Inspection Services
Over the years, NABP has gained extensive knowledge and experience inspecting pharmacies, drug distributors, and other facilities and assessing whether their operations meet requirements. We have created tools to build inspection programs, including Inspection Blueprint, Preoperational Inspection, Verified Pharmacy Program® (VPP®), and Supply Chain Inspection. Boards may request inspection reports and facility responses, which contain information about operational observations and facility feedback – data that may assist the boards in their licensure processes. Some of our accreditation programs utilize these inspections to determine eligibility to apply for an applicable accreditation program. For more details about these programs and other services available to the boards, explore the Member Manual.
Inspection Blueprint Program
A State-Based Program of Robust Inspection Processes
The Multistate Pharmacy Inspection Blueprint Program assists states that have the resources to perform resident inspections by providing the Inspection Blueprint, a living document that includes a minimum set of criteria for pharmacy inspections. Utilizing the current United States Pharmacopeia (USP) standards, along with Field Operations’ best practices developed in partnership with participating boards of pharmacy, the Inspection Blueprint provides the various tools needed to help ensure that you can inspect resident sterile compounding pharmacies that ship across state lines.
How to Become a Blueprint State
If you wish to join the Blueprint Program, your board must agree to the following processes for inspecting in-state sterile compounding pharmacies that ship to other states:
-
Use either the Universal Inspection Form – Sterile Compounding Module (Universal Inspection Form) or the state’s sterile compounding inspection form, which has been reviewed by our staff for alignment with the Inspection Blueprint standards.
- If you choose the Universal Inspection Form, you will use this form when inspecting pharmacies that ship sterile compounded products to other states. In the future, participation may expand to include general pharmacy and nonsterile compounding. Contact us to obtain a copy of the Universal Inspection Form.
- If you want to use your own sterile compounding inspection form, we will first “crosswalk” or compare it to the Universal Inspection Form. We will work with you on any changes that must be made to ensure uniformity across participating states.
-
Attest that the inspectors/compliance officers who conduct these inspections receive NABP-approved sterile compounding training.
-
Agree that the Board inspectors/compliance officers will participate in annual training.
- We will provide training at no cost to boards.
-
Inspect the sterile compounding pharmacies no less than once every 18 months.
-
Share inspection reports with other states (if not prohibited by state law).
States adopt a consistent baseline for inspections using the Universal Inspection Form or aligning their own forms, ensuring comparability and clarity across jurisdictions.
NABP provides inspector training at no cost to boards, supporting high-quality inspections.
Participating states share inspection reports, enabling faster licensure reviews.
Inspection Programs
NABP operates several inspection programs that not only support Association accreditation services but offer benefits for interested member boards of pharmacy. Our programs provide comprehensive evaluations for facilities at various stages of operation, from preoperational assessments to ongoing compliance monitoring. These programs include Preoperational Inspection, which helps reduce inspection workloads for regulators prior to operation; VPP, which helps make pharmacy licensure decisions by offering inspection and licensing verification services; and Supply Chain Inspection, which evaluates facilities and operational practices to help protect the integrity of the drug supply chain.
NABP can only verify the authenticity of an inspection report if it is transmitted directly from NABP to an intended recipient. NABP cannot verify the authenticity of an inspection report transmitted from any other party.
The pharmacy inspection is not an accreditation, and we do not make any determination of “passed” or “compliant” with regard to any specific state regulations. The state determines a facility’s compliance and eligibility for licensure, which may be based on the documented inspection observations. Completion of the inspection does not imply NABP’s endorsement or approval of the facility or its operations.
Preoperational Inspection
Reducing Regulators’ Inspection Workloads
The NABP Preoperational Inspection allows for a facility to obtain an on-site inspection prior to operation. States requiring pharmacies and distributors to undergo a preoperational inspection may find our Preoperational Inspection can supplement their own inspections, reducing board staff workload and assisting with inspection requests from facilities. The Preoperational Inspection report includes comprehensive information on the facility’s physical structure, security features, anticipated on-site activities/scope of services, and accountability processes in order to make licensing decisions.
A Comprehensive Tool for State Licensure
Facilities, boards, and other state regulators may use the Preoperational Inspection to obtain inspection documentation to help ensure they have complete and accurate information when facilities pursue state licensure and when regulators make licensure decisions. The inspection report and inspection responses may be requested via the secure NABP e-Profile Connect®.
Verified Pharmacy Program (VPP)
Cost-Effective For Facilities; Recognized By State Boards of Pharmacy Across the Nation
The Verified Pharmacy Program (VPP) includes inspection and license verification services that offer comprehensive information to facilities seeking licensure, as well as licensing agencies that make pharmacy licensure decisions. When states lack the resources to conduct inspections, VPP can bridge the gap. Through this program, surveyors perform the pharmacy inspection at no cost to regulators.
Utilizing VPP inspection reports, along with license verification and disciplinary information provided through the NABP Clearinghouse, can assist boards in efficiently making decisions on licensure or the licensure renewal for resident and nonresident pharmacies. Pharmacies that operate in multiple states have found VPP to be a practical and cost-effective solution because just one inspection often satisfies the requirements in most states.
Unified Licensing Decision Tool
If boards request VPP inspection reports, they will receive information collected about the inspected pharmacy for their consideration when making licensing and license renewal decisions. Using NABP e-Profile Connect, you can:
- request pharmacies’ inspection, disciplinary, and licensing data; and
- review the pharmacy’s response to the inspection report at any time.
A VPP inspection is conducted and documents inspector observations of the facility and its operations in accordance with USP Chapters <795>, <797>, <800>, and <825>, if applicable.
Pharmacy licenses (resident and nonresident) and pharmacist-in-charge licenses are verified to ensure they are active and in good standing in all jurisdictions in which the facilities are doing business.
Data are securely stored and easily accessible by board staff upon request through NABP e-Profile Connect.
Supply Chain Inspection
Reviews Facilities and Operations to Support Drug Supply Chain Integrity
Our Supply Chain Inspection program is an inspection for facilities engaged in the distribution of prescription drugs and prescription medical devices. This inspection’s focus is adopted from our Drug Distributor Accreditation and provides a snapshot of a supplier’s operations at a point in time. Participants of the program will receive an inspection report that may be used to support the facility’s quality assurance and improvement processes. The report may also satisfy an inspection requirement of a third party or licensing agency.
A Complete Inspection Dataset
If boards request Supply Chain Inspection reports, they will receive information collected about the inspected supplier for their consideration in making licensing and license renewal decisions. Using NABP e-Profile Connect, you can:
- request suppliers’ inspection, disciplinary, and licensing data; and
- review the facility’s response to the inspection report at any time.
Inspection reports may be requested through NABP e-Profile Connect. Inspection data may aid you in making licensure decisions.
The documentation of the inspector’s observations of a wholesale drug distributors facility’s alignment with the uniform Drug Supply Chain Security Act.
Facilities benefit from inspection reports, particularly when integrated into a facility’s continuing quality improvement program.
