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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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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR558.265]



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 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B - Specific New Animal Drugs for Use in Animal Feeds

Sec. 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.

(c) Related tolerances. See § 556.308 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) 2.72Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter016592
(ii) 2.72Bacitracin methylenedisalicylate, 10 to 50Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for improved feed efficiencyFeed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter016592
(iii) 2.72Bambermycins, 1 to 2Broiler 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 efficiencyFeed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter016592
(iv) 2.72Replacement 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. brunettiFeed 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 slaughter016592

(2) Turkeys -

Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(i) 1.36 to 2.72Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonisFeed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl016592
(ii) 1.36 to 2.72Bacitracin methylenedisalicylate, 10 to 50Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gainFeed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl016592
(iii) 1.36 to 2.72Bambermycins, 2Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gainFeed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl016592

(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]

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