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: 21CFR520.2260c]

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. 520.2260c Sulfamethazine sustained-release tablets.

(a) Specifications. Each extended-release tablet contains 8 grams sulfamethazine.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

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

(d) Conditions of use - (1) Amount. 8 grams (1 tablet) per 45 pounds of body weight as a single dose.

(2) Indications for use. In calves for sustained treatment of pneumonia caused by Pasteurella spp., colibacillosis (bacterial scours) caused by Escherichia coli; and calf diptheria caused by Fusobacterium necrophorum.

(3) Limitations. Treated animals must not be slaughtered for food within 18 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, 2014]