Federal

Title 21 — Food and Drugs

757 sections, each with the official text and a plain-English explanation of what it means for you.

• § 360fff–7 — Report
• § 360fff–8 — Sunset
• § 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
• § 360hh — Definitions
• § 360i — Records and reports on devices
• § 360ii — Program of control
• § 360j — General provisions respecting control of devices intended for human use
• § 360jj — Studies by Secretary
• § 360k — State and local requirements respecting devices
• § 360kk — Performance standards for electronic products
• § 360l — Postmarket surveillance
• § 360ll — Notification of defects in and repair or replacement of electronic products
• § 360m — Accredited persons
• § 360mm — Imports
• § 360n — Priority review to encourage treatments for tropical diseases
• § 360n–1 — Priority review for qualified infectious disease products
• § 360n–2 — Ensuring cybersecurity of devices
• § 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• § 360qq — Repealed.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
• § 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
• § 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
• § 379aa — Serious adverse event reporting for nonprescription drugs
• § 379aa–1 — Serious adverse event reporting for dietary supplements
• § 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
• § 379dd — Establishment and functions of the Foundation
• § 379dd–1 — Location of Foundation
• § 379dd–2 — Activities of the Food and Drug Administration
• § 379e — Listing and certification of color additives for foods, drugs, devices, and cosmetics
• § 379f — Recovery and retention of fees for freedom of information requests
• § 379g — Definitions
• § 379h — Authority to assess and use drug fees
• § 379h–1 — Fees relating to advisory review of prescription-drug television advertising
• § 379h–2 — Reauthorization; reporting requirements
• § 379i — Definitions
• § 379j — Authority to assess and use device fees
• § 379j–1 — Reauthorization; reporting requirements
• § 379j–11 — Definitions
• § 379j–12 — Authority to assess and use animal drug fees
• § 379j–13 — Reauthorization; reporting requirements
• § 379j–21 — Authority to assess and use generic new animal drug fees
• § 379j–22 — Reauthorization; reporting requirements
• § 379j–31 — Authority to collect and use fees
• § 379j–41 — Definitions
• § 379j–42 — Authority to assess and use human generic drug fees
• § 379j–43 — Reauthorization; reporting requirements
• § 379j–51 — Definitions
• § 379j–52 — Authority to assess and use biosimilar biological product fees
• § 379j–53 — Reauthorization; reporting requirements
• § 379j–61 — Definitions
• § 379j–62 — Authority to assess and use outsourcing facility fees
• § 379j–71 — Definitions
• § 379j–72 — Authority to assess and use OTC monograph fees
• § 379j–73 — Reauthorization; reporting requirements
• § 379k — Information system
• § 379k–1 — Electronic format for submissions
• § 379l — Education
• § 379o — Environmental impact
• § 379r — National uniformity for nonprescription drugs
• § 379s — Preemption for labeling or packaging of cosmetics
• § 379v — Safety report disclaimers
• § 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
• § 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
• § 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
• § 399j — Abraham Accords Office
• § 41 to 50 — Repealed. Pub. L. 104–128, § 2 , Apr. 9, 1996 , 110 Stat. 1198
• § 451 — Congressional statement of findings
• § 452 — Congressional declaration of policy
• § 453 — Definitions
• § 454 — Federal and State cooperation in development and administration of State poultry product inspection programs
• § 455 — Inspection in official establishments
• § 456 — Operation of premises, facilities and equipment
• § 457 — Labeling and container standards
• § 458 — Prohibited acts
• § 459 — Compliance by all establishments
• § 460 — Miscellaneous activities subject to regulation
• § 461 — Offenses and punishment
• § 462 — Reporting of violations; notice; opportunity to present views
• § 463 — Rules and regulations
• § 464 — Exemptions
• § 465 — Limitations upon entry of poultry products and other materials into official establishments
• § 466 — Imports
• § 467 — Inspection services
• § 467a — Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks
• § 467b — Seizure and condemnation
• § 467c — Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas
• § 467d — Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts
• § 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
• § 467f — Federal Food, Drug, and Cosmetic Act applications
• § 468 — Cost of inspection; overtime
• § 469 — Authorization of appropriations
• § 470 — Omitted
• § 471 — Safe Meat and Poultry Inspection Panel
• § 472 — Interstate shipment of poultry inspected by Federal and State agencies for certain small establishments
• § 473 — Grants for improvements to meat and poultry facilities to allow for interstate shipment
• § 501 to 517 — Repealed. Pub. L. 91–513, title III, § 1101(a)(10) , Oct. 27, 1970 , 84 Stat. 1292
• § 6 — Transferred
• § 601 — Definitions
• § 602 — Congressional statement of findings
• § 603 — Examination of animals prior to slaughter; use of humane methods
• § 604 — Post mortem examination of carcasses and marking or labeling; destruction of carcasses condemned; reinspection
• § 605 — Examination of carcasses brought into slaughtering or packing establishments, and of meat food products issued from and returned thereto; conditions for entry
• § 606 — Inspection and labeling of meat food products
• § 607 — Labeling, marking, and container requirements
• § 608 — Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products
• § 609 — Examination of animals and food products thereof, slaughtered and prepared during nighttime
• § 61 — Definitions
• § 610 — Prohibited acts