This week, APC sent members of FDA’s Pharmacy Compounding Advisory Committee a briefing memo on how and why traditional 503A pharmacy compounding works.
At PCAC’s July meeting, FDA staff provided an accurate but necessarily abbreviated overview of the laws and regulations governing compounded medications. It covered much of the what of pharmacy compounding, but less of the how and why behind the system Congress created.
Our memo is intended to help fill in that context — explaining why traditional compounding is patient-specific, why its regulatory standards appropriately differ from pharmaceutical manufacturing, and where responsibility lies for determining when a compounded medication is needed. We believe that context is important as PCAC evaluates issues that could affect patient access to compounded medications.
Give the memo a look – and share it with your pharmacy teammates as a great refresher.