How do we read the Inspection report?
The VPP inspection report is comprised of information observed and collected during the inspection of your facility. The VPP inspection form includes the following applicable modules: Pharmacy Information, General Pharmacy, Nonsterile <795>, Sterile <797>, and Hazardous Drug Compounding <800>.
Pharmacy Information Module
This module documents the demographic information of your facility, scope of practice, and activities performed.
General Pharmacy Module
This module documents the review of general pharmacy practices and activities. As this is a general inspection, some items may not be required by the state of residence. NABP does not make a determination of “passed” with regard to any specific state regulations.
Hazardous Drug Compounding
This module documents whether the pharmacy’s activities align with USP <800>, as applicable. Each state determines that pharmacy’s compliance based on the observations of the Verified Pharmacy Program (VPP) inspection report and other information. NABP does not make licensure decisions; the boards of pharmacy have authority over pharmacy licensing.
Nonsterile <795> and Sterile <797> Modules
These modules document whether the pharmacy’s activities align with USP <795> and <797>, as applicable. Each state determines compliance based on the observations of the VPP inspection report, among other information that may be considered. NABP does not make licensure decisions; the boards of pharmacy have authority over pharmacy licensing.
The Nonsterile and Sterile Compounding modules are color-coded to assist the inspector during the documentation process. Each module is divided and labeled into sections of differing topics. The sections are further divided using, Questions, Statements, and Informational Questions, to separate differing topics within each section. Observations will be documented as “Yes,” “No,” “N/A,” or “Unknown.” The Notes column may also contain additional details from the inspector.
- Questions: Questions are color-coded as white cells. A Question is an overarching question preceding a group of statements about the same topic. A “Yes” response confirms alignment with the specific topic. A “No” response indicates that the pharmacy did not meet the criteria for at least 1 statement within the topic.
- Statements: Statements are color-coded as light blue cells and support the overarching question of the same topic. statements contain greater detail to describe the activity observed. A “Yes” response confirms that the pharmacy has met the criteria specified for each statement. A “No” response indicates that the pharmacy did not meet the criteria listed in the statement.
- Inspector Notes: Inspector Notes are listed in bold navy italics and are used to communicate examples, definitions, USP references, and other information to support the inspector.
- Inspector Directions: Inspector Directions are listed in bold maroon italics and are used to communicate to the inspector when additional information (eg, descriptions, photos, document review) is needed and when a question or statement should be documented as “N/A.”
- Informational Questions: Informational Questions are color-coded as gray cells. These questions are for data collection purposes only. Responses selected do not indicate an area of non-alignment. Some of the USP recommendations are asked as informational questions.