GLP-1 Postmarket Safety Signals and Compounding Restrictions

FDA warning letters, including its action against Empower Pharmacy, describe concerns about large-scale compounded GLP-1 production, patient-specific-need documentation, telehealth prescribing, contamination controls, and quality assurance. FDA reports more than 1,700 adverse-event reports involving compounded semaglutide and tirzepatide, while the end of the tirzepatide shortage may restrict mass-market compounding. Possible NAION association remains unproven and under review; patients should not discontinue therapy independently.