What must be considered while establishing the beyond use dating for compounded sterile preparations?

Establishing the beyond use dating for compounded sterile preparations involves evaluating multiple factors, including sterility and stability. The assigned beyond use date is crucial to ensure that the compounded preparation maintains its effectiveness and safety for the patient.

Stability refers to the chemical and physical properties of the preparation over time, which can be affected by ingredients, concentrations, and environmental conditions such as temperature and light exposure. Additionally, sterility ensures that the preparation is free from contamination, directly impacting patient safety. By considering these factors, health care professionals can provide accurate beyond use dates that reflect the compound's viability.

This comprehensive approach ensures that compounded preparations remain effective and safe for the duration of their use. Evaluating only one aspect, such as the preparation method, the individual preparing it, or the storage location, would not provide a complete picture and could lead to unsafe practices.