21 CFR 522.850 - Estradiol valerate and norgestomet in combination.

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§ 522.850 Estradiol valerate and norgestomet in combination.
(a) Specifications. The product is a two-component drug consisting of the following:
(1) An implant containing 6.0 milligrams of norgestomet.
(2) An injectable solution (sesame oil) containing 3.0 milligrams of norgestomet and 5.0 milligrams of estradiol valerate per 2 milliliters.
(b) Sponsor. See 050604 in § 510.600(c) of this chapter.
(c) Conditions of use—
(1) Amount. One implant and 2 milliliters of injection at time of implantation.
(2) Indications for use. For synchronization of estrus/ovulation in cycling beef cattle and non-lactating dairy heifers.
(3) Limitations. Insert implant subcutaneously in the ear only; then immediately inject solution intramuscularly only. Counting the day of implantation as day 1, remove the implant on day 10. Collect all implants as they are removed and burn them. While animals are restrained for artificial insemination, avoid other treatments such as vaccinations, dipping, pour-on grub and louse prevention, spraying, etc. When inseminating without estrus detection, the entire treated group should be started at 48 hours after the last implant has been removed and should be completed within 6 hours. Where estrus detection is preferred, insemination should be approximately 12 hours after first detection of estrus. Those that do not conceive can be re-bred when they return to estrus approximately 17 to 25 days after implant removal. Do not use in cows producing milk for human consumption.
[47 FR 55477, Dec. 10, 1982, as amended at 48 FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22, 1986; 54 FR 1165, Jan. 12, 1989]

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.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, 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.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558