21 C.F.R. § 558.258 Fenbendazole.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole. (b) Approvals. See No. 057926 in §510.600(c) of this chapter. (c) Related tolerances. See §556.275 of this chapter. (d) Special considerations. See §500.25 of this chapter. (e) Conditions of use—(1) Turkeys. (2) Swine. (3) Cattle—(i) Conditions of use are as follows: (ii) Formulate for use as a free-choice cattle feed as in paragraph (e)(3)(i)(B) of this section as follows: (4) Horses. (5) Zoo and wildlife animals. [66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.258 Fenbendazole.
---------------------------------------------------------------------------------------------------------------- Amount fenbendazole in grams per Combination in grams ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------14.5 (16 parts per million)...... .................... Growing turkeys: For Feed continuously 057926 the removal and as the sole ration control of for 6 days. For gastrointestinal growing turkeys worms: round worms, only. adult and larvae (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead).----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Amount fenbendazole in grams per Combination in grams ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 300 (to provide 9 .................... For the removal and Feed as sole ration 057926 milligrams per kilogram (mg/kg) control of: Adult of body weight) given over a 3- stage lungworms to 12-day period. (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages_liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages_intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus).(ii) 10 to 80 (to provide 9 mg/kg Lincomycin 20....... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not section; for increased feed to swine that rate of gain in weigh more than growing-finishing 250 pounds (lbs); swine. lincomycin as provided by 000009 in § 510.600(c) of this chapter.(iii) 10 to 80 (to provide 9 mg/ Lincomycin 40....... As in paragraph Feed as sole 057926 kg of body weight). (e)(2)(i) of this ration. Do not section; for control feed to swine that of swine dysentery in weigh more than animals on premises 250 lbs.; with a history of lincomycin as swine dysentery, but provided by 000009 where symptoms have in § not yet occurred. 510.600(c) of this chapter.(iv) 10 to 80 (to provide 9 mg/kg Lincomycin 100...... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not use section; for the within 6 days of treatment of swine slaughter. Do not dysentery. feed to swine that weigh more than 250 lbs.; lincomycin as provided by 000009 in § 510.600(c) of this chapter.(v) 10 to 80 (to provide 9 mg/kg Lincomycin 200...... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not use section; for reduction within 6 days of in the severity of slaughter. Do not swine mycoplasmal feed to swine that pneumonia caused by weigh more than Mycoplasma 250 pound (lb); hyopneumoniae. lincomycin as provided by 000009 in § 510.600(c) of this chapter.(vi) 10 to 300 (to provide 9 mg/ Bacitracin methylene Growing/finishing Feed as sole 046573 kg of body weight). disalicylate 10 to swine: As in paragraph ration. Under 30. (e)(2)(i) of this conditions of section; for increased continued exposure rate of weight gain to parasites, and improved feed retreatment may be efficiency. needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.(vii) 10 to 300 (to provide 9 mg/ Bacitracin methylene 1. Growing/finishing 1. Growing/ 046573 kg of body weight). disalicylate 250. swine: As in paragraph finishing swine: (e)(2)(i) of this Feed as sole section; for control ration. Not for of swine dysentery use in growing and associated with finishing swine Treponema that weigh more hyodysenteriae on than 250 lbs. premises with a Diagnosis of swine history of swine dysentery should dysentery, but where be confirmed by a signs of disease have veterinarian when not yet occurred; or results are not following an approved satisfactory. treatment of the Under conditions disease condition. of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter. .................... 2. Pregnant sows: As in 2. Pregnant sows: ......... paragraph (e)(2)(i) of Feed as sole this section; for ration. Diagnosis control of clostridial of clostridial enteritis in suckling enteritis should pigs caused by be confirmed by a Clostridium veterinarian when perfringens. results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter.