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 make copies of these drugs. This opened up a large market of lower-cost alternatives.
What Changed
- March/April 2025: The FDA declared the semaglutide and tirzepatide shortages officially over
- This triggered a deadline for compounders to stop producing these drugs
- 503A pharmacies (patient-specific compounding) faced an earlier cutoff
- 503B outsourcing facilities (larger-scale) were given slightly more time but faced legal action if they continued
Who Is Still Operating Legally (as of mid-2025)
Likely still compliant options:
- Hims & Hers - pivoted to FDA-approved branded drugs or personalized compounds with meaningful differences
- Ro - similar pivot strategy
- LifeMD / Rise - moved toward branded prescriptions
Important Caveats
- Rules are actively evolving and litigation is ongoing
- Some compounders are challenging the FDA's shortage determination in court
- Personalized compounds (different doses/additives) may still be allowed under certain conditions
My Recommendation
Verify current status directly with any provider before purchasing, as this situation is changing rapidly. Telehealth platforms like Hims & Hers or Ro are safest bets currently.