21 U.S.C.
United States Code, 2010 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
Front Matter
From the U.S. Government Printing Office, www.gpo.gov

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.
353b.
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.
355d.
Internal committee for review of pediatric plans, assessments, deferrals, and waivers.
355e.
Pharmaceutical security.
356.
Fast track products.
356–1.
Accelerated approval of priority countermeasures.
356a.
Manufacturing changes.
356b.
Reports of postmarketing studies.
356c.
Discontinuance of life saving product.
357.
Repealed.
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.
360b.
New animal drugs.
360c.
Classification of devices intended for human use.
360d.
Performance standards.
360e.
Premarket approval.
360e–1.
Pediatric uses of devices.
360f.
Banned devices.
360g.
Judicial review.
360h.
Notification and other remedies.
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.

        

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.

        

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–1.
Dispute resolution.
360bbb–2.
Classification of products.
360bbb–3.
Authorization for medical products for use in emergencies.
360bbb–4.
Technical assistance.
360bbb–5.
Critical Path Public-Private Partnerships.
360bbb–6.
Risk communication.

        

Part F—New Animal Drugs for Minor Use and Minor Species

360ccc.
Conditional approval of new animal drugs for minor use and minor species.
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.

        

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.

        

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.

        

Part D—Information and Education

379k.
Information system.
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.

        

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.