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, triggering a wind-down period
- Tirzepatide shortage was similarly resolved earlier
- This means most compounding of these drugs is no longer legally permitted
- The FDA has been sending warning letters and taking enforcement action against pharmacies continuing to compound standard doses
Who Can Still Legally Operate
503B Outsourcing Facilities may still compound personalized/customized doses for patients with documented clinical needs that differ from commercially available strengths — but this is a narrow exception.
503A Pharmacies can compound for individual patients with a valid prescription for a specific customized formulation, though this space is heavily scrutinized.
Reputable Still-Operating Options
- Hims & Hers shifted to FDA-approved branded versions
- Ro similarly transitioned
- Henry Meds and LifeMD are working with licensed providers for branded drugs
Bottom Line
If someone is offering cheap compounded semaglutide broadly right now, it's likely legally questionable. Consult a licensed telehealth provider about accessing the branded FDA-approved versions.