Dating the pharmacist on a
To ensure that product potency is retained through the manufacturer's labeled expiration date, pharmacists must monitor the drug storage areas within the pharmacy.
Controlled temperature storage areas in the pharmacy (refrigerators, 2 to 8; freezers, 20 to 10; and incubators, 30 to 35; etc.) should be monitored at least once daily and the results documented on a temperature log.
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.
Predictions based on other evidence, such as publications, charts, tables, and so forth would result in theoretical beyond-use dates.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.Discard the MDVs when empty, when suspected or visible contamination occurs, or when the manufacturer's stated expiration date is reached, provided the manufacturers storage conditions have been adhered to.Expiration dating not specifically referenced in the package insert should not exceed 30 days once the vial has been opened.