US Code Title 21 Chapter 9 Federal Food, Drug, and Cosmetic Act

Subchapter I - Short Title

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
§ 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
§ 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
§ 357 - Repealed. Pub. L. 105–115, Title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325
§ 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
§ 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
§ 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

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. Pub. L. 105–362, Title Vi, §601(a)(2)(a), Nov. 10, 1998, 112 Stat. 3285
§ 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-3a - Emergency Use of Medical Products
§ 360bbb-3b - Products Held for Emergency Use
§ 360bbb-4 - Countermeasure Development, Review, and Technical Assistance
§ 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

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

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

Subchapter VI - Cosmetics

§ 361 - Adulterated Cosmetics
§ 362 - Misbranded Cosmetics
§ 363 - Regulations Making Exemptions
§ 364 - Repealed. Pub. L. 86–618, Title I, §103(a)(3), July 12, 1960, 74 Stat. 398

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-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

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

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

Last modified: October 26, 2015