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: "520.905b"
section_subject: "Fenbendazole granules."
cfr_reference: "21 CFR 520.905b"
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 gram of granules contains 222 milligrams (mg) fenbendazole.
(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c)Special considerations. See § 500.25 of this chapter.
(d)Conditions of use—(1) Horses—(i) Amount. 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.
(ii)Indications for use. For the control of infections of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum).
(iii)Limitations. Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food.
(2)Dogs—(i) Amount. 50 mg/kg daily for 3 consecutive days.
(ii)Indications for use. For the treatment and control of ascarids (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis).
(iii)Limitations. Mix the appropriate amount of drug with a small amount of the usual food; dry dog food may require slight moistening to facilitate mixing. Medicated food must be fully consumed.
(3)Zoo and wildlife animals—(i) Amount. 10 mg/kg per day for 3 days.
(ii)Indications for use. For control of internal parasites of Felidae and Ursidae as follows:
(iii)Limitations. Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season.