FDA Submits Final and Proposed Rules to OMB on OTC Sunscreen Products
In its July 30, 2010 final rule submission to the Office of Management and Budget, the Food and Drug Administration states that the over-the-counter drug review establishes conditions under which OTC drugs are considered generally recognized as safe (GRAS) and…
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effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The last action addresses combination products containing sunscreen and insect repellent ingredients. Also on July 30, 2010, the FDA has submitted a proposed rule to OMB titled: "Revised Safety and Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use.'"