United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2006_register executive 2010-09-22 article Proposed Rules D09002ee1c80ede99 D09002ee1c80edf06 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 71 FR 51146 https://www.govinfo.gov/app/details/FR-2006-08-29/E6-14263 E6-14263 fr29au06-17 RIN 0910-AF53 4160-01-S Docket No. 1978N-0065 (formerly Docket No. 78N-0065) https://www.govinfo.gov/app/details/FR-2006-08-29/E6-14263 https://www.govinfo.gov/content/pkg/FR-2006-08-29/html/E6-14263.htm https://www.govinfo.gov/content/pkg/FR-2006-08-29/pdf/E6-14263.pdf 10 p. 51146 51155 71 FR 51146 Title 21 Part 310 21 CFR Part 310 RIN 0910-AF53 Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule; Federal Register Vol. 71, Issue PRORULE E6-14263 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2006-12-27 Docket No. 1978N-0065 (formerly Docket No. 78N-0065) 4160-01-S E6-14263 Proposed rule; withdrawal of previous proposed rule.

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.

Submit written or electronic comments by December 27, 2006; submit written or electronic comments on FDA's economic impact determination by December 27, 2006. The September 3, 1982, proposed rule (47 FR 39108) is withdrawn as of August 29, 2006. See section IX for the proposed effective date of any final rule that may publish based on this proposal. Michelle M. Jackson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5486, Silver Spring, MD 20993-0002, 301- 796-0923. Human drugs: Skin bleaching drug products; over-the-counter use, http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm http://www.regulations.gov Vol. 71, no. 167 Office of the Federal Register, National Archives and Records Administration 2006-08-29 continuing daily deposited born digital 337 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2006-08-29 P0b002ee180965019 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29au06 https://www.govinfo.gov/app/details/FR-2006-08-29 https://www.govinfo.gov/content/pkg/FR-2006-08-29/pdf/FR-2006-08-29.pdf https://www.govinfo.gov/content/pkg/FR-2006-08-29/xml/FR-2006-08-29.xml fdlp 51095 51420 DGPO 2010-09-22 2024-06-06 FR-2006-08-29 machine generated eng FR FR-2006-08-29 71 167