21 C.F.R. § 558.555

Current through October 31, 2024
Section 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)Sponsor. See No. 066104 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section; for use of product described in paragraph (a)(2) of this section 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 tonCombinations in grams per tonIndications for useLimitationsSponsor
(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) 22.7Bacitracin methylenedisalicylate 10 to 50Broiler 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 methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.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) [Reserved]

(f) Semduramicin may also be used in combination with virginiamycin as in § 558.635 .

21 C.F.R. §558.555

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; 79 FR 10983 , Feb. 27, 2014; 79 FR 13546 , Mar. 11, 2014; 81 FR 17609 , Mar. 30, 2016; 81 FR 95013 , Dec. 27, 2016; 86 FR 14826 , Mar. 19, 2021; 87 FR 17948 , Mar. 29, 2022
81 FR 17609, 3/30/2016; 81 FR 95013, 12/27/2016; 86 FR 14826, 3/19/2021; 87 FR 17948, 3/29/2022