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Code of Federal Regulations Title 21. Food and Drugs § 21.522.1680 Oxytocin

Current as of January 02, 2025 | Updated by Findlaw Staff

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

(b) 1 Sponsors. See Nos. 000856, and 061133 in § 510.600(c) of this chapter.

 1

 79 FR 16192 purported to amend subsection (b), but was without effect.

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.522.1680 Oxytocin - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-522-1680/

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