57. According to USP <795>, what is the maximum beyond-use date (BUD) for a nonsterile compounded preparation with a short stability period, stored at room temperature?
Answer: A
The maximum beyond-use date for a nonsterile compounded preparation with a short stability period is 14 days.
When compounded nonsterile preparations have a short stability period and are stored at room temperature, the maximum beyond-use date (BUD) established by USP is 14 days.
A) 14 days
This option is correct as it aligns with USP , which states that nonsterile compounded preparations with a short stability period must be assigned a BUD of 14 days when stored at room temperature.
B) 30 days
This option is incorrect because USP does not allow for a BUD of 30 days for nonsterile compounded preparations with a short stability period at room temperature. This duration exceeds the time frame specified for such preparations.
C) 60 days
This option is also incorrect as it suggests a BUD of 60 days, which is not permissible according to USP for nonsterile compounded preparations with a short stability period stored at room temperature.
D) 90 days
This option is incorrect because a BUD of 90 days is significantly longer than what USP permits for nonsterile compounded preparations with a short stability period when stored at room temperature.
Conclusion
The correct answer, 14 days, is firmly established by USP for nonsterile compounded preparations with a short stability period. All other options exceed the recommended maximum BUD for such preparations, which ensures safety and efficacy in pharmaceutical compounding practices.