With a new year in full swing, HDA President and CEO John M. Gray looked ahead to the organization’s 2019 priorities (along with other industry association executives) as part of the Chain Drug Review “Pharmacy Outlook” feature.
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.
Last year, FDA announced a period of “enforcement discretion” related to the deadline for manufacturers to serialize products under the Drug Supply Chain Security Act (DSCSA). As the industry quickly approaches the November 2018 deadline, it is essential for companies to prepare now for the reality of conducting business in a serialized environment. Is your company ready to meet the new requirements?