U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. Development Resources
  5. Over-the-Counter (OTC) Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Category II and III Drug Products
  1. Over-the-Counter (OTC) Drugs

Rulemaking History for OTC Category II and III Drug Products

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 RuleDateFR Citation
Proposed Rule: 21 OTC drug categories [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Proposed Rule: 7 OTC drug categories [PDF]8/25/199257FR38568
    Correction [PDF]9/8/199257FR40944
    Technical Amendment: Corrects an ingredient name [PDF]10/1/199257FR45295
    Correction [PDF]11/9/199257FR53300
Final RuleDateFR Citation
Final Rule: 19 OTC drug categories [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects several ingredient names [PDF]1/30/199257FR3526
Final Rule: 7 OTC drug categories [PDF]5/10/199358FR27636
Final Rule: Mercury compounds (first aid antiseptics, antimicrobial diaper rash, and vaginal contraceptive ingredients) [PDF]4/22/199863FR19799

Category II and III Drug Products: Category III (Administrative Procedures)

Advance Notice Of Proposed RulemakingDateFR Citation
Proposed Rule: Intent to revise procedures [PDF]10/26/197944FR61608
Proposed RuleDateFR Citation
Proposed Rule: Testing category 3 active ingredients [PDF]10/21/197540FR49097
Proposed Rule: Revises procedures [PDF]5/13/198045FR31422
Final RuleDateFR Citation
Final Rule: Testing category 3 Active Ingredients [PDF]4/12/197742FR19137
Final Rule: Revision of Procedures [PDF]9/29/198146FR47730

Category II and III Drug Products: Other Ingredients

Final RuleDateFR Citation
Final Rule: Internal analgesic ingredients atropine and ephedrine [PDF]8/24/199863FR44996
Final Rule: Vaginal contraceptive ingredient octoxynol 9 [PDF]5/9/200267FR31123
Final Rule: Laxative ingredients aloe and cascara sagrada [PDF]5/9/200267FR31125

Category II and III Drug Products: Miscellaneous Drug Categories

Advance Notice of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking: 60+ Drug Categories [PDF]12/31/200368FR75585
Proposed Rule: 60+ Drug Categories [PDF]6/19/200873FR34895