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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER WLICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.429Minimum Standards for Licensure

(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.

(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."

(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.

(d) Buildings and facilities.

  (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) No manufacturing, processing, packing, or holding of prescription drugs shall be conducted in any personal residence.

  (3) No sale of prescription drugs shall be conducted in any flea market.

  (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:

    (A) be in compliance with the requirements adopted in §229.420(a)(14) of this title;

    (B) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

    (C) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;

    (D) be maintained in a clean and orderly condition;

    (E) be free from infestation by insects, rodents, birds, or vermin of any kind; and

    (F) have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, or adulterated.

(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.

(f) Minimum restrictions on transactions.

  (1) Returns.

    (A) A wholesale distributor must receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse in accordance with the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse. An expired, damaged, recalled, or otherwise nonsalable prescription drug that is returned to the wholesale distributor may be distributed by the wholesale distributor only to either the original manufacturer or a third party returns processor. The returns or exchanges, salable or otherwise, received by the wholesale distributor as provided by this subsection, including any redistribution of returns or exchanges by the wholesale distributor, are not subject to the pedigree requirement under Health and Safety Code, §431.412, if the returns or exchanges are exempt from pedigree under:

      (i) §503, Prescription Drug Marketing Act of 1987 (21 U.S.C. §353(c)(3)(B));

      (ii) the regulations adopted by the Secretary of the U.S. Department of Health and Human Services to administer and enforce that Act; or

      (iii) the interpretations of that Act set out in the compliance policy guide of the United States Food and Drug Administration.

    (B) Each wholesale distributor and pharmacy shall administer the process of drug returns and exchanges to ensure that the process is secure and does not permit the entry of adulterated or counterfeit drugs into the distribution channel.

    (C) Notwithstanding any provision of state or federal law to the contrary, a person that has not otherwise been required to obtain a wholesale license under this subchapter and that is a pharmacy engaging in the sale or transfer of expired, damaged, returned, or recalled prescription drugs to the originating wholesale distributor or manufacturer and pursuant to federal statute, rules, and regulations, including the United States Food and Drug Administration's applicable guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293), is exempt from wholesale licensure requirements under this subchapter.

    (D) All other returns must comply with the requirements of Title 21, Code of Federal Regulations, §203.23(a)(1) - (5).

  (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 shall 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. Wholesale distributors physically located and conducting operations in another state shall verify, prior to purchasing or receiving product, that the suppliers of drugs are licensed under this subchapter and physically located in Texas; and, shall notify the department of unlicensed wholesale distributors.

  (3) Pedigree.

    (A) A person, who is engaged in the wholesale distribution of a prescription drug, including a repackager but excluding the original manufacturer, shall provide a pedigree for each prescription drug for human consumption that leaves or at any time has left the normal distribution channel and is sold, traded, or transferred to any other person.

    (B) A retail pharmacy or pharmacy warehouse is required to comply with this section only if the pharmacy or warehouse engages in the wholesale distribution of a prescription drug.

    (C) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager, but excluding the original manufacturer of the finished form of a prescription drug, and who is in possession of a pedigree for a prescription drug shall verify before distributing the prescription drug that each transaction listed on the pedigree has occurred.

    (D) A pedigree must include all necessary identifying information concerning each sale in the product's chain of distribution from the manufacturer, through acquisition and sale by a wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. At a minimum, the chain of distribution information must include:

      (i) the name, address, telephone number, and, if available, the e-mail address of each person who owns the prescription drug and each wholesale distributor of the prescription drug;

      (ii) the name and address of each location from which the product was shipped, if different from the owner's name and address;

      (iii) the transaction dates; and

      (iv) certification that each recipient has authenticated the pedigree.

    (E) The pedigree must include, at a minimum, the:

      (i) name of the prescription drug;

      (ii) dosage form and strength of the prescription drug;

      (iii) size of the container;

      (iv) number of containers;

      (v) lot number of the prescription drug; and

      (vi) name of the manufacturer of the finished dosage form.

    (F) Each pedigree statement must be:

      (i) maintained by the purchaser and the wholesale distributor for at least three years; and

      (ii) available for inspection and photocopying not later than the second business day after the date a request is submitted by the department or a peace officer in this state.

    (G) Verification procedures.

      (i) Each transaction listed on the pedigree must be affirmatively authenticated prior to any wholesale distribution of a prescription drug.

      (ii) A person who is engaged in the wholesale distribution of a prescription drug, and who is in possession of a pedigree for a prescription drug shall certify, using the following methods, that each transaction listed on the pedigree has occurred.

        (I) Invoice confirmation. Receipt of an invoice (or shipping document) from the seller to the purchaser, which may have the prices redacted. Documentation requirements include at a minimum a copy of the invoice or shipping document. If this method is used to authenticate a pedigree, the wholesaler shall review the document received for signs of tampering, incompleteness, or inconsistency with other invoices or shipping documents from that manufacturer or wholesaler, and shall randomly verify the authenticity of the invoice or shipping document with the seller or shipping point reflected on that document using one of the methods in the subsections below. Each wholesaler shall establish policies and procedures for the random verification of the authenticity of the invoices or shipping documents according to statistically sound standards. Each wholesaler shall establish policies and procedures for verification with those wholesalers in the distribution chain with which the wholesaler performing the authentication does not have an established prescription drug vendor relationship.

        (II) Telephonic confirmation. Documentation requirements include a signed statement by the person placing the telephone call identifying the person's name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and the quantity of prescription drugs involved in the transaction.

        (III) Electronic mail confirmation. Documentation requirements include a copy of the e-mail that identifies the person's name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and quantity of prescription drugs involved in the transaction.

        (IV) Electronic web-based confirmation. Verification of the transaction per a web-based system established by the seller or an independent person that is secure from intentional or unintentional tampering or manipulation to conceal an accurate and complete history of the prescription drug transaction(s). Documentation requirements include a written representation from the seller or independent person that the seller or independent person, as applicable, is responsible for the information included on the website and has adequate security on the information posted to prevent unauthorized tampering, manipulation, or modification of the information and a copy of the dated website page that confirms the sales transaction between the parties, including the date of the transaction and quantity of prescription drugs involved in the transaction.

        (V) Notarized copy confirmation. Receipt of a legible and unaltered copy of a previous transaction's pedigree paper that had been signed under oath at the time of the previous transaction to support the transaction to which the pedigree paper relates. If this method is used to authenticate a pedigree, the wholesaler shall review the document received for signs of tampering, incompleteness, or inconsistency, and shall randomly verify the authenticity of pedigrees using one of the methods in the this subparagraph. Each wholesaler shall establish policies and procedures for the random verification of the authenticity of these copies of pedigree according to statistically sound standards.

        (VI) Exclusive purchasing. A wholesale distributor may use a written agreement between the wholesale distributor and an authorized distributor of record that requires that all prescription drugs distributed to the wholesale distributor by the authorized distributor of record must be purchased by the authorized distributor of record from the manufacturer. If this method is used to authenticate a pedigree, the wholesale distributor shall establish policies and procedures for the random verification of the authenticity of the pedigrees that disclose the authorized distributor of record purchased the prescription drug from the manufacturer according to statistically sound standards.

Cont'd...

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