With fewer than 9 months until the Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification deadline, many manufacturers and wholesalers have yet to make significant progress in their planning. More important, many have yet to communicate with their trade partners about critical business and technical requirements—an essential first step in choosing a saleable returns solution.
The first webinar of TraceLink’s Solving Saleable Returns series clarified the roles and responsibilities of manufacturers and wholesalers for verifying products under DSCSA. Saleable Returns: DSCSA and Trade Partner Requirements Explained also focused on the need for a comprehensive approach that meets the Big 3 wholesalers’ requirements for a verification router service (VRS), EPCIS data exchange to enable self-verification, and master data sharing.
Poll questions revealed that companies should start their planning immediately to be ready by November 2019:
90% of companies do not have a final plan in place for managing saleable returns.
Less than 10% of the manufacturers and wholesalers attending the webinar indicated that they were ready for the November 2019 deadline. Only 15% were in the process of evaluating a saleable returns solution, while the remaining 75% of respondents said that they have only had initial conversations or are just starting to address show they will meet the salable returns requirement.
Half of companies have not talked with their trading partners about saleable returns verification.
Any company evaluating their salable return solution has to consider how their partners are preparing to exchange product data and process verification requests. While just over 50% of respondents have yet to initiate conversations with their trade partners about their saleable returns requirements, an additional 27% have spoken with fewer than one-quarter of companies in their business ecosystem. Only 6% had communicated with all of their trade partners.
Manufacturers show less concern about the impact of saleable returns than wholesalers.
While the majority of wholesalers expressed concern about the impact of saleable returns, most manufacturers said they are not worried about how the 2019 requirement will affect their operations.
Perhaps they should be. While the 2019 DSCSA Saleable Returns Verification Requirement is addressed to wholesale distributors, manufacturers have their own product verification requirements—in force since November 2018—that will be put to the test after the 2019 deadline, when wholesalers will start to request verification for an estimated 60 million saleable units every year. With only months to implement a VRS and EPCIS data exchange, manufacturers need to choose a solution that automates verification requests with minimal impact to operational efficiency.
There are wide variances in how manufacturers share product master data with their distributors—if they do at all.
Product master data, particularly the information encoded in the product GTIN, will be critical to routing verification requests to the correct manufacturer and for ensuring that warehouse operations are not slowed by salable returns verification. The Big 3 wholesalers have included product master data as part of their requirements, making it a priority that manufacturers and wholesalers be able to share master data in a consistent, efficient manner.
Among wholesalers, only 25% receive master data in the format they specify, while 38% receive it in whatever format their supplier is able to provide. The remaining companies say they rarely or never receive master data from their suppliers.
Manufacturers vary in how they send master data to their partners, with 22% using a spreadsheet or CSV file, 17% sending it as electronic data, and 28% able to send it in whatever format their partners need. Surprisingly, the largest percentage, 33%, responded that they do not currently provide master data to their distributors at all.
Summary: Saleable Returns Are an Industry-Wide Challenge.
DSCSA spells out product verification requirements for both manufacturers and wholesalers, but has left it to the industry to determine how they will comply with the regulation. As a leader in the Healthcare Distribution Alliance (HDA) Saleable Returns Task Force, TraceLink has recognized the need for an interoperable solution based on industry standards that prepares companies to meet the DSCSA requirements for saleable returns verification in 2019—and all-digital data exchange in 2023.
The webinar series, Solving Saleable Returns: Critical Steps Toward Meeting the Deadline, explores the technical and business decisions that manufacturers and wholesalers need to make to meet the 2019 DSCSA deadline, streamline business processes, and build stronger partner relationships. Learn more about upcoming and on-demand webinars.