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Rulemaking History for OTC Bronchodilator Drug Products

Rulemaking History for OTC Bronchodilator Drug Products
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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:

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

41FR54032
Reopening of Administrative Record 3/21/1980 45FR18400
Reopening of Administrative Record: Camphor-containing products 9/26/1980 45FR63874
Notice: Advisory Committee meeting 4/29/1983 48FR19470
Notice: Republication of 4/29/1983 notice 5/6/1983 48FR20502
Proposed Rule Date FR Citation
Tentative Final Monograph 10/26/1982 47FR47520
    Correction 1/25/1983 48FR3382
Final Rule Date FR Citation
Final Monograph 10/2/1986 51FR35326
    Correction 3/13/1987 52FR7830
    Correction 4/17/1987 52FR12521
Notice: OMB approval of final monograph 3/9/1987 52FR7126
Technical Amendment: Clarifies age range for children's dosage 9/15/1988 53FR45774

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

Bronchodilator Drug Products: Ephedrine
Proposed Rule Date FR Citation
Proposed Rule: Classifies pressurized metered dose aerosol as nonmonograph 3/9/1995 60FR13014
Proposed Rule: Classifies ephedrine as nonmonograph 7/27/1995 60FR38643
    Correction 8/18/1995 60FR43091
Final Rule Date FR Citation
Final Rule: Classifies pressurized metered dose aerosol as nonmonograph 5/20/1996 61FR25142
    Correction 3/4/1997 62FR9684

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

Bronchodilator Drug Products: Revised Labeling After 1986 Final Monograph
Proposed Rule Date FR Citation
Proposed Rule: Revises indications, warnings, and directions 7/13/2005 70FR40237

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