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DSCSA Blog Entries

VRS Update: Past, Present, Future

Posted by Justine Freisleben

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.

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HDA Traceability Seminar to Feature FDA Update, Discussions on DSCSA Milestones

Posted by Perry L. Fri

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.

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Verification Router Service Progress Update

Posted by Justine Freisleben

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.

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Are You Ready? Prepare for DSCSA Serialization with HDA Origin

Posted

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?

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Three Takeaways from the FDA Public Meetings on DSCSA

Posted by Anita T. Ducca

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.

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