21 C.F.R. § 558.555   Semduramicin.


Title 21 - Food and Drugs


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

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§ 558.555   Semduramicin.

(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:

 ------------------------------------------------------------------------ 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.------------------------------------------------------------------------

[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]

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