### **CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT**

#### SUBCHAPTER I—SHORT TITLE

Sec.
301.
Short title.

#### SUBCHAPTER II—DEFINITIONS

321.
Definitions; generally.
321a.
"Butter" defined.
321b.
"Package" defined.
321c.
Nonfat dry milk; "milk" defined.
321d.
Market names for catfish and ginseng.

#### SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES

331.
Prohibited acts.
332.
Injunction proceedings.
333.
Penalties.
333a.
Repealed.
334.
Seizure.
335.
Hearing before report of criminal violation.
335a.
Debarment, temporary denial of approval, and suspension.
335b.
Civil penalties.
335c.
Authority to withdraw approval of abbreviated drug applications.
336.
Report of minor violations.
337.
Proceedings in name of United States; provision as to subpoenas.
337a.
Extraterritorial jurisdiction.

#### SUBCHAPTER IV—FOOD

341.
Definitions and standards for food.
342.
Adulterated food.
343.
Misbranded food.
343–1.
National uniform nutrition labeling.
343–2.
Dietary supplement labeling exemptions.
343–3.
Disclosure.
343a.
Repealed.
344.
Emergency permit control.
345.
Regulations making exemptions.
346.
Tolerances for poisonous or deleterious substances in food; regulations.
346a.
Tolerances and exemptions for pesticide chemical residues.
346b.
Authorization of appropriations.
347.
Intrastate sales of colored oleomargarine.
347a.
Congressional declaration of policy regarding oleomargarine sales.
347b.
Contravention of State laws.
348.
Food additives.
349.
Bottled drinking water standards; publication in Federal Register.
350.
Vitamins and minerals.
350a.
Infant formulas.
350a–1.
Protecting infants and improving formula supply.
350b.
New dietary ingredients.
350c.
Maintenance and inspection of records.
350d.
Registration of food facilities.
350e.
Sanitary transportation practices.
350f.
Reportable food registry.
350g.
Hazard analysis and risk-based preventive controls.
350h.
Standards for produce safety.
350i.
Protection against intentional adulteration.
350j.
Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report.
350k.
Laboratory accreditation for analyses of foods.
350l.
Mandatory recall authority.
350l–1.
Annual report to Congress.
350m.
Requirements for critical food.

#### SUBCHAPTER V—DRUGS AND DEVICES

#### 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.
353d.
Process to update labeling for certain generic drugs.
354.
Veterinary feed directive drugs.
355.
New drugs.
355–1.
Risk evaluation and mitigation strategies.
355–2.
Actions for delays of generic drugs and biosimilar biological products.
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.
355h.
Regulation of certain nonprescription drugs that are marketed without an approved drug application.
356.
Expedited approval of drugs for serious or life-threatening diseases or conditions.
356–1.
Accelerated approval of priority countermeasures.
356–2.
Accelerated approval Council.
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.
356j.
Discontinuance or interruption in the production of medical devices.
356k.
Platform technologies.
356 l.
Advanced manufacturing technologies designation program.
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.
360b–1.
Priority zoonotic 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.
360e–4.
Predetermined change control plans for devices.
360f.
Banned devices.
360g.
Judicial review.
360g–1.
Agency documentation and review of significant decisions regarding devices.
360g–2.
Third party data transparency.
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.
360 l.
Postmarket surveillance.
360m.
Accredited persons.
360n.
Priority review to encourage treatments for tropical diseases.
360n–1.
Priority review for qualified infectious disease products.
360n–2.
Ensuring cybersecurity of devices.

#### 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.
360ee–1.
FDA rare neurodegenerative disease grant program.
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.
360 ll.
Notification of defects in and repair or replacement of electronic products.
360mm.
Imports.
360nn.
Inspection, records, and reports.
360 oo.
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–4b.
Medical countermeasure master files.
360bbb–5.
Critical Path Public-Private Partnerships.
360bbb–5a.
Emerging technology program.
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.
Repealed.
360fff–6.
Non-sunscreen time and extent applications.
360fff–7.
Report.
360fff–8.
Sunset.

#### SUBCHAPTER VI—COSMETICS

361.
Adulterated cosmetics.
362.
Misbranded cosmetics.
363.
Regulations making exemptions.
364.
Definitions.
364a.
Adverse events.
364b.
Good manufacturing practice.
364c.
Registration and product listing.
364d.
Safety substantiation.
364e.
Labeling.
364f.
Records.
364g.
Mandatory recall authority.
364h.
Small businesses.
364i.
Exemption for certain products and facilities.
364j.
Preemption.

#### 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–3b.
Strategic Workforce Plan and report.
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.

#### subpart 10—fees relating to over-the-counter drugs

379j–71.
Definitions.
379j–72.
Authority to assess and use OTC monograph fees.
379j–73.
Reauthorization; reporting requirements.

#### 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.
387v.
Reporting on tobacco regulation activities.

#### 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.
National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.
399i.
Food and Drug Administration Working Capital Fund.