[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: 21CFR522.246]

[Page 223-224]
 
                        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.  522.246  Butorphanol tartrate injection.

    (a) Specifications. Each milliliter of aqueous solution contains 
either 0.5, 2 or 10 milligrams of butorphanol (as butorphanol tartrate).
    (b) Sponsors. Approval to firms identified in Sec.  510.600(c) of 
this chapter for use as indicated:
    (1) See No. 057926 for use as in paragraph (c)(2) of this section.
    (2) See No. 000856 for use as in paragraphs (c)(1), (c)(2), and 
(c)(3) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.025 milligram of 
butorphanol base activity per pound of body weight (equivalent to 0.5 
milliliter per 10 pounds), using 0.5 milligram per milliliter solution.
    (ii) Indications for use. For the relief of chronic nonproductive 
cough associated with tracheo-bronchitis, tracheitis, tonsillitis, 
laryngitis, and pharyngitis associated with inflammatory conditions of 
the upper respiratory tract.

[[Page 224]]

    (iii) Limitations. For subcutaneous injection in dogs only. Repeat 
at intervals of 6 to 12 hours as required. If necessary, increase dose 
to maximum of 0.05 milligram per pound of body weight. Treatment should 
not normally be required for longer than 7 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (2) Horses--(i) Amount. 0.05 milligram of butorphanol base activity 
per pound of body weight (0.1 milligram/kilogram) using 10 milligrams 
per milliliter solution.
    (ii) Indications for use. For the relief of pain associated with 
colic and postpartum pain in adult horses and yearlings.
    (iii) Limitations. For intravenous use in horses only. Dose may be 
repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not 
for use in horses intended for food. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (3) Cats--(i) Amount. 0.2 milligram of butorphanol base activity per 
pound of body weight (0.4 milligram/kilogram), using 2 milligrams per 
milliliter solution.
    (ii) Indications for use. For the relief of pain in cats caused by 
major or minor trauma, or pain associated with surgical procedures.
    (iii) Limitations. For subcutaneous injection in cats only. Dose may 
be repeated up to 4 times per day. Do not treat for more than 2 days. 
Safety for use in pregnant female cats, breeding male cats or kittens 
less than 4 months of age has not been determined. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 29276, May 2, 1980, as amended at 50 FR 24508, June 11, 1985; 53 
FR 27851, July 25, 1988; 59 FR 41665, Aug. 15, 1994; 63 FR 66432, Dec. 
2, 1998]