How many entries into a sterile container are allowed for low-risk CSPs?

The guidelines for low-risk compounded sterile preparations (CSPs) permit up to two entry points into a sterile container. This allows for the necessary flexibility in the preparation of medications, as it typically enables one to withdraw a sterile product and then potentially add a second component without compromising sterility.

In the context of sterile compounding, low-risk CSPs are defined as those prepared in simple and straightforward processes, such as using sterile ingredients and manipulating them only once. Limiting the number of entries to two helps minimize the risk of contamination while still allowing for the combination of multiple ingredients if necessary, as long as proper aseptic techniques are observed.

Understanding these guidelines is crucial for maintaining sterility in compounded preparations and ensuring patient safety.