September 30, 2021 - Open Credentialing Initiative (OCI), a collaborative industry effort, today issued a call for the pharmaceutical industry to align on core standards around Authorized Trading Partner (ATP) authentication in compliance with the Drug Supply Chain Security Act (DSCSA). Formed by a group of trading partners, solution providers, and standards organizations, OCI is charting the course for ATP interoperability by 2023.

The DSCSA mandates the development of an interoperable electronic system to secure the safety of prescription drugs distributed throughout the United States. One such requirement for this system is to confirm that trading partners only engage in transactions with other “authorized” trading partners. This presents a major challenge between ATPs, particularly when no prior direct business relationship exists. To address this challenge, the OCI ecosystem developed an architecture to check the ATP status between trading partners involved in automated verification for saleable returns.

OCI establishes technical governance, specifications, and guidelines to support industry-wide adoption of credentialing on common ground. By utilizing W3C-specified Decentralized Identifiers (DIDs) and Verifiable Credentials (VCs), GS1 messaging standards and data attributes, and open standards, OCI-maintained architecture achieves safe and secure credentialing and information exchange between ATPs. 

”As the November 2023 deadline for DSCSA compliance approaches, the industry is working together like never before,” said Bob Celeste, C4SCS founder. “Identity is the missing piece of the puzzle. OCI’s foundation is a major step forward in advancing interoperability and further securing the US drug supply chain.” said Dave Mason, Novartis Supply Chain Compliance and Serialization.

The OCI was launched after the ATP Credentialing Pilot (initiated in response to FDA’s DSCSA Pilot Project Program) proved technical feasibility using verifiable credentials for DSCSA compliance. The initiators of the ecosystem include Novartis, SAP, rfxcel, Center for Supply Chain Studies (C4SCS), Spherity, and Legisym. Today, further service providers like Tracelink, Navitas, LSPedia, and RxScan; credentialing solution providers like XATP and .MED; and wholesale distributors like Atlantic Biologicals are part of the ecosystem. 

OCI is open to DSCSA trading partners, solution providers, associations, and others who aim to leverage OCI architecture and specifications to support the safety, security, and efficiency of the supply chain. 

ABOUT OCI

OCI is an incubator project of the Center for Supply Chain Studies (C4SCS). In 2020, C4SCS brought together companies representing all U.S. pharmaceutical supply chain segments, solution providers, a key industry association, and a standards body to pilot the use of Decentralized Identifiers and Verifiable Credentials to establish ATP status for trading partners involved in automated verifications for saleable returns.

After the pilot’s successful conclusion in February 2021, OCI was launched to advance the implementation of the piloted architecture.

ABOUT C4SCS

C4SCS is a neutral, nonprofit exploration and educational forum designed to assist the healthcare industry in its mission to improve efficiencies, increase productivity, and streamline compliance with DSCSA.

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