21 CFR 522.1222 - Ketamine.
(a)Specifications. Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams (mg) ketamine base activity.
(b)Sponsors. See Nos. 000859, 026637, 054628, 054771, 059399, and 063286 in § 510.600(c) of this chapter.
(c)Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)Conditions of use -
(i)Amount. 5 to 15 mg/pound body weight intramuscularly, depending on the effect desired.
(ii)Indications for use. For restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
(2)Subhuman primates -
(i)Amount. 3 to 15 mg/kilogram body weight intramuscularly, depending upon the species, general condition, and age of the subject.
(ii)Indications for use. For restraint.