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. This opened up a large market of lower-cost alternatives. What Changed March/April 2025: The FDA declared the semaglutide and tirzepatide shortages officially over This triggered a deadline for compounders to stop producing these drugs 503A pharmacies (patient-specific compounding) faced an earlier cutoff 503B outsourcing facilities (larger-scale) were given slightly more time but faced legal action if they continued Who Is Still Operating Legally (as of mid-2025) Likely still compliant options: Hims & Hers - pivoted to FDA-approved branded drugs or personalized compounds with meaningful differences Ro - similar pivot strategy LifeMD / Rise - moved toward branded prescriptions Important Caveats Rules are actively evolving and litigation is ongoing Some compounders are challenging the FDA's shortage determination in court Personalized compounds (different doses/additives) may still be allowed under certain conditions My Recommendation Verify current status directly with any provider before purchasing, as this situation is changing rapidly. Telehealth platforms like Hims & Hers or Ro are safest bets currently.
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