APC: Federal Advocacy

APC Advocacy

Federal issue priorities

Here’s what you need to know about APC’s federal legislative and regulatory priorities. Just click on the issue headline to find issue briefs and other information on that issue.

Urgent-Use & Shortage Drug Compounding Legislation (HR 3662)

Our effort to create a narrow but permanent path for 503A compounding pharmacies to prepare urgent-use medications for hospitals and physician specialists when those medications are not available from manufacturers or 503B outsourcing facilities.

The Threat to Compounded Hormone Therapy

Our broad campaign to protect the millions of patients who rely on compounded hormone therapy from FDA’s threat to restrict the use of cBHT based on a debunked and biased study.

FDA MOU on Interstate Shipments of Compounded Drugs

While the FDA’s MOU on interstate shipments has been remanded back to the agency by a federal judge, the issue is far from over — and very much on our radar.

Beyond-Use Dates in USP Chapters <795> and <797>

We’re committed to helping assure that new USP <795> and <797> chapters do not unduly restrict science-based beyond-use dating.

Compounding and HCG

Making the case to FDA that reclassifying HCG as a biologic has created medication access issues for patients — compounders should be allowed to compound HCG.

Compounding with Dietary Supplements

Working to have USP’s Dietary Supplement Compendium considered an “applicable” USP Monograph of the FDCA, so dietary supplements can be used within compounding practice.

GFI #256: FDA Draft Guidance for Industry on Animal Compounding (2020)

Working to have FDA withdraw its misguided draft guidance on the use of bulk drugs in veterinary compounding, so veterinarians can provide the best care for their animal patients.

503A and 503B Bulks Lists

We’re concerned that FDA’s review of nominated substances for 503B bulks list has taken a very restrictive view of the “clinical need” determination — a view that greatly favors the use of mass-produced manufactured products in compounding over bulk ingredients.

For more information on APC priorities or other issues on which we may be working, 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.

APC has made it easy for you to plan a pharmacy visit with your member of Congress. Take a look at our handy how-to guide, then contact scott@a4pc.org for assistance!

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.