[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.265] [Page 409-411] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents Subpart B--Specific New Animal Drugs for Use in Animal Feeds Sec. 558.265 Halofuginone hydrobromide. (a) Approvals. Type A medicated articles: 6 grams per kilogram (2.72 grams per pound) to 057926 in Sec. 510.600(c) of this chapter. (b) Related tolerances. See Sec. 556.308 of this chapter. (c) Conditions of use. (1) It is used in feed for broiler chickens as follows: (i) Amount. 2.72 grams per ton. (A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. (B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. (ii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bambermycins 1 to 2 grams. (A) Indications for use. 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. (B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers. (iii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 grams. (A) Indications for use. 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. (B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers. (iv) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus virginiamycin 5 to 15 grams. (A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, and E. maxima; for increased rate of weight gain. (B) Limitations. Feed continuously as sole ration; withdraw 6 days before slaughter; do not feed to layers. (v) Amount per ton. Halofuginone hydrobromide 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams and roxarsone 22.7 to 45.4 grams. (A) Indications for use. 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 for improved feed efficiency. (B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; use as sole source of organic arsenic; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. (vi) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus bacitracin methylene disalicylate 10 to 50 grams. (A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, E. maxima and for improved feed efficiency. (B) Limitations. Feed continuously as sole ration; withdraw 5 days before slaughter; do not feed to layers; avoid [[Page 410]] contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. (vii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus lincomycin 2 to 4 grams. (A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency. (B) Limitations. Feed continuously as sole ration; withdraw 4 days before slaughter; do not feed to layers; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. (viii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus roxarsone, 22.7 to 45.4 grams. (A) Indications for use. 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, improved feed efficiency, and improved pigmentation. (B) Limitations. 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. Use as the sole source of organic arsenic; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens or waterfowl. Withdraw 5 days before slaughter. (2) It is used in feed for turkeys as follows: (i) Amount per ton. 1.36 to 2.72 grams. (A) Indications for use. For the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis. (B) Limitations. Feed continuously as sole ration; withdraw 7 days before slaughter; do not feed to layers or water fowl; avoid contact with skin, eyes, or clothing; keep out of lakes, ponds, or streams. (ii) Amount per ton. Halofuginone hydrobromide 1.36 to 2.72 grams plus bacitracin methylene disalicylate 10 to 50 grams. (A) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis., and E. gallopavonis, and for increased rate of weight gain in growing turkeys. (B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl. Keep out of lakes, ponds, and streams. Halofuginone is toxic to fish and aquatic life. Halofuginone is an irritant to eyes and skin. Avoid contact with skin, eyes, or clothing. (iii) Amount per ton. 1.36 to 2.72 grams of halofuginone hydrobromide plus 2 grams of bambermycins. (A) Indications for use. For the prevention of coccidiosis caused by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain in growing turkeys. (B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl. Halofuginone hydrobromide is toxic to fish and other aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an eye and skin irritant. Avoid contact with skin, eyes, and clothing. (3) It is used in feed for replacement cage laying chickens and replacement broiler breeder chickens as follows: (i) Amount per ton. 2.72 grams. (A) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti. (B) Limitations. 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. Withdraw 4 days before slaughter. Do not feed to laying chickens or water fowl. Halofuginone hydrobromide is toxic to fish and aquatic life. Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an irritant to eyes and skin. Avoid contact with skin, eyes, and clothing. (ii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus roxarsone, 22.7 to 45.4 grams. (A) Indications for use. 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, improved [[Page 411]] feed efficiency, and improved pigmentation. (B) Limitations. 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. Use as the sole source of organic arsenic; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens or waterfowl. Withdraw 5 days before slaughter. [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]