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  7. Rulemaking History for OTC Oral Wound Healing Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Oral Wound Healing Drug Products

Final Monograph (21 CFR 310.5341):
Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents

Oral Wound Healing Drug Products

Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking:2 Includes oral wound cleansers and healing
 agents
11/2/197944FR63270
     Correction 2/1/198045FR7268
Proposed RuleDateFR Citation
 Tentative Final Monograph: Includes oral wound cleansers and healing agents7/26/198348FR33984
     Correction 8/9/198348FR36133
Final RuleDateFR Citation
 Final Monograph:6 No GRASE oral wound healing agents; transfers oral wound cleansers
 to oral healthcare monograph 
7/18/198651FR26112