The National Coalition for Drug Quality & Security (NCDQS) has issued an open letter to the North Dakota Board of Pharmacy, calling for fairness and choice in the state’s drug distributor accreditation process. Our request stems from a deep commitment to ensuring safety and integrity within the pharmaceutical supply chain while promoting competition and reducing unnecessary burdens on businesses.
Please find a copy of the letter here:
In the letter, we respectfully request the Board to recognize NCDQS’s Quality and Security (QAS) Accreditation Program as an additional pathway for wholesale distributor accreditation in North Dakota. For over five years, we’ve demonstrated our commitment to rigorous standards through 400+ inspections and the accreditation of 20+ facilities, providing a robust, transparent, and efficient alternative to existing options.
North Dakota has long championed patient choice and the success of independent businesses. By approving NCDQS as an additional accreditation provider, the Board has an opportunity to uphold these values while addressing inefficiencies and high costs associated with a single accreditation pathway.
Supporting Documentation
As part of this process, NCDQS has included supporting evidence in its submission to the North Dakota Board of Pharmacy. The documentation highlights the broader industry's challenges and concerns with existing accreditation frameworks and showcases the value and reliability of NCDQS accreditation. Key points include:
Public Comments from Iowa: Documented frustration with existing accreditation pathways, including concerns about delays, lack of transparency, and burdens on independent distributors. Stakeholders expressed strong support for alternatives like NCDQS.
Industry Feedback: Testimonials from accredited facilities and stakeholders attest to the thoroughness, fairness, and timeliness of NCDQS’s accreditation process.
Accreditation Standards Comparison: NCDQS's Inspections include thorough reviews of facility operations, security measures, compliance with the Drug Supply Chain Security Act (DSCSA), and policies to identify and prevent the distribution of suspect products. In many respects, NCDQS goes even further by offering a collaborative and educational approach that helps distributors improve their compliance practices, particularly for smaller, independent businesses without large compliance departments.
Performance Data: As of January 2024, NABP's reaccreditation process left 14% of facilities with expired accreditations under "Reaccreditation in Process." This highlights the need for additional accreditor options to avoid service interruptions.
Cost Analysis: NABP Expedited Accreditation and Inspection programs cost up to $47,000, compared to $15,500 for NCDQS’s Expedited Accreditation, demonstrating a significant financial advantage for distributors.
Accreditation Capabilities: Unlike NABP, NCDQS accredits medical gas distributors, filling a regulatory gap in the pharmaceutical supply chain.
Looking Ahead
This is an important step toward ensuring the state remains at the forefront of innovation, independence, and safety in pharmaceutical regulation. We look forward to engaging with the Board and other stakeholders as we work to build a stronger, more equitable accreditation framework for North Dakota.
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