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Electronic Code of Federal Regulations

e-CFR data is current as of December 9, 2019

Title 21Chapter ISubchapter EPart 522 → §522.2662


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§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. 069043 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

(2) Nos. 000010 and 061133 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. 059399 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. Do not use in horses intended for human consumption.

(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, 78 FR 21060, Apr. 9, 2013; 79 FR 16198, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019]

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