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Drug Traceability Test

Potentially dangerous drugs, including diverted, counterfeit, and imported unapproved drugs, can enter the supply chain and pose a threat to public health and safety. The Drug Supply Chain Security Act (DSCSA) provides the Food and Drug Administration (FDA) and others with new tools to prevent the introduction of harmful drugs into the supply chain and to identify and remove them. DSCSA requires trading partners to exchange drug product tracing information when they take ownership of drugs, resulting in a tracing record that FDA and others can use to investigate suspect and illegitimate drugs. Ensuring that DSCSA's drug product tracing requirements function as intended will help FDA to respond effectively to potentially harmful drugs in the supply chain. We will determine the extent to which selected drugs can be traced from the dispenser back to the manufacturer. This study - part of OIG's body of work in this area - builds on our previous examinations of trading partners' early experiences exchanging drug product tracing information by testing the accuracy of those tracing records.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
October 2017 Food and Drug Administration Drug Traceability Test Office of Evaluation and Inspections OEI-05-17-00460 2019

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201