Washington, D.C., September 16, 2020 – The Partnership for DSCSA Governance (PDG) Public Private Partnership (https://dscsagovernance.org/) announces the participation of the Food and Drug Administration (FDA) on the PDG Interoperability Committee. FDA will collaborate with PDG, and its members to support the development of a collective vision for drug traceability that is achievable by industry, informed by regulator input, and most importantly, advances supply chain security and patient safety.
The Interoperability Committee is responsible for the substantive, tactical, and technical work needed to establish and advance a consensus-based interoperable system to meet the DSCSA requirements that go into effect in 2023 (https://dscsagovernance.org/2023-interoperability/). The work of the Interoperability Committee is fundamental to PDG’s goal of publishing a consensus, industry-wide implementation plan for interoperable drug tracing in 2023 by the end of this year.
”We are excited to embark on this collaborative process with FDA in support of drug traceability and patient safety. FDA is a critical stakeholder in the interoperable drug tracing and verification solutions being developed, and their participation in the PDG governance process will help advance PDG’s goal of producing a vision that meets the needs and expectations of all stakeholders,” said Max Peoples, Chair of the PDG Board of Directors, affiliated with Uptown Pharmacy.
“We have always appreciated the FDA’s active, collaborative approach to DSCSA implementation, particularly with regard to the need for, and role of, industry governance. The engagement of PDG with FDA will allow for enhanced collaboration and dialogue to ensure the needs and expectations of all stakeholders, including FDA, are fully considered as part of the vision for DSCSA interoperability. We are excited to work with FDA as we advance this important collaboration,” added Eric Marshall, Executive Director of PDG.
PDG is an industry governance body to support interoperability as required by the Drug Supply Chain Security Act (DSCSA). It has been developed collaboratively and launched by dozens of stakeholders throughout the supply chain. Since forming in late-2019, the governance body has quickly gained support from throughout the supply chain, including authorized manufacturers, repackagers, wholesalers, third-party logistics providers, and dispensers, as well as leading industry trade associations and technical experts.
For more information, or to learn more about PDG membership, visit https://dscsagovernance.org.