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.”…
