Pharmacy Law Practice Exam

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What is the temperature range for Room Temperature BUD in Celsius?

0-15

15-20

20-25

The term "Room Temperature" in the context of Beyond-Use Dates (BUD) for pharmaceuticals generally refers to a temperature range that ensures the stability and efficacy of the medication. The correct range for Room Temperature as stated in pharmaceutical standards is typically defined as 20-25 degrees Celsius. This range is established to provide a balance, ensuring that medications are stored in conditions that prevent degradation or other adverse reactions that could affect safety and efficacy.

This definition is supported by various regulatory and compounding guidelines, such as those from the United States Pharmacopeia (USP). Options outside of 20-25 degrees Celsius do not adhere to these definitions. For example, temperatures below 20 degrees could result in a higher stability risk for many products, while temperatures above 25 degrees may put drugs at risk for degradation due to increased molecular activity. Therefore, the use of the 20-25 degrees Celsius range is critical to maintaining the integrity of medications stored at room temperature.

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