Verbatim response from Perplexity
The FDA has ended the grace periods allowing compounded semaglutide and tirzepatide injections as of May 2025, effectively phasing out "essentially copies" of these drugs because the national shortages for Ozempic/Wegovy (semaglutide) and Mounjaro/Zepbound (tirzepatide) have been resolved [1][2]. Legally, compounding is now restricted to patient-specific medical necessities (e.g., allergies to FDA-approved ingredients) or unique non-standard doses, and pharmacies can only compound these "essentially copies" if they fill four or fewer prescriptions of that specific compounded drug per calendar month under section 503A [2].
Who is still operating legally:
- State-licensed pharmacies (Section 503A): Those strictly filling four or fewer prescriptions per month of essentially copied semaglutide/tirzepatide, or those compounding for documented patient-specific medical needs (not based on shortage) [2].
- Outsourcing facilities (Section 503B): Those that have ended compounding of essentially copied versions (grace period ended May 22, 2025) and are now only producing for verified clinical necessity [2].
- Specific brands: Patients must now use FDA-approved versions from manufacturers like Novo Nordisk (Wegovy, Ozempic) and Eli Lilly (Mounjaro, Zepbound), which are the only fully legal and reviewed options for general weight loss [1].
Telehealth companies and online pharmacies that previously marketed compounded GLP-1s as "generic" equivalents or "bulk" versions are now facing warning letters and enforcement actions for misleading ads and unauthorized bulk compounding [4][5][8]. Compounded versions are not FDA-approved and carry risks of quality issues, with nearly 1,700 adverse event reports as of May 2026 [3].