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  6. Status of OTC Rulemakings
  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 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
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