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 Rulemaking4/5/197338FR8714disclaimer icon
    Correction5/29/197338FR14111disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph11/12/197338FR31260disclaimer icon
    Correction12/7/197338FR33774disclaimer icon
Notice: Public hearing on tentative final monograph1/8/197439FR1359disclaimer icon
Proposed Rule: Revises rate of acid addition1/22/197439FR2488disclaimer icon
    Correction2/21/197439FR6620disclaimer icon
Final RuleDateFR Citation
Final Monograph6/4/197439FR19862disclaimer icon
    Correction6/20/197439FR22140disclaimer icon
    Correction9/11/197439FR32736disclaimer icon
Notice: NDA withdrawal11/8/197439FR39591disclaimer icon
Technical Amendment: Revises indications3/13/197540FR11718disclaimer icon
Technical Amendment: Extends effective date5/23/197540FR22542disclaimer icon
Notice: Availability of Advisory Panel transcript12/15/197540FR58165disclaimer icon
Notice: Classifies Category III active ingredients as nonmonograph9/5/197843FR39427disclaimer icon
    Correction11/28/197843FR55464disclaimer icon
Notice: Classifies alginic acid as nonmonograph9/4/198752FR33576disclaimer icon

Antacid Drug Products: Indications

Proposed RuleDateFR Citation
Proposed Rule: Adds "upset stomach" indication9/21/197944FR54731disclaimer icon
Proposed Rule: Adds overindulgence indication12/24/199156FR66754disclaimer icon
Final RuleDateFR Citation
Final Rule: Adds "upset stomach" indication8/31/198247FR38481disclaimer icon

Antacid Drug Products: Warnings and Directions

Proposed RuleDateFR Citation
Proposed Rule: Calcium and magnesium (concomitant antibiotic use) 10/19/197944FR60328disclaimer icon
    Correction11/16/197944FR65992disclaimer icon
Proposed Rule: Exempts from "accidental overdose" warning4/13/198449FR14908disclaimer icon
     Correction5/21/198449FR21350disclaimer icon
Proposed Rule: Prescription drug interaction7/30/198651FR27342disclaimer icon
    Extension of comment period10/1/198651FR35002disclaimer icon
Proposed Rule: Sodium bicarbonate (gastric rupture)2/2/199459FR5060
    Extension of Comment Period4/14/199459FR17747
Final RuleDateFR Citation
Final Rule: Exempts from "accidental overdose" warning8/1/198651FR27762disclaimer icon
Final Rule: Prescription drug interaction8/26/199358FR45204disclaimer icon
    Correction9/10/198651FR32212disclaimer icon

Antacid Drug Products: Combination Products

Proposed RuleDateFR Citation
Proposed Rule: Antacids and analgesics11/16/198853FR46190disclaimer icon
Notice of Enforcement of Policy: Antacids and acetaminophen2/5/199257FR4456disclaimer icon
    Correction2/20/199257FR6165disclaimer icon
        Correction2/28/199257FR6892disclaimer icon

Antacid Drug Products: In Vitro Test Procedures

Proposed RuleDateFR Citation
Proposed Rule: Revises temperature5/23/197540FR22553disclaimer icon
Proposed Rule: Procedure for requesting test modification5/27/198045FR35349disclaimer icon
Proposed Rule: Requires testing based on USP method9/23/199358FR49826disclaimer icon
Final RuleDateFR Citation
Final Rule: Revises temperature10/15/197540FR48343disclaimer icon
Final Rule: Procedure for requesting test modification8/31/198247FR38480disclaimer icon
Final Rule: Requires testing based on USP method2/8/199661FR4822


Page Last Updated: 02/07/2017
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