CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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: 21CFR522.995]

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. 522.995 Fluprostenol.

(a) Specifications. Each milliliter of solution contains fluprostenol sodium equivalent to 50 micrograms ([micro]g) of fluprostenol.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount. Administer 0.55 [micro]g fluprostenol per kilogram of body weight by intramuscular injection.

(2) Indications for use. For use in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021]