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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Antacid Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antacid Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 331):*Antacid Products for Over-the-Counter Human Use*

OTC Antacid Drug Products found on this page:

Original Active Ingredients and Labeling
	Indications
	Warnings and Directions
	Combination Products
	In Vitro Test ProceduresAntacid Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			4/5/1973
			38FR8714Correction
			5/29/1973
			38FR14111Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			11/12/1973
			38FR31260Correction
			12/7/1973
			38FR33774Notice: Public hearing on tentative final monograph
			1/8/1974
			39FR1359Proposed Rule: Revises rate of acid addition
			1/22/1974
			39FR2488Correction
			2/21/1974
			39FR6620Final Rule
			Date
			*FR* CitationFinal Monograph
			6/4/1974
			39FR19862Correction
			6/20/1974
			39FR22140Correction
			9/11/1974
			39FR32736Notice: NDA withdrawal
			11/8/1974
			39FR39591Technical Amendment: Revises indications
			3/13/1975
			40FR11718Technical Amendment: Extends effective date
			5/23/1975
			40FR22542Notice: Availability of Advisory Panel transcript
			12/15/1975
			40FR58165Notice: Classifies Category III active ingredients as nonmonograph
			9/5/1978
			43FR39427Correction
			11/28/1978
			43FR55464Notice: Classifies alginic acid as nonmonograph
			9/4/1987
			52FR33576

Antacid Drug Products: Indications

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds "upset stomach" indication
			9/21/1979
			44FR54731Proposed Rule: Adds overindulgence indication
			12/24/1991
			56FR66754Final Rule
			Date
			*FR* CitationFinal Rule: Adds "upset stomach" indication
			8/31/1982
			47FR38481

Antacid Drug Products: Warnings and Directions

Proposed Rule
			Date
			*FR* CitationProposed Rule: Calcium and magnesium (concomitant antibiotic use)
			10/19/1979
			44FR60328Correction
			11/16/1979
			44FR65992Proposed Rule: Exempts from "accidental overdose" warning
			4/13/1984
			49FR14908Correction
			5/21/1984
			49FR21350Proposed Rule: Prescription drug interaction
			7/30/1986
			51FR27342Extension of comment period
			10/1/1986
			51FR35002Proposed Rule: Sodium bicarbonate (gastric rupture)
			2/2/1994
			59FR5060Extension of Comment Period
			4/14/1994
			59FR17747Final Rule
			Date
			*FR* CitationFinal Rule: Exempts from "accidental overdose" warning
			8/1/1986
			51FR27762Final Rule: Prescription drug interaction
			8/26/1993
			58FR45204Correction
			9/10/1986
			51FR32212

Antacid Drug Products: Combination Products

Proposed Rule
			Date
			*FR* CitationProposed Rule: Antacids and analgesics
			11/16/1988
			53FR46190Notice of Enforcement of Policy: Antacids and acetaminophen
			2/5/1992
			57FR4456Correction
			2/20/1992
			57FR6165Correction
			2/28/1992
			57FR6892

Antacid Drug Products: In Vitro Test Procedures

Proposed Rule
			Date
			*FR* CitationProposed Rule: Revises temperature
			5/23/1975
			40FR22553Proposed Rule: Procedure for requesting test modification
			5/27/1980
			45FR35349Proposed Rule: Requires testing based on USP method
			9/23/1993
			58FR49826Final Rule
			Date
			*FR* CitationFinal Rule: Revises temperature
			10/15/1975
			40FR48343Final Rule: Procedure for requesting test modification
			8/31/1982
			47FR38480Final Rule: Requires testing based on USP method
			2/8/1996
			61FR4822Correction
			10/9/1997
			62FR52659

                                                                                  Content current as of:
      02/04/2020Historical Status of OTC Rulemakings
 
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