What to do if Your Organization is not Going to Meet the November 27, 2025 DSCSA Deadline
The DSCSA exemption for large dispensers expires on November 27, 2025. If your organization is not going to meet the deadline, this is what you need to do. Information Gathering In order to complete an FDA WEE application (waiver, exemption, and exception application) you must provide detailed justification for your application. The FDA does not […]
Who is responsible for following DSCSA, and what are they responsible for?
The most significant evolution in the DSCSA framework, now actively being enforced, is the move from lot-level tracing to package-level tracing. For a decade, the industry worked with a system where transaction data was exchanged for large batches (lots) of product. While helpful, a lot can contain hundreds of thousands of individual packages. If a […]
DISPENSERS – DSCSA Demands Your Attention NOW
That November 2025 and 2026 deadline for Drug Supply Chain Security Act (DSCSA) compliance might seem like a comfortable cushion, but if you’re a dispenser—a retail pharmacy, hospital pharmacy, or healthcare entity that dispenses medication—waiting until then to act would be a critical mistake. The reality of the DSCSA isn’t some far-off future event; it’s […]
The Wholesaler Firewall is Up: Product Quarantine is the New DSCSA Reality
For wholesale distributors, a significant, non-negotiable shift occurred on August 27, 2025. The extended period of “enforcement flexibility” officially ended. This isn’t just a regulatory formality; it’s a fundamental, permanent change in how the Drug Supply Chain Security Act (DSCSA) is enforced, particularly regarding how wholesalers receive and handle inventory. The FDA’s signal is clear: […]
Unpacking the Drug Supply Chain Security Act (DSCSA)
In an increasingly complex and globalized world, ensuring the safety and security of our prescription drug supply chain has never been more critical. The stakes are profoundly high: patient health, public trust, and the integrity of the healthcare system itself. Enter the Drug Supply Chain Security Act (DSCSA) – a landmark piece of federal legislation […]