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VRS solution to address pending DSCSA requirements for sale of returned products
June 29, 2018
By: Tim Wright
Editor-in-Chief, Contract Pharma
Adents, a serialization and track & trace solutions provider, has addressed a looming compliance issue through its recently introduced and blockchain-based NovaTrack product. Developed in collaboration with Microsoft, the supply chain solution has led to the introduction of a Verification Router Service Solution per upcoming U.S. pharmaceuticals serialization requirements. A Verification Router Service, or VRS, is one of a series of milestone requirements that will come into play during the next phase of the Drug Supply Chain Security Act. Beginning in late November 2019, no returned serialized product may be resold until the wholesale distributor verifies that product’s unique identifiers, including the SNI for each sealed homogeneous case or package. A VRS is an interoperable solution used to manage the acceptance, formatting and delivery of requests and responses to support these DSCSA verification requirements, as well as other business requirements defined between trading partners. Some 60 million pharmaceutical saleable product returns occur each year in the U.S. market. This year, the establishment of shared standards for sales stream reintegration has become vital for the pharmaceutical industry. Through a dedicated working group-of which Adents is a member-the Healthcare Distribution Alliance has communicated the specifications, standards and user case scenarios that any effective VRS solution must address, such as requirements for both Requestors and Responders and a Lookup Directory with repository connectivity. Amidst this, VRS has emerged as a complex supply chain issue requiring heightened levels of interoperability and security. Among other demands, VRS solutions must share information reliably and safely, remain nimble for new entrants, and be subject to public and industry-driven governance. Essentially, a VRS allows companies to verify products by entering the four product identifier elements – GTIN, serial number, lot and expiry – into a request, which is then forwarded, via the lookup directory, to the appropriate manufacturer repository. Next, a response is generated from the manufacturer’s repository and routed back to the requestor, detailing whether the product is verified – and whether it can be returned to saleable inventory.
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