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e-CFR Data is current as of February 10, 2009


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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§ 558.55   Amprolium.

(a) Approvals. Type A medicated articles: 25 percent to No. 016592 in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(b) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

(c) Related tolerances. See §556.50 of this chapter.

(d) Conditions of use —(1) Cattle . It is used as follows:

Amprolium in Grams per TonIndications for UseLimitationsSponsor
(i) 113.5 to 11, 350; to provide 5 milligrams (mg) per kilogram of body weight per day.Calves: As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii Top-dress on or mix in the daily ration. Feed for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard; as sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal050604
(ii) 113.5 to 11, 350; to provide 10 mg per kilogram of body weight per day.Calves: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii Top-dress on or mix in the daily ration. Feed for 5 days; as sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. For a satisfactory diagnosis, a microscopic examination of the feces should be done by a veterinarian or diagnostic laboratory before treatment; when treating outbreaks, the drug should be administered promptly after diagnosis is determined050604

(i) Amount. 227 milligrams per 100 pounds (5 milligrams per kilogram) body weight per day.

( a ) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii.

( b ) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(ii) Amount. 454 milligrams per 100 pounds (10 milligrams per kilogram) body weight per day.

( a ) Indications for use. As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii.

( b ) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 5 days; for a satisfactory diagnosis, a microscopic examination of the feces should be done by a veterinarian or diagnostic laboratory before treatment; when treating outbreaks, the drug should be administered promptly after diagnosis is determined; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Chickens and turkeys. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 36.3 to 113.5 (0.004% to 0.0125%)  Replacement chickens; development of active immunity to coccidiosisFeed as follows—
Growing conditionsUp to 5 weeks of ageFrom 5 to 8 weeks of ageOver 8 weeks of age
   Amprolium
grams per ton
Amprolium
grams per ton
Amprolium
grams per ton
Severe exposure to coccidiosis113.5 (0.0125%)72.6–113.5
(0.008%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
Moderate exposure to coccidiosis72.6–113.5
(0.008%–0.0125%)
54.5–113.5
(0.006%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
Slight exposure to coccidiosis36.3–113.5
(0.004%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
  
Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
  Arsanilate sodium 90 (0.01%)Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic; feed according to subtable in item (i)
  
  
  Arsanilic acid 90 (0.01%)Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic; feed according to subtable in item (i)
  
