![]() At that time, no topical otic drug products for these conditions were proposed as generally recognized as safe and effective and not misbranded. Of J( 51 FR 27366), the agency proposed to amend this tentative final monograph to consider OTC topical otic drug products for the prevention of swimmer's ear and for the drying of water-clogged ears. Of J( 47 FR 30012), the agency published a tentative final monograph for OTC topical otic drug products used as earwax removal aids. ![]() Rachanow, Center for Drug Evaluation and Research (HFD–560), Food and Drug Administration, 5600įishers Lane, Rockville, MD 20857, 301–827–2307.Įnd Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. Start Further Info FOR FURTHER INFORMATION CONTACT: The compliance date for all other OTC drug products is May 17, 2002. The compliance date for products with annual sales less that $25,000 is May 17, 2003. The stay of § 310.545 (a)(15)(ii) for topical otic drug products for the drying of water-clogged ears that published at 60 FR 42436 on August 16, 1995, and effective June 22, 1995, is lifted effective September 11, 2000. This final rule is part of the ongoing review of OTC drug products conducted by FDA. The agency is also lifting a partial stay of the effective date of certain provisions of the regulations for topical otic drug products for the drying of water clogged ears. The agency is amending its final regulations for OTC drug labeling requirements to include the new flammability warning for topical otic drug products for drying water-clogged ears. The amendment adds conditions for marketing topical otic drug products for drying water-clogged ears and includes labeling in the new OTC drug format. The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) topical otic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). ACTION:įinal rule lift of partial stay of effective date. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications ![]() Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register.
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