Partnership for
DSCSA Governance

A collaborative forum and FDA public-private partnership dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S.

DSCSA 2023 Requirements

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.

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A Track and Trace System

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.

Foundational Blueprint

PDG has developed a Foundational Blueprint for 2023 Interoperability, which outlines the compliance and business requirements necessary to achieve interoperability in the pharmaceutical supply chain as mandated by the Drug Supply Chain Security Act (DSCSA).

News & Updates

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 Quarterly Activities Update

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

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