A water-containing oral formulation that is compounded from commercially available drug products has a maximum beyond-use-date (BUD) of how many days when refrigerated?

When compounding a water-containing oral formulation from commercially available drug products, the regulation stipulates that the maximum beyond-use date (BUD) when refrigerated is set at 14 days. This guideline is grounded in the stability and safety of compounded preparations, as the presence of water facilitates microbial growth.

The 14-day BUD is based on studies and standard practices that identify how long such formulations remain stable and safe under refrigeration. It recognizes the importance of ensuring that compounded products do not risk contamination or degradation, which could occur beyond this timeframe, particularly in formulations that are susceptible to stability issues due to their aqueous nature. This time frame helps pharmacists ensure they dispense effective and safe medications to patients.

The other options suggest longer storage times that exceed the established guidelines for refrigeration of water-containing formulations, which increases the risk of formulation degradation or microbial contamination. Therefore, 14 days is the appropriate period as recommended by compounding standards.