Federal Advocacy


 

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 compounding, to our advocacy before regulatory agencies like the Food & Drug Administration and the Drug Enforcement Administration, to the counsel and collaboration we provide to 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. In 2019 alone, our federal advocacy activities included:

  • Proposing to FDA a "middle way" on a Memorandum of Understanding with states that satisfies FDA's need for information on interstate shipments of compounded drugs and state board of pharmacy concerns about state level regulation of patient-specific compounded medications. MORE HERE.
  • Appealing beyond-use date restrictions in the new USP <795> and <797> chapters, which has resulted in an indefinite postponement of the effective date of the new chapters until USP can address concerns. MORE HERE.
  • On November 4 USP released a FAQ on Compounding Appeals on its website.
  • Encouraging the National Academies of Science, Engineering and Medicine to seek input from prescribers and dispensers of cBHRT as a part of NASEM's FDA-funded study of cBHRT. We also joined with APhA and NCPA in recommending credible practitioners who were invited to testify before the NASEM committee. MORE HERE.

Current APC federal advocacy priorities

These are presented in no particular order. We will update this section, adding links as information becomes available.

  • Finalizing a workable FDA MOU with states. MORE HERE
  • Assuring new USP <795> and <797> chapters do not unduly restrict science-based beyond-use dating.
  • Informing NASEM's "Clinical Utility of cBHRT" study to assure a balanced final report that reflects the positive patient outcomes practitioners achieve with cBHRT. MORE HERE
  • Increasing co-sponsors and shepherding passage of H.R. 1959, federal legislation that would clarify DQSA as it relates to pharmacy compounding." APC BRIEFING PAPER
  • 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
  • Opposing FDA's draft Guidance for Industry document (November 2019) on animal compounding, based on our concerns about the draft's substance and lack of statutory authority. APC BRIEFING PAPER | APC BRIEFING PAPER FOR PET OWNERS

For information on APC priorities, email info@a4pc.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. (If you need help with talking points, email scott@a4pc.org.)


 

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.