More than a decade in the making, DSCSA compliance remains a work-in-progress for many across the pharmaceutical industry. Questions abound and authoritative answers can be hard to find. That’s what DSCSA Hub is all about. A panel of experts from across the industry gathered in one place to provide the vital answers that you need to continue your journey toward DSCSA compliance and beyond.
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The time required to become DSCSA compliant varies based on your current processes, technology readiness, and trading partner connectivity. For most pharmacies, implementation typically takes a few weeks to a few months, depending on system setup, data testing, and staff training. Starting early helps reduce disruption and allows time to resolve issues before full enforcement.
No. Four of six core DSCSA compliance requirements are in effect already. Even with an exemption through November 27, 2026, the FDA expects active, good-faith progress toward compliance with the balance. Waiting until the deadline increases the risk of disrupted trading relationships and compliance failures once enforcement resumes.
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