As we turn the calendar to 2025 and continue the journey towards DSCSA being fully operational across the supply chain, Ten Count Consulting reflects on 2024 with our DSCSA 2024 Ten Count. Ten Count Consulting's list of top DSCSA moments and stories from 2024.

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Number 9:

FDA 483s Issued for DSCSA Requirements

While the FDA issued connected trading partners a phased exemption, primarily in regard to the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), other requirements are fully in effect. This serves as a wake-up call for all trading partners—manufacturers, wholesale distributors, dispensers, and third-party logistics providers—to ensure they are fully complying withthe law’s requirements not under exemption.

In case you missed it, our article FDA 483s for DSCSA Requirements Are Happening highlights the growing scrutiny on the industry's adherence to DSCSA mandates. The issuance of 483 observations for non-compliance confirms that the FDA is serious about enforcing the law to safeguard patient safety and ensure a secure pharmaceutical supply chain.

What Are FDA 483s, and Why Do They Matter for DSCSA?
A Form 483, or “Inspectional Observations,” is issued when FDA inspectors identify conditions or practices that may violate regulatory requirements. While receiving a 483 isn’t an automatic enforcement action, it signals that corrective action is needed. For trading partners, this underscores the critical importance of compliance with DSCSA requirements currently in effect.

Key Takeaways from the FDA's Recent Actions

1. Accountability Is Here: For years, the industry has been preparing for DSCSA. The 483’s issued in 2024 were a result of “for cause” visits but we anticipate DSCSA will continue to be worked into regular FDA and state inspections. Now that enforcement is active, gaps in compliance can no longer be overlooked.
2. Systems and Processes Matter: The FDA’s observations reveal that inadequate systems and processes are the primary reasons for 483 citations. Investments in technology, procedures, and process optimization, including documentation and training, are no longer optional—they’re essential.
3. Collaboration Is Critical: DSCSA success depends on the entire supply chain working together to ensure compliance. You should be working with peers, customers, and experienced professionals to understand requirements and the guidance, guides, and solutions that are becoming best practices.

The Industry’s Call to Action
As we reflect, the question is clear: Are you prepared for regulatory scrutiny? DSCSA compliance isn’t just about avoiding penalties; it’s about protecting patients from counterfeit and substandard drugs.

At Ten Count Consulting, we’ve dedicated over a decade to helping trading partners navigate DSCSA compliance. From system evaluations and procedure assessments to training and mock inspections, we’re here to ensure your operations align with regulatory expectations.

Let’s work together to strengthen the supply chain and uphold patient safety. Contact Ten Count Consulting today to learn how we can help your organization achieve and maintain DSCSA compliance.

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The List Revealed So Far:

Number 10: Decommissioning: Can the End of Commerce Serial Number Decommissioning Play a Role in Preventing and Detecting Counterfeit Drugs?

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Stay tuned to our blog over the coming days as we share the remaining 8 highlights of 2024!

Number 8

Number 7

Number 6

Number 5

Number 4

Number 3

Number 2

Number 1

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