Rulemaking History for OTC Anthelmintic Drug Products
Final Monograph (21 CFR part 357 subpart B):
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Anthelmintic Drug Products
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Anthelmintic Drug Products
Anthelmintic Drug Products
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 9/9/1980 | 45FR59540 |
| Correction | 10/3/1980 | 45FR65609 |
| Notice: Hearing for NDA withdrawal | 12/2/1987 | 52FR45868 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 8/24/1982 | 47FR37062 |
| Correction | 9/21/1982 | 47FR41581 |
| Correction | 1/28/1983 | 48FR4003 |
| Correction | 3/4/1983 | 48FR9300 |
| Final Rule | Date | FR Citation |
| Final Monograph | 8/1/1986 | 51R27756 |
| Correction | 9/5/1986 | 51FR31763 |
| OMB (PRA) Approval Notice | 1/23/1987 | 52FR2515 |
| Correction | 3/13/1987 | 52FR7830 |