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CFR > 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 (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.575—Sulfadimethoxine, ormetoprim.

CFR

558.575—Sulfadimethoxine, ormetoprim.

(a) Approvals. Type A medicated articles to sponsors as identified in § 510.600(c) of this chapter for uses as in paragraph (d) of this section as follows:
(1) 25 percent sufadimethoxine and 15 percent ormetoprim to 046573 for use for poultry as in paragraphs (d)(1), (d)(2), (d)(3), (d)(4), and (d)(7) of this section.
(2) 25 percent sulfadimethoxine and 5 percent ormetoprim to No. 015331 for use for fish as in paragraphs (d)(5) and (d)(6) of this section.
(b) Related tolerances. See §§ 556.490 and 556.640 of this chapter.
(c) [Reserved]
(d) Conditions -of use. It is used in feeds for animals as follows:
(1) Broiler chickens— (i) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).
(a) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).
(b) Limitations. Feed as sole ration; withdraw 5 days before slaughter.
(ii) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent) plus roxarsone, 22.7 grams (0.0025 percent).
(a) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli, (colibacillosis); and P. multocida (fowl cholera); growth promotion and feed efficiency; improving pigmentation.
(b) Limitations. Withdraw 5 days before slaughter; as sole source of organic arsenic.
(2) Replacement chickens— (i) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).
(ii) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. galmaxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).
(iii) Limitations. Feed as a sole ration; do not feed to chickens over 16 weeks (112 days) of age; withdraw 5 days before slaughter.
(3) Turkeys— (i) Amount per ton. Sulfadimethoxine, 56.75 grams (0.00625 percent) plus ormetoprim, 34.05 grams (0.00375 percent).
(ii) Indications for use. As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to turkeys, namely, E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial infection due to P. multocida (fowl cholera).
(iii) Limitations. Do not feed to turkeys producing eggs for food; withdraw 5 days before slaughter.
(4) Ducks— (i) Amount per ton. Sulfadimethoxine, 227 grams (0.025 percent) plus ormetoprim, 136.2 grams (0.015 percent).
(a) Indications for use. As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks, including breeding ducks.
(b) Limitations. Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; do not feed to ducks producing eggs for food.
(ii) Amount per ton. Sulfadimethoxine, 454 grams (0.05 percent) plus ormetoprim, 272.4 grams (0.03 percent).
(a) Indications for use. As an aid in the control of bacterial infections due to E. coli, Riemerella anatipestifer, and severe challenge of P. multocida (fowl cholera) in ducks.
(b) Limitations. Feed as a sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.
(5) Salmonids— (i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.
(ii) Indications of use. For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.
(iii) Limitations. Administer for 5 consecutive days; withdraw 42 days before release as stocker fish or slaughter.
(6) Catfish— (i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.
(ii) Indications for use. For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.
(iii) Limitations. Administer for 5 consecutive days; withdraw 3 days before slaughter or release as stocker fish.
(7) Chukar partridges— (i) Amount per ton. Sulfadimethoxine 113.5 grams (0.0125 percent) plus ormetoprim 68.1 grams (0.0075 percent).
(ii) Indications for use. For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.
(iii) Limitations. Feed continuously to young birds up to 8 weeks of age as sole ration.

Code of Federal Regulations

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005]
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