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2018 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Front Matter

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Editorial Notes PART A—DRUGS AND DEVICES
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.
354.Veterinary feed directive drugs.
355.New drugs.
355–1.Risk evaluation and mitigation strategies.
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.
356.Expedited approval of drugs for serious or life-threatening diseases or conditions.
356–1.Accelerated approval of priority countermeasures.
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.
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.
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.
360f.Banned devices.
360g.Judicial review.
360g–1.Agency documentation and review of significant decisions regarding devices.
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.

        

PART B—DRUGS FOR RARE DISEASES OR CONDITIONS
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.
360ff.Priority review to encourage treatments for rare pediatric diseases.
360ff–1.Targeted drugs for rare diseases.

        

PART C—ELECTRONIC PRODUCT RADIATION CONTROL
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.
360qq.Repealed.
360rr.Federal-State cooperation.
360ss.State standards.

        

PART D—DISSEMINATION OF TREATMENT INFORMATION
360aaa to 360aaa–6. Omitted.

        

PART E—GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES
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–5.Critical Path Public-Private Partnerships.
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.

        

PART F—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
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.

        

PART G—MEDICAL GASES
360ddd.Definitions.
360ddd–1.Regulation of medical gases.
360ddd–2.Inapplicability of drug fees to designated medical gases.

        

PART H—PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN
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.

        

PART I—NONPRESCRIPTION SUNSCREEN AND OTHER ACTIVE INGREDIENTS
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.Sunscreen monograph.
360fff–6.Non-sunscreen time and extent applications.
360fff–7.Report.

        

SUBCHAPTER VI—COSMETICS
361.Adulterated cosmetics.
362.Misbranded cosmetics.
363.Regulations making exemptions.
364.Repealed.

        

SUBCHAPTER VII—GENERAL AUTHORITY PART A—GENERAL ADMINISTRATIVE PROVISIONS
371.Regulations and hearings.
372.Examinations and investigations.
372a.Transferred.
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.
379c.Transferred.
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–4.Reporting requirements.
379d–5.Guidance document regarding product promotion using the Internet.

        

PART B—COLORS
379e.Listing and certification of color additives for foods, drugs, devices, and cosmetics.

        

PART C—FEES SUBPART 1—FREEDOM OF INFORMATION FEES
379f.Recovery and retention of fees for freedom of information requests.

        

SUBPART 2—FEES RELATING TO DRUGS
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.

        

SUBPART 3—FEES RELATING TO DEVICES
379i.Definitions.
379j.Authority to assess and use device fees.
379j–1.Reauthorization; reporting requirements.

        

SUBPART 4—FEES RELATING TO ANIMAL DRUGS
379j–11.Definitions.
379j–12.Authority to assess and use animal drug fees.
379j–13.Reauthorization; reporting requirements.

        

SUBPART 5—FEES RELATING TO GENERIC NEW ANIMAL DRUGS
379j–21.Authority to assess and use generic new animal drug fees.
379j–22.Reauthorization; reporting requirements.

        

SUBPART 6—FEES RELATED TO FOOD
379j–31.Authority to collect and use fees.

        

SUBPART 7—FEES RELATING TO GENERIC DRUGS
379j–41.Definitions.
379j–42.Authority to assess and use human generic drug fees.
379j–43.Reauthorization; reporting requirements.

        

SUBPART 8—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
379j–51.Definitions.
379j–52.Authority to assess and use biosimilar biological product fees.
379j–53.Reauthorization; reporting requirements.

        

SUBPART 9—FEES RELATING TO OUTSOURCING FACILITIES
379j–61.Definitions.
379j–62.Authority to assess and use outsourcing facility fees.

        

PART D—INFORMATION AND EDUCATION
379k.Information system.
379k–1.Electronic format for submissions.
379l.Education.

        

PART E—ENVIRONMENTAL IMPACT REVIEW
379o.Environmental impact.

        

PART F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
379r.National uniformity for nonprescription drugs.
379s.Preemption for labeling or packaging of cosmetics.

        

PART G—SAFETY REPORTS
379v.Safety report disclaimers.

        

PART H—SERIOUS ADVERSE EVENT REPORTS
379aa.Serious adverse event reporting for nonprescription drugs.
379aa–1.Serious adverse event reporting for dietary supplements.

        

PART I—REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
379dd.Establishment and functions of the Foundation.
379dd–1.Location of Foundation.
379dd–2.Activities of the Food and Drug Administration.

        

SUBCHAPTER VIII—IMPORTS AND EXPORTS
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.

        

SUBCHAPTER IX—TOBACCO PRODUCTS
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.

        

SUBCHAPTER X—MISCELLANEOUS
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.Grants for studying continuous drug manufacturing.
399i.Food and Drug Administration Working Capital Fund.

        
Publication Title United States Code, 2018 Edition, Title 21 - FOOD AND DRUGS
Category Bills and Statutes
Collection United States Code
SuDoc Class Number Y 1.2/5:
Contained Within Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
- Front Matter
Date 2018
Laws In Effect As Of Date January 14, 2019
Positive Law No
Disposition standard
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