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 > 520.1720a—Phenylbutazone tablets and boluses.

520.1720a—Phenylbutazone tablets and boluses.

(a) Specifications. Each tablet contains 100, 200, or 400 milligrams (mg), or 1 gram (g) of phenylbutazone. Each bolus contains 1, 2, or 4 gram g of phenylbutazone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter, as follows:
(1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses.
(2) Nos. 000010 and 059130 for use of 100- or 200-mg or 1-g tablets in dogs and horses.
(3) Nos. 000856 and 061623 for use of 100-mg or 1-g tablets in dogs and horses.
(4) No. 055246 for use of 100-mg tablets in dogs.
(5) No. 000143 for use of 1-g tablets in horses.
(6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
(c) Conditions of use— (1) Dogs— 20 mg per pound of body weight daily.
(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses— (i) Amount. 1 to 2 g per 500 pounds of body weight daily.
(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011]

Code of Federal Regulations

Effective Date Note: At 76 FR 17777, Mar. 31, 2011, § 520.1720a was amended by removing and reserving paragraph (b)(4), effective April 11, 2011.