New effort to standardize DSCSA identities gathers momentum

A key concept of the 2013 Drug Supply Chain Security Act (DSCSA) is the Authorized Trading Partner (ATP)—an understanding that drugs are purchased directly from the manufacturer, and sold to a known entity; subsequent transactions should also be recognized by both buyer and seller. How to verify ATPs is not defined by the law or by FDA. But now, solutions based broadly or specifically on blockchain technology are being proposed.

Thus, rfxcel, a provider of serialization software for DSCSA compliance, has recently joined the Open Credentialing Initiative (OCI) by implementing software from a German company, Spherity, which created a “digital wallet” into which identity credentials are contained. The credentials can be provided by another OCI participant, Legisym, a US company that has a track record in organizing information for controlled substances documentation. Other participants in an OCI pilot that was conducted over the past year are SAP (providers of DSCSA compliance software known as ATTP), AmerisourceBergen, Bristol Myers Squibb, Johnson & Johnson and Novartis. The Healthcare Distribution Alliance served a coordinating role.

“Although rfxcel continues to evaluate other ATP solutions, this is the most mature and comprehensive in the industry,” said rfxcel Vice President of Marketing and Strategic Initiatives Herb Wong, in a statement.

Digitizing ATP verification is “just the tip of the iceberg,” said Georg Jürgens, Spherity’s manager of industry solutions. “We envision that trading partners won’t have to manually verify their new business partners’ process and can leverage ATP credentials in other ways, such as order-to-cash or drop shipment processes.”

OCI has a life beyond the pilot program: the Center for Supply Chain Studies, a collaborative group, is the informal locus of activity for now. Bob Celeste, Center founder, tells Pharmaceutical Commerce that the Center will serve as an incubator for bringing in other participants and helping establish standards.

“OCI is a significant step forward and will open up other interesting applications, such as master data management for pharmaceuticals,” he says. Ultimately, some governing board will be established if sufficient industry interest is demonstrated.

3/31 update: More information about OCI has just come out from the Healthcare Distribution Alliance, which posted a news release about its involvement in the ATP Pilot project. Additionally, the Center for Supply Chain Studies, which is hosting an incubator to continue development of the effort, notes that software vendors Adents, Antares Vision (parent of rfxcel), Axway, Navitas, RxScan, Systech and TraceLink are "intended" participants.