Title 21 — Food and Drugs
Chapter 9. Federal Food, Drug, and Cosmetic Act
310 sections
Subchapter I — Short Title
Subchapter II — Definitions
Subchapter III — Prohibited Acts and Penalties
- 331Prohibited acts
- 332Injunction proceedings
- 333Penalties
- 333aRepealed. Pub. L. 101–647, title XIX, § 1905
- 334Seizure
- 335Hearing before report of criminal violation
- 335aDebarment, temporary denial of approval, and suspension
- 335bCivil penalties
- 335cAuthority to withdraw approval of abbreviated drug applications
- 336Report of minor violations
- 337Proceedings in name of United States; provision as to subpoenas
- 337aExtraterritorial jurisdiction
Subchapter IV — Food
- 341Definitions and standards for food
- 342Adulterated food
- 343Misbranded food
- 343–1National uniform nutrition labeling
- 343–2Dietary supplement labeling exemptions
- 343–3Disclosure
- 343aRepealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517]
- 344Emergency permit control
- 345Regulations making exemptions
- 346Tolerances for poisonous or deleterious substances in food; regulations
- 346aTolerances and exemptions for pesticide chemical residues
- 346bAuthorization of appropriations
- 347Intrastate sales of colored oleomargarine
- 347aCongressional declaration of policy regarding oleomargarine sales
- 347bContravention of State laws
- 348Food additives
- 349Bottled drinking water standards; publication in Federal Register
- 350Vitamins and minerals
- 350aInfant formulas
- 350a–1Protecting infants and improving formula supply
- 350bNew dietary ingredients
- 350cMaintenance and inspection of records
- 350dRegistration of food facilities
- 350eSanitary transportation practices
- 350fReportable food registry
- 350gHazard analysis and risk-based preventive controls
- 350hStandards for produce safety
- 350iProtection against intentional adulteration
- 350jTargeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
- 350kLaboratory accreditation for analyses of foods
- 350lMandatory recall authority
- 350l–1Annual report to Congress
- 350mRequirements for critical food
Part A — Drugs and Devices
- 351Adulterated drugs and devices
- 352Misbranded drugs and devices
- 353Exemptions and consideration for certain drugs, devices, and biological products
- 353aPharmacy compounding
- 353a–1Enhanced communication
- 353bOutsourcing facilities
- 353cPrereview of television advertisements
- 353dProcess to update labeling for certain generic drugs
- 354Veterinary feed directive drugs
- 355New drugs
- 355–1Risk evaluation and mitigation strategies
- 355–2Actions for delays of generic drugs and biosimilar biological products
- 355aPediatric studies of drugs
- 355bAdverse-event reporting
- 355cResearch into pediatric uses for drugs and biological products
- 355c–1Report
- 355dInternal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
- 355ePharmaceutical security
- 355fExtension of exclusivity period for new qualified infectious disease products
- 355gUtilizing real world evidence
- 355hRegulation of certain nonprescription drugs that are marketed without an approved drug application
- 356Expedited approval of drugs for serious or life-threatening diseases or conditions
- 356–1Accelerated approval of priority countermeasures
- 356–2Accelerated approval Council
- 356aManufacturing changes
- 356bReports of postmarketing studies
- 356cDiscontinuance or interruption in the production of life-saving drugs
- 356c–1Annual reporting on drug shortages
- 356dCoordination; task force and strategic plan
- 356eDrug shortage list
- 356fHospital repackaging of drugs in shortage
- 356gStandards for regenerative medicine and regenerative advanced therapies
- 356hCompetitive generic therapies
- 356iPrompt reports of marketing status
- 356jDiscontinuance or interruption in the production of medical devices
- 356kPlatform technologies
- 356lAdvanced manufacturing technologies designation program
- 357Qualification of drug development tools
- 358Authority to designate official names
- 359Nonapplicability of subchapter to cosmetics
- 360Registration of producers of drugs or devices
- 360aClinical trial guidance for antibiotic drugs
- 360a–1Clinical trials
- 360a–2Susceptibility test interpretive criteria for microorganisms
- 360bNew animal drugs
- 360b–1Priority zoonotic animal drugs
- 360cClassification of devices intended for human use
- 360c–1Reporting
- 360dPerformance standards
- 360ePremarket approval
- 360e–1Pediatric uses of devices
- 360e–3Breakthrough devices
- 360e–4Predetermined change control plans for devices
- 360fBanned devices
- 360gJudicial review
- 360g–1Agency documentation and review of significant decisions regarding devices
- 360g–2Third party data transparency
- 360hNotification and other remedies
- 360h–1Program to improve the device recall system
- 360iRecords and reports on devices
- 360jGeneral provisions respecting control of devices intended for human use
- 360kState and local requirements respecting devices
- 360lPostmarket surveillance
- 360mAccredited persons
- 360nPriority review to encourage treatments for tropical diseases
- 360n–1Priority review for qualified infectious disease products
- 360n–2Ensuring cybersecurity of devices
Part B — Drugs for Rare Diseases or Conditions
- 360aaRecommendations for investigations of drugs for rare diseases or conditions
- 360bbDesignation of drugs for rare diseases or conditions
- 360ccProtection for drugs for rare diseases or conditions
- 360ddOpen protocols for investigations of drugs for rare diseases or conditions
- 360eeGrants and contracts for development of drugs for rare diseases and conditions
- 360ee–1FDA rare neurodegenerative disease grant program
- 360ffPriority review to encourage treatments for rare pediatric diseases
- 360ff–1Targeted drugs for rare diseases
Part C — Electronic Product Radiation Control
- 360hhDefinitions
- 360iiProgram of control
- 360jjStudies by Secretary
- 360kkPerformance standards for electronic products
- 360llNotification of defects in and repair or replacement of electronic products
- 360mmImports
- 360nnInspection, records, and reports
- 360ooProhibited acts
- 360ppEnforcement
- 360qqRepealed. Pub. L. 105–362, title VI, § 601(a)(2)(A)
- 360rrFederal-State cooperation
- 360ssState standards
Part D — Dissemination of Treatment Information
Part E — General Provisions Relating to Drugs and Devices
- 360bbbExpanded access to unapproved therapies and diagnostics
- 360bbb–0Expanded access policy required for investigational drugs
- 360bbb–0aInvestigational drugs for use by eligible patients
- 360bbb–1Dispute resolution
- 360bbb–2Classification of products
- 360bbb–3Authorization for medical products for use in emergencies
- 360bbb–3aEmergency use of medical products
- 360bbb–3bProducts held for emergency use
- 360bbb–3cExpedited development and review of medical products for emergency uses
- 360bbb–4Countermeasure development, review, and technical assistance
- 360bbb–4aPriority review to encourage treatments for agents that present national security threats
- 360bbb–4bMedical countermeasure master files
- 360bbb–5Critical Path Public-Private Partnerships
- 360bbb–5aEmerging technology program
- 360bbb–6Risk communication
- 360bbb–7Notification
- 360bbb–8Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
- 360bbb–8aOptimizing global clinical trials
- 360bbb–8bUse of clinical investigation data from outside the United States
- 360bbb–8cPatient participation in medical product discussion
- 360bbb–8dNotification, nondistribution, and recall of controlled substances
Part F — New Animal Drugs for Minor Use and Minor Species
Part G — Medical Gases
Part H — Pharmaceutical Distribution Supply Chain
Part I — Nonprescription Sunscreen and Other Active Ingredients
- 360fffDefinitions
- 360fff–1Submission of requests
- 360fff–2Eligibility determinations; data submission; filing
- 360fff–3GRASE determination
- 360fff–4Guidance; other provisions
- 360fff–5Repealed. Pub. L. 116–136, div. A, title III, § 3854(b)(5)
- 360fff–6Non-sunscreen time and extent applications
- 360fff–7Report
- 360fff–8Sunset
Subchapter VI — Cosmetics
- 361Adulterated cosmetics
- 362Misbranded cosmetics
- 363Regulations making exemptions
- 364Definitions
- 364aAdverse events
- 364bGood manufacturing practice
- 364cRegistration and product listing
- 364dSafety substantiation
- 364eLabeling
- 364fRecords
- 364gMandatory recall authority
- 364hSmall businesses
- 364iExemption for certain products and facilities
