Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.242 - 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, 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 201, Labeling, as
				  amended;
(11) 21 CFR, Part 206,
				  Imprinting of Solid Oral Dosage Form Drug Products for Human Use, as
				  amended;
(12) 21 CFR, Part 207,
				  Registration of Producers of Drugs and Listing of Drugs in Commercial
				  Distribution, as amended;
(13) 21
				  CFR, Part 210, Current Good Manufacturing Practice in Manufacturing,
				  Processing, Packing, or Holding of Drugs; General, as amended;
(14) 21 CFR, Part 211, Current Good
				  Manufacturing Practice for Finished Pharmaceuticals, as amended;
(15) 21 CFR, Part 225, Current Good
				  Manufacturing Practice for Medicated Feeds, as amended;
(16) 21 CFR, Part 226, Current Good
				  Manufacturing Practice for Type A Medicated Articles, as amended;
(17) 21 CFR, Part 250, Special Requirements
				  For Specific Human Drugs, as amended;
(18) 21 CFR, Part 299, Drugs; Official Names
				  and Established Names, as amended;
(19) 21 CFR, Part 300, General, as
				  amended;
(20) 21 CFR, Part 310, New
				  Drugs, as amended;
(21) 21 CFR,
				  Part 312, Investigational New Drug Application, as amended;
(22) 21 CFR, Part 314, Applications for FDA
				  Approval to Market a New Drug or an Antibiotic Drug, as amended;
(23) 21 CFR, Part 316, Orphan Drugs, as
				  amended;
(24) 21 CFR, Part 320,
				  Bioavailability and Bioequivalence Requirements, as amended;
(25) 21 CFR, Part 328, Over-the-Counter (OTC)
				  Drug Products Intended for Oral Ingestion that Contain Alcohol, as
				  amended;
(26) Part 330,
				  Over-the-Counter (OTC) Human Drugs Which are Generally Recognized as Safe and
				  Effective and Not Misbranded, as amended;
(27) 21 CFR, Part 331, Antacid Products for
				  Over-the-Counter (OTC) Human Use, as amended;
(28) 21 CFR, Part 332, Antiflatulent Products
				  for Over-the-Counter (OTC) Human Use, as amended;
(29) 21 CFR, Part 333, Topical Antimicrobial
				  Drug Products for Over-the-Counter (OTC) Human Use, as amended;
(30) 21 CFR, Part 335, Antidiarrheal Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(31) 21 CFR, Part 336, Antiemetic Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(32) 21 CFR, Part 338, Nighttime Sleep-aid
				  Drug Products for Over-the-Counter (OTC) Human Use, as amended;
(33) 21 CFR, Part 340, Stimulant Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(34) 21 CFR, Part 341, Cold, Cough, Allergy,
				  Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter (OTC)
				  Human Use, as amended;
(35) 21 CFR,
				  Part 343, Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for
				  Over-The-Counter (OTC) Human Use, as amended;
(36) 21 CFR, Part 344, Topical OTIC Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(37) 21 CFR, Part 346, Anorectal Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(38) 21 CFR, Part 347, Skin Protectant Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(39) 21 CFR, Part 348, External Analgesic
				  Drug Products for Over-the-Counter (OTC) Human Use, as amended;
(40) 21 CFR, Part 349, Ophthalmic Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(41) 21 CFR, Part 350, Antiperspirant Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(42) 21 CFR, Part 352, Sunscreen Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(43) 21 CFR, Part 355, Anticaries Drug
				  Products for Over-the-Counter (OTC) Human Use, as amended;
(44) 21 CFR, Part 357, Miscellaneous Internal
				  Drug Products for Over-the-Counter (OTC) Human Use, as amended;
(45) 21 CFR, Part 358, Miscellaneous External
				  Drug Products for Over-the-Counter (OTC) Human Use, as amended; and
(46) 21 CFR, Part 369, Interpretive
				  Statements Re: Warnings on Drugs and Devices for Over-the-Counter (OTC) Sales,
				  as amended.