DSCSA 2024 Ten Count: Summary
2024 was a big year for DSCSA. Here is a summary of our 2024 DSCSA Ten Count- the top ten DSCSA moments/stories from 2024. (Click on the links to see the full articles)
Number 1 - Counterfeit Ozempic and the Ongoing Fight for Supply Chain Security
In Ten Count Consulting's 2024 DSCSA reflection, the rise of counterfeit Ozempic emerged as the most impactful story, underscoring the urgent need for supply chain security.
Number 2: State Regulators Are Engaging
State regulators play a pivotal role in successfully implementing the Drug Supply Chain Security Act (DSCSA) by ensuring compliance, enforcement, and industry collaboration to protect the drug supply chain.
Number 3 – FDA Grants Exemption to Connected Trading Partners
In a pivotal move to support the pharmaceutical supply chain, the FDA has granted an exemption to trading partners who are working to establish electronic data connections with their immediate partners under DSCSA.
Number 4 – PDG-FDA-Industry Listening Sessions
The September 2024 FDA-industry listening sessions highlighted both significant progress and ongoing challenges in implementing the DSCSA’s enhanced drug distribution security requirements.
Number 5- Counterfeit Drug Threats in the US Supply Chain
The surge in counterfeit drugs, particularly weight loss medications like Ozempic and Wegovy, highlights the urgent need for the full implementation of the Drug Supply Chain Security Act (DSCSA).
Number 6-Exception Handling Building Resilient Processes
2024 brought a focus on exception handling as trading partners worked to align with the FDA’s stabilization period goals. This blog post explores effective exception-handling strategies rooted in industry guidelines, pilot studies, and collaborative discussions.
Number 7-DSCSA Stabilization Period Midway Checkpoint PDG-FDA Joint Public Meeting
A highlight from the year was the PDG-FDA Joint Public Meeting in June, where over 800 stakeholders convened to evaluate the DSCSA stabilization period. The meeting emphasized collaboration, continuous improvement, and the reality of managing imperfect data through robust, risk-based processes.
Number 8- Two-Year Exemption for Small Dispensers
At number 8, we explore the FDA’s pivotal decision to grant a two-year exemption for small dispensers.
Number 9- FDA 483s
The FDA’s issuance of 483 observations tied to DSCSA requirements marks a pivotal moment for the pharmaceutical supply chain as full compliance with the law becomes mandatory. Now more than ever, trading partners must prioritize robust systems, process optimization, and collaboration to meet regulatory expectations.
Number 10- Decommissioning
One standout story is the National Association of Boards of Pharmacy's (NABP) pilot exploring serial number decommissioning to combat counterfeit drugs. The pilot's findings show that capturing these events is feasible and could have limited past counterfeit incidents.
2024 was a big year for DSCSA and we expect 2025 to be bigger. As the DSCSA journey continues, Ten Count Consulting is here to guide stakeholders toward readiness and interoperability, ensuring a secure and efficient pharmaceutical supply chain.
Connect with us for a free consultation to discuss how your company is finishing strong.
