NEWTOWN, PA — June 12, 2023 — The Open Credentialing Initiative (OCI), the leading driver of trusted digital interactions within the U.S. pharmaceutical supply chain, is pleased to announce the release of its DSCSA Interoperability Specification version 3.1. This update expands the credentialing ecosystem to include repackagers and third-party logistics providers (3PLs) under the Drug Supply Chain Security Act (DSCSA).

With this update, OCI’s DSCSA Interoperability Specification for 2023 Compliance includes all major trading partner groups. Now repackagers and 3PLs can join manufacturers, wholesalers, and dispensers in obtaining credentials for verification and tracing activities, unlocking a seamless and secure way for pharmaceutical supply chain stakeholders to interoperate.

OCI is pleased to make this contribution, which has been made possible through the collaborative efforts of its members to address industry requirements . In response to a change request from the Partnership for DSCSA Governance (PDG), a public-private partnership between the industry and FDA, OCI is also working diligently to specify credentials for regulatory authorities, pushing the envelope on interoperability even further.

"Expanding our DSCSA specifications to include repackagers and 3PLs strengthens the integrity of the pharmaceutical supply chain," said Elizabeth Waldorf, Director, Global Traceability and Standards at TraceLink. "We remain committed to advancing an open standard for proving DSCSA Authorized Trading Partner status, avoiding fragmentation in the industry."

“OCI’s update comes at a crucial time, when the VRS community is working together to deliver on a major upgrade to drug verification for November 2023,” said Bob Celeste, founder of the Center for Supply Chain Studies. “With the expansion of a mature and well-tested specification, ATP credentialing is on track to meet industry needs.”

OCI’s DSCSA Interoperability Specification version 3.1 features updates to three of the specification’s core elements:

• Credential Issuer Conformance Criteria. Requirements for OCI-compliant credential issuers, including published standards for ATP and identity validation due diligence.

• Digital Wallet Conformance Criteria. Requirements for OCI-compliant digital wallets, which hold and manage the credentials. Includes API specifications for integration with the Verification Router Service (VRS).

• DSCSA ATP & Identity Credential Schema. An open linked data vocabulary to ensure the standardization of credentials.

The remaining three core elements (VRS Conformance Criteria, Digital Wallet Provider OpenAPI Specification, and Conformance Program) are unaffected, ensuring minimal impact on the VRS community’s ongoing integration and deployment.

To learn more about the OCI DSCSA Interoperability Specification version 3.1.0 and how it supports the pharmaceutical industry, visit oc-i.org or email hello@oc-i.org.

About OCI

The Open Credentialing Initiative (OCI) is a collaborative non-profit industry collaboration formed in April 2021 by a group of trading partners, solution providers, and standards organizations to support the pharmaceutical industry in adopting credentialing and digital wallet technologies to enhance supply chain security, and thus the protection of consumers.

The ecosystem is open to trading partners, solution providers, associations, standards bodies and others interested in contributing to future enhancements of the architecture and use cases.