21 CFR 522.2662 - Xylazine.

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There are 4 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.2662 Xylazine.
(a) Specifications. Each milliliter (mL) of solution contains xylazine hydrochloride equivalent to:
(1) 20 milligrams (mg) xylazine.
(2) 100 mg xylazine.
(3) 300 mg xylazine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.
(1) No. 000010 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(2) No. 000010 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section.
(3) Nos. 000859 and 061651 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1); and product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section.
(4) No. 061690 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section; and product described in paragraph (a)(3) of this section as in paragraphs (d)(3)(i), (d)(3)(ii)(B), and (d)(3)(iii) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use—
(1) Dogs and cats—
(i) Amount. 0.5 mg/pound (lb) intravenously or 1.0 mg/lb subcutaneously.
(ii) Indications for use. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.
(2) Horses—
(i) Amount. 0.5 mg/lb intravenously or 1.0 mg/lb intramuscularly.
(ii) Indications for use. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.
(iii) Limitations. Not for use in horses intended for food.
(3) Elk and deer—
(i) Amount. Administer intramuscularly, by hand syringe, or by syringe dart, in the heavy muscles of the croup or shoulder as follows:
(A) Elk (Cervus canadensis): 0.25 to 0.5 mg/lb.
(B) Mule deer (Odocoileus hemionus), sika deer (Cervus nippon), and white-tailed deer (Odocoileus virginianus): 1 to 2 mg/lb.
(C) Fallow deer (Dama dama): 2 to 4 mg/lb.
(ii) Indications for use.
(A) To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia.
(B) To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine.
(iii) Limitations. Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.
[68 FR 26206, May 15, 2003, as amended at 75 FR 10167, Mar. 5, 2010]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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

Title 21 published on 2014-04-01

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

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558