CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.460]

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

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.460 Cloprostenol.

(a) Specifications. Each milliliter of solution contains cloprostenol sodium equivalent to:

(1) 125 micrograms ([micro]g) of cloprostenol; or

(2) 250 [micro]g 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.

(3) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(iv) and (c)(2) of this section.

(c) Conditions of use in cattle - (1) Amount and indications for use. (i) Administer 375 [micro]g 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 [micro]g by intramuscular injection for abortion of unwanted pregnancies from mismatings from 1 week after mating until 5 months after conception; for unobserved (non-detected) estrus; for treatment of mummified fetus, luteal cysts, and pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(iii) Administer 500 [micro]g by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers.

(iv) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 86 [micro]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 [micro]g gonadorelin by intramuscular injection.

(2) Limitations. Gonadorelin acetate for use in paragraph (c)(1)(iv) of this section as provided by No. 000061 in § 510.600(c) of this chapter.

[79 FR 16185, Mar. 25, 2014, as amended at 85 FR 4208, Jan. 24, 2020]