Section 229.580 - General Provisions for Handling and Movement of Distressed Drugs(a) Notice to the department. (1) When the source of distressed drugs is the result of a natural disaster, accident, power failure, or other emergency, the salvage establishment or salvage broker shall make contact with the department within 24 hours after their initial awareness of the emergency and prior to any removal of distressed drugs from the place at which it was located when it became distressed.(2) If emergency removal of distressed drugs referenced in subsection (a)(1) of this section is required, notice to the department shall be made as soon thereafter as possible. It shall be the duty of the salvage establishment or salvage broker to make contact with the department within 48 hours whenever distressed drugs subject to the provisions of this subsection are obtained.(3) Distressed drugs referenced in this subsection shall not be moved out of the State of Texas without prior approval of the department and the responsible state agency in the state to receive the drugs. Concurrence shall also be obtained from the U.S. Food and Drug Administration, or U.S. Department of Agriculture, Food Safety and Inspection Service, prior to interstate movement.(b) Protection of Salvageable and Salvaged Drugs.(1) All salvageable and salvaged drugs stored by salvage establishments or salvage brokers shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs.(2) All salvageable and salvaged drugs, while being stored or processed at a salvage establishment, salvage warehouse, or during transportation, shall be protected from contamination.(3) Poisonous and toxic materials shall be identified and handled under such conditions as will not contaminate other salvageable or salvaged drugs, or constitute a hazard to personnel.(c) Segregation of drugs. All salvageable drugs shall be promptly sorted and segregated from nonsalvageable drugs to prevent further contamination of the distressed drugs to be salvaged or offered for sale or distribution.(d) Nonsalvageable drugs. (1) Containers, including metal and glass containers with press caps, screw caps, pull rings, or other types of openings which have been in contact with nonpotable water, liquid foam, or other deleterious substances, as a result of fire fighting efforts, flood, sewer backups, or similar mishaps, shall be deemed unfit for sale or distribution, i.e., nonsalvageable drugs as defined in § 229.573(17) of this title (relating to Definitions).(2) Nonsalvageable drugs shall be disposed of as in § 229.579 of this title (relating to Sanitary Facilities and Controls).(3) Distressed drugs which are deemed to be nonsalvageable by a duly authorized agent of the Texas Department of Health shall, at the request of the agent, be destroyed under the supervision of that agent at the expense of the owner.(e) Transporting of distressed drugs. (1) Distressed drugs shall be moved from the site of a fire, flood, sewer backup, wreck, or other cause as expeditiously as possible after compliance with subsection (a) of this section so as not to become putrid, rodent or insect defiled, or otherwise hazardous to public health.(2) All distressed and salvageable drugs of a perishable nature shall be transported only in vehicles provided with adequate refrigeration, if necessary, for product maintenance prior to reconditioning.(f) Handling of distressed articles other than drugs. If distressed articles other than drugs are also salvaged, they shall be handled separately so as to prevent contamination from poisonous and toxic materials or other contaminants.(g) Cross-contamination protection. Sufficient precautions shall be taken to prevent cross-contamination among the various types of drugs that are salvageable or salvaged.(h) Salvageable drugs. All salvageable drugs shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid license to engage in a salvage operation.(i) Reconditioned drugs. All reconditioned drugs must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.(j) Labeling. All salvaged drugs must be labeled in accordance with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq. as amended; the Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq. as amended; and the federal regulations promulgated under those Acts.(k) Salvage warehouses. A person may not use a salvage warehouse to recondition drugs or sell to consumers.25 Tex. Admin. Code § 229.580
The provisions of this §229.580 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984