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

The Multistate Pharmacy Inspection Blueprint Program was established after working with our member boards of pharmacy to develop the Inspection Blueprint, a living document that provides a minimum set of inspection 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 member boards can inspect resident sterile compounding pharmacies that ship across state lines.

To participate in the Blueprint Program, states must:

• Utilize the NABP Universal Inspection Form or a state-developed inspection form that has been crosswalked to the NABP Inspection Blueprint standards
• Allocate inspection resources to inspect sterile compounding pharmacies that ship across state lines at least once every 18 months
• Share the inspection reports through the Verified Pharmacy Program (VPP) inspection-sharing network (unless prohibited by state law)
• Have inspectors who conduct sterile compounding inspections participate in free training from NABP or an NABP-sponsored provider

Current Blueprint States

Becoming a Blueprint State

Boards of pharmacy that wish to join the Blueprint Program 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 NABP staff to ensure that it meets the Inspection Blueprint standards.
   • States that choose the Universal Inspection Form 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.) Boards of pharmacy may contact Member Relations and Government Affairs at GovernmentAffairs@nabp.pharmacy to obtain a copy of the Universal Inspection Form.
   • States that want to use their own sterile compounding inspection form must first have us “crosswalk” or compare it to the Universal Inspection Form. We will work with the state on changes that must be made to ensure uniformity across participating states.
2. Attest that the inspectors/compliance officers who conduct these inspections receive qualified training, which includes, but is not limited to, CriticalPoint’s Boot Camp, NABP and CriticalPoint Sterile Compounding Inspector Training (SCIT), or NABP in-state inspection training. The training must be NABP-approved.
3. Agree that the inspectors/compliance officers will participate in annual training.
   • We will provide training at no cost to the boards of pharmacy.
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).

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 they 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 the boards of pharmacy.

Utilizing VPP inspection reports, along with license verification and disciplinary information provided through the Clearinghouse, boards of pharmacy can efficiently make informed decisions on licensure or renewal of licensure for nonresident pharmacies. Pharmacies that operate in multiple states have also found VPP to be a practical and cost-effective solution with just one inspection often satisfying the requirements in most states.

VPP Benefits for the Boards

• A VPP inspection is conducted by NABP surveyors and verifies that pharmacy licenses (resident and nonresident), pharmacist-in-charge licenses, disciplinary actions taken by other states, and compliance with United States Pharmacopeia Chapters <795> and <797>.
• Data is securely stored and easily accessible to board staff through NABP e-Profile Connect, where notifications help board staff stay informed about new documents and requests such as pharmacies seeking licensure or shipping medications into their state.

A Comprehensive Tool for Your Board

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

• View pharmacies’ inspection, disciplinary, and licensing data
• View immediate reporting of significant violations of state and federal law to boards of pharmacy
• View these 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

NABP’s supply chain inspection service 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 boards with the detailed information they need to make accurate, fully informed licensing and license renewal decisions. Via NABP e-Profile Connect, boards may:

• View a supplier’s inspection, disciplinary, and licensing data
• View immediate reporting of significant violations of state and federal law to boards of pharmacy
• View these records at any time with secure access 24/7

Supply Chain Inspection Benefits for the Boards

• Inspection sharing across states through e-Profile Connect aids boards of pharmacy 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.