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Evolving Compliance

April 2014 : State of Pharmacy Compounding - Vol.11 No. 4 - Page #4

For seven years, PP&P has surveyed pharmacy directors nationwide to ascertain their successes and challenges in creating and maintaining a compliant sterile compounding operation. The survey includes a focus on <797> compliance, with the goal of identifying those areas where full compliance remains elusive. Furthermore, we explore budget and staffing issues, trends in compounding volumes and outsourcing, and satisfaction with compounding equipment, among other topics.

The survey responses are solicited via email and this year, a total of 375 responses were received yielding a confidence interval of 4.89% (95% +/-4.89) based on the total population of pharmacy directors nationwide. We purposely survey a random sampling of pharmacy directors, not just readers of PP&P, to ensure the data herein reflects trends across the entirety of health system practices. Therefore, we are quite pleased to learn that 76% of respondents rely on PP&P as a resource for <797>-related information.

Regulatory Enforcement
Regulatory agencies, including accrediting bodies, CMS, and state boards of pharmacy, continue to inspect for <797> compliance, with particular emphasis this year on written policies and procedures, single- and multiple-dose vial usage, and measurements of staff competency. While regulatory action in response to compounding practices remains rare, the number of facilities receiving citations and recommendations doubled to 10% this year, underscoring the importance of achieving and documenting compliant practices.

Regulatory enforcement clearly has a strong impact on pharmacy practice; in fact, a lack of enforcement can be detrimental to pharmacy’s performance. Facilities in states whose boards of pharmacy do not enforce <797> reported lower compliance rates and projected longer timelines to achieve compliance. These facilities were less likely to have read the current version of USP <797> and conducted gap analyses more infrequently than facilities in states whose board of pharmacy requires compliance with <797>. 

Compliance Challenges
Over the past two years, self-reported compliance rates with USP <797> have remained flat and while 93% of facilities are actively addressing compliance, just 32% are confident they have achieved full compliance. Most facilities have had success in complying with BUD requirements, eliminating compounding on the units, implementing training programs, and establishing recall systems, for example. But other areas continue to pose challenges, including the establishment of an effective environmental monitoring program, which stymies many facilities. To solve this issue, more pharmacies are turning to outsourced vendors to provide regular monitoring services, an option worth exploring for those facilities that are not confident in their current monitoring processes. 

The New USP <800>
Investments in safe hazardous drug (HD) compounding have been low for many facilities. In the past it was not uncommon for facilities to cite their low volume of HD compounding as a reason for not investing in the appropriate containment equipment or not assigning designated areas for HD compounding. However, with two-thirds of all US hospitals now compounding HDs, the adoption of safety measures for staff cannot be volume dependent. Engineering controls, for example, are widely used in cleanrooms and are highly rated by pharmacy. However, one third of those facilities conducting HD compounding have yet to ensure this preparation occurs in a chemo hood within a negative pressure cleanroom that vents to the exterior of the facility. 

We expect to see progress in this area once the new chapter USP <800> Hazardous Drugs—Handling in Healthcare Settings is finalized and published. This proposed chapter establishes clear expectations and guidelines for ensuring safety in the handling of HDs and is currently available for review and comment in advance of its publication; it can be accessed at:

Developing Trends
The pace of adoption for new technology solutions in the cleanroom, such as IV workflow management tools and closed system transfer devices, has been less than expeditious. This reluctance to adopt novel approaches has not been limited to just those products that require budgetary planning; in fact, few facilities are conducting wipe analyses on a regular basis to determine the presence of HD residue. With the anticipated publication of USP <800> Hazardous Drugs, we will be watching for new practice trends to develop.

Despite slow rates of adoption, satisfaction rates with compounding equipment and services are extraordinarily high, reflecting the fact that there are myriad options for high quality products and services in this marketplace, from training programs and engineering controls, to software and outsourced vendors.

Notable in this year’s survey is the combination of concern with outsourced compounding and the high satisfaction rates assigned to outsourced vendors. Given the number of recalls driven by sterility and stability issues over the past few years, many hospitals have decreased their outsourcing volume, reduced the number of vendors they use, and increased their oversight of these vendors. At the same time, the number of recalls plummeted this year, fewer quality problems were reported, and most pharmacy directors gave high marks to their own outsourced vendors. Few facilities currently plan to change vendors based on the new FDA registration, but the number of facilities planning to outsource fewer CSPs in the future grew for the third year in a row. 

Benchmark Your Progress
To support your efforts, PP&P provides additional benchmarking data on our website. For example, you can compare your staffing structure against the national average of FTEs by daily compounding volume, or benchmark your renovation budget against that of like-sized facilities.

The goal of this report is to continue the conversation about compliance; this holds true whether the results provide an opportunity to enjoy self-congratulations for outperforming similar sized facilities, or if the data impels your department to make further strides in improving your compounding program. To that end, we are happy to make much of the data herein available on our website as PowerPoint slides. Please feel free to use these slides (with the required attribution line) in your own presentations. 

By design, achieving compliance is not a task that is ever completed and then permanently checked off the to-do list; rather, it must be part of an ongoing and continuous striving for improvement. In exploring the common challenges pharmacy faces and detailing the hard-won successes of your peers on the pages of PP&P, we aim to support your ongoing efforts at compliance.

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

Download SOPC 2014 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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