Drugs

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

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OTC Exocrine Pancreatic Insufficiency Drug Products found on this page:

Exocrine Pancreatic Insufficiency Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/21/197944FR75666
   Correction3/25/198045FR19266
   Extension of Comment Period3/25/198045FR19265
Proposed RuleDateFR Citation
Tentative Final Monograph Pancreatin and pancrelipase are GRASE11/8/198550FR46594
    Correction12/2/198550FR49409
Proposed Rule: Withdraws tentative final monograph; No GRASE active ingredients7/15/199156FR32282
Notice: Public workshop to discuss testing (needed for NDAs)3/11/199257FR8586
Final RuleDateFR Citation
Final Rule: No GRASE active ingredients4/24/199560FR20162
Notice: Availability of guidance on submitting an NDA4/28/200469FR23414

Exocrine Pancreatic Insufficiency Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
   Correction12/3/199055FR49973
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526

 

Page Last Updated: 12/01/2016
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