Food and Drug Administration, HHS § 520.905a

where reinfection is likely to occur, re- stenocephala), whipworms (Trichuris treatment may be necessary. For most vulpis), ascarids ( and effective results, retreat in 6 to 8 ), and tapeworms weeks. (Dipylidium caninum and Taenia (2) Indications for use. For removal of pisiformis). ascarids (—adult and (ii) Cats and kittens: For removal of sexually immature), pinworms (Oxyuris ( tubaeforme), equi—adult and 4th stage larvae), large ascarids () and tapeworms strongyles (Strongylus vulgaris, S. (Dipylidium caninum and Taenia edentatus, S. equinus), and various taeniaeformis). small strongyles in horses, breeding (3) Limitations. Federal law restricts stallions and mares, pregnant mares, this drug to use by or on the order of a foals, and ponies. licensed veterinarian. (3) Limitations. Do not use in horses [50 FR 19167, May 7, 1985, as amended at 53 intended for human consumption. Fed- FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; eral law restricts this drug to use by or 79 FR 28821, May 20, 2014] on the order of a licensed veterinarian. (d) Special considerations. Febantel § 520.903e Febantel tablets. suspension may be used in combination (a) Specifications. Each scored tablet with trichlorfon oral liquid in accord- contains 27.2 milligrams of febantel for ance with the provisions of § 520.2520c, use in dogs, puppies, cats, and kittens this section, and the following condi- or 163.3 milligrams of febantel for use tions: in dogs, puppies, and cats. (1) Combine 1 part febantel suspen- (b) Sponsor. See No. 000859 in sion with 5 parts trichlorfon liquid. § 510.600(c) of this chapter. (2) Allow to consume a por- (c) Conditions of use—(1) Amount—(i) tion of daily grain ration; administer Dogs and cats. Ten milligrams per kilo- mixture by stomach tube at rate of 18 gram body weight. Administer once milliliters per 100 pounds of body daily for 3 consecutive days. weight. (ii) Puppies and kittens fewer than 6 [45 FR 8587, Feb. 8, 1980, as amended at 79 FR months of age. Fifteen milligrams per 28821, May 20, 2014] kilogram body weight. Administer once daily for 3 consecutive days. § 520.903c [Reserved] (2) Indications for use. (i) For removal of hookworms ( § 520.903d Febantel and and Uncinaria stenocephala), ascarids paste. (Toxocara canis and Toxascaris leonina) (a) Specifications. Each gram of paste and whipworms (Trichuris vulpis) in contains 34 milligrams of febantel and dogs and puppies. 3.4 milligrams of praziquantel. (ii) For removal of hookworms (b) Sponsor. See No. 000859 in () and ascarids § 510.600(c) of this chapter. (Toxocara cati) in cats and kittens. (c) Conditions of use—(1) Amount—(i) (3) Limitations. Federal law restricts Dogs and cats (over 6 months of age): 10 this drug to use by or on the order of a milligrams of febantel and 1 milligram licensed veterinarian. of praziquantel per kilogram of body [56 FR 50655, Oct. 8, 1991, as amended at 79 FR weight (1 gram of paste per 7.5 pounds 28821, May 20, 2014] body weight) administered by mouth or in the food once daily for 3 days. § 520.905 oral dosage (ii) Puppies and kittens (less than 6 forms. months of age): 15 milligrams of febantel and 1.5 milligrams of § 520.905a Fenbendazole suspension. praziquantel per kilogram of body (a) Specifications. Each milliliter of weight (1 gram of paste per 5 pounds suspension contains 100 milligrams body weight) administered by mouth (mg) fenbendazole for use as in para- on a full stomach once daily for 3 days. graphs (e)(1), (2), (3), and (4) of this sec- (2) Indications for use. (i) Dogs and tion; or 200 mg fenbendazole for use as puppies: For removal of hookworms in paragraphs (e)(5) and (6) of this sec- (Ancylostoma caninum and Uncinaria tion.

