[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.100c]

[Page 106]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.100c  Amprolium crumbles.

    (a) Specifications. Amprolium crumbles contain 1.25 percent 
amprolium.
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 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.
    (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.

[42 FR 41855, Aug. 19, 1977, as amended at 62 FR 63270, Nov. 28, 1997]