[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.100a]

[Page 102-103]
 
                        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. 520.100a  Amprolium drinking water.

    (a) Chemical name. 1-(4-Amino-2-n-propyl-5-pyrimidinylmethyl)-2-
picolinium chloride hydrochloride.
    (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 used in drinking water as follows:
    (1) Chickens and turkeys--(i) Amount. 20 percent soluble powder.
    (ii) Indications for use. Treatment of coccidiosis.
    (iii) Limitations. Administer at the 0.012 percent level in drinking 
water as soon as coccidiosis is diagnosed and continue for from 3 to 5 
days (in severe outbreaks, give amprolium at the 0.024

[[Page 103]]

percent level); continue with 0.006 percent amprolium-medicated water 
for an additional 1 to 2 weeks; no other source of drinking water should 
be available to the birds during this time; as sole source of amprolium.
    (2) Calves--(i) Amount. 9.6 percent solution or 20 percent soluble 
powder.
    (a) Indications for use. As an aid in the treatment of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (b) Limitations. Add 16 fluid ounces of the 9.6 percent solution to 
each 100 gallons of drinking water; or 4 ounces of the soluble powder to 
each 50 gallons of drinking water; at the usual rate of water 
consumption, this will provide an intake of approximately 10 milligrams 
per kilogram (2.2 pounds) of body weight; offer this solution as the 
only source of water for 5 days; for a satisfactory diagnosis, a 
microscopic examination of the feces 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.
    (ii) Amount. 9.6 percent solution or 20 percent soluble powder.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (b) Limitations. Add 8 fluid ounces of the 9.6 percent solution or 4 
ounces of the 20 percent soluble powder to each 100 gallons of drinking 
water; at the usual rate of water consumption, this will provide an 
intake of approximately 5 milligrams per kilogram (2.2 pounds) of body 
weight; offer this solution as the only source of water for 21 days 
during periods of exposure or when experience indicates that coccidiosis 
is likely to be a hazard; withdraw 24 hours before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63270, Nov. 28, 1997]