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RULE §229.251Minimum Standards for Licensure

(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.

(e) Storage of nonprescription drugs. All nonprescription drugs stored by wholesale distributors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs.

(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 shall be established and followed and shall include:

  (1) a procedure for identifying and retrieving nonprescription drug products that are 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 shall meet the labeling requirements of the Act and 21 CFR, Part 201, titled "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).

Source Note: The provisions of this §229.251 adopted to be effective February 1, 2007, 32 TexReg 315

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