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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC External Analgesic Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC External Analgesic Drug Products

Final Monograph (21 CFR part 348):
External Analgesic Drug Products for Over-the-Counter Human Use 

OTC External Analgesic Drug Products found on this page:

External Analgesic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/4/197944FR69768
    Correction2/5/198045FR7820
    Correction3/25/198045FR19265
Reopening of Administrative Record: Panel recommends 2.5%>

9/26/1980

45FR63878
    Extension of Comment Period

12/28/1982

47FR57738
Proposed RuleDateFR Citation
Tentative Final Monograph2/8/198348FR5852
    Correction3/11/198348FR10373

External Analgesic Drug Products: Corticosteroids

Proposed RuleDateFR Citation
Tentative Final Monograph

2/8/1983

48FR5852
Proposed Rule: Adds seborrheic dermatitis/psoriasis indication for hydrocortisone

7/30/1986

51FR27360
Proposed Rule: Adds anal and genital itch indication for hydrocortisone8/25/198853FR32592
Proposed Rule: Increases hydrocortisone concentration from 0.25% to 1%2/27/199055FR6932
   Notice of Enforcement: Allows marketing of 1% hydrocortisone8/30/199156FR43025
Notice: Advisory Committee meeting on topical corticosteroid safety2/17/200570FR8104

External Analgesic Drug Products: Diaper Rash

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record9/7/198247FR39412
    Correction12/7/198247FR54982
Proposed RuleDateFR Citation
Proposed Rule: Classifies diaper rash indication as nonmonograph6/20/199055FR25234
Final RuleDateFR Citation
Final Rule12/18/199257FR60426

External Analgesic Drug Products: Diphenhydramine

Proposed RuleDateFR Citation
Proposed Rule: Adds warnings and directions8/29/199762FR45767

External Analgesic Drug Products: Fever Blister and Cold Sore

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice Of Proposed Rulemaking9/7/198247FR39412
    Correction12/7/198247FR54982
Proposed RuleDateFR Citation
Proposed Rule: Adds fever blister and cold sore indication1/31/199055FR3370
    Correction3/27/199055FR11291

External Analgesic Drug Products: Aloe Vera and Urea

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data12/31/200368FR75585

External Analgesic Drug Products: Vaginal Douche

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record11/19/199762FR61710

External Analgesic Drug Products: Male Genital Desensitizers

Proposed RuleDateFR Citation
Proposed Rule: Adds indication for benzocaine and lidocaine10/2/198550FR40260
Final RuleDateFR Citation
Final Rule6/19/199257FR27654

External Analgesic Drug Products: Patches, Plasters, and Poultices

Proposed RuleDateFR Citation
Proposed Rule: Classifies dosage forms as category III7/17/200368FR42324

External Analgesic Drug Products: Poison Ivy, Oak, Sumac and Insect Bites

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record9/7/198247FR39412
    Correction12/7/198247FR54982
Proposed RuleDateFR Citation
Proposed Rule: Adds poison ivy, oak, sumac and insect bite indications10/3/198954FR40818

External Analgesic Drug Products: Insect Repellent

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data2/22/200772FR7941

External Analgesic Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Proposed Rule: Classifies category II and III ingredients without data as non-monograph8/25/199257FR38568
    Correction9/8/199257FR40944
    Correction11/9/199257FR53300
Proposed Rule: 60+ Drug Categories6/19/200873FR34895
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636

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