USP Chapter 797 and Environmental Monitoring

Over the last 10 years, there has been increasing morbidity and mortality resulting from infections caused by intravenous or intrathecal preparations sterilely compounded in hospitals or freestanding pharmacies. Although individual state boards of pharmacy have oversight of these activities, prior to 2004 there were no universal guidelines to ensure that all compounded products were aseptically prepared. That year, the United States Pharmacopeia (USP) developed such guidelines, which resulted in an outcry from pharmacists across the country. Over 500 comments were submitted to the USP. Three years later, the guidelines are about to take effect, and all the comments have been addressed. In light of the continuing number of deaths from contaminated preparations, the infection control implications are huge for all patients who receive these products. Do not be surprised if you are asked to support pharmacy environmental monitoring programs in your hospital in the near future. Vol. 30, No. 14