CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.2260]

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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.2260 Sulfamethazine.

(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams (mg) sulfamethazine sodium.

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

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

(d) Conditions of use in cattle - (1) Amount. Initially administer 20 mL for each 50 pounds (lb) of body weight (100 mg/lb) by intravenous injection, followed by 20 mL per 100 lb of body weight (50 mg/lb) by intravenous injection, daily thereafter. Treatment should not exceed a total of 5 consecutive days.

(2) Indications for use. For cattle for 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 and acute metritis (Streptococcus spp.) when caused by one or more pathogenic organisms sensitive to sulfamethazine.

(3) Limitations. Withdraw medication from cattle 10 days prior to slaughter. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[46 FR 62055, Dec. 22, 1981, as amended at 67 FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5, 2010; 76 FR 53051, Aug. 25, 2011; 81 FR 17608, Mar. 30, 2016]