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 copies of these drugs. This opened a massive market for cheaper alternatives.
The Key Ruling
The FDA declared the semaglutide shortage officially over in early 2025, and the tirzepatide shortage resolved in late 2024. This triggered deadlines for compounders to wind down production:
- Tirzepatide compounding deadline passed ~March 2025
- Semaglutide compounding deadline was set for ~April 2025
- The FDA began enforcement actions against pharmacies continuing to produce copies
Who Is Still Operating Legally
503A compounding pharmacies can still legally compound for individual patients with a specific prescription need (like allergies to inactive ingredients), but cannot mass-produce.
Legitimate telehealth platforms that pivoted to FDA-approved drugs include:
- Hims & Hers (moved to branded medications)
- Noom Med
- Ro
- WeightWatchers (WW)
⚠️ Red Flags to Avoid
- Sites still advertising cheap "semaglutide" injections without brand names
- Unlicensed online pharmacies
Always verify through NABP.pharmacy for legitimate providers.