21 CFR 522.1680 - Oxytocin.

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§ 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.

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558