The next deadline for the Drug Supply Chain Security Act (DSCSA) is November 27, so the clock is ticking for the pharma industry. To meet the DSCSA’s Saleable Returns Verification requirement, wholesale distributors (WDs) must initiate a verification request to verify returned products before reselling them, and manufacturers that receive a verification request must provide a verification response within 24 hours.
Though time is short, there is a solution: The Verification Router Service (VRS). Before we talk about that, let’s quickly see what the new DSCSA Saleable Returns Verification requirement is all about.
What Is the DSCSA Saleable Returns Verification?
Pharmaceutical manufacturers and WDs must constantly deal with saleable products that have been returned. Starting in November 2019, things will change.
The DSCSA Saleable Returns Verification requires WDs to verify the serialized product identifiers on returned products before reselling or restocking them. As we said above, when WDs submit a verification request, manufacturers must provide the verification response within 24 hours.
However, because of projected return volumes, the Big 3 and other WDs need manufacturers to provide verification responses almost instantaneously — at the sub-second level. So, in a few short months, manufacturers and WDs will have to be able to minimize the operational impact of the Saleable Returns Verification by leveraging the VRS.
What Is the Verification Router Service?
The VRS was initiated by the Healthcare Distribution Alliance (HDA) with feedback from the pharma industry. It is an automated service that verifies if a Product Identifier (PI) is valid. A PI has four components: a Global Trade Item Number (GTIN ), a unique serial number, a lot ID, and an expiration date.
There are multiple VRS providers, each responsible for determining if a specific group of PIs is valid. A WD can call any VRS provider to verify if a PI is valid. If a provider does not manage the PI in question, it will automatically route the verification request to the appropriate provider. All of this happens in real time, and VRS ensures that information is accurate and up to date.
Interoperability standards help streamline communication within the VRS network by helping all parties structure data properly and ensure it is error-free. Thanks to VRS, everyone in the pharmaceutical supply chain can exchange data quickly and securely and verify a product’s validity for sale. Ultimately, this will promote the safety of patients and consumers, and ensure the authenticity of products.
[h1]You are correct that the US uses NDC’s but for serialization, most if not all companies convert the NDC into a GTIN. GS1 which defines the standards for a GTIN has a formula on how companies can convert the number. NDC’s is a specific US/FDA implantation. GTIN has become the global standard for communicated serialization data (even in the US).
rfxcel Is Helping Companies Prepare for Deadlines
rfxcel is the industry thought leader in VRS. We extended the testing of VRS and are implementing a pilot program for the U.S. Food and Drug Administration (FDA). 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.
We’re doing this by keeping testing completely transparent. In fact, we’re sharing pilot deliverables with all VRS providers, including WDs, manufacturers, repackagers, national/regional pharmacies, and dispensers. On top of that, rfxcel will collaborate with VRS providers to ensure that test conditions are viable.
Over the course of the last couple of months, we have learned a lot of valuable lessons from testing our VRS to help you meet DSCSA. For more information on how you can be ready for the November deadline, contact us today!