Protecting pharmacy compounding — and the patients it serves
As the only pharmacy association whose advocacy focus is solely pharmacy compounding, APC is the leading voice at the federal level — and increasingly in states, too — on a range of issues impacting pharmacy compounders and the patients served by compounded preparations.
From our lobbying on Capitol Hill to assure that legislation elevates and preserves pure ingredient compounding, to our advocacy before regulatory agencies like the Food & Drug Administration; and from our work with state boards of pharmacy to our counsel and collaboration with standards-setting bodies like the United States Pharmacopeia (USP), APC is active and assertive in representing pharmacy compounding.
We also lead coalitions of sister pharmacy-related groups and work hand-in-hand with partners like National Community Pharmacists Association and the American Pharmacists Association on a range of important issues that impact pharmacy compounding.
And we get stuff done. Last year alone, our advocacy successes included:
- Successfully urging FDA to issue temporary pandemic guidance permitting compounders not only to make and distribute alcohol-based hand sanitizer, but also to fill drug shortage gaps by allowing 503A compounders to provide scarce Covid-19 medications to hospitals under tight guardrails overseen by state boards of pharmacy.
- Filing an amicus brief in support of litigation challenging FDA’s flawed MOU on out-of-state shipments of compounded preparations and working with state boards of pharmacy to provide feedback to FDA about their concerns with the MOU.
- Taking the lead in a $1.5 million campaign to preserve the role of compounded bio-identical hormone therapy as a safe and valued treatment — and in opposing FDA efforts to restrict cBHT.
- Prevailing in an appeal of arbitrary beyond-use dates in USP’s new <795> and <797> chapters, and proposing to USP’s Compounding Expert Committee protocols for establishing science-based BUDs under the new chapters.
- Achieving a suspension and reimbursement by Tricare of its ham-fisted recoupment effort of compounders’ claims from 2015.
Pharmacy compounding continues to be threatened by ill-conceived regulation, making APC’s role even more important. We advocate for sensible, science-based regulation and will continue to fight overreach by regulatory agencies that hinders patient access to physician-prescribed compounded medications.
Federal Advocacy Efforts
From compounded hormones to animal compounding from pure ingredients, and from the MOU to the USP chapters, here are APC’s current issue priorities.
State-Level Monitoring and Resources
Your one-stop resource for state-level legislative and regulatory tracking on compounding issues.
Support APC’s advocacy on behalf of compounding
Who Think Like You
Fueling APC’s Advocacy