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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER OLICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.242Applicable Laws and Regulations

(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.

(b) Copies of these laws and regulations are indexed and filed at the department, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours, 8:00 a.m. - 5:00 p.m. (except weekends and holidays). Electronic copies of these laws and regulations are available online at http://www.dshs.state.tx.us/license.shtm.

(c) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable Texas and federal laws and regulations.


Source Note: The provisions of this §229.242 adopted to be effective February 1, 2007, 32 TexReg 315

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