Drugs
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Rulemaking History for OTC Bronchodilator Drug Products
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Final Monograph (21 CFR part 341): |
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
| 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 |
| 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] | 9/14/1988 | 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 |
| 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 |
| 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 |
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