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

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  The department adopts by reference the following laws and regulations:
(1) Federal Food, Drug, and Cosmetic Act, 21
				  United States Code (U.S.C.), §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, Registration of Producers of Drugs and Listing of Drugs in Commercial
				  Distribution, 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 216, Pharmacy Compounding,
				  as amended;
(20) 21 CFR, Part 225,
				  Current Good Manufacturing Practice for Medicated Feeds, as amended;
(21) 21 CFR, Part 226, Current Good
				  Manufacturing Practice for Type A Medicated Articles, as amended;
(22) 21 CFR, Part 250, Special Requirements
				  For Specific Human Drugs, as amended;
(23) 21 CFR, Part 290, Controlled Drugs, as
				  amended;
(24) 21 CFR, Part 299,
				  Drugs; Official Names and Established Names, as amended;
(25) 21 CFR, Part 300, General, as
				  amended;
(26) 21 CFR, Part 310, New
				  Drugs, as amended;
(27) 21 CFR,
				  Part 312, Investigational New Drug Application, as amended;
(28) 21 CFR, Part 314, Applications for FDA
				  Approval to Market a New Drug or an Antibiotic Drug, as amended;
(29) 21 CFR, Part 315, Diagnostic
				  Radiopharmaceuticals, as amended;
(30) 21 CFR, Part 316, Orphan Drugs, as
				  amended;
(31) 21 CFR, Part 320,
				  Bioavailability and Bioequivalence Requirements, as amended;
(32) 21 CFR, Part 361, Prescription Drugs for
				  Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs
				  Used In Research, as amended;
(33)
				  21 CFR, Part 500, General, as amended;
(34) 21 CFR, Part 510, New Animal Drugs, as
				  amended;
(35) 21 CFR, Part 511, New
				  Animal Drugs for Investigational Use, as amended;
(36) 21 CFR, Part 514, New Animal Drug
				  Applications, as amended;
(37) 21
				  CFR, Part 515, Medicated Feed Mill License, as amended;
(38) 21 CFR, Part 520, Oral Dosage Form New
				  Animal Drugs, as amended;
(39) 21
				  CFR, Part 522, Implantation or Injectable Dosage Form New Animal Drugs, as
				  amended;
(40) 21 CFR, Part 524,
				  Opthalmic and Topical Dosage Form New Animal Drugs, as amended;
(41) 21 CFR, Part 526, Intramammary Dosage
				  Forms, as amended;
(42) 21 CFR,
				  Part 529, Certain Other Dosage Form New Animal Drugs, as amended;
(43) 21 CFR, Part 530, Extralabel Drug Use in
				  Animals, as amended;
(44) 21 CFR,
				  Part 556, Tolerances for Residues of New Animal Drugs in Food, as
				  amended;
(45) 21 CFR, Part 558, New
				  Animal Drugs for Use in Animal Feeds, as amended;
(46) 21 CFR, Part 589, Substances Prohibited
				  From Use in Animal Food or Feed, as amended;
(47) 21 CFR, Part 600, Biological Products:
				  General, as amended;
(48) 21 CFR,
				  Part 601, Licensing, as amended;
(49) 21 CFR, Part 610, General Biological
				  Products Standards, as amended;
(50) 21 CFR, Part 660, Additional Standards
				  for Diagnostic Substances for Laboratory Tests, as amended;
(51) 21 CFR, Part 680, Additional Standards
				  for Miscellaneous Products, as amended;
(52) 21 CFR, Part 1300,
				  Definitions;
(53) 21 CFR, Part
				  1301, Registration of Manufacturers, Distributors, and Dispensers of Controlled
				  Substances;
(54) 21 CFR, Part 1302,
				  Labeling and Packaging Requirements For Controlled Substances, as
				  amended;
(55) 21 CFR, Part 1304,
				  Records and Reports of Registrants;
(56) 21 CFR, Part 1305, Orders for Schedule I
				  and Schedule II Controlled Substances;
(57) 21 CFR, Part 1306, Prescriptions;
				  and
(58) 21 CFR, Part 1307,
				  Miscellaneous.