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21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC : Title 21 - FOOD AND DRUGS

§ 321d - Market names for catfish and ginseng

§ 321c - Nonfat dry milk; “milk” defined

§ 321b - “Package” defined

§ 321a - “Butter” defined

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 332 - Injunction proceedings

§ 333a - Repealed.

§ 333 - Penalties

§ 334 - Seizure

§ 335b - Civil penalties

§ 335a - Debarment, temporary denial of approval, and suspension

§ 335 - Hearing before report of criminal violation

§ 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

§ 341 - Definitions and standards for food

§ 342 - Adulterated food

§ 343a - Repealed.

21 USC § 343–3 - Disclosure

21 USC § 343–2 - Dietary supplement labeling exemptions

21 USC § 343–1 - National uniform nutrition labeling

§ 343 - Misbranded food

§ 344 - Emergency permit control

§ 345 - Regulations making exemptions

§ 346b - Authorization of appropriations

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 346 - Tolerances for poisonous or deleterious substances in food; regulations

§ 347b - Contravention of State laws

§ 347a - Congressional declaration of policy regarding oleomargarine sales

§ 347 - Intrastate sales of colored oleomargarine

§ 348 - Food additives

§ 349 - Bottled drinking water standards; publication in Federal Register

§ 350e - Sanitary transportation practices

§ 350d - Registration of food facilities

§ 350c - Maintenance and inspection of records

§ 350b - New dietary ingredients

§ 350a - Infant formulas

§ 350 - Vitamins and minerals

§ 350g - Hazard analysis and risk-based preventive controls

§ 350f - Reportable food registry

21 USC § -

21 USC § -

§ 350k - Laboratory accreditation for analyses of foods

§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

§ 350i - Protection against intentional adulteration

§ 350h - Standards for produce safety

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353b - Prereview of television advertisements

§ 353a - Pharmacy compounding

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 354 - Veterinary feed directive drugs

§ 355e - Pharmaceutical security

§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers

§ 355c - Research into pediatric uses for drugs and biological products

§ 355b - Adverse-event reporting

§ 355a - Pediatric studies of drugs

21 USC § 355–1 - Risk evaluation and mitigation strategies

§ 355 - New drugs

§ 356c - Discontinuance of life saving product

§ 356b - Reports of postmarketing studies

§ 356a - Manufacturing changes

21 USC § 356–1 - Accelerated approval of priority countermeasures

§ 356 - Fast track products

§ 357 - Repealed.

§ 358 - Authority to designate official names

§ 359 - Nonapplicability of subchapter to cosmetics

§ 360 - Registration of producers of drugs or devices

21 USC § -

§ 360kk - Performance standards for electronic products

§ 360jj - Studies by Secretary

§ 360ii - Program of control

§ 360hh - Definitions

§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions

§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions

§ 360cc - Protection for drugs for rare diseases or conditions

§ 360bb - Designation of drugs for rare diseases or conditions

§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions

§ 360n - Priority review to encourage treatments for tropical diseases

§ 360m - Accredited persons

21 USC § -

§ 360k - State and local requirements respecting devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360i - Records and reports on devices

§ 360h - Notification and other remedies

§ 360g - Judicial review

§ 360f - Banned devices

21 USC § 360e–1 - Pediatric uses of devices

§ 360e - Premarket approval

§ 360d - Performance standards

§ 360c - Classification of devices intended for human use

§ 360b - New animal drugs

§ 360a - Clinical trial guidance for antibiotic drugs

21 USC § 360ccc–2 - Designated new animal drugs for minor use or minor species

21 USC § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species

§ 360ccc - Conditional approval of new animal drugs for minor use and minor species

21 USC § 360bbb–6 - Risk communication

21 USC § 360bbb–5 - Critical Path Public-Private Partnerships

21 USC § 360bbb–4 - Technical assistance

21 USC § 360bbb–3 - Authorization for medical products for use in emergencies

21 USC § 360bbb–2 - Classification of products

21 USC § 360bbb–1 - Dispute resolution

§ 360bbb - Expanded access to unapproved therapies and diagnostics

§ 360aaa to 360aaa–6 - Omitted

§ 360ss - State standards

§ 360rr - Federal-State cooperation

§ 360qq - Repealed.

