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.

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

Amprolium in Grams per Ton	Indications for Use	Limitations	Sponsor
(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 veal	050604
(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 determined	050604

(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 ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(i) 36.3 to 113.5 (0.004% to 0.0125%)		Replacement chickens; development of active immunity to coccidiosis	Feed as follows—

Growing conditions	Up to 5 weeks of age	From 5 to 8 weeks of age	Over 8 weeks of age
	Amprolium grams per ton	Amprolium grams per ton	Amprolium grams per ton
Severe exposure to coccidiosis	113.5 (0.0125%)	72.6-113.5(0.008%-0.0125%)	36.3-113.5(0.004%-0.0125%)
Moderate exposure to coccidiosis	72.6-113.5(0.008%-0.0125%)	54.5-113.5(0.006%-0.0125%)	36.3-113.5(0.004%-0.0125%)
Slight exposure to coccidiosis	36.3-113.5(0.004%-0.0125%)	36.3-113.5(0.004%-0.0125%)	36.3-113.5(0.004%-0.0125%)

Amprolium in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
	Arsanilic acid 90 (0.01%)	Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentation	Withdraw 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 18.5	Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency; improving pigmentation	Withdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)
	Arsanilic acid 90 (0.01%) plus erythromycin 92.5	1. 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 stress	Feed 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 coryza	Feed 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 185	Replacement 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 disease	Feed 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)
Code of Federal Regulations 396
	Bacitracin methylene disalicylate 4 to 50	Replacement 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 45.4	Replacement 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 200	Chickens; development of active immunity to coccidiosis; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Chlortetracycline 200 to 400	Chickens; 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 chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Erythromycin 4.6 to 18.5	Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency	As erythromycin thiocyanate. Feed according to subtable in item (i)
	Erythromycin 92.5	1. Replacement chickens; development of active immunity to coccidiosis; as an aid in the prevention of infectious coryza	Feed 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 stress	Feed 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 185	Replacement chickens; development of active immunity to coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease	Feed 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 12	Replacement 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 50	Replacement chickens; development of active immunity to coccidiosis; growth promotion and feed efficiency	As 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 pigmentation	Withdraw 5 d before slaughter; as sole source of organic arsenic. Feed according to subtable in item (i)
Code of Federal Regulations 397
(ii) 72.6 to 113.5 (0.008% to 0.0125%)		Broiler chickens; prevention of coccidiosis caused by Eimeria tenella only	Feed according to subtable in item (i)
	Arsanilic acid 90 (0.01%)	......do	......do
	Bacitracin 100 to 200	Broiler 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 200	Chickens; prevention of coccidiosis caused by E. tenella only; control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Chlortetracycline 200 to 400	Chickens; 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 chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Hygromycin B 8 to 12	Broiler 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 50	Broiler chickens; prevention of coccidiosis caused by E. tenella only; growth promotion and feed efficiency	As 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 pigmentation	Withdraw 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 coccidiosis	For 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 pigmentation	Feed 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 slaughter	016592
	Bambermycins 1 to 4	Growing turkeys; prevention of coccidiosis; increased rate of weight gain and improved feed efficiency	Feed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter	016592
(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
	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
Code of Federal Regulations 398
	2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation	......do
	Arsanilic acid 90 (0.01%) plus erythromycin 92.5	1. 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 stress	Feed 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 coryza	Feed for 7 to 14 d; withdraw 5 d before slaughter; as sole source of organic arsenic
	Arsanilic acid 90 (0.01%) plus erythromycin 185	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 and reduction of lesions and in lowering severity of chronic respiratory disease	Feed 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 18.5	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improved pigmentation	Withdraw 5 d before slaughter; as sole source of organic arsenic
	Bacitracin 4 to 50	1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency	As bacitracin methylene disalicylate or bacitracin zinc	1 012769
	2. Turkeys; prevention of coccidiosis; growth promotion and feed efficiency	......do
	Bacitracin 100 to 200	1. 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 500	Turkeys; prevention of coccidiosis; treatment of infectious sinusitis, blue comb (mud fever)	As bacitracin zinc
Code of Federal Regulations 399
	Bacitracin plus penicillin 100 to 500 (of combination)	......do	Feed contains 50% to 75% of bacitracin but not more than 125 g penicillin; as procaine penicillin; as bacitracin zinc
	Carbarsone 227 to 340.5	Turkeys; aid in prevention of coccidiosis (Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis) and blackhead	Feed 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 chapter	016592
	Chlortetracycline 100 to 200	Chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Chlortetracycline 200 to 400	Chickens 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 chlortetracycline	Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d
	Erythromycin 4.6 to 18.5	Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency	As erythromycin thiocyanate
	Erythromycin 92.5	1. 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 stress	Feed 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 coryza	Feed for 7 to 14 d; withdraw 24 h before slaughter
	Erythromycin 185	Broiler 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 disease	Feed for 5 to 8 d, do not use in birds producing eggs for food purposes; withdraw 48 h before slaughter
	Hygromycin B 8 to 12	Broiler 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 50	1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency	As procaine penicillin
Code of Federal Regulations 400
	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 pigmentation	Withdraw 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 coccidiosis	For severe outbreaks of coccidiosis; administer for 2 weeks
1 Bacitracin zinc in § 510.600(c) of this chapter.

(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.

Code of Federal Regulations

[41 FR 10985, Mar. 15, 1976]

Code of Federal Regulations

Editorial Note: For Federal Register citations affecting § 558.55 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.