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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Stimulant Drug Product
  1. Historical 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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 12/8/1975 40FR57292
    Correction 1/8/1976 41FR1498
    Correction 1/26/1976 41FR3745
    Correction 1/30/1976 41FR4600
Proposed Rule Date FR Citation
Tentative Final Monograph 6/13/1978 43FR25544
Reopening of Administrative Record: Category II and III active ingredients 10/26/1979 44FR61611
    Correction 11/16/1979 44FR65992
Reopening of Administrative Record 3/21/1980 45FR18399
Notice: Prohibits combination of caffeine, PPA, and ephedrine 8/13/1982 47FR35344
Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine 11/18/1983 48FR52513
Final Rule Date FR Citation
Final Monograph 2/29/1988 53FR6100
    Correction 4/8/1988 53FR11731

Stimulant Drug Products: Hangover Symptoms

Proposed Rule Date FR Citation
Proposed Rule: Adds hangover relief indication 12/24/1991 56FR66758
    Correction 2/24/1992 57FR6352
    Correction 3/17/1992 57FR9346

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