Dating the pharmacist on a
Additionally, pharmacy personnel should note the storage temperature when placing the product into or removing the product from the storage unit in order to monitor any temperature aberrations.
Suitable temperature recording devices may include a calibrated continuous recording device or an NBS calibrated thermometer that has adequate accuracy and sensitivity for the intended purpose and should be properly calibrated at suitable intervals.
Predictions based on other evidence, such as publications, charts, tables, and so forth would result in theoretical beyond-use dates.
Examples include CSPs with a narrow therapeutic index, where close monitoring or dose titration is required to ensure therapeutic effectiveness and to avoid toxicity; where a theoretically established beyond-use dating period is supported by only marginal evidence; or where a significant margin of safety cannot be verified for the proposed beyond-use dating period.
In short, because beyond-use dating periods established from product-specific data acquired from the appropriate instrumental analyses are clearly more reliable than those predicted theoretically, the former approach is strongly urged to support dating periods exceeding 30 days.
The extent of hydrolysis and other heat-catalyzed degradation reactions at any particular time point in the life of a CSP represents the thermodynamic sum of exposure temperatures and durations.
Such lifetime stability exposure is represented in the mean kinetic temperature calculation (see Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs.For example, antioxidant, buffering, or antimicrobial properties of a sterile vial for injection (SVI) might be lost upon its dilution, with the potential of seriously compromising the chemical stability of the SVIs active ingredient or the physical or microbiological stability of the SVI formulation in general.