(a) Specifications. Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains 125 milligrams (mg) or 500 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 in cattle—(1) Lactating cows—(i) Amount. Infuse 125 mg per affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.

(ii) Indications for use. For use in lactating dairy cattle:

(A) For the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli; and

(B) For the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and S. dysgalactiae.

(iii) Limitations. Milk taken from cows during treatment (a maximum of eight daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to 8 consecutive days, a 2-day preslaughter 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 lactating dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.

(2) Dry cows—(i) Amount. Infuse 500 mg per affected quarter at the time of dry off.

(ii) Indications for use. For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.

(iii) Limitations. Milk taken from cows completing a 30-day dry-off period may be used for food with no milk discard due to ceftiofur residues. Following intramammary infusion, a 16-day preslaughter withdrawal period is required for treated cows. Following label use, no preslaughter withdrawal period is required for neonatal calves from treated cows regardless of colostrum consumption. 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 dry dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.

[70 FR 9516, Feb. 28, 2005, as amended at 70 FR 20048, Apr. 18, 2005. Redesignated and amended at 71 FR 39545, July 13, 2006; 79 FR 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; 80 FR 34279, June 16, 2015]