GS1 standards and US regulations for drug suppliers

The Drug Quality and Security Act (DQSA) went into effect on 27 November 2013 and outlines critical steps to build an electronic, interoperable system for the identification and traceability of prescription drugs as they are distributed in the US.

The new law replaces all state-level requirements. The requirements are phased in over a 10-year period by providing a migration path from batch traceability to serialisation to item-level traceability.

The new system allows for verification of the legitimacy of the drug identification down to the package level, improves detection and reporting of illegal products in the drug supply chain and facilitates more efficient recalls.

European legislation

Discover how to use GS1 standards to comply with the Falsified Medicines Directive

Regulations in the United Kingdom

Find out what NHS regulations you need to take into account if you operate in the UK market.