(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 Sec. 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. 000859 and 054628 for use of 100- or 200-mg or 1-g tablets in dogs and horses.
(3) Nos. 054771 and 061623 for use of 100-mg or 1-g tablets in dogs and horses.
(4) [Reserved]
(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--(i) Amount. 20 mg per pound of body weight daily.
(1) Dogs--(i) Amount. 20 mg per pound of body weight daily.
(i) Amount. 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.
(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. [73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014] Sec. 520.1720b Phenylbutazone granules.
(a) Specifications. Each package of granules contains 1 or 8 grams of phenylbutazone.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 000061 for 8-gram package.
(2) No. 059320 for 1-gram package.
(c) Conditions of use in horses--(1) Amount. Administer 1 to 2 grams per 500 pounds of body weight, not to exceed 4 grams, daily as required. by adding to a portion of the usual grain ration.
(1) Amount. Administer 1 to 2 grams per 500 pounds of body weight, not to exceed 4 grams, daily as required. by adding to a portion of the usual grain ration.
(2) Indications for use. For the treatment of inflammatory conditions associated with the musculoskeletal system.
(3) 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. [78 FR 28826, May 20, 2014] Sec. 520.1720c Phenylbutazone paste.
(a) Specifications--(1) Each gram of paste contains 0.2 grams phenylbutazone.
(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 Sec. 510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section.
(2) No. 017030 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.
(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. 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. [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; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 FR 74020, Dec. 15, 2014] Sec. 520.1720d Phenylbutazone gel.
(a) Specifications. Each 30 grams of gel contains 4 grams of phenylbutazone.
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter. require bioequivalency and safety information.
(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.
(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. 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. [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; 78 FR 28826, May 20, 2014] Sec. 520.1720e Phenylbutazone powder.
(a) Specifications--(1) Each 1.15 grams (g) of powder contains 1 g phenylbutazone.
(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 Sec. 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.
(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]