FDA proposes excluding semaglutide and tirzepatide from the 503B bulks list
The FDA has proposed that semaglutide, tirzepatide, and liraglutide not be added to the 503B bulk drug substances list, pointing to insufficient evidence and the availability of FDA-approved products. A public comment period is open, closing on or around June 29, 2026. The agency has cited hundreds of adverse-event reports linked to compounded versions, many involving dosing errors from multi-dose vials.
Source: FDA press announcement
For informational use only — not medical advice. 21+.
