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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 12/8/1975 40FR57292
    Correction [PDF] 1/8/1976 41FR1498
    Correction [PDF] 1/26/1976 41FR3745
    Correction [PDF] 1/30/1976 41FR4600
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 6/13/1978 43FR25544
Reopening of Administrative Record: Category II and III active ingredients [PDF] 10/26/1979 44FR61611
    Correction [PDF] 11/16/1979 44FR65992
Reopening of Administrative Record [PDF] 3/21/1980 45FR18399
Notice: Prohibits combination of caffeine, PPA, and ephedrine [PDF] 8/13/1982 47FR35344
Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine [PDF] 11/18/1983 48FR52513
Final Rule Date FR Citation
Final Monograph [PDF] 2/29/1988 53FR6100
    Correction [PDF] 4/8/1988 53FR11731

Stimulant Drug Products: Hangover Symptoms
Proposed Rule Date FR Citation
Proposed Rule: Adds hangover relief indication [PDF] 12/24/1991 56FR66758
    Correction [PDF] 2/24/1992 57FR6352
    Correction [PDF] 3/17/1992 57FR9346


Page Last Updated: 04/06/2016
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