21 CFR 522.313b - Ceftiofur hydrochloride.

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§ 522.313b Ceftiofur hydrochloride.
(a) Specifications. Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) ceftiofur equivalents.
(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.113 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use.
(1) Swine—
(i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
(ii) Indications for use. For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, and Streptococcus suis.
(iii) Limitations. Treated swine must not be slaughtered for 4 days following the last treatment.
(2) Cattle—
(i) Amount. For bovine respiratory disease and acute bovine interdigital necrobacillosis, administer 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease only, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis only, administer 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days. Product in peanut oil suspension may be administered by either intramuscular or subcutaneous injection. Product in caprylic/capric triglyceride suspension may be administered by subcutaneous injection only.
(ii) Indications for use. For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
(iii) Limitations. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
[61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, 2002; 69 FR 47362, Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 73 FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, 2011]

Title 21 published on 2013-04-01

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.

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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

Title 21 published on 2013-04-01

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

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522