Should CSPs not immediately dispensed be refrigerated?

Prepare for the USP 797 Sterile Compounding Test with detailed questions and explanations. Study effectively with flashcards and multiple-choice questions. Get exam-ready now!

The correct response to the question of whether compounded sterile preparations (CSPs) that are not immediately dispensed should be refrigerated is that they should not. According to USP 797 standards, the storage requirements for CSPs depend significantly on the intended use and the stability of the components within the preparation. If a CSP is not administered or dispensed immediately, it is typically stored at controlled room temperature unless otherwise recommended based on sterility assurance and stability guidelines.

Refrigerating a CSP that does not require it might lead to undesirable effects such as precipitate formation, phase separation, or changes in potency, particularly for certain medications that have specific storage requirements. Each CSP should be evaluated based on its stability profile, and the storage conditions indicated in the manufacturer's guidelines should be closely adhered to, which usually includes room temperature if refrigeration is not specified.

Therefore, it is essential to properly assess the requirements for different types of CSPs to ensure their effectiveness and safety prior to their administration.

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