Six Mistakes Pharmaceutical Companies Make When Implementing Serialization

By Brian Stephens

In June 2017 the FDA announced that they would not enforce the Drug Supply Chain Security Act (DSCSA) until November 2018 in a move to avoid supply disruptions by providing manufacturers with additional time to implement compliant systems. The Agency still maintains the goal of complete serialization of the supply chain to the package level by 2023, meaning that industry should view this short delay of enforcement as a “goodwill gesture” from the FDA and not a sign that they are rethinking implementation of the Act. Because of this, plans for completing serialization of companies’ products should continue moving forward, especially since upgrading or installing a serialization system that brings companies into 100% compliance with DCSCA’s 2023 regulation is much more than just a simple packaging line upgrade. This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project, and proposes a solution to avoid each of these issues.