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21 C.F.R. § 520.905a   Fenbendazole suspension.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.905a   Fenbendazole suspension.

(a) Specifications. The drug is a suspension containing 10 percent (100 milligrams per milliliter) fenbendazole.

(b) Sponsor. See No. 057926 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.275 of this chapter.

(d) Conditions of use—(1) Horses—(i) Amount. 5 milligrams per kilogram (2.3 milligrams per pound) for the control of large strongyles, small strongyles, and pinworms; 10 milligrams per kilogram 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 orally by dose syringe or suitable plastic syringe. Do not use in horses intended for food. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(2) Cattle including dairy cows of breeding age—(i) Amount. Administer orally 5 milligrams per kilogram of body weight (2.3 milligrams per pound).

(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. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 8 days following last treatment. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(3) Beef cattle—(i) Amount. Administer orally 10 milligrams per kilogram of body weight.

(ii) For the removal and control of stomach worm (4th-stage inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and tapeworm, Moniezia benedeni.

(iii) Limitations. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 8 days following last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Goats—(i) Amount. Administer orally 5 milligrams per kilogram of body weight (2.3 milligrams per pound).

(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.

(e) Special considerations. Fenbendazole suspension 10 percent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (d) 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.

[42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR 26205, May 15, 2003]

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