While USP Chapter <797> is still commonly thought of as simply a source of minimum guidelines for gaining compounding compliance, in truth, <797> contains proven and established metrics to provide a framework to measure the quality and effectiveness of your compounding practices. Furthermore, upon application of these metrics, if compounding practices are deemed insufficient in the eyes of an accreditation agency, regulatory body, or even an institution’s own quality requirements, <797> can serve as a valuable tool in driving budget allocation for process improvement.
Of course, convincing administration to allocate additional dollars is rarely a straightforward task. However, when a facility’s compounding practices clearly do not meet the minimum standards set forth in <797>, the argument for additional funds tends to be fairly transparent. For example, if humidity levels are not monitored in your cleanroom complex, there may be an unknown elevated contamination risk, yet ignorance to such a situation will not excuse your facility from state or federal regulatory scrutiny. In this case, you may need the support of administration to implement temperature and humidity monitors and address any HVAC issues as necessary, and <797> tenets can support such a request.
It is important to leverage USP <797> regulations to help modernize pharmacy equipment and elevate practices. To do this successfully, the pharmacy director must assume the responsibility of educating administration on the importance of compliance, both from a patient safety and financial impact standpoint. PP&P is happy to provide a slide kit with data from last month’s State of Pharmacy Compounding for just this purpose. Visit our website—www.pppmag.com/slides—to download the slide package in PowerPoint and use the data to support your case for budget allocation to drive process improvement.
Compounding safety must become an institutional priority, not simply an issue for pharmacy to manage alone.
All the best,
R. Mitchell Halvorsen
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