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Most refrigerated vaccines are relatively stable at room temperature for limited periods of time, although certain vaccines are temperature-sensitive. Products stored in a closed refrigerator (or freezer, if appropriate) during a power outage may maintain their potency unless the power outage is of such duration that the refrigerator’s (or freezer’s) internal temperature rises significantly. It is recommended that thermometers be located in the refrigerator and freezer section so that temperatures can be read when power resumes to see if excursions outside of recommended temperatures have occurred. The „How Supplied/Storage and Handling“ section of the product label may also be consulted for information. Most vaccine manufacturers have filed data with CBER to support the stability of their products at somewhat elevated temperatures and related duration of storage; they may consult with CBER concerning the impact of temperature/time duration on product stability.
During normal business hours, questions may be directed to 1-800-835-4709. After business hours parties may call the FDA emergency operations line at 301-796-8240. These questions will be forwarded to the appropriate Center or office for advice.
When a flood is anticipated, storage facilities have taken steps to raise stored products out of range of anticipated flood waters. For example:
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