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: 21CFR520.23]

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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.23 Acepromazine.

(a) Specifications. Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate.

(b) Sponsors. See Nos. 000010 and 086117 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Dogs - (i) Amount. 0.25 to 1.0 mg per pound (/lb) body weight orally.

(ii) Indications for use. As an aid in tranquilization and as a preanesthetic agent.

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

(2) Cats - (i) Amount. 0.5 to 1.0 mg/lb body weight orally.

(ii) Indications for use. As a tranquilizer.

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

[75 FR 10165, Mar. 5, 2010, as amended at 88 FR 84699, Dec. 6, 2023]