Mich. Admin. Code R. 338.3617 - Inspection and storage of donated prescription drugs; destruction; recall
Rule 17.
(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 manufacturers 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.
Notes
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