§ 520.905a Fenbendazole suspension.

Specifications.(a) Each milliliter of suspension contains 100 milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3), and (4) of this section; or 200 mg fenbendazole for use as in paragraphs (e)(5) and (6) of this section.

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

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

Special considerations.(d) (1) See § 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 § 520.2520, have been shown to be compatible and not to interfere with one another.

Conditions of useHorsesAmount.(e) —(1) —(i) 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.

Indications for use.Strongylus edentatus, S. equinus, S. vulgaris, TriodontophorusCyathostomumCylicocyclusCylicostephanusCylicodontophorusOxyuris equiParascaris equorum(ii) For the treatment and control of large strongyles ( species), small strongyles ( species, species, species, species), pinworms () and ascarids ().

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

Beef and dairy cattleAmount.(2) —(i) Administer orally 2.3 mg/lb of body weight (5 mg/kg).

Indications for use.Dictyocaulus viviparusOstertagia ostertagiHaemonchus contortusH. placeiTrichostrongylus axeiBunostomum phlebotomumNematodirus helvetianusCooperia punctataC. oncophoraTrichostrongylus colubriformisOesophagostomum radiatum(ii) For the treatment and control of: Lungworms: Adult (); Stomach worms: Adult brown stomach worms (); adult and fourth-stage larvae barberpole worms ( and ); adult and fourth-stage larvae small stomach worms (); Intestinal worms (adult and fourth-stage larvae): Hookworms (), thread-necked intestinal worms (), small intestinal worms ( and ), bankrupt worms (), and nodular worms ().

Limitations.(iii) Milk taken from cows during treatment and for 48 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves.

Beef cattleAmount.(3) —(i) Administer orally 4.6 mg/lb of body weight (10 mg/kg).

Indications for use.Ostertagia ostertagi,Moniezia benedeni.(ii) For the treatment and control of stomach worms (fourth-stage inhibited larvae/type II ostertagiasis), and tapeworms,

Limitations.(iii) Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

GoatsAmount.(4) —(i) Administer orally 2.3 mg/lb of body weight (5 mg/kg).

Indications for use.Haemonchus contortusTeladorsagia circumcincta.(ii) For the treatment and control of stomach worms (adults) and

Limitations.(iii) Goats must not be slaughtered for human consumption within 6 days following last treatment with this drug product. Because a milk discard time has not been established, do not use in lactating goats.

ChickensAmount.(5) —(i) Administer orally via drinking water at a daily dose of 1 mg/kg body weight (0.454 mg/lb) for 5 consecutive days.

Indications for use.Ascaridia galliA. galliHeterakis gallinarum(ii) For the treatment and control of adult in broiler chickens and replacement chickens, and for the treatment and control of adult and in breeding chickens and laying hens.

Swine, except for nursing pigletsAmount.(6) —(i) Administer orally via the drinking water at a daily dose of 2.2 mg/kg of body weight (1.0 mg/lb) for 3 consecutive days.

Indications for use.Metastrongylus apri,Metastrongylus pudendotectus;Ascaris suumOesophagostomum dentatum, O. quadrispinulatumHyostrongylus rubidusTrichuris suisStephanurus dentatus.(ii) For the treatment and control of: Lungworms: Adult Adult Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (), Adult nodular worms (), Adult small stomach worms (), Adult and larvae (L2, L3, L4 stages—intestinal mucosal forms) whipworms (); and Kidney worms: Adult and larvae

Limitations.(iii) Swine intended for human consumption must not be slaughtered within 2 days from the last treatment.

[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; 80 FR 76386, Dec. 9, 2015; 81 FR 22523, Apr. 18, 2016; 86 FR 14818, Mar. 19, 2021; 86 FR 61684, Nov. 8, 2021; 87 FR 58961, Sept. 29, 2022]