NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

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What is the BUD for multiple-dose containers (MDC) opened inside or outside an ISO 5 environment?

Up to 28 days
1 hour
Up to 6 hours
14 days

The correct answer is: Up to 28 days

The BUD (Beyond Use Date) for multiple-dose containers opened inside or outside an ISO 5 environment is up to 28 days. This is because multiple-dose containers contain preservatives that help prevent contamination of the contents. These preservatives only have a certain effectiveness, so it is important to use the contents of the container within a set amount of time to ensure the efficacy of the medication. Option B (1 hour) is too short of a time frame for the BUD, and option C (up to 6 hours) is also too short as multiple-dose containers do not have stability for that long. Option D (14 days) is closer to the correct answer, but it may not be as effective as option A as it exceeds the recommended time frame for the BUD for MDC in an ISO 5 environment.