CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.905b]

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. 520.905b Fenbendazole granules.

(a) Specifications. Each gram of granules contains 222 milligrams (mg) fenbendazole.

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

(c) Special considerations. See § 500.25 of this chapter.

(d) Conditions of use - (1) Horses - (i) Amount. 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.

(ii) Indications for use. For the control of infections of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, pinworms (Oxyuris equi ), and ascarids (Parascaris equorum ).

(iii) Limitations. Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food.

(2) Dogs - (i) Amount. 50 mg/kg daily for 3 consecutive days.

(ii) Indications for use. For the treatment and control of ascarids (Toxocara canis, Toxascaris leonina ), hookworms (Ancylostoma caninum, Uncinaria stenocephala ), whipworms (Trichuris vulpis ), and tapeworms (Taenia pisiformis ).

(iii) Limitations. Mix the appropriate amount of drug with a small amount of the usual food; dry dog food may require slight moistening to facilitate mixing. Medicated food must be fully consumed.

(3) Zoo and wildlife animals - (i) Amount. 10 mg/kg per day for 3 days.

(ii) Indications for use. For control of internal parasites of Felidae and Ursidae as follows:

(A) Lion (Panthera leo ) and Tiger (Panthera tigris ): Ascarid (Toxocara cati, Toxascaris leonina ), Hookworm (Ancylostoma spp.).

(B) Cheetah (Acinonyx jubatus ): Ascarid (Toxocara cati, Toxascaris leonina ).

(C) Puma (Felis concolor ), Panther (Panthera spp.), Leopard (Panthera pardus ), Jaguar (Panthera onca ): Ascarid (Toxocara cati, Toxascaris leonina ), Hookworm (Ancylostoma spp.), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis ).

(D) Black Bear (Ursus americanus ): Ascarid (Baylisascaris transfuga, Toxascaris leonina ), Hookworm (Ancylostoma caninum ), Tapeworm (Taenia hydatigena, T. krabbei ).

(E) Polar Bear (Ursus maritimus ) and Grizzly Bear (Ursus horribilis ): Ascarid (Baylisascaris transfuga, Toxascaris leonina ).

(iii) Limitations. Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season.

[44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009]