The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to improve the safety and security of medication distribution and dispensing in the United States, by keeping illegitimate product out of the supply chain. Its detailed and multi phased implementation is changing the ways 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 2-13 and completes in 2023. To learn more about the DSCSA implementation plan click here.
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 (though FDA has stated that it will not begin to enforce manufacturers’ product identifier requirements until November 27, 2018). The Healthcare Distribution Alliance (HDA) has started an initiative called Origin to create a repository of Global Trade Identity Numbers (GTINs) for all manufacturers and wholesalers to participate. To learn more, read here.