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  7. Rulemaking History for OTC Bronchodilator Drug Products
  1. Status of OTC Rulemakings

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 9/9/1976

41FR38312disclaimer icon

Notice: Prohibits single-ingredient theophylline marketing 12/10/1976

41FR54032disclaimer icondisclaimer icon

Reopening of Administrative Record 3/21/1980

45FR18400disclaimer icon

Reopening of Administrative Record: Camphor-containing products 9/26/1980

45FR63874disclaimer icon

Notice: Advisory Committee meeting 4/29/1983

48FR19470disclaimer icon

Notice: Republication of 4/29/1983 notice 5/6/1983 48FR20502disclaimer icon
Proposed Rule Date FR Citation
Tentative Final Monograph 10/26/1982 47FR47520disclaimer icon
    Correction 1/25/1983 48FR3382disclaimer icon
Final Rule Date FR Citation
Final Monograph 10/2/1986 51FR35326disclaimer icon
    Correction 3/13/1987 52FR7830disclaimer icon
    Correction 4/17/1987 52FR12521disclaimer icon
Notice: OMB approval of final monograph 3/9/1987 52FR7126disclaimer icon
Technical Amendment: Clarifies age range for children's dosage 11/14/1988 53FR45774disclaimer icon

">Bronchodilator Drug Products: Combination Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Classifies caffeine, PPA, ephedrine combinations as nonmonograph 8/13/1982 47FR35344disclaimer icon
Notice: Classifies caffeine, PPA, ephedrine, pseudoephedrine combinations as nonmonograph 11/18/1983 48FR52513disclaimer icon
Proposed Rule Date FR Citation
Proposed Rule 8/12/1988 53FR30522disclaimer icon
    Clarification: Promethazine HCl combinations 11/14/1988 53FR45774disclaimer icon
Notice: Bans interim marketing of promethazine HCl combinations 9/5/1989 54FR36762disclaimer icon
Reopening of Administrative Record: Promethazine HCl combinations 11/28/1989 54FR48914disclaimer icon
    Correction 1/4/1990 55FR310disclaimer icon
    Extension of Comment Period 1/24/1990 55FR2387disclaimer icon
Proposed Rule: Classifies diphenhydramine HCl and citrate combinations as GRASE 2/23/1995 60FR10286disclaimer icon
Proposed Rule: Classifies bronchodilator, expectorant, nasal decongestant combinations as nonmonograph 7/13/2005 70FR40232disclaimer icon
Final Rule Date FR Citation
Final Rule: Nonmonograph combinations 9/27/2001 66FR49276disclaimer icon
    Correction 10/19/2001 66FR53088disclaimer icon
Final Rule: GRASE combinations 12/23/2002 67FR78158disclaimer icon
    Technical Amendment: Correction 3/19/2007 72FR12730disclaimer icon

">Bronchodilator Drug Products: Ephedrine
Proposed Rule Date FR Citation
Proposed Rule: Classifies pressurized metered dose aerosol as nonmonograph 3/9/1995 60FR13014disclaimer icon
Proposed Rule: Classifies ephedrine as nonmonograph 7/27/1995 60FR38643disclaimer icon
    Correction 8/18/1995 60FR43091disclaimer icon
Proposed Rule: Withdraws 1995 proposed rule and provides additional labeling for products containing ephedrine 7/13/2005 70FR40237disclaimer icon
Final Rule Date FR Citation
Final Rule: Classifies pressurized metered dose aerosol as nonmonograph 5/20/1996 61FR25142disclaimer icon
    Correction 3/4/1997 62FR9684disclaimer icon
Notice: Public meeting to educate the public about removal of epinephrine metered dose inhalers from the market 8/20/2009 74FR42080disclaimer icon

">Bronchodilator Drug Products: Monoamine Oxidase Inhibitor (MAOI) Warning
Proposed Rule Date FR Citation
Proposed Rule: Requires warning 6/19/1992 57FR27662disclaimer icon
    Extension of Comment Period 8/6/1992 57FR34733disclaimer icon
Final Rule Date FR Citation
Final Rule 10/20/1993 58FR54238disclaimer icon