21 CFR § 520.1720e - Phenylbutazone powder.

§ 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]