Title 21
664 sections in this title — page 4 of 7.
§ 360c
Classification of devices intended for human use
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360cc
Protection for drugs for rare diseases or conditions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360ccc
Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part F— New Animal Drugs for Minor Use and Minor Species
§ 360ccc–1
Index of legally marketed unapproved new animal drugs for minor species
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part F— New Animal Drugs for Minor Use and Minor Species
§ 360ccc–2
Designated new animal drugs for minor use or minor species
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part F— New Animal Drugs for Minor Use and Minor Species
§ 360c–1
Reporting
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360d
Performance standards
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360dd
Open protocols for investigations of drugs for rare diseases or conditions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360ddd
Definitions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part G— Medical Gases
§ 360ddd–1
Regulation of medical gases
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part G— Medical Gases
§ 360ddd–2
Inapplicability of drug fees to designated medical gases
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part G— Medical Gases
§ 360e
Premarket approval
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360ee
Grants and contracts for development of drugs for rare diseases and conditions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360eee
Definitions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain
§ 360eee–1
Requirements
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain
§ 360eee–2
National standards for prescription drug wholesale distributors
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain
§ 360eee–3
National standards for third-party logistics providers
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain
§ 360eee–4
Uniform national policy
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain
§ 360ee–1
FDA rare neurodegenerative disease grant program
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360e–1
Pediatric uses of devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360e–3
Breakthrough devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360e–4
Predetermined change control plans for devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360f
Banned devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360ff
Priority review to encourage treatments for rare pediatric diseases
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360fff
Definitions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–1
Submission of requests
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–2
Eligibility determinations; data submission; filing
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–3
GRASE determination
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–4
Guidance; other provisions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–6
Non-sunscreen time and extent applications
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–7
Report
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–8
Sunset
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360ff–1
Targeted drugs for rare diseases
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360g
Judicial review
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360g–1
Agency documentation and review of significant decisions regarding devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360g–2
Third party data transparency
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360h
Notification and other remedies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360hh
Definitions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360h–1
Program to improve the device recall system
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360i
Records and reports on devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360ii
Program of control
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360j
General provisions respecting control of devices intended for human use
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360jj
Studies by Secretary
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360k
State and local requirements respecting devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360kk
Performance standards for electronic products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360l
Postmarket surveillance
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360ll
Notification of defects in and repair or replacement of electronic products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360m
Accredited persons
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360mm
Imports
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360n
Priority review to encourage treatments for tropical diseases
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360nn
Inspection, records, and reports
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360n–1
Priority review for qualified infectious disease products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360n–2
Ensuring cybersecurity of devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360oo
Prohibited acts
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360pp
Enforcement
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360rr
Federal-State cooperation
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 360ss
State standards
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part C— Electronic Product Radiation Control
§ 361
Adulterated cosmetics
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 362
Misbranded cosmetics
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 363
Regulations making exemptions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364
Definitions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364a
Adverse events
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364b
Good manufacturing practice
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364c
Registration and product listing
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364d
Safety substantiation
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364e
Labeling
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364f
Records
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364g
Mandatory recall authority
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364h
Small businesses
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364i
Exemption for certain products and facilities
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 364j
Preemption
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS
§ 371
Regulations and hearings
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 372
Examinations and investigations
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 373
Records
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 374
Inspection
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 374a
Inspections relating to food allergens
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 375
Publicity
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 376
Examination of sea food on request of packer; marking food with results; fees; penalties
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 377
Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 378
Advertising of foods
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379
Confidential information
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379a
Presumption of existence of jurisdiction
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379aa
Serious adverse event reporting for nonprescription drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part H— Serious Adverse Event Reports
§ 379aa–1
Serious adverse event reporting for dietary supplements
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part H— Serious Adverse Event Reports
§ 379b
Consolidated administrative and laboratory facility
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d
Automation of Food and Drug Administration
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379dd
Establishment and functions of the Foundation
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part I— Reagan-Udall Foundation for the Food and Drug Administration
§ 379dd–1
Location of Foundation
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part I— Reagan-Udall Foundation for the Food and Drug Administration
§ 379dd–2
Activities of the Food and Drug Administration
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part I— Reagan-Udall Foundation for the Food and Drug Administration
§ 379d–1
Conflicts of interest
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d–2
Policy on the review and clearance of scientific articles published by FDA employees
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d–3
Streamlined hiring authority
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d–3a
Hiring authority for scientific, technical, and professional personnel
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d–3b
Strategic Workforce Plan and report
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d–4
Reporting requirements
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379d–5
Guidance document regarding product promotion using the Internet
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions
§ 379e
Listing and certification of color additives for foods, drugs, devices, and cosmetics
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part B— Colors
§ 379f
Recovery and retention of fees for freedom of information requests
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 1— freedom of information fees
§ 379g
Definitions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 2— fees relating to drugs
§ 379h
Authority to assess and use drug fees
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 2— fees relating to drugs