The USP <797> was originally published in 2004 and revised in 2008 with the goal of preventing harm associated with the preparation of medications and fluids. Its provisions address “Compounded Sterile Products” (CSPs), which are any parenteral medication or fluid prepared using a syringe and needle, with or without dilution.

When pharmacists prepare CSPs, they often use special environments called “clean rooms.” The International Standards Organization (ISO) categorizes the air quality in clean rooms based upon airborne particle counts per cubic meter. For particles sized 0.5 micrometers, the ISO 5 standard requires an environment in which there are fewer than 3,520 particles per cubic meter.

According to the USP <797>, CSPs prepared outside of an ISO 5 air quality must be used within one hour of the time of preparation; these are termed “immediate-use compounded sterile products.” Immediate-use...

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