08-13-2014 07:25 AM
We compound 2 different Vancomycin IVPB doses that are not available commercially. The procedure involves adding SWFI to the vials and then adding the appropriate drug volumes to a 250 ml NS bag.
There is a question whether this procedure is considered low risk or medium risk compounding. The Texas State Board classifies it as low-risk which means we can give it a 14-day expiration date, but in one of the CE's in Critical point, it seems to classified as a medium risk meaning we would have to adjust the BUD we are currently using.
08-13-2014 08:34 AM
I am not aware that the state BOP is determining risk level. That assignment should be your responsibility. The answer to risk level is dependent on how you make it. If you make a single dose from a single vial, then that is low-risk. If you are using a pharmacy bulk package (PBP) which is a single dose vial with many single doses (10gm vial) then that should be considered medium-risk level since you are making multiple doses for a single patient or multiple doses for a single patient. I attached a couple of slides for your consideration. Hope this helps.
10-30-2016 11:53 PM
It is my understanding that when a bulk 10 gram vial of vancomycin is distributed among several final doses it makes a final product a medium risk preparation...
I came across a new swabable vial adaptor from West Pharmaceuticals that I'm hoping will make a final product a low risk level preparation. The company has conducted a 7 DAY MICROBIAL CHALLENGE EVALUATION (see link below) which I found quite impressive. It seems that after microbial challenge and 140 activations over a 7-day period, valve maintained its microbial barrier properties. It seems as if the valve described here converts a single dose vial into a multiple dose vial as far as sterility goes. If this swabable vial adaptor is used to transfer from bulk pharmacy vial (swabbing between transfers and using a new syringe each time) will it make a final preparation a low risk compound? Thoughts? Does this fall into a category of "Point-of-Care Activated System" where one can use "manufacturer’s instructions for storage and stability"?
11-06-2016 01:32 PM
In my opinion, this is NOT a point of care activated system. There is NO provision currently in USP Chapter <797> for any type of device, this one or CSTDs to extend the BUD of single-dose or pharmacy-bulk packages. The testing might look good but you would need to prove that you can get the same results. I would advise caution in using this system to extend dating. Hope this helps.
12-05-2016 05:28 AM
Low Risk compounding conditions limit a BUD to 14 days refrigerated. Medium Risk limits to 9 days refrigerated. What stability references are you using for vanco in NS? The recent package insert does not state (Hospira), but recommends using as soon "after preparation as is feasible". An old insert said 96 hours refrigerated. Stability data will limit the USP 797 BUD. I am interested in your stability references as we struggle with this. One is required to use the same concentrations, containers, diluents and temps as the stability study referenced. I am interested in what others have to say. Thank you!
12-05-2016 05:47 AM
We use B. Braun Excel bags.
According to B. Braun, "Studies have shown drug compatibility with B. Braun IV containers to be similar to that of glass."
02-27-2018 11:11 AM
I'm saying that batching is medium-risk and the default microbial BUD is 9-days. The actual CSP BUD will be the shorter of the USP BUDs or the chemical stability of the drug. All CSPs with BUDs that exceed the default BUDs in the chapter must be sterility tested according to USP 71 per batch.