BUD of Pharmacy Bulk Packages

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Fri, 04/17/2020 - 18:22
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Karen Thompson
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Joined: 05/03/2009 - 02:30
BUD of Pharmacy Bulk Packages

I am having a tough time wrapping my head around why we have to give opened Pharmacy Bulk Packages (PBP) a BUD of 4 hours, but we can continue using single dose vials for 6 hours (or 12 hours, if you follow the revised 2019 version of USP 797). Both products are preservative-free. Both products are only accessed within ISO Class 5 air (e.g., LAFW). In the case of calcium gluconate 10%, the ingredients of the SDV (10mL) and the Pharmacy Bulk Package (100mL) are IDENTICAL. Can someone please help me understand why we have to use shorter dating on a PBP in our cleanroom? Can we ignore the 4 hr BUD on the PBP labeling just like we ignore "single dose" on the SDV, and defer to USP 797 dating for both?

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