Due to recent medication shortages, we have begun to use bulk single-dose vials to "compound" smaller vials with a 9 day BUD (refrigerated) over the 6 hours (if maintained in an ISO class 5 environment) we would get to using the original single-dose containers. We've done this primarily in our TPN area for certain electrolyte and trace element solutions.
My question is this, once we enter those compouned vials, what sort of a BUD (if we have the luxury of any) should we assign? We've not been able to figure out how to apply existing standards of which we are aware.
In that other chapter you referenced for repackaging of Singe dose containers (chapter 1136), it does say in one of the paragraphs the following:
"The manufacturer should provide appropriate stability information that can be used to determine appropriate label-
ing, storage, and shipping statements that will properly inform patients and practioners".
Does this mean if there is stability information beyond 6 hours but not exceed BUD limitations for medium risk compounding for example, we can use it? For example, we remove a certain volume of drug from a single dose container and inject into a minibag with documentation that supports giving it 9 days refrigerated. We can give this date to the minibag but 6 hours only on the left over drug in the SDV.
Am I being dense? I am asking this in regards to pediatrics. We sometimes use already prepared antibiotics (for example, vancomycin 5mg/ml 100ml) and would unit dose a pediatric dose in a syringe from this already prepared bag. We would have to give this repackaging 6 hours stability versus mixing it traditionally with a vancomycin 500mg powder for injection vial, SWFI and a diluent and have better stability data?
There is a fine line between repackaging and compounding as you are describing but what you are doing is compounding. USP Chapter <1136> would not apply to compounded medications. Repackagers are required to validate that their packaging/container will maintain the sterility and stability of the drug over time and meet the other rigors of good manufacturing practices. Relative to USP 797, there is a difference between chemical stability and sterility. How do you know what you made is sterile? USP 797 creates a "safe harbor" for pharmacists/technicians who are not required to meet the rigorous testing/quality standards of manufacturers/repackagers. The ready-use antibiotic is a single-dose container that once punctured has not been tested to maintain the sterility of the solution in the container over time. Being mindful of the SDVs and how we need to practice, USP 797 is giving you the benefit of the doubt that sterility is maintained over the 6 hours while the vial/container is in the ISO Class 5 area. That assumption is being currently being examined by the CDC, FDA and USP. If you draw doses out of this bag, USP 797 allows you to assign a BUD commensurate to the risk level of the final CSP. If you are drawing multiple doses off a ready-to-use container versus reconstituting a drug vial with SWFI, in the end, both CSPs in my mind are medium-risk level CSPs. Hope this helps.
We cannot get fentanyl except in the 50 ml vials. It has gone beyond critically low inventory. We want to compound our own syringes in 50 mcg increments and label with at least a 28 day stability BUD. This would be done in a barrier isolation chamber.
What BUD is permitted? What provisions (if any) are there for situations such as this? It is happening with increasing frequency and with larger number of medications.
