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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: 21CFR520.2325a]



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. 520.2325a Sulfaquinoxaline powder and solution.

(a) Sponsor. See § 510.600(c) of this chapter for identification of the sponsors.

(1) To No. 016592 for use of a 25-percent sulfaquinoxaline soluble powder and a 20-percent sulfaquinoxaline sodium solution as provided for in paragraph (c) of this section.

(2) To Nos. 016592 and 054771 for use of a 31.92-percent sulfaquinoxaline solution (sodium and potassium salts) as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.

(3) No. 054771 for use of a 28.62-percent sulfaquinoxaline sodium solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this section.

(b) Related tolerances. See § 556.685 of this chapter.

(c) Conditions of use. It is used in drinking water as follows:

(1) Chickens. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti.

(ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for 2 more days. If bloody droppings appear, repeat treatment at the 0.025 percent level for 2 more days. Do not change litter unless absolutely necessary. Do not give flushing mashes.

(2) Turkeys. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.

(ii) Administer at the 0.025 percent level for 2 days, skip 3 days, give for 2 days, skip 3 days and give for 2 more days. Repeat if necessary. Do not change litter unless absolutely necessary. Do not give flushing mashes.

(3) Chickens and turkeys. (i) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline.

(ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat treatment. If cholera has become established as the respiratory or chronic form, use feed medicated with sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not be kept for laying house replacements or breeders unless tests show they are not carriers.

(4) Cattle and calves. (i) For the control and treatment of outbreaks of coccidiosis caused by Eimeria bovis or E. zurnii.

(ii) Administer at the 0.015-percent level for 3 to 5 days in drinking water medicated with sulfaquinoxaline solution.

(iii) In lieu of treatment as provided in paragraph (e)(4)(ii) of this section, administer 1 teaspoon of 25-percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water.

(d) Limitations. May cause toxic reactions unless the drug is evenly mixed in water at dosages indicated and used according to directions. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Medicated chickens, turkeys, cattle, and calves must actually consume enough medicated water which provides a recommended dosage of approximately 10 to 45 milligrams per pound per day in chickens, 3.5 to 55 milligrams per pound per day in turkeys, and approximately 6 milligrams per pound per day in cattle and calves depending on the age, class of animal, ambient temperature, and other factors. A withdrawal period has not been established for sulfaquinoxaline in preruminating calves. Do not use in calves to be processed for veal. Not for use in lactating dairy cattle. Do not give to chickens, turkeys or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Make fresh drinking water daily. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR 28831, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 94990, Dec. 27, 2016]

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