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

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 Rulemaking [PDF]10/1/198247FR43540
    Correction [PDF]12/10/198247FR55497
    Correction [PDF]12/21/198247FR56871
    Extension of Comment Period [PDF]1/4/198348FR270
Notice: Classifies "prevention of inebriation" claim as nonmonograph [PDF]7/19/198348FR32872
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]12/24/199156FR66742
    Correction [PDF]3/4/199257FR7847

Food and Drink Overindulgence Drug Products: Internal Analgesics
Proposed RuleDateFR Citation
Proposed Rule: Amends 21 CFR part 343 to allow stimulant and internal analgesic combinations [PDF]12/24/199156FR66762

Food and Drink Overindulgence Drug Products: Antacids
Proposed RuleDateFR Citation
Proposed Rule: Amends 21 CFR part 331 to allow overindulgence claims for antacids [PDF]12/24/199156FR66754

Food and Drink Overindulgence Drug Products: Bismuth Subsalicylate
Proposed RuleDateFR Citation
Proposed Rule: Requires Reye syndrome warning [PDF]5/5/199358FR26886
Proposed Rule: Adds "upset stomach" claim [PDF]1/5/200570FR741

Food and Drink Overindulgence Drug Products: Stimulants
Proposed RuleDateFR Citation
Proposed Rule: Amends 21 CFR part 340 to allow stimulant and internal analgesic combinations [PDF]12/24/199156FR66758
    Correction [PDF]2/24/199257FR6352

 

Page Last Updated: 04/06/2016
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