| (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.
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