What does Beyond Use Date define?

• A. API expiration date
• B. The date by which the compounded preparation should be used
• C. The supplier expiration date
• D. The manufacturing date

Answer: (B)

Beyond Use Date indicates the window of time in which a compounded preparation is expected to remain safe and effective when used as directed. It is set at the time of compounding based on the formulation, whether water is present, stability data, and how the product will be stored. After that date, the preparation should be discarded or replaced to prevent reduced potency or increased risk. This is different from an API expiration date, which concerns the shelf life of the active ingredient, and from a supplier’s expiration or a manufacturing date, which relate to other stages of the product’s lifecycle. For example, a water-containing preparation typically has a shorter BUD than a nonaqueous formulation, assuming standard storage conditions.