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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER WLICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.420Applicable 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 (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.

(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. Electronic copies of these laws and regulations are available online at http://www.dshs.state.tx.us/license.shtm.

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


Source Note: The provisions of this §229.420 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755

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