So the FDA made an announcement: It’s launching what it calls a “green list” of GLP-1 APIs from overseas facilities that “the agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards.” GLP-1s coming from other sources will be “subject to detention without physical examination.”
Some media outlets — looking at you, Axios — made it sound as if this green list was all about compounded drugs (and, to be fair, the FDA did throw a little unnecessary shade on compounding). In reality, of course, it doesn’t affect legitimate compounders. The list is of manufacturers, while you get your APIs from FDA-approved wholesalers, with a CoA to boot. Not to mention that the wholesalers used by pharmacies must vet the manufacturers they purchase their API from.
Worryingly, based on the language of the release, it seems FDA doesn’t quite understand how compounders actually acquire their APIs. The wording also implies that illicit substances might somehow be making their way into legitimate, state-licensed compounding pharmacies — and that’s simply not true.
Who should be worried about a new “green list” and a possible FDA crackdown? Those already-illegal pop-up shops selling questionable ‘do-it-yourself GLP-1 injections’. Then again, they’re not exactly the kind of shops to worry about green lists or the whole “Is that legal?” thing.
We get it, of course. Even the FDA has to engage in a little security theater. But how much good will this green list do against those illegal online shops? Who’s to say? One thing we do know, though, is that it shouldn’t be an issue for legitimate, licensed compounders like you.