The practice of health system pharmacy has witnessed some extraordinary changes in the last decade, not the least of which are the myriad practice and regulatory changes affecting compounding. With the growth in drug regimen complexity over the last 25 years, hospital pharmacy practitioners have become keenly aware of the need for comprehensive control over compounding processes—particularly those involving hazardous or other sterile compounds. As the industry reacted by developing hardware and software solutions to aid in physical preparation, quality control, and workflow management, so too have regulatory and accreditation bodies focused their efforts on fostering safer, more efficient compounding practices.
Never has it been more important or more essential to strive for and achieve the practice standards set forth by regulatory bodies. Although USP General Chapter <797> has been available for years, it is not too late to prioritize its tenets. As accreditation becomes more of a necessity, adopting these tenets can no longer be viewed as optional, or even secondary in priority. The simple fact is that increasing regulatory changes—the introduction of USP General Chapter <800> (becomes official 7/1/18), forthcoming updates to <797>, FDA’s Compounding Quality Act introducing 503A and 503B categories for compounders, NIOSH’s update to the Hazardous Drug List—indicate an attendant increase in regulatory inspections.
In the recent past, it was not uncommon for hospital inspections to include only a cursory review of pharmacy practices, especially if the inspector did not have a pharmacy background. This is a truism no longer, as several bodies—including state boards of pharmacy, accrediting agencies, FDA, OSHA, and others—now apply scrutiny to pharmacy compounding and all of its aspects. Most accrediting bodies treat USP chapters as standards of care and expect full compliance. In the wake of the tragic failures at NECC, many state boards of pharmacy have reviewed their inspecting policies and have overhauled their training of pharmacy inspectors. These inspectors—now well versed in <797>—understand the special risks in HD compounding and recognize the actions that increase risk for microbial contamination during compounding. As such, they will enter your facility with high expectations.
Now is the time. Commit to meeting these expectations, as doing so will help ensure the viability of your pharmacy operation into the future.
All the best,
R. Mitchell Halvorsen
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