FDA CRACKS DOWN ON COMPOUNDED GLP-1s
The FDA is warning telehealth firms and compounders over unapproved weight-loss drugs including semaglutide, tirzepatide and retatrutide. $HIMS
The agency says retatrutide and cagrilintide cannot legally be used in compounding, and has already warned companies marketing unapproved retatrutide directly to consumers.
As of May 31, the FDA had received 990 adverse-event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide.
The FDA is also flagging dosing errors, fraudulent labels, improper refrigeration during shipping and questionable foreign-made ingredients, while reiterating that compounded GLP-1s are not FDA-approved or reviewed for safety, effectiveness or quality before being marketed.