Rulemaking History for OTC Antacid Drug Products

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

OTC Antacid Drug Products found on this page:

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**Antacid 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
Notice: Public hearing on tentative final monograph	1/8/1974	39FR1359
Proposed Rule: Revises rate of acid addition	1/22/1974	39FR2488
Correction	2/21/1974	39FR6620
Final Rule	Date	FR Citation
Final Monograph	6/4/1974	39FR19862
Correction	6/20/1974	39FR22140
Correction	9/11/1974	39FR32736
Notice: NDA withdrawal	11/8/1974	39FR39591
Technical Amendment: Revises indications	3/13/1975	40FR11718
Technical Amendment: Extends effective date	5/23/1975	40FR22542
Notice: Availability of Advisory Panel transcript	12/15/1975	40FR58165
Notice: Classifies Category III active ingredients as nonmonograph	9/5/1978	43FR39427
Correction	11/28/1978	43FR55464
Notice: Classifies alginic acid as nonmonograph	9/4/1987	52FR33576

**Antacid Drug Products: Indications**
Proposed Rule	Date	FR Citation
Proposed Rule: Adds "upset stomach" indication	9/21/1979	44FR54731
Proposed Rule: Adds overindulgence indication	12/24/1991	56FR66754
Final Rule	Date	FR Citation
Final Rule: Adds "upset stomach" indication	8/31/1982	47FR38481

**Antacid Drug Products: Warnings and Directions**
Proposed Rule	Date	FR Citation
Proposed Rule: Calcium and magnesium (concomitant antibiotic use)	10/19/1979	44FR60328
Correction	11/16/1979	44FR65992
Proposed Rule: Exempts from "accidental overdose" warning	4/13/1984	49FR14908
Correction	5/21/1984	49FR21350
Proposed Rule: Prescription drug interaction	7/30/1986	51FR27342
Extension of comment period	10/1/1986	51FR35002
Proposed Rule: Sodium bicarbonate (gastric rupture)	2/2/1994	59FR5060
Extension of Comment Period	4/14/1994	59FR17747
Final Rule	Date	FR Citation
Final Rule: Exempts from "accidental overdose" warning	8/1/1986	51FR27762
Correction	9/5/1986	51FR31763
Final Rule: Prescription drug interaction	8/26/1993	58FR45204
Correction	9/10/1986	51FR32212

**Antacid Drug Products: Combination Products**
Proposed Rule	Date	FR Citation
Proposed Rule: Antacids and analgesics	11/16/1988	53FR46190
Notice of Enforcement of Policy: Antacids and acetaminophen	2/5/1992	57FR4456
Correction	2/20/1992	57FR6165
Correction	2/28/1992	57FR6892

**Antacid Drug Products: In Vitro Test Procedures**
Proposed Rule	Date	FR Citation
Proposed Rule: Revises temperature	5/23/1975	40FR22553
Proposed Rule: Procedure for requesting test modification	5/27/1980	45FR35349
Proposed Rule: Requires testing based on USP method	9/23/1993	58FR49826
Final Rule	Date	FR Citation
Final Rule: Revises temperature	10/15/1975	40FR48343
Final Rule: Procedure for requesting test modification	8/31/1982	47FR38480
Final Rule: Requires testing based on USP method	2/8/1996	61FR4822
Correction	10/9/1997	62FR52659

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