Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
§ 522.1870 - Praziquantel.

(a) Specifications. Each milliliter (mL) of solution contains 56.8 milligrams of praziquantel.

(b) Sponsors. See Nos. 058198 and 061133 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL.

(ii) Indications for use. For removal of canine cestodes Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and removal and control of canine cestode Echinococcus multilocularis.

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

(2) Cats—(i) Amount. Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum.

(ii) Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis.

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

[46 FR 10464, Feb. 3, 1981, as amended at 47 FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868, Mar. 25, 2013; 81 FR 67151, Sept. 30, 2016; 84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021]
authority: 21 U.S.C. 360b.
source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 522.1870