Drugs

Rulemaking History for OTC Bronchodilator Drug Products

Final Monograph (21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
 

OTC Bronchodilator Drug Products found on this page:


Bronchodilator Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/9/1976 41FR38312
Notice: Prohibits single-ingredient theophylline marketing [PDF] 12/10/1976

41FR54032

Reopening of Administrative Record [PDF] 3/21/1980 45FR18400
Reopening of Administrative Record: Camphor-containing products [PDF] 9/26/1980 45FR63874
Notice: Advisory Committee meeting [PDF] 4/29/1983 48FR19470
Notice: Republication of 4/29/1983 notice [PDF] 5/6/1983 48FR20502
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 10/26/1982 47FR47520
    Correction [PDF] 1/25/1983 48FR3382
Final Rule Date FR Citation
Final Monograph [PDF] 10/2/1986 51FR35326
    Correction [PDF] 3/13/1987 52FR7830
    Correction [PDF] 4/17/1987 52FR12521
Notice: OMB approval of final monograph [PDF] 3/9/1987 52FR7126
Technical Amendment: Clarifies age range for children's dosage [PDF] 9/14/1988 53FR45774

Bronchodilator Drug Products: Combination Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Classifies caffeine, PPA, ephedrine combinations as nonmonograph [PDF] 8/13/1982 47FR35344
Notice: Classifies caffeine, PPA, ephedrine, pseudoephedrine combinations as nonmonograph [PDF] 11/18/1983 48FR52513
Proposed Rule Date FR Citation
Proposed Rule [PDF] 8/12/1988 53FR30522
    Clarification: Promethazine HCl combinations [PDF] 11/14/1988 53FR45774
Notice: Bans interim marketing of promethazine HCl combinations [PDF] 9/5/1989 54FR36762
Reopening of Administrative Record: Promethazine HCl combinations [PDF] 11/28/1989 54FR48914
    Correction [PDF] 1/4/1990 55FR310
    Extension of Comment Period [PDF] 1/24/1990 55FR2387
Proposed Rule: Classifies diphenhydramine HCl and citrate combinations as GRASE [PDF] 2/23/1995 60FR10286
Proposed Rule: Classifies bronchodilator, expectorant, nasal decongestant combinations as nonmonograph [PDF] 7/13/2005 70FR40232
Final Rule Date FR Citation
Final Rule: Nonmonograph combinations [PDF] 9/27/2001 66FR49276
    Correction [PDF] 10/19/2001 66FR53088
Final Rule: GRASE combinations [PDF] 12/23/2002 67FR78158
    Technical Amendment: Correction [PDF] 3/19/2007 72FR12730

Bronchodilator Drug Products: Ephedrine
Proposed Rule Date FR Citation
Proposed Rule: Classifies pressurized metered dose aerosol as nonmonograph [PDF] 3/9/1995 60FR13014
Proposed Rule: Classifies ephedrine as nonmonograph [PDF] 7/27/1995 60FR38643
    Correction [PDF] 8/18/1995 60FR43091
Proposed Rule: Withdraws 1995 proposed rule and provides additional labeling for products containing ephedrine 7/13/2005 70FR40237
Final Rule Date FR Citation
Final Rule: Classifies pressurized metered dose aerosol as nonmonograph [PDF] 5/20/1996 61FR25142
    Correction [PDF] 3/4/1997 62FR9684
Notice: Public meeting to educate the public about removal of epinephrine metered dose inhalers from the market 8/20/2009 74FR42080

Bronchodilator Drug Products: Monoamine Oxidase Inhibitor (MAOI) Warning
Proposed Rule Date FR Citation
Proposed Rule: Requires warning [PDF] 6/19/1992 57FR27662
    Extension of Comment Period [PDF] 8/6/1992 57FR34733
Final Rule Date FR Citation
Final Rule [PDF] 10/20/1993 58FR54238

 

Page Last Updated: 11/19/2014
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