We’ve heard from a few APC members who received communication recently from an entity claiming to...
Kudos to FDA!?
Yeah, you read that right. We’re actually congratulating FDA for getting an agency communication mostly right.
Accurate? Check. Nuanced? Check. Perfect in every way? Well, not quite, but much better than usual.
This week the agency updated its webpage titled “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” to address the growing presence of counterfeit, research-grade, and fraudulent products being marketed as compounded semaglutide or tirzepatide. FDA distinguishes these illicit products from legally compounded medications, which are prepared in response to a valid prescription from a licensed prescriber and dispensed by a state-licensed pharmacy. The agency’s message is clear: the danger lies not in compounding itself, but in unauthorized distribution and questionable sourcing.
Importantly, the FDA does not state that compounding with GLP-1 active ingredients is banned (because it’s not). Instead, it provides guidance for patients and providers and urges them to be vigilant in ensuring compounded medications are obtained appropriately, after a legitimate provider visit and through a trusted, state-licensed pharmacy.