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 large market of telehealth companies offering cheaper compounded versions.
What Changed
- March 2025: The FDA declared the semaglutide shortage officially over, triggering a wind-down period for compounders
- The deadline: Most compounding pharmacies were required to stop producing and selling compounded semaglutide by late April/early May 2025
- Tirzepatide: Was removed from the shortage list earlier, with compounders given deadlines as well
Who Can Still Legally Operate
503A pharmacies can still compound for individual patients with a specific prescription need (documented allergy, different dosage form, etc.) — not for general sale.
Still operating legally in various capacities:
- Hims & Hers – pivoted to FDA-approved branded medications
- Ro – similarly shifted to brand-name prescriptions
- Nuvation/Calibrate – adjusted offerings
Bottom Line
If a company is still openly advertising cheap compounded semaglutide for general use right now, that's a significant legal red flag. Stick with licensed telehealth platforms prescribing FDA-approved branded versions.
Want recommendations for legitimate GLP-1 telehealth services?