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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Nov 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1010]



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

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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. 058198 as described in paragraph (a)(2) of this section 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; 86 FR 14820, Mar. 19, 2021]

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