21 C.F.R. § 558.555 Semduramicin.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated article containing 22.7 grams per pound (50 grams per kilogram) semduramicin sodium. (b) Approvals. See No. 066104 in §510.600(c) of this chapter for use as in paragraph (d) 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: [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]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.555 Semduramicin.
------------------------------------------------------------------------ Semduramicin Combinations in grams per in grams per Indications Limitations Sponsor ton ton for use------------------------------------------------------------------------(1) 22.7 (25 ............. Broiler Do not feed to 066104 ppm) chickens: laying hens. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/ E. mitis, E. necatrix, and E. tenella.------------------------------------------------------------------------(2) 22.7 Bacitracin Broiler Feed 066104 methylene chickens: continuously disalicylate As in as sole 10 to 50 paragraph ration. Do (d)(1) of not feed to this laying hens. section; Bacitracin for methylene improved disalicylate feed as provided efficiency. by No. 046573 in § 510.600(c) of this chapter.------------------------------------------------------------------------(3) 22.7 Bacitracin Broiler Feed 066104 methylene chickens: continuously disalicylate As in as sole 10 to 50 paragraph ration. Use plus (d)(4) of feed within 2 roxarsone this weeks of 45.4 section; production. for Do not feed improved to laying feed hens. Use as efficiency. 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.------------------------------------------------------------------------(4) 22.7 Roxarsone Broiler Feed 066104 45.4 chickens: continuously For the as sole prevention ration. For of broiler coccidiosis chickens caused by only. Do not Eimeria feed to acervulina, laying hens. E. Use as sole brunetti, source of E. maxima, organic E. mivati/ arsenic. E. mitis, Withdraw 5 E. days before necatrix, slaughter. and E. Roxarsone as tenella, provided by including No. 046573 in some field § strains of 510.600(c) of E. tenella this chapter. that are more susceptible to semduramici n combined with roxarsone than semduramici n alone.------------------------------------------------------------------------(5) 22.7 Virginiamycin Broiler Feed 066104 5 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided increased by No. 066104 rate of in § weight gain 510.600(c) of and this chapter. improved feed efficiency.------------------------------------------------------------------------(6) 22.7 Virginiamycin Broiler Feed 066104 5 to 15 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided increased by No. 066104 rate of in § weight 510.600(c) of gain. this chapter.------------------------------------------------------------------------(7) 22.7 Virginiamycin Broiler Feed 066104 20 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided prevention by No. 066104 of necrotic in § enteritis 510.600(c) of caused by this chapter. Clostridium perfringens susceptible to virginiamyc in.------------------------------------------------------------------------(8) 22.7 Virginiamycin Broiler Feed 066104 20 plus chickens: continuously roxarsone As in as sole 22.7 to 45.4 paragraph ration (d)(1) of throughout this growing section; period. Do for not feed to prevention laying hens. of necrotic Use as sole enteritis source of caused by organic Clostridium arsenic. perfringens Poultry susceptible should have to access to virginiamyc drinking in; for water at all increased times. Drug rate of overdose or weight gain lack of water and may result in improved leg weakness. feed Roxarsone as efficiency; in § and for 558.530(b)(1) improved of this pigmentatio chapter n. provided by No. 046573 in § 510.600(c) of this chapter; semduramicin and virginiamycin as provided by No. 066104.------------------------------------------------------------------------

