21 CFR 522.1155 - Imidocarb dipropionate sterile powder.

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§ 522.1155 Imidocarb dipropionate sterile powder.
(a) Specifications. Imidocarb dipropionate powder is reconstituted with sterile water. Each milliliter of solution contains 100 milligrams of imidocarb base.
(b) Sponsor. No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use. The drug is used in horses and zebras as follows:
(1) Amount. For Babesia caballi infections, use intramuscularly 2 milligrams of imidocarb base per kilogram of body weight, repeating dosage once after 24 hours. For Babesia equi infections, use 4 milligrams of imidocarb base per kilogram of body weight, repeating dosage four times at 72-hour intervals.
(2) Indications for use. For the treatment of babesiosis (piroplasmosis) caused by Babesia caballi and Babesia equi.
(3) Limitations. Administer intramuscularly in the neck region. Do not inject intravenously. Do not use for other equidae or for animals of other species. Do not use in horses less than 1 year old. Do not use for animals in near-term pregnancies. Imidocarb dipropionate is a cholinesterase inhibitor. Do not use this product simultaneously with or a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Imidocarb dipropionate is sold only under permit issued by the Director of the National Program Planning Staff, Veterinary Services, APHIS, USDA, to licensed or full-time State, Federal, or military veterinarians.
[43 FR 40455, Sept. 12, 1978, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558