Exceptions Handling Guidelines For The DSCSA

Published 2023

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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Exceptions Handling Guidelines