HDA fires warning shot over DSCSA compliance

New data from the Healthcare Distribution Alliance (HDA) in the US has suggested the pharma supply chain still has a long way to go to prepare for medicine traceability requirements due to come into force in November.

In its latest analysis, the trade organisation representing pharma distributors raised concerns about readiness of supply chain partners to share trading information as required by the Drug Supply Chain Security Act (DSCSA) – specifically the serialised transaction data exchange using GS1’s Electronic Product Code Information Services (EPCIS) standard.

First enacted in 2013, the DSCSA is designed to create a controlled, closed prescription drug distribution system to prevent counterfeit, stolen or otherwise illegal medicines from entering the supply chain, locate harmful drugs if they do, and make it easier to pull them from distribution quickly.

From November 27, pharmaceutical manufacturers, wholesale distributors, third-part logistics (3PL) companies and pharmacy dispensers will have to ship, receive and manage serialised medicines, connecting with trading partners via EPCIS to provide track-and-trace and aggregation data.

In its latest readiness survey, which covers the last quarter of 2022, the HDA found that 90 per cent of pharma manufacturers have already adopted EPCIS, but “data quality issues with EPCIS event files threaten to stall the progress toward full DSCSA compliance.”

The work to connect with downstream trading partners was still a work in progress, with 56 per cent of these “in progress” or “completed” up from 51% in the third quarter. For distributors, the tally currently stands at just 33 per cent for small- and medium-sized suppliers.

Manufacturer reported that the main obstacles in establishing connections through EPCIS were onboarding length of time, employee knowledge and information technology-related issues.

The supply chain is moving swiftly toward the final deadline for DSCSA compliance, but the momentum of implementation dwindled in the fourth quarter of 2022, according to the report.

“It is critical for the FDA to communicate how they plan to address the very real potential for product shortages and supply chain disruptions if trading partners are not ready by November 27,” said the trade organisation’s spokesman Perry Fri.

The HDA reiterated its position however that the FDA should not provide an across-the-board enforcement discretion, setting back the effective implementation date for DSCSA traceability, given that it has been 10 years since the law was enacted. Other organisations, notably the American Pharmacists Association (APA) have been seeking a blanket enforcement holiday.

“The hard work of implementation must continue across the supply chain,” said Fri.