The FDA recently announced a 12-month enforcement discretion and system stabilization period for the final phase of the U.S. Drug Supply Chain Security Act (DSCSA), but the law will still take effect on Nov. 27, 2023. And whether you’re a pharmaceutical manufacturer, wholesale distributor, or dispenser, organizations that delay their DSCSA projects risk failing to be ready for a complex regulation. Critically, they will also miss out on the strategic competitive advantage that other industry stakeholders are acquiring right now by using DSCSA to digitalize end-to-end supply chain operations and access industry-wide supply chain intelligence.
In guidance shared with the pharma industry in late August, the FDA stated that the enforcement discretion period is not a delay in the law and strongly urged supply chain stakeholders to avoid slowing or delaying DSCSA compliance projects. Instead, the 12-month stabilization period, which ends on Nov. 26, 2024, should be used to stabilize and mature DSCSA systems and processes with supply chain partners. But that’s not the only reason to make sure that DSCSA compliance projects remain a top digitalization priority.
Ranging from advanced drug shortage predictions to item-level inventory management to the digitalization of the product recall process, many organizations are leveraging the information-sharing requirements of DSCSA to create business value right now. Organizations ought to be leading the end-to-end digitalization race, instead of standing on the sidelines. Read More >
