21 CFR 522.1083 - Gonadotropin releasing factor analog-diphtheria toxoid conjugate.

§ 522.1083 Gonadotropin releasing factor analog-diphtheria toxoid conjugate.

(a)Specifications. Each milliliter of solution contains 0.2 milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid conjugate.

(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c)Conditions of use in swine -

(1)Amount. Administer 0.4 mg (2 milliliter (mL)) by subcutaneous injection no earlier than 9 weeks of age. A second subcutaneous injection of 0.4 mg (2 mL) should be administered at least 4 weeks after the first dose.

(2)Indications for use. For the temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.

(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Pigs should be slaughtered no earlier than 3 weeks and no later than 10 weeks after the second dose.

[ 76 FR 27889, May 13, 2011, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, 2014]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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

Title 21 published on 09-Jun-2018 03:51

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

  • 2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018
    1. 83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 5, 2018.
      21 CFR Parts 510, 520, 522, 526, and 558