One of the first issues dealt with was the terminology.The familiar "Expiration Date" terminology was replaced with "Beyond-use Date" (BUD).Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations.
In such cases, compounding personnel are responsible for considering the potential additional risks to the integrity of CSPs when assigning BUDs.
The direct "end preparation sterility testing" must test for both microbial and fungal contamination.
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.
BUDs are best assigned on the basis of direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations ) or, if not available using the default dates provided in the chapters.
The pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs.
The risk levels defined in the apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation.Upon subsequent storage and shipping of freshly finished CSPs, an increase in the risks of chemical degradation of ingredients, contamination from physical damage to packaging, and permeability of plastic and elastomeric packaging is expected.This presentation looks at the differences between a manufacturer's expiration date and a sterile compounds beyond-use date (BUD).Trissel's 2 Clinical Pharmaceutics Standard Operating Procedures Formulas Physicochemical Flavorings Discontinued Medications Filter Membrane Compatibility Oral Vehicles Base-Salt-Ester Weight Conversion Na Cl Equivalent Values Veterinary Transdermals p H Adjustment Chemotherapy Vial Reconstitution and Stability Preservatives and Antioxidants Article Search Interactive Claim Form , the long-standing concept of drug stability (beyond-use dates and expiration dates) came to the forefront of pharmacy compounding practice.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.