APC: Issue: Urgent-Use

APC Advocacy

Urgent-use & shortage drug compounding legislation (HR 3662)

The issue

Americans needed help in the pandemic. Compounders stepped up, with FDA’s permission. Now the agency should acknowledge how much more compounders can do … and let them do it.

HR 3662 would create a narrow but permanent path for 503A compounding pharmacies to prepare urgent-use medications for hospitals and physician specialists when those medications are not available from manufacturers or 503B outsourcing facilities.

Resources and information