21 CFR 522.558 - Dexmedetomidine.

§ 522.558 Dexmedetomidine.

(a)Specifications. Each milliliter of solution contains:

(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or

(2) 0.5 mg dexmedetomidine hydrochloride.

(b)Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 026637 for use of product described in paragraph (a)(2) of this section;

(2) No. 052483 for use of products described in paragraph (a) of this section.

(c)Conditions of use -

(1)Dogs -

(i)Indications for use and amount. (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m 2) of body surface area by intravenous injection or 500 µg/m 2 of body surface area by intramuscular injection.

(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m 2 of body surface area or 375 µg/m 2 of body surface area by intramuscular injection.

(ii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2)Cats -

(i)Amount. 40 µg/killogram by intramuscular injection.

(ii)Indications for use. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, Mar. 13, 2015]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 21 - FOOD AND DRUGS