Under what risk categories are parenteral nutrition preparations prepared?
Parenteral Nutrition preparations in almost all circumstances falls into the category of medium-risk level CSPs no matter if fat emulsion is present or not. In the absence of passing a sterility test, the storage conditions cannot exceed 30 hours at controlled room temperature or 9 days at a cold temperature. Parenteral Nutrition preparations shall not be frozen. About the only instance where low-risk level compounding would be applicable would be using a dual-chamber container system and only making two injections into the container. In the absence of a sterility test, the storage conditions cannot exceed 14 days at a cold temperature. Parenteral Nutrition preparations may also be high-risk level compounding if one of the ingredients is compounded under high-risk conditions such as from a non-sterile bulk powder. In the absence of a sterility test, storage conditions cannot exceed 3 days at a cold temperature.
