Understanding DSCSA

The Drug Supply Chain Security Act of 2014 (DSCSA) was enacted to improve the safety and security of Rx distribution and dispensing in the United States by keeping illegitimate product out of the supply chain. Its detailed, phased implementation is changing the way transactions happen, from manufacturers to the wholesale channel, and finally to points of dispensing and patients. There are many incremental steps along the path of full adoption, which began in 2013 and completes in 2023.

The next step is the requirement for manufacturers to apply serial numbers to all packages and send all transaction information exclusively electronically, beginning November 28, 2017; this is where Origin comes in.

The traceability system the DSCSA mandates will require a massive amount of frequent and accurate data exchange. To accomplish this data exchange, the DSCSA and FDA both point to the need for standards that comply with a form & format developed by a widely recognized international standards development organization.

A GTIN repository provides a uniform method for manufacturers to share consistent and accurate product master data with downstream supply chain trading partners and relieves them of the burden of sharing the same data multiple times with multiple trading partners. Manufacturers will submit their GTINs to the central repository which will become a reliable source for the GTIN and important associate product information.