558.198—Diclazuril.

(a) Specifications. Type A medicated article containing 0.2 percent diclazuril.

(b) Approvals. See No. 016592 in § 510.600(c) of this chapter.

(d) Conditions of use. (1) Chickens. For chickens it is used as follows:

Diclazuril grams/ton	Combination grams/ton	Indications for use	Limitations	Sponsor
(i) 0.91 (1 part per million (ppm))		Broiler 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. maxima.	Feed continuously. Not for use in hens producing eggs for human food.	016592
(ii) 0.91 (1 ppm)	Bacitracin methylene disalicylate 4 to 50	Broiler chickens: As in item (i) of this table; for increased rate of weight gain and improved feed efficiency.	As in item (i) of this table. Bacitracin methylene disalicylate provided by 046573.	016592
(iii) 0.91 (1 ppm).	Bacitracin methylene disalicylate 50 plus roxarsone 22.7 to 45.4	Broiler chickens: As in item (i) of this table; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.	Feed continuously as the sole ration throughout growing period. Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter.	016592
(iv) 0.91 (1 ppm).	Bacitracin methylene disalicylate 100 to 200 plus roxarsone 22.7 to 45.4	Broiler chickens: As in item (i) of this table; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.	Feed continuously as the sole ration throughout growing period. Start at first clinical signs of disease; vary dosage of bacitracin based on severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton (g/ton). Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter.	016592
Code of Federal Regulations 426
(v) 0.91 (1 ppm)	Bambermycins 1 to 2	Broiler chickens: As in item (i) of this table); for increased rate of weight gain and improved feed efficiency.	As in item (i) of this table. Bambermycins provided by 057926.	016592
(vi) 0.91(1 ppm)	Roxarsone 22.7 to 45.4	Broiler chickens: As in item (i) of this table; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.	Feed continuously as the sole ration throughout growing period. Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter.Roxarsone provided by No. 046573 in § 510.600(c) of this chapter.	046573
(vii) 0.91 (1 ppm)	Virginiamycin 5	Broiler chickens: As in item (i) of this table; for increased rate of weight gain and improved feed efficiency.	As in item (i) of this table; Virginiamycin provided by 066104.	016592
(viii) 0.91 (1 ppm)	Virginiamycin 5 to 15	Broiler chickens: As in item (i) of this table; for increased rate of weight gain.	As in item (i) of this table. Virginiamycin provided by 066104.	016592

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

Diclazuril grams/ton	Combination grams/ton	Indications for use	Limitations	Sponsor
(i) 0.91 (1 ppm)		Growing turkeys: For the prevention of coccidiosis caused by E. 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.	016592
(ii) 0.91 (1 ppm).	Bacitracin methylene disalicylate 4 to 50.	Growing turkeys: As in paragraph (d)(2)(i) of this section; for increased rate of weight gain and improved feed efficiency.	As in paragraph (d)(2)(i) of this section. Bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter.	016592
(iii) 0.91 (1 ppm).	Bambermycins 1 to 2	Growing turkeys: As in paragraph (d)(2)(i) of this section; for improved feed efficiency.	As in paragraph (d)(2)(i) of this section. Bambermycins provided by No. 057926 in § 510.600(c) of this chapter.	016592
(iv) 0.91 (1 ppm).	Bambermycins 2	Growing turkeys: As in paragraph (d)(2)(i) of this section; for increased rate of weight gain and improved feed efficiency.	As in paragraph (d)(2)(i) of this section. Bambermycins provided by No. 057926 in § 510.600(c) of this chapter.	016592

Code of Federal Regulations

[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]

CFR

558.198—Diclazuril.

Code of Federal Regulations