Additionally, OCI Adoption at 34% of Manufacturer Sector and One-Third of Wholesaler Sector
NEWTOWN, PA — January 6, 2025 — The Open Credentialing Initiative (OCI), the leading driver of trusted digital interactions within the U.S. pharmaceutical supply chain, marks the start of 2025 with its credential ecosystem encompassing over 10,000 pharmacy locations across the United States, ranging from retail to specialty and inpatient pharmacies, clinics, and hospital systems. Manufacturers representing 34% of the market by value and wholesalers representing one-third of the market by value are also credentialed by OCI solution providers.
The DSCSA requires an electronic, interoperable system to identify, verify, and trace the vast majority of prescription drug products as they are distributed within the United States. OCI’s DSCSA Interoperability Specification creates the foundation for stakeholders to digitally interact with each other, even if they have no prior business relationship and use different solution providers. These DSCSA stakeholders include Authorized Trading Partners (ATPs) as defined by the statute (i.e. manufacturers, repackagers, wholesalers, 3PLs, and dispensers) alongside federal and state authorities and ATP Equivalents.
As an open ecosystem and forum for the creation and maintenance of an open and neutral architecture, guidelines, and trust frameworks, the mission of OCI is to deliver true interoperability among trading partners and solution providers. OCI W3C Verifiable Credentials with NIST level 2 identity proofing allow pharmaceutical supply chain stakeholders to authenticate and authorize across networks including the Verification Router Service (VRS) in compliance with the Partnership for DSCSA Governance (PDG) Blueprint and GS1 standards.
“Secure, electronic interoperability under DSCSA has been years in the making,” said Bob Celeste, Executive Director of OCI. “From the original pilot under the FDA DSCSA Pilot Project Program, to interoperability testing with the entire VRS community, to publishing standards for open review, to delivering on auditability requirements, the OCI specification is the result of thousands of hours of hard work under close industry observation.”
“Internationally recognized standards are the key to delivering interoperability among solution providers, unlocking efficiency and allowing stakeholders to focus on what matters,” said Max Peoples, RPh, pharmacy owner and DSCSA solution provider. “Built on open standards pioneered by the main international standards organization for the web, W3C Verifiable Credentials are formally recognized in the GS1 Lightweight Messaging Standard for DSCSA Verification of Product Identifiers.”
Through the course of 2024 and moving into 2025, supply chain stakeholders have pulled together to deliver secure, electronic interoperability under the law. In addition, the OCI community has marked several key milestones, including expanded support for virtual manufacturers and state regulators, providing an open-source setup for VRS performance testing, and releasing independent audit results. OCI collaborates with industry organizations such as PDG, HDA, and GS1 to ensure that its open specifications meet industry requirements for identity assurance, privacy protection, and interoperability.
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. For more information, including how to join OCI or submit a contribution or change request, reach out at https://www.oc-i.org/contact.
