West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

What is the BUD for a nonaqueous formulation (lotion, cream, ointment, etc.)?

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 beyond-use date (BUD) for a nonaqueous formulation is determined based on the stability of the ingredients within the formulation. For nonaqueous products, which can include lotions, creams, and ointments that do not contain water, the general guideline is that the BUD is set at 6 months, or until the earliest expiration date of any active pharmaceutical ingredient (API) in the formulation, whichever is sooner. This guideline is crucial for maintaining the efficacy and safety of the preparation, as nonaqueous formulations may have longer stability due to the absence of water, which can promote microbial growth and chemical degradation. The 6-month timeframe is a standard established by the United States Pharmacopeia (USP) for nonaqueous preparations, reflecting a balance of practicality and safety in pharmacy practice. In contrast, shorter BUDs such as 14 days and 30 days are applicable to other specific situations, like aqueous formulations (those containing water), which are more prone to microbial contamination and degradation due to hydrolysis. Therefore, selecting the BUD of 6 months aligns with the best practices in compounding pharmacy for nonaqueous formulations.