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In this section: Historical 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:

Original Active Ingredients and Labeling
Combination Products
Ephedrine and Epinephrine
Monoamine Oxidase Inhibitor (MAOI) Warning
Revised Labeling After 1986 Final Monograph

**">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	11/14/1988	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
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	5/20/1996	61FR25142
Correction	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	6/19/1992	57FR27662
Extension of Comment Period	8/6/1992	57FR34733
Final Rule	Date	FR Citation
Final Rule	10/20/1993	58FR54238

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