[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.850]

[Page 237-238]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  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 Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. One implant and 2 milliliters of 
injection at time of implantation.

[[Page 238]]

    (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]