Last week in Washington DC, a coalition of federal and state regulators, manufacturers, wholesalers, and dispensers gathered to conduct interoperable electronic tracing as required under the U.S. Drug Supply Chain Security Act (DSCSA). Mapping the path of a suspect product through the pharmaceutical supply chain, leading representatives from a state regulator, big pharma manufacturer, and health system unmasked a counterfeit package and prevented it from reaching any patients.
Luckily for everyone involved, this was an exercise at Leavitt Partners HQ in Washington, so bad actor Bob Celeste won’t be going to jail just yet! But with full electronic interoperability achieved between real-world stakeholders using different solution providers and the Partnership for DSCSA Governance (PDG) tracing standard supported by Open Credentialing Initiative (OCI) compliant credentials, this is a major milestone as we move through FDA’s DSCSA Stabilization Period.
Thanks to our hosts at the Center for Supply Chain Studies (C4SCS) and PDG, our participants, our partners in this exercise at ConsortiEX and Legisym, and to C4SCS’s Bob Celeste for being our “bad actor!”
