I guess my initial question is: What authority does FDA have to restrict compounding with a particular API that otherwise meets Congress’ plain language in the Food, Drug & Cosmetic Act about what can be compounded? The agency notice seems to suggest they're not looking to restrict compounding of GLP-1s; they are looking to restrict the API itself. I suppose they could move to do what the drugmakers have long demanded and add the GLP-1 API to the (not-yet-existent) Demonstrably Difficult to Compound List, but that would require notice-and-comment rulemaking. Are they telegraphing an intention to do rule-making? Good to know.
I find it interesting, too, that part of FDA’s focus in its statement today is once again on misleading marketing claims. Saying the API in the compounded drug is the same API as the FDA-approved drug – as Hims statement yesterday asserted – is a factual statement. Otherwise, the compounded drug would not meet the FD&C Act requirement about what substances can be compounded. We've gone through four years of compounded GLP-1 frenzy and not once has FDA asserted that the semaglutide (or tirzepatide) API the drugmakers are using is somehow superior or even different from that used by compounding pharmacies. So I’m curious to see what FDA’s beef may be.
APC will continue to watch this issue, and we’d certainly be willing to advise FDA if invited.