On August 27, 2025, the Drug Supply Chain Security Act (DSCSA) hit its biggest milestone yet when the US pharmaceutical supply chain officially began to require that every prescription drug product sold have serialized, item-level traceability from manufacturing to dispensing. In other words, data quality has become just as important as drug quality. It’s been a long time coming. The DSCSA was first enacted in 2013 under the Drug Quality and Security Act (DQSA), establishing a 10-year phased implementation timeline, followed by a two-year stabilization period.
While it’s been over a decade in the making, the US pharmaceutical supply chain has achieved something many considered impossible: a seamless transition to comprehensive data-tracking without compromising patient access. Based on the most recent numbers, pharmaceutical distributors report a 98.5 percent accuracy rate in data exchange as of June 2025, validating the years of strategic preparation across the industry.
Having led Cencora's implementation efforts through this transition, I've observed critical factors that separated successful organizations from those still struggling with compliance challenges: robust data management systems capable of handling massive transaction volumes, equipment infrastructure that could scale across distribution networks, and collaborative relationships with partners who understand their invaluable role in the ecosystem.
The difference lies not just in financial investment, but in understanding that DSCSA represents operational transformation, not just compliance obligation.
Building the right infrastructure
The August deadline wasn't just about meeting regulatory requirements; it was about building infrastructure for the next generation of pharmaceutical security. DSCSA success depends on understanding that no single organization controls the entire data chain. Manufacturers, distributors and dispensers each play critical roles, and weakness in any link affects the entire system.
With that, everyone needs to play a part and work together to achieve – and maintain – a smooth operation. This process begins as soon as a prescription product leaves the manufacturer. It involves monitoring data feeds to make sure distributors receive what they need on time, flagging data issues early instead of waiting until shipments reach distribution centers, and conducting thorough quality checks to confirm that labels can be scanned throughout the product’s lifecycle, with barcode data that accurately reflects DSCSA information such as lot numbers and expiration dates.
These operational fundamentals are essential for maintaining the smooth flow of medications through the supply chain. Organizations that have embedded DSCSA requirements into their core operations see consistently better performance than those treating the requirements as an add-on compliance function.
Long-term impact
The infrastructure created for DSCSA compliance extends far beyond regulatory requirements. Building the foundations for unprecedented visibility and traceability throughout pharmaceutical distribution will enable innovations that can only be imagined. The real measure of DSCSA success won't be compliance rates, but evidence that this infrastructure enhances the ability to detect and respond to supply chain threats, improves inventory management, and strengthens access to safe, authentic medications.
The August 27 milestone proved that complex regulatory transformations can succeed when industry participants understand their interdependence and commit to shared success. As we support the remaining implementation phases, the lessons from distributor success provide a clear roadmap for pharmacy partners.
DSCSA is about fully securing the entire healthcare supply chain and safeguarding patient wellbeing. A secure and reliable supply chain is essential to maintaining uninterrupted access to the medications dispensers and their patients need. Ongoing collaboration and industry support will be critical to helping stakeholders meet these obligations.
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