Beyond use dating
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This includes the issue of increased waste and the cost associated with it.
Many facilities opined that this would cause irreparable harm to both the care of the patient and the fiscal well-being of the institution.
Due to the expense, one independent laboratory may allow several hospitals within the same system to band together to decrease the initial cost of degradation studies.
Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations.
BUDs are defined by as the date after which a compounded preparation should not be used; determined from the date the preparation is compounded.
Once the testing is completed, then it is possible to use stability information that is already published and all the parameters match (e.g., fluid, concentration, storage conditions) and has been verified by high-performance liquid chromatography (HPLC) testing.
The alternative method is to develop in-house stability data/information through previously vetted processes. Food and Drug Administration (FDA) defines SIM as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from potential interferences like degradation products, process impurities, excipients, or other potential impurities.