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 229.251 - Minimum Standards for Licensure

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  General requirements. All persons engaged in the wholesale distribution of
				  nonprescription drugs must comply with the applicable minimum standards in this
				  section, in addition to the statutory requirements contained in the Texas Food,
				  Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) and those
				  requirements adopted in §
										229.242
				  of this title (relating to Applicable Laws and Regulations). For the purpose of
				  this section, the policies described in the United States Food and Drug
				  Administration's (FDA's) Compliance Policy Guides as they apply to
				  nonprescription drugs shall be the policies of the department.
(b) Federal establishment registration and
				  drug listing. All persons who operate as nonprescription drug manufacturers in
				  Texas shall meet the requirements in 21 Code of Federal Regulations (CFR), Part
				  207, titled "Registration of Producers of Drugs and Listing of Drugs in
				  Commercial Distribution." New nonprescription drugs offered for sale by
				  wholesale distributors shall have met, if applicable, the requirements of 21
				  CFR, Part 314, titled "Applications for FDA Approval to Market a New
				  Drug."
(c) Good manufacturing
				  practices. Manufacturers of nonprescription drug products shall be in
				  compliance with the applicable requirements in 21 CFR, Part 210, titled
				  "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or
				  Holding of Drugs"; 21 CFR, Part 211, titled "Current Good Manufacturing
				  Practice for Finished Pharmaceuticals; General"; 21 CFR, Part 225, titled
				  "Current Good Manufacturing Practice for Medicated Feeds"; and 21 CFR, Part
				  226, titled "Current Good Manufacturing Practice for Type A Medicated Article."
				  The regulations in these parts govern the methods used in, and the facilities
				  or controls used for, the manufacture, processing, packing, or holding of a
				  drug to assure that each drug meets the requirements of the Federal Act as to
				  safety, and has the identity and strength and meets the quality and purity
				  characteristics that it purports or is represented to possess.
(d) Buildings and facilities.
(1) All manufacturing, processing, packing,
				  or holding of drugs by nonprescription drug manufacturers shall take place in
				  buildings and facilities described in subsection (c) of this section.
(2) No manufacturing, processing, packing, or
				  holding of nonprescription drugs shall be conducted in any personal
				  residence.
(3) No sale of
				  nonprescription drugs shall be conducted in any flea market.
(4) Any place of business used by a wholesale
				  distributor of nonprescription drugs who is not a manufacturer to store,
				  warehouse, hold, offer, transport, or display drugs shall:
(A) be of suitable size and construction to
				  facilitate cleaning, maintenance, and proper operations;
(B) have storage areas designed to provide
				  adequate lighting, ventilation, temperature, sanitation, humidity, and
				  space;
(C) be maintained in a clean
				  and orderly condition;
(D) be free
				  from infestation by insects, rodents, birds, or vermin of any kind;
				  and
(E) have a quarantine area for
				  storage of drugs that are outdated, damaged, deteriorated, misbranded, or
				  adulterated.