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 under shortage exemptions.
What Changed
- The FDA declared semaglutide shortage resolved (March 2025) and tirzepatide shortage resolved (early 2025)
- This triggered deadlines for compounders to stop production
- The FDA gave 503B outsourcing facilities and 503A pharmacies wind-down periods
- Deadlines passed in early-mid 2025, meaning most compounded versions are now in a legal gray area or outright prohibited
Who Is Still Operating Legally (Generally)
- 503A compounding pharmacies can still make personalized compounds for individual patients with a valid prescription and documented clinical need, but not in bulk
- 503B outsourcing facilities largely had to stop routine compounding of these specific drugs
Reputable Options Now
- Hims & Hers, Ro, LifeMD - were adjusting their models; verify their current status
- Novo Nordisk and Eli Lilly programs - offer legitimate branded medications, sometimes with savings programs
Important Caveat
⚠️ This situation is actively evolving with ongoing litigation. Check the FDA website and consult your doctor for the most current guidance before purchasing.