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Compounding Instructions
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Beyond Use Date (BUD) and Diffusimax®
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Standards from the National Association of Pharmacy Regulatory Authorities (NAPRA)
and the United States Pharmacopeia (USP) require that every compounded non-sterile
product must "state the date... beyond which the preparation cannot be used
and must be discarded (i.e., the BUD)."1
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For preserved aqueous gels such as Diffusimax, proposed USP Standards state:
- BUD = 35 days in the absence of specific stability information2
- BUDs can be extended up to 180 days with supportive stability studies33>
- Extended BUDs apply only to the drug, drug concentration, base, mixing
conditions, and storage conditions under which the drug was tested3,4
- Extended BUDs can be applied only if a pharmacy protocol adheres exactly to
the storage conditions used for stability testing, including the same container-
closure system (i.e. formulations cannot be stored or transported in large batches
and aliquoted at the time of dispensing)1-4
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180 Days - See Updated List
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Maxima makes no claims about the efficacy of any drug or drug combination
in Diffusimax.
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1USP Chapter<795>10.1 proposed
3USP Chapter<795>10.5 proposed
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2USP Chapter<795>10.3 proposed
4USP Chapter<795>10.2 proposed
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