Standards and Procedures for Accepting Donated Prescription Drugs

PURPOSE: This rule contains the criteria by which pharmacies, hospitals and nonprofit clinics will determine drugs to be acceptable for donation under the Prescription Drug Repository Program. (1) No controlled substances or drugs that require storage temperatures other than normal room temperature as specified by the manufacturer and/or United States Pharmacopoeia shall be donated or accepted as part of the Prescription Drug Repository Program. (A) Controlled substances shall not be donated or accepted because a pharmacy, hospital or nonprofit clinic cannot accept controlled substances from a person to whom they have been dispensed, according to applicable state and federal law. (B) Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer and/or United States Pharmacopoeia shall not be donated or accepted because of the potential for these drugs to become adulterated. (2) A prescription drug may only be accepted by a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program if the following requirements are met: (A) The drug is in its original sealed and tamper-evident unit dose packaging; (B) The packaging is unopened except that a drug packaged in single-unit doses may be accepted and dispensed when the outside packaging is opened if the single-unit-dose packaging is undisturbed; (C) The drug has been in the possession of a licensed dispenser of prescription drugs, a licensed wholesale distributor of prescription drugs or a licensed health care professional and not in the possession of the ultimate user; (D) The drug has been stored according to manufacturer and/or United States Pharmacopoeia storage requirements; (E) The drug has an expiration date of six (6) months or greater; (F) The packaging contains the lot number and expiration date of the drug; (G) The drug does not have any physical signs of tampering or adulteration, and there is no reason to believe that the drug is adulterated as defined in section 196.095, RSMo; (H) The packaging does not have any physical signs of tampering, deterioration, compromised integrity or adulteration; and (I) Drugs that were dispensed for individuals are packaged and labeled in compliance with 4 CSR 220-2.130, 4 CSR 220-2.140 and (3) Prior to receiving each donation of donated drugs, a pharmacy, hospital or nonprofit clinic shall inquire of the donor or donor’s representative if the drugs have been examined to determine that no controlled substances or drugs that require storage temperatures other than normal room temperature as specified by the manufacturer and/or United States Pharmacopoeia are included. AUTHORITY: section 196.984, RSMo Supp. 2004.* Emergency rule filed Dec. 15, 2004, effective Jan. 1, 2005, expired June 29, 2005. Original rule filed Dec. 15, 2004, effective June 30, 2005. *Original authority: 196.984, RSMo 2004. Communicable Disease Prevention