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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.

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2260b]



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. 520.2260b Sulfamethazine sustained-release boluses.

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

(b) 22.5-gram bolus - (1) Sponsor. See No. 058198 in § 510.600(c) of this chapter for use of a 22.5-gram sulfamethazine prolonged-release bolus.

(2) Conditions of use - (i) Amount. Depending on the duration of therapeutic levels desired, administer boluses as a single dose as follows: 3 1/2 days - 1 bolus (22.5 grams) per 200 pounds of body weight; 5 days - 1 bolus per 100 pounds of body weight.

(ii) Indications for use. Beef and nonlactating cattle for sustained treatment of shipping fever pneumonia caused or complicated by Pasteurella multocida; as an aid in the treatment of foot rot, mastitis, pneumonia, metritis, bacterial enteritis, calf diphtheria, and septicemia when caused or complicated by bacteria susceptible to sulfamethazine.

(iii) Limitations. Cattle that are acutely ill should be treated parenterally with a suitable antibacterial product to obtain immediate therapeutic blood levels; do not slaughter animals for food within 16 days of treatment; do not use in lactating dairy cattle; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(c)(1) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of a 27-gram sulfamethazine sustained-release bolus.

(2) Conditions of use - (i) Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose.

(ii) 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.

(iii) 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.

(d)(1) Sponsor. See No. 061133 in § 510.600(c) of this chapter for use of a 32.1-gram sustained-release bolus.

(2) Conditions of use - (i) Amount. 32.1 grams (1 bolus) per 200 pounds of body weight.

(ii) 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.)

(iii) Limitations. After 72 hours, all animals should be reexamined for persistence of observable disease signs. If signs are present, consult a veterinarian. It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy, particularly in more severe cases. The dosage schedule should be used at each 72-hour interval. Animals should not receive more than 2 doses because of the possibility of incurring residue violations. This drug, like all sulfonamides, may cause toxic reactions and irreparable injury unless administered with adequate and continuous supervision; follow dosages carefully. Fluid intake must be adequate at all times throughout the 3-day therapy, 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.

(e) 22.5-gram bolus - (1) Sponsor. See No. 058198 in § 510.600(c) of this chapter for use of a 22.5-gram sulfamethazine sustained release bolus.

(2) Conditions of use - (i) Amount. Administer 1 bolus (22.5 grams) per 200 pounds of body weight, as a single dose.

(ii) Indications for use. Beef and nonlactating dairy cattle for the prolonged 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) (Pasteurella spp.), bacterial pneumonia (Pasteurella spp.), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum ), colibacillosis (bacterial scours) (Escherichia coli ), calf diphtheria (Fusobacterium necrophorum ), acute mastitis (Streptococcus spp.) and acute metritis (Streptococcus spp.).

(iii) Limitations. Cattle that are acutely ill should be treated by injection with a suitable antibacterial product to obtain immediate therapeutic blood levels; do not slaughter animals for food within 16 days of treatment; do not use in lactating dairy cattle; if treated animals do not respond within 2 to 3 days, consult a veterinarian.

(f)(1) Sponsor. See No. 061133 in § 510.600(c) of this chapter for use of an 8.02-gram sulfamethazine sustained-release bolus.

(2) Conditions of use - (i) Amount. Administer 2 boluses (8.02 grams per bolus) per 100 pounds of body weight, as a single dose.

(ii) 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 diptheria (Fusobacterium necrophorum ).

(iii) Limitations. For use in ruminating replacement calves only; 72 hours after dosing all animals should be reexamined for persistence of disease signs; if signs are present, consult a veterinarian; do not slaughter animals for food for at least 12 days after the last dose; this product has not been shown to be effective for nonruminating calves; 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.

(g)(1) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use of a 30-gram sulfamethazine sustained-release bolus.

(2) Conditions of use - (i) Amount. Administer at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body weight, as a single dose.

(ii) 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.

(iii) Limitations. For use in beef cattle and nonlactating dairy cattle only; if symptoms persist for 2 or 3 days after use, consult a veterinarian; 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.

(h)(1) Sponsor. See No. 000010 in § 510.600(c) of this chapter for use of an 8.25-gram sulfamethazine sustained-release bolus.

(2) Conditions of use - (i) Amount. Administer at the rate of 1 bolus (8.25 grams per bolus) per 50 pounds of body weight, as a single dose. If signs of disease are significantly reduced, it is recommended that a second dose be given to provide an additional 72 hours of therapy.

(ii) Indications for use. Administer orally to ruminating beef and dairy calves for treatment of the following diseases when caused by one or more of the listed pathogenic organisms susceptible to sulfamethazine: bacterial pneumonia associated with Pasteurella spp.; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; and calf diphtheria caused by Fusobacterium necrophorum.

(iii) Limitations. Do not use in calves to be slaughtered under 1 month of age or calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older. If symptoms persist after 3 days, consult a veterinarian. Do not administer more than 2 consecutive doses. Do not slaughter animals for food for at least 8 days after the last dose. Do not crush bolus.

[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]

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