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21 CFR Ch. I (4–1–10 Edition) § 520.905C

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21 CFR Ch. I (4–1–10 Edition) § 520.905C § 520.905c 21 CFR Ch. I (4–1–10 Edition) (Strongylus edentatus, S. equinus, S. Do not use 14 days before or during the vulgaris), small strongyles, pinworms hunting season. (Oxyuris equi), and ascarids (Parascaris [44 FR 1375, Jan. 5, 1979, as amended at 47 FR equorum). 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 (iii) Limitations. Sprinkle the appro- FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, priate amount of drug on a small 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, amount of the usual grain ration. Pre- Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] pare for each horse individually. With- holding feed or water is not necessary. § 520.905c Fenbendazole paste. Retreat in 6 to 8 weeks if required. Do (a) Specifications. Each gram of paste not use in horses intended for food. contains 100 milligrams (mg) (2) Dogs—(i) Amount. 50 mg/kg daily fenbendazole (10 percent). for 3 consecutive days. (b) Sponsor. See No. 000061 in (ii) Indications for use. For the treat- § 510.600(c) of this chapter. ment and control of ascarids (Toxocara (c) Related tolerances. See § 556.275 of canis, Toxascaris leonina), hookworms this chapter. (Ancylostoma caninum, Uncinaria (d) Special considerations. See § 500.25 stenocephala), whipworms (Trichuris of this chapter. vulpis), and tapeworms (Taenia (e) Conditions of use—(1) Horses—(i) pisiformis). Indications for use and amounts—(A) For (iii) Limitations. Mix the appropriate control of large strongyles (Strongylus amount of drug with a small amount of edentatus, S. equinus, S. vulgaris), small the usual food; dry dog food may re- strongyles, pinworms (Oxyuris equi), quire slight moistening to facilitate and ascarids (Parascaris equorum): 2.3 mixing. Medicated food must be fully mg per pound (/lb) of body weight, or consumed. for foals and weanlings (less than 18 (3) Zoo and wildlife animals—(i) months of age), 4.6 mg/lb of body Amount. 10 mg/kg per day for 3 days. weight. Retreatment at intervals of 6 to 8 weeks may be required. (ii) Indications for use. For control of (B) For control of arteritis caused by internal parasites of Felidae and the fourth-stage larvae of S. vulgaris: Ursidae as follows: 4.6 mg/lb of body weight daily for 5 (A) Lion (Panthera leo) and Tiger days. Treatment should be initiated in (Panthera tigris): Ascarid (Toxocara cati, the spring and repeated in 6 months. Toxascaris leonina), Hookworm (C) For treatment of encysted (Ancylostoma spp.). mucosal cyathostome (small strongyle) (B) Cheetah (Acinonyx jubatus): Asca- larvae including early third-stage rid (Toxocara cati, Toxascaris leonina). (hypobiotic), late third-stage, and (C) Puma (Felis concolor), Panther fourth-stage larvae: 4.6 mg/lb of body (Panthera spp.), Leopard (Panthera weight daily for 5 consecutive days. pardus), Jaguar (Panthera onca): Asca- (D) Fenbendazole paste 10 percent rid (Toxocara cati, Toxascaris leonina), may be used concomitantly with ap- Hookworm (Ancylostoma spp.), Tape- proved forms of trichlorfon for the in- worm (Taenia hydatigena, T. krabbei, T. dications provided in paragraph taeniaeformis). (e)(1)(i)(A) of this section and for treat- (D) Black Bear (Ursus americanus): ing infections of stomach bots as pro- Ascarid (Baylisascaris transfuga, vided in § 520.2520. Toxascaris leonina), Hookworm (ii) Limitations. Do not use in horses (Ancylostoma caninum), Tapeworm intended for human consumption. (Taenia hydatigena, T. krabbei). (2) Cattle—(i) Amount. 