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If the manufacturer cannot assist in assigning a beyond use date, the next step is to obtain published stability information from reference books or the primary literature.
Direct extrapolation of the information to the specific compounded formulation requires that the scientific study data utilize the same drug source, the same drug concentration, and the same compounding procedures, stores the formulation in the same container, and has subjected the formulation to the same anticipated environmental variables.
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"Where possible, the beyond use date should be in accordance with allowances specified in the approved labeling.
However, reliable, published stability information is sometimes lacking for many types of drugs.
Beyond use dates are used for compounded preparations and are generally in days or months.
The pharmacist should communicate the deviations from the package insert to the manufacturer when requesting stability information.In these instances, pharmacists should consult with the drug's manufacturer to establish a beyond use date.Because of compelling patient-care needs, a pharmacist may be unable to stay within the approved labeling and product guidelines stated in the package insert.Also, If the compounded formulation is an official monograph in the USP/NF, the beyond use date given in the monograph can be used provided the procedure in the monograph was followed.When an official monograph isn't present, a systematic approach to assigning the date can be as follows: Step 1.