§ 522.313b Ceftiofur hydrochloride. ( a ) *Specifications.* Each milliliter of suspension contains: ( 1 ) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil;
( 2 ) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate (polysorbate 80) in a caprylic/capric triglyceride suspension; or
( 3 ) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides.
( b ) *Sponsors.* See sponsors in § 510.600(c) of this chapter as follows: ( 1 ) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; and
( 2 ) No. 055529 for the product described in paragraph (a)(3) of this section.
( 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. Federal law prohibits extra-label use of this drug in cattle and swine for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.
( 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.* For products described in paragraphs (a)(1) and (3) of this section: Treated swine must not be slaughtered for 4 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated swine must not be slaughtered for 6 days following the last treatment when injection site volumes are greater than 5 mL up to the maximum injection site volume of 15 mL. Treated swine must not be slaughtered for 4 days when injection site volumes are less than or equal to 5 mL.
( 2 ) *Cattle* — ( i ) *Amount.* Administer by subcutaneous or intramuscular injection as follows: ( A ) For bovine respiratory disease and acute bovine interdigital necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days.
( B ) For bovine respiratory disease: 2.2 mg/kg of body weight administered twice at a 48 hour interval.
( C ) For acute metritis: 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days.
( 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.* ( A ) For products described in paragraphs (a)(2) and (3) of this section: Treated cattle must not be slaughtered for 3 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated cattle must not be slaughtered for 4 days following the last treatment.
( B ) 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; 78 FR 66264, Nov. 5, 2013; 84 FR 39183, Aug. 9, 2019; 84 FR 53311, Oct. 7, 2019]