West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

What is the BUD of a water-containing oral formulation?

1. 6 months or the time remaining until the earliest expiration date of any API, whichever is earlier

2. 14 days or the time remaining until the earliest expiration date of any API, whichever is earlier

3. 30 days or the time remaining until the earliest expiration date of any API, whichever is earlier

4. 12 months or the time remaining until the earliest expiration date of any API, whichever is earlier

The correct answer is: 6 months or the time remaining until the earliest expiration date of any API, whichever is earlier

The correct answer reflects the guidelines for determining the beyond-use date (BUD) for water-containing oral formulations. According to the United States Pharmacopeia (USP) standards, such formulations typically have a BUD of 14 days when stored in the refrigerator, unless specified otherwise by the manufacturer or if a stability study provides an alternative date. In this context, the BUD of 6 months actually pertains to non-aqueous formulations or certain conditions under which a product may be used, but it does not apply to water-containing preparations. The focus here is specifically on ensuring product safety and efficacy within a time frame that accounts for potential microbial growth and chemical stability in formulations that contain water. The choice that suggests 14 days aligns with the considerations of microbial risks in water-containing formulations and the need for a conservative approach in pharmacy practice. Recognizing the importance of correctly assigning BUD according to the nature of the formulation helps pharmacists ensure patient safety and effective medication management.