PAI (Pharmaceutical Associates, Inc.) is a manufacturer of generic liquid pharmaceuticals. They have produced suspensions, oral solutions, elixirs, syrups and liquids for nearly 50 years. PAI has implemented several Axway solutions including Axway Cloud B2B Service, Axway Cloud CSOS Service and Axway Cloud Track & Trace Service.
PAI was required under the Drug Supply Chain Safety Act (DSCSA) to implement a Verification Router Service (VRS) by November 27, 2019, later deferred to November 27, 2020, by the FDA (Federal Drug Administration). The purpose of the Verification Router Solution is to allow distributors to validate the status of a returned product with the manufacturer to ascertain its resell ability. The deadline for the statute was November 27, 2019. This is a federal compliance requirement (DSCSA) § 582(c)(4)(D).
Verification Router Service (VRS)
VRS is an interoperable solution used to manage the acceptance, formatting, and delivery of the verification requests and responses for pharmaceutical saleable returns in the US. The built-in look-up directory (LD) enables the proper routing of the verification requests and is synchronized across the ecosystem.
The goal is to provide distributors with the capability of determining if a returned product is in a state which allows it to be resold. The item is checked by four characteristics, GTIN (Global Trade Identification Number), Serial Number, Expiration Date and Lot Number.
Axway is a member of the GS1 Rx Secure Supply Chain Workgroup and HDA (Healthcare Distribution Alliance) which are both driving the standards and usage for VRS.
Axway developed a VRS responder solution powered by Axway’s market-leading AMPLIFY™ API Management solution and Axway Decision Insight. Our open-API based Verification Router Solution will work with any solution providers using the GS1 VRS guidelines. We can integrate with any Lookup Directory including blockchain or proprietary solutions and offer product update services as part of our support service package. The Axway VRS Service is the first multi-tenant API Service provided by Axway.
PAI chose Adents as their Lookup Directory and requestor service. Adents provides the Lookup Directory and the management of the clients’ GTINs. Adents also provides Requestor security and routing via the Lookup Directory to the VRS Responder Service.
- Lookup Directory Management
- Synchronize to other Lookup Directories
- Request direct from Adents Solution
- Request from other VRS Solution via Adents
- Request to Axway VRS Responder
- Request to PAI Repository
- Response from PAI Repository to Axway VRS Responder
- Response to Adents VRS Solution
- Response to Requestor on Adents VRS Solution
- Response to Requestor on Other VRS Provider
- Adents Transaction logs can be consumed to build reports
PAI also has access to user-friendly dashboards powered by Axway Decision Insight. PAI can view which partner is initiating the most request and can get counts, both positive and negative.
Read Axway’s announcement about API innovation for healthcare with Verification Router Service (VRS) Solution