Expiration dating of multidose vials
“Typically, most people will do the 28 days just because they don’t want to hassle with it, but I’ve run into some that were 10 days,” she says.
“Sometimes it depends on refrigeration, so you need to talk to the manufacturer and get it in writing.” Keep a log When Luebbert consults with facilities on how to handle multidose vials, she recommends developing a log, similar to sharps safety evaluations, so that you can track each medication and provide documentation to a surveyor to prove compliance.
“If you’re only using half a milliliter and you have a half-a-liter vial, you could go in that forever and ever, and so every time you go in you put yourself more at risk.” Talk to the manufacturer The best way to avoid complications is to contact the manufacturer for each multidose vial and get the exact recommendations for the beyond-use date, Luebbert says.
This will ensure that you are following the intended specifications.
The vial should be labeled to reflect the penetration date or the beyond-use date.
However, the CDC indicates that multidose vials can be used until the expiration date, unless there are concerns with sterility.
Dolan, RN, MS, CIC, director of the Department of Epidemiology at Children’s Hospital in Aurora, CO, and lead author of APIC’s position paper.
Your multidose vial may have an expiration date on the label, but that does not take into consideration the date the vial is first used, which is when the 28-day rule takes effect.
In addition, not all medications are alike—some must be used soon after being opened, which requires the manufacturer’s specific recommendations.
The US Pharmacopeia (USP 2008), A General Chapter Pharmaceutical Compounding?
Sterile Preparations, requires multidose vials to be discarded 28 days after initial stopper penetration unless the manufacturer specifies otherwise.