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: 21CFR522.1335]

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. 522.1335 Medetomidine.

(a) Specifications. Each milliliter of solution contains 1.0 milligrams of medetomidine hydrochloride.

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

(c) Conditions of use - (1) Amount. 750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface. The IV route is more efficacious for dental care.

(2) Indications for use. As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care.

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

[61 FR 21075, May 9, 1996, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, 2017]