CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS > 522.313a—Ceftiofur crystalline free acid.

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. 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. 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.
(2) Cattle. The formulation described in paragraph (a)(2) of this section is used as follows:
(i) Amount. 6.6 mg ceftiofur equivalents per kg of body weight as a single injection. For subcutaneous injection in the middle third of the posterior aspect of the ear or in the posterior aspect of the ear where it attaches to the head (base of the ear) in beef and non-lactating dairy cattle. For subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle.
(ii) Indications for use. 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.
(iii) Limitations. Following label use as a single treatment, a 13-day pre-slaughter withdrawal period is required. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
(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.

Code of Federal Regulations

[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]