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Column: Improving DSCSA Data Exchange Accuracy During the FDA’s Phased Exemption Periods

As the first exemption period has come to an end, the Healthcare Distribution Alliance and its members, have seen significant improvements in trading partner serialized transaction data exchange.

For distributors, technical troubleshooting for inadequate bar codes and label quality remains challenging to resolve and onboarding new manufacturers can be difficult because it is time-consuming and highly technical.
For distributors, technical troubleshooting for inadequate bar codes and label quality remains challenging to resolve and onboarding new manufacturers can be difficult because it is time-consuming and highly technical.
Getty images, Diego Antonio Maravilla Ruano

On May 27, manufacturers were the first group of trading partners to reach the end of the Food and Drug Administration’s (FDA) phased exemption periods[1] for Drug Supply Chain Security Act (DSCSA) implementation. This was a monumental milestone for the pharmaceutical industry, marking a significant achievement after over a decade of work and investment to implement and ensure further security of the supply chain.

As the first exemption period has come to an end, the Healthcare Distribution Alliance (HDA) and its members, who are longstanding leaders in this space, have seen significant improvements in trading partner serialized transaction data exchange and the accuracy of such data each month. In anticipation of final DSCSA implementation, our organization and members have collected survey information on the industry’s progress. According to our most recent survey, distributor members report receiving over 93% of purchase order lines with accurate data from manufacturers.

While this information is positive, given our unique vantage point at the center of the healthcare supply chain, HDA and our distributor members have identified lingering challenges in improving data accuracy. We have also identified strategies to improve such accuracy as we move toward the distributor exemption deadline on August 27, 2025, and the dispenser exemption deadline on November 27, 2025.

Lingering Challenges and Strategies for Improving Data Exchange Accuracy

While progress has been made, challenges persist for the healthcare supply chain. For example, members report that some data remains incomplete or inaccurate, while some data may not come in from a trading partner at all. In other instances, members report that some trading partners do not consistently deliver data at or before delivery, which is essential for timely receipt and stocking. When data does come through, some manufacturers are lagging in their responses to data exception reports, and are slow to send corrections, or may not respond at all.

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