Benefits of the Multistate Pharmacy Inspection Blueprint

Developed by member boards, the Multistate Pharmacy Inspection Blueprint (blueprint) allows states to ensure their own inspection forms and processes cover the minimum requirements agreed upon by the majority of state boards. The blueprint largely focuses on general areas of pharmacy and references existing national compounding standards, such as United States Pharmacopeia (USP) Chapters <795> and <797>.

As more states implement the common requirements included in the blueprint, the increased uniformity that the blueprint provides is expected to assist boards in making nonresident licensure decisions.

History and Development

During the October 2014 Interactive Executive Office Forum, attendees expressed overwhelming support for states to collaborate with NABP to develop the foundation for a uniform inspection process. So NABP convened a workgroup of executive officers and compliance officers to develop a living inspection outline that would focus on areas that members believed needed the most attention from all states, while allowing individual states to consider additional areas of focus. That document was the Multistate Pharmacy Inspection Blueprint. Previous inspection projects – like the Verified Pharmacy Program (VPP) – were used as a baseline for the blueprint, which has been vetted and revised by a workgroup of board representatives and 42 state representatives.

Implementation and Maintenance

NABP has been working with a small group of states in 2016 to begin implementation of the blueprint, develop a uniform inspection tool for states, and establish a platform for blueprint participating states. Based on this work, an Inspection Blueprint Participation Program Agreement has been created, which outlines for participating states the minimum requirements for conducting inspections of sterile compounding pharmacies that ship across state lines. Going forward, an advisory group will be formed to assist NABP staff with further implementation, any needed modification to maintain currency with pharmacy practice and regulation of such, and maintenance of the blueprint and associated forms.  This group will ensure the continued relevance of the blueprint and determine if and when blueprints for other types of facilities are needed – nuclear or institutional pharmacies, or wholesale distributors, for example. The advisory group will also develop a structured process for receiving feedback from the boards, as well as other stakeholders.

Training and Resources

NABP has developed a universal inspection form following a period of field testing in several states. The form was revised based on feedback received during the test period. Now, the form is available to all states who want their inspections recognized by other states, to use for in-state inspections (particularly for pharmacies that operate in multiple states), or for ensuring that the state’s own inspection form, at a minimum, covers the items on the universal form. NABP will provide training and educational resources and opportunities such as webinars and field training. Other future resources and inspection tools may include highly customizable inspection software and hardware for use by member boards.

Existing programs and services, such as VPP and NABP e-Profile Connect, will also continue to support the blueprint. States are encouraged to use these tools to share inspections and gather information on VPP applications and inspections.

Questions?

  • Want to learn more about training and resource opportunities?
  • Are you an NABP member who would like to see a copy of the Multistate Pharmacy Inspection Blueprint and the universal inspection form?
  • Want a copy of the Inspection Blueprint Participation Program Agreement?

Please email GovernmentAffairs@nabp.pharmacy for assistance.