Does the multi-dose vial need to be labeled with a new expiration date once it is opened or punctured?
A. Yes. Standard MM.03.01.01, EP 7 requires that all stored medications are labeled with the expiration date. The Joint Commission defines the expiration date as “the last date that the product is to be used”. The manufacturer’s expiration date is based on the fact that the product has not been opened. Once the vial cap is removed or the vial is punctured, the manufacturer’s expiration date is no longer valid and a revised date (also called the “beyond use date” in pharmaceutical terminology) needs to be determined. To be in compliance with MM.03.01.01 EP 7, The Joint Commission requires organizations to re-label multi-dose vials with a revised expiration date once the multi-dose vial is opened or punctured. If the manufacturer’s original expiration date is shorter than the revised expiration date then the shorter date must be used. Also, if sterility is questioned or compromised the multi-dose vials should be discarded regardless of the date. Labeling the multi-dose vial with the date
