PARTNERSHIP FOR DSCSA GOVERNANCE
Foundational Blueprint for
2023 Interoperability
PDG’s Foundational Blueprint for 2023 Interoperability provides a crucial framework for implementing the DSCSA's 2023 interoperability requirements and establishing business and compliance requirements believed necessary for efficient interoperability in line with the DSCSA's intentions.
PDG Blueprint Chapters
Scroll down to view or download each PDG Blueprint chapter or fact sheet. All materials references throughout the Blueprint are available here.
To propose a change, addition, or clarification in the Blueprint, please submit a change request.
Understanding of Compliance Requirements and Baseline Business Requirements
TI/TS Exchange Functional Design
The TI/TS exchange functional designs in this chapter provide detailed information on how the TI/TS Exchange components of the PDG-defined EDDS network will function.
Product Identifier Verification Functional Design
This Product Identifier Verification Functional Design provides detailed information on how electronic PI Verification functional components of the PDG-defined DSCSA EDDS network operate.
Tracing Architectural Functional Design
Credentialing and User Authentication
PDG Exception Notification Guideline Resources provides guidance to trading partners on implementing the Exception Notification Guideline of the PDG Blueprint. These documents have been ratified by the full PDG membership.
PDG Trace Model: Trace Request provides guidance to trading partners on implementing the Request Trace Models of the PDG Blueprint. These documents have been ratified by the full PDG membership.
PDG Trace Model: Trace Response provides guidance to trading partners on implementing the Response Trace Models of the PDG Blueprint. These documents have been ratified by the full PDG membership.
PDG Points of View are educational resources that provide trading partners further insights on interoperability. These documents do not represent formal PDG positions and have not been ratified by the full PDG membership.
PDG Point of View on Waivers, Exceptions, and Exemptions
Tracing SOP Considerations
Communications and Corrective Actions Between Trading Partners
DSCSA and Business Continuity Planning
DSCSA EPCIS Connection Configuration Template
This template allows solution providers to significantly expedite the onboarding of additional trading. Each solution provider—not PDG—will continue to define the specifics of their respective connection, but this standardized template will help them consistently communicate those connection methods. We hope solution providers will utilize this new template immediately, and we hope trading partners will encourage their solution providers to do so as well.
Exception Root Cause Document
As stakeholders consider the root causes of misalignment exceptions, it can be helpful to recognize where and how the root cause of a misalignment exception fits into the broader misalignment handling process. This document is specifically and narrowly focused on the root causes of misalignment exceptions, not the handling of misalignment exceptions once they occur. Those root causes are rooted in individual business practices—people, processes, and technology. This document is intended purely as an educational resource to aid individual companies as they evaluate and improve their business processes; it is not intended to establish specific recommendations or best practices.
The Partnership for DSCSA Governance publishes the Blueprint to provide a framework for stakeholders that is intended to assist stakeholders in implementing and complying with DSCSA requirements. The Blueprint is developed by PDG’s diverse members that span the supply chain, including authorized manufacturers, repackagers, wholesalers, third-party logistics providers, dispensers, trade associations, and technical experts. Following the requirements set forth in the Blueprint does not, and is not intended to, constitute adherence to the legal requirements in the DSCSA.
Although PDG encourages stakeholders across the industry to utilize the Blueprint, PDG does not engage in any activities to confirm, validate, or audit whether an individual stakeholder’s systems and processes conform to the Blueprint. PDG does not endorse any organization that portrays conformance to the Blueprint, nor does PDG maintain a list of stakeholders purporting to conform to the Blueprint. All information in the Blueprint is for informational purposes to aid stakeholders in making their business and compliance decisions when implementing the DSCSA.