[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.48]

[Page 95]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.48  Altrenogest solution.

    (a) Specifications. Each milliliter (mL) of solution contains 2.2 
milligrams (mg) altrenogest.
    (b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.36 of this chapter.
    (d) Conditions of use--(1)Horses--(i)Amount. 1.0 mL per 110 pounds 
body weight (0.044 mg/kg) daily for 15 consecutive days.
    (ii) Indications for use. For suppression of estrus in mares.
    (iii) Limitations. For oral use in horses only; avoid contact with 
the skin. Do not administer to horses intended for use as food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Swine--(i) Amount. Administer 6.8 mL (15 mg altrenogest) per 
gilt once daily for 14 consecutive days by top-dressing on a portion of 
each gilt's daily feed.
    (ii) Indications for use. For synchronization of estrus in sexually 
mature gilts that have had at least one estrous cycle.
    (iii) Limitations. Do not use in gilts having a previous or current 
history of uterine inflammation (i.e., acute, subacute or chronic 
endometritis). Gilts must not be slaughtered for human consumption for 
21 days after the last treatment.

[66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003]