Rulemaking History for OTC Exocrine Pancreatic Insufficiency Drug Products

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Rulemaking History for OTC Exocrine Pancreatic Insufficiency Drug Products
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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:

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**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 Guidance	4/28/2004	69FR23410

**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

Date created: December 28, 2006; Last updated: May 4, 2007