21 C.F.R. § 522.970 Flunixin.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of solution contains flunixin meglumine equivalent to 50 milligrams (mg) flunixin. (b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section. (1) See No. 000061 for use as in paragraph (e) of this section. (2) See Nos. 055529, 057561, 059130, and 061623 for use as in paragraphs (e)(1), (e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii), of this section. (3) See No. 000856 for use as in paragraph (e)(1) of this section. (c) Related tolerances. See §556.286 of this chapter. (d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) Conditions of use—(1) Horses—(i) Amount. 0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days. (ii) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. (iii) Limitations. Not for use in horses intended for food. (2) Cattle—(i) Amount. (A) 1.1 to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into two doses administered at 12-hour intervals, intravenously, for up to 3 days. (B) 2.2 mg/kg (1.0 mg/lb) of body weight given once by intravenous administration. (ii) Indications for use. (A) For control of pyrexia associated with bovine respiratory disease and endotoxemia. Also indicated for control of inflammation in endotoxemia. (B) For control of pyrexia associated with acute bovine mastitis. (iii) Limitations. Do not slaughter for food use within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. For Nos. 000061, 055529, 059130, and 061623: Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. For No. 057561: Not for use in lactating or dry dairy cows. (3) Swine—(i) Amount. Administer 2.2 mg/kg (1.0 mg/lb) of body weight as a single intramuscular injection. (ii) Indications for use. For the control of pyrexia associated with swine respiratory disease. (iii) Limitations. Swine must not be slaughtered for human consumption within 12 days of last treatment. [42 FR 39103, Aug. 2, 1977, as amended at 52 FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.970 Flunixin.
