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

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

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