The DSCSA established a set of product tracing, product identifier, authorized trading partner, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers. The requirements were phased in across the pharmaceutical supply chain over a 10-year timeframe, with the final enforcement date for full end-to-end traceability set at November 27, 2023. As that enforcement date nears, stakeholders across the supply chain are preparing to ensure compliance. They are also monitoring developments closely to understand whether the FDA will delay enforcement or hold to the current timeline.
Many conversations during the event revolved around the latest DSCSA requirements:
Serialized outbound shipments
Larger manufacturers reported significant progress in preparing for outbound EPCIS, noting that 75% of outbound shipments are serialized well ahead of deadlines. However, smaller manufacturers and specialty distributors lag the bigger players due to a lack of infrastructure and identifiers.
Removing suspect product from commerce
Major players also indicated progress in establishing the capability to remove suspect product from commerce. However, while advances have been evident, there is still significant work to ensure adherence to stringent data requirements across the entire supply chain, as well as to hire and retain critical skills.
Salable returns verification
Although the enabling infrastructure is in place (as part of VRS), many manufacturers, especially smaller and specialty pharma manufacturers, are opting to destroy returned product rather than accept salable returns where verification is required.
Suspect product verification requests from specialty distributors and dispensers are expected to increase the need for strict adherence to data requirements. This would also increase the workload for manufacturers to manage and resolve these requests. Manufacturers should enable VRS capabilities as a key enabler to support dispenser verification. Again, the larger industry players appear confident in their infrastructure and processes to meet this requirement.