Inspection Services
Member boards seeking to enhance their inspection processes have identified us as their best option for assistance. Over the years, we have proven our ability to balance the needs of the boards and make the protection of public health a primary concern. Working closely with board members, inspectors and compliance staff, and board executive officers, we have created tools and services that enable the exchange of valuable knowledge and the building of robust inspection programs in any state.
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.
