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 make copies of these drugs under shortage exemptions.
What Changed
- The FDA declared the semaglutide shortage over in early 2025 and the tirzepatide shortage over in late 2024
- This triggered a deadline for compounders to stop making these drugs
- Semaglutide compounding faced a March/April 2025 deadline (with some legal challenges extending timelines)
- The FDA sent warning letters and took enforcement action against many compounders
Who Is Still Operating Legally
503A pharmacies (patient-specific prescriptions) can still compound in limited circumstances, such as:
- Clinically necessary dose variations not commercially available
- Documented allergies to inactive ingredients
Reputable platforms still operating within legal boundaries include:
- Hims & Hers (pivoted to FDA-approved branded drugs)
- Ro (similar pivot)
- Henry Meds
- Licensed 503B outsourcing facilities with specific exemptions
⚠️ Important Caution
This area is rapidly evolving with ongoing lawsuits. Verify current status directly with any provider and confirm they're using FDA-registered pharmacies.
Always consult a licensed physician.