2.3 mg/lb of (E) Polar Bear (Ursus maritimus) and body weight. Retreatment may be Grizzly Bear (Ursus horribilis): Ascarid needed after 4 to 6 weeks. (Baylisascaris transfuga, Toxascaris (ii) Indications for use. For the re- leonina). moval and control of lungworms (iii) Limitations. Top dress or mix (Dictyocaulus viviparus), stomach with a small portion of food. Must be worms (Haemonchus contortus, fully consumed prior to feeding. Fed- Ostertagia ostertagi, Trichostrongylus eral law restricts this drug to use by or axei), and intestinal worms on the order of a licensed veterinarian. (Bunostomum phlebotomum, Nematodirus 160 VerDate Nov<24>2008 16:00 May 11, 2010 Jkt 220070 PO 00000 Frm 00170 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 Food and Drug Administration, HHS § 520.928 helvetianus, Cooperia punctata, C. § 520.905e Fenbendazole blocks. oncophora, Trichostrongylus (a) Specifications. (1) Each pound of colubriformis, and Oesophagostomum molasses block contains 750 milligrams radiatum). of fenbendazole. (iii) Limitations. Cattle must not be (2) Each pound of protein block con- slaughtered within 8 days following tains 750 milligrams of fenbendazole. last treatment. (b) Sponsor. See 000061 in § 510.600(c) of [72 FR 24185, May 2, 2007, as amended at 74 this chapter. FR 61516, Nov. 25, 2009] (c) Related tolerances. See § 556.275 of this chapter. § 520.905d Fenbendazole powder. (d) Conditions of use—(1) Amount. 0.1 (a) Specifications. (1) Each 2-ounce pound of block per 100 pounds of body packet contains 2.27 grams (4 percent) weight per day for 3 days. Total dose of fenbendazole plus other inert ingre- for the 3-day period is 2.27 milligrams dients. of fenbendazole per pound of body (2) Each 4-ounce packet contains 1.7 weight for mature cattle. grams (1.5 percent) of fenbendazole plus (2) Indications for use. For removal other inert ingredients. and control of infections of lungworms (b) Sponsors. (1) See No. 000061 in (Dictyocaulus viviparus) and gastro- § 510.600(c) of this chapter for use of the intestinal roundworms (Haemonchus 4-percent product. contortus, Ostertagia ostertagi, Trichostrongylus axei, Bunostomum (2) See No. 051311 in § 510.600(c) of this phlebotomum, Nematodirus helvetianus, chapter for use of the 1.5-percent prod- Cooperia oncophora and C. punctata, uct. Trichostrongylus colubriformis, and (c) Related tolerances. See § 556.275 of Oesophagostomum radiatum) in beef cat- this chapter. tle. (d) Conditions of use. It is adminis- (3) Limitations. Administer free choice tered to swine as follows: of beef cattle on pasture that have be- (1) Amount. 3 milligrams fenbendazole come accustomed to nonmedicated per kilogram body weight per day (1.36 block feeding during an adaptation pe- milligrams per pound per day). riod of 12 to 19 days. Molasses block: (2) Indications for use. For removal Cattle must not be slaughtered within and control of large roundworms 11 days following last treatment. Pro- (Ascaris suum); lungworms tein block: Cattle must not be slaugh- (Metastrongylus apri); nodular worms tered within 16 days following last (Oesophagostomum dentatum, O. treatment; do not use in dairy cattle of quadrispinulatum); small stomach breeding age. Animals maintained worms (Hyostrongylus rubidus); under conditions of constant worm ex- whipworms (Trichuris suis); and posure may require retreatment within kidneyworms (Stephanurus dentatus— 6 to 8 weeks. Consult your veterinarian mature and immature). for assistance in the diagnosis, treat- ment, and control of parasitism. (3) Limitations. Thoroughly mix the contents of the packet(s) with swine [51 FR 41783, Nov. 19, 1986, as amended at 54 ration and administer according to FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, label directions. Feed as sole ration for 2001; 74 FR 61516, Nov. 25, 2009] 3 consecutive days. Can be fed to preg- § 520.928 Firocoxib tablets. nant sows. No prior withdrawal of feed or water is necessary. Consult your (a) Specifications. Each chewable tab- veterinarian for assistance in the diag- let contains 57 or 227 milligrams (mg) nosis, treatment, and control of para- firocoxib. sitism. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. [49 FR 18090, Apr. 27, 1984, as amended at 49 (c) Conditions of use in dogs—(1) FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, Amount. 5 mg/kg (2.27 mg/lb) body 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, weight. Administer once daily for os- Nov. 25, 2009] teoarthritis. Administer approximately 161 VerDate Nov<24>2008 16:00 May 11, 2010 Jkt 220070 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150.
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