Rulemaking History for OTC Antiemetic Drug Products
Final Monograph (21 CFR part 336):
Antiemetic Drug Products for Over-the-Counter Human Use
OTC Antiemetic Drug Products found on this page:
Antiemetic Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 3/21/1975 | 40FR12902 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 7/13/1979 | 44FR41064 |
| Reopening of Administrative Record: Category II and III active ingredients [PDF] | 10/26/1979 | 44FR61610 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 4/30/1987 | 52FR15886 |
|
Technical Amendment: Clarifies age range for children's dosage [PDF] |
9/15/1988 | 53FR35808 |
Antiemetic Drug Products: Warnings Related to Age
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 8/26/1993 | 58FR45216 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 4/11/1994 | 59FR16981 |
Antiemetic Drug Products: Diphenhydramine Warnings
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 8/29/1997 | 62FR45767 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 12/6/2002 | 67FR72555 |