Drug Serialization

Drug manufacturers had until the end of November 2018 to serialize and affix new 2D data matrix barcodes. There must be a machine, and human, readable label on all DSCSA covered prescription drug products manufactured for the US market.   

Resalable Returns in 2019

The 2019 DSCSA Serialized Return requirement will require that drug, wholesalers can only resell a salable return if the drug product can be verified as authentic by the drug manufacturer.  

DSCSA Excluded products do not need serialized barcodes. Sell-through of the existing non-serialized products will be, “Grandfathered” into the supply chain after the November 2018 requirement.  We should still expect to see non-serialized drug product within the pharmacy until roughly 2020, due to drug expiration dates and product dispensing velocity. Products may also be waivered or exempt from serialization. If you are unsure of the correctness of the label please contact your manufacturer.