- Nelson advises manufacturers to let downstream partners know if a product is covered by a waiver, exception or exemption, to ensure product is not held up due to perceived lack of compliance.
- She also cautions manufacturers to be prepared for enforcement of Verification Systems related to the identification and handling of suspect and illegitimate products. Have detailed, written processes and procedures so FDA can inspect and evaluate them. Make sure those processes are carefully followed by employees, and that appropriate documentation is maintained.
- FDA invited stakeholders to submit pilot projects to explore and evaluate methods to enhance supply chain security, with a focus on advancing the 2023 interoperable track and trace system. Be sure to watch for the final reports, which the FDA will make available to the public upon completion of the program.
- Phase II: The next step in DSCSA—enhanced drug distribution security—will be implemented in November 2023. At that point, data must be exchanged in a secure, interoperable, electronic manner. Industry has begun discussion around the formation of a governance body—an independent, balanced, sector-neutral entity that can develop and advance a shared vision for DSCSA interoperability.
2023, the final deadline for full DSCSA implementation, may seem a long way off, but the deadlines for each phase will arrive quickly.
Cardinal Health has already processed 14.8 million inbound, serialized units and nearly 2,000 serialized lots of product. In April 2019, Cardinal Health 3PL Services operationalized outbound scanning and we are nearing our final selection for a VRS partner. We are on track to capture serialized returns by July 2019.
Pharma manufacturers can learn more about their responsibilities and working with Cardinal Health on DSCSA readiness by joining the Cardinal Health DSCSA Forum the first Monday of every month at 1 p.m. Eastern. Dial-in: 855.241.2663; Conference ID, 3863795.
Regardless of whether you’re on track with preliminary DSCSA requirements, or need assistance putting a program in place, Cardinal Health 3PL Services can help ensure you’re ready for 2023. To learn more about how we can help you comply with DSCSA, contact your CRM today.