---
kind: "section"
citation: "21 C.F.R. § 522.1860"
title: "21"
number: "522.1860"
heading: "Pradofloxacin."
url: "https://uscodex.org/cfr/21/522.1860"
---

# §522.1860. Pradofloxacin.

- (a) **Specifications.** Each milliliter (mL) of solution contains 200 milligrams (mg) pradofloxacin.
- (b) **Sponsor.** See No. 058198 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Related tolerances.** See [§ 556.530](/cfr/21/556.530.md) of this chapter.
- (d) **Conditions of use—**
  - (1) **Cattle—**
    - (i) **Amount.** Administer a single dose of 10 mg/kg (2.3 mL/100 lb) body weight by subcutaneous injection.
    - (ii) **Indications for use.** Cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age): for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
    - (iii) **Limitations.** Cattle intended for human consumption must not be slaughtered within 4 days of treatment. Not for use in female dairy cattle 1 year of age and older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
  - (2) **Swine—**
    - (i) **Amount.** Administer a single dose of 7.5 mg/kg (1.7 mL/100 lb) body weight by intramuscular injection.
    - (ii) **Indications for use.** Weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter): for the treatment of swine respiratory disease associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae.
    - (iii) **Limitations.** Swine intended for human consumption must not be slaughtered within 2 days of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

## Notes

### Amendments

[89 FR 85427, Oct. 28, 2024]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[89 FR 85427, Oct. 28, 2024]