U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Status of OTC Rulemakings
  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


Back to Top