§520.100. Amprolium.
21 C.F.R. § 520.100
Specifications.
Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).
Each gram of powder contains 200 mg amprolium (20 percent).
Sponsors. See sponsors in 510.600(c) of this chapter.
Nos. 016592 and 061133 for use of products described in paragraph (a) of this section as in paragraph (d) of this section.
Nos. 051072 and 066104 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section.
Related tolerances. See § 556.50 of this chapter.
Conditions of use—
Growing chickens, turkeys, and laying hens. It is used in drinking water as follows:
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.
Indications for use. For the treatment of coccidiosis.
Limitations. Use as the sole source of amprolium.
Calves. Administer concentrate solution or soluble powder as a drench or in drinking water as follows:
Indications for use and amounts—
As an aid in the prevention of coccidiosis caused by <I>Eimeria bovis</I> and <I>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.
As an aid in the treatment of coccidiosis caused by <I>E. bovis and E. zurnii, administer 10 mg/kg body weight for 5 days.
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.
Notes, amendments, and revision history
Amendments
[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; 89 FR 85426, Oct. 28, 2024]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 89 FR 85426, Oct. 28, 2024]