Questions about Single-dose/Single-use Vials
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.
Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient.
To prevent unnecessary waste or the temptation to use contents from single-dose or single-use vials for more than one patient, healthcare personnel should select the smallest vial necessary for their needs when making purchasing decisions.
Splitting of a single-dose or single-use vial into multiple single-use vehicles (e.g., syringes) is considered repackaging, which is defined by the United States Pharmacopeia as “The act of removing a sterile product or preparation from its original primary container and placing it into another primary container, usually of a smaller size without further manipulation.” If contents from a single-dose or single-use vial must be used for more than one patient, the full Category 1 or Category 2 requirements as described in USP Chapter <797> Pharmaceutical Compounding – Sterile Preparationsexternal icon, as well as the manufacturer’s recommendations pertaining to safe storage of that medication outside of its original container, must be followed.
The safest practice is to enter a single-dose or single-use vial only once so as to prevent inadvertent contamination of the vial and infection transmission. Single-dose or single-use vials should be used for a single patient and a single case/procedure/injection. Therefore, they should require only a single entry into the vial.
In certain situations, healthcare personnel may believe that drawing the entire contents of the vial into a single syringe will not allow for safe and accurate titration of dosage (e.g., pediatric dosing during a surgical procedure).In these circumstances, healthcare personnel must consider the risk of repeated entry into a single-dose or single-use vial for that single patient/procedure.
If the single-dose or single-use vial will be entered more than once for a single patient as part of a single procedure, it should be with a new needle and new syringe, and the vial must be discarded at the end of the procedure and not stored for future use.
No. Do not combine (pool) leftover contents of single-dose or single-use vials or store single-dose or single-use vials for later use. Single-dose or single-use vials are intended for use on a single patient for a single case/procedure. There have been outbreaks resulting from pooling of contents of single-dose or single-use vials and/or storage of contents for future use .
Medication vials should always be discarded whenever sterility is compromised or questionable.
In addition, the following recommendations are made for handling of single-dose or single-use vials:
- If a single-dose or single-use vial has been opened or accessed (e.g., needle-punctured) the vial should be discarded according to the time the manufacturer specifies for the opened vial or at the end of the case/procedure for which it is being used, whichever comes first. It should not be stored for future use.
- If a single-dose or single-use vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date.