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e-CFR data is current as of August 6, 2020

Title 21Chapter ISubchapter EPart 522 → §522.1010


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1010   Furosemide.

(a) Specifications. (1) Each milliliter (mL) of solution contains 50 milligrams (mg) furosemide monoethanolamine.

(2) Each mL of solution contains 50 mg furosemide diethanolamine.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use of products described in paragraph (a) of this section for use as in paragraph (d) of this section.

(1) No. 000010 as described in paragraph (a)(1) of this section for use as in paragraphs (d)(1) and (d)(2)(ii) of this section.

(2) No. 061133 as described in paragraph (a)(2) of this section for use as in paragraph (d)(2)(ii) of this section.

(3) No. 000859 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.

(4) No. 000061 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Dogs and cats—(i) Amount. 1.25 to 2.5 mg per pound (/lb) body weight once or twice daily, intramuscularly or intravenously.

(ii) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

(2) Horses—(i) Amount. 250 to 500 mg per animal once or twice daily, intramuscularly or intravenously.

(A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema.

(B) Limitations. Do not use in horses intended for human consumption.

(ii) Amount. 0.5 mg/lb body weight once or twice daily, intramuscularly or intravenously.

(A) Indications for use. For treatment of acute noninflammatory tissue edema.

(B) Limitations. Do not use in horses intended for human consumption.

(iii) Amount. 250 to 500 mg/animal once or twice daily, intramuscularly or intravenously.

(A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema.

(B) Limitations. Do not use in horses intended for human consumption.

(3) Cattle—(i) Amount. 500 mg/animal once daily, intramuscularly or intravenously; or 250 mg/animal twice daily at 12-hour intervals, intramuscularly or intravenously.

(ii) Indications for use. For the treatment of physiological parturient edema of the mammary gland and associated structures.

(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours (four milkings) after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.

[66 FR 47961, Sept. 17, 2001, as amended at 67 FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR 17338, Mar. 29, 2011; 78 FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, 2014; 84 FR 8973, Mar. 13, 2019]

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