21 C.F.R. § 558.366   Nicarbazin.


Title 21 - Food and Drugs


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

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§ 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:

 ----------------------------------------------------------------------------------------------------------------                                   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)..----------------------------------------------------------------------------------------------------------------

[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]

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