Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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According to USP 795, what is the BUD for water-containing topical, mucosal, and semisolid compounds?

14 days
30 days
6 months
3 days

The correct answer is: 30 days

The correct answer regarding the beyond-use date (BUD) for water-containing topical, mucosal, and semisolid compounds as defined by USP 795 is indeed 30 days. This guideline is established to ensure the safety and efficacy of compounded preparations. In the context of USP 795, which pertains to nonsterile compounding, the BUD represents the time period during which a compounded preparation is expected to retain its intended quality, assuming it is stored properly. For water-containing formulations, the 30-day BUD allows for adequate stability and minimizes the risk of microbial contamination, which is a significant concern when water is present in the formulation due to its ability to support the growth of microorganisms. In contrast, options such as 14 days or 3 days would not provide sufficient time for these preparations to be effective under typical use conditions, and 6 months is excessive for water-containing products, as the risks of degradation and microbial growth are considerably higher after such a prolonged period. Thus, adhering to the 30-day BUD ensures compliance with safety regulations and helps protect patient health.