GroundRules
21 CFR 520.1720e: e Phenylbutazone powder.
Where this section sits in the code
- 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
(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. 086119 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.
Collected 2026-08-27T02:24:47Z. Source file · JSON