21 CFR § 558.55
Amprolium
June 25, 2020
(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:
Open Table
| 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:
Open Table
| 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 |
Open Table
| Growing conditions | Up to 5 weeks of age | From 5 to 8 weeks of age | Over 8 weeks of age |
|---|---|---|---|
| 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%) |
Open Table
| 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:
Open Table
| 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:
Open Table
| 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]
[41 FR 10985, Mar. 15, 1976]
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