The Drug Supply Chain Security Act (DSCSA) established new FDA requirements for drug traceability. It applied to all prescription medications traded in the USA by November of 2017, although in June of 2017, the FDA delayed implementation of it until November of 2018.
The intent of the regulation is to eliminate the growing problem of counterfeit drugs throughout the supply chain. Under the regulation, drug packagers are required to affix a unique serial number to every saleable package, in the USA usually a bottle or carton, and provide data with those serial numbers when the package is sold to a wholesaler. The DSCSA requires repackagers to implement similar systems as of November 2018. Further requirements on wholesalers and retail pharmacies become effective between now and 2023.
In order to comply with the regulation, drug manufacturers need to install systems on their packaging lines to print a unique serial number onto the package, a bar code reader or camera system to read and inspect the label, and a software system to collect the data so they have a record of the good serial numbers associated with the batch. They also need to be able to provide this data electronically to downstream partners and to be able to respond quickly to queries from downstream partners about the serialization data. And, while initially not required by the law, many manufacturers choose to include aggregation equipment so they have a record of which serialized bottles or cartons went into which bundles and shippers.
Thomas Packaging offers track and trace serialization and aggregation hardware and software from our partners, Lixis and Verifarma, from Argentina. Together these manufacturers provide everything from manual to fully automated track and trace solutions. Thomas Packaging represents both these manufacturers in the USA and can provide a complete serialization solution for your packaging lines.