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What is traceability DSCSA?

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.

What is the DSCSA definition of a return under the DSCSA?

These are known as \u201csaleable returns.\u201d Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. In other words, every returned drug has to be vetted \u2014 declared as safe and legitimate \u2014 before it can be sold again.

What information does the product identifier contain DSCSA?

The product identifier consists of the National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date. Per the DSCSA, the data carrier is required to be a 2D data matrix barcode when affixed on the product package.

What is DSCSA track and trace?

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.

What is traceability in pharmacy?

GS1 US defines traceability (in healthcare) as the process that \u201cenables you to see the movement of prescription drugs or medical devices across the supply chain. You can trace backwards to identify the history of the transfers and locations of a product, from the point of manufacture onwards.

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