Verbatim response from Claude
FDA & Compounded GLP-1s: What Happened
The Background
During the semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) shortages, the FDA allowed compounding pharmacies to legally make copies of these drugs. This opened a massive market for telehealth companies offering cheaper alternatives.
What Changed
- The FDA declared the semaglutide shortage over in early 2025 and tirzepatide shortage over in early 2025 as well
- Once shortages end, 503A and 503B compounding pharmacies lose the legal basis to compound copies of brand-name GLP-1s
- The FDA set enforcement deadlines (around March-April 2025) after which compounding these drugs became legally problematic
- Many companies received warning letters or had to stop
Who Is Still Operating Legally (as of mid-2025)
- Hims & Hers - shifted toward personalized/combination formulations, though this is legally contested
- Ro - moved toward FDA-approved brand partnerships
- LifeMD - prescribes brand-name versions
- Noom Med - focuses on brand-name prescriptions
My Honest Recommendation
Go through a telehealth platform that prescribes the actual FDA-approved brand-name drugs (Wegovy, Zepbound) — companies like Ro, Calibrate, or your own doctor using manufacturer savings programs.
Always verify current legal status, as this situation is still evolving rapidly.