21 CFR § 522.1860 - Pradofloxacin.

---
identifier: "/us/cfr/t21/s522.1860"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1860 - Pradofloxacin."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1860"
section_name: "Pradofloxacin."
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"
---


# 522.1860 Pradofloxacin.

(a) *Specifications.* Each milliliter (mL) of solution contains 200 milligrams (mg) pradofloxacin.

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.530 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.

[89 FR 85427, Oct. 28, 2024]