  
  Arsanilic acid 90 (0.01%) plus erythromycin 4.6 to 18.5Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)
  Arsanilic acid 90 (0.01%) plus erythromycin 92.51. Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of chronic respiratory disease during periods of stressFeed for 2 d before stress and 3 to 6 d after stress; withdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)
    2. Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of infectious coryzaFeed for 7 to 14 d; withdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)
(i) 36.3 to 113.5 (0.004% to 0.0125%)Arsanilic acid 90 (0.01%) plus erythromycin 185Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory diseaseFeed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)  
  Bacitracin 100 to 200.Replacement chickens; development of active immunity to coccidiosis; treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis)As bacitracin methylene disalicylate or bacitracin zinc. Feed according to subtable in item (i)  
  Bacitracin methylene disalicylate 4 to 50Replacement chickens; development of active immunity to coccidiosis, increased rate of weight gain, and improved feed efficiency.  Feed according to subtable in item (i); bacitracin methylene disalicylate as provided by 046573 in §510.600(c) of this chapter.046573
  Bacitracin methylene disalicylate 50 plus roxarsone 22.7 to 45.4Replacement chickens; development of active immunity to coccidiosis; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; increased rate of weight gain, improved feed efficiency, and improved pigmentation.Feed according to subtable in entry (i); bacitracin methylene disalicylate and roxarsone as provided by 046573 in §510.600(c) of this chapter.046573
  Chlortetracycline 100 to 200Chickens; development of active immunity to coccidiosis; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d  
Chlortetracycline 200 to 400Chickens; development of active immunity to coccidiosis; control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d  
Erythromycin 4.6 to 18.5Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiencyAs erythromycin thiocyanate. Feed according to subtable in item (i)  
  Erythromycin 92.51. Replacement chickens; development of active immunity to coccidiosis; as an aid in the prevention of infectious coryzaFeed for 7 to 14 d; withdraw 24 h before slaughter. Feed according to subtable in item (i)  
  2. Replacement chickens; development of active immunity to coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stressFeed for 2 d before stress and 3 to 6 d after stress; withdraw 24 h before slaughter. Feed according to subtable in item (i)  
  Erythromycin 185Replacement chickens; development of active immunity to coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory diseaseFeed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 48 h before slaughter. Feed according to subtable in item (i)  
  Hygromycin B 8 to 12Replacement chickens; development of active immunity to coccidiosis; control of infestation of large round worms ( Ascaris galli ), cecal worms ( Heterakis gallinae ), and capillary worms ( Capillaria obsignata )Feed according to subtable in item (i)  
  Penicillin 2.4 to 50Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiencyAs procaine penicillin. Feed according to subtable in item (i)  
  Roxarsone 22.7 to 45.4 (0.0025% to 0.005%)Replacement chickens; development of active immunity to coccidiosis; growth promotion, and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)  
(ii) 72.6 to 113.5 (0.008% to 0.0125%)Broiler chickens; prevention of coccidiosis caused by Eimeria tenella onlyFeed according to subtable in item (i)  
  Arsanilate sodium 90 (0.01%)Broiler chickens; prevention of coccidiosis caused by E. tenella only; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic
  Arsanilic acid 90 (0.01%)......do......do
  Bacitracin 100 to 200Broiler chickens; prevention of coccidiosis caused by E. tenella only; treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis)As bacitracin methylene disalicylate, or zinc bacitracin
  Chlortetracycline 100 to 200Chickens; prevention of coccidiosis caused by E. tenella only; control of infectious synovitis caused by M. synoviae susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
Chlortetracycline 200 to 400Chickens; prevention of coccidiosis caused by E. tenella only; control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
  Hygromycin B 8 to 12Broiler chickens; prevention of coccidiosis caused by Eimeria tenella only; control of infestation of large round worms ( Heterakis gallinae ), and capillary worms ( Capillaria obsignata )Feed according to subtable in item (i)
  Penicillin 2.4 to 50Broiler chickens; prevention of coccidiosis caused by E. tenella only; growth promotion and feed efficiencyAs procaine penicillin
  Roxarsone 22.7 to 45.4 (0.0025% to 0.005%)Broiler chickens; prevention of coccidiosis caused by E. tenella only; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic
(iii) 113.5 (0.0125%)1. Laying chickens; prevention of coccidiosis
  2. Laying chickens; treatment of coccidiosisFor moderate outbreaks of coccidiosis; administer for 2 weeks
  Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1 (0.0025% to 0.00375%)Broiler chickens; as an aid in the prevention of coccidiosis; for increased rate of weight gain, improved feed efficiency, and improved pigmentationFeed continuously as the sole ration; as sole source of amprolium and organic arsenic; roxarsone as provided by No. 053501 in §510.600(c) of this chapter, bambermycins by No. 016592; withdraw 5 d before slaughter016592
  Bambermycins 1 to 4Growing turkeys; prevention of coccidiosis; increased rate of weight gain and improved feed efficiencyFeed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in §510.600(c) of this chapter016592
(iv) 113.5 to 227 (0.0125% to 0.025%)1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis
  2. Turkeys; prevention of coccidiosis
  Arsanilate sodium 90 (0.01%)1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic
  2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation......do
  Arsanilic acid 90 (0.01%)1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation......do
  2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation......do
  Arsanilic acid 90 (0.01%) plus erythromycin 92.51. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of chronic respiratory disease during periods of stressFeed for 2 d before stress and 3 to 6 d after stress; withdraw 5 d before slaughter; as sole source of organic arsenic
  2. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of infectious coryzaFeed for 7 to 14 d; withdraw 5 d before slaughter; as sole source of organic arsenic
  Arsanilic acid 90 (0.01%) plus erythromycin 185Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory diseaseFeed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 5 d before slaughter; as sole source of organic arsenic
  Arsanilic acid 90 (0.01%) plus erythromycin 4.6 to 18.5Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improved pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic
  Bacitracin 4 to 501. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiencyAs bacitracin methylene disalicylate or bacitracin zinc1012769
  2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency......do
  Bacitracin 100 to 2001. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection), blue comb (nonspecific infectious enteritis)......do
  2. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic ry disease (air-sac infection), blue comb (nonspecific infectious enteritis)As bacitracin zinc
  Bacitracin 100 to 500Turkeys; prevention of coccidiosis; treatment of infectious sinusitis, blue comb (mud fever)As bacitracin zinc
  Bacitracin plus penicillin 100 to 500 (of combination)......doFeed contains 50% to 75% of bacitracin but not more than 125 g penicillin; as procaine penicillin; as bacitracin zinc
  Carbarsone 227 to 340.5Turkeys; aid in prevention of coccidiosis ( Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis ) and blackheadFeed continuously 2 weeks before coccidiosis and blackhead are expected and continue as long as prevention is needed; withdraw 5 days before slaughter; use as sole source of amprolium and organic arsenic; do not use as a treatment for outbreaks of coccidiosis; carbarsone by 046573 in §510.600(c) of this chapter000006
  Chlortetracycline 100 to 200Chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis caused by M. synoviae susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
  Chlortetracycline 200 to 400Chickens where immunity to coccidiosis is not desired; control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
  Erythromycin 4.6 to 18.5Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiencyAs erythromycin thiocyanate
  Erythromycin 92.51. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stressFeed for 2 d before stress and 3 to 6 d after stress; withdraw 24 h before slaughter
  2. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryzaFeed for 7 to 14 d; withdraw 24 h before slaughter
  Erythromycin 185Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory diseaseFeed for 5 to 8 d, do not use in birds producing eggs for food purposes; withdraw 48 h before slaughter
  Hygromycin B 8 to 12Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infestation of large round worms ( Heterakis gallinae ) and capillary worms ( Capillaria obsignata )Feed according to subtable in item (i)
  Penicillin 2.4 to 501. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiencyAs procaine penicillin
  2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency......do
  Roxarsone 22.7 to 45.4 (0.0025% to 0.005%)1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentationWithdraw 5 d before slaughter; as sole source of organic arsenic
  2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation......do
(v) 227 (0.025%)Laying chickens; treatment of coccidiosisFor severe outbreaks of coccidiosis; administer for 2 weeks  

(3) Pheasants . It is used as follows:

(i) Amount . 0.0175 percent (159 grams per ton).

(ii) Indications for use . For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duodenalis, and E. phasiani.

(iii) Limitations . Feed continuously as sole ration. Use as sole source of amprolium. Fertility, hatchability, and other reproductive data are not available on amprolium in breeding pheasants. Do not use in feeds containing bentonite.

[41 FR 10985, Mar. 15, 1976]

Editorial Note:   ForFederal Registercitations affecting §558.55, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

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