CFR > 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 (parts 500 to 590) > PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS > 522.460—Cloprostenol sodium.

522.460—Cloprostenol sodium.

(a) (1) Specifications. Each milliliter of the aqueous solution contains 263 micrograms of cloprostenol sodium (equivalent to 250 micrograms of cloprostenol) in a sodium citrate, anhydrous citric acid and sodium chloride buffer containing 0.1 percent w/v chlorocresol B.P. as a bactericide.
(2) Sponsor. See Nos. 000061 and 068504 in § 510.600(c) of this chapter.
(3) Conditions of use. For intramuscular use in beef and dairy cattle to induce luteolysis.
(i) Amount. 2 milliliters (equivalent to 500 micrograms of cloprostenol).
(ii) Indications. (a) For scheduling estrus and ovulation to control the time at which cycling cows or heifers can be bred.
(1) Single cloprostenol injection. Treat only animals with a mature corpus luteum. Estrus should occur in 2 to 5 days, and cattle should be inseminated at the usual time relative to the detection of estrus. If estrus is not observed, treated animals may be inseminated either once at 72 hours post injection or twice at 72 and 96 hours post injection.
(2) Double cloprostenol injection. Give cattle a second injection 11 days after the first injection. Estrus should occur 2 to 5 days after the second injection, and cattle should be inseminated at the usual time relative to the detection of estrus. If estrus is not observed, treated animals may be inseminated either once at about 72 hours post injection or twice at 72 and 96 hours following the second injection.
(b) Single cloprostenol injection for terminating unwanted pregnancies from mismatings from 1 week after mating until 5 months after conception, or for treating unobserved (nondetected) estrus, mummified fetus, and luteal cysts.
(c) Single cloprostenol injection for the treatment of pyometra.
(iii) Do not administer to pregnant animals where the calf is not to be aborted.
(iv) Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Cloprostenol is readily absorbed through the skin and may cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water.
(v) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b) (1) Specifications. Each milliliter of sterile aqueous solution contains 131.5 micrograms of cloprostenol sodium (equivalent to 125 micrograms of cloprostenol).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Special considerations. Labeling shall bear the statements prescribed in paragraphs (a)(3) (iii) and (iv) of this section.
(4) Conditions of use— (i) Amount. 3 milliliters (equivalent to 375 micrograms of cloprostenol) intramuscularly per animal as a single dose.
(ii) Indications for use. To induce abortion in pregnant feedlot heifers from 1 week after mating until 4 1/2 months of gestation.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[47 FR 4678, Feb. 2, 1982, as amended at 48 FR 15619, Apr. 12, 1983; 49 FR 5100, Feb. 10, 1984; 49 FR 29957, July 25, 1984; 65 FR 6892, Feb. 11, 2000; 69 FR 40766, July 7, 2004]