What is the BUD for aqueous topical, dermal, and mucosal formulations?

The beyond-use date (BUD) for aqueous topical, dermal, and mucosal formulations is set at 30 days. This timeframe is established based on the stability of these formulations, particularly in terms of microbial growth and chemical degradation. Aqueous preparations tend to support the growth of microorganisms, which is why they have a relatively shorter BUD when compared to solid or non-aqueous formulations. Many guidelines, including those from the United States Pharmacopeia (USP), recommend this 30-day limit for formulations that do not contain preservatives, ensuring that patients receive medications that are both effective and safe to use.

In contrast, other options like 6 months, 14 days, or 1 year do not align with scientific recommendations for the stability of these specific types of formulations. The BUD is carefully determined to balance efficacy and safety for patients, making it crucial to adhere to the 30-day limit for aqueous topical, dermal, and mucosal products.