The 2014 USP Chapter <797> Compliance Survey

October 2014 : Cleanrooms & Compounding - Vol.11 No. 10 - Page #6




Since 2011, Critical Point’s annual, nationwide survey of sterile compounding practice provides insight into current compounding practices and rates of compliance to <797>. Respondents from this year’s survey hail from 45 states, Washington DC, Puerto Rico, and include 41 respondents from Canada. 

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The survey results for physical plant metrics demonstrate both improvement and confusion. An increasing number of hospitals have achieved compliance with air pressure and velocity documentation. However, we would like to see hospitals make a stronger commitment to implementing straightforward, inexpensive compliance solutions, such as installing required pressure gauges and lines of demarcation. Likewise, it is imperative that every pharmacy director ensure that all PECs (not just BSCs) are certified to CETA guidelines.  

Six of the 113 respondents with neither an ante nor buffer room reported that they perform high-risk compounding utilizing one of the following approaches:

  • LAFW for non-HD compounding
  • LAFW for HD and non-HD compounding
  • BSC for HD compounding
  • CACI for HD compounding, CACI for non-HD compounding

High-risk compounding may be performed only in a sterile compounding facility with both an anteroom and buffer room separated by physical walls and doors, or within an isolator. 

In the scenarios above, only the instance where CACIs are used is acceptable (as long as separate isolators are used for hazardous and non-hazardous compounding).

This item should have been asked only of those respondents who at least have an anteroom, but the entire population was asked this question, which may have skewed the results lower. 

Compliance with LOD based on type of physical plant:

  • Buffer only: 62% 
  • Anteroom only: 62% 
  • Both ante and buffer: 83%
  • Neither ante nor buffer: 41%

Upon further review, that issue does partly account for the low overall compliance; however, it is easy to comply with the requirement for a LOD. It does not cost more than a roll of cleanroom tape and the time to train staff to use the LOD properly.

Next year, the logic behind this question will be changed so that it is only asked of those who have both an ante and buffer room or a segregated compounding area. We hope for 100% compliance for the placement of lines of demarcation.

This question raises an interesting issue. In 2011, a high percentage (86%) of locations reported that their primary engineering controls were certified according to CETA 003-2006 (or similar). Over the past three years, the percentage has continued to climb (91%, 92%, and 95%, respectively).

These results are somewhat surprising, as they differ from what has been observed by the study directors in audits of hospital certification reports and in talking with state board of pharmacy inspectors and Sterile Compounding Boot Camp attendees. 

We have observed (through reviews of actual certification reports, as well as conversations with hospital staff), that certification of primary engineering controls is often not performed in accordance with CETA 003-2006. Many reports do indicate that BSCs are certified according to NSF/ANSI 49-2012, which is an appropriate standard for BSCs, but not for all other primary engineering controls. 

Although the study directors have noticed that a growing number of certification reports indicate they are performed according to CETA 003-2006, our anecdotal observations do not jibe with these data.



Compliance to <797> continues to trend upward. The charts in this section detail the types of facilities that have achieved the highest compliance rates, demonstrate current trends in compliance, and identify those areas that receive the lowest compliance scores.

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Compliance with the daily and monthly cleaning activities ranges between 69.8% and 72.9%. The importance of cleaning activities has been highlighted by the NECC event, and it is disappointing that only three-quarters of hospitals comply.

It is important to understand how many hours are required to perform daily deactivation (for HDs), cleaning (with germicidal detergent), and disinfection (with sterile 70% IPA) inside the primary engineering controls; how long it takes to perform daily cleaning of high touch, horizontal surfaces and floors; and the investment in time required to properly perform a monthly cleaning. This must be accounted for in staffing models and in the personnel budget.

The importance of a robust sanitization program is crucial to achieving and maintaining a suitable environment for sterile compounding.

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It is puzzling that there seems to be a barrier to achieving full compliance on the first item above. Since the chapter was first written, cleaning supplies and equipment have improved vastly. Most mops have changeable heads and mop head covers, making labeling unnecessary. Nonetheless, a container or bucket is needed to mix the cleaning solution (germicidal detergent and sterile water) for use inside the primary engineering control. That container should not be used to hold cleaning solutions used on the walls and ceilings or the floors. This requirement should be relatively easy to comply with.

