Verbatim response from Claude
FDA and Compounded GLP-1s: What Happened
The Background
During the semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) shortages, the FDA allowed compounding pharmacies to legally produce these medications. This opened a massive market for telehealth companies offering cheaper compounded versions.
The FDA's Decision
- The FDA removed semaglutide and tirzepatide from the drug shortage list in early-mid 2025
- This triggered deadlines for compounders to stop producing these medications
- 503B outsourcing facilities had a deadline around May 2025
- 503A pharmacies (filling individual prescriptions) faced earlier deadlines
- Several telehealth companies sued the FDA to delay enforcement, with mixed results
Who Is Still Operating Legally (as of mid-2025)
- Hims & Hers - faced legal uncertainty but has been transitioning
- Ro - similarly adjusting their model
- Nuvation/503A compounders - may still fill personalized compounds with specific clinical justifications
⚠️ Important Caveats
- This situation is actively evolving with ongoing litigation
- Verify current status directly with any provider before purchasing
- The FDA can update enforcement at any time
I'd recommend checking FDA.gov directly for the most current enforcement status before making any decisions.