Partnership for DSCSA Governance releases a ‘Foundational Blueprint’ for managing interoperability

The end-to-end US pharma supply chain, from manufacturers to distributors to pharmacies, is under the gun to have an effective, interoperable, data-collection, -transmission and -verification system up and running in November 2023, the culmination of a process that started with passage of the Drug Supply Chain Security Act (DSCSA) in 2013. That deadline might be postponed (as have previous interim deadlines) given the complexity of the undertaking, but industry is moving forward in the form of a “blueprint” brought together by the Partnership for DSCSA Governance (PDG), which came into being about two years ago. PDG stands out for having active participation from manufacturers, distributors, pharmacies and health systems, as well as a good number of the leading vendors in this space. About a third of its membership of 62 represents the pharma industry.

The blueprint, developed by working groups within PDG over the past year, contains 32 requirements or recommendations for identifying tradeable products, 19 for credentialling trading entities, 17 for tracing a product through the supply chain, and nine for verification of a product’s provenance. It’s a hefty list. PDG will hold a series of workshops, open to the public, beginning on July 28.

A key part of PDG’s effort is to generate sufficient consensus that its requirements and recommendations will be followed; PDG does not have force of law. “The DSCSA expressly permits trading partners to adopt ‘alternate methods of compliance,’ and the PDG blueprint is not intended to foreclose that option,” the blueprint states. “PDG’s goal simply is that its blueprint can serve as an optimal approach to implementation that trading partners will opt to follow.” Woven into this stance is what is called the “PDG ecosystem,” which would include trading partners following the blueprint guidance, and specifically the process laid out for credentialing trading partners so that queries or investigations—even among entities that are not direct trading partners—becomes possible.

A third of the membership of PDG represents vendors and consultants; presumably, any vendor who is not following the PDG guidance could find itself out in the cold by 2023.