The FDA has issued a warning letter to Empower Pharmacy, a large compounding operation, over its production of compounded GLP-1 drugs. Following a November 2025 inspection, the agency concluded that the pharmacy was making large quantities of semaglutide and tirzepatide products that were essentially copies of approved brands like Ozempic and Mounjaro. Under federal law, compounding pharmacies may only produce such drugs when there is a documented, individualized prescription need; the FDA said the sheer volume suggested the differences were pretextual.
The letter also flagged serious sterility problems. Inspectors found that sterile products were prepared under insanitary conditions, with failures to perform proper smoke studies, media fills that didn't stress-test aseptic technique, and inadequate environmental monitoring and equipment maintenance. Because of these violations, the products lost their exemptions and were reclassified as unapproved new drugs and misbranded.
The agency noted that some of Empower's corrective actions were adequate, but others were not. The pharmacy has 15 working days to respond. The warning comes as the FDA has stepped up enforcement against GLP-1 compounding, which had surged during shortages of the branded drugs. Those shortages have since ended—tirzepatide in December 2024 and semaglutide in February 2025—so the legal basis for large-scale compounding has weakened.