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Rulemaking History for OTC Digestive Aid Drug Product
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Non-Monograph (21 CFR 310.545(a)(8)):
Drug Products Containing Certain Ingredients Offered Over-The-Counter (OTC) For Certain Uses


Date Federal Register Citation Description

1/5/1982

47FR454 PDF document

Advance Notice of Proposed Rulemaking

1/29/1988

53FR2706 PDF document

Tentative Final Monograph: Classifies all active ingredients as nonmonograph

4/19/1988

53FR12779 PDF document

Extension of Comment Period: Tentative Final Monograph

5/16/1990 55FR20434 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990 55FR23235 PDF document Correction: 5/16/1900 Proposed Rule
11/7/1990 55FR46914 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990 55FR49973 PDF document Correction: 11/7/1990 Final Rule
1/30/1992 57FR3526 PDF document Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
8/25/1992 57FR38568 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
9/8/1992 57FR40944 PDF document Correction: 8/25/1992 Proposed Rule
10/1/1992 57FR458295 PDF document Technical Amendment: Correct an ingredient name (8/25/1992 Proposed Rule)
11/9/1992 57FR53300 PDF document Correction: 8/25/1992 Proposed Rule

5/10/1993

58FR27636 PDF document

Final Rule: Classifies category II and III ingredients without data as nonmonograph

10/21/1993

58FR54450 PDF document

Final Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme 

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Date updated: May 9, 2007

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