GUIDEs

CHAPTER 9                               FEDERAL FOOD, DRUG, AND COSMETIC ACT (sections 321 to 399i) [View]

• SUBCHAPTER I                  SHORT TITLE (section 301)  [View]

• SUBCHAPTER II                 DEFINITIONS (sections 321 to 321d)    [View]​

  • Sec. 321.                      Definitions; generally [View]

  • Sec. 321a.                   "Butter" defined  [View]

  • Sec. 321b.                   "Package" defined [View]​

  • Sec. 321c.                     Nonfat dry milk; "milk" defined  [View]

  • Sec. 321d.                    Market names for catfish and ginseng  [View]

• SUBCHAPTER III                PROHIBITED ACTS AND PENALTIES (sections 331 to 337a)   [View]

  • Sec. 331.                       Prohibited acts    [View]

  • Sec. 332.                       Injunction proceedings [View]​

  • Sec. 333.                       Penalties       [View]​

  • Sec. 333a.                     Repealed. Pub. L. 101-647, title XIX, §1905, Nov. 29, 1990, 104 Stat. 4853    [View]​

  • Sec. 334.                       Seizure    [View]​

  • Sec. 335.                       Hearing before report of criminal violation  [View]​

  • Sec. 335a.                     Debarment, temporary denial of approval, and suspension [View]​

  • Sec. 335b.                    Civil penalties [View]

  • Sec. 335c.                     Authority to withdraw approval of abbreviated drug applications [View]

  • Sec. 336.                       Report of minor violations   [View]​

  • Sec. 337.                       Proceedings in name of United States; provision as to subpoenas [View]​

  • Sec. 337a.                     Extraterritorial jurisdiction [View]

• SUBCHAPTER IV                FOOD (sections 341 to 350l-1) [View]

  • Sec. 341.                       Definitions and standards for food     [View]

  • Sec. 342.                       Adulterated food      [View]

  • Sec. 343.                       Misbranded food [View]

  • Sec. 343-1.                    National uniform nutrition labeling  [View]

    • Sec. 343-2.             Dietary supplement labeling exemptions [View]

  • Sec. 344                        Emergency permit control   [View]

  • Sec. 345.                       Regulations making exemptions  [View]

  •  Sec. 346.                      Tolerances for poisonous or deleterious substances in food; regulations   [View]

    • Sec. 346a.              Tolerances and exemptions for pesticide chemical residues [View]

    • Sec. 346b.              Authorization of appropriations [View]

  • Sec. 347.                       Intrastate sales of colored oleomargarine[View]​

    • Sec. 347a.              Congressional declaration of policy regarding oleomargarine sales   [View]

  • Sec. 348.                       Food additives   [View]

  • Sec. 349.                       Bottled drinking water standards; publication in Federal Register  [View]

  • Sec. 350.                       Vitamins and minerals [View]​

    • Sec. 350a.              Infant formulas   [View]​

    • Sec. 350b.              New dietary ingredients  [View] 

    • Sec. 350c.              Maintenance and inspection of records [View]

    • Sec. 350d.              Registration of food facilities [View]

    • Sec. 350e.              Sanitary transportation practices  [View]​

    • Sec. 350f.               Reportable food registry  [View]

    •  Sec. 350g.             Hazard analysis and risk-based preventive controls [View]

    • Sec. 350h.              Standards for produce safety [View]​

    • Sec. 350i.               Protection against intentional adulteration [View]

    • Sec. 350j.               Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report                                  [View]​

    • Sec. 350k.              Laboratory accreditation for analyses of foods     [View]​

    • Sec. 350l.               Mandatory recall authority  [View]​

    • Sec. 350l-1.            Annual report to Congress   [View]

• SUBCHAPTER V Part A      DRUGS AND DEVICES (sections 351 to 360fff-8) [View]

  • Sec. 351.                       Adulterated drugs and devices [View]

  • Sec. 352.                       Misbranded drugs and devices [View]

  • Sec. 353.                       Exemptions and consideration for certain drugs, devices, and biological products [View]

    • Sec. 353a.              Pharmacy compounding  [View]

    • Sec. 353a-1.           Enhanced communication   [View]

