21 C.F.R. § 526.313 Ceftiofur.
Title 21 - Food and Drugs
(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. 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 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 the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. (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 pre-slaughter withdrawal period is required. (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 pre-slaughter 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. [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]
Title 21: Food and Drugs
PART 526—INTRAMAMMARY DOSAGE FORMS
§ 526.313 Ceftiofur.
