21 CFR 522.1193 - Ivermectin and clorsulon.

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There are 2 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1193 Ivermectin and clorsulon.
(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent) clorsulon.
(b) Sponsors. See Nos. 050604, 055529, and 058005 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.163 and 556.344 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use in cattle—
(1) Amount. Administer 1 mL (10 mg ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by subcutaneous injection.
(2) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); liver flukes (adults only) (Fasciola hepatica); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis); and for control of infections of D. viviparus and O. radiatum for 28 days afer treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; and H. placei and C. oncophora for 14 days after treatment.
(3) Limitations. For subcutaneous use only. Not for intravenous or intramuscular use. Do not treat cattle within 49 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
[55 FR 38984, Sept. 24, 1990, as amended at 62 FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR 64717, Oct. 23, 2012]

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.

  • 2014-07-02; vol. 79 # 127 - Wednesday, July 2, 2014
    1. 79 FR 37617 - New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 2, 2014.
      21 CFR Parts 510, 520, 522, 529, 556, 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.

  • 2014-07-02; vol. 79 # 127 - Wednesday, July 2, 2014
    1. 79 FR 37617 - New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 2, 2014.
      21 CFR Parts 510, 520, 522, 529, 556, and 558