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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Exocrine Pancreatic Insufficiency Drug Products

Final Monographs (21 CFR 310.543):
Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency 

OTC Exocrine Pancreatic Insufficiency Drug Products found on this page:


Exocrine Pancreatic Insufficiency Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 12/21/1979 44FR75666
    Correction [PDF] 3/25/1980 45FR19266
    Extension of Comment Period [PDF] 3/25/1980 45FR19265
Proposed Rule Date FR Citation
Tentative Final Monograph: Pancreatin and pancrelipase are GRASE [PDF] 11/8/1985 50FR46594
     Correction [PDF] 12/2/1985 50FR49409
Proposed Rule: Withdraws tentative final monograph; No GRASE active ingredients [PDF] 7/15/1991 56FR32282
Notice: Public workshop to discuss testing (needed for NDAs) [PDF] 3/11/1992 57FR8586
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients [PDF] 4/24/1995 60FR20162
Notice: Availability of guidance on submitting an NDA 4/28/2004 69FR23414

Exocrine Pancreatic Insufficiency 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 6/7/1990 55FR23235
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
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