• Contact this ProgramSearch this Program
    Customer Surveys

    Please let us know how we are doing by completing our customer service survey.


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)

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)

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

Last updated July 2, 2015