21 CFR 522.1680 - Oxytocin.

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There are 4 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1680 Oxytocin.
(a) Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin.
(b) Sponsors. See Nos. , 000859, 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, as amended at 52 FR 18691, May 19, 1987; 52 FR 25212, July 6, 1987; 52 FR 36023, Sept. 25, 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 14642, Apr. 11, 1991, 56 FR 16002, Apr. 19, 1991; 59 FR 31139, June 17, 1994; 62 FR 35076, June 30, 1997; 62 FR 38906, July 21, 1997; 65 FR 45877, July 26, 2000; 66 FR 22117, May 3, 2001; 68 FR 36913, June 20, 2003; 77 FR 55414, Sept. 10, 2012; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 16192, Mar. 25, 2014]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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

Title 21 published on 2014-04-01

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

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558