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 drugs under shortage exemptions. This opened a large market for cheaper compounded versions.
What Changed
- March-April 2025: The FDA officially removed semaglutide and tirzepatide from the drug shortage list
- This triggered a deadline for compounders to stop producing these medications
- 503B outsourcing facilities had a deadline around May 22, 2025 for tirzepatide and a similar timeline for semaglutide
- 503A pharmacies (smaller, patient-specific) faced earlier deadlines
Who Is Still Operating Legally
As of mid-2025, personalized/combination compounds may still be permitted in some cases, such as:
- Semaglutide combined with other ingredients (like B12)
- Patient-specific allergies or clinical needs
Still operating legitimately:
- Hims & Hers - transitioned to FDA-approved branded drugs
- Ro - similar transition
- Licensed 503A compounding pharmacies with valid prescriptions for specific documented needs
Bottom Line
Be cautious - many gray-market sellers are still advertising compounded GLP-1s illegally. Stick with telehealth platforms prescribing branded Wegovy, Zepbound, or Ozempic to stay safe and legal.