.C. § 360bbb–5 — Critical Path Public-Private Partnerships
• 21 U.S.C. § 360bbb–5a — Emerging technology program
• 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. § 360b–1 — Priority zoonotic animal drugs
• 21 U.S.C. § 360c — Classification of devices intended for human use
• 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. § 360c–1 — Reporting
• 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. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• 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. § 360ee–1 — FDA rare neurodegenerative disease grant program
• 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. § 360f — Banned devices
• 21 U.S.C. § 360ff — Priority review to encourage treatments for rare pediatric 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. § 360ff–1 — Targeted drugs for rare diseases
• 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. § 360hh — Definitions
• 21 U.S.C. § 360h–1 — Program to improve the device recall system
• 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. § 360nn — Inspection, records, and reports
• 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. § 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. § 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. § 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. § 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