The Food and Drug Administration (FDA) has issued a warning to Empower Pharmacy, a compounding pharmacy based in Houston, Texas, over concerns that it is producing large quantities of copies of popular weight-loss drugs. The warning, dated September 18 and released online recently, is the first time the FDA has explicitly addressed the line between legitimate customized drug production and mass copying of patented medications. Empower responded by stating it has "already remediated many of the issues outlined in the Warning Letter" and pledged to continue working with the FDA to ensure safe access to compounded drugs. The pharmacy openly advertises two widely used weight-loss medications on its website, though these are intended for healthcare providers, not directly for consumers. Compounding pharmacies typically create customized medications for individual patients, such as turning pills into liquid form for those who cannot swallow them. Unlike traditional drug manufacturers, the FDA does not review or approve the specific medications these pharmacies produce, meaning they cannot guarantee the same level of safety and efficacy as FDA-approved drugs. With the rising demand for GLP-1 receptor agonists—weight-loss drugs like Wegovy and Ozempic—compounding pharmacies have increasingly made copies of these medications. FDA regulations allow such copies when a drug is in short supply. In 2022, when major manufacturers like Novo Nordisk and Eli Lilly struggled to meet demand, many compounding pharmacies began producing their own versions, often at lower prices. The FDA declared the shortage over in 2025, and most federally licensed compounding pharmacies have since stopped making copies of these drugs. However, some state-licensed pharmacies continue to produce versions of the medications, citing a policy that allows them to alter a drug’s formulation—such as changing the dosage or adding a vitamin—if a licensed medical professional determines it will significantly benefit an individual patient. Both Eli Lilly and Novo Nordisk have criticized this practice, with Eli Lilly currently suing Empower Pharmacy, alleging that the pharmacy is misleadingly marketing "personalized" versions of its drugs while actually mass-producing standardized knockoffs. Empower denies these claims, and the legal battle is ongoing. The FDA’s warning is notable because it is the first time the agency has publicly addressed the boundary between personalized drug production and mass manufacturing. Following an inspection in November 2025, the FDA concluded that Empower was using the pretext of personalization to produce large quantities of FDA-approved drugs. The agency cited three main concerns: orders without documentation from prescribers stating the drug was necessary for individual patients, repeated use of the same rationale from prescribers, and the high volume of production. While the exact numbers were not disclosed, experts suggest the FDA is not solely focused on quantity but on the lack of evidence that these drugs were truly customized for individual needs. Legal experts say the warning may not stop compounding pharmacies from making these drugs immediately but could force them to reframe how they market their products.