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 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS > 522.970—Flunixin.

522.970—Flunixin.

(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 Nos. 000061, 055529, and 061623 for use as in paragraph (e) of this section.
(2) See No. 000856 for use as in paragraph (e)(1) of this section.
(3) See Nos. 057561 and 059130 for use as in paragraphs (e)(1) and (2) 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— 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. Do not use in horses intended for human consumption.
(2) Cattle— (i) Amounts and indications for use— Administer 1.1 to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day intravenously, as a single dose or divided into two doses administered at 12-hour intervals, for up to 3 days for control of pyrexia associated with bovine respiratory disease and endotoxemia or for control of inflammation in endotoxemia.
(B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once intravenously for control of pyrexia associated with acute bovine mastitis.
(ii) Limitations. Cattle must not be slaughtered for human consumption within 4 days of last treatment. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Do not use in dry dairy cows. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal.
(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.

Code of Federal Regulations

[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; 73 FR 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, Dec. 8, 2010]