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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Wart Remover Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Wart Remover Drug Products

Final Monograph (21 CFR part 358 subpart B:)
Miscellaneous External Drug Products for Over-the-Counter Human Use: Wart Remover Drug Products 

OTC Wart Remover Drug Products found on this page:

Wart Remover Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 10/3/1980 45FR65609
    Correction 12/5/1980 45FR80551
Proposed Rule Date FR Citation
Tentative Final Monograph 9/3/1982 47FR39102
    Correction 11/19/1982 47FR52200
Proposed Rule: Revises to be consistent with corn and callus tentative final monograph 3/27/1987 52FR9992
Final Rule Date FR Citation
Final Monograph 8/14/1990 55FR33246
    Correction 9/11/1990 55FR37403
    Technical Amendment: Clarifies that collodoin-like vehicles applied with applicator or
    brush		 9/28/1992 57FR44494

Wart Remover Drug Products: Salicylic Acid

Proposed Rule Date FR Citation
Proposed Rule: Revises directions for 15% salicylic acid in karaya gum glycol plaster vehicle 1/28/1994 59FR4015
Final Rule Date FR Citation
Final Rule: Revises directions for 15% salicylic acid in karaya gum glycol plaster vehicle 11/23/1994 59FR60315

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