Covectra announced the Covectra Verification Router Service (VRS), a complete API solution enabling pharmaceutical brands to validate the status of a returned product to ascertain its resell ability and ensure regulatory compliance with the upcoming Drug Supply Chain and Security Act (DSCSA) saleable returns requirement.
In November 2020, the FDA enforcement will begin as pharmaceutical distributors of regulated medicines will need to be compliant - or at least on a path to compliance - for the DSCSA saleable returns verification requirement. Implementation of these requirements is intended to enable the U.S. Food and Drug Administration (FDA) to better protect consumers from counterfeit, contaminated, or stolen drugs, and better detect and remove such drugs from the U.S. pharmaceutical supply chain. Wholesalers and distributors will need to verify the unique identifier of returned products before these can be placed into inventory for resale.
Covectra’s new VRS automates DSCSA compliance by managing the acceptance, formatting, and delivery of verification requests and responses for saleable pharmaceutical returns of serialized products in the U.S. It supports secure data exchange between manufacturers and distributors that confirms the authenticity of drug labels, determining if a returned product is in a state which allows it to be resold.
“VRS is a key defense mechanism to increase confidence that the U.S. drug supply is authentic, unadulterated, and safe for consumers, said Steve Wood, Covectra’s CEO. “Returned drugs can be fake, substandard and Covectra VRS provides an automated solution to combat this large issue.”
Covectra is an active member of the GS1 verification messaging standards workgroup comprised of leading pharmaceutical traceability and supply chain manufacturers, distributors and solution providers and helped create a messaging standard for product verification request and response. This verification standard will allow the use of a streamlined, purpose-built request/response messaging set while still being a globally standardized solution to enable interoperability of systems.
Covectra’s new VRS solution has the following features:
- Automates compliance with standards - incorporates GS1 and HDA standards and is built on the GS1 EPCIS certified AuthentiTrack product serialization solution
- Advanced verification capabilities - The item is checked by four characteristics, GTIN (Global Trade Identification Number), Serial Number, Expiration Date and Lot Number. Furthermore, it informs wholesalers of suspect or recalled information in addition to basic verification requirement, which can in turn inform the handling of negative verification responses by the wholesalers and avoid unnecessary suspect investigations. The built-in look-up directory enables the proper routing of the verification requests and is synchronized across the ecosystem.
- Interoperable with other systems - Interoperable with Covectra’s platform as well as any solution providers using the GS1 VRS guidelines, as well as integrate with any look-up directory including block chain or proprietary solutions.