21 CFR 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, 000859, 055529, 057561, and 061623 for use as in paragraph (e) of this section.

(2) See No. 054771 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. Do not use in horses intended for human consumption.

(2)Cattle -

(i)Amounts and indications for use - (A) 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. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. 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) [Reserved]

(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; 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; 79 FR 16189, Mar. 25, 2014; 82 FR 43484, Sept. 18, 2017]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 20-Sep-2017 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2017-09-18; vol. 82 # 179 - Monday, September 18, 2017
    1. 82 FR 43482 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective September 18, 2017.
      21 CFR Parts 510, 520, 522, 524, and 558

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