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: "520.1638"
section_subject: "Oxibendazole."
cfr_reference: "21 CFR 520.1638"
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—(1) Each gram of paste contains 227 milligrams (mg) (22.7 percent) oxibendazole.
(2)Each milliliter of suspension contains 100 mg (10 percent) oxibendazole.
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Special considerations—(1) See § 500.25 of this chapter.
(2)Suspension product described in paragraph (a)(2) of this section shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(d)Conditions of use in horses—(1) Amount. For uses other than for threadworms (Strongyloides westeri), 10 mg oxibendazole per kilogram (/kg) body weight; for threadworms (Strongyloides westeri), 15 mg/kg. Horses maintained on premises where reinfection is likely to occur should be re-treated in 6 to 8 weeks. Administer suspension product by stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a portion of the normal grain ration.
(2)Indications for use. For removal and control of large strongyles (Strongylus edentatus, S. equinus,
S. vulgaris); small strongyles (genera Cylicostephanus, Cylicocyclus,
Cyathostomum, Triodontophorus,
Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including various larval stages; and threadworms (Strongyloides westeri).
(3)Limitations. Do not use in horses intended for human consumption.