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  7. Rulemaking History for OTC Antiemetic Drug Products
  1. Status of OTC Rulemakings

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