Drugs

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]5/16/199055FR20434disclaimer icon
    Correction [PDF]6/7/199055FR23235disclaimer icon
Proposed Rule: 7 OTC drug categories [PDF]8/25/199257FR38568disclaimer icon
    Correction [PDF]9/8/199257FR40944disclaimer icon
    Technical Amendment: Corrects an ingredient name [PDF]10/1/199257FR45295disclaimer icon
    Correction [PDF]11/9/199257FR53300disclaimer icon
Final RuleDateFR Citation
Final Rule: 19 OTC drug categories [PDF]11/7/199055FR46914disclaimer icon
    Correction [PDF]12/3/199055FR49973disclaimer icon
    Technical Amendment: Corrects several ingredient names [PDF]1/30/199257FR3526disclaimer icon
Final Rule: 7 OTC drug categories [PDF]5/10/199358FR27636disclaimer icon
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]10/26/197944FR61608disclaimer icon
Proposed RuleDateFR Citation
Proposed Rule: Testing category 3 active ingredients [PDF]10/21/197540FR49097disclaimer icon
Proposed Rule: Revises procedures [PDF]5/13/198045FR31422disclaimer icon
Final RuleDateFR Citation
Final Rule: Testing category 3 Active Ingredients [PDF]4/12/197742FR19137disclaimer icon
Final Rule: Revision of Procedures [PDF]9/29/198146FR47730disclaimer icon

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

 

Page Last Updated: 02/22/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English