21 C.F.R. § 558.366 Nicarbazin.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated articles containing 25 percent nicarbazin. (b) Approvals. See Nos. 000986, 060728, and 066104 in §510.600(c) of this chapter for use as in paragraph (d) of this section. (c) Related tolerances. See §556.445 of this chapter. (d) Conditons of use. It is used in chicken feed as follows: [42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 FR 40887, July 13, 1979; 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June 5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar. 7, 2000; 66 FR 46706, Sept. 7, 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 63500, Dec. 7, 2001; 67 FR 30327, May 6, 2002; 71 FR 16224, Mar. 31, 2006; 71 FR 27957, May 15, 2006]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.366 Nicarbazin.
---------------------------------------------------------------------------------------------------------------- Combination in grams Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------27 to 45......................... Narasin 27 to 45.... Broiler chickens; Sec. 000986 prevention of 558.363(d)(1)(iii). coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.. Narasin 27 to 45 and Broiler chickens; Feed continuously 000986 bacitracin prevention of as sole ration. methylene coccidiosis caused by Withdraw 5 days disalicylate 4 to Eimeria tenella, E. before slaughter. 50. necatrix, E. Do not allow acervulina, E. maxima, turkeys, horses, E. brunetti, E. or other equines mivati; for increased access to rate of weight gain formulations and improved feed containing efficiency. narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate by 046573. Narasin 27 to 45 and Broiler chickens: For Feed continuously 046573 bacitracin prevention of as sole ration. Do methylene coccidiosis caused by not feed to laying disalicylate 50.. Eimeria tenella, E. hens. Withdraw 5 necatrix, E. days before acervulina, E. maxima, slaughter. Do not E. brunetti, and E. allow turkeys, mivati; as an aid in horses or other the prevention of equines access to necrotic enteritis formulations caused or complicated containing by Clostridium spp. or narasin. Ingestion other organisms of narasin by susceptible to these species has bacitracin.. been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 046573 in § 510.600(c) of this chapter.. Narasin 27 to 45 and Broiler chickens: For To control necrotic 046573 bacitracin prevention of enteritis, start methylene coccidiosis caused by medication at disalicylate 100 to Eimeria tenella, E. first clinical 200.. necatrix, E. signs of disease; acervulina, E. maxima, vary dosage based E. brunetti, and E. on the severity of mivati; as an aid in infection; the control of administer necrotic enteritis continuously for 5 caused or complicated to 7 days or as by Clostridium spp. or long as clinical other organisms signs persist, susceptible to then reduce bacitracin.. bacitracin to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 046573 in § 510.600(c) of this chapter.. Narasin 27 to 45, Broiler chickens; Feed continuously 046573 bacitracin prevention of as sole ration. methylene coccidiosis caused by Withdraw 5 days disalicylate 50, Eimeria tenella, E. before slaughter. and roxarsone 22.7 necatrix, E. Do not allow to 45.4.. acervulina, E. maxima, turkeys, horses or E. brunetti, and E. other equines mivati, as an aid in access to the prevention of formulations necrotic enteritis containing caused or complicated narasin. Ingestion by Clostridium spp. or of narasin by other organisms these species has susceptible to been fatal. Do not bacitracin, for feed to laying increased rate of hens. Use as sole weight gain, improved source of organic feed efficiency, and arsenic. Narasin improved pigmentation.. and nicarbazin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573.. Narasin 27 to 45, Broiler chickens: As an Feed continuously 000986 and bambermycins 1 aid in preventing as sole ration to 2. outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis; ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed coccidiosis; do efficiency.. not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bambermycins provided by No. 016592; nicarbazin and narasin by No. 066104 in § 510.600(c) of this chapter. Narasin 27 to 45 and Broiler chickens; Feed continuously 000986 Lincomycin 2 to 4. prevention of as sole ration. coccidiosis caused by Withdraw 5 days Eimeria tenella, E. before slaughter. necatrix, E. Do not allow acervulina, E. maxima, turkeys, horses, E. brunetti, E. or other equines mivati; for increased access to rate of weight gain formulations and improved feed containing efficiency. narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Narasin and nicarbazin as provided by 000986, lincomycin by 000009. Narasin 27 to 45 and Broiler chickens; for Feed continuously 000986 roxarsone 22.7 to prevention of as sole ration. 