FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

Which of the following high-risk sterile preparations requires sterility testing before administration?

1. Single-dose packages of 25 or fewer

2. Multidose vials for a single patient

3. Prepared in groups of more than 25 identical individual single-dose packages

4. Exposed for less than 6 hours at warmer than 8°C

The correct answer is: Prepared in groups of more than 25 identical individual single-dose packages

The correct choice indicates that high-risk sterile preparations that are prepared in groups of more than 25 identical individual single-dose packages require sterility testing before administration. This requirement is crucial because the increase in the number of preparations increases the risk of contamination. Preparations in larger quantities represent a higher risk for potential microbial growth and contamination, necessitating sterility testing to ensure patient safety. Options related to single-dose packages, multidose vials for a single patient, or those exposed to specific temperature limits generally pose a lower risk than those produced in bulk. The standards typically allow single-dose preparations that are properly stored and used promptly without the same stringent sterility testing requirements. Additionally, multidose vials, while they are exposed to multiple uses, are designed for use with individual patients and hence do not require the same level of sterility assurance before administration when handled according to guidelines. Similarly, the exposure time and temperature conditions specified in the other options mitigate risk sufficiently to forgo extensive sterility testing under normal circumstances.