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Looking for some clarity here. I'm pretty confused with BUD vs. Expiration dating vs. Hang time with the new USP 797 guidelines, and I tend to overthink things.
Scenario: Sterile compounding of TPN 2000mL to be infusing at 83.3mL/hour over 24 hours: (Clinimix + MVI Infuvite + Trace elements + NaCl + KCl + other electrolytes etc) made in a ISO 5 PEC, at 10/19/19 @1200. To my knowledge, once you add MVI, stability is 24 hours (can anyone confirm?)
So onto my next question:
In this case, the BUD would be 10/20/19 @1200, correct?
Meaning the nurse can hang the bag anytime from 10/19/19 @1200 to 10/20/19 @1200?
So if it's compounded at 10/19/19 @1200 and then stored in the fridge, and it's timed to start hanging at 10/19/19 @2100 (ie new bag replaced the following day 10/20@2100), is that in compliance with the new guidelines and BUD? This would be considered a Category 2 BUD (aseptic prep in a PEC and fridge gives 10 day BUD, but stability of MVI makes it a BUD of 24 hours?)
Scenario: Sterile compounding of TPN 2000mL to be infusing at 83.3mL/hour over 24 hours: (Clinimix + MVI Infuvite + Trace elements + NaCl + KCl + other electrolytes etc) made in a ISO 5 PEC, at 10/19/19 @1200. To my knowledge, once you add MVI, stability is 24 hours (can anyone confirm?)
So onto my next question:
In this case, the BUD would be 10/20/19 @1200, correct?
Meaning the nurse can hang the bag anytime from 10/19/19 @1200 to 10/20/19 @1200?
So if it's compounded at 10/19/19 @1200 and then stored in the fridge, and it's timed to start hanging at 10/19/19 @2100 (ie new bag replaced the following day 10/20@2100), is that in compliance with the new guidelines and BUD? This would be considered a Category 2 BUD (aseptic prep in a PEC and fridge gives 10 day BUD, but stability of MVI makes it a BUD of 24 hours?)
