21 C.F.R. § 522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin suspension.
Title 21 - Food and Drugs
(a)(1) Specifications. Chorionic gonadotropin for injection is supplied in vials containing 5,000, 10,000 or 20,000 U.S.P. units of lyophilized powder for reconstitution with the accompanying sterile diluent to a 10 milliliter solution. (2) Sponsor. See sponsor numbers in §510.600(c) of this chapter, as follows: (i) Nos. 000402 and 053501 for use of 10,000 U.S.P. units intramuscularly, 2,500 to 5,000 U.S.P. units intravenously, and 500 to 2,500 U.S.P. units intrafollicularly in cattle. (ii) Nos. 058639 and 063323 for use of 10,000 U.S.P. units intramuscularly and 500 to 2,500 U.S.P. units intrafollicularly in cattle. (iii) No. 057926 for use of 10,000 U.S.P. units intramuscularly in cattle and finfish. (3) Related tolerances. See §556.304 of this chapter. (4) Conditions of use in cattle—(i) Amount. 10,000 USP units as a single, deep intramuscular injection; 500 to 2,500 USP units for intrafollicular injection; 2,500 to 5,000 USP units intravenously. (b) 500 to 2,500 U.S.P. units for intrafollicular injection. (c) 2,500 to 5,000 U.S.P. units intravenously. (ii) Indications for use. For parenteral use in cows for treatment of nymphomania (frequent or constant heat) due to cystic ovaries. (iii) Limitations. Dosage may be repeated in 14 days if the animal's behavior or rectal examination of the ovaries indicates the necessity for retreatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (5) Conditions of use in finfish—(i) Amount. 50 to 510 I.U. per pound of body weight for males, 67 to 1816 I.U. per pound of body weight for females, by intramuscular injection. (ii) Indications for use. An aid in improving spawning function in male and female brood finfish. (iii) Limitations. May administer up to three doses. The total dose administered per fish (all injections combined) should not exceed 25,000 I.U. chorionic gonadotropin (25 milliliters) in fish intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (b) [Reserved] [42 FR 58167, Nov. 8, 1977, as amended at 45 FR 81038, Dec. 9, 1980; 50 FR 41489, Oct. 11, 1985; 50 FR 45603, Nov. 1, 1985; 52 FR 25212, July 6, 1987; 56 FR 67175, Dec. 30, 1991; 56 FR 14642, Apr. 11, 1991; 63 FR 51822, Sept. 29, 1998; 64 FR 48544, Sept. 7, 1999; 66 FR 22117, May 3, 2001]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin suspension.
