ACCP Endocrine and Metabolism Practice and Research Network opinion on compounded semaglutide and tirzepatide, reviewing limited outcome data from small cohorts, legal concerns regarding 503A/503B compounding pharmacy regulations, safety issues from contamination and incorrect dosing, and the context of FDA drug shortage designations that have enabled compounding. Advocates for caution. Provides an authoritative pharmacist-led clinical opinion on compounded tirzepatide—recommending against routine compounded incretin use given inadequate evidence, regulatory uncertainty, and patient safety risks from unvalidated compounded formulations versus FDA-approved products.
Courtney, Lindsay A; Clements, Jennifer N; Isaacs, Diana; Pitlick, Jamie M; Reece, Sara Mandy; Whitley, Heather P