What is DSCSA?

The Law that Changed the Drug Supply Chain for Manufacturers,
Distributors, Repackagers, and Dispensers

The Drug Supply Chain Security Act (DSCSA) was passed by Congress in the fall of 2013. It was signed into law on November 27th, 2013. This law set new requirements administered by the Food and Drug Administration (FDA). 

Lot-based tracing of pharmaceuticals from manufacturer to dispenser became mandatory in 2015. Since 2017, drug manufacturers must apply unique identifiers on all prescription drug packages. Manufacturers, distributors, repackagers, and dispensers can only trade products with these identifiers. See the full "DSCSA Timeline".

Come Nov. 27th, 2023 the US Drug Supply Chain cannot ship products without the exchange of this data. Electronic access to product data will be mandatory for all shipments by all parties.

The DSCSA sets rules for trading partners in the drug supply chain. It started in 2014 and will be fully implemented by 2023. FDA collaborates with partners for effective implementation.

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