Code of Federal Regulations (Last Updated: November 8, 2024) |
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 558 - New Animal Drugs for Use in Animal Feeds |
Subpart B - Specific New Animal Drugs for Use in Animal Feeds |
§ 558.195 - Decoquinate.
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§ 558.195 Decoquinate.
(a) Specifications. Type A medicated article containing 6 percent decoquinate.
(b) ApprovalsSponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.170 of this chapter.
(d) Special considerations.
(1) Bentonite should not be used in decoquinate feeds.
(2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section.
(3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises.
(e) Conditions of use. It is used as follows:
(1) Chickens -
Decoquinate in
grams/tonCombination in grams/ton Indications for use Limitations Sponsor (i) 27.2 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti Do not feed to laying hens producing eggs for human consumption 054771 (ii) 27.2 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration; do not feed to laying chickens. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 27.2 Bacitracin zinc, 10 to 50 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti Feed continuously as sole ration; do not feed to laying chickens. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 054771 (2) Cattle -
Decoquinate in
grams/tonCombination in grams/ton Indications for use Limitations Sponsor (i) 12.9 to 90.8 Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuernii Feed Type C feed or milk replacer to provide 22.7 milligrams (mg) per 100 pounds (lb) of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for human consumption. See paragraph (d)(3) of this section 054771 (ii) 12.9 to 90.8 Monensin, 5 to 30 Cattle fed in confinement for slaughter: For prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592, 054771 (iii) 90.9 to 535.7 Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuernii Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section 054771 (3) Minor species -
Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12.9 to 90.8 1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption 054771 2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni and E. ninakohlyakimovae Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption (ii) 90.9 to 535.7 1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption 054771 2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni and E. ninakohlyakimovae Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 22525, Apr. 18, 2016; 81 FR 67152, Sept. 30, 2016; 81 FR 95004, Dec. 27, 2016; 83 FR 48947, Sept. 28, 2018; 84 FR 12496, Apr. 2, 2019; 85 FR 18121, Apr. 1, 2020; 86 FR 14822, Mar. 19, 2021]