Verbatim response from Claude
FDA & 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. This opened a massive market for telehealth companies offering cheaper compounded versions.
What Changed
- The FDA declared the semaglutide shortage over in late 2024 and the tirzepatide shortage over in early 2025
- Once shortages end, most compounding of these drugs becomes illegal under federal law
- The FDA set enforcement deadlines (early-mid 2025) for compounders to wind down
- There was significant legal pushback from compounders and telehealth companies, with some court challenges
Who Can Still Legally Operate
- 503B outsourcing facilities may still compound for specific patient needs (personalized dosing, documented allergies) - more tightly regulated
- 503A pharmacies with a valid patient-specific prescription showing clinical necessity may have a narrower path
- Companies like Hims & Hers, Ro, and Noom faced pressure to pivot back to branded drugs
My Recommendation
If you want GLP-1 treatment now, the safest routes are:
- Novo Nordisk's Wegovy/Ozempic directly
- Eli Lilly's Zepbound/Mounjaro
- Telehealth platforms like Ro or Hims & Hers that now prescribe branded versions
Always verify your pharmacy's current legal status before purchasing compounded versions.