[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: 21CFR558.363]

[Page 440-443]
 
                        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.  558.363  Narasin.

    (a) Approvals. Type A medicated articles containing specified levels 
of narasin approved for sponsors identified in Sec.  510.600(c) of this 
chapter for use as in paragraph (d) of this section are as follows:
    (1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph 
(d)(1)(i) of this section.
    (2) To 000986: 36, 45, 54, 72, and 90 grams per pound, with 10, 20, 
50, and 80 percent roxarsone, paragraph (d)(1)(ii) of this section.
    (3) To 000986: 36 grams per pound, with 36 grams per pound 
nicarbazin, paragraph (d)(1)(iii) of this section.
    (4) To 057926: 36, 45, 54, 72, and 90 grams per pound, with 2 and 10 
grams per pound bambermycins, paragraph (d)(1)(iv) of this section.
    (5) To 057926: 45 grams per pound, with 4 and 10 grams per pound 
bambermycins, and 45.4, 90, and 227 grams per pound roxarsone, paragraph 
(d)(1)(vii) of this section.
    (6) To 046573: 45 grams per pound with 10, 25, 30, 40, 50, 60, or 75 
grams per pound bacitracin methylene disalicylate and 45.4, 90, or 227 
grams per pound roxarsone, paragraphs (d)(1)(viii) and (d)(1)(ix) of 
this section.
    (7) To 046573: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 
40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this 
section.
    (b) Tolerances. See Sec.  556.428 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used as follows:
    (1) Broiler chickens--(i) Amount per ton. Narasin, 54 to 72 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or

[[Page 441]]

other equines access to narasin formulations. Ingestion of narasin by 
these species has been fatal.
    (ii) Amount per ton. Narasin, 54 to 72 grams, plus roxarsone 45.4 
grams (0.005 percent).
    (A) Indications for use. For the prevention of coccidiosis in 
broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, 
E. maxima, E. brunetti, and E. mivati including some field strains of E. 
tenella which are more susceptible to roxarsone combined with narasin 
than to narasin alone.
    (B) Limitations. For broiler chickens only; feed continuously as the 
sole ration; do not feed to laying chickens; may be fatal if 
accidentally fed to adult turkeys or to horses; withdraw 5 days before 
slaughter; as sole source of organic arsenic; not approved for use with 
pellet binders.
    (iii) Amount per ton. Narasin, 27 to 45 grams, plus nicarbazin, 27 
to 45 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima.
    (B) Limitations. For broiler chickens only. Feed continuously as the 
sole ration. Do not feed to laying hens. Do not allow adult turkeys, 
horses, or other equines access to formulations containing narasin. 
Ingestion of narasin by these animals has been fatal. Withdraw 5 days 
before slaughter. The 2 drugs can be combined only at a 1:1 ratio for 
the 27 to 45 grams per ton range. Only granular nicarbazin as provided 
by No. 000986 in Sec.  510.600(c) of this chapter may be used in the 
combination.
    (iv) Amount per ton. Narasin, 54 to 72 grams, plus bambermycins, 1 
to 2 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as the 
sole ration. May be fatal if fed to adult turkeys, horses, or other 
equines.
    (v) Amount per ton. Narasin 54 to 72 grams, roxarsone 22.7 to 45.4 
grams, and bacitracin methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, for increased rate of weight gain, and for improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Withdraw 5 days before slaughter. Do not feed to laying 
hens. Use as sole source of organic arsenic. Drug overdose or lack of 
water may result in leg weakness. Do not allow adult turkeys, horses, or 
other equines access to narasin formulations. Ingestion of narasin by 
these species has been fatal. Narasin as provided by 000986, roxarsone 
by 046573, bacitracin methylene disalicylate by 046573 in Sec.  
510.600(c) of this chapter.
    (vi) Amount per ton. Narasin 54 to 72 grams, and bacitracin 
methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and 
E. tenella, for increased rate of weight gain, and for improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Do not allow adult turkeys, 
horses, or other equines access to narasin formulations. Ingestion of 
narasin by these species has been fatal. Narasin as provided by 000986, 
bacitracin methylene disalicylate by 046573 in Sec.  510.600(c) of this 
chapter.
    (vii) Amount per ton. Narasin 54 to 72 grams, bambermycins 1 to 2 
grams, and roxarsone 22.7 to 45.4 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and 
E. brunetti, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in broiler chickens.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Do not allow adult turkeys or 
horses or other equines access to formulations containing narasin. 
Ingestion of narasin by these animals has been fatal. Use as sole source 
of organic arsenic. Poultry

