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Rulemaking History for OTC Oral Wound Healing Drug Products
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Final Monograph (21 CFR 310.534):
Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents

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Oral Wound Healing Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking: Includes oral wound cleansers and healing agents 11/2/1979 44FR63270
    Correction 2/1/1980 45FR7268
Proposed Rule Date FR Citation
Tentative Final Monograph: Includes oral wound cleansers and healing agents 7/26/1983 48FR33984
    Correction 8/9/1983 48FR36133
Final Rule Date FR Citation
Final Monograph: No GRASE oral wound healing agents; transfers oral wound cleansers to oral healthcare monograph 7/18/1986 51FR26112

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Date created: December 28, 2006; Last updated: May 4, 2007
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