CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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: 21CFR520.1720e]

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. 520.1720e Phenylbutazone powder.

(a) Specifications. (1) Each 1.15 grams (g) of powder contains 1 g phenylbutazone.

(2) Each 10 g of powder contains 1 g phenylbutazone.

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

(1) No. 027053 for use of product described in paragraph (a)(1) of this section.

(2) No. 057699 for use of product described in paragraph (a)(2) of this section.

(c) Conditions of use in horses - (1) Amount. Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed, not exceed 4 g per animal daily.

(2) Indications for use. For the relief of inflammatory conditions associated with the musculosketetal system.

(3) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the extralabel use of this product in female cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 27956, May 18, 2007]