NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

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What is the beyond-use date for single-dose containers (SDC) opened 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: 1 hour

Single-dose containers (SDC) that are opened outside an ISO 5 environment generally have a very short beyond-use date due to the increased risk of contamination once the seal is broken. Therefore, the correct answer is B: 1 hour. After this time period, the risk of microbial contamination increases significantly, making the medication potentially unsafe for patient use. Options A, C, and D are incorrect because allowing the medication to be stored for up to 28 days, 6 hours, or indefinitely after opening outside an ISO 5 environment would pose a significant risk to patient safety due to the likelihood of contamination within the container.

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