subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.454"
section_subject: "Clodronate."
cfr_reference: "21 CFR 522.454"
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 milliliter of solution contains 60 milligrams (mg) clodronate disodium.
(b)Sponsor. See No. 043264 in § 510.600(c) of this chapter.
(c)Conditions of use in horses—(1) Amount. Administer 1.8 mg per kilogram of body weight by intramuscular injection up to a maximum dose of 900 mg per horse.
(2)Indications for use. For the control of clinical signs associated with navicular syndrome.
(3)Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.