INSIDE COMPLIANCE

A viral weight-loss craze that promised to trim waistlines has become one of the most urgent compliance battles for the U.S. Food and Drug Administration (FDA). In early 2025, the FDA uncovered counterfeit Ozempic circulating through unauthorized distributors and compounding pharmacies, some containing unknown ingredients that put patients at serious risk. The discovery exposed the continued fragility of the nation’s pharmaceutical supply chain, even after years of reform under the Drug Supply Chain Security Act (DSCSA). As demand for GLP-1 drugs like Ozempic and Wegovy skyrockets, regulatory gaps in manufacturing, compounding, and distribution have created new avenues for fraud, forcing the FDA to tighten enforcement and redefine the rules of pharmaceutical oversight.