USP <797> Enforcement Impacts Compliance

April 2013 : State of Pharmacy Compounding - Vol. 10 No. 4 - Page #2

The ongoing challenge of building and managing a fully compliant sterile compounding operation raises the question as to what factors drive successful compliance. In the first quarter of 2013, PP&P surveyed a random nationwide sampling of directors of health-system pharmacies. We asked about inspection experiences, outsourced compounding, staffing levels, and compliance achievements.

Responses were solicited via email, and a total of 394 were received, yielding a confidence interval of 4.76 (95% +/-4.76) based on the total population of pharmacy directors nationwide.

We purposely surveyed a random sampling of pharmacy directors, not just readers of PP&P, to ensure the following data reflects trends across the entirety of health system practices. Therefore, we are quite pleased to learn that 73% of respondents rely on PP&P as a resource for USP Chapter <797>-related information.

Regulatory Impact
The number of hospital pharmacies that have achieved full compliance with <797> remained flat this year; just 34% meet all requirements. This is particularly concerning given the strong regulatory interest in <797>. Regulatory agencies, from CMS to state boards and accreditors, are demonstrating an increased interest in compounding practices and many inspections include queries on training practices, single- and multiple-dose vial usage, beyond use dating, and immediate-use issues.

It is important to be aware of who is inspecting your facility. When the accreditor is trained as a pharmacist, you can expect a higher level of scrutiny in the pharmacy in general, and of your compounding practices in particular. Most regulatory inspections now include questions relating to <797> compliance.

Fortunately, pharmacy directors’ awareness of their state board’s position on <797> is increasing. This is a crucial point, as a state board’s position on <797> enforcement directly impacts compliance: facilities located in a state that requires <797> compliance have higher compliance rates, conduct gap analyses more regularly, and are more likely to have compliant cleanroom cleaning practices (carried out by dedicated personnel) than facilities in states that do not require <797> compliance. Of note, those facilities that are unaware of their state board’s position on <797> are also the least compliant. They are the least likely to have a compounding training program in place, to utilize a cleanroom, or to document cleaning practices. 

Without a doubt, thoughtfully developed and clearly written regulations are necessary to fostering compliant practices, however, enforcement of regulations is also a key component to ensuring safe practices are implemented universally to the benefit of every patient, not just the patients of the most committed practitioners. In short, it matters when regulation is enforced.

Ultimately, compliance matters because patient incidents stemming from compounding errors do occur—almost one third of facilities reported experiencing such an incident, and given the difficulty of connecting a patient incident to a compounding error, it is safe to assume that the actual incident rate is even higher. Sadly, the events of the past year have underscored the reality of the potential danger that exists for patients when a medication product is not properly compounded. 

New Trends
The popularity of cleanroom implementations continued this year and for the first time, cleanroom usage passed the 70% mark. Nonetheless, gaining budgeted funding for pharmacy renovations remains difficult for many facilities. Likewise, environmental monitoring continues to be a challenge; few pharmacy directors are confident in their systems and as a result there is a growing interest in outsourcing oversight of these activities.

Awareness of the risks to staff posed by hazardous compounding is growing; facilities have been quick to adopt CSTDs in the pharmacy, but CSTD adoptions on the floor to protect nursing staff have been slower. In addition, pharmacy’s oversight of nurses compounding medications on floor dipped this year. Given the likelihood of contamination in emergent situations, it is crucial that pharmacy actively provide nurses with aseptic technique training and reinforce this education on a periodic basis.

Additional staff and systems were necessary this year to address the skyrocketing number of recalls. Despite the wide use of recall systems, many facilities struggle to identify all affected products and patients, especially when recalls involve outsourced products. IV workflow automation provides a solution to identifying recalled products, and interest in this new technology is on the rise.

Monitoring outsourced compounding vendors is a challenge for many pharmacy directors; few are conducting site visits of their vendor and irregular receipt of QA reports is the norm. As a result, expected increases in compounding volume this year will be largely managed in-house, as few facilities plan to increase their outsourcing volume. More facilities also are relying on the safety and convenience of RTU products and this usage is projected to continue to expand.

Benchmark to Like-sized Institutions
When planning future departmental initiatives or simply requesting funding for pharmacy improvements, benchmarked data can serve as a powerful tool in making your case. To support these efforts, we provide additional benchmarking data on our website. Overall <797> compliance rates are included in this report, but on our website you will find a more detailed breakdown of compliance rates by facility size. On the pages that follow, note the Bonus Online Benchmarking Data sections for directions on how to access this additional information.

Facilities with the highest compliance rates are those whose state boards require <797> compliance—they consistently outperform their peers in states without such a requirement. Conversely, those unaware of the position of their state board on <797> compliance are woefully unprepared, are unlikely to have ever conducted a gap analysis, and have the lowest overall levels of compliance. Setting expectations is key to achieving goals and state boards committed to <797> principles create positive results for compliant compounding practices in their states. However, committed pharmacy directors are the linchpins to creating quality compounding practices. Therefore, adherence to the tenets of <797> should be a designated priority of all hospital pharmacies regardless of state requirement, because doing so will improve patient safety.

Deanne Halvorsen is the editorial director at Ridgewood Medical Media, publishers of Pharmacy Purchasing & Products and Medical Lab Management. She can be reached at


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Download SOPC 2013 Powerpoint SlidesSelect graphs from the State of Pharmacy Compounding are available for your use as PowerPoint slides. Click here to download


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