Code of Federal Regulations (Last Updated: July 5, 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 |
§ 558.205 - Diclazuril.
-
§ 558.205 Diclazuril.
(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.185 of this chapter.
(d) Conditions of use -
(1) Chickens. For chickens it is used as follows:
Diclazuril
grams/tonCombination in
grams/tonIndications for use Limitations Sponsor (i) 0.91 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maximaFeed continuously. Not for use in hens producing eggs for human food. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption 058198 (ii) 0.91 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously. Not for use in hens producing eggs for human food. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 058198 (iii) 0.91 Bambermycins, 1 to 2 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously. Not for use in hens producing eggs for human food. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima Feed continuously as the sole ration. Bambermycins as Do not feed to birds producing eggs for human consumption. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter 058198 (2) Turkeys. For turkeys it is used as follows:
Diclazuril
grams/tonCombination in
grams/tonIndications for use Limitations Sponsor (i) 0.91 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis. Feed continuously as the sole ration. Do not feed to breeding turkeys. Not for use in hens Do not feed to birds producing eggs for human consumption. 058198 (ii) 0.91 Bacitracin methylenedisalicylate, 4 to 50 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration. Do not feed to breeding turkeys. Not for use in hens Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 058198 (iii) 0.91 Bambermycins , 1 to 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiency Feed continuously as the sole ration. Do not feed to breeding turkeys. Not for use in hens Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 058198 (iv) 0.91 Bambermycins , 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration. Do not feed to breeding turkeys. Not for use in hens Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 058198 (3) Diclazuril may also be used in combination with virginiamycin as in § 558.635.
[64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016. Redesignated and amended at 84 FR 12497, 12498, Apr. 2, 2019; 87 FR 10970, Feb. 28, 2022]