Rulemaking History for OTC Digestive Aid Drug Products

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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

OTC Digestive Aid Drug Products found on this page:

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**Digestive Aid Drug Products: Original Active Ingredients and Labeling**:
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	1/5/1982	47FR454
Proposed Rule	Date	FR Citation
Tentative Final Monograph: Classifies all active ingredients as nonmonograph	1/29/1988	53FR2706
Extension of Comment Period	4/19/1988	53FR12779
Final Rule	Date	FR Citation
Final Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme	10/21/1993	58FR54450

**Digestive Aid 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
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	8/25/1992	57FR38568
Correction	9/8/1992	57FR40944
Technical Amendment: Correct an ingredient name	10/1/1992	57FR45295
Correction	11/9/1992	57FR53300
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
Final Rule: Classifies category II and III ingredients without data as nonmonograph	5/10/1993	58FR27636

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