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U.S. Department of Health and Human Services

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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 4/5/1973 38FR8714
    Correction [PDF] 5/29/1973 38FR14111
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 11/12/1973 38FR31260
    Correction [PDF] 12/7/1973 38FR33774
Notice: Public hearing on tentative final monograph [PDF] 1/8/1974 39FR1359
Proposed Rule: Revises rate of acid addition [PDF] 1/22/1974 39FR2488
    Correction [PDF] 2/21/1974 39FR6620
Final Rule Date FR Citation
Final Monograph [PDF] 6/4/1974 39FR19862
    Correction [PDF] 6/20/1974 39FR22140
    Correction [PDF] 9/11/1974 39FR32736
Notice: NDA withdrawal [PDF] 11/8/1974 39FR39591
Technical Amendment: Revises indications [PDF] 3/13/1975 40FR11718
Technical Amendment: Extends effective date [PDF] 5/23/1975 40FR22542
Notice: Availability of Advisory Panel transcript [PDF] 12/15/1975 40FR58165
Notice: Classifies Category III active ingredients as nonmonograph [PDF] 9/5/1978 43FR39427
    Correction [PDF] 11/28/1978 43FR55464
Notice: Classifies alginic acid as nonmonograph [PDF] 9/4/1987 52FR33576

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

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

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

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