National Distribution & Contracting, Inc. (NDC) stands as a testament to the evolving complexities of supply chain management and regulatory adherence, particularly within the pharmaceutical sector. Mike Price, Operations Manager at NDC, recently illuminated the company's journey towards compliance with the Drug Supply Chain Security Act (DSCSA) during LSPedia's 4/9/24 webinar.
Established in 1953, NDC began as a coalition of 10 to 12 vendors creating a shared catalog, blossoming into a master distributor within the medical, dental, and physical therapy sectors in the U.S. and Canada. Price describes NDC as "a niche business" with over 400 vendors contributing to a robust supply chain. He candidly admits, "I'm a realist of the world," acknowledging the complexity and ongoing challenges faced by the company.
NDC's approach to the DSCSA is methodical, employing a phased strategy to transition inventory management practices in compliance with FDA's DSCSA guidelines. This approach is critical as Price reflects, "there was hundreds of thousands of dollars on the books that inevitably, had the law not changed, we were going to have to throw away." The company uses LSPedia's OneScan suite and Investigator Platform in Phase One to monitor and manage suppliers' EPCIS onboarding, data quality, and exceptions handling performance, thus ensuring a smooth transition without jeopardizing product flow or compliance standards.
The organization’s dedication to meeting the DSCSA enforcement deadline is unwavering. Price asserts, "At NDC, we will meet the Nov. 2024 deadline with a mature operational process." This reflects a commitment to regulatory compliance that is both rigorous and adaptive. In fact, NDC's preparedness for the deadline is such that regardless of whether Congress puts pressure on the FDA to extend the enforcement date, NDC’s process will remain unaffected.
The integration of LSPedia's OneScan solution and the Investigator Platform have been pivotal to navigating the DSCSA’s intricate requirements. The tool allows NDC to effectively manage serialized shipping and EPCIS data exchange with suppliers, which is crucial given Price’s statement; "We're using the investigator in to monitor suppliers. For suppliers with poor EPCIS data quality, we're proactively reviewing the data and then managing the exceptions."
NDC’s calculated and proactive stance, underpinned by LSPedia’s OneScan solution, demonstrates a forward-thinking approach to regulatory compliance. Price's practical acknowledgment of the hurdles - "So first of all, now I would love to tell the team that we have an all buttoned up and now that's not true "- encapsulates the company's realistic yet determined strategy to transform its supply chain operations in alignment with the impending DSCSA enforcement deadline. NDC's commitment to excellence serves as an instructive model for industry peers navigating similar regulatory landscapes.
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