As the pharmaceutical supply chain industry looks toward 2023, PDG has collaborated with industry stakeholders to develop a Foundational Blueprint for 2023 Interoperability (The Blueprint). The Blueprint is a critical initial framework for implementation of the Drug Supply Chain Security Act (DSCSA)’s 2023 interoperability requirements across the pharmaceutical supply chain, and 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.
This document sets forth the PDG-defined compliance requirements and business requirements for 2023 interoperability. Compliance requirements represent characteristics of proposed systems and processes that are necessary to meet the statutory obligations of the DSCSA. Business requirements represent technical characteristics of proposed systems and processes that are operationally necessary to satisfy a compliance requirement. Individual companies’ legal interpretations of the specific scope compliance may differ, PDG believes all of the requirements in this document are practically necessary to efficiently achieve interoperability as intended by the DSCSA.
Chapter 1: Understanding of Compliance Requirements and Baseline Business Requirements
Drug traceability is a highly technical and detailed topic and the systems and processes necessary to implement it are complex. The DSCSA, for the most part, provides only general requirements and leaves many of the details of implementation to industry and/or FDA. Recognizing the divergence between statute and practice, this Chapter provides PDG’s general understanding of the statutory requirements of the DSCSA and defines baseline business requirements that frame the general systems and processes for implementation of the main components of the DSCSA: (1) secure, electronic, interoperable systems and processes for the exchange of serialized transaction information (TI) and transaction statements (TS), (2) secure, electronic, interoperable systems and processes for product-identifier verification, and (3) secure, electronic, interoperable systems and processes for tracing.
Blueprint Public Workshops
PDG will host a series of public workshops to discuss the content of the Blueprint and next steps as industry works toward full compliance with the DSCSA 2023 requirements. The public workshops are open to all industry stakeholders.
Each workshop will cover different substantive components of 2023 interoperability, building on the foundation set by the initial chapter of the Blueprint and encouraging broad industry dialogue on the path forward.
Join the Conversation
The Blueprint should not be taken as requirements and recommendations only for members of PDG. As an independent, balanced, and sector-neutral governance body, PDG believes this member-approved, consensus-based output from months of collaboration will begin to provide the necessary certainty and longevity of an effective implementation plan for the DSCSA’s 2023 requirements for all pharmaceutical industry stakeholders.
PDG is not a governmental entity or agency thereof and therefore does not represent the views or positions of the government or enforcement agencies. Trading partners can implement the DSCSA requirements and comply fully with the DSCSA without implementing the PDG blueprint. However, PDG’s goal is that the Blueprint can serve as an optimal approach to implementation that trading partners will opt to follow.
Change Request Form
It is PDG’s goal that the Blueprint will serve as an optimal approach to DSCSA implementation and that trading partners will find it presents the most efficient pathway to compliance. Stakeholder feedback is essential to that goal. To support broad stakeholder adoption, the Blueprint Change Request process is available to all stakeholders without regard to PDG membership.
To propose a change, addition, or clarification in the Blueprint, please submit a change request.
Change requests will be promptly reviewed and acted upon by the PDG Interoperability Committee according to the urgency level assigned by the Committee Chairs. To facilitate that process you may be asked to clarify your request or join the PDG discussion of your proposal. For questions about the Change request process, please contact firstname.lastname@example.org.