Rulemaking History for OTC Stimulant Drug Products

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Rulemaking History for OTC Stimulant Drug Product
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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:

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**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	41FR4600
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

Date created: December 28, 2006; Last updated: May 4, 2007