Multistate Inspection Blueprint Program
Working together to create a state-based program of robust inspection processes.
The Multistate Inspection Blueprint Program is a voluntary program that assists states interested in standardized inspection processes and committed to using the Pharmacy Inspection Blueprint for Sterile Compounding or the Distribution Inspection Blueprint. These living documents include a minimum set of criteria for pharmacy and distribution inspections.
Pharmacy Inspection Blueprint
NABP and its member boards of pharmacy jointly developed the Pharmacy Inspection Blueprint for Sterile Compounding, utilizing the current United States Pharmacopeia standards and best pharmacy practices. It is available to member boards to use when inspecting resident sterile compounding pharmacies that ship across state lines. If you wish to join the Multistate Inspection Blueprint Program and use the Pharmacy Inspection Blueprint for Sterile Compounding, your board must agree to the following processes for inspecting in-state sterile compounding pharmacies that ship to other states:
- Use either the jointly-developed Pharmacy Inspection Blueprint for Sterile Compounding or the state’s sterile compounding inspection form, which has been reviewed by NABP staff to assess whether it meets the Pharmacy Inspection Blueprint for Sterile Compounding standards.
- If you choose the Pharmacy Inspection Blueprint for Sterile Compounding, you will use this form when inspecting pharmacies that ship sterile compounded products to other states.
- Contact us to obtain a copy of the Pharmacy Inspection Blueprint for Sterile Compounding.
- If you want to use your own sterile compounding inspection form, we will first “crosswalk” or compare it to the Pharmacy Inspection Blueprint for Sterile Compounding. We will work with you on any changes that must be made to promote uniformity across participating states.
- If you choose the Pharmacy Inspection Blueprint for Sterile Compounding, you will use this form when inspecting pharmacies that ship sterile compounded products to other states.
- Attest that the board inspectors/compliance officers who conduct these inspections receive training through NABP or training offered by an NABP-approved provider. NABP will provide training at no cost to participating member boards.
- Agree that the board inspectors/compliance officers will participate in ongoing training as required.
- Inspect the sterile compounding pharmacies no less than once every 24 months.
- Share inspection reports with other states (if not prohibited by state law).
Distribution Inspection Blueprint – recruiting its first participants now
Utilizing the content from NABP’s Supply Chain Inspection form as the foundation, state boards of pharmacy and non-pharmacy board agencies responsible for regulating prescription drug and device distribution may volunteer to participate in modifying and shaping the initial Distribution Blueprint Inspection Form to include a minimum set of criteria for distribution inspections. Following the initial collaboration, the Distribution Inspection Blueprint will assist states that are interested in standardized inspection processes for distribution inspections. Regulators interested in participating in the program will receive and utilize inspection reports that reflect uniform agreed-upon distribution inspection processes.
If you wish to join the Multistate Inspection Blueprint Program and be a part of shaping the initial Distribution Inspection Blueprint Form, your state’s distribution regulating agency must agree to do the following when the form is available:
- Use either the Distribution Inspection Blueprint Form or the state’s distribution inspection form, which has been reviewed by NABP staff to assess whether it meets the Distribution Inspection Blueprint criteria.
- If you choose the Distribution Inspection Blueprint Form, you will use this form when inspecting distribution facilities.
- If you want to use your distribution inspection form, we will first “crosswalk” or compare it to the Distribution Inspection Blueprint Form. We will work with you on any changes that must be made to promote uniformity across participating states.
- Attest that board or state regulatory agency inspectors/compliance officers who conduct these inspections receive training through NABP or training offered by an NABP-approved provider. NABP will provide training at no cost to state distribution regulators.
- Agree that the board or state regulatory agency inspectors/compliance officers will participate in ongoing annual training.
- Share inspection reports with other states (if not prohibited by state law).
Comments Sought from Multistate Inspection Blueprint Program Participants
Blueprint Program participants are provided with access to an electronic form used to submit comments about the Multistate Inspection Blueprint forms, and NABP pharmacy and distribution inspection forms. Blueprint participants can use the electronic form to submit comments at any time. Comments are routinely monitored to determine if any require immediate consideration; however, in January of each year, programs are targeted for a formal review on a rotating basis.
Content Review Process for Inspection Forms
NABP has developed a process for the regular review of inspection form content. Through this content review, we strive to provide an inclusive comment process that continuously monitors the pharmacy and distribution landscapes to determine if changes should be considered.
Inspection forms are evaluated on a rotating basis. Those who have an opportunity to review and comment on potential changes include states that voluntarily participate in the Multistate Inspection Blueprint program.
Annual Review Process
| Step 1 – January of each year Each year, in January, comments for the inspection form* undergoing formal review are compiled and shared with NABP subject matter experts (SMEs). * In some years, comments about the NABP Model Act distribution content will also be compiled and included in the process. |
| Step 2 – 15-30 business days NABP SMEs assess the comments and prepare draft edits to the applicable inspection form. If warranted, the draft edits are forwarded to participants in the corresponding Multistate Inspection Blueprint program. |
| Step 3 – 30 business days The Inspection Blueprint participants may review proposed edits and provide written feedback. |
| Step 4 – 15-30 business days The SMEs review the Inspection Blueprint participants’ feedback to determine if additional edits are needed. |
| Step 5 – 30 business days Proposed edits are made available for public review by NABP customers who have completed an inspection within the last three years. |
| Step 6 – 15-30 business days The SMEs review comments from inspection customers to determine if further edits are needed to the inspection form. |
| Step 7 – 30 business days The Inspection Blueprint participants review edits, if any, based on customer comments. |
| Step 8 – 15-30 business days SMEs review Inspection Blueprint participants’ comments and make final edits. |
| Step 9 – 5 business days Final edits are shared with the Inspection Blueprint participants; if there are none this will be announced. |
NABP retains sole discretion to edit the universal inspection forms. All timelines are approximate and may be adjusted at NABP’s discretion in response to comment volume.