DSCSA 2023: The Role of Service Providers and the VRSSeptember 16, 2022 HDA is hosting a webinar series to discuss the upcoming Drug Supply Chain Security Act (DSCSA) requirements. These webinars, which focus on education specific to dispensers, will lead up to HDA’s annual Traceability Seminar on October 12–14 in Washington D.C.
HDA’s second Traceability Webinar, held on August 25, centered on how service providers can help dispensers prepare to meet the 2023 Drug Supply Chain Security Act (DSCSA) requirements, what dispensers will need to do on their own and the purpose and function behind the Verification Router Service (VRS). The VRS is an industry-developed solution that allows companies to verify products in a manner that complies with the 2019 DSCSA requirement for serialized saleable returns.
Bob Celeste, Founder of the Center for Supply Chain Studies, laid out how VRS helps to track movement through the supply chain, retrieve the status of products and support investigations for excessive or illegitimate product sales. “It also provides an audit trail for when inspections from FDA and state pharmacy boards need dispensers to test systems to verify product legitimacy or that a system is properly functioning,” Celeste said. When verifying products, dispensers need to be mindful that they will need to use the Global Trade Item Number (GTIN) with an embedded NDC, the serial number, the lot number and expiration date.
Outlining how solutions providers can help, Elizabeth Waldorf, Director, Global Traceability and Standards, TraceLink Inc., explained that solution providers can help dispensers set up master data information for EPCIS exchanges and provide a centralized repository for this data. She caveated, saying, “Master data is not a ‘one-and –done' deal. As suppliers introduce new products or trading partners engage in mergers and acquisitions, dispensers need to maintain that information for accurate data exchange.”
Herb Wong, VP Strategy & Innovation, Antares Vision Group, discussed how solutions providers can offer support to dispensers in troubleshooting issues with VRS where two-way communication adds a layer of complexity. Additionally, Ilir Ivezaj, Customer Support Engineer, LSPediA, explained that while service providers can help dispensers with collecting identifiers and helping to identify what data is required for the VRS data exchange, “it's best practice to have your team gather that information from your suppliers directly.”
Dwight de Vera, Vice President, Healthcare Intelligence, Inmar Intelligence, offered insight into how solutions providers have created a vast ecosystem of solutions for dispensers, wholesalers and manufacturers that include dispenser systems for track-and-trace and EPCIS repositories, VRS solutions and decommissioning systems that will help saleable and non-saleable returns. In calling the industry to action, de Vera said, “Now is the time for us to partner with each other to implement and execute our plans for DSCSA.”
To learn more, watch the August 25 webinar recording.
More resources are located at DSCSA.pharmacy, including the HDA-developed “All About the VRS” and “How Can Your Service Provider Help Prepare for DSCSA” fact sheets.
Those interested in continuing their DSCSA preparation and learning should consider registering for HDA’s upcoming Traceability Seminar.
For more information, contact Jaidalyn Rand, Director, Industry Relations.