Updates
OCI Celebrates Major Milestone with Independent Audit Results
Drummond Group announces LedgerDomain, Legisym, and Spherity have completed OCI Conformance Program audits
OCI's Response to the FDA’s Request for Progress Reports on the Stabilization Period
OCI is honored to respond to the FDA’s request for progress reports on the Stabilization Period as we collaborate to ensure compliance with DSCSA requirements for secure, interoperable, and electronically traceable products at the package level.
OCI’s DSCSA Interoperability Specification 3.3 Expands Support to Virtual Manufacturers
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).
Who Are You Sharing Information With? DSCSA Enhanced Drug Distribution Security System - A Point of View
PI Verification and Trace records are part of your official record for DSCSA investigations. Traditional authentication and authorization methods through onboarding procedures suffer from vulnerabilities, delays, and interoperability issues. The industry has turned to the promising world of decentralized identity and verifiable credentials to address these shortcomings.
OCI’s DSCSA Interoperability Specification 3.2 Expands Support to DSCSA Authorities and ATP Equivalents
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).
OCI Introduces DSCSA Interoperability Specification Version 3.1 with Expanded Support for Repackagers and 3PLs
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).
OCI members honored by HDA with 2023 Distribution Management Award
OCI congratulates the OCI members and supporters whose tenacious work on a credentialing solution for Drug Supply Chain Security Act (DSCSA) Authorized Trading Partner (ATP) authentication has been honored with the prestigious Distribution Management Award at this year’s HDA Distribution Management Conference and Expo. This year’s award recognizes the achievements of the original ATP pilot participants from the inception of the credentialing idea to its practical implementation and foundation of OCI.
OCI Releases Complete DSCSA Interoperability Specification for 2023 Compliance
OCI’s complete DSCSA Interoperability Specification for 2023 Compliance is a 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).
OCI-Hosted Virtual Conference “DSCSA for Dispensers and their Trading Partners” Charts the Course for Enhanced Drug Distribution Security
OCI in partnership with the NCPA ran a virtual conference on the DSCSA requirements geared towards dispensers and their trading partners. Participants included representatives from FDA, GS1, and PDG. While the full recording series is available on YouTube, here are some quick highlights from each day’s closing panel.
OCI SUPPORTS PDG TRACING EFFORT
OCI strongly supports and encourages the work undertaken by PDG in developing, advancing, and sustaining the effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals as required by the DSCSA.
OCI article published in Pharmaceutical Commerce, June issue
Closing a Key Gap in DSCSA Compliance - An article about the origin, purpose and our work at OCI.
OCI Closes U.S. DSCSA Compliance Gap with an Industry-First
OCI invites pharmaceutical supply chain actors into its Early Adopter Program to trial the industry’s first compliance solution for U.S. DSCSA Authorized Trading Partner authentication. The launch of the program now makes the industry’s first functional, scalable solution widely available enabling U.S. supply chain actors to become DSCSA-compliant well ahead of the deadline.
Open Credentialing Initiative (OCI) Gains Momentum Supporting DSCSA Compliance for Authorized Trading Partners
OCI, a collaborative industry effort, issued a call for the pharmaceutical industry to align on core standards around Authorized Trading Partner (ATP) authentication in compliance with the Drug Supply Chain Security Act (DSCSA). Formed by a group of trading partners, solution providers, and standards organizations, OCI is charting the course for ATP interoperability by 2023.