Insights on Supply Chain Risk Management
Criterion Consulting’s expertise helps pharmaceutical supply chain management with exceptions handling and achieving DSCSA compliance.
2025 DSCSA Deadlines Are Approaching — Is Your Team Ready?
With the May 27 deadline for manufacturers behind us, and
final 2025 DSCSA enforcement deadlines rapidly approaching
– August 27 for wholesale distributors, and November 27 for dispensers –
the industry is bracing for impact.
Most of the attention has gone to EPCIS data exchanges, digital credentials, and system readiness. But I want to shift focus for a moment. Let’s talk about process. Because while data matters and systems matter, what’s going to make or break a successful audit (or a drug shortage) is whether your people know what to do when something goes wrong. And right now, based on what the FDA and several state boards of pharmacy have found in recent audits, that “what to do” isn’t always clear.
Read full article here.
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DSCSA Compliance FAQ
Gain clarity on key Drug Supply Chain Security Act (DSCSA) requirements with our free FAQ guide.
Data Quality Issues At The Heart Of FDA's DSCSA Troubles
By Matt Campasano, Criterion Consulting LLC
With the FDA’s newly extended Drug Supply Chain Security Act (DSCSA) deadlines for 2025, pharmaceutical supply chain partners now have additional time to meet compliance requirements — but that doesn’t mean they should delay their implementations. Managing data quality and mitigating exceptions between trading partners remain critical for ensuring smooth compliance with the DSCSA.
Read more of Criterion’s and Matt Campasano’s pharma logistics and supply chain compliance expertise in recent media.