The use of prescription drug samples is governed by the federal Prescription Drug Manufacturing Act (PDMA), 21 C.F.R. 203.39. PDMA sets forth various requirements governing the distribution of drug samples by manufacturers to licensed practitioners. This law permits the donation of samples to charitable institutions, as long as a strong system of controls is in place to minimize diversion.
These requirements are:
- Donations only to “charitable institutions,” thus importance of 501(c)3
- Original, unopened packaging with labelling intact
- Received by authorized employee of charitable institution
- Licensed practitioner or pharmacist to examine product
- Unsuitable donations destroyed or returned to manufacturer
- Accurate records of donation, distribution, inventory, return & destruction kept for 3 years
- Annual inventory of drug sample stocks
- Samples must be stored properly to maintain integrity
- Significant loss or known theft must be reported to FDA in 5 days
For more information on use of medication samples in a charity pharmacy, see Donations from Prescribers and Practices.