2019 GS1 Barcode Assessment Study Results – Pharma Packaging Compliance

It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.

Over the past three years, GS1 and the "Big Three" distributors (AmerisourceBergen, McKesson and Cardinal Health) have conducted a study of pharmaceutical packaging barcodes and their compliance to the new standard. In studies conducted in 2017 and 2018—as the industry was ramping up to DSCSA go-live dates—the barcode assessments were VERY bad.

For example, in 2017, just one year before the mandated compliance deadline, only 15% of products had a 2D barcode on them. And this didn't include evaluating those barcodes for necessary data elements and readability, where many were lacking. 

This year’s GS1 barcode assessment shows incredible progress in the industry. Based on this assessment, well over 70% of pharmaceutical packages meet the full DSCSA requirements, including all the necessary data elements incorporated into the 2D barcode.

This is obviously great improvement over the past three years.

Angela Fernandez, vice president, community engagement, GS1 US, noted, “ The tremendous progress made in the past year underscores how pharmaceutical companies are prioritizing serialization to benefit the entire healthcare system and prepare for DSCSA electronic data exchange requirements by November 27, 2023. The industry has come a long way since 2017, when only 7% of packages carried all the necessary data elements. The number of serialized products found in this year’s assessment is particularly significant considering the supply chain still contains some products that were ‘grandfathered’ and placed into inventory before November 27, 2018.”