Title 21, Chapter 9
Food and Drugs — 228 active sections, 6 inactive
Sections in this chapter
- § 0Expanded access policy required for investigational drugs
- § 0aInvestigational drugs for use by eligible patients
- § 1Enforcement action plan for advertising and promotion restrictions
- § 2Activities of the Food and Drug Administration
- § 3Streamlined hiring authority
- § 3aHiring authority for scientific, technical, and professional personnel
- § 3bProducts held for emergency use
- § 3cExpedited development and review of medical products for emergency uses
- § 4Reporting requirements
- § 4aPriority review to encourage treatments for agents that present national security threats
- § 4bMedical countermeasure master files
- § 5Guidance document regarding product promotion using the Internet
- § 6Non-sunscreen time and extent applications
- § 7Report
- § 8Sunset
- § 8aOptimizing global clinical trials
- § 8bUse of clinical investigation data from outside the United States
- § 8cPatient participation in medical product discussion
- § 8dNotification, nondistribution, and recall of controlled substances
- § 11Definitions
- § 12Authority to assess and use animal drug fees
- § 13Reauthorization; reporting requirements
- § 21Authority to assess and use generic new animal drug fees
- § 22Reauthorization; reporting requirements
- § 31Authority to collect and use fees
- § 41Definitions
- § 42Authority to assess and use human generic drug fees
- § 43Reauthorization; reporting requirements
- § 51Definitions
- § 52Authority to assess and use biosimilar biological product fees
- § 53Reauthorization; reporting requirements
- § 61Definitions
- § 62Authority to assess and use outsourcing facility fees
- § 71Definitions
- § 72Authority to assess and use OTC monograph fees
- § 73Reauthorization; reporting requirements
- § 301Short title
- § 321Definitions; generally
- § 321a“Butter” defined
- § 321b“Package” defined
- § 321cNonfat dry milk; “milk” defined
- § 321dMarket names for catfish and ginseng
- § 331Prohibited acts
- § 332Injunction proceedings
- § 333Penalties
- § 333aRepealed. Pub. L. 101–647, title XIX, § 1905 , Nov. 29, 1990 , 104 Stat. 4853Repealed
- § 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
- § 341Definitions and standards for food
- § 342Adulterated food
- § 343Misbranded food
- § 343aRepealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517] , Dec. 21, 2000 , 114 Stat. 2763 , 2763A–73Repealed
- § 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
- § 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
- § 351Adulterated drugs and devices
- § 352Misbranded drugs and devices
- § 353Exemptions and consideration for certain drugs, devices, and biological products
- § 353aPharmacy compounding
- § 353bOutsourcing facilities
- § 353cPrereview of television advertisements
- § 354Veterinary feed directive drugs
- § 355New drugs
- § 355aPediatric studies of drugs
- § 355bAdverse-event reporting
- § 355cResearch into pediatric uses for drugs and biological products
- § 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
- § 356aManufacturing changes
- § 356bReports of postmarketing studies
- § 356cDiscontinuance or interruption in the production of life-saving drugs
- § 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
- § 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
- § 360aaRecommendations for investigations of drugs for rare diseases or conditions
- § 360bNew animal drugs
- § 360bbDesignation of drugs for rare diseases or conditions
- § 360bbbExpanded access to unapproved therapies and diagnostics
- § 360cClassification of devices intended for human use
- § 360ccProtection for drugs for rare diseases or conditions
- § 360cccConditional approval of new animal drugs for minor use and minor species and certain new animal drugs
- § 360dPerformance standards
- § 360ddOpen protocols for investigations of drugs for rare diseases or conditions
- § 360dddDefinitions
- § 360ePremarket approval
- § 360eeGrants and contracts for development of drugs for rare diseases and conditions
- § 360eeeDefinitions
- § 360fBanned devices
- § 360ffPriority review to encourage treatments for rare pediatric diseases
- § 360fffDefinitions
- § 360gJudicial review
- § 360hNotification and other remedies
- § 360hhDefinitions
- § 360iRecords and reports on devices
- § 360iiProgram of control
- § 360jGeneral provisions respecting control of devices intended for human use
- § 360jjStudies by Secretary
- § 360kState and local requirements respecting devices
- § 360kkPerformance standards for electronic products
- § 360lPostmarket surveillance
- § 360llNotification of defects in and repair or replacement of electronic products
- § 360mAccredited persons
- § 360mmImports
- § 360nPriority review to encourage treatments for tropical diseases
- § 360nnInspection, records, and reports
- § 360ooProhibited acts
- § 360ppEnforcement
- § 360qqRepealed. Pub. L. 105–362, title VI, § 601(a)(2)(A) , Nov. 10, 1998 , 112 Stat. 3285Repealed
- § 360rrFederal-State cooperation
- § 360ssState standards
- § 361Adulterated cosmetics
- § 362Misbranded cosmetics
- § 363Regulations making exemptions
- § 364Repealed. Pub. L. 86–618, title I, § 103(a)(3) , July 12, 1960 , 74 Stat. 398Repealed
- § 371Regulations and hearings
- § 372Examinations and investigations
- § 372aTransferredTransferred
- § 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
- § 379aaSerious adverse event reporting for nonprescription drugs
- § 379bConsolidated administrative and laboratory facility
- § 379cTransferredTransferred
- § 379dAutomation of Food and Drug Administration
- § 379ddEstablishment and functions of the Foundation
- § 379eListing and certification of color additives for foods, drugs, devices, and cosmetics
- § 379fRecovery and retention of fees for freedom of information requests
- § 379gDefinitions
- § 379hAuthority to assess and use drug fees
- § 379iDefinitions
- § 379jAuthority to assess and use device fees
- § 379kInformation system
- § 379lEducation
- § 379oEnvironmental impact
- § 379rNational uniformity for nonprescription drugs
- § 379sPreemption for labeling or packaging of cosmetics
- § 379vSafety report disclaimers
- § 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
- § 387Definitions
- § 387aFDA authority over tobacco products
- § 387bAdulterated tobacco products
- § 387cMisbranded tobacco products
- § 387dSubmission of health information to the Secretary
- § 387eAnnual registration
- § 387fGeneral provisions respecting control of tobacco products
- § 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
- § 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
- § 399hGrants for studying continuous drug manufacturing
- § 399iFood and Drug Administration Working Capital Fund
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