Where does my prescription come from? Has it been altered or
diluted? Can I trust the label? With millions of prescriptions
filled each year, quality control and security across the
pharmaceutical supply chain seems like a herculean task. In an
attempt to slay this proverbial hydra, the Food and Drug
Administration (FDA) developed a new pilot program – the
DSCSA Blockchain Interoperability Pilot (the "Blockchain
Pilot") – which aims to use blockchain to create a
secure electronic, interoperable system that tracks and traces
certain prescription drugs as they are distributed in the United
States.
Background
To address quality control issues within the pharmaceutical
supply chain, Congress enacted the Drug Supply Chain Security Act
(DSCSA) on November 27, 2013. Among other things, the DSCSA
requires FDA to create an electronic, interoperable system to
identify and track prescription drugs distributed within the United
States by 2023.1 In February 2019, FDA
