Industry and service providers continue to work to implement the Drug Supply Chain Security Act’s (DSCSA) serialized saleable return milestone. With the end of FDA-granted enforcement discretion ending on November 27, 2020, and the industry simultaneously responding to COVID-19, it is all hands on deck to reach the compliance finish line.
It has been clear for some time that the pharmaceutical supply chain has been concerned with meeting the November 27, 2019, saleable returns milestone. As the HDA’s Research Foundation’s annual Serialization Readiness Survey (conducted in May) notes, 79 percent of manufacturers have concerns with the viability of the Verification Router Service (VRS), while 82 percent of distributors are unsure about meeting the requirement.
The Verification Router Service (VRS) started off as an idea in 2015. In 2016, it was identified as a preferred option for compliance with the 2019 saleable returns requirement (along with sending data via EPCIS). Since 2017, HDA has been convening industry stakeholders to write business requirements for the VRS, later pulling in solution providers to help with the technical details and then facilitating the group that developed the documentation that exists today.
As the summer winds down, HDA is hard at work planning our 2018 Traceability Seminar, which will take place three weeks earlier, on October 17–19 at the Renaissance Washington, DC Downtown Hotel. As the industry passes the halfway mark for DSCSA implementation, our 2018 agenda leverages HDA and our members’ unique expertise to help fellow stakeholders answer critical questions while planning for the multiple milestones ahead.
As mentioned in our February 16 blog post, HDA and industry participants continue to make progress working with solution providers as Verification Router Service (VRS) solutions are developed for the 2019 DSCSA saleable returns requirement. This work has taken three paths: establishing governance processes; creating testing scenarios; and launching the testing phase.