What is the BUD for low risk compounded medications stored in a refrigerator?

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The beyond-use date (BUD) for low-risk compounded medications stored in a refrigerator is established based on stability studies and industry standards. For low-risk sterile compounding, when such medications are prepared and stored in a refrigerator at the appropriate temperatures, they can remain potent and safe for up to 14 days.

This standard is in accordance with guidelines set by organizations like the United States Pharmacopeia (USP), specifically under the General Chapter <797> which governs the compounding of sterile preparations. The rationale for this 14-day guideline is built upon the understanding that refrigeration can help slow down microbial growth and preserve the integrity of the compounded medication, thus allowing for a longer storage period compared to those stored at room temperature, which typically have a shorter BUD.

In clinical practice, ensuring adherence to these standards is critical for maintaining patient safety and ensuring the efficacy of compounded medications.

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