As the pharmaceutical supply chain transitions into full compliance with the Drug Supply Chain Security Act (DSCSA), one issue that has been simmering below the surface for years is now starting to boil over: exception handling. While much of the attention has focused on barcodes, serialization data feeds, and SOP enforcement, the day-to-day disruptions caused by data and product mismatches are becoming a defining challenge, especially as dispensers have now moved into full compliance as of November 27, 2025.
Karuna Therapeutics - A Bristol Myers Squibb Company, a cutting-edge neuroscience company, was in the midst of preparing for a critical U.S. product launch when it encountered the complex regulatory requirements of DSCSA compliance.
Exelixis, a leader in biopharmaceutical innovation, is dedicated to developing therapies that meet critical medical needs. However, as DSCSA requirements and regulations continued to evolve, Exelixis encountered obstacles in maintaining a compliance framework that could keep pace with its rapid growth.
