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Verification Router Service Update

As an outgrowth of the Healthcare Distribution Alliance's 2019 saleable returns pilot work, the group has been exploring a VRS as an option for compliance to support DSCSA verification requirements.

A VRS could be used to manage acceptance, formatting and delivery of requests/responses to support DSCSA verification requirements (Credit: HDA)
A VRS could be used to manage acceptance, formatting and delivery of requests/responses to support DSCSA verification requirements (Credit: HDA)

Given the volume of saleable returns that wholesale distributors handle, the returns process could become very onerous under DSCSA requirements in 2019. Per 582(c)(4)(D):

“... upon receipt of a returned product that the Wholesale Distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier for each sealed homogeneous case of suchproduct or, if such product is not in a sealed homogeneouscase, verify the product identifier, including the standardizednumerical identifier, on each package.”

In general, approximately 2-3% of total sales are saleable returns. For large pharmaceutical distribution centers, the numbers of return units per day could stretch into the thousands, or tens of thousands.

As an outgrowth of the 2019 saleable returns pilot work, the Healthcare Distribution Alliance (HDA) has been exploring a verification router service (VRS) as an option for compliance. At HDA’s recent Traceability Seminar, group members discussed the background, progress and goals.

What is a VRS?

As was explained at the seminar, a VRS is an interoperable solution used to manage the acceptance, formatting and delivery of requests and responses in order to support DSCSA verification requirements and other business requirements as defined between trading partners.

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