[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: 21CFR529.1940]

[Page 329-330]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  529.1940  Progesterone intravaginal inserts.

    (a) Specifications. Each insert contains 1.38 grams of progesterone 
in molded silicone over a nylon spine.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.540(a) of this chapter.
    (d) Special considerations. (1) Wear latex gloves when handling 
inserts. Store removed inserts in a plastic bag or other sealable 
container until they can be disposed in accordance with applicable 
local, State, and Federal regulations.
    (2) This product is approved with the concurrent use of dinoprost 
solution on day 6 of the 7-day administration period. See Sec.  
522.690(c) of this chapter.
    (e) Conditions of use--(1) Amount. Administer one intravaginal 
insert per animal for 7 days. Administer 25 milligrams (mg) dinoprost (5 
milliliters (mL) of 5 mg/mL solution as in Sec.  522.690(a) of this 
chapter) 1 day prior to insert removal.
    (2) Indications for use. For synchronization of estrus in suckled 
beef cows and replacement beef and dairy heifers, for advancement of 
first postpartum estrus in suckled beef cows, and for advancement of 
first pubertal estrus in replacement beef heifers.
    (3) Limitations. Do not use in animals with abnormal, immature, or 
infected genital tracts; or in beef cows that are fewer than 20 days 
postpartum; or in beef or dairy heifers of insufficient size or age for 
breeding; or in lactating dairy cows. Do not use an insert more than 
once. To prevent the potential transmission of venereal and bloodborne 
diseases, the inserts should be disposed after a single use. 
Administration of vaginal inserts for periods greater than 7 days may 
result in reduced fertility. Dinoprost solution as

[[Page 330]]

provided by No. 000009 in Sec.  510.600(c) of this chapter.

[67 FR 41824, June 20, 2002, as amended at 67 FR 51080, Aug. 7, 2002]