Drugs

Rulemaking History for OTC Food and Drink Overindulgence Drug Products

Pending Final Monograph (21 CFR part 357 subpart J):  
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

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OTC Food and Drink overindulgence Drug Products found on this page:

Food and Drink Overindulgence Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/1/198247FR43540
   Correction12/10/198247FR55497
   Correction12/21/198247FR56871
   Extension of Comment Period1/4/198348FR270
Notice: Classifies "prevention of inebriation" claim as nonmonograph7/19/198348FR32872
Proposed RuleDateFR Citation
Tentative Final Monograph12/24/199156FR66742
   Correction3/4/199257FR7847

Food and Drink Overindulgence Drug Products: Internal Analgesics

Proposed RuleDateFR Citation
Proposed Rule: Amends 21 CFR part 343 to allow stimulant and internal analgesic combinations12/24/199156FR66762

Food and Drink Overindulgence Drug Products: Antacids

Proposed RuleDateFR Citation
Proposed Rule: Amends 21 CFR part 331 to allow overindulgence claims for antacids12/24/199156FR66754

Food and Drink Overindulgence Drug Products: Bismuth Subsalicylate

Proposed RuleDateFR Citation
Proposed Rule: Requires Reye syndrome warning5/5/199358FR26886
Proposed Rule: Adds "upset stomach" claim1/5/200570FR741

Food and Drink Overindulgence Drug Products: Stimulants

Proposed RuleDateFR Citation
Proposed Rule: Amends 21 CFR part 340 to allow stimulant and internal analgesic combinations12/24/199156FR66758
   Correction2/24/199257FR6352

 

 

Page Last Updated: 12/01/2016
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