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21 CFR § 522.313c - Ceftiofur sodium.

---
identifier: "/us/cfr/t21/s522.313c"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.313c - Ceftiofur sodium."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.313c"
section_name: "Ceftiofur sodium."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---

# 522.313c Ceftiofur sodium.

(a) *Specifications.* Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.

(b) *Sponsors.* See Nos. 017033 and 054771 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. Federal law prohibits extra-label use of this drug in cattle, swine, chickens, and turkeys 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) body weight by intramuscular injection for 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.* Treated pigs must not be slaughtered for 4 days following the last treatment.

(2) *Cattle*—(i) *Amount.* 0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

(ii) *Indications for use.* For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with *Mannheimia haemolytica, Pasteurella multocida,* and *Histophilus somni.* Also, for the treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with *Fusobacterium necrophorum* and *Bacteroides melaninogenicus.*

(iii) *Limitations.* Treated cattle must not be slaughtered for 4 days following the last treatment.

(3) *Sheep*—(i) *Amount.* 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

(ii) *Indications for use.* For treatment of sheep respiratory disease (sheep pneumonia) associated with *Mannheimia haemolytica* and *Pasteurella multocida.*

(4) *Goats*—(i) *Amount.* 0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

(ii) *Indications for use.* For treatment of caprine respiratory disease (goat pneumonia) associated with *Mannheimia haemolytica* and *Pasteurella multocida.*

(5) *Chickens*—(i) *Amount.* 0.08 to 0.20 mg as a single subcutaneous injection in the neck.

(ii) *Indications for use.* For control of early mortality associated with *Escherichia coli* organisms susceptible to ceftiofur in day-old chicks.

(6) *Turkeys*—(i) *Amount.* 0.17 to 0.5 mg as a single subcutaneous injection in the neck.

(ii) *Indications for use.* For control of early mortality associated with *E. coli* organisms susceptible to ceftiofur in day-old poults.

(7) *Horses*—(i) *Amount.* 2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.

(ii) *Indications for use.* For treatment of respiratory infections in horses associated with *Streptococcus zooepidemicus.*

(iii) *Limitations.* Do not use in horses intended for human consumption.

(8) *Dogs*—(i) *Amount.* 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 5 to 14 days.

(ii) *Indications for use.* For treatment of canine urinary tract infections associated with *E. coli* and *Proteus mirabilis.*

[53 FR 5369, Feb. 24, 1988, as amended at 55 FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR 51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, 2001; 66 FR 32540, June 15, 2001; 69 FR 47362, Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 74 FR 34236, July 15, 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 82 FR 12169, Mar. 1, 2017; 89 FR 95103, Dec. 2, 2024]