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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.905a]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.905a Fenbendazole suspension.

(a) Specifications. 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.

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

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

(d) Special considerations. (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.

(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.

(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.

(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.

(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). Retreatment may be needed after 4 to 6 weeks.

(ii) Indications for use. For the removal and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta.

(iii) Limitations. Goats must not be slaughtered for food within 6 days following last treatment. Do not use in lactating goats.

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

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

(6) Swine, except for nursing piglets - (i) Amount. 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.

(ii) Indications for use. For the treatment and control of: Lungworms: Adult Metastrongylus apri, Adult Metastrongylus pudendotectus; Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum ), Adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum ), Adult small stomach worms (Hyostrongylus rubidus ), Adult and larvae (L2, L3, L4 stages - intestinal mucosal forms) whipworms (Trichuris suis ); and Kidney worms: Adult and larvae Stephanurus dentatus.

(iii) Limitations. 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]

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