02-05-2018 05:26 PM
For chemotherapy (hazardous) meds, there's a debate within our department regarding the Beyond Use Dating.
If we're compounding a chemotherapy (i.e. cytarbine in NS), it would be patient specific and it would be less than 2 entries into a container and it's sterile to sterile in an ISO Class 7 clean room with an ISO 8 ante room. Would this be considered low risk and therefore have a 48hr RT BUD?
However a group of the other pharmacist believe the nature of the med is chemotherapy and would be considered medium risk although it's not making a batch (for multiple patients, or one patient multiple times). But it may be due to 'complex manipulations'.
02-05-2018 05:43 PM
I agree with you that mixing chemotherapy does NOT get factored into the risk level. One dose compounded under the conditions you describe, I would consider this CSP is a low-risk. Assuming the cytarabine is chemically stable for 48-hours room temperature, then you can assign the room temp is 48-hours. Hope this helps.
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