21 C.F.R. § 520.100c   Amprolium crumbles.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.100c   Amprolium crumbles.

(a) Specifications. Amprolium crumbles contain 1.25 percent amprolium.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

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

(d) Conditions of use. It is top-dressed on or thoroughly mixed in the daily feed ration of calves as follows:

(1) Amount. 1.6 ounces of crumbles per 250 pounds of body weight per day (5 milligrams per kilogram of body weight).

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

(ii) Limitations. Administer for 21 consecutive days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard. Withdraw 24 hours before slaughter. Use 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) Amount. 3.2 ounces of crumbles per 250 pounds of body weight per day (10 milligrams per kilogram of body weight).

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

(ii) Limitations. Administer for 5 consecutive days. For satisfactory diagnosis, a microscopic fecal examination 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. Use 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.

[42 FR 41855, Aug. 19, 1977, as amended at 62 FR 63270, Nov. 28, 1997; 70 FR 16934, Apr. 4, 2005]

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