Code of Federal Regulations Title 21. Food and Drugs § 21.558.55 Amprolium

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Specifications. Type A medicated article containing 25 percent amprolium.

(b) Sponsor. No. 016592 in § 510.600(c) of this chapter.

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

(e) 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 per kilogram of body weight per day	Calves: As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zuernii	Top-dress on or mix in the daily ration. Feed for 21 days when experience indicates that coccidiosis is likely to be a hazard, as the 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	016592
(ii) 113.5 to 11, 350; to provide 10 milligrams per kilogram of body weight per day	Calves: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zuernii	Top-dress on or mix in the daily ration. Feed for 5 days as the 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	016592

(2) Chickens. 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		Replacement chickens: For development of active immunity to coccidiosis	Feed continuously until onset of production as follows:	016592

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

Amprolium in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(ii) 36.3 to 113.5	Bacitracin methylenedisalicylate 4 to 50	Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency	Feed according to subtable in item (i). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771
(iii) 72.6 to 113.5		Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only	Feed continuously as the sole ration; as sole source of amprolium	016592
(iv) 72.6 to 113.5	Bambermycins 1 to 2	Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only; and for increased rate of weight gain and improved feed efficiency	Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter	016592
(v) 113.5		1. Laying chickens: For prevention of coccidiosis	Feed continuously as the sole ration; as the sole source of amprolium	016592
		2. Laying chickens: For treatment of coccidiosis in moderate outbreaks	Feed for 2 weeks
(vi) 113.5 to 227		1. Replacement chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired	Feed continuously from day-old until onset of production; as the sole source of amprolium	016592
		2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired	Feed continuously as the sole ration; as sole source of amprolium
(vii) 113.5 to 227	Bambermycins 1 to 2	Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of weight gain and improved feed efficiency	Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter	016592
(viii) 227		Laying chickens: For treatment of coccidiosis in severe outbreaks.	Feed for 2 weeks	016592

(3) Turkeys. It is used as follows:

Amprolium in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(i) 113.5	Bambermycins 1 to 4	Growing turkeys: For prevention of coccidiosis; and for 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
(ii) 113.5 to 227		Turkeys: For prevention of coccidiosis	Feed continuously as the sole ration; as sole source of amprolium	016592

(4) Pheasants. It is used as follows:

Amprolium in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(i) 159		Growing pheasants: For the prevention of coccidiosis caused by Eimeria colchici, E. duodenalis, and E. phasiani	Feed continuously as sole ration. Use as sole source of amprolium	016592
(ii) [Reserved]

(5) Permitted combinations. Amprolium may also be used in combination with:

(i) Virginiamycin as in § 558.635.

(ii) [Reserved]

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.558.55 Amprolium - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-558-55/

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