Federal

Title 21 — Food and Drugs

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

• § 2201 — Performance standards
• § 2202 — National Agriculture and Food Defense Strategy
• § 2203 — Food and Agriculture Coordinating Councils
• § 2204 — Building domestic capacity
• § 2205 — Food allergy and anaphylaxis management
• § 2206 — Alcohol-related facilities
• § 221 to 237 — Repealed. July 1, 1944, ch. 373 , title XIII, § 1313, 58 Stat. 714
• § 2221 — Food emergency response network
• § 2222 — Integrated consortium of laboratory networks
• § 2223 — Enhancing tracking and tracing of food and recordkeeping
• § 2224 — Surveillance
• § 2225 — Decontamination and disposal standards and plans
• § 2241 — Inspection by the Secretary of Commerce
• § 2242 — Foreign offices of the Food and Drug Administration
• § 2243 — Smuggled food
• § 2251 — Jurisdiction; authorities
• § 2252 — Compliance with international agreements
• § 23 — Penalties
• § 2301 — Sense of Congress
• § 2302 — Definitions
• § 2311 — Identification of foreign opioid traffickers
• § 2312 — Imposition of sanctions
• § 2313 — Description of sanctions
• § 2313a — Designation of transactions of sanctioned persons as of primary money laundering concern
• § 2314 — Waivers
• § 2315 — Procedures for judicial review of classified information
• § 2316 — Briefings on implementation
• § 2331 — Director of National Intelligence program on use of intelligence resources in efforts to sanction foreign opioid traffickers
• § 2332 — Authorization of appropriations
• § 2333 — Regulatory authority
• § 2334 — Termination
• § 2335 — Exception relating to importation of goods
• § 2341 — Definitions
• § 2351 — Finding; policy
• § 2352 — Use of national emergency authorities; reporting
• § 2353 — Imposition of sanctions with respect to fentanyl trafficking by transnational criminal organizations
• § 2354 — Penalties; waivers; exceptions
• § 2355 — Treatment of forfeited property of transnational criminal organizations
• § 2361 — Treatment of transnational criminal organizations in suspicious transactions reports of the Financial Crimes Enforcement Network
• § 2371 — Exception relating to importation of goods
• § 24 — Omitted
• § 2401 — Definitions
• § 2402 — Major international doping fraud conspiracies
• § 2403 — Criminal penalties and statute of limitations
• § 2404 — Coordination and sharing of information with USADA
• § 25 — Oleomargarine, butterine, or imitation butter or cheese transported into a State subject to its police powers
• § 26 — Omitted
• § 301 — Short title
• § 321 — Definitions; generally
• § 321a — “Butter” defined
• § 321b — “Package” defined
• § 321c — Nonfat dry milk; “milk” defined
• § 321d — Market names for catfish and ginseng
• § 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
• § 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
• § 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
• § 360aa — Recommendations for investigations of drugs for rare diseases or conditions
• § 360aaa to 360aaa–6 — Omitted
• § 360b — New animal drugs
• § 360b–1 — Priority zoonotic animal drugs
• § 360bb — Designation of drugs for rare diseases or conditions
• § 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
• § 360c — Classification of devices intended for human use
• § 360c–1 — Reporting
• § 360cc — Protection for drugs for rare diseases or conditions
• § 360ccc — Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
• § 360ccc–1 — Index of legally marketed unapproved new animal drugs for minor species
• § 360ccc–2 — Designated new animal drugs for minor use or minor species
• § 360d — Performance standards
• § 360dd — Open protocols for investigations of drugs for rare diseases or conditions
• § 360ddd — Definitions
• § 360ddd–1 — Regulation of medical gases
• § 360ddd–2 — Inapplicability of drug fees to designated medical gases
• § 360e — Premarket approval
• § 360e–1 — Pediatric uses of devices
• § 360e–3 — Breakthrough devices
• § 360e–4 — Predetermined change control plans for devices
• § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• § 360ee–1 — FDA rare neurodegenerative disease grant program
• § 360eee — Definitions
• § 360eee–1 — Requirements
• § 360eee–2 — National standards for prescription drug wholesale distributors
• § 360eee–3 — National standards for third-party logistics providers
• § 360eee–4 — Uniform national policy
• § 360f — Banned devices
• § 360ff — Priority review to encourage treatments for rare pediatric diseases
• § 360ff–1 — Targeted drugs for rare diseases
• § 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