Which factors contribute to the beyond use dating for Category 1?

Beyond use dating (BUD) refers to the date or time after which a compounded sterile preparation should not be used. For Category 1 compounds, factors influencing BUD play a crucial role in ensuring the safety and efficacy of the product.

Storage conditions are paramount because they directly affect the stability and integrity of the compounded preparation. Proper storage can prevent degradation of active ingredients, inhibit microbial growth, and maintain the product's sterility. Factors such as temperature, humidity, and exposure to light are essential aspects of storage. For instance, some compounds may require refrigeration to remain stable, while others should be stored at room temperature. If the storage conditions are not ideal, it can lead to a shorter BUD due to potential degradation or contamination.

While other factors like compounding methods, sterility testing, and environmental monitoring are also important in the overall process of sterile compounding, they do not directly determine the BUD in the same way that storage conditions do. For instance, the type of compounding method can impact the sterility and quality of the product but does not provide specific guidelines for determining a BUD. Similarly, while sterility testing ensures that the preparation is free from contamination and environmental monitoring helps maintain a safe compounding environment, neither directly