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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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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).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.814]



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. 522.814 Eprinomectin.

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

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 500.1410 and 556.227 of this chapter.

(d) Conditions of use in cattle on pasture - (1) Amount. Administer 1 mg/kilogram of body weight by subcutaneous injection.

(2) Indications for use. For the treatment and control of the following internal and external parasites: Gastrointestinal roundworms (adults and fourth-stage larvae) Bunostomum phlebotomum, Cooperia oncophora, C. punctata, C. surnabada, Trichostrongylus axei, Ostertagia ostertagi (including inhibited stage); (adults) Haemonchus placei, Oesophagostomum radiatum, O. lyrata, T. colubriformis; lungworms (adults) Dictyocaulus viviparus; cattle grubs Hypoderma bovis; mites Sarcoptes scabiei var. bovis. Prevents reinfection with C. oncophora, C. punctata, and T. axei for 100 days following treatment; H. placei, O. radiatum, O. lyrata, and O. ostertagi for 120 days following treatment; and B. phlebotomum and D. viviparus for 150 days following treatment.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Animals intended for human consumption must not be slaughtered within 48 days of the last treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.

[76 FR 72618, Nov. 25, 2011, as amended at 79 FR 37620, July 2, 2014; 84 FR 39184, Aug. 9, 2019]

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