OCI Releases Complete DSCSA Interoperability Specification for 2023 Compliance
Digital Credential and Wallet Specifications Support Verification and Tracing Requirements for November 27, 2023
WASHINGTON, DC — February 6, 2023 — The Open Credentialing Initiative (OCI), an open initiative enabling trusted digital interactions in the pharmaceutical supply chain, today announced the release of its complete DSCSA Interoperability Specification for 2023 Compliance. This set of specifications, conformance criteria, and resources is the culmination of a two-year effort to support the secured enhanced verification and tracing activities required by the U.S. Drug Supply Chain Security Act (DSCSA).
By November 27, 2023, Authorized Trading Partners (ATPs) in the U.S. pharmaceutical supply chain will be required to exchange product compliance information, including drug verification and tracing data. The members of OCI support the use of W3C-specified Decentralized Identifiers and Verifiable Credentials, GS1 messaging standards and data attributes, and open standards to achieve safe and secure credentialing and information exchange between ATPs for verification, tracing, and recalls.
“We have a decentralized system today, one that has been well-tested over three years and where players can come in and out. The worst thing that can happen is that we’ll end up with 4 or 5 different ways of proving DSCSA Authorized Trading Partner status, because every solution provider would have to support every one of these methods. In the end, we need to agree on one way to do this using an open standard.”
– Oliver Nürnberg, Chief Product Manager SAP Life Sciences, at the DSCSA for Dispensers and Their Trading Partners Conference (November 2022)
“Community pharmacies are familiar with credentialing for payer networks. Most will see the utility of a digital credential that any supply chain trading partner can use to prove they are authorized for a transaction.”
– Lisa Schwartz, PharmD, Senior Director, Professional Affairs, National Community Pharmacists Association (NCPA)
By using OCI-compliant Verifiable Credentials, members of the U.S. pharmaceutical supply chain and their software providers can easily sign and exchange secure credentialed messages. OCI’s ATP Verifiable Credential framework has found strong support from several leading industry organizations on the forefront of DSCSA compliance. These include GS1 US, the Partnership for DSCSA Governance (PDG), and the Healthcare Distribution Alliance (HDA):
GS1 US published ATP credential specifications in its Implementation Guideline for DSCSA Verification of Product Identifiers.
PDG’s Foundational Blueprint for 2023 Interoperability supports the use of OCI’s ATP credentialing framework for verification and tracing activity.
Under the stewardship of HDA, interoperability testing and production preparation with the Verification Router Service (VRS) has been underway.
“As the industry comes together to meet the DSCSA 2023 requirements, interoperability is essential. With more than 60 pharmaceutical supply chain stakeholders and a public-private partnership with the FDA, PDG has been on the forefront of building industry consensus around these requirements. As an open credentialing framework with published DSCSA specifications, we congratulate OCI on the publication of the full DSCSA Interoperability Specification.”
– Eric Marshall, Executive Director at PDG
The OCI DSCSA Interoperability Specification contains six core elements. Together, they represent a fully realized and interoperable framework to meet the ATP requirements under the DSCSA.
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).
VRS Conformance Criteria. Requirements for VRS providers to integrate OCI components and enable trusted interactions between requesters and responders.
DSCSA ATP & Identity Credential Schema. An open linked data vocabulary to ensure the standardization of credentials.
Digital Wallet Provider OpenAPI Specification. An open API for checking and generating verifiable presentations.
Conformance Program. The framework for OCI’s monitoring of participants’ adherence to the conformance criteria.
To learn more about the OCI DSCSA Interoperability Specification for 2023 Compliance and where it fits into the final implementation phase for DSCSA requirements, 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.
