USA – Drugmakers Make Significant Headway in Track-and-Trace Compliance

A new GS1 Healthcare report on the progress made in meeting the serialization requirements of the Drug Supply Chain Security Act (DSCSA) found significant progress, especially in comparison to reports from 2017 and 2018.

Part of the reason for the progress can be attributed to a US Food and Drug Administration (FDA) deadline extension to November 2018 for certain product identifiers.

“Of course, the compliance deadline really drove suppliers’ actions toward serialization,” said Ameer Ali, senior manager at AmerisourceBergen. “We recently started seeing significantly more serialized products in our warehouse distribution network. So, the serialized inventory in the supply chain is steadily increasing as expected, with grandfathered inventory expected to continue to decrease over the next several months.”

Drug wholesalers previously raised concerns that drugmakers would not meet that November deadline.

Background

The DSCSA defines the requirements for how pharmaceuticals are tracked and traced throughout their distribution in the US. As part of the requirements, pharmaceuticals must be marked with a National Drug Code, serial number, lot number and expiration date. In addition, packages (also known as “lowest saleable units”) must be marked with 2D barcodes and homogeneous cases with either a 2D barcode or a linear barcode…