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News
The FDA issued a warning letter to Empower Pharmacy for mass-producing compounded versions of semaglutide and tirzepatide — the active ingredients in Ozempic and Mounjaro — in violation of federal law. Inspectors also flagged insanitary conditions at the facility. The pharmacy has 15 working days to respond.
The FDA sent a formal warning letter to Houston-based Empower Pharmacy on September 18, citing illegal mass production of compounded GLP-1 drugs — specifically semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) — in violation of Section 503A of the Federal Food, Drug, and Cosmetic Act. The agency determined that Empower's high-volume output of these drugs, which were essentially copies of FDA-approved products, stripped them of their legal exemptions, reclassifying them as unapproved new drugs and misbranded products.
The compounded formulations also included added B vitamins — tirzepatide mixed with niacinamide and semaglutide mixed with cyanocobalamin — which the FDA viewed as a pretextual attempt to differentiate them from approved drugs. Beyond the copycat manufacturing issue, inspectors found serious sterility and quality control failures at the facility.
Key Takeaways:
Why it matters: With GLP-1 drug shortages now resolved, the FDA is tightening its grip on compounders that continued mass production. This crackdown signals stricter enforcement ahead for pharmacies still operating in a legal gray zone.
