DSCA Serialization Requirement Delayed One Year

On June 30, the FDA announced that it will delay enforcement of the Drug Supply Chain Security Act (DSCSA), more commonly referred to as track and trace. The act requires pharmaceutical manufacturers to include a unique serial number on all prescription drug packages and cases as of November 27, 2017. The FDA delayed enforcement of this provision to November of 2018 to avoid disruption in the drug supply chain. You can read the FDA announcement for further details or download the full Draft Guidance Document.

Serialization Systems From Thomas Packaging

The delay gives drug manufacturers, including CMOs and contract packagers, additional time to implement their track and trace serialization systems. Thomas Packaging offers hardware and software for serialization from our partners Lixis and Verifarma. These two companies are from Argentina, where track and trace was implemented several years ago. They offer full customized, cost effective solutions for serializing pharmaceutical bottle filling and blister packaging lines in a short time frame.