Rx Update: October 2001

Expiration Dates for Multi-Dose Vials

Mary Ross, R.Ph., M.B.A.
Peer Review Status: Internally Reviewed

Multi-dose vials (MDV) will now expire according to the manufacturers' expiration date after they are opened, unless the manufacturer recommends discarding the vial after initial entry within a certain time frame (e.g., epoetin MDV discard 21 days after initial entry). The previous policy required MDV to expire within 30 days of opening. MDV also no longer need to be dated. This applies to MDV containing a bacteriostatic preservative including heparin flush (preserved), bacteriostatic 0.9% sodium chloride, bacteriostatic sterile water, and lidocaine (1% and 2% with and without epinephrine). These policy changes are consistent with the 1996 CDC document "Guideline for Prevention of Intravascular Device Related Infections" (http://www.cdc.gov/ncidod/hip/iv/iv.htm).

The CDC guidelines state the following:

• MDV should be refrigerated after opened if recommended by the manufacturer.
• Cleanse the rubber diaphragm of MDV with 70% alcohol before inserting a device into the vial.
• Use a sterile device each time a MDV is accessed and avoid touch contamination of the device before penetrating the rubber diaphragm.
• Discard MDV when empty, when suspected or visible contamination occurs, or when the manufacturers' stated expiration date is reached.

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