Federal Advocacy

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, 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:

We’re working with FDA to assure continued clear understanding of compliance standards and enforcement on GFI 256.
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 167 from the previous Congress.
We’re developing a “decision points document” to assist state boards of pharmacy in implementing and enforcing USP <800> and <797>.
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.

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.

For more information on our current priorities:

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Events

APC hosts three big events each year

Advocacy

Protecting pharmacy compounding—and the patients it serves

Education