Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 522.246: Butorphanol.

(a) Specifications. Each milliliter of solution contains butorphanol (as butorphanol tartrate) in the following amounts:
(1) 0.5 milligrams (mg);
(2) 2 mg; or
(3) 10 mg
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section; for use of the product described in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use of the product described in paragraph (a)(3) as in paragraph (d)(3) of this section.
(2) Nos. 000061, 017033, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) 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—(i) Amount. Administer 0.025 mg per pound of body weight by subcutaneous injection at intervals of 6 to 12 hours, as required. If necessary, increase dose to a maximum of 0.05 mg per pound of body weight. Treatment should not normally be required for longer than 7 days.
(ii) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.
(2) Cats—(i) Amount. Administer 0.2 mg per pound of body weight by subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days.
(ii) Indications for use. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
(3) Horses—(i) Amount. Administer 0.05 mg per pound of body weight by intravenous injection. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.
(ii) Indications for use. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
(iii) Limitations. Do not use in horses intended for human consumption.

Where this section sits in the code

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

(a) Specifications. Each milliliter of solution contains butorphanol (as butorphanol tartrate) in the following amounts:

(1) 0.5 milligrams (mg);

(2) 2 mg; or

(3) 10 mg

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section; for use of the product described in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use of the product described in paragraph (a)(3) as in paragraph (d)(3) of this section.

(2) Nos. 000061, 017033, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section.

(d) Conditions of use—(1) Dogs—(i) Amount. Administer 0.025 mg per pound of body weight by subcutaneous injection at intervals of 6 to 12 hours, as required. If necessary, increase dose to a maximum of 0.05 mg per pound of body weight. Treatment should not normally be required for longer than 7 days.

(ii) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.

(2) Cats—(i) Amount. Administer 0.2 mg per pound of body weight by subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days.

(ii) Indications for use. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

(3) Horses—(i) Amount. Administer 0.05 mg per pound of body weight by intravenous injection. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.

(ii) Indications for use. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.

(iii) Limitations. Do not use in horses intended for human consumption.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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