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 these medications. This opened a large market of telehealth companies offering cheaper alternatives.
What Changed
The FDA declared the semaglutide shortage over in early 2025 and the tirzepatide shortage over in early 2025 as well. This triggered enforcement deadlines:
- Semaglutide compounding faced a wind-down deadline (around April 2025)
- Tirzepatide compounding faced similar deadlines shortly after
This forced many compounders to stop or face legal risk.
Who Can Still Legally Operate
503B outsourcing facilities can still compound for specific patients with a documented clinical difference (different dose, formulation need, allergy). Some options include:
- Hims & Hers - pivoted to personalized/differentiated formulations
- Empower Pharmacy (503B) - still operating under compliant frameworks
- Hallandale Beach Pharmacy - similar 503B status
Important Caveats
- This space is changing rapidly — regulations and enforcement shift frequently
- Always verify a pharmacy's current 503B status
- Consult a licensed provider about your specific situation
Would you like help finding a legitimate telehealth provider?