12-10-2017 03:19 PM
My facility is nearly out of NS 100mL and D5W 100mL bags so we are going to repackage 1L bags of these solutions into empty 100mL bags. What will the BUD be if done in an ISO 5 hood? Does anyone have any data on repackaging?
12-13-2017 01:10 PM
Using the "one-to-many" rule of thumb, the BUD would be 9 days under refrigeration, considering it a medium risk. However, one could argue that being a simple transfer it could be given a 14 days BUD under refrigeration.
12-13-2017 01:14 PM
An excellent rule of thumb! :-) Any batching or repackaging using a bulk container into smaller containers should be considered as a medium-risk level CSP, whether accessed with a needle or dispensing pin. Hope this helps.
01-17-2018 10:10 AM
Is it acceptable to assign a second BUD to these batched fluids after adding additional medications at later date? USP states that the BUD is determined from the date or time of preparation. I have previously interpreted this as the BUD is assigned to the final preparation. Just wanted to get further clarification since I believe there is room for intepretation in this case (and know that I could be totally off base!).
01-18-2018 09:35 AM
My understanding is once you add any med to these "home-made" ND/D5W bags, they are only good for 6 hours under the hood. The rational is these 100-mL bags with 9-day BUD are considered to be Single Dose Container.