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Blueprint 2023

by Nathan Zachary
Blueprint 2023

Blueprint 2023 is a national strategy for implementing data-driven decisions for healthcare. The Blueprint will help health systems improve the quality of patient care. Its goal is to make data accessible and interoperable. PDG has outlined the goals for this blueprint and is in the process of implementing it.

PDG’s goals for the Blueprint

The Partnership for DSCSA Governance (PDG) is an independent, sector-neutral governance organization for the DSCSA. The group’s goals are to advance the development of a secure and interoperable tracing system. These goals are outlined in the Blueprint 2023, which is being developed by PDG in collaboration with industry stakeholders.

PDG is conducting a series of public workshops to discuss the contents of the Blueprint and the next steps. These workshops are open to the industry and are designed to foster a broader discussion within the industry about a common industry goal: interoperability. The Blueprint’s content includes compliance requirements, business requirements, and technical and operational characteristics.

PDG’s approach to implementation

Implementing the DSCSA requires a coordinated approach from the supply chain to data exchange and verification and the PDG Blueprint signals industry action for this purpose. It includes recommendations on trade partner authentication, serialized data exchange, and interoperability. Among other recommendations, PDG encourages companies to use direct-to-source and direct-to-replica verification. The PDG will host public workshops to help companies prepare for Blueprint 2023 and determine the next steps toward successful implementation.

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The Blueprint is divided into phases, each defining overarching goals and priorities. It also includes concrete strategies endorsed by all stakeholders. The blueprint will serve as a roadmap for collaborative efforts, leveraging existing research and clarifying roles for stakeholders. In addition, it will enable cost mapping of implementation strategies, ensuring that they target contextual barriers.

The Blueprint was developed in collaboration with industry stakeholders. It provides a foundation for supply chain security efforts that will lead to interoperability across the pharmaceutical supply chain by 2023. The Blueprint is an important first step toward fulfilling the PDG’s mission – developing an interoperable tracing model for the supply chain.

DSCSA’s business requirements for interoperability

The DSCSA Foundational Blueprint 2023 provides an important resource to advance supply chain security and interoperability. It is the result of a collaborative effort of industry and FDA to address the important compliance and business requirements needed to implement interoperability by 2023. The Blueprint documents the key compliance requirements and business requirements for interoperability and is intended to be adopted by the pharmaceutical supply chain industry.

Implementing DSCSA’s Enhanced Drug Distribution Security requirements will require a number of different systems and processes to achieve full interoperability. The FDA is conducting two pilot programs to evaluate the use of blockchain technology to meet the DSCSA’s requirements. The FDA will leverage TraceLink’s blockchain solution to achieve full unit-level traceability throughout the supply chain.

The PDG Blueprint signals the start of a major industry-wide push to implement DSCSA compliance solutions. The next phase of solution design and development is expected to begin in 2022. Companies are advised to budget accordingly. As the deadline for implementation and testing approaches, TraceLink is prepared to assist with the process.

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