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AgVetLink April 2005 

Default in-use period statements for multi-use vaccine vials

In the October 2004 issue of AgVetLink, industry was requested to consider and comment upon the advisability of adopting the APVMA default label statement requirements for the in-use period of multi-use vaccines.

Four submissions were received – all supportive of the proposed change. The ACVM Group has considered the submissions and the following amendment to ACVM policy and the ACVM Labelling Guide for Veterinary Medicines has been approved:

Where no in-use stability data is or has been supplied at the time of registration for non-Clostridial multi-use vaccines, where appropriate the following statement will be required:

“Unused vaccine must be discarded within 12 hours of opening”.

For Clostridial vaccines, a similar statement limiting the period of use to the next day (maximum 36 hours) may be included instead.  Advice regarding appropriate resealing practices including, at minimum, the removal of the delivery tube, disinfection of the stopper and storage of the vaccine in the refrigerator must also be stated on the label. 

The ACVM Labelling Guide for Veterinary Medicines has been altered to reflect this change in policy.