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: 21CFR522.2474]

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. 522.2474 Tolazoline.

(a) Specifications. Each milliliter of solution contains tolazoline hydrochloride equivalent to 100 milligrams (mg) of base activity.

(b) Sponsor. See No. 059399 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount. Administer slowly by intravenous injection 4 mg per kilogram of body weight or 1.8 mg per pound (4 milliliters (mL) per 100 kilograms or 4 mL per 220 pounds).

(2) Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014, as amended at 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015]