Pharma making big progress on DSCSA compliance; report

Around 87 per cent of medicine packs scanned by the ‘big three’ pharmaceutical distributors in the US contain readable codes that comply with Drug Supply Chain Security Act (DSCSA) requirements, according to a new report.

The annual update from AmerisourceBergen, McKesson and Cardinal Health – in association with barcode standards company GS1 – looked at the proportion of packs and cases bearing the four DSCSA application identifiers: the Global Trade Identification Number (GTIN) including a National Drug Code (NDC), serial number, lot number and expiration date.

The 19 per cent increase over 2019 in proper barcoding on packages is another indication that the pharma industry is well placed to meet the deadline for full DSCSA interoperability in 2023, according to GS1.

Case level readability rose from just under 79 per cent to 93 per cent, which was an 18 per cent improvement on 20189, according to the report, which was based on more than 21,000 package scans.

Knock off the knock offs: The Importance of Changing Security Features

2020 was shaping up to be a critical year for DSCSA compliance because of the November deadline for saleable returns verification, which requires wholesalers and distributors to verify the serialised unique identifiers of returned products before they can be placed into inventory for resale, but as it turned out the FDA set back the enforcement of that until 2023.

“Even with all the issues worked through to date, barcode assessments are just a snapshot of industry adoption and compliance with the DSCSA and will always be an ongoing process,” says the report.

“New products coming onto the market, new packaging developed for existing products, third party manufacturers being contracted by pharmaceutical companies all present the potential for tweaks to serialization.”