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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.800


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


§522.800   Droperidol and fentanyl.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of droperidol and 0.4 mg of fentanyl citrate.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount.

(i) For analgesia and tranquilization, administer as follows:

(A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight; or

(B) 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight.

(ii) For general anesthesia, administer as follows:

(A) Administer 1 mL per 40 lbs of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed in 10 minutes by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight; or

(B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed within 15 seconds by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight.

(2) Indications for use. As an analgesic and tranquilizer and for general anesthesia.

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

[79 FR 16187, Mar. 25, 2014]

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