Compliance may be compromised on the second item above because it includes gloved fingertip sampling. This item will be changed, and the text in the parentheses will be deleted in future studies to see if that explains the low compliance. In the case of pharmacies that outsource daily and/or monthly cleaning to non-pharmacy personnel, those performing cleaning must complete the hand hygiene and garbing competency and the cleaning and disinfection competency, but they do not need to complete gloved fingertip sampling. Since only trained pharmacy personnel may clean inside ISO Class 5 devices, an outsourced cleaning company would not be required to complete GFS.


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Compliance remains low on items that relate to the written Environmental Sampling Plan, including: sample locations for viable air and surface samples, method of collection, frequency of sampling, volume of air sampled (for viable air samples), time of day in relation to compounding, and action levels. The study directors believe that many pharmacies continue to rely on their certification professional (at least with regard to viable air sampling). 

By way of this report, we would like to challenge pharmacies to create their own Environmental Sampling Plan. As the facility expert, you know where contamination is likely to affect compounding. If you rely on the certification company to perform viable air sampling twice a year in association with recertification of the physical plant (currently the minimum acceptable practice), then we challenge you to at least do the following:

  • Decide how many liters of air to sample. The chapter states 400 to 1000 liters. We recommend 1000 liters in the ISO Class 5 spaces and 400 liters in ISO Class 7 and 8 spaces.
  • Use general AND fungal specific media. At this time, the chapter requires both for high-risk operations only, but we believe fungal specific media should be used by all compounders regardless of risk level.
  • Perform surface sampling. Although the chapter states “periodically,” consider starting at least at the time of media fill testing (along with gloved fingertip sampling). We recommend sampling occur at least weekly in operations performing high-riskcompounding and monthly in those performing low/medium risk level compounding. Surface sampling, like gloved fingertip sampling, is always best performed at the end of the compounding shift. We recommend it be performed randomly and always associated with specific persons and primary engineering controls.
  • Develop your own sampling plan based on your knowledge of areas at greatest risk of contamination (such as work areas near the ISO Class 5 environment, counters near doors, pass-throughs, etc).

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Chapter <797> requires that all employees of reproductive age (male or female) be provided with a document to “confirm in writing that they understand the risks of handling HDs. The training shall include at least the following: (1) safe aseptic manipulation practices; (2) pressure techniques when utilizing a BSC or CACI; (3) correct use of CSTD devices; (4) containment, cleanup, and disposal procedures for breakages and spills; and (5) treatment of personnel contact and inhalation exposure.” This document is often referred to as an Acknowledgement of Risk or Confirmation of Risk form. CriticalPoint is again making their template available for download for anyone who wishes to use it:



Of the 162 hospitals that said they use a 0.22 micron filter to sterilize solutions, only 20% said they routinely perform a bubble point (filter integrity) test, which is a requirement of USP <797>. 

If a 0.22 micron sterilizing filter is used for the purpose of sterilizing a solution (meaning that the solution is nonsterile and must be made sterile), that meets the definition of high-risk compounding. 

Each batch or CSP that is made sterile by using a 0.22 micron filter must be followed by a filter integrity test wherein the filter just used to compound is tested to ensure that it has maintained its integrity throughout the compounding process. This test, often called a bubble point test, is easy and inexpensive to perform. Let’s work to improve this compliance!



In 2012 and 2013, only 12% and 15% of the entire study respondents (respectively) cited concern about state board of pharmacy (SBOP) sanctions as the strongest factors motivating their pursuit of compliance. Currently, 24% of respondents name their concern for SBOP sanctions as the most influential factor driving their pursuit of compliance.

It’s been two years since the NECC event occurred, and the study directors were puzzled by these data. The primary challenge to compliance is reported as budget restrictions, which is understandable. But if that is the case, why has compliance not risen dramatically on the wide variety of inexpensive work practice controls that can and should be instituted even in non-compliant physical plants? It is even more important to perform surface, air, and gloved fingertip sampling when the physical plant is known to be an issue. 

Nineteen percent of respondents said that their chief limitation was the availability of training and competency resources. There is a wide variety of offerings available, including distance learning and electronic competency programs.

Of grave concern, 16% of respondents said the time required to become compliant with the chapter was their major challenge. Remember that USP <797> standards represent only minimum acceptable practice standards. We are fearful for the outcomes of patients at organizations that are too busy to do the minimum!


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