21 CFR 522.2670 - Yohimbine.

§ 522.2670 Yohimbine.
(a) Specifications. Each milliliter of solution contains either 2 or 5 milligrams of yohimbine (as hydrochloride).
(b) Sponsor. See 061690 in § 510.600(c) of this chapter for use of 2 milligrams per milliliter solution in dogs.
(1) Amount. 0.05 milligram per pound (0.11 milligram per kilogram) of body weight.
(2) Indications for use. To reverse the effects of xylazine in dogs.
(3) Limitations. For intravenous use in dogs only. Not for use in food-producing animals. Safety of use in pregnant dogs or in dogs intended for breeding has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c) Sponsor. See 053923 in § 510.600(c) of this chapter for use of 5 milligrams per milliliter solution in deer and elk.
(1) Amount. 0.2 to 0.3 milligram per kilogram of body weight.
(2) Indications for use. As an antagonist to xylazine sedation in free ranging or confined members of the family Cervidae (deer and elk).
(3) Limitations. For intravenous use only. 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.
[58 FR 8543, Feb. 16, 1993, as amended at 60 FR 57832, Nov. 22, 1995; 79 FR 16198, Mar. 25, 2014]
Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 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]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558