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(b) Sponsor. See No. 000061 in has not been established for this prod- § 510.600(c) of this chapter. uct in preruminating calves. Do not (c) Related tolerances. See § 556.275 of use in calves to be processed for veal. this chapter. (3) Beef cattle—(i) Amount. Administer (d) Special considerations. (1) See orally 10 mg/kg of body weight (2.3 mg/ § 500.25 of this chapter. lb). Retreatment may be needed after 4 (2) Fenbendazole suspension 10 per- to 6 weeks. cent and approved forms of trichlorfon, (ii) Indications for use. For the re- when used concomitantly for treating moval and control of stomach the indications provided in paragraph (4th stage inhibited larvae/type II (e) of this section and for treating in- ostertagiasis), Ostertagia ostertagi, and fections of stomach bot as provided in tapeworm, Moniezia benedeni. § 520.2520, have been shown to be com- (iii) Limitations. Cattle must not be patible and not to interfere with one slaughtered within 8 days following another. last treatment. A withdrawal period (e) Conditions of use—(1) Horses—(i) has not been established for this prod- Amount. Administer orally 5 mg per uct in preruminating calves. Do not kilogram (/kg) (2.3 mg per pound (/lb)) use in calves to be processed for veal. for the control of large strongyles, Federal law restricts this drug to use small strongyles, and pinworms; 10 mg/ by or on the order of a licensed veteri- kg for the control of ascarids. narian. (ii) Indications for use. For the control (4) Goats—(i) Amount. Administer of large strongyles (Strongylus orally 5 mg/kg of body weight (2.3 mg/ edentatus, S. equinus, S. vulgaris), small lb). Retreatment may be needed after 4 strongyles (Cyanthostomum spp., to 6 weeks. Cylicocyclus spp., Cylicostephanus spp., (ii) Indications for use. For the re- Triodontophorus spp.), pinworms moval and control of stomach (Oxyuris equi), and ascarids (Parascaris (adults) Haemonchus contortus and equorum) in horses. Teladorsagia circumcincta. (iii) Limitations. Administer by dose (iii) Limitations. Goats must not be syringe or suitable plastic syringe. Do slaughtered for food within 6 days fol- not use in horses intended for human lowing last treatment. Do not use in consumption. lactating goats. (2) Cattle including dairy cows of breed- (5) Chickens—(i) Amount. Administer ing age—(i) Amount. Administer orally 5 orally via drinking water at a daily mg/kg of body weight (2.3 mg/lb). Re- dose of 1 mg/kg body weight (0.454 mg/ treatment may be needed after 4 to 6 lb) for 5 consecutive days. weeks. (ii) Indications for use. For the treat- (ii) Indications for use. For the re- ment and control of adult Ascaridia moval and control of lungworm galli in broiler chickens and replace- (Dictyocaulus viviparus); stomach worm ment chickens intended to become (adults)—brown stomach worm breeding chickens, and for the treat- (Ostertagia ostertagi); stomach worms ment and control of adult A. galli and (adults and 4th-stage larvae)— Heterakis gallinarum in breeding chick- barberpole worm (Haemonchus contortus ens. and H. placei) and small stomach worm (iii) Limitations. Not for use in laying (Trichostongylus axei); intestinal worms hens and replacement chickens in- (adults and 4th-stage larvae)— tended to become laying hens. (Bunostonmum phlebotomum), (6) Swine, except for nursing piglets—(i) threadnecked intestinal worm Amount. Administer orally via the (Nematodirus helvetianus), small intes- drinking water at a daily dose of 2.2 tinal worm (Cooperia punctata and C. mg/kg of body weight (1.0 mg/lb) for 3 oncophora), bankrupt worm consecutive days. ( colubriformis), and (ii) Indications for use. For the treat- nodular worm (Oesophagostomum ment and control of lungworms: Adult radiatum). apri, adult M. (iii) Limitations. Cattle must not be pudendotectus; gastrointestinal worms: slaughtered within 8 days following Adult and larvae (L3, L4 stages, liver, last treatment. A withdrawal period lung, intestinal forms) large

