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How Long Are Multidose Vials Good?

Q: Once we've opened a multidose vial, how long is it good? Can you recommend a Policy and Procedure for our office?

A: Page 13 of the United States Pharmacopeia (USP) chapter 797, Pharmaceutical Compounding--Sterile Preparation, states in the section entitled Single-Dose and Multiple-Dose Containers:

"The BUD [by use date] after initially entering or opening (e.g., needle-punctured) multiple dose containers is 28 days (see Antimicrobial Effectiveness Testing) unless otherwise specified by the manufacturer.

An example P& P would read:

Date multidose medication vials when opened and use on single patients when possible. Discard multidose vials 28 days after opening, unless the manufacturer specifies a shorter beyond-use date or the manufacturers' expiration date occurs before the 28 day date.

Hope this helps!

Posted by Quality America on February 1, 2008 | Comments (0)


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