What is the Beyond Use Date for water-containing formulations when stored at controlled cold temperatures?

The Beyond Use Date (BUD) is critical in ensuring the safety and efficacy of compounded formulations. For water-containing formulations, particularly when stored at controlled cold temperatures (typically at or below 4°C), the established beyond use date is not later than 14 days. This guideline reflects the stability and microbiological safety of the formulation, considering factors such as potential contamination and degradation over time.

Water-containing formulations can support microbial growth, and storing them in cooler conditions slows down, but does not completely halt, this process. Therefore, a BUD of 14 days has been determined as a balance between allowing sufficient time for patient use while minimizing the risk of contamination and degradation.

The alternatives presented suggest longer durations (21 or 30 days), which exceed the recommended timeframe and could increase the risk of exposure to bacteria and other pathogens, potentially compromising patient safety. Thus, adhering to the 14-day guideline ensures that formulations remain effective and safe for use during that period.