West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

What is the BUD of a water-containing topical/dermals and mucosal liquids and semisolid formulations?

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 is 14 days or the time remaining until the earliest expiration date of any API, whichever is earlier. Beyond-use dating (BUD) for water-containing topical, dermal, and mucosal formulations is crucial for ensuring the safety and efficacy of these products. The 14-day guideline is based on the risk of microbial growth in water-containing preparations, which can deteriorate more quickly than dry formulations. This brief BUD helps mitigate the risk of contamination and preserves the integrity of the active pharmaceutical ingredients (APIs). Formulations that contain water are more susceptible to spoilage and microbial growth than those without water; hence, a shorter BUD is justified in this context. The regulation emphasizes monitoring the expiration dates of any APIs present in the formulation alongside the BUD, ensuring that products are not only safe but also effective for patients. A longer BUD of 6 months or 12 months is not appropriate for these types of formulations due to the reasons outlined, while 30 days does not adequately consider the specific risks associated with water-containing products.