Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 529.1186 - Isoflurane.

(a) Specifications. The drug is a clear, colorless, stable liquid.

(b) Sponsors. See Nos. 017033, 054771, and 065085 in § 510.600(c) of this chapter.

(c) Conditions of use. Administer by inhalation:

(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. Do not use in horses intended for human consumption. 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; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015; 87 FR 58963, Sept. 29, 2022; 89 FR 14411, Feb. 27, 2024; 89 FR 42360, May 15, 2024]
authority: 21 U.S.C. 360b.
source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 529.1186