Rulemaking History for OTC Antiflatulent Drug Products

Final Monograph (21 CFR part 332):
Antiflatulent Products for Over-the-Counter Human Use

OTC Antiflatulent Drug Products found on this page:

 Antiflatulent Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]4/5/197338FR8714
    Correction [PDF]5/29/197338FR14111
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]11/12/197338FR31260
    Correction [PDF]12/7/197338FR33774
Final RuleDateFR Citation
Final Monograph [PDF]6/4/197439FR19862
Technical Amendment: Revises indications [PDF]3/13/197540FR11718
Technical Amendment: Extends effective date [PDF]5/23/197540FR22542

 Antiflatulent Drug Products: Statement of Identity and Indications

Proposed RuleDateFR Citation
Proposed Rule [PDF]1/29/198853FR2716
     Correction [PDF]3/3/198853FR6916
Extension of Comment Period [PDF]4/19/198853FR12778
Final RuleDateFR Citation
Final Rule [PDF]3/5/199661FR8836

 Antiflatulent Drug Products: Warnings

Proposed RuleDateFR Citation
Proposed Rule: Exempts from "accidental overdose" warning [PDF]4/13/198449FR14908
     Correction [PDF]5/21/198449FR21350
Final RuleDateFR Citation
Final Rule [PDF]8/1/198651FR27762
    Correction [PDF]9/10/198651FR32212


Page Last Updated: 03/20/2017
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