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

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 Rulemaking12/21/197944FR75666disclaimer icon
   Correction3/25/198045FR19266disclaimer icon
   Extension of Comment Period3/25/198045FR19265disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph Pancreatin and pancrelipase are GRASE11/8/198550FR46594disclaimer icon
    Correction12/2/198550FR49409disclaimer icon
Proposed Rule: Withdraws tentative final monograph; No GRASE active ingredients7/15/199156FR32282disclaimer icon
Notice: Public workshop to discuss testing (needed for NDAs)3/11/199257FR8586disclaimer icon
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 nonmonograph5/16/199055FR20434disclaimer icon
   Correction6/7/199055FR23235disclaimer icon
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914disclaimer icon
   Correction12/3/199055FR49973disclaimer icon
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526disclaimer icon

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Page Last Updated: 02/23/2017
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