Preoperational Inspection Program

NABP’s Preoperational Inspection program is for pharmacies or businesses engaged in prescription drug, prescription device, and certain over-the-counter medical device distribution that may or may not yet hold a resident state license and are not yet operational.

If your facility is seeking licensure and is not yet operational, the Preoperational Inspection program allows state boards of pharmacy and other applicable regulators access to your verified details, inspection report, inspection responses, and other important data using a secure information sharing network. The program equips the state boards of pharmacy and other regulators with quality and timely data that can assist in decreasing the time it takes to make licensing decisions.

A Preoperational Inspection is ideal for facilities that:

• Just finished construction of the facility;
• Are not yet operational; and
• May need a resident state inspection to obtain state licensure.

The first step in the process is to apply for an inspection after you have agreed to the terms and conditions. Once your application, required documentation, and specified fees have been received:

• NABP conducts an unannounced on-site inspection of your facility.
• All business e-Profile information is accessible to the state boards of pharmacy and other applicable regulators.
• The board staff receives alerts when new documents are available on the business e-Profile for facilities that are seeking licensure.

Follow these steps to submit a Preoperational Inspection application.

1. Ensure that your facility is eligible for a Preoperational Inspection. 
2. Log in to your business e-Profile and apply for a Preoperational Inspection.
   • Review the information needed when creating your business e-Profile.
   • Read the basic instructions on creating a new business e-Profile.
   • Use this guide to request access to additional Business e-Profile Accounts, after creating your initial e-Profile.
3. When the request for an e-Profile ID is approved, complete the full profile for your facility in the My Business e-Profile section. The information is needed before an inspection application can be completed.
4. Gather supporting documents for the application.
5. Start an application by clicking the Application tile on your e-Profile dashboard. Then click Create New Application in the top right corner of the page.
   • Select the + icon next to the Preoperational Inspection tile and select your facility to begin the application.
   • Proceed through the application and submit when complete.

Review the Policy Information prior to starting the Preoperational Inspection application.

Interested in pricing?

Log in to your business e-Profile account and visit the Instructions and FAQs section to access pricing. Don’t have an account? Create your free business e-Profile account today.