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.

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

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National Association of Boards of Pharmacy® (NABP®) organized a focused, voluntary pilot that explored the facilitation of decommissioning serial numbers as a foundational step in further preventing and detecting counterfeit medicines. The Serial Number Decommissioning Pilot explored how the industry might work together to prevent the growing tactic of counterfeiters that often reuse already-dispensed prescription drug packaging with valid product identifiers, particularly the reuse of valid serial numbers by counterfeiters such as those highlighted in CNBC's Investigates from December 2023 Fraud in a Bottle: Big Pharma Takes on Counterfeit Drugs. (If you haven't watched this you really should! The piece sheds light on some dangerous proliferation of fake pharmaceuticals and their devastating impact on patient safety.)

The NABP pilot engaged key stakeholders from the manufacturing (including manufacturers mentioned in the CNBC story) and select dispensing organizations to determine the feasibility of capturing end-of-commerce events—such as dispensing, damage, destruction, or theft—and translating these into decommissioned serial numbers. This process would prevent counterfeiters from reintroducing fake products with legitimate serial numbers into the supply chain. While decommissioning serial numbers is not currently a regulatory requirement under the DSCSA, it could become a critical step in preventing fake drugs from re-entering the supply chain and jeopardizing patient safety especially in high target areas or products.

Key findings from the pilot include:

• Feasibility of Capturing Events: It is possible to record end-of-commerce events for serial numbers in various product configurations without necessitating a shift to full unit-level tracking for all products.
• Enhanced Detection: Pilot participants indicated that these efforts could have prevented or significantly limited the historical counterfeit events that involved the reuse of valid product identifiers by providing immediate visibility to unfolding threats.

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The intersection of real-world challenges—like those described in the CNBC article—and regulatory solutions underscores why DSCSA compliance matters. For pharmacies, manufacturers, wholesale distributors, and all trading partners adherence to the law is more than a regulatory checkbox; it’s a commitment to patient safety and industry integrity.

As we reflect on the insights from both the CNBC article and NABP's proof-of-concept pilot, it’s clear that collaboration across the supply chain is essential. Let’s work together to ensure that counterfeit drugs never reach patients.

Contact Ten Count Consulting to learn how we can help you navigate DSCSA requirements and protect the health of your customers.

Stay tuned to our blog over the coming days as we share the remaining 9 highlights of 2024!

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Number 9

Number 8

Number 7

Number 6

Number 5

Number 4

Number 3

Number 2

Number 1

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