New GS1 US Implementation Guideline to Help Pharmaceutical Industry Prepare for Upcoming DSCSA Verified Returns Deadline

Published: 04 Sep 2019

GS1 US® has published a new Implementation Guideline titled Applying the GS1 Lightweight Messaging Standard for DSCSA Verification of Returned Product Identifiers to help the pharmaceutical industry address impending requirements of the Drug Supply Chain Security Act (DSCSA) for verification of saleable returns.

Commencing November 27, 2019, the DSCSA requires pharmaceutical wholesale distributors to verify the serialized product identifiers with the manufacturer or repackager before the product can be placed into inventory for resale. Verification consists of determining whether the product identifier on a package or case—specifically, the National Drug Code (NDC), serial number, batch/lot number, and expiry date—corresponds to the product identifier assigned by the manufacturer or the repackager. A manufacturer that receives a verification request from a "requestor" must respond to that request within 24 hours. The Act requires that each pharmaceutical product has a unique identifier, which the U.S. pharmaceutical industry has determined to be the GS1 Global Trade Item Number® (GTIN®) with an embedded NDC.

The new Implementation Guideline provides best practices for implementing the recently ratified GS1 Lightweight Messaging Standard for Verification of Product Identifiers. It was developed as a collaborative effort between pharmaceutical supply chain stakeholders and GS1 US as part of the GS1 Healthcare US® Rx Secure Supply Chain Workgroup. The Implementation Guideline includes technical details such as localization query parameters and settings, as well as configurations for verification requests and responses. The GS1 Lightweight Messaging Standard is designed to enable system interoperability and prevent the proliferation of multiple messaging formats. It also provides a simple, standardized lightweight messaging framework for asking verification questions and receiving information based on a check of the DSCSA Product Identifier and associated data—enabling the requestor to quickly determine whether to accept, reject, or quarantine the product in question.

"Improved assurance of pharmaceutical products' authenticity is crucial to protecting patient safety," said Angela Fernandez, vice president of community engagement, GS1 US. "By following standardized messaging formats and product identifiers, stakeholders can simplify the process of verifying returned pharmaceutical products before they are placed back into commerce, as required by the DSCSA. The result will be a far more efficient system for managing inventories, returns, and resale, as well as a more accurate means for identifying and removing illegitimate, expired, or recalled products from the supply chain. In this time of drug supply shortages and industry-wide cost containment efforts, optimizing inventory utilization is more important than ever."

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