- 364jPreemption
Part A — General Administrative Provisions
- 371Regulations and hearings
- 372Examinations and investigations
- 372aTransferred
- 373Records
- 374Inspection
- 374aInspections relating to food allergens
- 375Publicity
- 376Examination of sea food on request of packer; marking food with results; fees; penalties
- 377Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
- 378Advertising of foods
- 379Confidential information
- 379aPresumption of existence of jurisdiction
- 379bConsolidated administrative and laboratory facility
- 379cTransferred
- 379dAutomation of Food and Drug Administration
- 379d–1Conflicts of interest
- 379d–2Policy on the review and clearance of scientific articles published by FDA employees
- 379d–3Streamlined hiring authority
- 379d–3aHiring authority for scientific, technical, and professional personnel
- 379d–3bStrategic Workforce Plan and report
- 379d–4Reporting requirements
- 379d–5Guidance document regarding product promotion using the Internet
Part B — Colors
Subpart 1 — freedom of information fees
Subpart 2 — fees relating to drugs
Subpart 3 — fees relating to devices
Subpart 4 — fees relating to animal drugs
Subpart 5 — fees relating to generic new animal drugs
Subpart 6 — fees related to food
Subpart 7 — fees relating to generic drugs
Subpart 8 — fees relating to biosimilar biological products
Subpart 9 — fees relating to outsourcing facilities
Subpart 10 — fees relating to over-the-counter drugs
Part D — Information and Education
Part E — Environmental Impact Review
Part F — National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics
Part G — Safety Reports
Part H — Serious Adverse Event Reports
Part I — Reagan-Udall Foundation for the Food and Drug Administration
Subchapter VIII — Imports and Exports
- 381Imports and exports
- 382Exports of certain unapproved products
- 383Office of International Relations
- 384Importation of prescription drugs
- 384aForeign supplier verification program
- 384bVoluntary qualified importer program
- 384cInspection of foreign food facilities
- 384dAccreditation of third-party auditors
- 384eRecognition of foreign government inspections
- 384fStrengthening FDA and CBP coordination and capacity
- 384gRestricting entrance of illicit drugs
Subchapter IX — Tobacco Products
- 387Definitions
- 387aFDA authority over tobacco products
- 387a–1Final rule
- 387bAdulterated tobacco products
- 387cMisbranded tobacco products
- 387dSubmission of health information to the Secretary
- 387eAnnual registration
- 387fGeneral provisions respecting control of tobacco products
- 387f–1Enforcement action plan for advertising and promotion restrictions
- 387gTobacco product standards
- 387hNotification and other remedies
- 387iRecords and reports on tobacco products
- 387jApplication for review of certain tobacco products
- 387kModified risk tobacco products
- 387lJudicial review
- 387mEqual treatment of retail outlets
- 387nJurisdiction of and coordination with the Federal Trade Commission
- 387oRegulation requirement
- 387pPreservation of State and local authority
- 387qTobacco Products Scientific Advisory Committee
- 387rDrug products used to treat tobacco dependence
- 387sUser fees
- 387tLabeling, recordkeeping, records inspection
- 387uStudies of progress and effectiveness
- 387vReporting on tobacco regulation activities
Subchapter X — Miscellaneous
- 391Separability clause
- 392Exemption of meats and meat food products
- 393Food and Drug Administration
- 393aOffice of Pediatric Therapeutics
- 394Scientific review groups
- 395Loan repayment program
- 396Practice of medicine
- 397Contracts for expert review
- 398Notices to States regarding imported food
- 399Grants to enhance food safety
- 399aOffice of the Chief Scientist
- 399bOffice of Women’s Health
- 399cImproving the training of State, local, territorial, and tribal food safety officials
- 399dEmployee protections
- 399eNanotechnology
- 399fEnsuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
- 399gFood and Drug Administration Intercenter Institutes
- 399hNational Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
- 399iFood and Drug Administration Working Capital Fund
- 399jAbraham Accords Office