Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed

ACTION: Proposed rule; withdrawal of previous proposed rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing. DATES: Submit written or electronic comments by [insert date 120 days after date of publication in the Federal Register] ; submit written or electronic cd03139 i R? g4W&bv ~j PF,,5 2 comments on FDA's economic impact determination by [insert date 120 days after date of publication in the Federal Register]. The September 3, 1982, proposed rule (47 FR 39108) is withdrawn as of [insert date of publication in the Federal Register]. See section IX for the proposed effective date of any final rule that may publish based on this proposal