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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 Digestive Aid Drug ProductHistorical Status of OTC Rulemakings Rulemaking History for OTC Digestive Aid Drug Product
  
  	
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    Print**Non-Monograph** (21 CFR 310.545(a)(8)):*Drug Products Containing Certain Ingredients Offered Over-The-Counter (OTC) For Certain Uses*

FDA Archive-It webpage:
Rulemaking History for OTC Digestive Aid Drug ProductSearch for Federal Register documents:

GPO Federal Register Database (1994 to present)
	Library of Congress (1936 - 1993)

OTC Digestive Aid Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients**Digestive Aid Drug Products: Original Active Ingredients and Labeling**:

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			1/5/1982
			47FR454Proposed Rule
			Date
			*FR* CitationTentative Final Monograph: Classifies all active ingredients as nonmonograph
			1/29/1988
			53FR2706Extension of Comment Period
			4/19/1988
			53FR12779Final Rule
			Date
			*FR* CitationFinal Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme
			10/21/1993
			58FR54450

**Digestive Aid Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
			8/25/1992
			57FR38568Correction
			9/8/1992
			57FR40944Technical Amendment: Correct an ingredient name
			10/1/1992
			57FR45295Correction
			11/9/1992
			57FR53300Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526Final Rule: Classifies category II and III ingredients without data as nonmonograph
			5/10/1993
			58FR27636

                                                                                  Content current as of:
      06/06/2017Historical Status of OTC Rulemakings
 
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