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U.S. Department of Health and Human Services

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Rulemaking History for OTC Category II and III Drug Products

OTC Category II and III Drug Products found on this page:


Category II and III Active Ingredients in OTC Drug Products: Additional Ingredients
Proposed Rule Date FR Citation
Proposed Rule: 21 OTC drug categories [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Proposed Rule: 7 OTC drug categories [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Corrects an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: 19 OTC drug categories [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects several ingredient names [PDF] 1/30/1992 57FR3526
Final Rule: 7 OTC drug categories [PDF] 5/10/1993 58FR27636
Final Rule: Mercury compounds (first aid antiseptics, antimicrobial diaper rash, and vaginal contraceptive ingredients) [PDF] 4/22/1998 63FR19799

Category II and III Drug Products: Category III (Administrative Procedures)
Advance Notice Of Proposed Rulemaking Date FR Citation
Proposed Rule: Intent to revise procedures [PDF] 10/26/1979 44FR61608
Proposed Rule Date FR Citation
Proposed Rule: Testing category 3 active ingredients [PDF] 10/21/1975 40FR49097
Proposed Rule: Revises procedures [PDF] 5/13/1980 45FR31422
Final Rule Date FR Citation
Final Rule: Testing category 3 Active Ingredients [PDF] 4/12/1977 42FR19137
Final Rule: Revision of Procedures [PDF] 9/29/1981 46FR47730

Category II and III Drug Products: Other Ingredients
Final Rule Date FR Citation
Final Rule: Internal analgesic ingredients atropine and ephedrine [PDF] 8/24/1998 63FR44996
Final Rule: Vaginal contraceptive ingredient octoxynol 9 [PDF] 5/9/2002 67FR31123
Final Rule: Laxative ingredients aloe and cascara sagrada [PDF] 5/9/2002 67FR31125

Category II and III Drug Products: Miscellaneous Drug Categories
Advance Notice of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking: 60+ Drug Categories [PDF] 12/31/2003 68FR75585
Proposed Rule: 60+ Drug Categories [PDF] 6/19/2008 73FR34895