21 U.S.C. Chapter 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT

• § 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
• § 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
• § 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
• § 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
• § 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
• § 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
• § 360rr— Federal-State cooperation
• § 360ss— State standards
• § 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
• § 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
• § 360ddd— Definitions
• § 360ddd–1— Regulation of medical gases
• § 360ddd–2— Inapplicability of drug fees to designated medical gases
• § 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
• § 360fff— Definitions
• § 360fff–1— Submission of requests
• § 360fff–2— Eligibility determinations; data submission; filing
• § 360fff–3— GRASE determination
• § 360fff–4— Guidance; other provisions
• § 360fff–6— Non-sunscreen time and extent applications
• § 360fff–7— Report
• § 360fff–8— Sunset
• § 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
• § 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
• § 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
• § 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
• § 379aa— Serious adverse event reporting for nonprescription drugs
• § 379aa–1— Serious adverse event reporting for dietary supplements
• § 379dd— Establishment and functions of the Foundation
• § 379dd–1— Location of Foundation
• § 379dd–2— Activities of the Food and Drug Administration
• § 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