A third might compound at 5 mg/ml or 15 mg/ml
During shortages of Wegovy, Ozempic, Mounjaro, and Zepbound, the FDA exercised temporary enforcement discretion , allowing compounding pharmacies to help meet patient demand. Once manufacturing stabilized: Semaglutide injection products were removed from the FDA Drug Shortage List Tirzepatide injection products were formally declared resolved Compounding reverted to pre-shortage federal and state limits Broad, shortage-based compounding is no longer allowed in 2026
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Overview of the FDAs Compounded Semaglutide Manufacturing Ban In response to concerns about safety, efficacy, and regulatory oversight, the FDA issued a ruling requiring compounding pharmacies to stop manufacturing compounded semaglutide by May 22, 2025