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

 

 
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