CFR - Code of Federal Regulations Title 21

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[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

Sec. 522.147 Atipamezole.

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

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

(c) Conditions of use in dogs - (1) Amount. Inject intramuscularly the same volume as that of dexmedetomidine or medetomidine used.

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