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 under shortage exemptions.
What Changed
- March 2025: The FDA officially declared the semaglutide shortage resolved, giving compounders a deadline to stop producing it
- Tirzepatide shortage was also declared resolved around the same time
- This meant most compounded versions became illegal to sell after the wind-down periods
Who Can Still Legally Operate
503B Outsourcing Facilities can still compound under certain conditions:
- Personalized/customized doses not commercially available
- Patients with documented allergies to inactive ingredients
503A Pharmacies can still make:
- Truly patient-specific prescriptions with legitimate clinical need
Reputable Companies That Adapted Legally
- Hims & Hers shifted to personalized dosing formulations
- Ro similarly pivoted
- Strive Pharmacy (503B) continues operating
Bottom Line
Be cautious — many providers are now in legal gray areas. Your safest options are:
- Brand-name Wegovy/Zepbound through your doctor
- Telehealth platforms that transitioned to FDA-approved medications
Always verify your pharmacy's 503A/503B status at the FDA website.