National Coalition for
Drug Quality & Security
Quality and Security (QAS) Accreditation
The Quality and Security (QAS) Accreditation Program encompasses federal and state requirements spanning key business activities including the sourcing, sales and storage of pharmaceuticals. Companies that are accredited by NCDQS are verified to have proper licensing, appropriately source, handle and secure prescription products to protect product quality and integrity, verify vendors and customers, and comply to state and federal regulations including reporting requirements.
Accreditation Process Information
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Standard accreditation is 3 years.
Timeline
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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..
Accreditation Process Instructions
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Review the standards and compare to your SOPs and business activities. Ensure SOPs are complete and that both SOPs and business activities meet all NCDQS QAS requirements and standards.
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Complete the application and attach the requested information and documentation.
Special Circumstances
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Facilities must have at least 90 days of distribution operation before applying.
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Facilities with less than 180 days of distribution operations at the time of application will be accredited for one year at which time additional documentation will be requested and reviewed. Upon successful review and approval, the accreditation will be extended two additional years (for the full three-year cycle).
Supplemental Documents Required
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Organizational chart
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Description of positions on the organizational chart
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Vendor List for Prescription and OTC products
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License List
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Table of Contents of the Policy and Procedures
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Table of Contents of the Employee Handbook
Standard Operating Procedures (SOP) Required
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Document Control
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Vendor Authentication
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Customer Authentication
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Product Receiving & Authentication
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Suspect & Illegitimate Product Detection, Handling, Investigation and Reporting
Accreditation Fee Schedule
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Accreditation Application submission: $1,000* **
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Due upon award of Accreditation: $5,000
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Annual Review, beginning of Year 2: $2,500
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Annual Review, beginning of Year 3: $2,500
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Total for Accreditation + Inspection is $15,000.
* $4,000 QAS Inspection is required for Accreditation application.
**Additional fees may be incurred for deviations in Accreditation process including, but not limited to, additional site visits.
Key Standards
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OTC product due diligence. Our QAS Accreditation program evaluates OTC sourcing practices in addition to prescription drug product due diligence. This is part of our standards for all applicants, not just wholesale distributors that exclusively handle OTC products and devices. This is to prevent grey market insulin and diabetic test supplies from being brought back into the supply chain, after being dispensed to patients / reimbursed.
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Suspicious Order Monitoring. Our organization has a robust SOM requirement that spans all product classes, including short-dated products, devices, non-prescription drugs and OTC products, not just controlled substances and drugs of interest.
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Sourcing of Diverted Product. QAS Accreditation program evaluates prescription drug sourcing to ensure product isn't diverted from the traditional supply chain, including 340B, pharmacy-contracted and even previously dispensed/patient sources.