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  7. Rulemaking History for OTC Stimulant Drug Product
  1. Status of OTC Rulemakings

Rulemaking History for OTC Stimulant Drug Product

Final Monograph (21 CFR part 340):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
 

OTC Stimulant Drug Products found on this page:

Stimulant Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/8/197540FR57292
    Correction1/8/197641FR1498
    Correction1/26/197641FR3745
    Correction1/30/197641FR4600
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544
Reopening of Administrative Record: Category II and III active ingredients10/26/197944FR61611
    Correction11/16/197944FR65992
Reopening of Administrative Record3/21/198045FR18399
Notice: Prohibits combination of caffeine, PPA, and ephedrine8/13/198247FR35344
Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine11/18/198348FR52513
Final RuleDateFR Citation
Final Monograph2/29/198853FR6100
    Correction4/8/198853FR11731

Stimulant Drug Products: Hangover Symptoms

Proposed RuleDateFR Citation
Proposed Rule: Adds hangover relief indication12/24/199156FR66758
    Correction2/24/199257FR6352
    Correction3/17/199257FR9346

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