August 11, 2023
What does HR 167 do?
New resource provides current vs. future comparison
Sure, you know that 503A pharmacies may compound drugs on the FDA shortage list. What you may not know is that the authorization for that comes from an FDA guidance document, not federal law. Preserving that ability in law is one of several substantive provisions of HR 167 (Griffith/Cuellar), APC’s shortage drug legislation now pending in Congress.
To help illuminate all that HR 167 does, we’ve created this comparison brief.
For instance, the legislation would allow 503A compounding pharmacies to distribute small batches of compounded drugs to hospitals or clinics, including drugs on the FDA Drug Shortage List or the ASHP Drug Shortage List, within some regulatory guardrails. You’ll recall that FDA allowed this for 13 COVID drugs during the pandemic under temporary guidance that has now expired. HR 167 would make that pathway permanent and expand it to other drugs that hospitals are unable to source from a manufacturer or a 503B outsourcing facility.
“We urge our members to read up on this bill,” said APC’s Savannah Cunningham. “It will be a key priority for Hill visits during Compounders on Capitol Hill – and likely for the remainder of the year and beyond.”
