Rulemaking History for OTC Oral Healthcare Drug Products
Pending Final Monograph (21 CFR part 356):
Oral Health Care Drug Products for Over-the-Counter Human Use
Oral Health Care Drug Products for Over-the-Counter Human Use
OTC Oral Healthcare Drug Products found on this page:
- Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant
- Antigingivitis/Antiplaque
- Oral Antiseptic
- Toothache Relief, Tooth Desensitizer, Oral Mucosal Analgesic, Oral Mucosal Protectant
- Nonmonograph Ingredients
Oral Healthcare Drug Products: Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 5/25/1982 | 47FR22760--]){kind=small} |
| Extension of Comment Period | 7/30/1982 | 47FR32953 |
| Correction | 10/15/1982 | 47FR46117 |
| Extension of Comment Period | 12/28/1982 | 47FR57738 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 1/27/1988 | 53FR2436 |
| Correction | 3/17/1988 | 53FR8845 |
| Proposed Rule: Exempts menthol lozenges from accidental overdose warning | 5/13/1992 | 57FR20434 |
| Correction | 6/25/1992 | 57FR28555 |
| Correction | 7/9/1992 | 57FR30534 |
| Correction | 7/27/1992 | 57FR33237 |
Oral Healthcare Drug Products: Antigingivitis/Antiplaque
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Request for Data | 9/19/1990 | 55FR38560 |
| Correction | 10/9/1990 | 55FR41170 |
| Extension of Comment Period | 3/8/1991 | 56FR9915 |
| Notice: Advisory Committee meeting | 9/19/1994 | 59FR47880 |
| Advance Notice of Proposed Rulemaking | 5/29/2003 | 68FR32232 |
| Extension of Comment Period | 8/25/2003 | 68FR50991 |
| Correction | 10/6/2003 | 68FR57642 |
| Notice: Availability of Draft Guidance on development and evaluation of these drug products Guidance | 6/28/2005 | 70FR37102 |
| Extension of Comment Period: Gingivitis claims | 8/24/2005 | 70FR49660 |
| Request for Data: Triclosan time and extent application | 7/6/2004 | 69FR40640 |
Oral Healthcare Drug Products: Oral Antiseptic
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 5/25/1982 | 47FR22760 |
| Extension of Comment Period | 7/30/1982 | 47FR32953 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule | 2/9/1994 | 59FR6084 |
| Correction | 3/14/1994 | 59FR11836 |
Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 5/25/1982 | 47FR22712 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule | 9/24/1991 | 56FR48302 |
| Correction | 12/19/1991 | 56FR 65930 |
Oral Healthcare Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 5/16/1990 | 55FR20434 |
| Correction | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 11/7/1990 | 55FR46914 |
| Correction | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name | 1/30/1992 | 57FR3526 |