Verbatim response from Claude
FDA & Compounded GLP-1s: What Happened
The Background
During the semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) shortage, the FDA allowed compounding pharmacies to legally make copies under shortage exemptions.
What Changed
- The FDA declared the semaglutide shortage over in early 2025, meaning most compounders had to stop producing semaglutide compounds by April 2025
- Tirzepatide's shortage was similarly resolved, with compounders facing deadlines to wind down
- Large-scale "503B" outsourcing facilities faced earlier, stricter deadlines
- Smaller "503A" pharmacies compounding for individual patients had slightly more flexibility
Who Can Still Operate Legally
503A pharmacies may still compound if there's a specific patient need (allergy to an ingredient, dosage customization) with a valid prescription — but not for general weight loss at scale.
Legitimate current players to look for:
- Hims & Hers adjusted their model but faced FDA scrutiny
- LifeMD/Ro similarly had to adapt
- Local 503A compounding pharmacies with physician partnerships may still serve specific cases
⚠️ Important Warning
Many services advertising "compounded semaglutide" after the deadlines are operating illegally. Stick with telehealth platforms that connect you to brand-name Wegovy or Zepbound through insurance or manufacturer savings programs like Novo Nordisk's savings card.
Always verify with your prescriber.