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.

Working together to create a state-based program of robust inspection processes.

The Multistate Pharmacy Inspection Blueprint Program supports 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 standards, along with field operations’ best practices developed in partnership with participating boards of pharmacy, the Inspection Blueprint provides the various tools needed to 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: 

1. 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 to ensure that it meets 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. 
2. Attest that the inspectors/compliance officers who conduct these inspections receive qualified NABP-approved training. 
3. Agree that the inspectors/compliance officers will participate in annual training.
   • We will provide training at no cost to boards. 
4. Inspect the sterile compounding pharmacies no less than once every 18 months.
5. Share inspection reports with other states (if not prohibited by state law). 

Reducing regulators’ inspection workloads.

The NABP Preoperational Inspection allows for a facility to obtain an onsite 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 onsite activities/scope of services, and accountability processes in order to make licensing decisions.

A Comprehensive Tool

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.

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.

NABP does not issue a certificate of inspection or make any determination of “passed” or “compliant” with regard to any specific state regulations. The state may determine a facility’s compliance and eligibility for licensure based on the observations documented during the inspection. Completion of the inspection does not imply NABP’s endorsement or approval of the facility or its operations.

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, assists 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.

A Comprehensive Tool

The information collected about a pharmacy when it goes through a VPP inspection equips you with detailed data for consideration when making licensing and license renewal decisions. Via NABP e-Profile Connect, you may: 

• request pharmacies’ inspection, disciplinary, and licensing data; and
• review the pharmacy’s response to the inspection report at any time. 

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 Comprehensive Tool

The information collected about a supplier when it goes through an inspection equips your board with detailed data for consideration in making licensing and license renewal decisions. Via NABP e-Profile Connect, you may: 

• request suppliers’ inspection, disciplinary, and licensing data; and
• review the facility’s response to the inspection report at any time.