Federal Regulations Adopted by Reference - Drug Manufacturers and Distributors
Table of Contents
Federal Laws and Regulations Adopted by Reference (Nonprescription Drugs)
Federal Food, Drug, and Cosmetic Act (FD&C Act)
9 Code of Federal Regulations (CFR)
- Part 113 - Standard Requirements
21 Code of Federal Regulations (CFR)
- Part 70 - Color Additives
- Part 71 - Color Additive Petitions
- Part 73 - Color Additives Exempt From Certification
- Part 74 - Color Additives Subject to Certification
- Part 80 - Color Additive Certification
- Part 81 - Provisional Color Additives for use in Foods, Drugs, and Cosmetics (General Specifications and General Restrictions)
- Part 82 - Certified Provisionally Listed Colors and Specifications
- Part 201 - Labeling
- Part 206 - Imprinting of Solid Oral Dosage Form Drug Products for Human Use
- Part 207 - Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
- Part 299 - Drugs; Official Names and Established Names
- Part 300 - General
- Part 310 - New Drugs
- Part 312 - Investigational New Drug Application
- Part 314 - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug
- Part 316 - Orphan Drugs
- Part 320 - Bioavailability and Bioequivalence Requirements
Current Good Manufacturing Practice
- Part 210 - Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211 - Finished Pharmaceuticals
- Part 225 - Medicated Feeds
- Part 226 - Type A Medicated Articles
- Part 250 - Special Requirements For Specific Human Drugs
Over-The-Counter (OTC) Human Use
- Part 328 - Drug Products Intended for Oral Ingestion that Contain Alcohol
- Part 330 - Human Drugs Which are Generally Recognized as Safe, Effective, & Not Misbranded
- Part 331 - Antacid Products
- Part 332 - Antiflatulent Products
- Part 333 - Topical Antimicrobial Drug Products
- Part 335 - Antidiarrheal Drug Products
- Part 336 - Antiemetic Drug Products
- Part 338 - Nighttime Sleep-aid Drug Products
- Part 340 - Stimulant Drug Products
- Part 341 - Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products
- Part 343 - Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
- Part 344 - Topical OTIC Drug Products
- Part 346 - Anorectal Drug Products
- Part 347 - Skin Protectant Drug Products
- Part 348 - External Analgesic Drug Products
- Part 349 - Ophthalmic Drug Products
- Part 350 - Antiperspirant Drug Products
- Part 352 - Sunscreen Drug Products
- Part 355 - Anticaries Drug Products
- Part 357 - Miscellaneous Internal Drug Products
- Part 358 - Miscellaneous External Drug Products
- Part 369 - Interpretive Statements Re: Warnings on Drugs and Devices for Sales
Federal Laws and Regulations Adopted by Reference (Prescription Drugs)
Federal Food, Drug, and Cosmetic Act, 21 United States Code (U.S.C), §301 et seq.
9 Code of Federal Regulations (CFR)
- Part 113 - Standard Requirements
21 Code of Federal Regulations (CFR)
- Part 70 - Color Additives
- Part 71 - Color Additive Petitions
- Part 73 - Listing of Color Additives Exempt From Certification
- Part 74 - Listing of Color Additives Subject to Certification
- Part 80 - Color Additive Certification
- Part 81 - General Specifications & Restrictions for Provisional Color Additives for use in Foods, Drugs, & Cosmetics
- Part 82 - Listing of Certified Provisionally Listed Colors and Specifications
- Part 200 - General
- Part 201 - Labeling
- Part 202 - Prescription Drug Advertising
- Part 203 - Prescription Drug Marketing
- Part 205 - Guidelines for State Licensing of Wholesale Prescription Drug Distributors
- Part 206 - Imprinting of Solid Oral Dosage Form Drug Products for Human Use
- Part 207 - Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
- Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
- Part 216 - Pharmacy Compounding
- Part 225 - Current Good Manufacturing Practice for Medicated Feeds
- Part 226 - Current Good Manufacturing Practice for Type A Medicated Articles
- Part 250 - Special Requirements For Specific Human Drugs
- Part 290 - Controlled Drugs
- Part 299 - Drugs; Official & Established Names
- Part 300 - General
- Part 310 - New Drugs
- Part 312 - Investigational New Drug Application
- Part 314 - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug
- Part 315 - Diagnostic Radiopharmaceuticals
- Part 316 - Orphan Drugs
- Part 320 - Bioavailability and Bioequivalence Requirements
- Part 361 - Prescription Drugs for Human Use Generally Recognized as Safe, Effective, & Not Misbranded: Used In Research
- Part 500 - General
- Part 510 - New Animal Drugs
- Part 511 - New Animal Drugs for Investigational Use
- Part 514 - New Animal Drug Applications
- Part 515 - Medicated Feed Mill License
- Part 520 - Oral Dosage Form New Animal Drugs
- Part 522 - Implantation or Injectable Dosage Form New Animal Drugs
- Part 524 - Opthalmic and Topical Dosage Form New Animal Drugs
- Part 526 - Intramammary Dosage Forms
- Part 529 - Certain Other Dosage Form New Animal Drugs
- Part 530 - Extralabel Drug Use in Animals
- Part 556 - Tolerances for Residues of New Animal Drugs in Food
- Part 558 - New Animal Drugs for Use in Animal Feeds
- Part 589 - Substances Prohibited From Use in Animal Food or Feed
- Part 600 - Biological Products: General
- Part 601 - Licensing
- Part 610 - General Biological Products Standards
- Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests
- Part 680 - Additional Standards for Miscellaneous Products
- Part 1300 - Definitions
- Part 1301 - Registration of Manufacturers, Distributors, & Dispensers of Controlled Substances
- Part 1302 - Labeling & Packaging Requirements For Controlled Substances
- Part 1304 - Records & Reports of Registrants
- Part 1305 - Orders for Schedule I & II Controlled Substances
- Part 1306 - Prescriptions
- Part 1307 - Miscellaneous
U.S. Food and Drug Administration
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Compressed Medical Gases - Medical Gases Are Drugs, Too