What is the BUD for a non-sterile aqueous non-oral formulation?

The beyond-use date (BUD) for non-sterile aqueous non-oral formulations is determined based on stability and the nature of the formulation. According to established guidelines, non-sterile aqueous formulations that are not intended for oral use typically have a BUD of 30 days when stored at room temperature. This time frame is based on the stability of the ingredients used in the formulation and their susceptibility to microbial contamination, as well as the need to ensure safety and efficacy throughout the time the product is in use.

This guidance is important for ensuring that patients receive medications that are both effective and safe. The selection of a 30-day BUD reflects a balance between providing sufficient time for patients to use the product while minimizing the risk of degradation or contamination that could occur over a longer period.

The other choices reflect BUDs that are either too short or pertain to specific types of formulations not appropriate for non-sterile aqueous non-oral preparations. For instance, a shorter duration of 7 days or 14 days would not adequately account for the stability of these formulations at room temperature.