Rx-360 Summary of FDA’s Draft Guidance for Industry DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs

The guidance “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information’’ addresses the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which requires the Secretary of the Department of Health and Human Services to establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format.

Specifically, the guidance establishes standards for how transaction information, transaction history, and transaction statements should be exchanged among trading partners through the extension and/or use of current systems and processes.

Under section 582(h)(4) of the FD&C Act, FDA intends to eventually "update...as necessary and appropriate, and finalize" this document to reflect standards for interoperable data exchange at the package level. Because the Drug Supply Chain Security Act (DSCSA) clearly intends for stakeholders to rely on this draft guidance before finalization, FDA is immediately implementing this document, and it is intended to provide additional guidance as stakeholders implement the requirements in the DSCSA.

To view or download the FDA Draft Guidance, click here

To view or download the Rx-360 Summary of the Draft Guidance, click here