Standards and Procedures for Inspecting and Storing Donated Prescription Drugs

PURPOSE: This rule contains the criteria by which pharmacies, hospitals and nonprofit clinics will determine drugs to be acceptable for dispensing under the Prescription Drug Repository Program. This rule also establishes documentation of receipt of donated drugs. (1) A pharmacy, hospital or nonprofit clinic shall inspect donated prescription drugs to determine that they are safe and suitable for dispensing, the drug and the packaging are in compliance with 19 CSR 20-50.025, and there are no controlled substances or drugs that require storage temperatures other than normal room temperature as specified by the manufacturer and/or United States Pharmacopoeia. The person who inspects the drugs shall sign an inspection record stating the above and attach it to the copy of the ownership record or alternate donor record provided with the drugs. (2) Donated drugs shall be stored in the pharmacy, hospital or nonprofit clinic in a location separate from other drugs. (3) When donated drugs are not inspected immediately upon receipt, they shall not be placed in the dispensing area until they have been inspected. (4) Donated non-controlled substances that are not suitable for dispensing, shall be destroyed and a record made of such destruction. (5) Controlled substances found upon inspection shall not be accepted for donation. (A) Controlled substances submitted for donation shall be documented and returned immediately to the donor or the donor’s representative that provided the drugs. (B) In the event that it is not possible to return the controlled substances to the donor or donor’s representative due to inability to identify the donor or donor’s representative or due to refusal by the donor or donor’s representative to receive them, abandoned controlled substances shall be documented, quarantined and destroyed as required in this subsection. 1. Abandoned controlled substances shall be documented as required in subsection (C) of this section. 2. Abandoned controlled substances shall be quarantined separate from other controlled substances in a location that meets requirements of 19 CSR 30-1. 3. Abandoned controlled substances shall be destroyed beyond reclamation. Such destruction shall be performed by a pharmacist or other person that has authority to dispense controlled substances and witnessed by another responsible employee of the pharmacy, hospital or nonprofit clinic according to 19 CSR 30-1.078 and 21 CFR 1307.21. (C) A controlled substance donor return or destruction record shall be prepared and retained by the pharmacy, hospital or nonprofit clinic. The controlled substance donor return or destruction record shall include the following when applicable: 1. The name and address of the pharmacy, hospital or nonprofit clinic; 2. The date the drug was received by the pharmacy, hospital or nonprofit clinic; 3. The brand name of the drug; or the generic name and either the name of the manufacturer or the national drug code number (NDC #) when available; 4. The strength of the drug; 5. The quantity of the drug; 6. The lot number of the drug when available; 7. The expiration date of the drug; 8. The name and address of the donor; 9. The name and address of the donor’s representative; 10. The circumstances under which the drug was abandoned; 11. The signature of the donor or donor’s representative when the drug is returned to the donor; 12. The signature of the representative of the pharmacy, hospital or nonprofit clinic when the drug is returned to the donor; 13. The signature of the individual performing the destruction of the drug; 14. The signature of the individual witnessing the destruction of the drug; and 15. The date the drug was returned or destroyed. 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.