21 C.F.R. § 558.205

Current through September 30, 2024
Section 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/ton
Combination
grams/ton
Indications for useLimitationsSponsor
(i) 0.91Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. 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. maximaFeed continuously as the sole ration. Do not feed to birds producing eggs for human consumption058198
(ii) 0.91Bacitracin methylenedisalicylate, 4 to 50Broiler 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 efficiency. 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. maximaFeed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter058198
(iii) 0.91Bambermycins, 1 to 2Broiler 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 efficiency. 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. maximaFeed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter058198

(2)Turkeys. For turkeys it is used as follows:

Diclazuril
grams/ton
Combination
grams/ton
Indications for useLimitationsSponsor
(i) 0.91Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitisFeed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption058198
(ii) 0.91Bacitracin methylenedisalicylate, 4 to 50Growing 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 efficiencyFeed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter058198
(iii) 0.91Bambermycins 1 to 2Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiencyFeed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter058198
(iv) 0.91Bambermycins 2Growing 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 efficiencyFeed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter058198

(3) Diclazuril may also be used in combination with virginiamycin as in § 558.635 .

21 C.F.R. §558.205

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
81 FR 17609, 3/30/2016; 81 FR 95004, 12/27/2016; 83 FR 48947, 9/28/2018; Redesignated and amended at 84 FR 12497, 12498, 4/2/2019; 87 FR 10970, 2/28/2022