Q&A: Prepare for FDA Inspection on Compounded GLP-1s

Annie Lambert, PharmD, BCSCP, compliance program manager at Wolters Kluwer Health, discussed the shifting regulatory landscape around compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and what it means for pharmacists. She explained that by excluding GLP-1s from the 503B bulk compounding list, the FDA is signaling a narrower role for widespread compounding of agents like semaglutide (Ozempic, Wegovy; Novo Nordisk), tirzepatide (Mounjaro, Zepbound; Eli Lilly and Company), and liraglutide (Victoza, Saxenda; Novo Nordisk), while 503A pharmacies face increased scrutiny.