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

Becoming 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 our Member Relations and Government Affairs staff 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’ workloads for inspection compliance

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 will find our Preoperational Inspection can supplement their own inspections, reducing board staff workload and assisting with inspection requests from facilities. After completion of the Preoperational Inspection, the boards and other state regulators will have 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 for Your Board

The boards and other state regulators can use the Preoperational Inspection to obtain inspection documentation to ensure they have complete and accurate information when making licensure decisions. The following information can be accessed at any time via the secure NABP e-Profile Connect:

1. inspection application documents; 
2. inspection report; 
3. inspection responses; and
4. immediate reporting of significant violations of state and federal law. 

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 determines a facility’s compliance based on the findings of the inspection, and completion of the inspection does not imply our endorsement or approval.

The third-party pharmacy inspection program most widely recognized by state boards of pharmacy across the nation

The Verified Pharmacy Program^® (VPP^®) provides boards of pharmacy with inspection and license verification services and ensures that you have complete and accurate information to make pharmacy licensure decisions. When states lack the resources to conduct timely and robust inspections, VPP can bridge the gaps. Through this program, our surveyors perform the pharmacy inspection at no cost to you. 

Utilizing VPP inspection reports, along with license verification and disciplinary information provided through the NABP Clearinghouse, you can efficiently make informed decisions on licensure or the licensure renewal for 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.

VPP Benefits for the Boards

• A VPP inspection is conducted by our inspectors and, when applicable, verifies compliance with United States Pharmacopeia Chapters <795> and <797>. 
• 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 they are doing business.
• Data is securely stored and easily accessible for board staff through NABP e-Profile Connect, where notifications help staff stay informed about new documents and requests, such as pharmacies seeking licensure or shipping medications into your state. 

A Comprehensive Tool for Your Board

The information collected about a pharmacy when it goes through a VPP inspection equips you with the detailed information you need to make accurate, fully informed licensing and license renewal decisions. Via NABP e-Profile Connect, you may view: 

• pharmacies’ inspection, disciplinary, and licensing data, 
• immediate reporting of significant violations of state and federal law, and 
• records at any time with secure access 24/7. 

The pharmacy inspection is not an accreditation program, 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 based on the findings of the inspection, and completion of the inspection does not imply our endorsement or approval. 

Protecting the public health against ongoing threats to our nation’s drug supply chain

Our Supply Chain Inspection program is a regulatory 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 satisfy an inspection requirement from an entity or agency. 

The information collected about a supplier when it goes through an inspection equips your board with the detailed information needed to make accurate, fully informed licensing and license renewal decisions. Via NABP e-Profile Connect, you may view: 

• suppliers’ inspection, disciplinary, and licensing data, 
• immediate reporting of significant violations of state and federal law, and 
• records at any time with secure access 24/7. 

Supply Chain Inspection Benefits for the Boards

• Inspection sharing across states through NABP e-Profile Connect aids you in making informed licensure decisions. 
• The uniform Drug Supply Chain Security Act (DSCSA) compliance assessment of wholesale drug distributors provides personalized state inspection projects for the boards. 

The supply chain inspection is not an accreditation program, 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 based on the findings of the inspection, and completion of the inspection does not imply our endorsement or approval.

We developed several accreditations to provide uniform standards that enhance pharmacy practice and protect public health. Several states recognize NABP accreditation as a prerequisite for licensure. Learn more about how our accreditation programs ensure public safety.