APC is leading federal advocacy on compounding issues.
As the only pharmacy association whose advocacy focus is solely the interests of pharmacy compounders, APC is the leading voice at the federal level on a range of issues impacting your compounding patients and business.
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 the Drug Enforcement Administration, to our counsel and collaboration with standards-setting bodies like the United States Pharmacopeia (USP), APC is active and assertive in representing your interests.
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.
Most important of all, we get stuff done. Last year alone, our federal advocacy successes included:
- Successfully urging FDA to issue temporary pandemic guidance permitting compounders not only to make and distribute alcohol-based hand sanitizer, but, critically, 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 with FDA about their concerns with the MOU.
- Taking the lead in an emerging cBHT coalition dedicated to preserving the role of compounding bio-identical hormone therapy as a safe and valued treatment and to opposing FDA efforts to restrict cBHT
- Achieving a brief suspension and reevaluation by Tricare of its ham-fisted recoupment effort of compounders claims from 2015.
Current APC federal advocacy priorities
These are presented in no particular order. We will update this section, adding links as information becomes available.
- Demonstrating to FDA, in light of temporary guidances allowing compounders to meet drug shortage needs in the pandemic, that compounders should be allowed to meet shortage drug needs ongoing. MORE HERE
- Opposing FDA’s draft November 2019 Guidance for Industry document on animal compounding, based on our concerns about the draft’s substance and lack of statutory authority. APC BRIEFING PAPER
- Requesting a delay in the October 26, 2021 enforcement date of FDA’s MOU on interstate shipments, given that several states have said they lack statutory authority to sign it without action by their state legislature. MORE HERE
- Providing expert input to USP’s Compounding Expert Committee to help assure that new USP <795> and <797> chapters do not unduly restrict science-based beyond-use dating. APC INPUT ON <795> BUDS | APC INPUT ON <797> BUDS
- Informing Congress about NASEM’s deeply flawed “Clinical Utility of cBHRT” – and engaging members of Congress in pushing back against FDA’s heavy-handed efforts to restrict compounded hormone therapy. MORE HERE
- Supporting legislation to clarify that dietary supplement monographs, like drug monographs, are sufficient for compounding. APC BRIEFING PAPER
- Working to assure 503A and 503B bulk lists are robust and do not exclude substances without substantive scientific or economic justification. APC BRIEFING PAPER
For more information on APC priorities, email firstname.lastname@example.org.
Invite your member of Congress to work
When your members of Congress are home in their district, it’s a perfect time for you to host them at your pharmacy. Pharmacy visits allow them to see what you do and how you do it, and you can brief them on the challenges compounders are facing. It’s as easy as calling your Congressperson’s district office and scheduling a date. And without a doubt it’s the very best way to educate elected officials on compounding policy priorities.
Meet your advocate
APC’s governmental affairs counsel is David Pore, Esq., a partner in the Washington D.C. office of Hance Scarborough LLP, with more than 20 years of public policy experience, and a track record as a successful, bipartisan attorney and lobbyist.
Before rejoining Hance Scarborough in March of 2017, David was counsel at the DC offices of Arnold & Porter LLP. David has worked as an in-house attorney and lobbyist for a trade association (2002-2004), served as legislative director for a U.S. Congressman from Texas (1999-2002) and as a legislative aide to a member of the Texas Legislature (1998-1999). He is a graduate of the Texas Tech University School of Law.