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Review of Information Exchange in the Drug Supply Chain

The drug supply chain is growing increasingly complex, with drugs often passing through numerous companies before ultimately reaching patients. This may make it difficult to track products to their sources in case of a recall and potentially complicate Food and Drug Administrations task of ensuring the integrity of products. We will review drug supply chain trading partners (e.g., wholesale distributors and dispensers) early experiences in exchanging transaction information and transaction history as required by section 202 of the Drug Supply Chain Security Act. Transaction information includes basic information about the drug (the strength and dosage form, the National Drug Code, etc.), and the transaction history includes transaction information for every prior transaction for that drug back to the manufacturer. Together, this information forms the foundation of drug traceability and the security of the drug supply chain. We will interview trading partners about how they have successfully exchanged this information and what, if any, obstacles they have faced.

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Announced or Revised Agency Title ComponentReport Number(s) Expected Issue Date (FY)
November 2016 Food and Drug Administration Review of Information Exchange in the Drug Supply Chain Office of Evaluation and Inspections OEI-05-14-00640; 05-16-00550 2017, 2018