Washington, D.C., July 14, 2021—The Partnership for DSCSA Governance (PDG), an industry consortium of more than 60 pharmaceutical supply chain stakeholders and a public-private partnership with the FDA, has released its Foundational Blueprint for 2023 Interoperability (“Blueprint”). The Blueprint is a critical initial framework for implementation of the DSCSA’s 2023 interoperability requirements across the pharmaceutical supply chain and is available at: https://dscsagovernance.org/blueprint/.
The Blueprint documents important compliance requirements and business requirements to support the effective, efficient implementation of the DSCSA’s 2023 requirements. Specifically, the Blueprint addresses baseline requirements for the exchange of serialized transaction information, product identifier verification, product tracing, and trading partner credentialing. Collectively, these requirements lay the foundation for PDG’s continued work throughout 2021 to develop consensus technical specifications for interoperability.
The Blueprint is a product of more than a year of discussion and consensus development among PDG’s more than 60 members representing innovator and generic manufacturers; large and mid-sized wholesale distributors; third-party logistics providers; chain, independent, and health system pharmacies; and technical experts in the DSCSA field. The member-approval of the Blueprint is an important step toward achieving PDG’s mission to develop, advance, and sustain an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals, which has also been furthered through PDG’s public-private partnership with the FDA.
While PDG’s work does not carry the force of law, it represents the consensus work of many of the pharmaceutical supply chain’s leading entities and is intended to serve as a tool that can be used and adopted throughout the pharmaceutical supply chain by PDG member and non-members alike. As such, PDG is seeking broad industry feedback on the Blueprint and is simultaneously rolling out a process by which any stakeholder may request revisions and additions to PDG documentation. For more information, visit https://dscsagovernance.org/blueprint/.
To further encourage dialogue and collaboration across the pharmaceutical industry, PDG will host a series of public workshops to discuss the content of the Blueprint and next steps to continue progress toward successful implementation of the compliance and business requirements defined in the Blueprint. More information on how to participate in the workshops is available at https://dscsagovernance.org/blueprint/.
View the Blueprint here.
PDG Board Member Quotes:
“The release of the Blueprint marks significant progress across the pharmaceutical supply chain in coming together to create consensus-based requirements for achieving interoperable, unit-level tracing in 2023. With this progress comes a continued commitment to working with the broadest base of stakeholders possible to build upon this work and align around the systems and processes to achieve the consensus-based foundational requirements outlined in the Blueprint. We look forward to continued collaboration and engagement across the pharmaceutical supply chain to refine the Blueprint and continue to progress toward the 2023 compliance deadline,” said Matthew Price, PDG Vice Chair, affiliated with Medline Industries.
“The Blueprint is the result of a complex and collaborative effort to put forward requirements and recommendations for 2023 interoperability, including identification of what is needed for industry stakeholders to efficiently, reliably, securely, and interoperably work with other stakeholders in the supply chain, verify product, trace the chain of product ownership at the unit-level, and ensure overall supply chain integrity. This is essential to the successful, industry-wide implementation of the DSCSA,” says Michael Mazur, PDG Board Member, affiliated with Pfizer.
“Successful implementation of the DSCSA requires close coordination and a shared vision between industry stakeholders. The Blueprint is intended to provide the added certainty and longevity of an effective implementation plan for meeting the 2023 DSCSA requirements. It is also intended to provide industry stakeholders flexibility in implementing DSCSA compliance requirements to best meet their business and organizational needs. While the Blueprint requirements do not carry the force of law, we hope that the Blueprint will be leveraged by PDG members and non-members across the supply chain, including small businesses,” said Melva Chavoya, PDG Board Member, affiliated with Walgreens.
“The Blueprint is the result of the tireless efforts of dozens of diverse supply chain stakeholders dedicated to successful implementation of the DSCSA, but it was developed to serve as a framework for use and adoption throughout the full pharmaceutical supply chain. To that end, continued stakeholder feedback is essential, and we encourage all stakeholders to provide feedback on the Blueprint and engage in stakeholder dialogue through our change request process and the upcoming public workshops,” says PDG Executive Director, Eric Marshall.
Background:
For more information on the Drug Supply Chain Security Act (DSCSA) and the Partnership for DSCSA Governance (PDG), visit: https://dscsagovernance.org.
Prior PDG press releases are available at: https://dscsagovernance.org/news-updates/.