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 request 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.
Bundle Inspection & Accreditations to Maximize Your Investment
Apply for Preoperational Inspection as a standalone program or maximize your investment by creating a comprehensive compliance package for one streamlined, cost-effective accreditation process.
Benefits of Preoperational Inspection
A Preoperational Inspection serves as the first inspection needed to obtain resident and/or non-resident state licensure. Preoperational inspections provide state boards of pharmacy and additional regulators with your verified data and inspection report to assist with licensing decisions.
Interested in learning more?
Learn how you can better position your business by obtaining a Preoperational Inspection. Complete the form to request more information.
Eligibility Requirements at Time of Application
The following eligibility requirements must be met in order for NABP to perform a preoperational inspection. A facility that is unable to meet these eligibility requirements will have their application closed in accordance with the program terms and conditions.
1. A facility must be 1 of the following business models to be eligible to apply for a Preoperational Inspection:
- Pharmacy (not an Outsourcing Facility that is registered or unregistered with the FDA as human compounding outsourcing facility)
- Due to the complexity of operations and exclusion of current Good Manufacturing Practices from NABP’s inspection process, NABP is not offering preoperational inspections to Outsourcing facilities.
- Prescription drug wholesale distributors
- Prescription medical device distributors
- Active pharmaceutical ingredient (API) distributors
- API repackagers
- Repackagers of finished prescription drugs
- Veterinary prescription drug distributors
- Reverse distributors
- Sample distributors
- Investigational drug distributors
- For prescription drugs and/or prescription devices.
- Virtual distributors and manufacturers
- For prescription drugs and/or prescription devices.
- Third-party logistics providers (3PLs)
- OTC medical device distributors
- Distributing OTC medical devices for diagnostic purposes (ie, diabetic meters and test strips).
2. Facility must not be a personal residence.
3. Facility must be located in the United States or the District of Columbia. (Preoperational Inspections are not offered for pharmacies in Puerto Rico at this time.)
4. The facility completes and submits an application, which includes agreeing to the program terms and conditions and applicable payment
5. Facility must not be operational as defined by VPP and Supply Chain Inspection.
6. The facility must be fully constructed. The facility should not be actively engaged in construction or finishing work that impedes inspection of the facility for the functions the inspection is designed to assess.
- Fully constructed is defined as: building sufficient to maintain security, storage, and safety of drugs/devices and their records. This would include but not limited to: HVAC; electricity; internet; lighting; plumbing fixtures including hot/cold running water; refrigerator/freezer (if applicable to types of items that will be purchased, received, stored, and/or sold); security systems, locks, and/or alarms; vault for controlled substances (if applicable); and other necessary equipment, stock, or fixtures.
- Fully constructed is not defined as: final punch out construction list, all shelving units are installed, temperature mapping is scheduled but not completed (not applicable for pharmacies).
Requirements for Preoperational Inspection at Time of Inspection
Facility must be able to meet the following requirements at the time of inspection for NABP to conduct and complete a preoperational inspection. At any time, whether upon arrival of the inspector at the facility or during the inspection, it becomes apparent to the inspector that the applicant has not met all requirements, or if a business denies or limits authorization to the facility in a way that hinders NABP’s ability to perform a complete inspection, the NABP Inspector shall utilize the Incomplete Inspection or Survey Form accordingly and have the facility sign the Form that will be made available for the Boards of Pharmacy, upon their request, to NABP. The application will be closed in accordance with the terms and conditions.
- The facility identifies a pharmacist-in-charge (for a pharmacy) or a designated representative (for a distributor and all other business models) with contact information prior to the arrival/start of the inspection.
- The facility must be able to confirm, prior to the inspection, the days and hours the facility will be available during their 4 week unannounced inspection window. The hours of availability, during those days, must be sufficient for the inspection purposes.