NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

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What is the BUD for ampules opened inside or outside an ISO 5 environment?

  1. Up to 28 days

  2. 1 hour

  3. Up to 6 hours

  4. Cannot be stored, must be discarded

The correct answer is: Cannot be stored, must be discarded

Ampules opened inside or outside an ISO 5 environment must be discarded and cannot be stored. A is incorrect because up to 28 days is the Beyond Use Date (BUD) only for ampules that have been opened and used in an ISO 5 environment. B is incorrect because 1 hour is the BUD for ampules opened outside of an ISO 5 environment, not inside. C is incorrect because up to 6 hours is the BUD for ampules opened and used in a lower classified cleanroom, such as ISO 7. However, this option does not specify the environment and therefore is not applicable.

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