Common Findings from NABP Pharmacy Inspections

NABP’s accreditation and inspection programs help ensure the quality and safety of pharmacies and distributors, helping to keep patients safe. With over 120 years of industry knowledge and expertise, NABP’s deep understanding of pharmacy and distributor operations makes our accreditation and inspection programs the industry standard.  

Among our inspection offerings is our Verified Pharmacy Program^® (VPP)^®, the most widely recognized multistate, uniform inspection program accepted by state boards of pharmacy across the nation. VPP allows state boards of pharmacy to request access to your verified pharmacy licensure details, inspection report, inspection responses, and other important data through the use of a secure information sharing network. Through analyzing inspection data we’ve collected, NABP has identified common findings and deficiencies in pharmacies. This blog post will identify key areas where gaps were identified against USP compounding chapter standards during VPP inspections in the 12 months after the revised compounding chapters went into effect. 

How is Inspection Data Gathered and Shared?

NABP’s VPP inspection report and applicant provided responses are made available to the boards of pharmacy to request from NABP. This can include updated policies and procedures (P&P), images of updates, and/or clarifying statements to address unknown or noncompliant observations in the inspection report. The onsite inspection includes the following:

Inspection Trends in Compounding Pharmacies

NABP has identified trends in the analyzed data from 213 VPP inspections conducted between November 3, 2023-October 31, 2024. This data includes only the pharmacies that perform nonsterile (99) and/or sterile compounding (100) following USP compounding chapters 795 and 797, respectively. The data was further analyzed to identify opportunities where additional education may be warranted on the USP Compounding Chapter standards. These educational opportunities are suggested when NABP found 10% or more pharmacies were found to have gaps. The trends NABP identified as learning opportunities for the current, compendially applicable USP compounding chapters include:

Nonsterile and Sterile Compounding	Nonsterile Compounding	Sterile Compounding
Initial staff training is not documented for all required personnel.	Beyond Use Dates for aqueous dosage units exceeded Table 4.	Surfaces in cleanroom suite were not smooth, impervious, had cracks, and/or were not cleanable.
Ongoing staff training and competency assessment is not documented and/or not performed at the correct frequency.	Floors were not cleaned daily, when compounding occurred.	Dynamic conditions were not well described in the certification report(s).
	Pharmacy did not perform a proper risk assessment related to use of the containment ventilated enclosure(s).	An item was not wiped with sterile isopropyl alcohol prior to being introduced into the primary engineering control and allowed to dry.
	Master Formulation Record (MFR) does not contain the physical description of the preparation, quality control procedures, and/or complete instructions.
	Compounding Record (CR) does not contain the physical description of the final preparation and quality control results.

Although the vast majority of pharmacies are compliant with applicable laws and regulations, it is important to track what areas are most prone to issues, gaps, or where enhanced knowledge on the compounding standards are needed.

How Can Compliance With Current USP Compounding Chapters Improve?

There are two major focus areas that can assist pharmacies in staying compliant with USP compounding chapter standards. Initial training and ongoing competency assessment documentation is one major focus area and the second is improvement in the MFR development and CR documentation for nonsterile compounding. Educational efforts in these focused areas may have the greatest impact for overall improved compliance with the USP compounding chapters: 

1. For nonsterile compounding, documentation for initial personnel training was found to be 68% full compliance for the compounder, 71% full compliance for oversight personnel, and 66% full compliance for ongoing competency assessment. Some of the trends NABP identified include:
   1. The training record was incomplete on topics such as equipment, interpretation of the certificate of analysis, and/or evaluation of spill management.
   2. Ongoing competency assessment was in place for the compounder at the correct frequency, but not for the oversight personnel.
   3. There were some improvements seen in the last eight (8) months of the evaluation period, compared to the initial four (4) months, suggesting pharmacy personnel had not completed their reviews at the time of the revision change.
2. For sterile compounding, documentation for initial personnel training and ongoing competency assessment was found to be 87% full compliance for the compounder. In some instances, the records were locked and simply inaccessible during the inspection.
3. For sterile compounding, aseptic manipulation competency documentations were found to be 80% full compliance, and hand hygiene competency documentation was found to be 87% full compliance.
   1. Pharmacy should ensure the oversight personnel are completing their training and competency assessment documentation at the required frequency.
   2. The media fill competency was occasionally found to not be representative of the most difficult and challenging manipulations.
4. For nonsterile compounding, MFR Development was found to be 68% full compliance, and the CR documentation was found to be 72% full compliance.
   1. 17% of pharmacies had insufficient instructions for quality control procedures (such as pH testing or visual inspection) and expected results. Quality control procedures were not consistently documented in these instances on the CR.
   2. 14% of pharmacies were missing the reference source to support the established beyond use date for the compounded preparation.
   3. 15% of pharmacies did not have a physical description of the final preparation in the MFR. This led to the physical description of the compounded preparation to not be documented on the CR.
   4. While 92% of pharmacies had complete instructions within the MFR for preparing the compound, it was occasionally found (8% of the time), the compounder was not following the MFR during the onsite inspection.
   5. Since the evaluation period, NABP has identified improvements in MFR development during more recent VPP inspections.

For more information on how to prepare for a pharmacy inspection, read our 2-part blog.