[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR529.1044a]

[Page 327-328]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  529.1044a  Gentamicin sulfate intrauterine solution.

    (a) Specifications. Each milliliter of the drug contains 50 or 100 
milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
    (b) Sponsor. See Nos. 000010, 000061, 000856, 000864, 057561, and 
059130 in Sec.  510.600(c) of this chapter.

[[Page 328]]

    (c) Conditions of use. (1) The drug is indicated for use for control 
of bacterial infections of the uterus in horses (metritis) and as an aid 
in improving conception in mares with uterine infections caused by 
bacteria sensitive to gentamicin.
    (2) It is administered at a dosage level of 2 to 2.5 grams per day 
for 3 to 5 days during estrus, each dose being diluted with 200 to 500 
milliliters of sterile physiological saline before aseptic infusion into 
the uterus.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (4) Not for use in horses intended for food.

[40 FR 13881, Mar. 27, 1975, as amended at 40 FR 48676, Oct. 17, 1975; 
48 FR 31386, July 8, 1983; 52 FR 7833, Mar. 13, 1987; 58 FR 14314, Mar. 
17, 1993; 59 FR 31140, June 17, 1994; 60 FR 45042, Aug. 30, 1995; 60 FR 
48894, Sept. 21, 1995; 61 FR 17830, Apr. 23, 1996; 62 FR 611, Jan. 6, 
1997; 62 FR 35077, June 30, 1997; 63 FR 6644, Feb. 10, 1998]