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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Exocrine Pancreatic Insufficiency Drug Products
  1. Historical Status of OTC Rulemakings

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 12/21/1979 44FR75666
   Correction 3/25/1980 45FR19266
   Extension of Comment Period 3/25/1980 45FR19265
Proposed Rule Date FR Citation
Tentative Final Monograph Pancreatin and pancrelipase are GRASE 11/8/1985 50FR46594
    Correction 12/2/1985 50FR49409
Proposed Rule: Withdraws tentative final monograph; No GRASE active ingredients 7/15/1991 56FR32282
Notice: Public workshop to discuss testing (needed for NDAs) 3/11/1992 57FR8586
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients 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 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 11/7/1990 55FR46914
   Correction 12/3/1990 55FR49973
   Technical Amendment: Corrects an ingredient name 1/30/1992 57FR3526

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