The pharmaceutical industry marked an important step forward towards full DSCSA compliance readiness this past year with the successful launch of the Verification Router System (VRS), meeting the November 2019 deadline outlined in the Drug Supply Chain and Security Act (DSCSA). The November 2019 DSCSA milestone mandated that the pharmaceutical industry be able to verify saleable returns at the distributor level before product re-enters the supply chain.
Prior to its launch, Cardinal Health was among the distributors partnering with the Healthcare Distribution Alliance (HDA) to test and validate the system. As a leader in DSCSA preparedness, Cardinal Health has implemented the MediLedger Product Verificaiton Solution (PVS) to ensure compliance with the saleable returns requirement. MediLedger is the first commercially launched, decentralized blockchain network in the pharmaceutical industry. In fact, Cardinal Health was the first to launch a MediLedger blockchain node within its infrastructure and the first to launch the PVS solution within its commercial operations. Cardinal Health 3PL Services was among the first third party logistics providers to go live on the VRS. We are pleased to report that the system has been running smoothly.
Industry watchers will recall that enforcement of the November 2019 milestone was delayed until November 2020. During their April 2020 Distribution Management Webinar Series, HDA provided an update on industry readiness to handle the millions of anticipated returns verification requests. Although VRS work is progressing, there are challenges with bringing all providers up to speed, integrating the new GS1 messaging standards into existing solutions and building out credentialing to support ATP status verification. The consensus is that the volume of returns will make manual verification at the distributor level effectively impossible. Manufacturers will need to either participate in the VRS or exchange EPCIS serialized data, otherwise product in a saleable condition may go to waste.
Because delayed enforcement of the saleable returns verification at the distributor level has reduced the expected activity on the VRS, now is an ideal time to launch your serialization solution – prior to the rapid scaling-up period that is likely to begin later this year. (The previous recommendation was to have 100 percent of manufacturers live on the VRS by June 2020.) A proactive start will allow distributors to ramp up their verification volume and ensure your customers have access to the information they need.
In other news, Cardinal Health 3PL Services recently completed successful deployment of our returns serialization project. This capability enables clients who subscribe to outbound scanning services to match product returns, based on their DSCSA barcode that was scanned and shipped, to an invoice. This allows for more accurate financial reconciliations on returned goods as we can verify the original sale price down to the specific unit of drug product sold. This solution may be particularly desirable for products with pricing that changes, either at launch due to stocking discounts, or on a more regular basis.
Cardinal Health 3PL Services stands ready to support your company’s next steps in track and trace planning. To help your business comply with the DSCSA requirements, we offer configurable solutions, from serialization to creation and transfer of event data and VRS support. Our solutions come backed by the knowledge, scale and resources of Cardinal Health Pharmaceutical distribution, IT and Regulatory teams. Adding DSCSA support services to your existing 3PL services agreement helps reduce the risk of disconnects in the supply chain that come with introducing new partners and allows you to maintain a single point of contact for support.
Contact your CRM today to learn more and evaluate your options for DSCSA preparedness.