Section 229.251 - Minimum Standards for Licensure(a) General requirements. (1) 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 Act and in § 229.242 of this subchapter (relating to Applicable Laws and Regulations).(2) For the purpose of this section, the policies that apply to nonprescription drugs as described in the United States Food and Drug Administration's (FDA) Compliance Policy Guides are the policies of the department.(3) Nonprescription drug wholesalers must not purchase or receive drugs in this state other than from drug distributors licensed by the department.(b) Federal establishment registration and drug listing.(1) All persons who operate as nonprescription drug manufacturers in Texas must meet the requirements in 21 Code of Federal Regulations (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.(2) New nonprescription drugs offered for sale by wholesale distributors must have met, if applicable, the requirements of 21 CFR Part 314, Applications for FDA Approval to Market a New Drug.(c) Good manufacturing practices. Manufacturers of nonprescription drug products must comply with the applicable requirements in:(1) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;(2) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, as amended;(3) 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds, as amended(4) 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended; and(5) the regulations in this subsection governing the methods used in, and the facilities or controls used for, the manufacture, processing, packing, or holding of a drug to ensure each drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, 21 USC § 301, et seq., as amended, (Federal Act) as to safety, and has the identity and strength meeting the quality and purity characteristics it purports or is represented to possess.(d) Buildings and facilities.(1) All manufacturing, processing, packing, or holding of drugs by nonprescription drug manufacturers must take place in buildings and facilities described in subsection (c) of this section.(2) Manufacturing, processing, packing, or holding of nonprescription drugs must not be conducted in any personal residence.(3) Sale of nonprescription drugs must not 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 must:(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 and in good repair, including the walls, ceilings, windows, doors, and floors of the premises;(D) be free from infestation by insects, rodents, birds, or vermin of any kind; and(E) utilize a quarantine area for storage of drugs that are outdated, damaged, deteriorated, returned, recalled, misbranded, or adulterated, that is clearly designated and separated from other sections where drugs are stored so drugs in this subchapter are not confused with usable drugs.(e) Storage of nonprescription drugs. All nonprescription drugs stored by wholesale distributors must be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs and the standards set forth in the latest edition of the United States Pharmacopeia/National Formulary (USP/NF). If no storage requirements are established for a nonprescription drug, the nonprescription drug may be held at controlled room temperature, as defined in the USP/NF, to help ensure that its identity, strength, quality, and purity are not adversely affected. Prior to storage in inventory, a wholesale distributor must:(1) upon receipt, visually examine each outside shipping container for identity and to prevent the acceptance of contaminated drugs otherwise unfit for distribution; and(2) carefully inspect each outgoing shipment for identity of the drug and to prevent delivery of drugs that have been damaged in storage, including drugs held under improper conditions.(f) Operating procedures for wholesale distributors who are not manufacturers. Written procedures describing the holding of nonprescription drug products by wholesale distributors of nonprescription drugs who are not manufacturers must be established and followed and include:(1) a procedure for identifying and retrieving nonprescription drug products subject to a recall; and(2) a quarantine procedure for nonprescription drug products that have expired; are subject to recall; or are otherwise determined to be adulterated or misbranded, for the return, destruction, or other disposal of those items.(g) Nonprescription drug labeling. Nonprescription drugs sold by wholesale distributors must meet the labeling requirements of the Act and 21 CFR Part 201, Labeling.(h) Nonprescription drugs that are combination products. Any nonprescription drug that is a combination product as described in § 229.246(c) of this title (relating to Licensure Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers).(i) Nonprescription drugs that are also cosmetics. Any nonprescription drug that is also a cosmetic or component thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to Regulation of Cosmetics).25 Tex. Admin. Code § 229.251
The provisions of this §229.251 adopted to be effective February 1, 2007, 32 TexReg 315; Amended by Texas Register, Volume 49, Number 37, September 13, 2024, TexReg 7327, eff. 9/18/2024