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  7. Rulemaking History for OTC Antacid Drug Products
  1. Status of OTC Rulemakings

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 Rulemaking4/5/197338FR8714
    Correction5/29/197338FR14111
Proposed RuleDateFR Citation
Tentative Final Monograph11/12/197338FR31260
    Correction12/7/197338FR33774
Notice: Public hearing on tentative final monograph1/8/197439FR1359
Proposed Rule: Revises rate of acid addition1/22/197439FR2488
    Correction2/21/197439FR6620
Final RuleDateFR Citation
Final Monograph6/4/197439FR19862
    Correction6/20/197439FR22140
    Correction9/11/197439FR32736
Notice: NDA withdrawal11/8/197439FR39591
Technical Amendment: Revises indications3/13/197540FR11718
Technical Amendment: Extends effective date5/23/197540FR22542
Notice: Availability of Advisory Panel transcript12/15/197540FR58165
Notice: Classifies Category III active ingredients as nonmonograph9/5/197843FR39427
    Correction11/28/197843FR55464
Notice: Classifies alginic acid as nonmonograph9/4/198752FR33576

Antacid Drug Products: Indications

Proposed RuleDateFR Citation
Proposed Rule: Adds "upset stomach" indication9/21/197944FR54731
Proposed Rule: Adds overindulgence indication12/24/199156FR66754
Final RuleDateFR Citation
Final Rule: Adds "upset stomach" indication8/31/198247FR38481

Antacid Drug Products: Warnings and Directions

Proposed RuleDateFR Citation
Proposed Rule: Calcium and magnesium (concomitant antibiotic use) 10/19/197944FR60328
    Correction11/16/197944FR65992
Proposed Rule: Exempts from "accidental overdose" warning4/13/198449FR14908
     Correction5/21/198449FR21350
Proposed Rule: Prescription drug interaction7/30/198651FR27342
    Extension of comment period10/1/198651FR35002
Proposed Rule: Sodium bicarbonate (gastric rupture)2/2/199459FR5060
    Extension of Comment Period4/14/199459FR17747
Final RuleDateFR Citation
Final Rule: Exempts from "accidental overdose" warning8/1/198651FR27762
Final Rule: Prescription drug interaction8/26/199358FR45204
    Correction9/10/198651FR32212

Antacid Drug Products: Combination Products

Proposed RuleDateFR Citation
Proposed Rule: Antacids and analgesics11/16/198853FR46190
Notice of Enforcement of Policy: Antacids and acetaminophen2/5/199257FR4456
    Correction2/20/199257FR6165
        Correction2/28/199257FR6892

Antacid Drug Products: In Vitro Test Procedures

Proposed RuleDateFR Citation
Proposed Rule: Revises temperature5/23/197540FR22553
Proposed Rule: Procedure for requesting test modification5/27/198045FR35349
Proposed Rule: Requires testing based on USP method9/23/199358FR49826
Final RuleDateFR Citation
Final Rule: Revises temperature10/15/197540FR48343
Final Rule: Procedure for requesting test modification8/31/198247FR38480
Final Rule: Requires testing based on USP method2/8/199661FR4822
    Correction10/9/199762FR52659