Rulemaking History for OTC Allergy Drug Products
Final Monograph (21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
OTC Allergy Drug Products found on this page:
- Antihistamines for Cold Symptoms
- Chlorocyclizine HCl and Doxylamine Succinate
- Bronchodilators for Asthma Symptoms
Allergy Drug Products: Antihistamines for Cold Symptoms
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 9/9/1976 | 41FR38312 |
| Reopening of Administrative Record | 3/21/1980 | 45FR18400 |
| Notice: Advisory Committee meeting | 4/29/1983 | 48FR19470 |
| Notice: Republication of 4/29/1983 notice | 5/6/1983 | 48FR20502 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule | 1/15/1985 | 50FR2200 |
| Correction | 2/14/1985 | 50FR6199 |
| Correction | 3/6/1985 | 50FR9040 |
| Final Rule | Date | FR Citation |
| Final Rule | 12/9/1992 | 57FR58356 |
Allergy Drug Products: Chlorocyclizine HCl and Doxylamine Succinate
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Chlorocyclizine HCl and doxylamine succinate | 8/24/1987 | 52FR31892 |
| Correction | 9/22/1987 | 52FR35610 |
| Final Rule | Date | FR Citation |
| Final Rule: doxylamine succinate | 1/28/1994 | 59FR4216 |
Allergy Drug Products: Bronchodilators for Asthma Symptoms
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Tentative Final Monograph | 10/26/1982 | 47FR47520 |
| Notice: Advisory Committee meeting on metaproterenol | 4/29/1983 | 48FR19470 |
| Notice: Advisory Committee meeting on metaproterenol | 5/6/1983 | 48FR20502 |