CFR > 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 (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.555—Semduramicin.

558.555—Semduramicin.

(a) Specifications. Type A medicated article containing:
(1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin (as semduramicin sodium).
(2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium biomass).
(b) Approvals. See No. 066104 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (d) of this section; for use of product described in paragraph (a)(2) as in paragraph (e) of this section.
(c) Related tolerances. See § 556.597 of this chapter.
(d) Conditions of use in chickens. It is used in chicken feed as follows:
Semduramicin in grams per ton Combinations in grams per ton Indications for use Limitations Sponsor
(1) 22.7 (25 ppm) Broiler chickens: For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. necatrix, and E. tenella. Do not feed to laying hens. 066104
(2) 22.7 Bacitracin methylene disalicylate 10 to 50 Broiler chickens: As in paragraph (d)(1) of this section; for improved feed efficiency. Feed continuously as sole ration. Do not feed to laying hens. Bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter. 066104
(3) 22.7 Bacitracin methylene disalicylate 10 to 50 plus roxarsone 45.4 Broiler chickens: As in paragraph (d)(4) of this section; for improved feed efficiency. Feed continuously as sole ration. Use feed within 2 weeks of production. Do not feed to laying hens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter. 066104
(4) 22.7 Roxarsone 45.4 Broiler chickens: For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. necatrix, and E. tenella, including some field strains of E. tenella that are more susceptible to semduramicin combined with roxarsone than semduramicin alone. Feed continuously as sole ration. For broiler chickens only. Do not feed to laying hens. Use as sole source of organic arsenic. Withdraw 5 days before slaughter. Roxarsone as provided by No. 046573 in § 510.600(c) of this chapter. 066104
(5) 22.7 Virginiamycin 5 Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. Do not feed to laying hens. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter. 066104
Code of Federal Regulations 504
(6) 22.7 Virginiamycin 5 to 15 Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain. Feed continuously as sole ration. Do not feed to laying hens. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter. 066104
(7) 22.7 Virginiamycin 20 Broiler chickens: As in paragraph (d)(1) of this section; for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin. Feed continuously as sole ration. Do not feed to laying hens. Virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter. 066104
(8) 22.7 Virginiamycin 20 plus roxarsone 22.7 to 45.4 Broiler chickens: As in paragraph (d)(1) of this section; for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; for increased rate of weight gain and improved feed efficiency; and for improved pigmentation. Feed continuously as sole ration throughout growing period. Do not feed to laying hens. Use as sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdose or lack of water may result in leg weakness. Roxarsone as in § 558.530(b)(1) of this chapter provided by No. 046573 in § 510.600(c) of this chapter; semduramicin and virginiamycin as provided by No. 066104. 066104
(e) Conditions of use in chickens. It is used in chicken feed as follows:
Semduramicin in grams per ton Combination in grams per ton Indications for use Limitations Sponsor
(1) 22.7 (25 ppm) Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis. Do not feed to laying hens. 066104
(2) 22.7 Virginiamycin 5 Broiler chickens: As in paragraph (e)(1) of this section; for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter. 066104
(3) 22.7 Virginiamycin 5 to 15 Broiler chickens: As in paragraph (e)(1) of this section; for increased rate of weight gain. Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter. 066104
(4) 22.7 Virginiamycin 20 Broiler chickens: As in paragraph (e)(1) of this section; for prevention of necrotic enteritis caused by C. perfringens susceptible to virginiamycin. Feed continuously as sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin provided by No. 066104 in § 510.600(c) of this chapter. 066104

Code of Federal Regulations

[59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, Aug. 18, 2009]