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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Digestive Aid Drug Product

Non-Monograph (21 CFR 310.545(a)(8)):
Drug Products Containing Certain Ingredients Offered Over-The-Counter (OTC) For Certain Uses 

OTC Digestive Aid Drug Products found on this page:


Digestive Aid Drug Products: Original Active Ingredients and Labeling:
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 1/5/1982 47FR454
Proposed Rule Date FR Citation
Tentative Final Monograph: Classifies all active ingredients as nonmonograph [PDF] 1/29/1988 53FR2706
    Extension of Comment Period [PDF] 4/19/1988 53FR12779
Final Rule Date FR Citation
Final Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme [PDF] 10/21/1993 58FR54450

Digestive Aid Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/10/1993 58FR27636
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