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 Rulemaking12/8/197540FR57292disclaimer icon
    Correction1/8/197641FR1498disclaimer icon
    Correction1/26/197641FR3745disclaimer icon
    Correction1/30/197641FR4600disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544disclaimer icon
Reopening of Administrative Record: Category II and III active ingredients10/26/197944FR61611disclaimer icon
    Correction11/16/197944FR65992disclaimer icon
Reopening of Administrative Record3/21/198045FR18399disclaimer icon
Notice: Prohibits combination of caffeine, PPA, and ephedrine8/13/198247FR35344disclaimer icon
Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine11/18/198348FR52513disclaimer icon
Final RuleDateFR Citation
Final Monograph2/29/198853FR6100disclaimer icon
    Correction4/8/198853FR11731disclaimer icon

Stimulant Drug Products: Hangover Symptoms

Proposed RuleDateFR Citation
Proposed Rule: Adds hangover relief indication12/24/199156FR66758disclaimer icon
    Correction2/24/199257FR6352disclaimer icon
    Correction3/17/199257FR9346disclaimer icon

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Page Last Updated: 02/16/2017
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