§ 558.258 — Fenbendazole

(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) Sponsor. See No. 000061 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.

(iii) Top dress medicated feed—(A) Proprietary formulas. The following feed can be manufactured only per an approved proprietary formula and specifications:

(B) [Reserved]

(iv) Free-choice medicated feeds—(A) Proprietary formulas (21 CFR 510.455(e)(2)). The following feeds can be manufactured only per an approved proprietary formula and specifications:

(B) Published formulas (§ 510.455(e)(1) of this chapter). The following feeds can be manufactured only per one of the formulas and specifications published below:

(1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:

(2) Indications for use. As in paragraph (e)(3)(i) of this section.

(3) Limitations. 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. Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 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 pre-ruminating calves.

(4) Horses.

(5) Zoo and wildlife animals.

(6) Fenbendazole may also be used in combination with:

(i) [Reserved]

(ii) Lincomycin as in § 558.325.