Exceptions Handling Guidelines For The DSCSA
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.
Enter your name and email address below to download a copy of the Exceptions Handling Guidelines.
Download Supplemental Documents on Communications and Corrections
HDA has created two addendums to the Exceptions Guidelines: a communication guide providing recommendations and clarifications on what should be communicated during certain exceptions and a correction guide detailing best practices for preventing and correcting transaction data exceptions incidents. Click below to download the addendums:DSCSA Exceptions Handling Communication Guide
Exceptions Data Correction Guide for DSCSA
Enter your name and email address to download the publication:
