FDA puts a major GLP-1 compounder on notice

What happened

In a September 18 warning letter, FDA said Empower Pharmacy appeared to compound semaglutide and tirzepatide products that were essentially copies of approved drugs in substantial quantities. The agency also cited deficiencies in sterile-production practices that could put patients at risk. If your practice prescribes compounded GLP-1s, review your supplier and the patient-specific rationale for prescribing; do not assume that adding another ingredient resolves the agency’s concerns. FDA

Originally published in The Longevity Medicine Intelligence newsletter (#108).