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Guidance on Tracing Rx Drugs

12/02/2014

Federal Register Notice: FDA is making available a draft guidance for industry: DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information. It addresses the drug supply chain security provisions of the FD&C Act, which requires the HHS Secretary to establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format. It 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. To download this guidance, click here. To view this notice, click here.

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