Rulemaking History for OTC Antacid Drug Products
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Date	Federal Register Citation	Description
4/5/1973	38FR8714	Advance Notice of Proposed Rulemaking
5/29/1973	38FR14111	Correction: Advance Notice of Proposed Rulemaking
11/12/1973	38FR31260	Tentative Final Monograph
12/7/1973	38FR33774	Correction: Tentative Final Monograph
1/8/1974	39FR1359	Notice: Public hearing on Tentative Final Monograph
1/22/1974	39FR2488	Proposed Rule: Revised rate of acid addition
2/21/1974	39FR6620	Correction: 1/22/1974 Proposed Rule
6/4/1974	39FR19862	Final Monograph
6/20/1974	39FR22140	Correction: Final Monograph
9/11/1974	39FR32736	Correction: Final Monograph
11/8/1974	39FR39591	Notice: Withdraws NDA
3/13/1975	40FR11718	Technical Amendment: Revises indications
5/23/1975	40FR22542	Technical Amendment: Extends effective date
5/23/1975	40FR22553	Proposed Rule: Revised in vitro test (temperature)
10/15/1975	40FR48343	Final Rule: Revised in vitro test (temperature)
12/15/1975	40FR58165	Notice: Availability of Advisory Panel transcript
9/5/1978	43FR39427	Notice: Classifies Category III active ingredients as nonmonograph
11/28/1978	43FR55464	Correction: 9/5/1978 Notice
9/21/1979	44FR54731	Proposed Rule: Adds "upset stomach" indication
10/19/1979	44FR60328	Proposed Rule: Requires warning and directions (concomitant antibiotic use) for calcium & magnesium
11/16/1979	44FR65992	Correction: 10/19/1979 Proposed Rule
5/27/1980	45FR35349	Proposed Rule: Procedure for request in vitro test modification
8/31/1982	47FR38480	Final Rule: Procedure for request in vitro test modification
8/31/1982	47FR38481	Final Rule: Adds "upset stomach" indication
4/13/1984	49FR14908	Proposed Rule: Exempts from "accidental overdose" warning
5/21/1984	49FR21350	Correction: 4/13/1984 Proposed Rule
7/30/1986	51FR27342	Proposed Rule: Requires prescription drug interaction warning
8/1/1986	51FR27763	Final Rule: Exempts from "accidental overdose" warning
9/5/1986	51FR31763	Correction: 8/1/1986 Final Rule
9/10/1986	51FR32212	Correction: 8/1/1986 Final Rule
10/1/1986	51FR35002	Extension of comment period: 7/30/1986 Proposed Rule
9/4/1987	52FR33576	Notice: Classifies alginic acid as nonmonograph
11/16/1988	53FR46190	Proposed Rule: antacid and analgesic combinations
12/24/1991	56FR66754	Proposed Rule: Adds overindulgence indication
2/5/1992	57FR4456	Notice of Enforcement Policy: Allows marketing of antacid and acetaminophen combinations
2/20/1992	57FR6165	Correction: 2/5/1992 Notice of Enforcement Policy
2/28/1992	57FR6892	Correction: 2/5/1992 Notice of Enforcement Policy
8/26/1993	58FR45204	Final Rule: Requires prescription drug interaction warning
9/23/1993	58FR49826	Proposed Rule: Requires in vitro test based on USP method
2/2/1994	59FR5060	Proposed Rule: Requires sodium bicarbonate (gastric rupture) warnings and directions
4/14/1994	59FR17747	Extension of Comment Period: 2/2/1994 Proposed Rule
11/25/1994	59FR60555	Correction: 8/26/1993 Final Rule
2/8/1996	61FR4822  [HTML]	Final Rule: Requires in vitro test based on USP method
10/9/1997	62FR52659 [HTML]	Correction: 2/8/1996 Proposed Rule

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Date updated: May 9, 2007

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