Rulemaking History for OTC Antiflatulent Drug Product

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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 4/5/1973 38FR8714
    Correction [PDF] 5/29/1973 38FR14111
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 11/12/1973 38FR31260
    Correction [PDF] 12/7/1973 38FR33774
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/1974 39FR19862
Technical Amendment: Revises indications [PDF] 3/13/1975 40FR11718
Technical Amendment: Extends effective date [PDF] 5/23/1975 40FR22542

Antiflatulent Drug Products: Statement of Identity and Indications
Proposed Rule Date FR Citation
Proposed Rule [PDF] 1/29/1988 53FR2716
     Correction [PDF] 3/3/1988 53FR6916
Extension of Comment Period [PDF] 4/19/1988 53FR12778
Final Rule Date FR Citation
Final Rule [PDF] 3/5/1996 61FR8836

Antiflatulent Drug Products: Warnings
Proposed Rule Date FR Citation
Proposed Rule: Exempts from "accidental overdose" warning [PDF] 4/13/1984 49FR14908
     Correction [PDF] 5/21/1984 49FR21350
Final Rule Date FR Citation
Final Rule [PDF] 8/1/1986 51FR27762
    Correction [PDF] 9/10/1986 51FR32212


Page Last Updated: 04/06/2016
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