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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2261b]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.2261b Sulfamethazine powder.

(a) Specifications. A soluble powder composed of 100 percent sulfamethazine sodium.

(b) Sponsors. See Nos. 016592 and 061133 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.670 of this chapter.

(d) Conditions of use - (1) Chickens - (i) Amount. Administer in drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of body weight per day.

(ii) Indications for use. For control of infectious coryza (Avibacterium paragallinarum ), coccidiosis (Eimeria tenella, E. necatrix ), acute fowl cholera (Pasteurella multocida ), and pullorum disease (Salmonella Pullorum).

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate chickens producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated chickens must actually consume enough medicated water which provides the recommended dosages. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Turkeys - (i) Amount. Administer in drinking water to provide 50 to 124 mg/lb of body weight per day

(ii) Indications for use. For control of coccidiosis (E. meleagrimitis , E. adenoeides ).

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated turkeys must actually consume enough medicated water which provides the recommended dosages. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Swine - (i) Amount. Administer in drinking water, or as a drench, to provide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration.

(ii) Indications for use. For treatment of porcine colibacillosis (bacterial scours) (E. coli ), and bacterial pneumonia (Pasteurella spp.).

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 15 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated swine must actually consume enough medicated water which provides the recommended dosages. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Cattle - (i) Amount. Administer in drinking water, or as a drench, to provide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration.

(ii) Indications for use in beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (E. coli ), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum ), calf diphtheria (F. necrophorum ), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.)

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated cattle must actually consume enough medicated water which provides the recommended dosages. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not use in calves under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause violative residues to remain beyond the withdrawal time. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 70303, Dec. 4, 2006, as amended at 75 FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019]

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