FDA just dropped updated enforcement guidance on March 10, 2026. I've read through the 47-page document so you don't have to. Here's the TL;DR:
- Semaglutide remains on the shortage list — compounding is still permitted under section 503A and 503B
- Tirzepatide was removed from the shortage list in late 2024 — FDA has been actively enforcing against compounders still making it, though legal challenges continue
- New emphasis on "essentially a copy" — FDA is cracking down on compounded products that are essentially copies of commercially available drugs when there's no shortage
- State-level enforcement cooperation — FDA announced partnerships with 12 state boards for coordinated inspections
The big takeaway: if you're using compounded semaglutide, you're probably fine for now. If you're using compounded tirzepatide, the legal landscape is murky and getting murkier.