21 CFR 558.265 - Halofuginone.

View all text of Subpart B [§ 558.55 - § 558.680]

§ 558.265 - Halofuginone.

(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(d) Conditions of use. It is used in feed as follows:

(1) Chickens—

Halofuginone in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor	(i) 2.72		Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima	Feed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter	016592	(ii) 2.72	Bacitracin methylenedisalicylate, 10 to 50	Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for improved feed efficiency	Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter	016592	(iii) 2.72	Bambermycins, 1 to 2	Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter	016592	(iv) 2.72		Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti	Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter	016592

(2) Turkeys—

Halofuginone in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor	(i) 1.36 to 2.72		Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis	Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl	016592	(ii) 1.36 to 2.72	Bacitracin methylenedisalicylate, 10 to 50	Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain	Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl	016592	(iii) 1.36 to 2.72	Bambermycins, 2	Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain	Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl	016592

(3) Halofuginone may also be used in combination with:

(i) Lincomycin as in § 558.325.

(ii) [Reserved]

[50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014; 84 FR 8975, Mar. 13, 2019]