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.
GFI 256 on Animal Compounding
- Read GFI 256
- APC Briefing Paper
- July 2022: APC/NCPA letter to CVM requesting responses to questions
- Congress-signed letter postpone request to CVM (Aug 2022)
- Congress-signed clarification request letter to CVM (Oct 2022)
- APC memo to state BOPs re Veterinary office stock (Nov 28, 2022)
- APC/NCPA Letter to CVM requesting enforcement phase-in clarification (January 2023)
- APC NCPA ltr to CVM re enforcement clarification (Feb 8, 2023)
- CVM response to APC (Feb 15, 2023)
- APC updated briefing memo to state BOPs (Feb 20, 2023)
- CVM response to APC (Mar 10, 2023)
- GFI 256 Compliance webinar (on-demand), sponsored by APC and PCCA
- CVM issues Letter to Industry on GFI 256 phase-in (on FDA website, Mar 17, 2023)
- Harshbarger, Carter question CVM leader (Mar 30, 2023)
- APC sends letter to CVM to set record straight on “essential copies” in animal compounding (April 4, 2023)
DQSA Legislative Fix (MOU, Adverse Events Framework, Urgent-Use Compounding)
- APC White Paper on HB 167
- Pharmacy Times Opinion: The FDA is in a Hole with MOU on Compounding Medications—It Should Stop Digging
- Adverse Events reporting framework document
- HR 167 from 118th Congress: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
FDA’s Reclassification of Thyroid USP API as a biologic
USP 797 BUD and Batch Restrictions
USP 797 and USP 800: Guiding States
Timely 483 File Closure
Compounder direct billing CMS for pain pump drugs
For more information on APC priorities or other issues on which we may be working, email email@example.com.
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 firstname.lastname@example.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.