DSCSA VERIFICATION: Starting in November of 2019, the FDA will start requiring that wholesale distributors verify the product identifier before re-distributing saleable returned products. With the use of a Verification Routing 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.
Based on the Healthcare Distribution Alliance (HDA), a DSCSA Verification – VRS is an interoperable solution used to manage the acceptance, formatting and delivery of requests and responses in order to support DSCSA verification requirements and other business requirements as defined between trading partners.
In this webinar presentation document you’ll learn about the following VRS activities:
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- Accept information from an authorized Requestor via an interface or manual entry using a VRS portal. This information is 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.
- Verification request is sent to 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 he data and view an electronic record.
The idea is that when a return occurs, a distributor would scan the data matrix, format and send the verification request to the VRS provider. By the use of master data which is called a Lookup Directory (LI), the request is routed to the right source. The verification request goes to the manufacturer to check if the PI is present. The request is verified if the PI is present in the database. If not, then both parties need to investigate where the issue might be.
rfxcel designed, built and tested a DSCSA Verification VRS solution for wholesale distributors and manufacturers. At the moment we have multiple pilot programs running. With the help of the industry, customers, multiple testing and feedback, rfxcel is planning for a final refinement in spring of 2019.
rfxcel is one of the most tenured track and track provider in the market today. rfxcel provides leading-edge solutions to help organizations meet regulatory compliance requirements, protect their products, and brand reputations. For the last 15 years, pharmaceutical manufacturers, wholesale distributors, and pharmacies throughout the industry have trusted rfxcel to provide more than just compliance solutions; they rely on rfxcel’s platform for greater real-time supply chain visibility and value. rfxcel is located across the globe in the U.S., EU, Latin America, India, Russia, the Middle East and the Asia Pacific. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.
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