A DSCSA Checklist — Are You Ready?

Substandard and counterfeit drugs are a major worldwide problem, with up to one in 10 medical products in developing countries being falsified. North America is also heavily affected, with over one-fifth of all reported cases of counterfeit drugs occurring in the region according to the World Health Organization. This is likely only a small fraction of the real problem, as many cases go unreported.

To address the growing problem of substandard and counterfeit drugs, the U.S. signed the Drug Quality and Security Act (DQSA) into law in November 2013, which calls for the serialization of prescription drugs. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build a digital system to track and trace prescription drugs distributed in the U.S. By implementing product serialization, prescription drugs can be more easily tracked with a comprehensive system throughout the entire supply chain.