Working Together to Create a State-Based Program of Robust Inspection Processes
The Multistate Pharmacy Inspection Blueprint Program provides boards of pharmacy with the tools to inspect sterile compounding pharmacies that ship across state lines. States that participate in the Blueprint Program can easily tell which resident state inspections meet their requirements, alleviating the burden on staff and easing concerns for public safety during these times of limited resources.
NABP established the Blueprint Program after working with the member boards of pharmacy to develop the Multistate Pharmacy Inspection Blueprint, a living document that provides a minimum set of inspection criteria for pharmacy inspections. The Blueprint will be regularly reviewed to ensure it stays current with evolving pharmacy regulation and practices. The Multistate Pharmacy Inspection Blueprint can be found in Appendix A of the Model Act.
Becoming Part of the Blueprint Program
Boards of pharmacy who wish to join the Multistate Pharmacy Inspection Blueprint Program must agree to the following processes for inspecting sterile compounding pharmacies:
- Use either the Universal Inspection Form – Sterile Compounding Module or the crosswalk version of the state’s sterile compounding inspection form after NABP has compared it to the relevant sections of the Multistate Pharmacy Inspection Blueprint
- States that choose the Universal Inspection Form – Sterile Compounding Module can simply 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 choose the Multistate Pharmacy Inspection Blueprint can have NABP “crosswalk” or compare the Blueprint to their own sterile-compounding inspection form. NABP will identify changes that must be made to ensure uniformity across participating states.
- Attest that the inspectors/compliance officers received initial training
- Training must be obtained by those performing inspections of pharmacies that ship sterile compounded products across state lines.
- Qualified training includes but is not limited to CriticalPoint’s Boot Camp, NABP and CriticalPoint SCIT, or NABP in-state inspection training. The training must be NABP-approved.
- Agree that the inspectors/compliance officers will participate in annual training
- Training will be provided by NABP and will be at no cost to the boards of pharmacy.
- Inspect nonresident sterile compounding pharmacies no less than once every 18 months
- Share inspection reports with other states (if not prohibited by state law)
Want to Sign Up for the Blueprint Program?
If you want to participate in the Blueprint Program, contact Member Relations and Government Affairs staff for more information and to receive a program agreement form.
Which States Participate in the Blueprint Program?
The following states have signed the Multistate Pharmacy Inspection Blueprint Participation Program Agreement.
- New Jersey
- North Dakota
- South Dakota
- West Virginia