----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------Amount fenbendazole in Combination in grams grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(A) 5 mg/kg body ....................... For the removal and Feed as sole ration for 057926 weight (2.27 mg/lb) control of lungworms one day. Do not use (Dictyocaulus within 13 days of viviparus); barberpole slaughter. worms (Haemonchus contortus); brown stomach worms (Ostertagia ostertagi); small stomach worms (Trichostrongylus axei); hookworms (Bunostomum phlebotomum); thread- necked intestinal worms (Nematodirus helvetianus); small intestinal worms (Cooperia oncophora and C. punctata), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).(B) 5 mg/kg body ....................... As in paragraph Formulate as specified in 057926 weight (2.27 mg/lb) (e)(3)(i)(A) of this paragraph (e)(3)(ii) of in a free-choice feed section. this section. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment may be needed after 4 to 6 weeks. Do not slaughter within 13 days following last treatment.----------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------ International Ingredient\1\ Percent feed No.------------------------------------------------------------(A) Ingredient:................. ........... ............. Copper sulfate................. 0.45 6-01-720 Dried Cane Molasses............ 3.12 4-04-695 Monosodium phosphate........... 31.16 6-04-288 Salt (sodium chloride)......... 59.00 6-04-152 Zinc sulfate................... 0.76 6-05-556 Fenbendazole Type A article 5.51 ............. (20%)..........................(B) Ingredient:................. ........... ............. Dicalcium phosphate............ 32.31 6-00-080 Limestone...................... 17.13 6-02-632 Magnesium oxide................ 9.79 6-02-756 Zinc sulfate................... 1.47 6-05-556 Copper sulfate................. 0.29 6-01-720 Potassium iodide............... 0.0098 6-03-759 Dried Cane Molasses............ 0.98 4-04-695 Selenium....................... 0.0002 ............. Salt........................... 35.93 6-04-152 Fenbendazole Type A article 2.09 ............. (20%)..........................------------------------------------------------------------------------\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium must comply with published regulations.
---------------------------------------------------------------------------------------------------------------- Amount fenbendazole in grams per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 4,540............................. 5 mg/kg body weight (2.27 mg/ Feed at the rate of 0. 1lb of 057926 lb) for the control of large feed per 100 lb of body strongyles (Strongylus weight to provide 2.27 mg edentatus, S. equinus, S. fenbendazole/lb of body vulgaris, Triodontophorus weight in a 1-day treatment spp.), small strongyles or 0.2 lb of feed per 100 lb (Cyathostomum spp., of body weight to provide Cylicocyclus spp., 4.54 mg fenbendazole/lb of Cylicostephanus spp.), and body weight in a 1-day pinworms (Oxyuris equi); 10 treatment. All horses must mg/kg body weight (4.54 mg/ be eating normally to ensure lb) for the control of that each animal consumes an ascarids (Parascaris adequate amount of the equorum).. medicated feed. Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection. Do not use in horses intended for food..(ii) [Reserved]....................... .............................. ............................. .........----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Species/Class Amount fenbendazole Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) Feral swine (Sus scrofa)..... 3 mg/kg/day for 3 For the removal and Use as complete 057926 days.. control of kidney worm feed. Prior (Stephanurus withdrawal of feed dentatus), roundworm or water is not (Ascaris suum), necessary. nodular worm Retreatment may be (Oesophagostomum required in 6 dentatum). weeks. Do not use 14 days before or during the hunting season.(ii) Ruminants (subfamily 2.5 mg/kg/day for 3 For the removal and Use as complete 057926 Antilopinae, Hippotraginae, days.. control of small feed. Prior Caprinae). stomach worm withdrawal of feed (Trichostrongylus or water is not spp.), thread necked necessary. intestinal worm Retreatment may be (Nematodirus spp.), required in 6 barberpole worm weeks. Do not use (Haemonchus spp.), 14 days before or whipworm (Trichuris during the hunting spp.). season.(iii) Rocky mountain bighorn 10 mg/kg/day for 3 For the removal and Use as complete 057926 sheep (Ovis c. canadensis). days.. control of feed. Prior Protostrongylus spp. withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season.----------------------------------------------------------------------------------------------------------------
