Starting November 27, 2023, the second phase of traceability requirements comes into effect, shifting from lot-level to package-level product tracing.
Despite limited statutory details, three crucial and interconnected components make up these DSCSA 2023 requirements: Interoperable Exchange, Verification, and Tracing. Trading partners will need to securely share transaction information (including product identifiers) and statements electronically, verify product identifiers on packages or sealed cases, and maintain digital systems to supply transaction details upon request, all in an interoperable manner to enable tracing back to the manufacturer.
Efficient implementation requires an intentional implementation plan that builds toward a shared vision for 2023 interoperability.
As an independent, balanced, and sector-neutral governance body, PDG is working to establish an implementation plan and will provide certainty and longevity that benefits the effective, efficient implementation of the DSCSA. Each trading partner will be committing significant resources to implementation of the DSCSA 2023 requirements. The formal structure of PDG, with well-understood, agreed upon rules for governance will provide confidence and predictability in the allocation of those resources.
Stay informed with the latest news and updates on the Partnership for DSCSA Governance. Explore our progress, insights, and milestones as we work together to implement the Drug Supply Chain Security Act (DSCSA) standards.
PDG seeks tracing pilots & demos to validate protocol. Stakeholders urged to submit proposals for Q2 2023. PDG ensures efficient implementation.
FOR IMMEDIATE RELEASE The Partnership for DSCSA Governance (PDG) Publishes Four Additional Chapters for the Foundational Blueprint for 2023 Interoperability
Washington, D.C., July 14, 2021—The Partnership for DSCSA Governance (PDG), an industry consortium of more than 60 pharmaceutical supply chain
Over the past quarter, the Partnership for DSCSA Governance (PDG) has worked with its membership and the FDA to further define a vision for 2023 interoperability. Specifically, PDG has worked through