21 C.F.R. § 520.2261b Sulfamethazine sodium soluble powder.
Title 21 - Food and Drugs
(a) Sponsor. See No. 053501 in §510.600(c) of this chapter for use of a soluble powder composed of 100 percent sulfamethazine sodium. (b) Related tolerances in edible products. See §556.670 of this chapter. (c) Conditions of use—(1) Amount. Administer in drinking water to provide: Chickens 58 to 85 milligrams of sulfamethazine sodium per pound of body weight per day; turkeys 50 to 124 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. Administer to cattle and swine in drinking water, or as a drench, to provide 108 milligrams of sulfamethazine sodium per pound of body weight on the first day and 54 milligrams of sulfamethazine sodium per pound of body weight per day on the second, third, and fourth days of administration. (2) Indications for use. For treatment and control of disease 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 (Haemophilus gallinarum), 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 for 2 days, then reduce drug concentration 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 prior to slaughter for food. Not for use in lactating dairy animals. 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. (d) NAS/NRC status. The conditions of use specified in this section have been reviewed by NAS/NRC and are found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information. [47 FR 25322, June 11, 1982, as amended at 67 FR 78355, Dec. 24, 2002]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2261b Sulfamethazine sodium soluble powder.
