Inspection Services

Member boards seeking to enhance their inspection processes have identified us as their best option for assistance. Over the years, we have proven our ability to balance the needs of the boards and make the protection of public health a primary concern. Working closely with board members, inspectors and compliance staff, and board executive officers, we have created tools and services that enable the exchange of valuable knowledge and the building of robust inspection programs in any state.

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: 

1. 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.   
2. 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. 
3. Agree that the board inspectors/compliance officers will participate in ongoing training as required.  
4. Inspect the sterile compounding pharmacies no less than once every 24 months.
5. Share inspection reports with other states (if not prohibited by state law).  

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:

1. 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.
2. 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. 
3. Agree that the board or state regulatory agency inspectors/compliance officers will participate in ongoing annual training.
4. Share inspection reports with other states (if not prohibited by state law).

NABP operates several inspection programs that not only support Association accreditation services but offer benefits for interested member boards of pharmacy. Our programs provide comprehensive evaluations for facilities at various stages of operation, from preoperational assessments to ongoing compliance monitoring. These programs include Preoperational Inspection, which helps reduce inspection workloads for regulators prior to operation; VPP, which helps make pharmacy licensure decisions by offering inspection and licensing verification services; and Supply Chain Inspection, which evaluates facilities and operational practices to help protect the integrity of the drug supply chain.

NABP can only verify the authenticity of an inspection report if it is transmitted directly from NABP to an intended recipient. NABP cannot verify the authenticity of an inspection report transmitted from any other party.

The pharmacy inspection is not an accreditation, 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 and eligibility for licensure, which may be based on the documented inspection observations. Completion of the inspection does not imply NABP’s endorsement or approval of the facility or its operations.