1 Year Out, Where Do We Stand On DSCSA Implementation?

Article about DSCSA interoperability… one year out from Nov 27, 2023.

The path to DSCSA implementation has been a long and winding one. While signs of readiness have been observed, it’s also clear that many trading partners are still lagging in bringing together their capabilities in order to meet 2023 interoperability goals. Interoperability means a system that is wholly connected and cohesive — any missing links in the system will not only run counter to the intent of the DSCSA but could also stymie broader efforts to increase supply chain resiliency and to prevent drug shortages in the face of ongoing public health emergencies. Collaboration between and among trading partners and the FDA continues to top challenges faced in DSCSA implementation — both in working out technical issues at the local level, and in deepening stakeholder understanding about roles and responsibilities throughout supply chains. Additionally, greater insight into data management at facilities may help trading partners zero in on how traceability data should be transferred to, or accessed by, other trading partners or regulating authorities as part of the overall enhanced system.