21 CFR 522.1680 - Oxytocin.

§ 522.1680 Oxytocin.

(a)Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin.

(b)Sponsors. See Nos. 054628, 054771 and 061623 in § 510.600(c) of this chapter.

(c)Conditions of use -

(1)Amount -

(i)Obstetrical. Administer drug intravenously, intramuscularly, or subcutaneously under aseptic conditions as indicated. The following dosages are recommended and may be repeated as conditions require:

mL U.S.P. units
Cats 0.25 to 0.5 5 to 10.
Dogs 0.25 to 1.5 5 to 30.
Ewes, Sows 1.5 to 2.5 30 to 50.
Cows, Horses 5.0 100.

(ii)Milk letdown. Intravenous administration is desirable. The following dosage is recommended and may be repeated as conditions require:

mL U.S.P. units
Cows 0.5 to 1.0 10 to 20.
Sows 0.25 to 1.0 5 to 20.

(2)Indications for use. Oxytocin may be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state.

(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980]
Editorial Note:
For Federal Register citations affecting § 522.1680, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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
The section you are viewing is cited by the following CFR sections.