    • Sec. 353b.              Outsourcing facilities  [View]

    • Sec. 353c.               Prereview of television advertisements [View]

    • Sec. 353d.              Process to update labeling for certain generic drugs[View]

    • Sec. 354.                 Veterinary feed directive drugs [View]

    • Sec. 355.                New drugs  [View]

      • Sec. 355-1.      Risk evaluation and mitigation strategies [View]

      • Sec. 355-2.      Actions for delays of generic drugs and biosimilar biological products  [View]

      • Sec. 355a.       Pediatric studies of drugs  [View]

      • Sec. 355b.       Adverse-event reporting  [View]

      • Sec. 355c.       Research into pediatric uses for drugs and biological products  [View]

        • Sec. 355c-1.    Report    [View]

      • Sec. 355d.       Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and                                           waivers  [View]

      • Sec. 355e.       Pharmaceutical security  [View]

      • Sec. 355f.        Extension of exclusivity period for new qualified infectious disease products  [View]

      • Sec. 355g.       Utilizing real world evidence    [View]

      • Sec. 355h.       Regulation of certain nonprescription drugs that are marketed without an approved drug application [View]

    • Sec. 356.                Expedited approval of drugs for serious or life-threatening diseases or conditions[View]

      • Sec. 356-1.      Accelerated approval of priority countermeasures  [View]

      • Sec. 356a.       Manufacturing changes   [View]

      • Sec. 356b.       Reports of postmarketing studies [View]

      • Sec. 356c.       Discontinuance or interruption in the production of life-saving drugs  [View]

      • Sec. 356c-1.    Annual reporting on drug shortages  [View]

      • Sec. 356d.       Coordination; task force and strategic plan [View]

      • Sec. 356e.       Drug shortage list  [View]

      • Sec. 356f.        Hospital repackaging of drugs in shortage [View]

      • Sec. 356g.       Standards for regenerative medicine and regenerative advanced therapies     [View]

      • Sec. 356h.       Competitive generic therapies [View]

      • Sec. 356i.        Prompt reports of marketing status[View]

      • Sec. 356j.        Discontinuance or interruption in the production of medical devices  [View]

    • Sec. 357.                Qualification of drug development tools   [View]

    • Sec. 358.                Authority to designate official names   [View]

    • Sec. 359.                Nonapplicability of subchapter to cosmetics  [View]

    • Sec. 360.                Registration of producers of drugs or devices  [View]

      • Sec. 360a.       Clinical trial guidance for antibiotic drugs  [View]

        • Sec. 360a-1.      Clinical trials  [View]

        • Sec. 360a-2.      Susceptibility test interpretive criteria for microorganisms      [View]

      • Sec. 360b.      New animal drugs  [View]

        • Sec. 360b-1.      Priority zoonotic animal drugs   [View]

      • Sec. 360c.       Classification of devices intended for human use  [View]

        • Sec. 360c-1.      Reporting  [View]

      • Sec. 360d.       Performance standards  [View]

      • Sec. 360e.       Premarket approval  [View]

        • Sec. 360e-1.      Pediatric uses of devices [View]

        • Sec. 360e-3.      Breakthrough devices    [View]

      • Sec. 360f.        Banned devices [View]

      • Sec. 360g.       Judicial review  [View]

        • Sec. 360g-1.      Agency documentation and review of significant decisions regarding devices [View]

      • Sec. 360h.       Notification and other remedies    [View]

        • Sec. 360h-1.      Program to improve the device recall system [View]

      • Sec. 360i.         Records and reports on devices   [View]

      • Sec. 360j.         General provisions respecting control of devices intended for human use[View]

      • Sec. 360k.        State and local requirements respecting devices  [View]

      • Sec. 360l.         Postmarket surveillance​  [View]

      • Sec. 360m.      Accredited persons [View]

      • Sec. 360n.       Priority review to encourage treatments for tropical diseases[View]

        • Sec. 360n-1.      Priority review for qualified infectious disease products [View]

• ​​​SUBCHAPPTER V Part B    Drugs for Rare Diseases or Conditions (sections 360aa to 360ff-1)[View]

