How Pharma Manufacturers Should Address VRS

By Garrick Heidt

The Verification Router Service (VRS) is a virtual network of interoperable systems intended to provide industry stakeholders with the ability to verify the authenticity of returned pharmaceutical product against the manufacturer’s system-of-record database prior to that product being reintroduced into saleable inventory.

The need to create such a system starts with the clause in the Drug Supply Chain Security Act (DSCSA) that requires wholesale distributors to verify authenticity of the serial number and associated product information on saleable returns. In lieu of the requirement for manufacturers to send serialization track and trace information — a requirement that will not be in force until 2023 — wholesale distributors must have a solution to verify authenticity of the serial number with the manufacturer. A second clause in the DSCSA requires drugmakers to respond within 24 hours of receiving the request.