OCI’s DSCSA Interoperability Specification 3.2 Expands Support to DSCSA Authorities and ATP Equivalents
NEWTOWN, PA — August 1, 2023 — The Open Credentialing Initiative (OCI), the leading driver of trusted digital interactions within the U.S. pharmaceutical supply chain, is pleased to publish its DSCSA Interoperability Specification version 3.2. This update expands the credentialing ecosystem to include federal and state authorities as well as trading partners that are not required to register with FDA or obtain state licenses under the Drug Supply Chain Security Act (DSCSA).
The DSCSA requires an electronic, interoperable system to identify and trace the vast majority of prescription drug products as they are distributed within the United States. OCI’s DSCSA Interoperability Specification for 2023 Compliance enables all Authorized Trading Partners (ATPs) defined by the statute – manufacturers, repackagers, wholesalers, 3PLs, and dispensers – to obtain credentials for verification and tracing activities.
In response to a change request from the Partnership for DSCSA Governance (PDG), a public-private partnership between the industry and FDA, Version 3.2 expands the specification to include DSCSA Authorities and ATP-Equivalents. Examples of these include:
Authorities: FDA, State Licensing Authorities (ex: State Boards of Pharmacy), and DEA
ATP Equivalents: The Veterans Administration, The Department of Defense, Federal Prisons, The Bureau of Indian Affairs, Administration for Strategic Preparedness and Response (ASPR)/Strategic National Stockpile, and Tribal-operated dispensers
These stakeholder groups can now obtain credentials to digitally interoperate with the ATP community. The most recent list of supported organizations can be found in chapter 6 of the PDG Blueprint.
“State and federal regulators play a critical role in keeping the supply chain safe, and interoperability with DSCSA-exempt trading partners helps ensure fast and effective delivery of care,” said Elizabeth Waldorf, Director, Global Traceability and Standards at TraceLink. "Open standards for proving DSCSA status not only avoid fragmentation – they make the supply chain safer for everyone.”
“The DSCSA community has made huge progress on verification and trace over the last few months, with the successful deployment of GS1 Lightweight Verification Messaging Standard R1.3 on the VRS solutions and tracing pilots shining a light on what’s needed to deliver 2023 interoperability,” said Bob Celeste, founder of the Center for Supply Chain Studies. “Openly published vendor-neutral credentials are what make true interoperability possible.”
OCI’s DSCSA Interoperability Specification version 3.2 features updates to three of the specification’s core elements:
Credential Issuer Conformance Criteria. Requirements for OCI-compliant credential issuers, including published standards for Authority and ATP Equivalent status and identity.
Digital Wallet Conformance Criteria. Requirements for OCI-compliant digital wallets, which hold and manage the credentials. Ensures interoperable exchange of credentials and integrations with networks such as VRS.
DSCSA ATP & Identity Credential Schema. Two new open linked data vocabularies 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 deployment.
To learn more about the OCI DSCSA Interoperability Specification version 3.2.0 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.
