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Frequently Asked Questions for Pharmacists on Donating Prescriptions

CLICK HERE TO READ FAQs ABOUT DONATION AND DISPENSING OF PRESCRIPTION DRUGS, DEVICES, AND MEDICAL SUPPLIES - updated May 18, 2012

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Q: Can prescription drug samples be donated to free clinics?

A: FDA published the following text in the March 14, 2006 edition of the Federal Register:

FDA is announcing the availability of a guidance for industry entitled "Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics." The guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The guidance discusses concerns that have been expressed by certain individuals regarding regulatory requirements for drug sample donations. The guidance announces that FDA, after reviewing an independent study report analyzing the potential effects of the regulations on free clinics, has decided to propose revisions to those regulations. In the interim, FDA intends to exercise its enforcement discretion and does not intend to object if a free clinic fails to comply with certain regulatory requirements for drug sample donations.

Copies of the guidance may be obtained at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070317.pdf

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Q: Our local church group is planning to go on a medical mission to Central America. Can I take outdated drugs and samples on that trip?

A: Federal rules prohibit the use of outdated drugs in this way. Samples are also not intended for this purpose but may be used if complete treatments can be provided. Boxes of assorted samples of medications should not be left as donations.

Another solution is to contact MAP International (Medical Assistance Programs). This is a nonprofit relief and development organization based in Brunswick, Georgia. MAP can provide in-date and appropriate medicines for this purpose at a reasonable cost through their "Medicines for Missions" program. You can receive their guidelines and an application through their website at http://www.map.org or by calling MAP International at 800/225-8550.

 

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