Multi-dose vials must be labeled with the expiration date
. The relevant Joint Commission standard is as follows:MM.03.01.01 (same for Hospital and BH): "The hospital/organization safely stores medications."
EP7: "All stored medications and the components used in their preparation are labeled with the contents, expiration date, and any applicable warnings."
(Note: This is a Direct Impact element of performance.)
The expiration date can be based either on the manufacturer's recommendation or on the default expiration date of 28 days established by USP 797 Guidelines (United States Pharmacopeia www.usp.org
The common practice in most organizations is to require that nursing staff mark the vial with the date on which it was opened and then discard any unused content 28 days later.
However, this does not meet the specific requirement of MM.03.01.01 EP 7. Thus, in order to be compliant with this standard, the multi-dose vial must be labeled with the expiration date
. If the default expiration of 28 days is used, then the vial must be labeled with the date that is 28 days later than the open date. For example, if the vial was opened on March 15th, it must be labeled with the expiration date of April 12th.
The standard does not have a requirement to label the multi-dose vial with the date on which it was opened. However, since many organizations already have this practice in place, they are continuing to label the vial with the open date and have now added the expiration date as well.