DSCSA VERIFICATION: Starting in November 2020, the FDA will require wholesale distributors to verify the product identifier before re-distributing saleable returned products. By using the Verification Router Service (VRS), distributors will be able to rout the serialization data to manufacturers. In this case, when a saleable return is received, the distributor sends the product data to the third-party routing service, which then routes the information to the manufacturer.
Initiated by the Healthcare Distribution Alliance (HDA) with feedback from the pharma industry, the VRS is an interoperable solution used to manage the acceptance, formatting, and delivery of requests and responses to support DSCSA verification requirements and other business requirements as defined between trading partners.
In this webinar presentation document, you’ll learn about the VRS activities listed below. To get copy of the webinar recording, please email us email@example.com.
- Accept information from an authorized requestor via an interface or manual entry using a VRS portal. This information is a called product identifier (PI).
- The requester will provide the Global Company Prefix (GCP) or Global Trade Item Number (GTIN).
- With the GCP or GTIN, you determine the routing location to where the verification will be submitted.
- The verification request is sent to the responder’s master database/system directly or to a VRS used by the responder.
- After the response is obtained, the requestor will be able to view the data and view an electronic record.
The idea is that when a return occurs, a distributor would scan the Data Matrix code, format, and send the verification request to the VRS provider. By the use of master data, which is called a Lookup Directory (LD), the request is routed to the right source. The verification request goes to the manufacturer to check if the PI is present, If it is present, the request is verified; if it isn’t, then both parties need to investigate where the issue might be.
rfxcel is the industry thought leader in VRS. We extended the testing of VRS and implemented a pilot program for the U.S. Food and Drug Administration. Applying our expertise in supply chain track and trace, serialization, and compliance solutions, we are helping the pharma industry prepare for the November DSCSA Saleable Returns Verification deadline.