Drugs

Rulemaking History for OTC Antacid Drug Products

Final Monograph (21 CFR part 331):
Antacid Products for Over-the-Counter Human Use
 

OTC Antacid Drug Products found on this page:


Antacid 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
Notice: Public hearing on tentative final monograph [PDF]1/8/197439FR1359
Proposed Rule: Revises rate of acid addition [PDF]1/22/197439FR2488
    Correction [PDF]2/21/197439FR6620
Final RuleDateFR Citation
Final Monograph [PDF]6/4/197439FR19862
    Correction [PDF]6/20/197439FR22140
    Correction [PDF]9/11/197439FR32736
Notice: NDA withdrawal [PDF]11/8/197439FR39591
Technical Amendment: Revises indications [PDF]3/13/197540FR11718
Technical Amendment: Extends effective date [PDF]5/23/197540FR22542
Notice: Availability of Advisory Panel transcript [PDF]12/15/197540FR58165
Notice: Classifies Category III active ingredients as nonmonograph [PDF]9/5/197843FR39427
    Correction [PDF]11/28/197843FR55464
Notice: Classifies alginic acid as nonmonograph [PDF]9/4/198752FR33576

Antacid Drug Products: Indications
Proposed RuleDateFR Citation
Proposed Rule: Adds "upset stomach" indication [PDF]9/21/197944FR54731
Proposed Rule: Adds overindulgence indication [PDF]12/24/199156FR66754
Final RuleDateFR Citation
Final Rule: Adds "upset stomach" indication [PDF]8/31/198247FR38481

Antacid Drug Products: Warnings and Directions
Proposed RuleDateFR Citation
Proposed Rule: Calcium and magnesium (concomitant antibiotic use) [PDF]10/19/197944FR60328
    Correction [PDF]11/16/197944FR65992
Proposed Rule: Exempts from "accidental overdose" warning [PDF]4/13/198449FR14908
     Correction [PDF]5/21/198449FR21350
Proposed Rule: Prescription drug interaction [PDF]7/30/198651FR27342
    Extension of comment period [PDF]10/1/198651FR35002
Proposed Rule: Sodium bicarbonate (gastric rupture) [PDF]2/2/199459FR5060
    Extension of Comment Period [PDF]4/14/199459FR17747
Final RuleDateFR Citation
Final Rule: Exempts from "accidental overdose" warning [PDF]8/1/198651FR27762
Final Rule: Prescription drug interaction [PDF]8/26/199358FR45204
    Correction [PDF]9/10/198651FR32212

Antacid Drug Products: Combination Products
Proposed RuleDateFR Citation
Proposed Rule: Antacids and analgesics [PDF]11/16/198853FR46190
Notice of Enforcement of Policy: Antacids and acetaminophen [PDF]2/5/199257FR4456
    Correction [PDF]2/20/199257FR6165
        Correction [PDF]2/28/199257FR6892

Antacid Drug Products: In Vitro Test Procedures
Proposed RuleDateFR Citation
Proposed Rule: Revises temperature [PDF]5/23/197540FR22553
Proposed Rule: Procedure for requesting test modification [PDF]5/27/198045FR35349
Proposed Rule: Requires testing based on USP method [PDF]9/23/199358FR49826
Final RuleDateFR Citation
Final Rule: Revises temperature [PDF]10/15/197540FR48343
Final Rule: Procedure for requesting test modification [PDF]8/31/198247FR38480
Final Rule: Requires testing based on USP method [PDF]2/8/199661FR4822
    Correction [PDF]10/9/199762FR52659

 

Page Last Updated: 12/15/2014
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