[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.460]

[Page 227]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  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 No. 000061 in Sec.  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 Sec.  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.

[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]