West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

According to USP/NF standards, how do you determine the BUD for unit-dose containers?

1. 6 months from the date the drug is repackaged OR expiration date on the manufacturer's container, whichever is earlier

2. 1 year from the date the drug is repackaged OR expiration date on the manufacturer's container, whichever is earlier

3. 1 year from the date the drug is repackaged OR 6 months from the date the drug is repackaged, whichever is earlier

4. 2 years from the date the drug is repackaged OR expiration date on the manufacturer's container, whichever is earlier

The correct answer is: 6 months from the date the drug is repackaged OR expiration date on the manufacturer's container, whichever is earlier

The determination of the beyond-use date (BUD) for unit-dose containers is guided by USP/NF standards, which focus on ensuring the safety and efficacy of medications after they have been repackaged. The correct approach specifies that the BUD should be set for a duration of 6 months from the date the drug is repackaged or until the expiration date indicated on the manufacturer's container, whichever occurs first. This method provides a clear guideline that balances the safety of medication use with the practical considerations of shelf life. Option A is correct because it adheres to the recommendation that for repackaged medications in unit-dose forms, the shorter of the two time frames (the manufacturer's expiration date or 6 months) must be respected to ensure patient safety. This reflects the critical nature of maintaining the integrity and effectiveness of pharmaceutical products. The other choices present longer timeframes that exceed the recommendation established by USP/NF. However, they do not align with the established standards for unit-dose containers in practice, which are meant to prevent potential risks associated with medication degradation over longer periods.