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Title 21: Food and Drugs

« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / 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.

(d) Conditions of use -

(1) Chickens. For chickens it is used as follows:

Diclazuril grams/ton	Combination in grams/ton	Indications 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. maxima.	Feed 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.	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 efficiency.	Feed 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. 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 efficiency.	Feed 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. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.	058198

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

Diclazuril grams/ton	Combination in grams/ton	Indications 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 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 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 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 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]