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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: 21CFR520.2261a]



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. 520.2261a Sulfamethazine solution.

(a) Specifications. Each milliliter of solution contains 125 milligrams (12.5 percent) sulfamethazine sodium.

(b) Sponsors. See No. 016592 in § 510.600(c) of this chapter.

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

(d) Conditions of use - (1) Amount. Administer in drinking water to provide: Cattle and swine 112.5 milligrams of sulfamethazine sodium per pound of body weight per day on the first day and 56.25 milligrams per pound of body weight on subsequent days; Chickens, 61 to 89 milligrams of sulfamethazine sodium per pound of body weight per day, and turkeys 53 to 130 milligrams of sulfamethazine sodium per pound of body weight per day, depending upon the dosage, age, and class of chickens or turkeys, ambient temperature, and other factors.

(2) Indications for use. For treatment and control of diseases caused by organisms sensitive to sulfamethazine.

(i) Beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (Escherichia coli ), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum ), calf diphtheria (Fusobacterium necrophorum ), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.).

(ii) Swine. Treatment of porcine colibacillosis (bacterial scours) (Escherichia coli ), and bacterial pneumonia (Pasteurella spp.).

(iii) Chickens and turkeys. In chickens for control of infectious coryza (Avibacterium paragallinarum ), coccidiosis (Eimeria tenella, Eimeria necatrix ), acute fowl cholera (Pasteurella multocida ), and pullorum disease (Salmonella Pullorum). In turkeys for control of coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides ). Medicate as follows: Infectious coryza in chickens, medicate for 2 consecutive days; acute fowl cholera and pullorum disease, in chickens, medicate for 6 consecutive days; coccidiosis, in chickens and turkeys, medicate as in paragraph (c) of this section, then reduce amount of medication to one-half for 4 additional days.

(3) 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 from cattle, chickens, and turkeys 10 days prior to slaughter for food. Withdraw medication from swine 15 days before slaughter for food. Do not medicate chickens or 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, but not to exceed a total of 5 consecutive days in cattle or swine. Medicated cattle, swine, chickens, and turkeys 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. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016]

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