What is the beyond-use date (BUD) for non-sterile non-aqueous liquid and solid formulations?

The beyond-use date (BUD) for non-sterile non-aqueous liquid and solid formulations is set at 6 months. This timeframe is derived from guidelines provided by the United States Pharmacopeia (USP), which establishes the BUD based on the stability of the formulation when stored under appropriate conditions. Non-aqueous preparations generally have a longer shelf life compared to their aqueous counterparts, but 6 months is considered a safe benchmark to ensure the efficacy and safety of the medication over time.

In the context of compounding, the BUD reflects the period during which the product is expected to retain its intended quality, effectiveness, and safety. It is important for pharmacists to adhere to this timeframe to prevent the use of outdated preparations that could pose risks. Other durations like 14 days, 30 days, or 1 year may apply to different types of formulations or specific storage conditions but do not apply universally to all non-sterile non-aqueous formulations.