Verbatim response from Claude
FDA & Compounded GLP-1s: What Happened
The Short Version
The FDA declared the semaglutide (Ozempic/Wegovy) shortage officially over in early 2025, which triggered a deadline for compounding pharmacies to stop making copies. Tirzepatide (Mounjaro/Zepbound) followed shortly after.
Key Timeline
- March 2025: FDA finalized that the semaglutide shortage was resolved, giving compounders a wind-down period
- May 2025: Most 503A (small compounding pharmacies) had to stop producing semaglutide compounds
- 503B outsourcing facilities got a slightly longer runway but faced the same endpoint
Who Can Still Legally Operate
Legitimate ongoing options:
- 503B facilities may still compound for specific clinical needs (e.g., allergies to inactive ingredients, documented medical necessity) — but this is narrowly defined
- Personalized/combination compounds are still being debated legally
- Companies like Hims & Hers, Ro, and LifeMD faced pressure and adjusted their offerings accordingly
What to Watch For
- Several compounders are challenging the FDA in court
- The situation is still evolving — check FDA.gov for current status
Bottom line: Be cautious of any telehealth company still broadly offering compounded semaglutide — verify they're operating under a legitimate exemption.