Title 21

Food and Drugs

664 sections in this title — page 5 of 7.

§ 379h–1

Fees relating to advisory review of prescription-drug television advertising

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 2— fees relating to drugs

§ 379h–2

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 2— fees relating to drugs

§ 379i

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 3— fees relating to devices

§ 379j

Authority to assess and use device fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 3— fees relating to devices

§ 379j–1

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 3— fees relating to devices

§ 379j–11

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 4— fees relating to animal drugs

§ 379j–12

Authority to assess and use animal drug fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 4— fees relating to animal drugs

§ 379j–13

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 4— fees relating to animal drugs

§ 379j–21

Authority to assess and use generic new animal drug fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 5— fees relating to generic new animal drugs

§ 379j–22

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 5— fees relating to generic new animal drugs

§ 379j–31

Authority to collect and use fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 6— fees related to food

§ 379j–41

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 7— fees relating to generic drugs

§ 379j–42

Authority to assess and use human generic drug fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 7— fees relating to generic drugs

§ 379j–43

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 7— fees relating to generic drugs

§ 379j–51

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 8— fees relating to biosimilar biological products

§ 379j–52

Authority to assess and use biosimilar biological product fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 8— fees relating to biosimilar biological products

§ 379j–53

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 8— fees relating to biosimilar biological products

§ 379j–61

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 9— fees relating to outsourcing facilities

§ 379j–62

Authority to assess and use outsourcing facility fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 9— fees relating to outsourcing facilities

§ 379j–71

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 10— fees relating to over-the-counter drugs

§ 379j–72

Authority to assess and use OTC monograph fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 10— fees relating to over-the-counter drugs

§ 379j–73

Reauthorization; reporting requirements

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 10— fees relating to over-the-counter drugs

§ 379k

Information system

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part D— Information and Education

§ 379k–1

Electronic format for submissions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part D— Information and Education

§ 379l

Education

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part D— Information and Education

§ 379o

Environmental impact

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part E— Environmental Impact Review

§ 379r

National uniformity for nonprescription drugs

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part F— National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics

§ 379s

Preemption for labeling or packaging of cosmetics

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part F— National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics

§ 379v

Safety report disclaimers

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part G— Safety Reports

§ 381

Imports and exports

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 382

Exports of certain unapproved products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 383

Office of International Relations

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384

Importation of prescription drugs

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384a

Foreign supplier verification program

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384b

Voluntary qualified importer program

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384c

Inspection of foreign food facilities

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384d

Accreditation of third-party auditors

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384e

Recognition of foreign government inspections

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384f

Strengthening FDA and CBP coordination and capacity

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 384g

Restricting entrance of illicit drugs

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS

§ 387

Definitions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387a

FDA authority over tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387a–1

Final rule

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387b

Adulterated tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387c

Misbranded tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387d

Submission of health information to the Secretary

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387e

Annual registration

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387f

General provisions respecting control of tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387f–1

Enforcement action plan for advertising and promotion restrictions

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387g

Tobacco product standards

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387h

Notification and other remedies

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387i

Records and reports on tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387j

Application for review of certain tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387k

Modified risk tobacco products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387l

Judicial review

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387m

Equal treatment of retail outlets

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387n

Jurisdiction of and coordination with the Federal Trade Commission

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387o

Regulation requirement

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387p

Preservation of State and local authority

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387q

Tobacco Products Scientific Advisory Committee

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387r

Drug products used to treat tobacco dependence

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387s

User fees

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387t

Labeling, recordkeeping, records inspection

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387u

Studies of progress and effectiveness

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 387v

Reporting on tobacco regulation activities

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IX— TOBACCO PRODUCTS

§ 391

Separability clause

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 392

Exemption of meats and meat food products

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 393

Food and Drug Administration

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 393a

Office of Pediatric Therapeutics

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 394

Scientific review groups

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 395

Loan repayment program

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 396

Practice of medicine

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 397

Contracts for expert review

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 398

Notices to States regarding imported food

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399

Grants to enhance food safety

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399a

Office of the Chief Scientist

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399b

Office of Women’s Health

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399c

Improving the training of State, local, territorial, and tribal food safety officials

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399d

Employee protections

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399e

Nanotechnology

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399f

Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399g

Food and Drug Administration Intercenter Institutes

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399h

National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399i

Food and Drug Administration Working Capital Fund

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 399j

Abraham Accords Office

Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS

§ 451

Congressional statement of findings

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 452

Congressional declaration of policy

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 453

Definitions

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 454

Federal and State cooperation in development and administration of State poultry product inspection programs

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 455

Inspection in official establishments

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 456

Operation of premises, facilities and equipment

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 457

Labeling and container standards

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 458

Prohibited acts

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 459

Compliance by all establishments

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 460

Miscellaneous activities subject to regulation

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 461

Offenses and punishment

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 462

Reporting of violations; notice; opportunity to present views

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 463

Rules and regulations

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 464

Exemptions

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION

§ 465

Limitations upon entry of poultry products and other materials into official establishments

Chapter 10— POULTRY AND POULTRY PRODUCTS INSPECTION