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: 21CFR522.147]

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. 522.147 Atipamezole.

(a) Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.

(b) Sponsors. See Nos. 015914, 052483, and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer 3,750 mcg/m ² intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m ² intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

(2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.

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

[61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019; 88 FR 84700, Dec. 6, 2023]