Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 520  /  Sec. 520.905 Fenbendazole oral dosage forms. Sec. 520.905a Fenbendazole suspension.

(a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) fenbendazole.

(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.

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

(d) Special considerations. (1) See Sec. 500.25 of this chapter.

(1) See Sec. 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 Sec. 520.2520, have been shown to be compatible and not to interfere with one another.

(e) Conditions of use--(1) Horses--(i) Amount. 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.

(1) Horses--(i) Amount. 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.

(i) Amount. 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.

(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.

(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).

(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. [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; 74 FR 17770, Apr. 17, 2009; 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. 29, 2011] Sec. 520.905b Fenbendazole granules.

(a) Specifications. Each gram of granules contains 222 milligrams (mg) fenbendazole.

(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.

(c) Special considerations. See Sec. 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.

(1) Horses--(i) Amount. 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.

(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.

(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.

(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:

(A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.).

(B) Cheetah (Acinonyx jubatus): Ascarid (Toxocara cati, Toxascaris leonina).

(C) Puma (Felis concolor), Panther (Panthera spp.), Leopard (Panthera pardus), Jaguar (Panthera onca): Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis).

(D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga, Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia hydatigena, T. krabbei).

(E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina).

(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. [44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] Sec. 520.905c Fenbendazole paste.

(a) Specifications. Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent).

(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.

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

(d) Special considerations. See Sec. 500.25 of this chapter.

(e) Conditions of use--(1) Horses--(i) Indications for use and amounts--(A) For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body weight. Retreatment at intervals of 6 to 8 weeks may be required.

(1) Horses--(i) Indications for use and amounts--(A) For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body weight. Retreatment at intervals of 6 to 8 weeks may be required.

(i) Indications for use and amounts--(A) For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body weight. Retreatment at intervals of 6 to 8 weeks may be required.

(A) For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body weight. Retreatment at intervals of 6 to 8 weeks may be required.

(B) For control of arteritis caused by the fourth-stage larvae of S. vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment should be initiated in the spring and repeated in 6 months.

(C) For treatment of encysted mucosal cyathostome (small strongyle) larvae including early third-stage (hypobiotic), late third-stage, and fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive days.

(D) Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in paragraph (e)(1)(i)(A) of this section and for treating infections of stomach bots as provided in Sec. 520.2520.

(ii) Limitations. Do not use in horses intended for human consumption.

(2) Cattle--(i) Amount. 2.3 mg/lb of body weight. Retreatment may be needed after 4 to 6 weeks.

(i) Amount. 2.3 mg/lb of body weight. Retreatment may be needed after 4 to 6 weeks.

(ii) Indications for use. For the removal and control of lungworms (Dictyocaulus viviparus), stomach worms (Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms (Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C. oncophora, Trichostrongylus colubriformis, and 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. [72 FR 24185, May 2, 2007, as amended at 74 FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011] Sec. 520.905d Fenbendazole powder.

(a) Specifications. (1) Each 2-ounce packet contains 2.27 grams (4 percent) of fenbendazole plus other inert ingredients.

(1) Each 2-ounce packet contains 2.27 grams (4 percent) of fenbendazole plus other inert ingredients.

(2) Each 4-ounce packet contains 1.7 grams (1.5 percent) of fenbendazole plus other inert ingredients.

(b) Sponsors. (1) See No. 000061 in Sec. 510.600(c) of this chapter for use of the 4-percent product.

(1) See No. 000061 in Sec. 510.600(c) of this chapter for use of the 4-percent product.

(2) See No. 051311 in Sec. 510.600(c) of this chapter for use of the 1.5-percent product.

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

(d) Conditions of use. It is administered to swine as follows:

(1) Amount. 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day).

(2) Indications for use. For removal and control of large roundworms (Ascaris suum); lungworms (Metastrongylus apri); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); whipworms (Trichuris suis); and kidneyworms (Stephanurus dentatus-- mature and immature).

(3) Limitations. Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 25, 2009] Sec. 520.905e Fenbendazole blocks.

(a) Specifications. (1) Each pound of molasses block contains 750 milligrams of fenbendazole.

(1) Each pound of molasses block contains 750 milligrams of fenbendazole.

(2) Each pound of protein block contains 750 milligrams of fenbendazole.

(b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.

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

(d) Conditions of use--(1) Amount. 0.1 pound of block per 100 pounds of body weight per day for 3 days. Total dose for the 3-day period is 2.27 milligrams of fenbendazole per pound of body weight for mature cattle.

(1) Amount. 0.1 pound of block per 100 pounds of body weight per day for 3 days. Total dose for the 3-day period is 2.27 milligrams of fenbendazole per pound of body weight for mature cattle.

(2) Indications for use. For removal and control of infections of lungworms (Dictyocaulus viviparus) and gastrointestinal roundworms (Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei, Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia oncophora and C. punctata, Trichostrongylus colubriformis, and Oesophagostomum radiatum) in beef cattle.

(3) Limitations. Administer free choice of beef cattle on pasture that have become accustomed to nonmedicated block feeding during an adaptation period of 12 to 19 days. Molasses block: Cattle must not be slaughtered within 11 days following last treatment. Protein block: Cattle must not be slaughtered within 16 days following last treatment; do not use in dairy cattle of breeding age. Animals maintained under conditions of constant worm exposure may require retreatment within 6 to 8 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, 2001; 74 FR 61516, Nov. 25, 2009]