Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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 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 methylenedisalicylate 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 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.

Where this section sits in the code

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
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds

(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.

(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 methylenedisalicylate 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 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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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