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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2014]
[CITE: 21CFR522.2680]



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. 522.2680 Zeranol.

(a) Specifications. Each pellet contains 12, 18, or 20 milligrams (mg) zeranol.

(b) Sponsor. See 000061 in 510.600(c) of this chapter.

(c) Related tolerances. See 556.760 of this chapter.

(d) Conditions of use --(1) Beef cattle --(i) Amount. 36 mg zeranol (one implant consisting of 3 pellets, each pellet containing 12 mg zeranol) per implant dose.

(ii) Indications for use --(A) For increased rate of weight gain and improved feed conversion in weaned beef calves, growing beef cattle, feedlot steers, and feedlot heifers.

(B) For increased rate of weight gain in suckling calves.

(iii) Limitations. Implant subcutaneously in ear only. Do not use in bulls intended for reproduction or in dairy animals. Do not use before 1 month of age or after weaning in heifers intended for reproduction. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Feedlot lambs --(i) Amount. 12 mg zeranol (one implant consisting of 1 pellet containing 12 mg zeranol) per implant dose.

(ii) Indications for use. For increased rate of weight gain and improved feed conversion.

(iii) Limitations. Implant subcutaneously in ear only. Do not use in breeding animals. Do not implant animals within 40 days of slaughter. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(3) Steers fed in confinement for slaughter --(i) Amount. 72 mg zeranol (one implant consisting of 6 pellets, each pellet containing 12 mg zeranol) per implant dose.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.

(iii) Limitations. Implant subcutaneously in ear only. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(4) Pasture cattle (slaughter, stocker, feeder steers, and heifers) --(i) Amount. 138 mg zeranol (one implant consisting of 7 pellets, each of 6 pellets containing 20 mg zeranol and a seventh pellet containing 18 mg zeranol) per implant dose.

(ii) Indications for use. For increased rate of weight gain.

(iii) Limitations. Implant subcutaneously in ear only. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[59 FR 19639, Apr. 25, 1994; 60 FR 26360, May 17, 1995, as amended at 62 FR 61625, Nov. 19, 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005]

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