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Rulemaking History for OTC Food and Drink Overindulgence Drug Products
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Pending Final Monograph (21 CFR 357):  
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink for Over-the-Counter Human Use

Date Federal Register Citation Description
10/1/1982 47FR43540 PDF document Advance Notice of Proposed Rulemaking
12/10/1982 47FR55497 PDF document Correction: Advance Notice of Proposed Rulemaking
12/21/1982 47FR56871 PDF document Correction: Advance Notice of Proposed Rulemaking
1/4/1983 48FR270 PDF document Extension of Comment Period: Advance Notice of Proposed Rulemaking
7/19/1983 48FR32872 PDF document Notice: Classifies "prevention of inebriation" claim as nonmonograph
12/24/1991 56FR66742 PDF document Tentative Final Monograph
12/24/1991 56FR66758 PDF document Proposed Rule: Amends 21 CFR part 340 to allow stimulant and internal analgesic combinations
12/24/1991 56FR66754 PDF document Proposed Rule: Amends 21 CFR part 331 to allow overindulgence claims for antacids
12/24/1991 55FR66762 PDF document Proposed Rule: Amends 21 CFR part 343 to allow stimulant and internal analgesic combinations
2/24/1992 57FR6352 PDF document Correction: 1/24/1991 (56FR66758) Proposed Rule
3/4/1992 57FR7847 PDF document Correction: Tentative Final Monograph
5/5/1993 58FR26886 PDF document Proposed Rule: Requires Reyes' syndrome warning for bismuth subsalicylate
1/5/2005 70FR741PDF document
[HTML]		 Proposed Rule: Adds "upset stomatch" claim for bismuth subsalicylate

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Date updated: December 28, 2006
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