Section 338.3617. Inspection and storage of donated prescription drugs; destruction; recall.

(1) A licensed pharmacist employed by or under contract with the participating pharmacy or charitable clinic shall inspect donated prescription drugs to determine, in the professional judgment of the pharmacist, that the drugs are not adulterated, are safe and suitable for dispensing, and are eligible drugs. The pharmacist who inspects the drugs shall sign the transfer form included with the shipment of donated drugs attesting to the above.

(2)   The participating pharmacy or charitable clinic shall store donated drugs pursuant to the manufacturer’s guidelines or usp-nf guidelines. Donated drugs shall not be stored with non- donated inventory at any time.

(3)     When donated drugs are not inspected immediately upon receipt, a participating pharmacy or charitable clinic shall quarantine the donated drugs separately from all dispensing stock until  the donated  drugs have been inspected and approved for dispensing under the program.

(4)    A participating pharmacy or charitable clinic shall destroy donated prescription drugs that are not suitable for dispensing pursuant to protocols currently established by the pharmacy or charitable clinic for the destruction of prescription drugs.

(5)     A participating pharmacy or charitable clinic shall create and maintain a destruction and disposal record for donated drugs that are destroyed and disposed of as a result of being expired, adulterated, recalled, or otherwise not eligible for dispensing. A participating pharmacy or charitable clinic shall maintain a destruction record for 5 years after destruction of the donated drugs.

(6)     If a participating pharmacy or charitable clinic receives a recall notification, the participating pharmacy or charitable clinic shall perform a uniform destruction of all of the recalled prescription drugs in the participating pharmacy or charitable clinic and complete the destruction record for all donated drugs destroyed. The destruction shall be done pursuant to protocols currently established by the pharmacy or charitable clinic for the destruction and disposal of prescription drugs.

(7)    If a recalled drug has been dispensed, the participating pharmacy or charitable clinic shall immediately notify the eligible participant of the recalled drug pursuant to established drug recall procedures.

History: 2014 AACS.