CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.558]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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) Nos. 017033, 068504, 069043, and 086117 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 ([micro]g) per square meter (/m ²) of body surface area by intravenous injection or 500 [micro]g/m ² of body surface area by intramuscular injection.

(B) For use as a preanesthetic to general anesthesia, administer 125 [micro]g/m ² of body surface area or 375 [micro]g/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 [micro]g/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; 86 FR 57997, Oct. 20, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 27699, May 3, 2023; 88 FR 84701, Dec. 6, 2023]