Packaging and storage— Preserve in single-dose containers,or in light-resistant,multiple-dose containers,at a temperature between 2and 8.Multiple-dose containers for 50doses are adapted for use only in jet injectors,and those for 10doses for use by jet or syringe injection.

Expiration date— The expiration date is 1to 2years,depending on the manufacturer's data,after date of issue from manufacturer's cold storage (-20,1year).

Labeling— Label the Vaccine in multiple-dose containers to indicate that the contents are intended solely for use by jet injector or for use by either jet or syringe injection,whichever is applicable.Label the Vaccine in single-dose containers,if such containers are not light-resistant,to state that it should be protected from sunlight.Label it also to state that constituted Vaccine should be discarded if not used within 8hours.

Expert Committee:(VVI)Vaccines,Virology,and Immunology

USP28–NF23Page 1743

Phone Number:1-301-816-8397