The Drug Supply Chain Security Act (DSCSA) has transformed the way prescription drugs move through the U.S. supply chain. At the core of this transformation is the Electronic Product Code Information Services (EPCIS)standard, which ensures the interoperable exchange of serialized data at the package level.
But even in a fully digital ecosystem, problems can and do arise.
Continue reading EPCIS Exception Handling: Building a Resilient DSCSA Supply ChainWith the final DSCSA exemption deadline looming in May 2025, pharmaceutical manufacturers must act now to comply with the FDA’s interoperability, serialization, and traceability mandates. Non-compliance isn’t just a regulatory headache—it can cause severe disruptions, including halted product sales, costly recalls, and damaged supply chain relationships.
Continue reading DSCSA Compliance: Essential Steps for ManufacturersThe Drug Supply Chain Security Act (DSCSA) compliance deadlines are fast approaching. Despite the political landscape’s recent shifts, these deadlines remain firmly in place. The regulatory freeze introduced by the Trump administration in January 2025 has generated discussions, but it does not alter these legally mandated timelines. Businesses must continue their preparations to ensure compliance.
The clock is ticking for pharmaceutical manufacturers and repackagers. By May 27, 2025, they must comply with the Drug Supply Chain Security Act (DSCSA) requirements, a crucial step toward achieving transparency, safety, and accountability within the U.S. drug supply chain. This deadline marks a critical step in creating an interoperable electronic system to track and trace prescription drugs throughout their lifecycle. For those in the pharmaceutical supply chain, the time to act is now.
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