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.
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.
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.
On February 28, FDA hosted its third and final public meeting in a series focused on "Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act [DSCSA],” bringing together a broad group of stakeholders, including manufacturers, distributors, dispensers, hospitals and service providers.