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  Compounding Instructions  
Compounding Instructions
Beyond Use Date (BUD) and Diffusimax®

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

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 studies3

  • 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

BUD Info       BUD List

Maxima makes no claims about the efficacy of any drug or drug combination in Diffusimax.

1USP Chapter<795>10.1 proposed

3USP Chapter<795>10.5 proposed
2USP Chapter<795>10.3 proposed

4USP Chapter<795>10.2 proposed
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