21 CFR § 522.522 - Danofloxacin.

---
identifier: "/us/cfr/t21/s522.522"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.522 - Danofloxacin."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.522"
section_name: "Danofloxacin."
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"
---


# 522.522 Danofloxacin.

(a) *Specifications.* Each milliliter of solution contains 180 milligrams (mg) danofloxacin as the mesylate salt.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.169 of this chapter.

(d) *Conditions of use in cattle*—(1) *Amount and indications for use.* Administer by subcutaneous injection either:

(i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, for the treatment of bovine respiratory disease (BRD) associated with *Mannheimia haemolytica* and *Pasteurella multocida;* or

(ii) 8 mg/kg of body weight as a single dose for the treatment of BRD associated with *M. haemolytica* and *P. multocida* and for the control of BRD in beef cattle at high risk of developing BRD associated with *M. haemolytica* and *P. multocida.*

(2) *Limitations.* Animals intended for human consumption should not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

[67 FR 78972, Dec. 27, 2002, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 53136, Sept. 8, 2014]