Prepared by technical experts of the HDA Exceptions Handling Work Group, these guidelines were developed to address exceptions that may arise when passing or failing to pass Drug Supply Chain Security Act (DSCSA)-required transaction information and transaction statement data to authorized trading partners. The guidelines have been rewritten since its original publication (2022).

As the supply chain moves toward compliance, the mandatory interoperable exchange of serialized data adds significant complexity to sector operations and there will be instances where there is a mismatch between data and product. The scenarios covered within the document focus on transactions between manufacturers and distributors and fall within five categories: Data Issue, Product No Data, Data No Product, Packaging and Labeling and Unavailable for Distribution.

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DSCSA Exceptions Handling Communication Guide

Created in 2024, this voluntary communication guide is an addendum to the Exceptions Handling Guidelines for the DSCSA and clarifies communications around DSCSA transaction data exception incidents between trading partners. This brief document, based on an evolving understanding of DSCSA requirements, provides recommendations on what should be communicated during certain exceptions. Example use cases and sample messages are included.