[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: 21CFR558.175] [Page 396-397] 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. 558.175 Clopidol. (a) Approvals. Type A medicated articles: (1) 25 percent to 011526 in Sec. 510.600(c) of this chapter. (2) 25 percent of clopidol, 10 percent of roxarsone, and 4, 10. 15, or 25 grams of bacitracin methylene disalicylate per pound to 011526 in Sec. 510.600(c) of this chapter. (b) Related tolerances. See Sec. 556.160 of this chapter. (c) [Reserved] (d) Conditions of use. It is used as follows: (1) Broiler chickens--(i) Amount per ton. Clopidol 113.5 grams (0.0125 percent). (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (b) Limitations. Do not feed to chickens over 16 weeks of age. (ii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus roxarsone, 45.4 grams (0.005 percent). (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; growth promotion and feed efficiency; improved pigmentation. (b) Limitations. Do not feed to chickens over 16 weeks of age; withdraw 5 days before slaughter; as sole source of organic arsenic. (iii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus roxarsone, 45.4 grams (0.005 percent) plus bacitracin, 4-25 grams. (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; growth promotion and feed efficiency; improved pigmentation; increased rate of weight gain. (b) Limitations. Do not feed to chickens over 16 weeks of age; withdraw 5 days before slaughter; as sole source of organic arsenic; as bacitracin methylene disalicylate, provided by No. 046573 in Sec. 510.600(c) of this chapter; or as zinc bacitracin provided by Nos. 046573 and 063238 in Sec. 510.600(c) of this chapter. (iv) Amount per ton. Clopidol, 113.5 grams (0.0125%) plus zinc bacitracin, 5 to 25 grams. (a) Indications for use. For increased rate of weight gain and improved feed efficiency; aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (b) Limitations. Feed continuously as sole ration. Zinc bacitracin as provided by Nos. 046573 and 063238 of Sec. 510.600(c) of this chapter. (v) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus bacitracin methylene disalicylate, 4 to 50 grams per ton. (a) Indications for use. For increased rate of weight gain; to aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti. (b) Limitations. Feed continuously as the sole ration from the time chicks are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age. Bacitracin methylene disalicylate as provided by No. 046573 in Sec. 510.600(c) of this chapter. (vi) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus lincomycin, 2-4 grams. (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; increase in rate of weight gain and improved feed efficiency. (b) Limitations. As lincomycin hydrochloride monohydrate; do not feed to chickens over 16 weeks of age. [[Page 397]] (2) Broiler chickens and replacement chickens--(i) Amount per ton. Clopidol, 113.5 or 227 grams (0.0125 or 0.025 percent). (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (b) Limitations. Feed up to 16 weeks of age if intended for use as caged layers; feed continuously as the sole ration; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter. (ii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus chlortetracycline 100 to 200 grams. (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. (b) Limitations. Feed continuously as sole ration from the time chicks are placed in floor pens for 7 to 14 days. (3) [Reserved] (4) Replacement chickens--(i) Amount per ton. Clopidol 113.5 grams (0.0125 percent). (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (b) Limitations. For replacement chickens intended for use as caged layers; do not feed to chickens over 16 weeks of age. (ii) Amount per ton. Clopidol 113.5 grams (0.0125 percent) plus roxarsone 45.4 grams (0.005 percent). (a) Indications for use. Aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; growth promotion and feed efficiency; improving pigmentation. (b) Limitations. For replacement chickens intended for use as caged layers; do not feed to chickens over 16 weeks of age; withdraw 5 days before slaughter; as sole source of organic arsenic. (5) Turkeys--(i) Amount per ton. Clopidol 113.5 or 227 grams (0.0125 or 0.025 percent). (ii) Indications for use. Aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi. (iii) Limitations. For turkeys grown for meat purposes only; to be administered continuously in feed at 0.0125 or 0.025 percent clopidol as the sole ration depending upon management practices, degree of exposure, and amount of feed eaten; withdraw medication 5 days before slaughter. [40 FR 13959, Mar. 27, 1975, as amended at 40 FR 31935, July 30, 1975; 40 FR 52723, Nov. 12, 1975; 41 FR 1062, Jan. 6, 1976; 41 FR 53002, Dec. 3, 1976; 44 FR 20676, Apr. 6, 1979; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 53 FR 20843, June 7, 1988; 54 FR 6518, Feb. 13, 1989; 61 FR 35954, July 9, 1996; 62 FR 61626, Nov. 19, 1997; 62 FR 61912, Nov. 20, 1997; 62 FR 62243, Nov. 21, 1997; 63 FR 17948, Apr. 13, 1998; 63 FR 27845, May 21, 1998]