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
Proposed RuleDateFR Citation
Tentative Final Monograph11/12/197338FR31260
Notice: Public hearing on tentative final monograph1/8/197439FR1359
Proposed Rule: Revises rate of acid addition1/22/197439FR2488
Final RuleDateFR Citation
Final Monograph6/4/197439FR19862
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
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
Proposed Rule: Exempts from "accidental overdose" warning4/13/198449FR14908
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

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

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


Page Last Updated: 03/08/2017
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