VRS in the real world: VR-Day №2
- Christiane Wirrig
- 7 days ago
- 3 min read
The article was originally published by Chris Wirrig on Medium.
In early May 2025, the Louisiana Board of Drug and Device Distributors put VRS and digital DSCSA credentials to the test again with their second public interoperable drug verification readiness exercise. Just in time for the impending expiry of FDA's DSCSA exemption for manufacturers and repackagers on May 27, 2025.
The Board and a participating wholesaler made use of their standardised OCI-specified DSCSA Authority and ATP Credentials, respectively. The purpose was to observe the real-time results, compare to the first exercise in November 2024, and learn from the experience jointly with participants and observers.
In total, 73 manufacturers and repackagers received Product Identifier (PI) verification requests; 60 of these had already been included in the November exercise.
The re-run of 171 unique NDCs (GTINs) from the November exercise resulted in 82% VRS responses; 4% more than last year.
Interestingly, one part of the exercise involved re-runs of a real-world retail pharmacy order of 56 packages. Both the Board and the participating wholesaler got the same results — 47 VRS responses (84%) of which 45 were positive. This consistency demonstrates that the VRS network functioned as intended.
Some expired packages returned not verified, which explains a portion of the VRS outcomes classed as No response (i.e. PI check is neither positive nor negative) in the report. This is, indeed, a valid VRS response under the GS1 standard, but not particularly informative for an investigator. A suggestion from the Board to manufacturers is to provide this additional detail, as the Board’s activities may involve auditing or investigating expired products.
It should be noted that the requester GLNs were shared in advance in all runs this time. This would have mitigated undue rejections of requests caused by GLN allow or block listing, which caused a notable decline in VRS responses in the November exercise.
In principle, digital DSCSA credentials make GLN allow and block lists obsolete, as they automate the trading partner check backed by thorough due diligence. This removes the need for the maintenance of permission barriers based on publicly accessible identifiers and allows for uninterrupted VRS exchanges with indirect trading partners or other entities that are unknown, yet legitimate, parties.
As already observed in the last exercise, the digital DSCSA credentials integrated well and did not impede the VRS exchanges. The two OCI-compliant digital wallets, that is the software that handles digital credentials, recognised each other’s digital credentials and processed them as part of the VRS-facilitated PI verifications. Thus, they proved that adherence to a shared open standard enables seamless interoperability between solution providers. This is a foundation stone for free vendor choice in an open market.
Further Reading
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Disclaimer
Since this post touches on legal and regulatory requirements, I’d like to make clear that I’m not qualified to provide legal advice. Nothing stated here should be taken as such.
Why am I writing about this? — Because FDA puts strong emphasis on digitalising the US pharma supply chain, especially through its EDDS guidance. I currently work for a technology solution provider (Spherity) that offers a tool to perform automated electronic ‘Authorized Trading Partner’ checks via Verification Router Services. So, the topic is not only close to my job but also super interesting to think about and watch unfold.
