[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: 21CFR529.1186]

[Page 328-329]
 
                        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.  529.1186  Isoflurane.

    (a) Specifications. The drug is a clear, colorless, stable liquid 
containing no additives or chemical stabilizers. It is nonflammable and 
nonexplosive.
    (b) Sponsors. See Nos. 000074, 000209, 010019, 012164, 059258, and 
060307 in Sec.  510.600(c) of this chapter.

[[Page 329]]

    (c) Conditions of use--(1) Amount--(i) Horses: For induction of 
surgical anesthesia: 3 to 5 percent isoflurane (with oxygen) for 5 to 10 
minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent 
isoflurane (with oxygen).
    (ii) Dogs: For induction of surgical anesthesia: 2 to 2.5 percent 
isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of 
surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
    (2) Indications for use. For induction and maintenance of general 
anesthesia in horses and dogs.
    (3) Limitations. Administer by inhalation; not for use in horses or 
dogs sensitive to halogenated agents; increasing depth of anesthesia may 
increase hypotension and respiratory depression; use less than usual 
amounts of nondepolarizing relaxants; use with vaporizers producing 
predictable percentage concentrations; not for use in horses intended 
for food; Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 
17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 
1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, 
Apr. 2, 2001]