Regulators keep track of DSCSA readiness
FDA visits large pharmacy
Through its public-private Partnership for DSCSA Governance (PDG), FDA has been keeping its ear to the ground to understand the industry’s DSCSA readiness. Of course, there’s also been calls to contribute to their RFI. The most recent exemption exclusively for connected trading partners also demonstrated the agency’s nuanced understanding of the industry situation.
But did you know that FDA actually goes into facilities just to learn? Kevin Capatch shared an interesting story about FDA coming over for a visit at Geisinger’s facility back in 2018 when Connie Jung was still with the agency. As it turns out, Abha Kundi, who has since followed in Connie’s footsteps, was “one of those wide-eyed legal people in the background that day”.
It’s not simply a lovely little story, but a wonderful example of how a pharmaceutical business and the federal agency collaborate to create understanding — seeking to educate and learn fearlessly and with trust.
Ohio Board visits community pharmacy
The Ohio Board of Pharmacy has been working hard to stay on top of DSCSA. Max People’s told OCI that they visited his community pharmacy to learn how things work in real life. It appears that they’re looking to do more of such visits to various pharmacies to get educated and help others catch up. Kudos!
Louisiana Board uses VRS and digital credential
The Louisiana Board of Drug and Device Distributors ran a survey about different aspects of DSCSA readiness in August-September 2024. The Board has also 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. Thus, they can engage in the interoperable electronic network on equal terms with Authorized Trading Partners (ATP). This is leadership by example!
Now the Louisiana Board is taking the bull by the horns and just announced a Verification Router Service (VRS) test run to be conducted on Nov 19, 2024. Essentially, they’ll be sending Product Identifier verification requests to a sample of manufacturers. The purpose is to observe the real-time results and learn from the experience jointly with participants and observers. True interoperability can only be achieved through collaborative effort.
The message is clear
If you have not started your DSCSA preparations, start NOW. If you’ve started, keep going at pace. Remember, the large-scale exemptions granted by FDA are only partial. There are already plenty requirements of DSCSA enforceable now.
In the OCI interview, Kevin Capatch warns,
I don’t think delaying at this moment in time any longer has any advantage to anybody.
Max Peoples echoes,
It’s hard to come down too hard on you if you’re doing something. If you’re leaving your head in the sand, you’re showing no effort, no progress, you’re making it very easy for them to make an example out of you!
