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

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While some patients tolerate products well when appropriately selected, safety depends on skin sensitivity, product formulation, current routine, and clinical judgment

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