CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.905a—Fenbendazole suspension.

520.905a—Fenbendazole suspension.

(a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) fenbendazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.275 of this chapter.
(d) Special considerations. (1) See § 500.25 of this chapter.
(2) Fenbendazole suspension 10 percent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (e) of this section and for treating infections of stomach bot as provided in § 520.2520, have been shown to be compatible and not to interfere with one another.
(e) Conditions of use— (1) Horses— Administer orally 5 mg per kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large strongyles, small strongyles, and pinworms; 10 mg/kg for the control of ascarids.
(ii) Indications for use. For the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles (Cyanthostomum spp., Cylicocyclus spp., Cylicostephanus spp., Triodontophorus spp.), pinworms (Oxyuris equi ), and ascarids (Parascaris equorum) in horses.
(iii) Limitations. Administer by dose syringe or suitable plastic syringe. Do not use in horses intended for human consumption.
(2) Cattle including dairy cows of breeding age— (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb). Retreatment may be needed after 4 to 6 weeks.
(ii) Indications for use. For the removal and control of lungworm (Dictyocaulus viviparus ); stomach worm (adults)—brown stomach worm (Ostertagia ostertagi ); stomach worms (adults and 4th-stage larvae)—barberpole worm (Haemonchus contortus and H. placei) and small stomach worm (Trichostongylus axei ); intestinal worms (adults and 4th-stage larvae)— hookworm (Bunostonmum phlebotomum ), threadnecked intestinal worm (Nematodirus helvetianus ), small intestinal worm (Cooperia punctata and C. oncophora ), bankrupt worm (Trichostrongylus colubriformis ), and nodular worm (Oesophagostomum radiatum ).
(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(3) Beef cattle— (i) Amount. Administer orally 10 mg/kg of body weight (2.3 mg/lb). Retreatment may be needed after 4 to 6 weeks.
(ii) Indications for use. For the removal and control of stomach worm (4th stage inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and tapeworm, Moniezia benedeni.
(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Goats— (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
(ii) Indications for use. For the removal and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
(iii) Limitations. Retreatment may be needed after 4 to 6 weeks. Goats must not be slaughtered for food within 6 days following last treatment. Do not use in lactating goats.

Code of Federal Regulations

[42 FR 59069, Nov. 15, 1977]

Code of Federal Regulations

Editorial Note: For Federal Register citations affecting § 520.905a , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.