With so much at stake, we all hope that DSCSA will work. Unfortunately, the current standards and guidelines appear to “build in” potentially “fatal” design flaws. Providentially, the current initiative could clear the path for a system that could work.
Formerly referred to as ePedigree, Title II of the Drug Supply Chain Security Act—DSCSA—is a US federal law whose objectives include the prevention of counterfeit and diverted prescription drugs to improve quality and patient safety. In essence it is a legally mandated effort to create an industry-wide internet-of-things (IoT) platform. Its conception and implementation are well into their second decade. Industry participants are collaborating with government officials to set the standards and guidelines for how the system will work.