OCI’s DSCSA Interoperability Specification 3.3 Expands Support to Virtual Manufacturers
NEWTOWN, PA — November 16, 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 3.3. This latest update incorporates support for virtual manufacturers to obtain credentials for the purposes of verification, tracing, and other activities 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. To this end, OCI’s DSCSA Interoperability Specification for 2023 Compliance 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.
Within this ecosystem, virtual manufacturers are not only a vital element in the supply chain, but also play a unique role. By developing and marketing prescription drug products while outsourcing manufacturing and distribution operations, virtual manufacturers typically do not take physical possession of their products.
Version 3.3.0 of OCI’s DSCSA Interoperability Specification empowers virtual manufacturers to readily obtain credentials, along with a wealth of other updates to three of the specification’s core elements:
Credential Issuer Conformance Criteria. Requirements for OCI-compliant credential issuers. Changes include published standards for virtual manufacturer status and identity, and refinements to expiration and monitoring.
Digital Wallet Conformance Criteria. Requirements for OCI-compliant digital wallets, which hold and manage the credentials. Changes include refinements to revocation caching, key management, system response times, clarification on DIDcomm rollout, and more.
Conformance Program. The framework for OCI’s monitoring of participants’ adherence to the conformance criteria. Added VRS self-attestation reference and clarification on DIDcomm rollout.
For further information about how the OCI DSCSA Interoperability Specification version 3.3.0 supports the evolving needs of the pharmaceutical industry and maintains supply chain integrity, please visit oc-i.org or contact us at 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.
