Protecting pharmacy compounding — and the patients it serves
What you can do RIGHT NOW
- Share our DTE comment letter with your board of pharmacy and urge the board to adopt “enforcement discretion” on thyroid USP compounding, just as FDA has done.
- Invite your member of Congress to visit your pharmacy. We can help prep you!
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.
Here’s a general statement about what we stand for.
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:
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We’re advising FDA to assure clear understanding of compliance standards and enforcement on GFI 256, regarding veterinary compounding.
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We’re pushing back against FDA’s recent back-door reclassification of DTE as a biologic.
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We’re developing federal legislation that would:
- Eliminate the MOU and replace it with reporting by pharmacies that ship more than 50 percent of their production out of state
- Establish an adverse events reporting framework for 503A pharmacies
- Implement the “urgent-use compounding” provisions of HR 3662 from the previous Congress.
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With amoxicillin in shortage, our advocacy resulted in FDA issuing guidance creating a path by which 503A pharmacies can more easily compound beta lactams.
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We’re developing a “decision points document” to assist state boards of pharmacy in implementing and enforcing USP <800> and <797>.
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We’re still working to save compounded hormones—therapies that benefit millions of Americans – in the wake of implicit threats to restrict them. Contribute to our campaign at compounding.com.
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Via our Legal Action Fund, we filed two amicus briefs last year in court cases, one defending compounders’ right to compound methylcobalamin and another addressing ambiguity in FDA’s insanitary conditions guidance.
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
CompPAC
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