Issue Briefs: Compounders on Capitol Hill 2024

Here’s what we’re sharing with Congress at CCH — feel free to download them (each is a 2-page PDF) and please share them with your representative and senators! 

Overviews and links to each issue are below, or you can download all four briefs as one 8-page PDF.

Even if you’re unable to attend APC’s Compounders on Capitol Hill, you and your team members can advocate from afar. Here’s how to share these briefs with your members of Congress.

Shortage drug compounding

In case you haven’t noticed, the drug supply chain has had some problems lately. There are issues that can be fixed, and compounders can help fill the gap. To be able to do that, though, we need to expand the definition of drug shortage so the FDA can better anticipate and prepare. We also need a longer tail for 503Bs when a shortage ends, and stricter requirements on drugmakers for anticipating and reporting shortages. (Click here for the PDF issue brief.)

Concerns about FDA’s proposed demonstrably difficult to compound (DDC) list

The FDA is proposing adding entire drug categories to the 503A DDC list, which, frankly, it doesn’t have the legal right to do. (Categories can only be added to the 503B DDC list.) 

Why would it do this? We’re concerned that it might be the first step toward restricting hormone compounding and possibly GLP-1 compounding … possibly under pressure from drug makers. (Click here for the PDF issue brief.)

GLP-1 compounding: separate fact from fiction

We all know how drug makers are fighting tooth-and-nail against GLP-1 compounding, spreading a lot of misinformation in the process. (We used to call that “lying.”) We see the push against GLP-1 compounding as part of a larger effort against shortage compounding in general. 

The critical point we need to get across are the differences between counterfeits and legitimate compounding, focusing on the care and compliance legitimate compounders are taking with GLP-1s … and to urge legislators not to believe everything they read in the media. (Click here for the PDF issue brief.)

Animal drug compounding from bulk substances

Until recently, veterinarians could keep a variety of compounded medications in stock for office use. That allowed them to begin treatment immediately and reduce animal suffering. But the FDA’s recent action is jeopardizing that care. 

We need you to ask your member of Congress to contact FDA’s Center for Veterinary Medicine and express concerns about these restrictions — including the slowness in developing a robust set of “listed” drugs that can be compounded from bulk substances and the arbitrary nature of drugs they decline to add to the list. (Click here for the PDF issue brief.)