Repackaging from Sterile Single Dose Containers BUDs

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Fri, 06/05/2020 - 16:40
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Sarah Durham
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Joined: 01/15/2020 - 12:14
Repackaging from Sterile Single Dose Containers BUDs

This is a topic that gets tricky for me to comprehend, so wondering if others could weigh in on whether I am on the right track or not....

When repackaging a sterile single dose container (for example, fluconazole RTU 200mg/100ml into two 100mg/50ml doses), do the repackaged doses get the same BUD as the SDC once opened? So 6 hours with previous 797, 12 hours with new 797?

What if the container is not labeled for single dose or multi-dose?

What’s weird to me, is that single dose vials (i.e. norepi, mag,) and pharmacy bulk packages (10g Vanc or 10g Cefazolin) both get a BUD of 6 hours (old 797), but then when you make a compound with it, that compound gets a longer BUD? If I could make sense of it, it would be because you are no longer opening or puncturing the container/vial once the compound is made? Does dilution affect it? Curious, why wouldn't the same apply to repackaged single dose containers? (so we would give 48 hrs to the fluconazole examples above, since low risk with old 797).

Help!

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