Bipartisan House Bill Would Permit Office-Use Compounding From 503A Traditional Compounders Without a Patient-Specific Prescription

This week, Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) introduced a bipartisan bill, H.R. 2871, Preserving Patient Access to Compounded Medications Act of 2017, that would allow physician access to compounded drugs without a patient-specific prescription for office use from 503A traditional compounding pharmacies.

This bill comes shortly after ASCRS and others in the medical community testified at the Food and Drug Administration (FDA) last week, where concerns were expressed regarding physician access to compounded drugs from traditional 503A compounders to treat patients. In addition, a group of 65 bipartisan House members sent a letter to FDA commissioner Scott Gottlieb, MD, expressing significant concerns with the final guidance document, Prescription Requirement Under Section 503A. As a reminder, the final guidance prohibits office-use compounding from a traditional compounder without a patient-specific prescription, even in emergent situations.

ASCRS and the Drug Quality & Security Act (DQSA) coalition are discussing strategy on how to build support for the bill. We will keep you updated.