21 CFR 522.1081 - Chorionic gonadotropin.

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There are 3 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1081 Chorionic gonadotropin.
(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) Nos. 000402 and 053501 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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

Title 21 published on 2014-04-01

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

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558