What is the maximum beyond-use date for sterile compounded preparations dispensed to practitioners?

The maximum beyond-use date for sterile compounded preparations dispensed to practitioners is typically set at one week. This regulation is in place to ensure the safety and efficacy of compounded sterile products, given that the stability and sterility of these products can diminish over time.

When a sterile preparation is compounded, it is crucial to minimize the risk of contamination and ensure that the preparation maintains its potency until it is administered to a patient. The one-week limit strikes a balance between allowing practitioners time to use the preparation while recognizing that the risks associated with sterility can increase significantly beyond that period. This time frame helps to ensure that preparations are used while they remain within an acceptable range of sterility and efficacy.

In practice, this limit supports the regulation and standards put forth by pharmacy boards and practice standards aimed at protecting patient safety and ensuring effective treatment outcomes. A longer duration may lead to increased risks, which is why the one-week maximum is emphasized.