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Electronic Code of Federal Regulations

e-CFR data is current as of December 3, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1962


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


§522.1962   Promazine.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride.

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

(1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.

(2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section.

(c) Conditions of use—(1) Horses—(i) Amount. (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours.

(B) 0.2 to 0.5 mg/lb body weight intravenously as required.

(ii) Indications for use—(A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus.

(B) For use as a tranquilizer and preanesthetic.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs and cats—(i) Amount. 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours.

(ii) Indications for use. For use as a tranquilizer, preanesthetic, for minor operative procedures in conjunction with local anesthesia, as adjunctive therapy for tetanus, and as an antiemetic prior to worming; or to prevent motion sickness in dogs.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[46 FR 18962, Mar. 27, 1981, as amended at 68 FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974, Mar. 13, 2019]

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