  • Sec. 360aa.                   Recommendations for investigations of drugs for rare diseases or conditions  [View]

  • Sec. 360bb.                  Designation of drugs for rare diseases or conditions  [View]

  • Sec. 360cc.                   Protection for drugs for rare diseases or conditions[View]

  • Sec. 360dd.                  Open protocols for investigations of drugs for rare diseases or conditions [View]

  • Sec. 360ee.                  Grants and contracts for development of drugs for rare diseases and conditions[View]

    • Sec. 360ee-1.        FDA rare neurodegenerative disease grant program  [View]

  • Sec. 360ff.                    Priority review to encourage treatments for rare pediatric diseases [View]

    • Sec. 360ff-1.          Targeted drugs for rare diseases  [View]

• SUBCHAPTER V Part C     Electronic Product Radiation Control (sections 360hh to 360ss)   [View]​

• SUBCHAPTER V Part D     Dissemination of Treatment Information (sections 360aaa to 360aaa-6) [View]

• SUBCHAPTER V Part E     General Provisions Relating to Drugs and Devices (sections 360bbb to 360bbb-8d) [View]

  • ​​Sec. 360bbb.               Expanded access to unapproved therapies and diagnostics   [View]

    • Sec. 360bbb-0.     Expanded access policy required for investigational drugs[View]

      • Sec. 360bbb-0a.      Investigational drugs for use by eligible patients  [View]

    • Sec. 360bbb-1.     Dispute resolution  [View]

    • Sec. 360bbb-2.     Classification of products [View]

    • Sec. 360bbb-3.      Authorization for medical products for use in emergencies   [View]

      • Sec. 360bbb-3a.        Emergency use of medical products  [View]

      • Sec. 360bbb-3b.        Products held for emergency use [View]

      • Sec. 360bbb-3c.        Expedited development and review of medical products for emergency uses [View]

    • Sec. 360bbb-4.      Countermeasure development, review, and technical assistance [View]

      • Sec. 360bbb-4a.         Priority review to encourage treatments for agents that present national security threats [View]

      • Sec. 360bbb-4b.         Medical countermeasure master files [View]

    • Sec. 360bbb-5.       Critical Path Public-Private Partnerships [View]

    • Sec. 360bbb-6.       Risk communication [View]

    • Sec. 360bbb-7.       Notification [View]

    • Sec. 360bbb-8.       Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments[View]

      • Sec. 360bbb-8a.         Optimizing global clinical trials [View]

      • Sec. 360bbb-8b.         Use of clinical investigation data from outside the United States [View]

      • Sec. 360bbb-8c.         Patient participation in medical product discussion [View]

      • Sec. 360bbb-8d.         Notification, nondistribution, and recall of controlled substances [View]

• SUBCHAPTER V Part F        New Animal Drugs for Minor Use and Minor Species (sections 360ccc to 360ccc-2) [View]

  • Sec. 360ccc.                   Conditional approval of new animal drugs for minor use and minor species and certain new animal                                                      drugs [View]

    • Sec. 360ccc-1.                     Index of legally marketed unapproved new animal drugs for minor species [View]

    • Sec. 360ccc-2.                      Designated new animal drugs for minor use or minor species [View]

• SUBCHAPTER V Part G        Medical Gases (sections 360ddd to 360ddd-2) [View]

  • Sec. 360ddd-1.               Regulation of medical gases [View]

  • Sec. 360ddd-2.               Inapplicability of drug fees to designated medical gases [View]

• SUBCHAPTER V Part H        Pharmaceutical Distribution Supply Chain (sections 360eee to 360eee-4) [View]

  • ​​Sec. 360eee-1.                Requirements [View]

  • Sec. 360eee-2.                National standards for prescription drug wholesale distributors [View]

  • Sec. 360eee-3.                National standards for third-party logistics providers [View]

  • Sec. 360eee-4.                Uniform national policy [View]

• SUBCHAPTER V Part I          Nonprescription Sunscreen and Other Active Ingredients (sections 360fff to 360fff-8) [View]

• SUBCHAPTER VI                  COSMETICS (sections 361 to 364) [View]

  • Sec. 361.                         Adulterated cosmetics [View]

