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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.
Most biological products require specific storage conditions, as indicated in the product labeling, to maintain their safety, purity, and potency. These products include bacterial and viral vaccines, allergenic extracts, plasma derivatives, and other products requiring refrigeration or frozen storage, as well as products that can be stored at controlled room temperature (i.e., not exceptionally cold or hot). When there is an electrical power failure, whether due to accident, equipment failure, or disruption in the electrical power grid, the temperature control systems for product storage may not function. For example, on August 14, 2003, the northeast region of the country experienced a power outage lasting from one to several days, and some health professionals were uncertain what to do with products that they had in storage. Power failures are not only a concern regarding storage in a facility, as failure of the refrigeration or freezer unit on a carrier (e.g., truck) while the products are in transit may also occur. The information below may assist interested persons in determining what to do with their biological products in the event of a power failure.
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