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

Universal Citation: 25 TX Admin Code ยง 229.242

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 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, 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;

(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, 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 Drug Products Intended for Oral Ingestion that Contain Alcohol, as amended;

(26) 21 CFR 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 Human Use, as amended;

(29) 21 CFR Part 333, Topical Antimicrobial Drug Products for Over-the-Counter Human Use, as amended;

(30) 21 CFR Part 335, Antidiarrheal Drug Products for Over-the-Counter Human Use, as amended;

(31) 21 CFR Part 336, Antiemetic Drug Products for Over-the-Counter Human Use, as amended;

(32) 21 CFR Part 338, Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use, as amended;

(33) 21 CFR Part 340, Stimulant Drug Products for Over-the-Counter Human Use, as amended;

(34) 21 CFR Part 341, Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use, as amended;

(35) 21 CFR Part 343, Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use, as amended;

(36) 21 CFR Part 344, Topical Otic Drug Products for Over-the-Counter Human Use, as amended;

(37) 21 CFR Part 346, Anorectal Drug Products for Over-the-Counter Human Use, as amended;

(38) 21 CFR Part 347, Skin Protectant Drug Products for Over-the-Counter Human Use, as amended;

(39) 21 CFR Part 348, External Analgesic Drug Products for Over-the-Counter Human Use, as amended;

(40) 21 CFR Part 349, Ophthalmic Drug Products for Over-the-Counter Human Use, as amended;

(41) 21 CFR Part 350, Antiperspirant Drug Products for Over-the-Counter Human Use, as amended;

(42) 21 CFR Part 352, Sunscreen Drug Products for Over-the-Counter Human Use (Stayed Indefinitely), as amended;

(43) 21 CFR Part 355, Anticaries Drug Products for Over-the-Counter Human Use, as amended;

(44) 21 CFR Part 357, Miscellaneous Internal Drug Products for Over-the-Counter Human Use, as amended;

(45) 21 CFR Part 358, Miscellaneous External Drug Products for Over-the-Counter Human Use, as amended;

(46) 21 CFR Part 369, Interpretive Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale, as amended;

(47) 21 CFR Part 700, General, as amended;

(48) 21 CFR Part 701, Cosmetic Labeling, as amended; and

(49) 21 CFR Part 740, Cosmetic Product Warning Statements, as amended.

(b) 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 compliance 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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