Beginning on November 27, 2023, the Food and Drug Administration (FDA) will require wholesalers to verify key identifiers of saleable returns of prescription drugs. This requirement is part of the Drug Supply Chain Security Act (DSCSA), and one of the primary methods to being used to fulfill this verification requirement is Verification Routing Service (VRS).
What is Verification Routing Service?
In short, VRS provides a service where relevant product information is exchanged between the manufacturer and the wholesaler to authenticate key identifiers.
The DSCSA verification requirement provides verification on the authenticity of the pharmaceutical product. This step provides another level of security in the supply chain and will hopefully enhance traceability and decrease potential product tampering or counterfeiting.
When VRS is used in conjunction with a return authorization request, this provides information to the requestor so that they can make a decision to accept or reject the return request. The verification of authenticity also ensures a safer supply chain.
It’s estimated that approximately 2-4 % of prescription drugs on the market are saleable returns. VRS will allow these units to be resold in a timely and secure manner while maintaining DSCSA traceability requirements.
Verification Routing Service Process Overview
The VRS system requires some key identifiers to be scannable on the product label, including Global Identifier, the lot number, and serial number. It’s assumed that these key identifiers, including the serial number, are encoded on the packaging in an electronic readable format, such as a 2D barcode. It’s important to note that VRS capability builds on previous requirements of the DSCSA, such as serialization and track and trace.
Broadly, the VRS process consists of the following steps:
- A saleable return is received by the wholesaler
- The wholesaler then scans the serialized product
- The key identifiers are automatically checked against the manufacturers data
In the event that a false response is received by the VRS system, possibly caused by a system error or the key identifiers not matching the manufacturer’s data, a few steps must be taken. The product would be quarantined and a notification to the manufacturer would occur. The manufacturer may have to investigate to ensure that there hasn’t been a systems error or an occurrence of product tampering. Documented procedures should be in place to handle such an event.
Considerations for Verification Routing Service
It’s recommended that the implementation of a verification system, such as VRS, be complete by November 2022 to allow sufficient time for the systems to become standard practice before the verification requirement from the FDA goes into effect.
Many wholesalers and manufacturers have implemented or have begun implementing VRS systems in anticipation of the 2023 requirement. This verification requirement has been pushed back from the original 2020 date, and the VRS systems available have matured in this time. This has also given companies time to ensure they have adequate data integration to support tools like VRS.
When implementing a VRS system or beginning work with a new trading partner, it’s important to align on your trading partner’s expectations and capabilities. Have they worked with a VRS system in the past? If so, what tools are they using?
Other requirements to use a VRS system include any hardware that is necessary to read the 2D barcode. If these aren’t present in warehouses, then they’ll need to be implemented, and training will need to occur for the required individuals. Additionally, time needs to be spent to prepare the work instructions and procedures to be in place, as well as getting everyone trained.
With proper implementation and communication between wholesalers and manufacturers, VRS can be a streamlined solution. Ultimately, VRS can be an effective way to fulfill the verification requirement and contribute to a secure supply chain.
If you need help to implement, proceduralize, and/or validate your VRS solution, our team of serialization and traceability experts at Clarkston is ready to assist you.
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Contributions from Nicole Sharp