§520.2260b. Sulfamethazine sustained-release boluses.
21 C.F.R. § 520.2260b
Related tolerances. See § 556.670 of this chapter.
[Reserved]
Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of a 27-gram sulfamethazine sustained-release bolus.
Conditions of use—
Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose.
Indications for use. For nonlactating cattle for the treatment of infections caused by organisms sensitive to sulfamethazine such as hemorrhagic septicemia (shipping fever complex), bacterial pneumonia, foot rot, and calf diphtheria and as an aid in the control of bacterial diseases usually associated with shipping and handling of cattle.
Limitations. If no response within 2 to 3 days, reevaluate therapy; do not crush tablets; treated animals must not be slaughtered for food within 28 days after the latest treatment; Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Sponsor. See No. 061133 in § 510.600(c) of this chapter for use of a 32.1-gram sustained-release bolus.
Conditions of use—
Amount. 32.1 grams (1 bolus) per 200 pounds of body weight.
Indications for use. For beef and nonlactating dairy cattle for the treatment of diseases caused by sulfamethazine-sensitive organisms as follows: bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) caused by Pasteurella spp., colibacillosis (bacterial scours) caused by E. coli, necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum, and acute mastitis and acute metritis caused by Streptococcus spp.)
Limitations. 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 treat animals within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[Reserved]
Sponsor. See No. 061133 in § 510.600(c) of this chapter for use of an 8.02-gram sulfamethazine sustained-release bolus.
Conditions of use—
Amount. Administer 2 boluses (8.02 grams per bolus) per 100 pounds of body weight, as a single dose.
Indications for use. Administer orally to ruminating calves for the prolonged treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bacterial pneumonia (Pasteurella spp.), colibacillosis (bacterial scours) (E. coli), and calf diphtheria (Fusobacterium necrophorum).
Limitations. For use in ruminating replacement calves only. Do not slaughter animals for food for at least 12 days after the last dose. Exceeding two consecutive doses may cause violative tissue residue to remain beyond the withdrawal time. Do not use in calves under 1 month of age or calves being fed an all milk diet. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Sponsor. See No. 016592 in § 510.600(c) of this chapter for use of a 30-gram sulfamethazine sustained-release bolus.
Conditions of use—
Amount. Administer at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body weight, as a single dose.
Indications for use. Administer orally to beef cattle and nonlactating dairy cattle for the treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; bacterial pneumonia associated with Pasteurell spp.; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; acute mastitis and metritis caused by Streptococcus spp.
Limitations. For use in beef cattle and nonlactating dairy cattle only. Do not slaughter animals for food for at least 8 days after the last dose. Do not use in lactating dairy cattle. Do not administer more than two consecutive doses. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 85 FR 18119, Apr. 1, 2020; 86 FR 14819, Mar. 19, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 55564, Aug. 16, 2023]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 85 FR 18119, Apr. 1, 2020; 86 FR 14819, Mar. 19, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 55564, Aug. 16, 2023]