OCI's Response to the FDA’s Request for Progress Reports on the Stabilization Period

The Open Credentialing Initiative (OCI) Steering Committee is writing to thank the Food and Drug Administration (“FDA”) for your ongoing leadership regarding “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.”, Docket Number FDA-2023-N-4806. As we work together toward achieving compliance with the Drug Supply Chain Security Act (“DSCSA”) requirements for secure, interoperable, electronic tracing of products at the package level, we’re honored to respond to the FDA’s request for progress reports on the Stabilization Period.

View the progress report below or on the FDA website.

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OCI’s DSCSA Interoperability Specification 3.3 Expands Support to Virtual Manufacturers