21 CFR 522.313a - Ceftiofur crystalline free acid.

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§ 522.313a Ceftiofur crystalline free acid.

(a) Specifications. The product is a suspension of ceftiofur crystalline free acid.

(1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents.

(2) Each mL contains 200 mg ceftiofur equivalents.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.113 of this chapter.

(d) Conditions of use -

(1) Swine. The formulation described in paragraph (a)(1) of this section is used as follows:

(i) Amount. 5.0 mg CE per kilogram (kg) of body weight by intramuscular injection in the postauricular region of the neck.

(ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. For the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.

(iii) Limitations. Following label use as a single treatment, a 14-day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.

(2) Cattle. The formulation described in paragraph (a)(2) of this section is used as follows:

(i) Amount. For subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle. For SC injection in the middle third of the posterior aspect of the ear or in the base of the ear in beef and non-lactating dairy cattle.

(A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight as a single injection.

(B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight given as two injections in the base of the ear approximately 72 hours apart.

(ii) Indications for use - (A) Single-dose regimen: For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.

(B) Two-dose regimen: For the treatment of acute metritis (0-to 10-days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.

(iii) Limitations. Following label use as either a single-dose or 2-dose regimen, a 13-day pre-slaughter withdrawal period is required after the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved, major food-producing species/production classes.

(3) Horses. The formulation described in paragraph (a)(2) of this section is used as follows:

(i) Amount. Two intramuscular injections, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.

(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004. Redesignated and amended at 71 FR 39546, July 13, 2006; 73 FR 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 FR 62468, Oct. 12, 2010; 77 FR 26162, May 3, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620, July 2, 2014]

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

Title 21 published on 2015-04-01

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

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558