| (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. |
