Exceptions Handling Guidelines for the DSCSA

Published 2022

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 information to authorized trading partners in compliance with the law.

As the supply chain moves to 2023 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 six categories: Data Issue, Damaged Product, Product No Data, Data No Product, Packaging and Product Hold.

Exceptions Handling Guidelines