Making Waves

One stone tossed into water creates many ripples. Sometimes those ripples reach farther and impact more things than the thrower initially intended or realized. Such is the case when the US Congress passed the Drug Quality and Security Act November 27, 2013. The intent was to protect consumers from counterfeit, stolen, contaminated, or harmful drugs. The reality is that the law affects multiple components of the drug manufacturing and distributing process—including printing, labeling and software. Tablets & Capsules takes a look at those three steps in a series of articles in this issue. 

Time is of the essence, because companies have until November 27, 2023 to fully comply with what the US Food & Drug Administration (FDA) now calls the U.S. Drug Supply Chain Security Act (DSCSA). The core concept driving successful adaptation is the ability for supply chain partners to communicate transaction information “in a secure, interoperable, electronic manner,” according to the FDA guidance. But what does “interoperable” mean here? 

There appear to be three elements: the ability to digitally and securely share transaction information between supply chain partners, confirm and verify that shipments match the data, and trace each product throughout the supply chain. 

The entire process rests upon one underlying assumption: that software and data management systems can effectively take on this burden. One wild card? Artificial Intelligence. “A.I.” has been a buzzword for a few years. But if its implementation can successfully address the issues the DSCSA identified, then A.I. could be a rock—or even a boulder—making waves in supply chain management and drug security.