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Top 10 of 2023 - #3: Op-ed: Data Issues Abound as DSCSA Deadline Nears

Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #3 is an HDA op-ed detailing the significant challenges that remain ahead of the November finish line to connect data systems in compliance with the DSCSA.

Dscsa 2023 Getty Images 1130947928

In this story published in February 2023, Elizabeth Gallenagh and Anita Ducca outline challenges that remain for the healthcare supply chain in complying with the Drug Supply Chain Security Act (DSCSA). Prior to the summer announcement of an FDA stabilization period, trading partners were required to add serialized pharmaceutical product data to the transaction information already provided when a DSCSA-covered product changes ownership by November 27, 2023.

They note that while dispenser readiness, labeling issues, and outstanding FDA guidance certainly are challenges, significant gaps between manufacturers and distributors should be addressed immediately in the final stretch of DSCSA implementation. 

Much progress has been made, but there is much more to do. In comments submitted in early February to the U.S. Food and Drug Administration (FDA), the Healthcare Distribution Alliance (HDA), the national association representing the pharmaceutical distribution industry, flagged several urgent issues while making recommendations to the agency to help keep the supply chain on track for compliance.

Get the full story here.  

List: Top 10 Healthcare Packaging stories of 2023

Related traceability reading:

What Does a DSCSA Stabilization Period Mean?

Tackling DSCSA Communication Issues

Op-ed: Phased Approach to DSCSA an Alternative to Nov. 27 Disruptions

GS1 US Publishes New Guideline on Healthcare Industry Use of RFID

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