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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Category II and III Drug Products
  1. Historical Status of OTC Rulemakings

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

 

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