VRS or Verification Router Service is an automated way of verifying saleable returns to improve supply chain efficiency while maintaining the integrity of the supply chain and keeping it free from counterfeit drugs.
What are saleable returns?
When products are returned to the wholesaler for any reason, then the wholesaler can resell the product to others assuming the packaging etc is intact and the product is in a resalable state.
What is the risk in this?
There is a possibility that the returned product is counterfeit while the original shipped product was genuine. Without a way to determine which is which, there is the possibility of this counterfeit drug being resold to another unsuspecting customer. The criminals who have managed to “return” this counterfeit drug can recover their money from the wholesaler for the return while also making profit with the sale of the original product in the market.
How does VRS help in identifying counterfeit returns?
VRS queries a database in which it checks if the manufacturer has indeed created a product with the SNI (Serialized Numerical Identifier) mentioned in the returned product. Since done manually, this would be a tedious and time consuming job, the HDA (Healthcare Distribution Alliance) with feedback from the Pharma Industry came up with VRS as a solution to manage the return requests and the responses by querying a database listing the manufacturer’s SNIs.
(download the info graphic to see the diagram)
How does VRS query the database?
VRS accepts a Product Identifier (PI) request (which includes the Data Matrix code and Format) from an authorized requester through a VRS Portal
The requester provides the GTIN (Global Trace Identification Number) or the GCP (Global Company Prefix)
Based on the GTIN, the VRS routes the request to the correct master database (also called lookup directory) used by the responder
The Manufacturer attempts to check if the Product Identifier is present in the database. If it exists then the verification is successful and if it fails then investigation is done to determine the cause of the failure.
How is the VRS implemented?
Drug manufacturers need to implement a “VRS Responder” service with access to the database that contains the serialization packaging history. DSCSA requires that the manufacturer responds at most within 24 hours for a saleable return response but as specified by the HDA task force, most industry VRS solutions have a sub-second and a near real time response to minimize delays in the supply chain as there are approximately 60 million annual returns
At CosmoTrace, we offer all VRS related services including Master Data and Trade Partner Management implementing verification requests, verification response and whitelisting.
Fast track your way to DSCSA’s VRS compliance with our team of experts, get in touch with us today.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
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