Pharmacy Law Practice Exam

What temperature range is considered "room temperature" for BUD?

1. 15-20 degrees Celsius

2. 20-25 degrees Celsius

3. 25-30 degrees Celsius

4. 30-35 degrees Celsius

The correct answer is: 20-25 degrees Celsius

The definition of "room temperature" for the purpose of Beyond Use Date (BUD) is established to ensure the stability and efficacy of compounded medications. The range of 20-25 degrees Celsius is recognized as room temperature by the United States Pharmacopeia (USP). This range is important for pharmaceutical practices because it reflects typical conditions in which medications are stored in pharmacies and utilized by patients. The significance of adhering to this temperature range lies in the potential impact on the chemical properties and stability of the medication. Storing medications within this range helps to mitigate risks of degradation, which can occur at temperatures outside this defined range. Understanding and applying this definition correctly is crucial for pharmacists in determining the appropriate BUD for compounded products to ensure patient safety and therapeutic effectiveness.