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roundworms (Ascaris suum); nodular (iii) Limitations. Mix the appropriate worms (Oesophagostomum dentatum, O. amount of drug with a small amount of quadrispinulatum); small stomach the usual food; dry dog food may re- worms (Hyostrongylus rubidus): Adult quire slight moistening to facilitate and larvae (L2, L3, L4 stages—intes- mixing. Medicated food must be fully tinal mucosal forms) whipworms consumed. (Trichuris suis); and kidney worms: (3) Zoo and wildlife —(i) Adult and larvae Stephanurus dentatus. Amount. 10 mg/kg per day for 3 days. (iii) Limitations. Swine intended for (ii) Indications for use. For control of human consumption must not be internal parasites of and slaughtered within 2 days from the last Ursidae as follows: treatment. (A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid (Toxocara cati, [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. Toxascaris leonina), Hookworm 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, (Ancylostoma spp.). 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, (B) Cheetah (Acinonyx jubatus): Asca- Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR rid (Toxocara cati, Toxascaris leonina). 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; (C) Puma (Felis concolor), Panther 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. (Panthera spp.), Leopard (Panthera 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR pardus), Jaguar (Panthera onca): Asca- 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; rid (Toxocara cati, Toxascaris leonina), 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. Hookworm (Ancylostoma spp.), Tape- 29, 2011; 80 FR 76386, Dec. 9, 2015; 81 FR 22523, worm (, T. krabbei, T. Apr. 18, 2016] taeniaeformis). § 520.905b Fenbendazole granules. (D) Black Bear (Ursus americanus): Ascarid ( transfuga, (a) Specifications. Each gram of gran- Toxascaris leonina), Hookworm ules contains 222 milligrams (mg) (Ancylostoma caninum), Tapeworm fenbendazole. (Taenia hydatigena, T. krabbei). (b) Sponsor. See No. 000061 in (E) Polar Bear (Ursus maritimus) and § 510.600(c) of this chapter. Grizzly Bear (Ursus horribilis): Ascarid (c) Special considerations. See § 500.25 (Baylisascaris transfuga, Toxascaris of this chapter. leonina). (d) Conditions of use—(1) Horses—(i) (iii) Limitations. Top dress or mix Amount. 5 mg/kilogram (kg) for large with a small portion of food. Must be strongyles, small strongyles, and fully consumed prior to feeding. Fed- pinworms; 10 mg/kg for ascarids. eral law restricts this drug to use by or (ii) Indications for use. For the control on the order of a licensed veterinarian. of infections of large strongyles Do not use 14 days before or during the (Strongylus edentatus, S. equinus, S. hunting season. vulgaris), small strongyles, pinworms [44 FR 1375, Jan. 5, 1979, as amended at 47 FR (Oxyuris equi), and ascarids (Parascaris 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 equorum). FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, (iii) Limitations. Sprinkle the appro- 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, priate amount of drug on a small Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] amount of the usual grain ration. Pre- pare for each horse individually. With- § 520.905c Fenbendazole paste. holding feed or water is not necessary. (a) Specifications. Each gram of paste Retreat in 6 to 8 weeks if required. Do contains 100 milligrams (mg) not use in horses intended for food. fenbendazole (10 percent). (2) Dogs—(i) Amount. 50 mg/kg daily (b) Sponsor. See No. 000061 in for 3 consecutive days. § 510.600(c) of this chapter. (ii) Indications for use. For the treat- (c) Related tolerances. See § 556.275 of ment and control of ascarids (Toxocara this chapter. canis, Toxascaris leonina), hookworms (d) Special considerations. See § 500.25 (Ancylostoma caninum, Uncinaria of this chapter. stenocephala), whipworms (Trichuris (e) Conditions of use—(1) Horses—(i) vulpis), and tapeworms (Taenia Indications for use and amounts—(A) For pisiformis). control of large strongyles (Strongylus

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