Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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What is the BUD for medium risk sterile compounds stored in the freezer according to USP 797 guidelines?

  1. 14 days

  2. 45 days

  3. 6 months

  4. 30 days

The correct answer is: 45 days

The correct answer is based on the guidelines established by the United States Pharmacopeia (USP) under USP 797, which governs sterile compounding practices. For medium-risk sterile compounds that are stored in the freezer, the assigned beyond-use date (BUD) is indeed 45 days. This time frame is based on considerations of the complexity involved in compounding these medications and potential microbial contamination risks. Medium-risk preparations typically include those that involve multiple sterile ingredients, complex procedures, or a longer compounding process. Freezing these compounds helps to minimize degradation and maintain stability, which justifies the longer beyond-use date compared to those stored at room temperature or refrigerating practices. Understanding the rationale behind BUDs is critical for pharmacists in order to provide safe and effective patient care, particularly in ensuring that medications maintain their integrity and efficacy throughout their use.