Pharmaceutical Serialization Extended Mandate Is Now: Is Your Data Management System Ready?

By Nicolas Girard, Ropack Pharma Solutions and Graham Clark, TraceLink

Last year the US Food and Drug Administration (FDA) announced its intent to not take action against pharmaceutical companies and CMOs not meeting the requirements of the Drug Supply Chain Security Act (DSCSA) at the deadline of November 2017. The FDA extended the enforcement date until November 2018, and that date is upon us. The extension can be interpreted as the FDA’s acknowledgement that the industry may have underestimated the amount of time and resources required to be serialization ready.