What is the beyond-use date (BUD) for nonsterile, semisolid preparations containing water?

The beyond-use date (BUD) for nonsterile, semisolid preparations containing water is 30 days. This guideline is primarily based on stability considerations. Nonsterile semisolids, such as creams and ointments, that contain water are susceptible to microbial growth, which can compromise the preparation's integrity and safety.

In the context of compounding, the BUD is determined to provide a balance between the risks of microbial contamination and the expected stability of the compound. The 30-day duration allows sufficient time for the product to remain effective and safe for use while minimizing the risks associated with microbiological contamination. This timeframe reflects the industry standards and recommendations provided by compounding guidelines, ensuring that pharmacists can deliver safe and effective pharmaceutical products to patients.

Other durations, such as 7 days or 14 days, would generally apply to more unstable formulations or those less likely to support microbial growth, while 60 days would exceed the recommended timeframe for nonsterile water-containing preparations, potentially leading to decreased efficacy and safety.