PURPOSE: This rule sets guidelines for the return and reuse of drugs and devices. FINANCIAL INSTITUTIONS AND PROFESSIONAL REGISTRATION

1. (1) Pharmacists and pharmacies shall not accept from patients or their agents for reuse or resale any drugs, prescribed medications, chemicals, poisons or medical devices unless otherwise provided for in this regulation.

2. (2) A pharmacist or pharmacy may receive and reuse drugs from long-term care facilities, hospitals, and hospice facilities (as regulated by the Department of Health and Senior Services, in 19 CSR 30-35.020 Hospices Providing Direct Care in a Hospice Facility), provided that the following conditions are met:

   1. (A) The pharmacist has assurance from a person in responsible charge of the drugs at a facility delineated in this section that the drugs being returned have been stored in accordance with the manufacturer’s recommendations and meet U.S.P. standards;
   2. (B) The drugs were originally dispensed by the pharmacist or pharmacy to the facility delineated in section (2);
   3. (C) There is an established mechanism to trace the expiration date and the manufacturer’s lot number of the drugs being returned;

   4. (D) Only drug products dispensed by a licensed pharmacy utilizing one (1) of the following sources may be reused and no drug products for reuse shall be in any way subject to further repackaging:

      1. 1. Drug products in the original manu-

facturer’s packaging that remains sealed in tamper-evident packaging;

1. 2. Drug products repackaged by facili-

ties that are federally registered as a repackager of medications and the packaging remains sealed in tamper-evident packaging;

1. 3. Drug products that have been repack-

aged by a licensed pharmacy and are returned unused by the facility and remain sealed in tamper-evident packaging;

1. 4. Drug products that have been repack-

aged by a licensed pharmacy and are provided in unit of use packaging whereby unused portions can be separated and reused without any further repackaging processes necessary on the returned product; and

1. (E) Any products that are accepted for return and can be reused based on standards provided in this rule shall be re-labeled to provide accurate information concerning patient and prescription information. Original lot numbers, expiration or beyond-usedates assigned to a product that is reused by a pharmacy shall not be altered or in any way updated.

AUTHORITY: section 338.280, RSMo 2000.* This rule originally filed as 4 CSR 220-3.040. Original rule filed Dec. 12, 1983, effective May 11, 1984. Amended: Filed July 5, 1988, effective Nov. 11, 1988. Amended: Filed Sept. 2, 1997, effective April 30, 1998. Amended: Filed April 5, 2002, effective Nov. 30, 2002. Amended: Filed May 17, 2004, effective Dec. 30, 2004. Moved to 20 CSR 2220-3.040, effective Aug. 28, 2006.

*Original authority: 338.280, RSMo 1951, amended 1971, 1981.