Dispenser Question of the Week: Does PAP Product Require DSCSA Documentation?
We received the following inquiry from a Pharmacy Manager in Miami Beach, Florida:
At our pharmacy, we receive medications from manufacturers' Patient Assistance Programs. Do we need tracing information for medications obtained from this source?
There is no explicit exemption in DSCSA for all scenarios under which Patient Assistance Program (PAP) products are distributed in the United States. There are certain exemptions in the law based on distribution through charitable (501(c)(3) organization or for product samples.
To date, the FDA has not provided specific guidance with respect to PAP products and DSCSA compliance.
Given statements by lawmakers during the formation of DSCSA, the general industry interpretation is that drug products provided under PAP were not intended to be subject to DSCSA regulations.
If your pharmacy or hospital has a question on DSCSA requirements, send it to firstname.lastname@example.org. We'll feature it in an upcoming article.