Chapter_21

A single-dose injection conaining more than 100 mL of solution for intravenous use (i.e., bypassing the gastrointestinal tract)

A single-dose injection containing 100 mL or less of solution for intravenous use (i.e., bypassing the gastrointesinal tract); also called a minibag or piggyback

A large number of sterile products prepared by a single compounder at the same time

Required on an annual basis for compounding personnel. A simulated product is prepared by the compounder with the use of a culture medium, such as soy broth, to perform manipulations using aseptic technique. The product is then incubated and checked after a predetermined amount of time for growth contamination