State and Federal Laws - Drug Manufacturers and Distributors

Federal Food, Drug, and Cosmetic Act (FD&C Act) 

• FDA online reference edition of the Federal Food, Drug and Cosmetic 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 Food, Drug, and Cosmetic Act, 21 United States Code (U.S.C), §301 et seq. 

• FDA online reference edition of the Food, Drug, and Cosmetic 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 - 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 

• Compressed Medical Gases - FDA Medical Gas Inspection Compliance Guide

Texas Administrative Code: Licensing of Wholesale Distributors of Nonprescription Drugs -- including Good Manufacturing Practices 

25 Texas Administrative Code (TAC), §§229.241 – 229.252 (PDF, 140KB) 

Section: 

• 229.241 - Purpose 

• 229.242 - Applicable Laws and Regulations 

• 229.243 - Definitions 

• 229.244 - Sales of Nonprescription Drugs 

• 229.245 - Exemption 

• 229.246 - Licensure Requirements 

• 229.247 - Licensing Procedures 

• 229.248 - Report of Changes 

• 229.249 - Licensure Fees 

• 229.250 - Refusal, Cancellation, Suspension or Revocation of License 

• 229.251 - Minimum Standards for Licensure 

• 229.252 - Enforcement and Penalties 

25 Texas Administrative Code (TAC), Subchapter P - Assessment of Administrative Penalties 

Section: 

• 229.261 - Assessment of Administrative or Civil Penalties 

Federal Laws and Regulations Adopted by Reference 

For a complete list of regulations adopted by reference, please see the federal regulations page. 

Texas Administrative Code: Licensing of Wholesale Distributors of Prescription Drugs -- including Good Manufacturing Practices 

25 Texas Administrative Code (TAC), §§229.419 – 229.430 (PDF, 121KB) 

Section: 

• 229.419 - Purpose 

• 229.420 - Applicable Laws & Regulations 

• 229.421 - Definitions 

• 229.422 - Sale of Prescription Drugs 

• 229.423 - Exemptions 

• 229.424 - Licensure Requirements 

• 229.425 - Licensing Procedures 

• 229.426 - Report of Changes 

• 229.427 - Licensure Fees 

• 229.428 - Refusal, Cancellation, Suspension or Revocation of License 

• 229.429 - Minimum Standards for Licensure 

• 229.430 - Enforcement and Penalties 

25 Texas Administrative Code (TAC), Subchapter B - Donation of Unused Drugs 

Section: 

• 229.21 - Definitions 

• 229.22 - Donation of Drugs to Charitable Medical Clinics 

• 229.23 - Donation of Drugs From Nursing Homes to Foreign Countries 

• 229.24 - Dispensing of Drugs From Charitable Medical Clinics 

• 229.25 - Minimum Requirements for Licensing as a Charitable Drug Donor 

• 229.26 - Enforcement - Refusal, Revocation, or Suspension of License 

25 Texas Administrative Code (TAC), Subchapter P - Assessment of Administrative Penalties 

Section: 

• 229.261 - Assessment of Administrative or Civil Penalties 

Federal Laws and Regulations Adopted by Reference 

For a complete list of regulations adopted by reference, please see the federal regulations page. 

25 Texas Administrative Code (TAC) - Regulations to Prohibit the Sale of Dietary Supplements Containing Ephedrine 

• 229.461 - Prohibited Sale and Distribution of Dietary Supplements Containing Ephedrine Group Alkaloids 

• 229.464 - Restricted Sale and Distribution of Certain Drug Products Containing Ephedrine