[[Page 442]]

should have access to drinking water at all times. Drug overdosage or 
lack of water intake may result in leg weakness or paralysis. Withdraw 5 
days before slaughter. Narasin as provided by 000986 in Sec.  510.600(c) 
of this chapter, bambermycins by 057926, and roxarsone by 046573.
    (viii) Amount per ton. Narasin, 54 to 72 grams, and bacitracin 
methylene disalicylate, 50 grams, with roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Withdraw 5 days before slaughter. Do not feed to laying 
hens. Do not allow adult turkeys, horses, or other equines access to 
narasin formulations. Ingestion of narasin by these species has been 
fatal. Use as sole source of organic arsenic. Poultry should have access 
to drinking water at all times. Drug overdose or lack of water intake 
may result in leg weakness or paralysis. Narasin as provided by 000986, 
bacitracin methylene disalicylate and roxarsone by 046573 in Sec.  
510.600(c) of this chapter.
    (ix) Amount per ton. Narasin, 54 to 72 grams, and bacitracin 
methylene disalicylate, 100 to 200 grams, with roxarsone, 22.7 to 45.4 
grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Withdraw 5 days before slaughter. Do not feed to laying 
hens. Do not allow adult turkeys, horses, or other equines access to 
narasin formulations. Ingestion of narasin by these species has been 
fatal. Use as sole source of organic arsenic. Poultry should have access 
to drinking water at all times. Drug overdose or lack of water intake 
may result in leg weakness or paralysis. Narasin as provided by 000986, 
bacitracin methylene disalicylate and roxarsone by 046573 in Sec.  
510.600(c) of this chapter.
    (x) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 
to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines access 
to formulations containing narasin. Ingestion of narasin by these 
species has been fatal. Narasin as provided by 000986, bacitracin zinc 
by 046573 in Sec.  510.600(c) of this chapter.
    (xi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 
grams.
    (A) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, for increased rate of weight gain, and improved 
feed efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines access 
to formulations containing narasin. Ingestion of narasin by these 
species has been fatal. Narasin sodium and tylosin phosphate as provided 
by 000986 in Sec.  510.600(c) of this chapter.
    (xii) Amount per ton. Narasin, 27 to 45 grams; nicarbazin, 27 to 45 
grams; and bambermycins, 1 to 2 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. Feed continuously as the sole ration. Do not allow 
adult turkeys, horses, or other equines access to formulations 
containing narasin. Ingestion of narasin by these animals has been 
fatal. Do not feed to laying hens.

[[Page 443]]

Withdraw 5 days before slaughter. Narasin and nicarbazin as provided by 
000986, bambermycins by 057926 in Sec.  510.600(c) of this chapter.
    (2) Narasin may also be used for broilers in combination with:
    (i) Nicarbazin with lincomycin as in Sec.  558.366.
    (ii) Nicarbazin and bacitracin methylene disalicylate as in Sec.  
558.366.
    (iii) Bacitracin methylene disalicylate, nicarbazin, and roxarsone 
as in Sec.  558.366.
    (iv) Nicarbazin and roxarsone as in Sec.  558.366.

[51 FR 29098, Aug. 14, 1986

    Editorial Note: For Federal Register citations affecting Sec.  
558.363, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.