OCI SUPPORTS PDG TRACING EFFORT

The Open Credentialing Initiative (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. We congratulate PDG on their recent advances in driving traceability to secure the drug supply chain, and stand ready to support with interoperable open standards.

Under the DSCSA, Authorized Trading Partners in the U.S. pharmaceutical supply chain are required to have systems and processes in place to:

“promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer… in the event of a request by the Secretary (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official).”

Over the past two years, the PDG tracing working group has collaboratively developed a model for exchanging tracing requests and responses, including a draft JSON-based tracing schema. A key element of this schema is the inclusion of an ATP Verifiable Presentation (VP). This enables senders and recipients of tracing messages to be assured that they are interoperating with a duly authorized trading partner, allowing ATPs to meet their compliance goals.

OCI has published protocols on the generation and exchange of VPs which address the VP inclusion requirement. As a collaborative, non-profit initiative formed by a group of trading partners, solution providers, and standards organizations, we look forward to PDG’s ongoing advancement of tracing. We are committed to supporting the industry with globally recognized and collaboratively developed standards, including National Institute of Standards and Technology (NIST) guidelines, W3C verifiable credential standards, the GS1 Lightweight Messaging Standard, and now the draft PDG tracing schema.