21 CFR 522.460 - Cloprostenol.

§ 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.

(b)Sponsors. See sponsors in § 510.600(c) of this chapter.

(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.

[ 79 FR 16185, Mar. 25, 2014]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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

Title 21 published on 19-May-2018 03:57

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

  • 2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018
    1. 83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 5, 2018.
      21 CFR Parts 510, 520, 522, 526, and 558


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