What does serialization mean for you?

Counterfeit medications have been a concern for years. Images of small rooms covered in mold around the world churning out counterfeit pills filled with a mix of everything from ground up bricks to homemade antibiotics have circled the internet. With the passing of the Drug Quality and Security Act (Including both the Compounding Quality Act and the Drug Supply Chain Security Act) into law in 2013, the US government took steps to ensure Americans would be protected from these dangerous fakes.

The DQSA created a requirement for serialization of every medication eligible for sale in the United States by 2017. Eventually settling on the EPCIS data standard, the FDA created a system that allows for both aggregation tracking (unit dose medication into a package into a case into a box into a pallet into a lot) and de-aggregation tracking (a lot into a pallet into a box into a case into a package into unit dose medication). This system ensures that every medication in a pharmacy can be traced directly to the manufacturer that created it.

Serialization on it’s own can be faked though. If someone is willing to grind up bricks and pass them off as medications, they would certainly be willing to create a fraudulent serial number. The DQSA (and the DSCSA) recognized this limitation and called for the creation of a network that would connect pharmacies with the manufacturers and distributors of those medications in order to allow for verification of the serial numbers and the passing of pedigree information to verify authenticity.

The real limitation of the DQSA and DSCSA was that they offered no solution to pharmacies for how to make that system a reality. Finally, in 2022, the FDA decided on the EPCIS data protocols as the basis for data transfers between pharmacies, distributors and manufacturers, paving the way for real software development around the DSCSA.

With that framework, MedTrax began building our system for pharmacies. We connected with the wholesalers and manufacturers and we are excited to begin welcoming pharmacies onto our platform. We know you’ll appreciate the simple layout and little extras that we have put into it for you. The platform is still growing, so we’d love to hear your feedback. Let us know what you’d like to see and we will work to incorporate your ideas into it.

Thanks for choosing MedTrax!