21 C.F.R. § 558.530   Roxarsone.


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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§ 558.530   Roxarsone.

(a) Specifications. Type A medicated articles containing 10, 20, 50, or 80 percent roxarsone.

(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 046573 for use of 10, 20, and 50 percent Type A medicated articles as in paragraph (d)(1)(i) of this section.

(2) No. 046573 for use of 10, 20, 50, and 80 percent Type A medicated articles as in paragraphs (d)(1) through (d)(3) of this section.

(c) Related tolerances. See §556.60 of this chapter.

(d) Conditions of use—(1) Chickens. It is used in chicken feed as follows:

 ------------------------------------------------------------------------Roxarsone in   Combinations  grams per    in grams per    Indications     Limitations     Sponsor     ton            ton          for use------------------------------------------------------------------------(i) 22.7 to   ..............  Growing        Feed                 046573 45.4                          chickens:      continuously                               For            throughout                               increased      growing                               rate of        period; do                               weight gain,   not feed to                               improved       chickens                               feed           producing                               efficiency,    eggs for                               and improved   human                               pigmentation   consumption;                               .              withdraw 5                                              days before                                              slaughter; as                                              sole source                                              of organic                                              arsenic; drug                                              overdose or                                              lack of water                                              may result in                                              leg weakness.------------------------------------------------------------------------(ii) 22.7 to  Chlortetracycl  Growing        As in           ........... 45.4          ine 10 to 50    chickens: As   paragraph                               in paragraph   (d)(1)(i) of                               (d)(1)(i) of   this section.                               this           Chlortetracyc                               section.       line as                                              provided by                                              No. 046573 in                                              §                                              510.600(c) of                                              this chapter.------------------------------------------------------------------------(iii) 22.7    Chlortetracycl  Growing        As in           ........... to 45.4       ine 100 to      chickens: As   paragraph               200             in paragraph   (d)(1)(i) of                               (d)(1)(i) of   this section                               this           except feed                               section; and   continuously                               for control    for 7 to 14                               of             days.                               infectious     Chlortetracyc                               synovitis      line as                               caused by      provided by                               Mycoplasma     No. 046573 in                               synoviae       §                               susceptible    510.600(c) of                               to             this chapter.                               chlortetracy                               cline.------------------------------------------------------------------------(iv) 22.7 to  Chlortetracycl  Growing        As in           ........... 45.4          ine 200 to      chickens: As   paragraph               400             in paragraph   (d)(1)(i) of                               (d)(1)(i) of   this section                               this           except feed                               section; and   continuously                               for control    for 7 to 14                               of chronic     days.                               respiratory    Chlortetracyc                               disease        line as                               (CRD) and      provided by                               air sac        No. 046573 in                               infection      §                               caused by M.   510.600(c) of                               gallisepticu   this chapter.                               m and                               Escherichia                               coli                               susceptible                               to                               chlortetracy                               cline.------------------------------------------------------------------------(v) 22.7 to   Chlortetracycl  Growing        As in           ........... 45.4          ine 500         chickens: As   paragraph                               in paragraph   (d)(1)(i) of                               (d)(1)(i) of   this section                               this           except feed                               section; and   continuously                               for            for 5 days.                               reduction of   Chlortetracyc                               mortality      line as                               due to E.      provided by                               coli           No. 046573 in                               infections     §                               susceptible    510.600(c) of                               to             this chapter.                               chlortetracy                               cline.------------------------------------------------------------------------

(2) Turkeys. It is used in turkey feed as follows:

 ------------------------------------------------------------------------Roxarsone in   Combinations  grams per    in grams per    Indications     Limitations     Sponsor     ton            ton          for use------------------------------------------------------------------------(i) 22.7 to   ..............  Growing        Feed                 046573 45.4                          turkeys: For   continuously                               increased      throughout                               rate of        growing                               weight gain,   period; do                               improved       not feed to                               feed           turkeys                               efficiency,    producing                               and improved   eggs for                               pigmentation   human                               .              consumption;                                              withdraw 5                                              days before                                              slaughter; as                                              sole source                                              of organic                                              arsenic; drug                                              overdose or                                              lack of water                                              may result in                                              leg weakness.------------------------------------------------------------------------(ii) 22.7 to  Chlortetracycl  Growing        As in           ........... 45.4          ine 10 to 50    turkeys: As    paragraph                               in paragraph   (d)(2)(i) of                               (d)(2)(i) of   this section.                               this           Chlortetracyc                               section.       line as                                              provided by                                              No. 046573 in                                              §                                              510.600(c) of                                              this chapter.------------------------------------------------------------------------(iii) 22.7    Chlortetracycl  Growing        As in           ........... to 45.4       ine 200         turkeys: As    paragraph                               in paragraph   (d)(2)(i) of                               (d)(2)(i) of   this section                               this           except feed                               section; and   continuously                               for control    for 7 to 14                               of             days.                               infectious     Chlortetracyc                               synovitis      line as                               caused by      provided by                               Mycoplasma     No. 046573 in                               synoviae       §                               susceptible    510.600(c) of                               to             this chapter.                               chlortetracy                               cline.------------------------------------------------------------------------(iv) 22.7 to  Chlortetracycl  1. Growing     As in           ........... 45.4          ine 400         turkeys: As    paragraph                               in paragraph   (d)(2)(i) of                               (d)(2)(i) of   this section                               this           except feed                               section; and   continuously                               for control    for 7 to 14                               of             days.                               hexamitiasis   Chlortetracyc                               caused by      line as                               Hexamita       provided by                               meleagrides    No. 046573 in                               susceptible    §                               to             510.600(c) of                               chlortetracy   this chapter.                               cline.                              2. Turkey                               poults not                               over 4 weeks                               of age:                               Reduction of                               mortality                               due to                               paratyphoid                               caused by                               Salmonella                               typhimurium                               susceptible                               to                               chlortetracy                               cline.------------------------------------------------------------------------(v) 22.7 to   Chlortetracycl  Growing        As in           ........... 45.4          ine 25 mg/lb    turkeys: As    paragraph               body weight     in paragraph   (d)(2)(i) of               daily           (d)(2)(i) of   this section                               this           except feed                               section; and   continuously                               for control    for 7 to 14                               of             days.                               complicating   Chlortetracyc                               bacterial      line as                               organisms      provided by                               associated     No. 046573 in                               with           §                               bluecomb       510.600(c) of                               (transmissib   this chapter.                               le                               enteritis,                               coronaviral                               enteritis)                               susceptible                               to                               chlortetracy                               cline.------------------------------------------------------------------------

