CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.1870]

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

Sec. 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]