[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: 21CFR522.690]

[Page 233-234]
 
                        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.  522.690  Dinoprost solution.

    (a) Specifications. Each milliliter (mL) of solution contains 
dinoprost tromethamine equivalent to 5 milligrams (mg) dinoprost.
    (b) Sponsors. See Nos. 000009 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Special considerations. (1) Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) Women of child-bearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. Dinoprost tromethamine is readily absorbed 
through the skin and can cause abortion and bronchiospasms. Accidental 
spillage on the skin should be washed off immediately with soap and 
water.
    (d) Conditions of use--(1) Horses--(i) Amount. 1 mg per 100 pounds 
of body weight as a single intramuscular injection.
    (ii) Indications. For its luteolytic effect to control timing of 
estrus in estrus cycling mares and in clinically anestrous mares that 
have a corpus luteum.
    (iii) Limitations. Not for use in horses intended for food.
    (2) Cattle--(i) Beef cattle and nonlactating dairy heifers--(A) 
Amount. 25 mg as an intramuscular injection either once or twice at a 
10- to 12-day interval.
    (B) Indications. For its luteolytic effect to control timing of 
estrus and ovulation in estrous cycling cattle that have a corpus 
luteum.
    (ii) Beef cattle and nonlactating dairy heifers--(A) Amount. 25 mg 
as a single intramuscular injection.
    (B) Indications. For treatment of pyometra (chronic endometritis).
    (iii) Nonlactating cattle--(A) Amount. 25 mg as a single 
intramuscular injection during the first 100 days of gestation.
    (B) Indications. For its abortifacient effect in nonlactating 
cattle.
    (iv) Lactating dairy cattle--(A) Amount. 25 mg as a single 
intramuscular injection.
    (B) Indications. For treatment of unobserved (silent) estrus in 
lactating dairy cattle that have a corpus luteum.
    (v) Dinoprost solution as provided by No. 000009 in Sec.  510.600(c) 
of this chapter may be used concurrently with progesterone intravaginal 
inserts as in Sec.  529.1940 of this chapter.
    (3) Swine--(i) Amount. 10 mg as a single intramuscular injection.

[[Page 234]]

    (ii) Indications. For parturition induction in swine when injected 
within 3 days of normal predicted farrowing.

[67 FR 41824, June 20, 2002]