To evaluate entities in the pharmaceutical supply chain for compliance with Federal and State regulations and industry best practices.
At the National Coalition for Drug Quality & Security (NCDQS), our accreditation programs evaluate wholesale drug distributors for compliance with state and federal regulations and industry best practices to maintain the quality and security of drug products. We understand the pressures involved in running a business and the needs of the industry; the importance of protecting the public from drug products that may be ineffective or dangerous due to compromised integrity or counterfeiting; and the need for a thorough and efficient process to evaluate a facility for regulatory compliance and compliance to our accreditation standards.
Time to Accreditation
We are able to grant Accreditation in 90-days due to our innovative approach. Facilities that have not achieved accreditation will be given detailed information regarding the areas of non-compliance so that they may remediate any issues identified within their operation.
Conflict of Interest
NCDQS takes an educational approach rather than a punitive approach in working with companies through the Accreditation process. Staff and contracted surveyors/reviewers are carefully selected to prevent potential conflicts of interest. And, NCDQS does not provide paid consulting services as we believe it is a conflict of interest, and may be perceived as a requirement for accreditation.
Experienced Surveyors & Inspectors
QAS Accreditation Surveyors are either licensed pharmacists or have at least 10 years of experience specifically in wholesale drug distribution (experience may be derived from a regulatory agency or from industry). We also provide an Inspection program – our inspections are only performed by licensed pharmacists.
The industry is rapidly changing as technology becomes more advanced, new regulations are implemented and business practices evolve. Wholesale distributors are also innovative in improving the quality and efficiency of their operations. It is important that our accreditation standards remain up to date. Our standards are continuously reviewed and updated to keep pace with regulatory changes and industry best practices as well as to address emerging issues in the security and integrity of prescription and OTC products in the supply chain.
NCDQS QAS accreditation programs evaluate whether applicants are compliant with regulations and implement best practices by reviewing the business and operations, key personnel backgrounds, licensure/registrations, business-critical SOPs for compliance to regulations and to our accreditation standards, and an on-site survey to assess facility security and environmental conditions for compliance to the facility SOPs.
Leadership & Advisory Board
Denise Frank RPh, Director of Accreditation and Inspection Services, is a pharmacist and an independent consultant with extensive experience in pharmacy practice and expertise in accreditation and regulatory compliance. She served as a member of the Minnesota Board of Pharmacy for eight years and participatedin National Association of Boards of Pharmacy (NABP) committees for almost 20 years. She also served as a surveyor consultant and Accreditation and Inspection Services manager for NABP.
Furthering our commitment to the actual operations of the pharmaceutical supply chain, our Advisory Board is comprised of members with experience and expertise in the following areas: Manufacturing, Distribution, Pharmacy/Healthcare provider, and Legal/Regulatory (FDA, DEA, Board of Pharmacy, Attorney, Consultant).