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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: 21CFR520.2200]



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. 520.2200 Sulfachlorpyridazine.

(a) Specifications. (1) Sodium sulfachlorpyridazine powder.

(2) Each bolus contains 2 grams sulfachlorpyridazine.

(3) Each tablet contains 250 milligrams (mg) sulfachlorpyridazine.

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

(c) Related tolerances. See § 556.630 of this chapter.

(d) Conditions of use. It is used as follows:

(1) Calves - (i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per pound (/lb) of body weight per day in milk or milk replacer, or in a bolus, in divided doses twice daily for 1 to 5 days.

(ii) Indications for use. For the treatment of diarrhea caused or complicated by Escherichia coli (colibacillosis).

(iii) Limitations. Treated ruminating calves must not be slaughtered for food during treatment or for 7 days after the last treatment. 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.

(2) Swine - (i) Amount. Administer 20 to 35 mg/lb body weight per day, in divided doses twice daily for 1 to 5 days:

(A) In drinking water or

(B) For individual treatment, in an oral suspension containing 50 mg per milliliter.

(ii) Indications for use. For the treatment of diarrhea caused or complicated by E. coli (colibacillosis).

(iii) Limitations. Treated swine must not be slaughtered for food during treatment or for 4 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Dogs - (i) Amount. Administer tablets orally at 500 mg per 10 to 15 lb of body weight daily, in two or three divided doses.

(ii) Indications for use. As an aid in the treatment of infectious tracheobronchitis and infections caused by E. coli , and in the treatment of infections caused by other Gram-positive and Gram-negative organisms that are susceptible to sulfonamide therapy.

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

[75 FR 10166, Mar. 5, 2010, as amended at 79 FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016]

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