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Contract Review
QAS Inspection Program

The QAS Inspection Program encompasses federal and state requirements spanning business activities including the sourcing, sales and storage of pharmaceuticals. All entities that successfully complete the QAS Inspection Program verified to have proper licensing, handle and secure prescription products to protect product quality and integrity, and comply to state and federal regulations.

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Business Models Served

Our QAS Inspection​ program covers facilities with business models including, but not limited to, the following:

  • Prescription drug manufacturers (distribution activities only, not cGMP)

  • Virtual manufacturers

  • 503B Outsourcing facilities (distribution activities only, not cGMP)

  • Prescription drug wholesalers

  • Medical Gas Distributors (distribution activities only, not cGMP) 

  • Reverse Distributors

  • Drug Repositories

  • Specialty wholesalers

  • Virtual wholesale distributors

  • OTC wholesalers

  • OTC-only wholesalers

  • Medical device wholesalers

  • Veterinary wholesalers

  • Third-party logistics (3PL) providers (for prescription products, OTC and OTC only, medical devices, veterinary, etc.)

Inspection Process Overview

  • Facility submits Pre-Inspection Application and attaches the requested information and documentation. 

  • NCDQS will review materials before reaching out to schedule an Intake Call.

  • NCDQS and Applicant will have an Intake Call.

  • NCDQS will perform the Inspection.

  • NCDQS will provide the Inspection Report to Applicant. NCDQS will provide Inspection Reports to state agencies directly, if requested by Applicant. 

Frequently Asked Questions

  • Inspections are unannounced (i.e. not scheduled with the entity).

    • Inspections for virtual entities that do not take possession of product will be announced and scheduled due to the remote nature of their business.

  • We will typically perform an inspection between 4 and 8 weeks from accepting the application.

  • Inspections are performed during normal hours of operation.

Inspection Fee Schedule

  • Pre-Inspection Application submission: $4,000* **

  • ​

  • *Additional fees may be incurred for deviations in Inspection process including, but not limited to, additional site visits.

  • **Inspection Fee is non-refundable unless site visit is not performed. If site-visit is not performed, Applicant will be refunded $2,000 site visit fees.

States that Formally Accept QAS Inspection

  • Iowa*

  • Kansas

  • Maryland

  • Mississippi

  • Nebraska

  • New Hampshire

  • South Carolina

  • South Dakota

  • Utah

  • Vermont

  • Washington

  • Wyoming*

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Additional states have informally accepted QAS Inspection reports.

*Accreditation may be required.

FAQ
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