Drug Serialization — The Key To Protecting Patients In U.S. And International Markets

Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise, according to Ian Parsonage, Senior Director, Global Serialization Services at PCI Pharma Services.

Since late November 2017, pharmaceuticals sold in the U.S. must be marked with a National Drug Code (NDC), a serial number, a lot number, and an expiration date. The requirement, stipulated in 2013’s Drug Quality and Security Act (DQSA) (H.R. 3204), is designed to harmonize existing state-to-state variations in track-and-trace laws.

The idea is to eventually establish a nationwide tracking system to secure supply chains and accelerate the identification of substandard and counterfeit products. Another aim is to provide manufacturers with clear guidelines on how their products should be marked.

How effective the new laws will be remains to be seen, but what is certain is that drug makers that supply multiple countries will soon have another set of market-specific requirements with which to comply.