21CFR558.55

(a) Specifications. Type A medicated article containing 25 percent amprolium. (b) Sponsor. No. 016592 in § 510.600(c) of this chapter . (c) Related tolerances. See § 556.50 of this chapter . (d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite. (e) Conditions of use — [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 (1) Cattle. It is used as follows: [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: [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 (3) Turkeys. It is used as follows: [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: [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]