(a) Specifications. Each vial contains 5,000, 10,000 or 20,000 USP units of lyophilized powder for constitution with accompanying diluent to a 10-milliliter solution.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of this section.

(2) [Reserved]

(3) No. 000061 for use as in paragraphs (d)(1)(i)(A) and (d)(2) of this section.

(c) Related tolerances. See §556.304 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. As a single dose. Dosage may be repeated in 14 days if the animal's behavior or examination of the ovaries per rectum indicates retreatment.

(A) 10,000 USP units by intramuscular injection.

(B) 500 to 2,500 USP units by intrafollicular injection.

(C) 2,500 to 5,000 USP units by intravenous injection.

(ii) Indications for use. For parenteral use in cows for treatment of nymphomania (frequent or constant heat) due to cystic ovaries.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Finfish—(i) Amount. 50 to 510 IU per pound of body weight for males, 67 to 1,816 IU per pound of body weight for females, by intramuscular injection. Up to three doses may be administered.

(ii) Indications for use. An aid in improving spawning function in male and female brood finfish.

(iii) Limitations. In fish intended for human consumption, the total dose administered per fish (all injections combined) should not exceed 25,000 IU chorionic gonadotropin. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[74 FR 61516, Nov. 25, 2009, as amended at 76 FR 17778, Mar. 31, 2011; 77 FR 55414, Sept. 10, 2012; 79 FR 16189, Mar. 25, 2014; 83 FR 13635, Mar. 30, 2018]