45.4. coccidiosis caused by Use as sole source Eimeria tenella, E. of organic necatrix, E. arsenic. Withdraw acervulina, E. maxima, 5 days before E. brunetti, and E. slaughter. Do not mivati; for increased allow turkeys, rate of weight gain, horses or other improved feed equines access to efficiency, and formulations improved pigmentation.. containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Use as sole source of organic arsenic. Narasin and nicarbazin as provided by 000986, roxarsone by 046573..90.8 to 181.6 (0.01 to 0.02 pct). Bacitracin methylene Broiler chickens: As an Feed continuously 066104 disalicylate 4 to aid in preventing as sole ration 50 and roxarsone outbreaks of cecal from time chicks 22.7 to 45.4. (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed outbreaks of efficiency, and coccidiosis. Feed improved pigmentation. as the sole source of organic arsenic; drug overdose or lack of water may result in leg weakness; do not use in flushing mashes. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by No. 066104; bacitracin methylene disalicylate and roxarsone by No. 046573 in § 510.600(c) of this chapter. Penicillin 2.4 to 50 Broiler chickens: As an Feed continuously 066104 aid in preventing as sole ration outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed outbreaks of efficiency. coccidiosis. Do not use in flushing mashes. Do not feed to chickens producing eggs for human consumption. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104 in § 510.600(c) of this chapter. Penicillin 2.4 to 50 Broiler chickens: As an Feed continuously 066104 and roxarsone 22.7 aid in preventing as sole ration to 45.4. outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a and for increased rate hazard; do not use of weight gain and as a treatment for improved feed outbreaks of efficiency, and coccidiosis. Feed improved pigmentation. as the sole source of organic arsenic; drug overdose or lack of water may result in leg weakness; do not use in flushing mashes. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104; roxarsone by No. 046573 in § 510.600(c) of this chapter.113.5 (0.0125 pct)............... .................... Chickens; aid in Feed continuously 000986 preventing outbreaks as sole ration 060728 of cecal (Eimeria from time chicks 066104 tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis. ordinarily a hazard; do not use as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bacitracin methylene Broiler chickens; aid ......do........... 060728 disalicylate 30. in preventing 066104 outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency. Bacitracin zinc 4 to Broiler chickens; aid For broiler 066104 50.. in preventing chickens only. outbreaks of cecal Feed continuously (Eimeria tenella) and as sole ration intestinal (E. from time chicks acervulina, E. maxima, are placed on E. necatrix, and E. litter until past brunetti) coccidiosis, the time when and for increased rate coccidiosis is of weight gain and ordinarily a improved feed hazard. efficiency.. Discontinue medication 4 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by 066104, bacitracin zinc by 046573.. Bambermycins 1 to 2. Broiler chickens; aid Feed continuously 057926 in preventing as sole ration outbreaks of cecal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis, ordinarily a for increased rate of hazard; do not use weight gain and as a treatment for improved feed coccidiosis; do efficiency.. not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Nicarbazin as provided by 066104.. Bambermycins 1 to 2. Broiler chickens: For Feed continuously 016592 prevention of as sole ration. coccidiosis caused by Bambermycins Eimeria tenella, E. provided by No. necatrix, E. 016592 in § acervulina, E. 510.600(c) of this brunetti, E. mivati, chapter. and E. maxima; and for increased rate of weight gain and improved feed efficiency.. Lincomycin 2 Broiler chickens; aid Feed continuously 060728 (0.00044 pct). in preventing as sole ration 066104 outbreaks of secal from time chicks (Eimeria tenella) and are placed on intestinal (E. litter until past acervulina, E. maxima, the time when E. necatrix, and E. coccidiosis is brunetti) coccidiosis; ordinarily a for increased rate of hazard; do not use weight gain.. as a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter.. Roxarsone 22.7 ......do............... Feed continuously 060728 (0.0025).. as sole ration 066104 from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; as sole source of organic arsenic; do not use a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 5 days before slaughter. Roxarsone 22.7 ......do............... ......do........... 060728 (0.0025) plus 066104 lincomycin 2 (0.0004)..----------------------------------------------------------------------------------------------------------------

