Pharmacy Practice FAQs

DRUG DONATION/DISPENSING OF DONATED DRUGS

Q: May I donate prescription drugs for redispensing?

A: Yes, in certain circumstances.  This guidance document details which drugs are eligible for donation, who eligible donors are, and who eligible recipients are: Drug Donation FAQ

Q: May I donate prescription drug samples to free or charitable clinics?

A: Yes.  The recipient free or charitable clinic must, however, conform to FDA guidance on the receipt and dispensing of donated samples

Q: Do I need a pharmacy permit to distribute prescription drug samples?

A: The federal Prescription Drug Marketing Act (“PDMA”) prohibits a pharmacy from receiving or dispensing sample medications.  A free or charitable clinic, however, may provide samples of prescription drugs to patients so long as the samples are obtained in conformance with the PDMA and are provided to the patient under the direct supervision of the physician charged by the PDMA with responsibility for appropriate receipt and disbursement of prescription drug samples.

A pharmacy permit is not required if prescription drug samples are the only prescription drugs being provided to patients.  The key question is whether the prescription drugs provided to patients are truly “samples.”  For instance, full course of therapy or month-long prepackaged medications received from manufacturers or other organizations are almost certainly not samples, and a pharmacy permit would be required for dispensing.  It is the responsibility of the pharmacist manager to ensure that any prescription drugs provided to patients – even if received prepackaged – meet all federal and state labeling requirements.

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