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: 21CFR520.812]

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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.812 Enrofloxacin.

(a) Specifications. (1) Each tablet contains:

(i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or

(ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.

(2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.

(3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) No. 058198 for use of products described in paragraph (a) of this section.

(2) Nos. 017033 and 086117 for use of product described in paragraph (a)(1)(i) of this section.

(3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section.

(c) Conditions of use in dogs and cats - (1) Amount. Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.

(i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.

(ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight.

(2) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.

(3) Limitations. 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.

[78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 53310, Oct. 7, 2019; 86 FR 13184, Mar. 8, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27698, May 3, 2023]