  • Sec. 362.                         Misbranded cosmetics [View]

  • Sec. 363.                         Regulations making exemptions [View]

  • Sec. 364.                         Repealed. Pub. L. 86-618, title I, §103(a)(3), July 12, 1960, 74 Stat. 398 [View]

• SUBCHAPTER VII                 GENERAL AUTHORITY (sections 371 to 379dd-2) [View]

  • Part A                             General Administrative Provisions (sections 371 to 379d-5) [View]

  • Part B                             Colors (section 379e) [View]

  • Part C                             Fees (sections 379g to 379j-73) [View]

  • Part D                             Information and Education (sections 379k to 379l) [View]

  • Part E                              Environmental Impact Review (section 379o) [View]

  • Part F                              National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics (sections 379r to 379s) [View]

  • Part G                              Safety Reports (section 379v) [View]

  • Part H                              Serious Adverse Event Reports (sections 379aa to 379aa-1) [View]

  • Part I                                Reagan-Udall Foundation for the Food and Drug Administration (sections 379dd to 379dd-2) [View]​

• SUBCHAPTER VIII                 IMPORTS AND EXPORTS (sections 381 to 384g) [View]

• SUBCHAPTER IX                   TOBACCO PRODUCTS (sections 387 to 387v) [View]

  • Sec. 387.                         Definitions [View]

  • Sec. 387a.                       FDA authority over tobacco products [View]​

    • Sec. 387a-1.             Final rule [View]​

  • Sec. 387b.                       Adulterated tobacco products [View]

  • Sec. 387c.                        Misbranded tobacco products [View]

  • Sec. 387d.                       Submission of health information to the Secretary [View]

  • Sec. 387e.                       Annual registration [View]

  • Sec. 387f.                        General provisions respecting control of tobacco products [View]

  • Sec. 387f-1.                     Enforcement action plan for advertising and promotion restrictions [View]

  • Sec. 387g.                       Tobacco product standards [View]

  • Sec. 387h.                       Notification and other remedies [View]

  • Sec. 387i.                        Records and reports on tobacco products [View]

  • Sec. 387j.                        Application for review of certain tobacco products [View]

  • Sec. 387k.                       Modified risk tobacco products [View]

  • Sec. 387l.                       Judicial review [View]

  • Sec. 387m. Equal treatment of retail outlets [View]

  • Sec. 387n. Jurisdiction of and coordination with the Federal Trade Commission [View]

  • Sec. 387o. Regulation requirement [View]

  • Sec. 387p. Preservation of State and local authority [View]

  • Sec. 387q. Tobacco Products Scientific Advisory Committee [View]

  • Sec. 387r. Drug products used to treat tobacco dependence [View]

  • Sec. 387s. User fees [View]

  • Sec. 387t. Labeling, recordkeeping, records inspection [View]

  • Sec. 387u. Studies of progress and effectiveness [View]

  • ​Sec. 387v. Reporting on tobacco regulation activities [View]

• SUBCHAPTER X—MISCELLANEOUS (sections 391 to 399i) [View]

  • Sec. 391. Separability clause [View]

  • Sec. 392. Exemption of meats and meat food products [View]

  • Sec. 393. Food and Drug Administration [View]

  • Sec. 393a. Office of Pediatric Therapeutics [View]

  • Sec. 394. Scientific review groups [View]

  • Sec. 395. Loan repayment program [View]

  • Sec. 396. Practice of medicine [View]

  • Sec. 397. Contracts for expert review [View]

  • Sec. 398. Notices to States regarding imported food [View]

  • Sec. 399. Grants to enhance food safety [View]

    • Sec. 399a. Office of the Chief Scientist [View]

    • Sec. 399b. Office of Women's Health[View]

    • Sec. 399c. Improving the training of State, local, territorial, and tribal food safety officials [View]

    • Sec. 399d. Employee protections [View]

    • Sec. 399e. Nanotechnology [View]

    • Sec. 399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups [View]

    • Sec. 399g. Food and Drug Administration Intercenter Institutes [View]

    • Sec. 399h. Grants for studying continuous drug manufacturing [View]

    • Sec. 399i. Food and Drug Administration Working Capital Fund [View]