(3) Swine. It is used in swine feed as follows:

 ------------------------------------------------------------------------Roxarsone in   Combinations  grams per    in grams per    Indications     Limitations     Sponsor     ton            ton          for use------------------------------------------------------------------------(i) 22.7 to   ..............  Growing and    Feed                 046573 34.1                          finishing      continuously                               swine: For     throughout                               increased      growing                               rate of        period;                               weight gain    withdraw 5                               and improved   days before                               feed           slaughter; as                               efficiency.    sole source                                              of organic                                              arsenic.------------------------------------------------------------------------(ii) 22.7 to  Chlortetracycl  Growing and    Feed for not    ........... 34.1          ine 400 (to     finishing      more than 14               administer 10   swine: As in   days;               mg/lb body      paragraph      withdraw 5               weight)         (d)(3)(i) of   days before                               this           slaughter; as                               section; and   sole source                               for            of organic                               treatment of   arsenic.                               bacterial                               enteritis                               caused by E.                               coli and S.                               choleraesuis                               and                               bacterial                               pneumonia                               caused by                               Pasteurella                               multocida                               susceptible                               to                               chlortetracy                               cline.------------------------------------------------------------------------(iii) 181.5   ..............  Growing and    Feed for not         046573                               finishing      more than 6                               swine: For     consecutive                               the            days; if                               treatment of   improvement                               swine          is not                               dysentery.     observed,                                              consult a                                              veterinarian;                                              withdraw 5                                              days before                                              slaughter; as                                              a sole source                                              of organic                                              arsenic;                                              animals must                                              consume                                              enough                                              medicated                                              feed to                                              provide a                                              therapeutic                                              dose.------------------------------------------------------------------------(iv) 181.5    Chlortetracycl  Growing and    Feed for not    ...........               ine 10 to 50    finishing      more than 6                               swine: As in   consecutive                               paragraph      days; if                               (d)(3)(i) of   improvement                               this           is not                               section; and   observed,                               for            consult a                               treatment of   veterinarian;                               swine          withdraw 5                               dysentery.     days before                                              slaughter; as                                              a sole source                                              of organic                                              arsenic;                                              animals must                                              consume                                              enough                                              medicated                                              feed to                                              provide a                                              therapeutic                                              dose.------------------------------------------------------------------------(v) 181.5     Chlortetracycl  Growing and    Feed for not    ...........               ine 400 (to     finishing      more than 6               administer 10   swine: As in   consecutive               mg/lb body      paragraph      days; if               weight)         (d)(3)(iii)    improvement                               of this        is not                               section; and   observed,                               for            consult a                               treatment of   veterinarian;                               bacterial      withdraw 5                               enteritis      days before                               caused by E.   slaughter; as                               coli and S.    a sole source                               choleraesuis   of organic                               and            arsenic;                               bacterial      animals must                               pneumonia      consume                               caused by P.   enough                               multocida      medicated                               susceptible    feed to                               to             provide a                               chlortetracy   therapeutic                               cline.         dose.------------------------------------------------------------------------

(4) Permitted combinations. It may be used in accordance with this section in combination with:

(i) Aklomide as in §558.35.

(ii) Amprolium as in §558.55.

(iii) Amprolium and ethopabate as in §558.58.

(iv) Bacitracin methylene disalicylate as in §558.76.

(v) Bacitracin zinc as in §558.78.

(vi) Bambermycins and bambermycins plus certain anticoccidials as in §558.95.

(vii) Chlortetracycline as in §558.128.

(viii) Clopidol as in §558.175.

(ix) Decoquinate alone or in combination as in §558.195.

(x) Diclazuril alone or in combination as in §558.198.

(xi) Halofuginone alone or in combination as in §558.265.

(xii) Lasalocid alone or in combination as in §558.311.

(xiii) Monensin alone or in combination as in §558.355.

(xiv) Narasin alone or in combination as in §558.363.

(xv) Nequinate as in §558.365.

(xvi) Nicarbazin alone or in combination as in §558.366.

(xvii) Nitromide and sulfanitran as in §558.376.

(xviii) Penicillin and zoalene as in §558.680.

(xix) Robenidine hydrochloride as in §558.515.

(xx) Salinomycin alone or in combination as in §558.550.

(xxi) Semduramicin alone or in combination as in §558.555.

(xxii) Sulfadimethoxine, ormetoprim as in §558.575.

(xxiii) Zoalene alone or in combination as in §558.680.

[46 FR 52331, Oct. 27, 1981]

Editorial Note:  For Federal Register citations affecting §558.530, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

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