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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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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2220a]



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. 520.2220a Sulfadimethoxine oral solution and soluble powder.

(a) Specifications. (1) Each ounce of solution contains 3.75 grams (12.5 percent) sulfadimethoxine.

(2) Each 107 grams of powder contains the equivalent of 94.6 grams sulfadimethoxine as sulfadimethoxine sodium.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:

(1) Nos. 016592, 054771, 054925, and 069043 for use of the product described in paragraph (a)(1) of this section.

(2) Nos. 016592, 054771, 054925, 058829, 061133, and 066104 for use of the product described in paragraph (a)(2) of this section.

(c) Related tolerances. See § 556.640 of this chapter.

(d) Conditions of use - (1) Broiler and replacement chickens - (i) Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

(ii) Indications for use. For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.

(iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Turkeys - (i) Amount. Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

(ii) Indications for use. Growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.

(iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Cattle - (i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

(ii) Indications for use. Dairy calves, dairy heifers, and beef cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus ) sensitive to sulfadimethoxine.

(iii) Limitations. Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

[79 FR 28829, May 20, 2014, as amended at 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019]

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