CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.1720d—Phenylbutazone gel.

520.1720d—Phenylbutazone gel.

(a) Specifications. Each 30 grams of gel contains 4 grams of phenylbutazone.
(b) Sponsor. See No. 061623 in § 510.600(c) of this chapter.
(c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in § 514.111 of this chapter, but may require bioequivalency and safety information.
(d) Conditions of use in horses— (1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily.
(2) Indications for use. For relief of inflammatory conditions associated with the musculoskeletal system of horses.
(3) Limitations. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level at the lowest level capable of producing the desired clinical response. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[50 FR 13561, Apr. 5, 1985, as amended at 50 FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]