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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 Mar 22, 2024.

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: 21CFR522.1680]



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. 522.1680 Oxytocin.

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

(b) Sponsors. See Nos. 054771 and 061133 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
Cats0.25 to 0.55 to 10.
Dogs0.25 to 1.55 to 30.
Ewes, Sows1.5 to 2.530 to 50.
Cows, Horses5.0100.

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

mL U.S.P. units
Cows0.5 to 1.010 to 20.
Sows0.25 to 1.05 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.govinfo.gov.

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