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  7. Rulemaking History for OTC External Analgesic Drug Products
  1. 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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