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  7. Rulemaking History for OTC Food and Drink Overindulgence Drug Products
  1. Status of OTC Rulemakings

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

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

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