21 CFR 522.1820 - Pituitary luteinizing hormone powder for injection.

§ 522.1820 Pituitary luteinizing hormone powder for injection.

(a)Specifications. The drug is a lyophilized pituitary extract. Each 6-milliliter vial contains an amount equivalent to 25 milligrams of standard pituitary luteinizing hormone and is reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous sodium chloride solution.

(b)Sponsor. No. 000061 in § 510.600(c) of this chapter.

(c)Conditions of use -

(1)Amount. Cattle and horses: 25 milligrams; swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0 milligram. Preferably given by intravenous injection, it may be administered subcutaneously. Treatment may be repeated in 1 to 4 weeks, or as indicated.

(2)Indications for use. As an aid in the treatment of breeding disorders related to pituitary hypofunction in cattle, horses, swine, sheep, and dogs.

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

[ 40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 16193, 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 10-May-2017 03:43

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

  • 2017-05-10; vol. 82 # 89 - Wednesday, May 10, 2017
    1. 82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correcting amendments.
      This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017.
      21 CFR Parts 510, 520, 522, 524, and 558