Regulatory Focus™ > News Articles > 2019 > 10 > Drugmakers Make Significant Headway in Track-and-Trace Compliance

Drugmakers Make Significant Headway in Track-and-Trace Compliance

Posted 24 October 2019 | By Zachary Brennan 

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.

Results

The progress evaluated in the report comes from a review of products scanned at the three largest US drug wholesalers: AmerisourceBergen, McKesson and Cardinal Health.

AmerisourceBergen scanned 1,545 packages representing 270 manufacturers, and of the specialty products, 71.9% of all packages had a readable 2D barcode with all four DSCSA-required data elements (compared to 20.4% in 2018 and 7.2% in 2017).

Similarly, McKesson scanned 16,314 packages representing 477 manufacturers and of those, 71% had a readable 2D barcode with all four DSCSA-required data elements (compared to 20.8% in 2018 and 6.5% in 2017).

Cardinal Health, meanwhile, scanned 19,444 2D and linear barcodes on 7,996 cases from 177 manufacturers and found 78.7% of cases with 2D barcodes and 73.3% with linear barcodes had all four data elements (compared to 15.1% in 2018).

At both AmerisourceBergen and McKesson distribution centers, the GS1 Healthcare US team scanned more than 3,700 packages to provide an independent audit of the results. And GS1’s team also scanned 4,120 2D and linear barcodes on 1,548 cases at Cardinal Health.

“The results just blew me away,” said Scott Mooney, vice president at McKesson. “Now, we just have to fill the gap to get to 100 percent.”

GS1 Healthcare US and all three wholesalers are also participating in FDA’s pilot project to assess the ability of supply chain members to satisfy the requirements of DSCSA.

“The grandfathering allowance from the FDA was helpful to assure that supply chains remained stocked with inventory, and patients could get the proper medications that they needed, when they needed them. I think that there were far fewer manufacturers selling grandfathered product than might have been expected— given that we also saw such a high percentage of product with the 2D barcode,” said Mooney.

Moving forward, Peter Sturtevant, senior director of GS1 US, told Focus that, "Commencing November 27, 2019, the DSCSA requires pharmaceutical wholesale distributors to verify the serialized product identifiers with the manufacturer or repackager before the product can be placed into inventory for resale...A manufacturer that receives a verification request from a 'requestor' must respond to that request within 24 hours."

And by 27 November 2023, he noted that full traceability will "be required with the ability to track and communicate across the supply chain down to the unique lowest saleable unit. This will enable the capture, verification, and exchange of information between stakeholders." He also explained that many drrugmakers hae selected the Electronic Product Code Information Services (EPCIS) to support their DSCSA data exchange implementation, which enables trading partners to share information about the physical movement and status of products.

2019 Update: Barcode Readability for DSCSA 2023 Interoperability

Updated on 10/25/19 with comment from GS1's Sturtevant.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe