What is USP 797?
Incidences of patient morbidity and mortality associated with improperly prepared or contaminated sterile preparations have prompted the FDA to consider regulating or even banning pharmacy compounding. The first official, enforceable sterile preparation-compounding requirement in the United States took effect on January 1, 2004, when United States Pharmacopeia published USP Chapter <797>. This Chapter is now the US standard for pre-administration manipulations of compounded sterile preparations (CSPs), which includes compounding, transportation, and storage. <797> focuses on protecting patients and therefore applies not only to pharmacies but to all sites where CSPs are compounded and to all personnel who compound sterile preparations, regardless of practice setting or profession.
