Drugs

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 Rulemaking [PDF]12/4/197944FR69768
    Correction [PDF]2/5/198045FR7820
    Correction [PDF]3/25/198045FR19265
Reopening of Administrative Record: Panel recommends <2.5% camphor [PDF]

9/26/1980

45FR63878
    Extension of Comment Period [PDF]

12/28/1982

47FR57738
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]2/8/198348FR5852
    Correction [PDF]3/11/198348FR10373

External Analgesic Drug Products: Corticosteroids
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]

2/8/1983

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

7/30/1986

51FR27360
Proposed Rule: Adds anal and genital itch indication for hydrocortisone [PDF]8/25/198853FR32592
Proposed Rule: Increases hydrocortisone concentration from 0.25% to 1% [PDF]2/27/199055FR6932
   Notice of Enforcement: Allows marketing of 1% hydrocortisone [PDF]8/30/199156FR43025
Notice: Advisory Committee meeting on topical corticosteroid safety [PDF]2/17/200570FR8104

External Analgesic Drug Products: Diaper Rash
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]9/7/198247FR39412
    Correction [PDF]12/7/198247FR54982
Proposed RuleDateFR Citation
Proposed Rule: Classifies diaper rash indication as nonmonograph [PDF]6/20/199055FR25234
Final RuleDateFR Citation
Final Rule [PDF]12/18/199257FR60426

External Analgesic Drug Products: Diphenhydramine
Proposed RuleDateFR Citation
Proposed Rule: Adds warnings and directions [PDF]8/29/199762FR45767

External Analgesic Drug Products: Fever Blister and Cold Sore
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice Of Proposed Rulemaking [PDF]9/7/198247FR39412
    Correction [PDF]12/7/198247FR54982
Proposed RuleDateFR Citation
Proposed Rule: Adds fever blister and cold sore indication [PDF]1/31/199055FR3370
    Correction [PDF]3/27/199055FR11291

External Analgesic Drug Products: Aloe Vera and Urea
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data [PDF]12/31/200368FR75585

External Analgesic Drug Products: Vaginal Douche
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]11/19/199762FR61710

External Analgesic Drug Products: Male Genital Desensitizers
Proposed RuleDateFR Citation
Proposed Rule: Adds indication for benzocaine and lidocaine [PDF]10/2/198550FR40260
Final RuleDateFR Citation
Final Rule [PDF]6/19/199257FR27654

External Analgesic Drug Products: Patches, Plasters, and Poultices
Proposed RuleDateFR Citation
Proposed Rule: Classifies dosage forms as category III [PDF]7/17/200368FR42324

External Analgesic Drug Products: Poison Ivy, Oak, Sumac and Insect Bites
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]9/7/198247FR39412
    Correction [PDF]12/7/198247FR54982
Proposed RuleDateFR Citation
Proposed Rule: Adds poison ivy, oak, sumac and insect bite indications [PDF]10/3/198954FR40818

External Analgesic Drug Products: Insect Repellent
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data [PDF]2/22/200772FR7941
 

External Analgesic Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Proposed Rule: Classifies category II and III ingredients without data as non-monograph [PDF]8/25/199257FR38568
    Correction [PDF]9/8/199257FR40944
    Correction [PDF]11/9/199257FR53300
Proposed Rule: 60+ Drug Categories [PDF]6/19/200873FR34895
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526
    Technical Amendment: Correct an ingredient name [PDF]10/1/199257FR45295
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/10/199358FR27636

 

Page Last Updated: 09/29/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.