Serialization…Interoperability…EDDS…EPCIS

What do they all mean for pharmacy compliance?

Enacted in 2013, the Drug Supply Chain Security Act (DSCSA) outlines steps to provide an electronic, interoperable system to identify, track, and trace prescription drugs as they are distributed within the U.S. Pharmaceutical Drug Supply Chain with the goal of protecting consumers. The law was broken into phases beginning in 2015 with the final phase set to be enacted later this year.

Many terms have been used for this final phase: interoperability, serialization, enhanced drug distribution security, EDDS, EPCIS. All the different verbiage, when used individually means something different, however, taken in context with November 27, 2023, they all mean the same thing. An end-to-end electronic system that can track a single serialized drug from its manufacturer all the way to the dispenser and back. This system uses specific data protocol called EPCIS – electronic product code information services. The EPCIS data travels from point to point through a closed electronic system. Everyone in the supply chain has their own electronic system, interoperability allows all of these systems to communicate with each other so the data can be traced. Serialization occurred in 2018 when all products were required to have a serial number in addition to the lot, NDC, and expiration, however, the data was not required to transmit the serial number. When November 27, 2023, rolls around, this serial number will be included on all the individual products and the associated data. This will provide an excellent way for the United States to secure the drug supply chain, in addition to enhanced inventory visualization for pharmacies throughout the country. 

Bottomline: Pharmacies need to prepare to have an electronic means of receiving, storing, verifying, and sending this serialized data well before the November 2023 deadline.