Louisiana Board comments on digital credentials
The Louisiana Board of Drug and Device Distributors ran a survey about different aspects of DSCSA readiness in August-September 2024 (see also Joanne S. Eglovitch, RAPS & original report). A very timely initiative so close to the end of FDA’s Stabilization Period on November 27, 2024.
As expected, processes
- to identify authorized trading partners (ATP),
- to manage waivers, exceptions and exemptions (WEE), and
- to handle exceptions
are still major headaches given that only a few companies have solved these challenges. The Louisiana Board’s Executive Director, George Lovecchio, suspects that people are still confused about ATP checks and how to do them.
Meanwhile, the Louisiana Board has pro-actively prepared its engagement in the enhanced drug distribution security (EDDS) network in line with PDG’s Blueprint recommendations, including the implementation of OCI-compliant digital credentials for product verification and tracing. This demonstrates the insight that, while there are many other things to sort out, such as EPCIS data exchange, setting up Verification Router Service (VRS) enhanced with digital credentials can run in parallel. Not only that; it can even be useful for exception handling because that’s one reason to use VRS-facilitated Product Identifier (PI) verification.
In addition to the Louisiana Board, manufacturers have also signaled that they believe in the value of digital credentials by becoming early adopters. Current estimates are that about 10% of GTINs (NDCs) registered in the VRS network are covered by OCI-specified ATP Credentials.
The beauty of the OCI-specified approach is its foundation in open standards and thorough testing over the past 3 years. This has enabled an open and ready market across the US pharmaceutical supply chain well in time for the DSCSA enforcement deadline. For trading partners, this means that selecting and switching service providers as well as interacting with trading partners who use other solution providers will be less of a pain because all those providers who follow the OCI standard are seamlessly interoperable, which is, as it happens, a DSCSA requirement too.
