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  7. Rulemaking History for OTC Skin Protectant Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Skin Protectant Drug Products

Final Monograph (21 CFR part 347):
Skin Protectant Drug Products for Over-the-Counter Human Use 

OTC Skin Protectant Drug Products found on this page:

  • Original Active Ingredients and Labeling
  • Astringent
  • Diaper Rash
  • Fever Blister and Cold Sore
  • Nonnonograph Ingredients
  • Poison Ivy, Oak, Sumac and Insect Bites

Skin Protectant Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 8/4/1978 43FR34628
        Correction 9/19/1978 43FR42018
Reopening of Administrative Record 3/21/1980 45FR18402
Proposed Rule Date FR Citation
Tentative Final Monograph 2/15/1983 48FR6820
Correction 4/12/1983 48FR15655
Reopening of Administrative Record: To include "hard fat" 12/19/1991 56FR65873
Final Rule Date FR Citation
Final Monograph 6/4/2003 68FR33362
Technical Amendment: Corrects indications 12/9/2003 68FR68509
Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 8/19/2004 69FR51362
Technical Amendment: Lip protectant labeling 2/1/2008 73FR6014
Availability of Guidance (Labeling) 8/4/2008 73FR45227

Skin Protectant Drug Products: Astringent

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/7/1982 47FR39436
Correction 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule 4/3/1989 54FR13490
Correction 4/27/1989 54FR18197
Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph 6/13/2003 68FR35346
Final Rule Date FR Citation
Final Rule 10/21/1993 58FR54458
Final Rule: Revises "Hamamelis water" to "witch hazel" 6/3/1994 59FR28767
Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph 6/13/2003 68FR35290
Confirmation of effective date 10/9/2003 68FR58273
Correction 1/22/2004 69FR3005
Technical Amendment: Astringents producing aluminum acetate 3/6/2009 74FR9759

Skin Protectant Drug Products: Diaper Rash

Advance Notice Of Proposed Rulemaking Date FRCitation
Reopening of Administrative Record 9/7/1982 47FR39436
    Correction 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule 6/20/1990 55FR25204
    Extension of Comment Period: Vitamins A and D 12/18/1990 55FR51926
Final Rule Date FR Citation
Final Monograph 6/4/2003 68FR33362
        Technical Amendment: Corrects indications 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 8/19/2004 69FR51362

Skin Protectant Drug Products: Fever Blister and Cold Sore

Advance Notice Of Proposed Rulemaking Date FR Citation
Reopening of Administrative Record 9/7/1982 47FR39436
        Correction 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule: Skin Protectants; External Analgesics for Fever Blister and Cold Sore Treatment 1/31/1990 55FR3362
        Correction 3/27/1990 55FR11291
Final Rule Date FR Citation
Final Monograph 6/4/2003 68FR33362
        Technical Amendment: Corrects indications 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 8/19/2004 69FR51362

Skin Protectant Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434
    Correction 6/7/1990 55FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 8/25/1992 57FR38568
    Correction 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name 10/1/1992 57FR45295
    Correction 11/9/1992 57FR53300
Proposed Rule: 60+ Drug Categories 6/19/2008 73FR34895
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 11/7/1990 55FR46914
    Correction 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name 1/30/1992 57FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph 5/10/1993 58FR27636

Skin Protectant Drug Products: Poison Ivy, Oak, Sumac and Insect Bites

Advance Notice Of Proposed Rulemaking Date FR Citation
Reopening of Administrative Record 9/7/1982 47FR39436
        Correction 10/15/1982 47FR46117
Proposed Rule Date FR Citation
Proposed Rule

10/3/1989

55FR40808
Final Rule Date FR Citation
Final Monograph 6/4/2003 68FR33362
        Technical Amendment: Corrects indications 12/9/2003 68FR68509
        Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 8/19/2004 69FR51362

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