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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: 21CFR520.2260a]



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. 520.2260a Sulfamethazine oblet, tablet, and bolus.

(a)(1) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use of 2.5-, 5-, and 15-gram sulfamethazine oblet in beef cattle, nonlactating dairy cattle, and horses. See No. 061690 in § 510.600(c) of this chapter for use of 5-, 15-, and 25-gram tablet in beef and nonlactating dairy cattle.

(2) Related tolerance in edible products. See § 556.670 of this chapter.

(3) Conditions of use - (i) Amount. Administer as a single dose 100 milligrams of sulfamethazine per pound of body weight the first day and 50 milligrams per pound of body weight on each following day.

(ii) Indications for use. For treatment of diseases caused by organisms susceptible to sulfamethazine.

(A) Beef cattle 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.), acute metritis (Streptococcus spp.), coccidiosis (Eimeria bovis and Eimeria zurnii ).

(B) Horses. Treatment of bacterial pneumonia (secondary infections associated with Pasteurella spp.), strangles (Streptococcus equi ), and bacterial enteritis (Escherichia coli ).

(iii) Limitations. Administer daily until animal's temperature and appearance are normal. If symptoms persist after using for 2 or 3 days consult a veterinarian. Fluid intake must be adequate. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed 5 consecutive days. Follow dosages carefully. Do not treat cattle within 10 days of slaughter. 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. Do not use in horses intended for human consumption.

(b)(1) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of 5-gram sulfamethazine bolus.

(2) Related tolerances in edible products. See § 556.670 of this chapter.

(3) Conditions of use - (i) Amount. Administer 10 grams (2 boluses) of sulfamethazine per 100 pounds of body weight the first day, then 5 grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily for up to 4 additional consecutive days.

(ii) Indications for use. Ruminating beef and dairy calves. For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacilloosis) caused by E. coli ; necrotic pododermatitis (foot rot) and calf diphtheria caused by F. necrophorum ; bacterial pneumonia associated with Pasteurella spp.; and coccidiosis caused by E. bovis and E. zurnii.

(iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Administer with adequate supervision. Follows recomended dosages carefully. Fluid intake must be adequate. If symptoms persist after 2 or 3 days, consult a veterinarian.

[54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 28830, May 20, 2014; 81 FR 17607, Mar. 30, 2016]

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