§ 360pp - Enforcement

21 USC § -

§ 360nn - Inspection, records, and reports

§ 360mm - Imports

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

§ 363 - Regulations making exemptions

§ 364 - Repealed.

§ 371 - Regulations and hearings

§ 372a - Transferred

§ 372 - Examinations and investigations

§ 373 - Records

§ 374a - Inspections relating to food allergens

§ 374 - Inspection

§ 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

§ 379g - Definitions

§ 379f - Recovery and retention of fees for freedom of information requests

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

21 USC § 379d–2 - Policy on the review and clearance of scientific articles published by FDA employees

21 USC § 379d–1 - Conflicts of interest

§ 379d - Automation of Food and Drug Administration

§ 379c - Transferred

§ 379b - Consolidated administrative and laboratory facility

§ 379a - Presumption of existence of jurisdiction

§ 379 - Confidential information

§ 379i - Definitions

21 USC § 379h–2 - Reauthorization; reporting requirements

21 USC § 379h–1 - Fees relating to advisory review of prescription-drug television advertising

§ 379h - Authority to assess and use drug fees

21 USC § 379j–12 - Authority to assess and use animal drug fees

21 USC § 379j–11 - Definitions

21 USC § 379j–1 - Reauthorization; reporting requirements

§ 379j - Authority to assess and use device fees

§ 379k - Information system

21 USC § 379j–31 - Authority to collect and use fees

21 USC § 379j–22 - Reauthorization; reporting requirements

21 USC § 379j–21 - Authority to assess and use generic new animal drug fees

21 USC § 379j–13 - Reauthorization; reporting requirements

21 USC § -

21 USC § 379dd–2 - Activities of the Food and Drug Administration

21 USC § 379dd–1 - Location of Foundation

§ 379dd - Establishment and functions of the Foundation

21 USC § 379aa–1 - Serious adverse event reporting for dietary supplements

§ 379aa - Serious adverse event reporting for nonprescription drugs

§ 379v - Safety report disclaimers

§ 379s - Preemption for labeling or packaging of cosmetics

§ 379r - National uniformity for nonprescription drugs

21 USC § -

§ 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

§ 384d - Accreditation of third-party auditors

§ 384c - Inspection of foreign food facilities

§ 384b - Voluntary qualified importer program

§ 387a - FDA authority over tobacco products

§ 387 - Definitions

§ 387u - Studies of progress and effectiveness

§ 387t - Labeling, recordkeeping, records inspection

§ 387s - User fees

§ 387r - Drug products used to treat tobacco dependence

§ 387q - Tobacco Products Scientific Advisory Committee

§ 387p - Preservation of State and local authority

21 USC § -

§ 387n - Jurisdiction of and coordination with the Federal Trade Commission

§ 387m - Equal treatment of retail outlets

21 USC § -

§ 387k - Modified risk tobacco products

§ 387j - Application for review of certain tobacco products

§ 387i - Records and reports on tobacco products

§ 387h - Notification and other remedies

§ 387g - Tobacco product standards

21 USC § 387f–1 - Enforcement action plan for advertising and promotion restrictions

§ 387f - General provisions respecting control of tobacco products

§ 387e - Annual registration

§ 387d - Submission of health information to the Secretary

§ 387c - Misbranded tobacco products

§ 387b - Adulterated tobacco products

21 USC § 387a–1 - Final rule

§ 391 - Separability clause

§ 392 - Exemption of meats and meat food products

§ 393 - Food and Drug Administration

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 262 - Regulation of biological products

§ 263b - Certification of mammography facilities

§ 264 - Regulations to control communicable diseases

§ 4321 - Congressional declaration of purpose

§ 4332 - Cooperation of agencies; reports; availability of information; recommendations; international and national coordination of efforts

Presidential Documents

Executive Order ... 11514

Executive Order ... 11991

Executive Order ... 12114