West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Unless otherwise specified in the individual monograph, or in the absence of stability data to the contrary, the BUD for a multiple unit container is no later than _______ or ________, whichever is earlier.

1. 1 year from the date the drug is dispensed OR 6 months from the date the drug is dispensed

2. 6 months from the date the drug is dispensed OR expiration date on the manufacturer's container

3. expiration date on the manufacturer's container OR 1 year from the date the drug is dispensed

4. expiration date on the manufacturer's container OR 2 years from the date the drug is dispensed

The correct answer is: 1 year from the date the drug is dispensed OR 6 months from the date the drug is dispensed

The correct answer is based on the guidelines regarding Beyond-Use Dates (BUD) for multiple unit containers, particularly in the context of compounded medications and their regulations. The BUD is determined to ensure the safety and efficacy of pharmaceuticals after they have been dispensed. In this case, the BUD for a multiple unit container is established as being no later than 1 year from the date the drug is dispensed or 6 months from the date the drug is dispensed, whichever is earlier. This ensures that the medication remains effective and safe for use within a reasonable timeframe, minimizing the risk of degradation or potential harm to the patient. The justification for the 6-month period stems from common regulations that allow for a more conservative approach when stability data is limited or unspecified. Therefore, when both periods are considered, choosing the earliest date provides a safeguard for patient safety. Other options suggest different combinations of timeframes, but these either extend the usability beyond the recommended period or do not prioritize the patient safety measures embedded in the guidelines for multiple unit containers.