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  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Antacid Drug Products
  1. Historical 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

 

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