Rulemaking History for OTC Weight Control Drug Products
Final Monograph (21 CFR 310.545(a)(20)):
Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses
Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses
OTC Weight Control Drug Products found on this page:
- Benzocaine
- Original Active Ingredients and Labeling
- Nonmonograph Ingredients
- Phenylpropanolamine (PPA)
- Water-Soluble Gums
Weight Control Drug Products: Benzocaine
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 2/26/1982 | 47FR8466 |
| Correction | 4/20/1982 | 47FR16796 |
| Correction | 4/27/1982 | 47FR18004 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule: Proposes to reclassify benzocaine as nonmonograph | 3/9/2011 | 76FR12916 |
Weight Control Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 2/26/1982 | 47FR8466 |
| Correction | 4/20/1982 | 47FR16796 |
| Correction | 4/27/1982 | 47FR18004 |
| Extension of Comment Period: Phenylpropanolamine safety | 4/23/1982 | 47FR17576 |
| Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph | 8/13/1982 | 47FR35344 |
| Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph | 11/18/1983 | 48FR52513 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 10/30/1990 | 55FR45788 |
| Correction | 11/26/1990 | 55FR49200 |
| Final Rule | Date | FR Citation |
| Final Monograph: No GRASE active ingredients | 8/8/1991 | 56FR37792 |
| Correction | 9/16/1991 | 56FR46823 |
Weight Control Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: 60+ Drug Categories | 6/19/2008 | 73FR34895 |
Weight Control Drug Products: Phenylpropanolamine (PPA)
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 2/26/1982 | 47FR8466 |
| Correction | 4/20/1982 | 47FR16796 |
| Correction | 4/27/1982 | 47FR18004 |
| Extension of Comment Period: Phenylpropanolamine safety | 4/23/1982 | 47FR17576 |
| Reopening of Administrative Record: Advisory Committee meeting | 4/1/1991 | 56FR13295 |
| Correction | 4/11/1991 | 56FR14730 |
| Extension of Comment Period | 8/13/1991 | 56FR38391 |
| Notice: Advisory Committee meeting | 8/30/2000 | 65FR52775 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule: Reclassifies phenylpropanolamine from category I to II | 12/22/2005 | 70FR75988 |
Weight Control Drug Products: Water-Soluble Gums
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Requires choking warning | 10/30/1990 | 55FR45782 |
| Correction | 11/27/1990 | 55FR49377 |
| Clarification: Guar gums remain nonmonograph | 3/6/1991 | 56FR9312 |
| Final Rule | Date | FR Citation |
| Final Rule | 8/26/1993 | 58FR45194 |