Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS
Section 229.581 - Handling Distressed Drugs

Universal Citation: 25 TX Admin Code ยง 229.581

Current through Reg. 49, No. 38; September 20, 2024

(a) Good manufacturing practices. A person must follow and comply with the requirements in 21 CFR, Parts 205, §§205.1 - 205.50, titled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors," as amended, 21 CFR Part 210, §§210.1 - 210.3, titled "Current Good Manufacturing, Processing, Packing, or Holding of Drugs" as amended, and §§211.1 - 211.208, titled "Current Good Manufacturing Practice for Finished Pharmaceuticals" as amended, in the handling and reconditioning of all salvaged drugs.

(b) Distressed or nonsalvageable drugs. All distressed or nonsalvageable drugs shall be disposed of in accordance with § 229.579(f) of this title (relating to Sanitary Facilities and Controls).

(c) Relabeling. All salvaged drugs in containers shall be provided with labels meeting the requirements in § 229.580(i) of this title (relating to General Provisions for Handling and Movement of Distressed Drugs). When original labels are removed from containers that are to be resold or redistributed, the replacement labels must show the name and address of the salvage establishment.

(d) Procedures. All salvage establishments shall have written procedure for identifying and retrieving over-the-counter and prescription drug products that are subject to recall.

Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.