The degree of error or inaccuracy would be dependent on the extent of differences between the CPs' characteristics (e.g., composition, concentration of ingredients, fill volume, container type, material) and the characteristics of the products from which stability data or information is to be extrapolated.
Compounded sterile preparations (CSPs) with ingredients that have narrow therapeutic windows should be evaluated carefully so that safe BUDs are used.
The greater the doubt of the accuracy of theoretically predicted beyond-use dating, the greater the need to determine dating periods experimentally.
Where such is not available, care should be used to designate a BUD.
Predictions based on other evidence in the literature, such as charts, and tables results in theoretical BUDs which should act as reasonable estimates.
Recent history leads one to question whether we in the profession, and some in pharmaceutical education, recognize and appreciate the contribution that the pharmaceutical sciences have made and continue to make to the pharmacy profession and health care.
Preparation-specific, experimentally determined stability data evaluation protocols are preferable to published stability information.
Compounding personnel should consult stability references to understand the appropriate parameters that must be considered when initiating or evaluating a preparation-specific stability study.
It must be ascertained that CSPs must not be exposed to warm temperatures unless the compounding facility provides adequate evidence to justify stability of CSPs during such exposure.
It should be recognized that the correct evidence of stability for predicting beyond-use dating can be obtained only through preparation-specific experimental studies.