21 CFR 522.995 - Fluprostenol sodium injection.

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There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.995 Fluprostenol sodium injection.
(a) Specifications. Each milliliter of sterile aqueous solution contains fluprostenol sodium equivalent to 50 micrograms of fluprostenol.
(b) Sponsor. See 000859 in § 510.600(c) of this chapter.
(c) Conditions of use—
(1) Amount. 0.55 microgram fluprostenol per kilogram of body weight.
(2) Indications for use. The drug is used in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum.
(3) Limitations. Administer by intramuscular injection only. Warning: Not for use in horses intended for food. For veterinary use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Fluprostenol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
[44 FR 52191, Sept. 7, 1979, as amended at 47 FR 22092, May 21, 1982]

Title 21 published on 2013-04-01

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

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  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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

Title 21 published on 2013-04-01

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

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522