21 CFR 522.460 - Cloprostenol.
(a)Specifications. Each milliliter of solution contains cloprostenol sodium equivalent to:
(1) 125 micrograms (µg) of cloprostenol; or
(2) 250 µg of cloprostenol.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
(2) Nos. 000061 and 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii), (c)(1)(iii), and (c)(2) of this section.
(c)Conditions of use in cattle -
(1)Amount and indications for use - (i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4 1/2 months of gestation.
(ii) Administer 500 µg by intramuscular injection for terminating unwanted pregnancies from mismatings from 1 week after mating until 5 months after conception; for treating unobserved (nondetected) estrus, mummified fetus, and luteal cysts; and for the treatment of pyometra.
(iii) Administer 500 µg by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first, for scheduling estrus and ovulation to control the time at which cycling cows or heifers can be bred.
(2)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.