CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.522]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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]