Title 21

Food and Drugs

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

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