CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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: 21CFR522.1155]

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. 522.1155 Imidocarb powder for injection.

(a) Specifications. The product is a sterile powder containing imidocarb dipropionate. Each milliliter of constituted solution contains 100 milligrams (mg) of imidocarb base.

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

(c) Special considerations. Imidocarb dipropionate is sold only under permit issued by the Director of the National Program Planning Staff, Veterinary Services, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, to licensed or full-time State, Federal, or military veterinarians.

(d) Conditions of use in horses and zebras - (1) Amount. For Babesia caballi infections, administer 2 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage once after 24 hours. For Babesia equi infections, administer 4 mg of imidocarb base per kilogram of body weight by intramuscular injection in the neck region, repeating dosage four times at 72-hour intervals.

(2) Indications for use. For the treatment of babesiosis (piroplasmosis) caused by Babesia caballi and Babesia equi.

(3) 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.

[79 FR 16190, Mar. 25, 2014]