February 6, 2023

PDG Publishes Four Functional Design Blueprint Chapters


The Partnership for DSCSA Governance (PDG) Publishes Four Additional Chapters for the Foundational Blueprint for 2023 Interoperability

Washington, DC: Today, PDG announced the publication of four additional chapters of its Foundational Blueprint for 2023 Interoperability, which sets the PDG-defined compliance requirements, business requirements, and functional design of a Drug Supply Chain Security Act of 2013 (DSCSA) interoperable system. PDG is a collaborative forum and FDA public-private partnership formed in 2019 to develop an effective and efficient model for the interoperable exchange of pharmaceutical data, as required by the DSCSA.

On the publication of the Blueprint, which includes four new chapters on the functional design of a DSCSA interoperable system, PDG Executive Director Eric Marshall said, “The expanded Blueprint is a critical milestone and will significantly contribute to the industry’s efforts to achieve DSCSA interoperability by the November 27, 2023 deadline. While the Blueprint does not carry the force of law, it does represent the consensus best thinking of more than 60 of the nation’s leading DSCSA stakeholders.”

PDG Board Chair Matt Price added, “The collaboration found in the Blueprint illustrates the firm commitment of PDG to lead the successful implementation of DSCSA interoperability by the November 2023 requirement. The Blueprint will certainly play a crucial role in the smooth transition to compliance with all DSCSA requirements among all actors in the pharmaceutical supply chain.”
The Blueprint is the result of years-long efforts from members across all sectors of the pharmaceutical supply chain, including Manufacturers, Wholesalers, Third-Party Logistic Providers, Dispensers, and Pharmacies. The DSCSA requires all of these industry players to share data on pharmaceutical products when the product is transacted upon, and the Blueprint provides a system that can achieve interoperability.

About PDG: PDG is a collaborative forum dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the United States. PDG’s consensus development process fosters support of balanced, sector-neutral recommendations that will ensure the efficient and effective implementation of DSCSA requirements by trading partners of all types and sizes.

Blueprint Press Release

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