Understanding DSCSA

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 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 to 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 27, 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 the industry to use standards that comply with a form & format developed by a widely recognized international standards development organization. Many in the pharmaceutical industry are supporting standards developed by GS1, including using EPCIS for the data exchange the DSCSA requires. In turn, GS1’s EPCIS Standards will require assignment of GTINs to each of a manufacturer’s products, at each level of packaging.

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.