Kienle’s 10 New Building Blocks of Compounding Safety Each year, Patricia Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, shares 10 points that she believes pharmacists need to consider to ensure compounding safety and compliance with USP, state boards of pharmacy and other regulatory bodies. Get up to speed on USP compounding-related chapters and state regulations. USP remanded the long-anticipated revised USP General Chapters <795> and <797> on March 12, 2020, and USP <800> on hazardous drugs is not yet compendially applicable, because it ties its federal enforceability to approval of the 2019 revisions of <795> and <797>. The appeals of the USP chapters were all about beyond-use dates (BUDs) and the ability to extend them. The USP Committee isn’t finished with discussions about the new revisions, but it’s unlikely that content related to facilities, methods of environmental monitoring and other important aspects of compounding, will change. So, the information added to the remanded Chapter <797>— particularly information in the boxes in the remanded chapter—is valuable to incorporate into policies. To keep up to date, institutions should subscribe to the USP Compounding Compendium (www.usp.org/products/usp-compounding-compendium) and follow the USP compounding page (www.usp.org/compounding). Regarding state regulations, in some cases, they are more stringent than USP standards, and some states already have incorporated aspects of the revised but remanded USP chapters into their state regulations. For example, although USP <825>, the chapter concerning radiopharmaceuticals, has been official since Dec. 1, 2020, it has the same federal delay in enforceability as <800>, but some states have announced they will consider <825> enforceable in their states. Because of ongoing confusion about which standards to adhere to—USP or state regulations—especially around BUD and
frequency of personnel requalification, pharmacies should follow the more stringent regulations, which may be on the state side. Be aware of allowances and restrictions when unusual circumstances occur. The COVID-19 pandemic created situations no one anticipated. USP, ASHP, Institute for Safe Medication Practices (ISMP), CDC and FDA developed documents with allowances during the public health emergency. These included adjustments for BUDs, garb and personal protective equipment, as well as other components of compounding regulations and best practices, assuming appropriate oversight. As the situation has evolved, these documents have been updated. Given these frequent changes, compounding pharmacists should monitor key sources of information: ASHP Connect, USP compounding pages, ISMP’s website and newsletters, CDC, as well as FDA guidance pages. It’s important to remember that these allowances are usually only meant for the duration of the public health emergency and are not intended to be permanent policies. States also have issued alerts concerning their compounding expectations during the public health emergency, and many state health-system pharmacy societies provided summaries and notices to their members. So, it’s critically important to keep current with state-level changes by monitoring your state’s board of pharmacy website.
USP General Chapter <797> now includes strengthened recommendations for performing “at least monthly” surface wipe sampling for bacterial contamination in all classified areas and pass-through chambers. Photo credit: CriticalPoint Center for Training and Research
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