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For purposes of this paragraph (e), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a calendar year

Do not spray water directly onto the powder

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Batch 145675 complied with all applied sterility testing requirements

Under these conditions, the lyophilized material remains stable for several years