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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.100]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.100 Amprolium.

(a) Specifications. (1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).

(2) Each gram of powder contains 200 mg amprolium (20 percent).

(b) Sponsors. See sponsors in 510.600(c) of this chapter.

(1) Nos. 016592 and 061133 for use of products described in paragraph (a) of this section as in paragraph (d) of this section.

(2) No. 066104 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section.

(3) No. 051072 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section.

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

(d) Conditions of use - (1) Growing chickens, turkeys, and laying hens. It is used in drinking water as follows:

(i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

(ii) Indications for use. For the treatment of coccidiosis.

(iii) Limitations. Use as the sole source of amprolium.

(2) Calves. Administer concentrate solution or soluble powder as a drench or in drinking water as follows:

(i) Indications for use and amounts - (A) As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii , administer 5 mg per kilogram (mg/kg) body weight for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard.

(B) As an aid in the treatment of coccidiosis caused by E. bovis and E. zurnii , administer 10 mg/kg body weight for 5 days.

(ii) Limitations. 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. Use as the sole source of amprolium.

[71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, 2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133, Aug. 29, 2016; 84 FR 8972, Mar. 13, 2019; 86 FR 13184, Mar. 8, 2021]

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