Working Together to Create a State-Based Program of Robust Inspection Processes
The Multistate Pharmacy Inspection Blueprint Program (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 other state inspections meet their requirements, eliminating the need to perform their own inspections, thus 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 (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 regulations and practices. The Blueprint can be found in Appendix A of the Model Act.
The Blueprint, for compounding inspection criteria, simply references the relevant USP chapters without listing the detailed requirements of each relevant chapter. The detailed requirements are found in the Universal Inspection Form Sterile Compounding Module and the Universal Inspection Form – Nonsterile Compounding Module.
Becoming Part of the Blueprint Program
Boards of pharmacy who wish to join the Blueprint Program must agree to the following processes for inspecting in-state sterile compounding pharmacies that ship to other states:
- Use either the Universal Inspection Form – Sterile Compounding Module (Universal Inspection Form) or the state’s sterile compounding inspection form.
- 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 NABP “crosswalk” or compare it to the Universal Inspection Form. NABP will work with the state on changes that must be made to ensure uniformity across participating states.
- States must 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.
- 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 these 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 Program Participation Agreement.
- New Jersey
- North Carolina
- North Dakota
- South Dakota
- West Virginia