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: 21CFR522.2670]

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. 522.2670 Yohimbine.

(a) Specifications. Each milliliter (mL) of solution contains 2 or 5 milligrams (mg) of yohimbine (as hydrochloride).

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) No. 059399 for use of in 2 mg/mL solution as in paragraph (c)(1) of this section.

(2) No. 053923 for use of in 5 mg/mL solution as in paragraph (c)(2) of this section.

(c) Conditions of use - (1) Dogs - (i) Amount. Administer 0.05 mg per pound (0.11 mg per kilogram) of body weight by intravenous injection.

(ii) Indications for use. To reverse the effects of xylazine in dogs.

(iii) Limitations. Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Deer and elk - (i) Amount. Administer 0.2 to 0.3 mg per kilogram of body weight by intravenous injection.

(ii) Indications for use. A s an antagonist to xylazine sedation in free ranging or confined members of the family Cervidae (deer and elk).

(iii) Limitations. Do not use in domestic food-producing animals. Do not use for 30 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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