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[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2008]
[CITE: 21CFR558.366]



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. 558.366 Nicarbazin.

(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:

Nicarbazin in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
27 to 45Narasin 27 to 45Broiler chickens; prevention of coccidiosis caused byEimeria tenella,E. necatrix,E. acervulina,E. maxima,E. brunetti,E. mivati.Sec. 558.363(d)(1)(iii)000986
Narasin 27 to 45 and bacitracin methylene disalicylate 4 to 50Broiler chickens; prevention of coccidiosis caused byEimeria tenella,E. necatrix,E. acervulina,E. maxima,E. brunetti,E. mivati; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. 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. Do not feed to laying hens. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate by 046573000986
Narasin 27 to 45 and bacitracin methylene disalicylate 50.Broiler chickens: For prevention of coccidiosis caused byEimeria tenella,E. necatrix,E. acervulina,E. maxima,E. brunetti,andE. mivati; as an aid in the prevention of necrotic enteritis caused or complicated byClostridiumspp. or other organisms susceptible to bacitracin.Feed continuously as sole ration. 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.046573
Narasin 27 to 45 and bacitracin methylene disalicylate 100 to 200.Broiler chickens: For prevention of coccidiosis caused byEimeria tenella,E. necatrix,E. acervulina,E. maxima,E. brunetti,andE. mivati; as an aid in the control of necrotic enteritis caused or complicated byClostridiumspp. or other organisms susceptible to bacitracin.To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce 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.046573
Narasin 27 to 45, bacitracin methylene disalicylate 50, and roxarsone 22.7 to 45.4. Broiler chickens; prevention of coccidiosis caused byEimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,andE. mivati,as an aid in the prevention of necrotic enteritis caused or complicated byClostridiumspp. or other organisms susceptible to bacitracin, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.Feed continuously as sole ration. 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. Do not feed to laying hens. Use as sole source of organic arsenic. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate and roxarsone by 046573.046573
Narasin 27 to 45, and bambermycins 1 to 2Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix, andE. brunetti) coccidiosis; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is 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. Bambermycins provided by No. 016592; nicarbazin and narasin by No. 066104 in 510.600(c) of this chapter000986
Narasin 27 to 45 and Lincomycin 2 to 4Broiler chickens; prevention of coccidiosis caused byEimeria tenella,E. necatrix,E. acervulina,E. maxima,E. brunetti,E. mivati; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. 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. 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 000009000986
Narasin 27 to 45 and roxarsone 22.7 to 45.4Broiler chickens; for prevention of coccidiosis caused byEimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,andE. mivati; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.Feed continuously as sole ration. Use as sole source of organic arsenic. 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. Do not feed to laying hens. Use as sole source of organic arsenic. Narasin and nicarbazin as provided by 000986, roxarsone by 046573.000986
90.8 to 181.6 (0.01 to 0.02 pct)Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to 45.4Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix, andE. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency, and improved pigmentationFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis. Feed 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 chapter066104
Penicillin 2.4 to 50Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix, andE. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of 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 chapter066104
Penicillin 2.4 to 50 and roxarsone 22.7 to 45.4Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix, andE. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency, and improved pigmentationFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis. Feed 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 chapter066104
113.5 (0.0125 pct) Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,andE. brunetti) coccidiosisFeed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is 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 slaughter000986060728066104
Bacitracin methylene disalicylate 4 to 50.Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix, andE. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter.046573
Bacitracin methylene disalicylate 30Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix,andE. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency......do060728066104
Bacitracin methylene disalicylate 50.Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix, andE. brunetti) coccidiosis; as an aid in the prevention of necrotic enteritis caused or complicated byClostridiumspp. or other organisms susceptible to bacitracin.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter.046573
Bacitracin zinc 4 to 50.Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina,E. maxima,E. necatrix,andE. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency.For broiler chickens only. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. 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 046573.066104
Bambermycins 1 to 2Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,andE. brunetti) coccidiosis, for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is 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. Nicarbazin as provided by 066104.057926
Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused byEimeria tenella,E. necatrix,E. acervulina,E. brunetti,E. mivati, andE. maxima; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bambermycins provided by No. 016592 in 510.600(c) of this chapter016592
Lincomycin 2 (0.00044 pct)Broiler chickens; aid in preventing outbreaks of secal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,andE. brunetti) coccidiosis; for increased rate of weight gain.Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is 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.060728066104
Roxarsone 22.7 (0.0025).......doFeed continuously as sole ration 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 slaughter060728066104
Roxarsone 22.7 (0.0025) plus lincomycin 2 (0.0004).......do......do060728066104

[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; 73 FR 15884, Mar. 26, 2008]

Database Updated April 1, 2008

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