Rulemaking History for OTC Category II and III Drug Products

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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

Additional Ingredients
Category III (Administrative Procedures)
Other Ingredients
Miscellaneous Drug Categories

**Category II and III Active Ingredients in OTC Drug Products: Additional Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: 21 OTC drug categories	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Proposed Rule: 7 OTC drug categories	8/25/1992	57FR38568
Correction	9/8/1992	57FR40944
Technical Amendment: Corrects an ingredient name	10/1/1992	57FR45295
Correction	11/9/1992	57FR53300
Final Rule	Date	FR Citation
Final Rule: 19 OTC drug categories	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects several ingredient names	1/30/1992	57FR3526
Final Rule: 7 OTC drug categories	5/10/1993	58FR27636
Final Rule: Mercury compounds (first aid antiseptics, antimicrobial diaper rash, and vaginal contraceptive ingredients)	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	10/26/1979	44FR61608
Proposed Rule	Date	FR Citation
Proposed Rule: Testing category 3 active ingredients	10/21/1975	40FR49097
Proposed Rule: Revises procedures	5/13/1980	45FR31422
Final Rule	Date	FR Citation
Final Rule: Testing category 3 Active Ingredients	4/12/1977	42FR19137
Final Rule: Revision of Procedures	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	8/24/1998	63FR44996
Final Rule: Vaginal contraceptive ingredient octoxynol 9	5/9/2002	67FR31123
Final Rule: Laxative ingredients aloe and cascara sagrada	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	12/31/2003	68FR75585
Proposed Rule: 60+ Drug Categories	6/19/2008	73FR34895

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Date created: December 28, 2006; Last updated:June 23, 2008



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