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Rulemaking History for OTC Antiflatulent Drug Product
View by Date

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

OTC Antiflatulent Drug Products found on this page:

Note: This page links to PDF files which require the free Adobe Acrobat Reader.


Antiflatulent Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 4/5/1973 38FR8714
    Correction 5/29/1973 38FR14111
Proposed Rule Date FR Citation
Tentative Final Monograph 11/12/1973 38FR31260
    Correction 12/7/1973 38FR33774
Final Rule Date FR Citation
Final Monograph 6/4/1974 39FR19862
Technical Amendment: Revises indications 3/13/1975 40FR11718
Technical Amendment: Extends effective date 5/23/1975 40FR22542

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

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

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Date created: December 28, 2006; Last updated: May 4, 2007

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