OK to use a BUD not mentioned in the package insert?

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Wed, 12/09/2020 - 21:07
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Karen Thompson
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OK to use a BUD not mentioned in the package insert?

Does your facility allow you use a longer BUD than is stated in the PI of a sterile product if there is a published reference for it (and it does not exceed USP 797 guidelines)? Example: the PI for Ferrlecit brand sodium ferric gluconate in complex (and the Hikma generic product) says to "use immediately" after dilution. There is an article published in Current Medical Research & Opinion that shows a generic Sodium ferric gluconate in complex product (Nulecit) is stable for 24 hours at room temp and 7 days refrigerated (0.625 mg/mL and 1.25 mg/mL in NS).

What BUD would you give sodium ferric gluconate in complex diluted to 0.625 mg/mL in NS at your facility?

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