Urgent-use & shortage drug compounding legislation (HR 3662)
What you can do RIGHT NOW
Contact your member of Congress and ask them to co-sponsor HR 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, introduced by Rep. Morgan Griffith of Virginia.
This bipartisan legislation would allow 503A pharmacies to compound for office use the medications on the FDA Drug Shortage List or the ASHP Drug Shortage List, if those drugs are not available from a 503B Outsourcing Facility. The bill currently has seven cosponsors — it needs a lot more if it is to gain the momentum necessary for passage.
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.