DSCSA: New interoperability ‘blueprint’ released

Regulatory NewsRegulatory News | 06 February 2023 |  By 

With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a guide to help drugmakers and their trading partners establish the necessary electronic systems to track their products through the supply chain.
The new chapters complement an earlier guide on understanding the compliance and baseline business requirements on trading of information, which was released in July 2021 and revised in July 2022. (RELATED: Industry consortium releases blueprint for DSCSA tracking systems, Regulatory Focus 16 July 2021).
The chapters cover the functional design of a DSCSA interoperable system and were released on Monday by the Partnership for DSCSA Governance (PDG), a consortium of more than 60 pharmaceutical supply chain members established in 2019 to help industry in setting up these interoperable data exchanges.
According to PDG Executive Director Eric Marshall, “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.”
The blueprint was drafted with input from all sectors of the pharmaceutical supply chain, including manufacturers, wholesalers, third-party logistic providers (3PLs) and dispensers. The blueprint “provides a system that can achieve interoperability,” said PDG.
“The PDG functional design described in Chapters 2–6 weaves together those existing designs along with new areas (tracing, credentialing) and defines what PDG views as the optimal functional design that meets the compliance and business requirements defined in Chapter 1,” the blueprint states.
For example, Chapter 3 covers the functional design of the transaction information (TI) and transaction statement (TS) data exchange to be traded among supply chain partners, while Chapter 4 provides information on the design of electronic product information (PI) verification components. Chapter 5 addresses the network to use to trace suspect and illegitimate products and discusses secure interface methods to support the exchange of information.
PDG Board Chair Matt Price said the blueprint will “play a crucial role in the smooth transition to compliance with all DSCSA requirements among all actors in the pharmaceutical supply chain.”
In the meantime, the pharmaceutical industry is making some headway in implementing the necessary systems to comply with DSCSA yet needs to pick up the pace if the November 2023 deadline is to be met, according to a survey conducted last year by the Healthcare Distribution Alliance (HDA). (RELATED: Pharma industry making some headway in DSCA implementation, Regulatory Focus 18 October 2022).
PDG blueprint for interoperability


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