FDA Extends DSCSA Compliance: New Deadlines for Drug Supply Chain Partners
In a recent announcement, the FDA issued updates on exemptions from the Drug Supply Chain Security Act (DSCSA) final implementation deadline, extending compliance timelines for specific partners within the pharmaceutical industry. This decision acknowledges the difficulties faced by some manufacturers and distributors in meeting the stringent traceability requirements, despite the Act being in place for over a decade. The FDA aims to minimize potential disruptions in the pharmaceutical supply chain to ensure critical medications remain accessible to patients. Background of the DSCSA The DSCSA, enacted in November 2013, was established to enhance drug traceability within the U.S. pharmaceutical supply chain. By mandating unit-level serialization and visibility from manufacturers to dispensers, the DSCSA addresses issues of counterfeiting, contamination, and drug shortages. Under this law, each pharmaceutical product moving through the supply chain must b...