What BUD applies for medium-risk compounded sterile products at refrigeration?

The correct answer is that the beyond-use date (BUD) for medium-risk compounded sterile products stored at refrigeration is indeed 9 days. This timeframe is established based on stability studies conducted for compounded sterile preparations, which indicate that medium-risk products, when properly stored in refrigeration, can retain their sterility and potency for this duration.

Medium-risk compounded sterile products typically involve more complex compounding processes, such as the preparation of multiple ingredients or the use of non-sterile ingredients that are sterilized during the compounding process. The complexity of these preparations necessitates a more cautious approach to determining their shelf life.

In refrigeration, these products can remain stable for up to 9 days, balancing safe use with the requirements of sterility and efficacy. Products stored beyond this time frame may not maintain their intended quality and, therefore, may not be safe for patient use.

This regulation ensures that pharmacists manage the risks associated with compounded sterile products by providing guidance on appropriate use timelines, thus maintaining patient safety and product integrity.