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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
520.1720c - Phenylbutazone paste.
(a) Specifications(1) Each gram of paste contains 0.2 grams phenylbutazone.
(2) Each gram of paste contains 0.35 grams phenylbutazone.
(b) Sponsors. See sponsor numbers in 510.600(c) of this chapter.
(1) Nos. 000061 and 010797 for use of product described in paragraph (a)(1) of this section.
(2) No. 064847 for use of product described in paragraph (a)(2) of this section.
(c) 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.
(3) Limitations. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level of 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.
[45 FR 84762, Dec. 23, 1980, as amended at 58 FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, July 25, 2003]
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