Hospital Pharmacy: Repackaging Single Dose Vials

[DrWrong]

Hello! I'm a bit curious about the practice at your pharmacy since it is an extremely grey area. If you repackage (i.e. the FDA definition of repackaging - straight drug into a suitable storage container with no other manipulations) at your hospital, what BUD do you assign to it? For example, a Baxter vial of Potassium Chloride 2 mEq/mL says to discard 4 hours after opening the vial. If you were to repackage this item, what BUD would you assign to it?

The FDA released a guidance document in 2012 that says repackaged products shouldn't have a BUD beyond what is listed in the package labeling. CMS says repackaged SDV should get a BUD per 797 low risk compounding. USP doesn't really say what the BUD should be for repackaging of a SDV.

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[PharmDBro2017]

I believe in this case you'd stick with the manufacturer's recommendations (if it was aseptically manipulated in an ISO 5 environment). If not, It's a one-hour BUD/use asap.

That's a frowned-upon practice, though. What is the reasoning behind repackaging single-dose vials for your hospital and what is the actual drug being used?

 

[DrWrong]

I believe in this case you'd stick with the manufacturer's recommendations (if it was aseptically manipulated in an ISO 5 environment). If not, It's a one-hour BUD/use asap.

That's a frowned-upon practice, though. What is the reasoning behind repackaging single-dose vials for your hospital and what is the actual drug being used?

Omnipaque, for example. It’s a SDV and putting into syringes is repackaging. Repackaging is considered compounding per 797. Compounding in this manner would be Low Risk which would extend the 6-hour BUD given to the SDV and increase to 48 hours at room temperature.

 

[Sparda29]

I know we used to do this for Alteplase and repackage them into 2 mL syringes that we would then keep frozen.