Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.420 - Applicable Laws and Regulations

Universal Citation: 25 TX Admin Code ยง 229.420

Current through Reg. 49, No. 38; September 20, 2024

(a) The department adopts by reference the following laws and regulations:

(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301 et seq., as amended;

(2) 9 Code of Federal Regulations (CFR) Part 113, Standard Requirements, as amended;

(3) 21 CFR Part 70, Color Additives, as amended;

(4) 21 CFR Part 71, Color Additive Petitions, as amended;

(5) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, as amended;

(6) 21 CFR Part 74, Listing of Color Additives Subject to Certification, as amended;

(7) 21 CFR Part 80, Color Additive Certification, as amended;

(8) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;

(9) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended;

(10) 21 CFR Part 200, General, as amended;

(11) 21 CFR Part 201, Labeling, as amended;

(12) 21 CFR Part 202, Prescription Drug Advertising, as amended;

(13) 21 CFR Part 203, Prescription Drug Marketing, as amended;

(14) 21 CFR Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, as amended;

(15) 21 CFR Part 206, Imprinting of Solid Oral Dosage Form Drug Products for Human Use, as amended;

(16) 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code, as amended;

(17) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;

(18) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, as amended;

(19) 21 CFR Part 212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs, as amended;

(20) 21 CFR Part 216, Human Drug Compounding, as amended;

(21) 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds, as amended;

(22) 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended;

(23) 21 CFR Part 250, Special Requirements For Specific Human Drugs, as amended;

(24) 21 CFR Part 251, §804, Importation Program, as amended;

(25) 21 CFR Part 290, Controlled Drugs, as amended;

(26) 21 CFR Part 299, Drugs; Official Names and Established Names, as amended;

(27) 21 CFR Part 300, General, as amended;

(28) 21 CFR Part 310, New Drugs, as amended;

(29) 21 CFR Part 312, Investigational New Drug Application, as amended;

(30) 21 CFR Part 314, Applications for FDA Approval to Market a New Drug, as amended;

(31) 21 CFR Part 315, Diagnostic Radiopharmaceuticals, as amended;

(32) 21 CFR Part 316, Orphan Drugs, as amended;

(33) 21 CFR Part 320, Bioavailability and Bioequivalence Requirements, as amended;

(34) 21 CFR Part 361, Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research, as amended;

(35) 21 CFR Part 500, General, as amended;

(36) 21 CFR Part 510, New Animal Drugs, as amended;

(37) 21 CFR Part 511, New Animal Drugs for Investigational Use, as amended;

(38) 21 CFR Part 514, New Animal Drug Applications, as amended;

(39) 21 CFR Part 515, Medicated Feed Mill License, as amended;

(40) 21 CFR Part 516, New Animal Drugs for Minor Use and Minor Species, as amended;

(41) 21 CFR Part 520, Oral Dosage Form New Animal Drugs, as amended;

(42) 21 CFR Part 522, Implantation or Injectable Dosage Form New Animal Drugs, as amended;

(43) 21 CFR Part 524, Ophthalmic and Topical Dosage Form New Animal Drugs, as amended;

(44) 21 CFR Part 526, Intramammary Dosage Form New Animal Drugs, as amended;

(45) 21 CFR Part 528, New Animal Drugs in Genetically Engineered Animals, as amended;

(46) 21 CFR Part 529, Certain Other Dosage Form New Animal Drugs, as amended;

(47) 21 CFR Part 530, Extralabel Drug Use in Animals, as amended;

(48) 21 CFR Part 556, Tolerances for Residues of New Animal Drugs in Food, as amended;

(49) 21 CFR Part 558, New Animal Drugs for Use in Animal Feeds, as amended;

(50) 21 CFR Part 589, Substances Prohibited From Use in Animal Food or Feed, as amended;

(51) 21 CFR Part 600, Biological Products: General, as amended;

(52) 21 CFR Part 601, Licensing, as amended;

(53) 21 CFR Part 610, General Biological Products Standards, as amended;

(54) 21 CFR Part 660, Additional Standards for Diagnostic Substances for Laboratory Tests, as amended;

(55) 21 CFR Part 680, Additional Standards for Miscellaneous Products, as amended;

(56) 21 CFR Part 700, General, as amended;

(57) 21 CFR Part 701, Cosmetic Labeling, as amended;

(58) 21 CFR Part 740, Cosmetic Product Warning Statements, as amended;

(59) 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products, as amended;

(60) 21 CFR Part 1300, Definitions, as amended;

(61) 21 CFR Part 1301, Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances, as amended;

(62) 21 CFR Part 1302, Labeling and Packaging Requirements For Controlled Substances, as amended;

(63) 21 CFR Part 1304, Records and Reports of Registrants, as amended;

(64) 21 CFR Part 1305, Orders for Schedule I and Schedule II Controlled Substances, as amended;

(65) 21 CFR Part 1306, Prescriptions, as amended;

(66) 21 CFR Part 1307, Miscellaneous; and

(67) 21 CFR Part 1317, Disposal, as amended.

(b) Copies of these laws and regulations are indexed and filed at the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at www.dshs.texas.gov.

(c) Nothing in this subchapter relieves any person of the responsibility for complying with other applicable Texas and federal laws and regulations.

Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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