subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.645"
section_subject: "Difloxacin."
cfr_reference: "21 CFR 520.645"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each tablet contains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride.
(b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(d)Conditions of use—(i) Amount. Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per pound) of body weight orally once a day for 2 to 3 days beyond cessation of clinical signs of disease up to a maximum of 30 days.
(ii)Indications for use. For management of diseases in dogs associated with bacteria susceptible to difloxacin.
(iii)Limitations. Federal law prohibits the extra-label use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.