What is the purpose of determining a beyond use date for a CSP?

Determining a beyond use date (BUD) for a compounded sterile preparation (CSP) is primarily aimed at ensuring the efficacy and safety of the product. This date represents the time frame during which the CSP is expected to maintain its intended potency, sterility, and overall quality when stored under specified conditions. After the BUD, the risk of degradation, contamination, or loss of therapeutic effect increases, which could pose safety risks to patients.

Setting a BUD helps practitioners and pharmacists guarantee that they are providing patients with medications that are both safe and effective. This procedure involves considering factors such as the ingredients used, the method of preparation, and the storage conditions. While increasing shelf life, complying with labeling regulations, and identifying manufacturing dates are important aspects of pharmaceuticals, they do not capture the primary goal of BUD determination, which is to protect patients by ensuring the medication remains safe and effective for its intended use.