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Ten Count Consulting reflects on 2024 with our list of top DSCSA moments and stories from 2024.

Number 1-

Counterfeit Ozempic and the Ongoing Fight for Supply Chain Security

In a year filled with significant milestones for the Drug Supply Chain Security Act (DSCSA), one story stands out as the most impactful and urgent: the rise of counterfeit Ozempic in global markets. Katherine Eban's powerful investigative piece in Vanity Fair, "Why Counterfeit Ozempic Is a Global-Growth Industry," uncovers the dangerous proliferation of fake versions of this life-changing medication. This exposé not only sheds light on the vulnerabilities in the pharmaceutical supply chain but also underscores exactly why the DSCSA exists—to protect patients from harmful and counterfeit drugs. This story was so compelling that it earned a spot in Apple News' top 12 most fascinating reads of 2024.

The surge in demand for Ozempic, primarily used to manage type 2 diabetes and increasingly sought after for weight loss, created a perfect storm. Supply shortages further fueled counterfeiters' efforts to introduce fake products into the supply chain. These counterfeit drugs, often containing incorrect dosages or harmful substances, pose serious health risks to unsuspecting patients. The consequences are not merely hypothetical—people's lives are being endangered by these fraudulent products.

This crisis highlights the critical importance of the DSCSA in securing the pharmaceutical supply chain. The DSCSA was designed to prevent, detect, and respond exactly to this type of threat. See our blog post: Can DSCSA Really Keep Patients Safe?. DSCSA requires interoperable exchange of serialized transaction data, ensuring that every product can be traced back to its source. The law mandates that trading partners verify they are authorized, which significantly reduces the chance of counterfeit drugs entering legitimate distribution channels.

Katherine Eban's investigative journalism has long been a catalyst for change in the pharmaceutical industry. Her groundbreaking book, Dangerous Doses, exposed systemic vulnerabilities in the drug supply chain years before the DSCSA was enacted. Her latest work on counterfeit Ozempic is a stark reminder that despite regulatory advancements, threats remain. Eban's continued efforts amplify the need for vigilance and full compliance with DSCSA.

At Ten Count Consulting, we recognize that this story epitomizes why DSCSA compliance is not just a regulatory obligation but a moral imperative. The rise of counterfeit Ozempic is a wake-up call to the industry: every stakeholder must prioritize supply chain security to protect patients. This is why we placed this story at #1 in our Ten Count of the most significant DSCSA moments and stories of 2024. It is a real-world example of how non-compliance and supply chain vulnerabilities can have devastating consequences.

Our mission has always been to support clients in understanding and implementing DSCSA requirements. Stories like this drive home the urgency of that mission. We are committed to helping our clients strengthen their systems to prevent counterfeit drugs from reaching patients.

The fight against counterfeit medications is far from over, but by bringing DSCSA into full operational effectiveness and ongoing industry vigilance, we can make significant strides in protecting public health. Let this story serve as a powerful reminder: compliance matters.

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We hope you have found Ten Count Consulting's DSCSA 2024 Ten Count insightful. Ten Count Consulting has been dedicated to supporting clients with their DSCSA needs since the very beginning of the law. Our deep-rooted expertise and strong industry connections allow us to guide clients through the complexities of compliance. We offer many DSCSA Services and if a client needs a service beyond our offerings, we are well-connected and knowledgeable about trusted DSCSA resources to ensure they receive the best support possible. Our commitment is to be a trusted partner in safeguarding the pharmaceutical supply chain and advancing patient safety. If you would like to connect with us to share more about your DSCSA challenges reach out to Brent (brent.diller@tencountconsulting.com) or Mark (mark.karhoff@tencountconsulting.com) or find a time to connect through our scheduling link.

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DSCSA 2024 Ten Count List:

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

Number 9: FDA 483s Issued for DSCSA Requirements

Number 8: Two-Year Exemption for Small Dispensers

Number 7: DSCSA Stabilization Period Checkpoint PDG-FDA Joint Public Meeting

Number 6: DSCSA Exception Handling: Building Resilient Processes for 2025 and Beyond

Number 5: Counterfeit Drug Threats in the US Supply Chain

Number 4: PDG-FDA-Industry Listening Sessions

Number 3: FDA Grants Exemption to Connected Trading Partners

Number 2: State Regulators are Engaging

Number 1: Counterfeit Ozempic and the Ongoing Fight for Supply Chain Security

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