1. (a) General requirements. All persons engaged in the wholesale distribution of prescription 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 in §229.420 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 prescription drugs shall be the policies of the department.
2. (b) Federal establishment registration and drug listing. All persons who operate as prescription 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 prescription 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."
3. (c) Good manufacturing practices. Manufacturers of prescription 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 Articles." 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.

4. (d) Buildings and facilities.

   1. (1) All manufacturing, processing, packing, or holding of drugs by prescription drug manufacturers shall take place in buildings and facilities described in subsection (c) of this section.
   2. (2) No manufacturing, processing, packing, or holding of prescription drugs shall be conducted in any personal residence.
   3. (3) No sale of prescription drugs shall be conducted in any flea market.

   4. (4) Any place of business used by a wholesale distributor of prescription drugs who is not a manufacturer to store, warehouse, hold, offer, transport, or display drugs shall:

      1. (A) be in compliance with the requirements adopted in §229.420(a)(14) of this title;
      2. (B) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
      3. (C) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;
      4. (D) be maintained in a clean and orderly condition;
      5. (E) be free from infestation by insects, rodents, birds, or vermin of any kind; and
      6. (F) have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, or adulterated.
5. (e) Storage of prescription drugs. All prescription 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.

6. (f) Minimum restrictions on transactions.

   1. (1) Returns. A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or chain pharmacy warehouse in accordance with the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. The returns or exchanges received by the wholesale distributor as provided by this subsection are not subject to the pedigree requirement under §431.412 of the Act. In connection with the returned goods process, a wholesale distributor shall establish appropriate business practices and exercise due diligence designed to prevent the entry of adulterated or counterfeit drugs into the distribution channel.
   2. (2) Distributions. A manufacturer or wholesale distributor may distribute prescription drugs only to a person licensed under this subchapter, or the appropriate state licensing authorities, if an out-of-state wholesaler or retailer, or authorized by federal law to receive the drug. Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor must verify that the person is legally authorized by the department or the appropriate state licensing authority to receive the prescription drugs or authorized by federal law to receive the drugs.

   3. (3) Premises. Prescription drugs distributed by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license, except as listed in paragraph (4) of this subsection. A manufacturer or wholesale distributor may distribute prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if:

      1. (A) the identity and authorization of the recipient is properly established; and
      2. (B) delivery is made only to meet the immediate needs of a particular patient of the authorized person.
   4. (4) Delivery to hospital pharmacies. Prescription drugs may be distributed to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor not later than the next business day after the date of delivery to the pharmacy receiving area.
7. (g) Prescription drug labeling. Prescription drugs sold by wholesale distributors shall meet the labeling requirements of the Act and those adopted in §229.420(a) of this title.
8. (h) Prescription drugs that are combination products. Any prescription drug that is a combination product as described in §229.424(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).
9. (i) Prescription drugs that are also cosmetics. Any prescription 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).
10. (j) Nonprescription drugs. Nonprescription drugs offered for sale by wholesale distributors of prescription drugs shall be in compliance with the applicable requirements of Subchapter O of this chapter (relating to Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices).

Source Note:The provisions of this §229.429 adopted to be effective February 1, 2007, 32 TexReg 315.