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.
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
