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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 Mar 22, 2024.

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: 21CFR522.2343]



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. 522.2343 Testosterone propionate and estradiol benzoate.

(a) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 054771 for use as in paragraphs (d)(1)(i) and (d)(2) and (3) of this section.

(2) No. 058198 for use as in paragraph (d) of this section.

(b) Related tolerances. See §§ 556.240 and 556.710 of this chapter.

(c) Special considerations. Labeling of implants described in paragraph (d)(1)(ii) of this section shall bear the following: "Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(d) Conditions of use. For implantation in growing beef heifers weighing 400 lb or more as follows:

(1) Amount. (i) 20 milligrams (mg) estradiol benzoate and 200 mg testosterone propionate (one implant consisting of 8 pellets, each pellet containing 2.5 mg estradiol benzoate and 25 mg testosterone propionate) per implant dose.

(ii) 20 mg estradiol benzoate and 200 mg testosterone propionate (one implant consisting of 9 pellets, each of 8 pellets containing 2.5 mg estradiol benzoate and 25 mg testosterone propionate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.

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

(3) Limitations. For subcutaneous ear implantation, one dose per animal. Not for use in dairy or beef replacement heifers. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been established. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[69 FR 68252, Nov. 24, 2004, as amended at 77 FR 31723, May 30, 2012; 79 FR 16187, Mar. 25, 2014; 81 FR 48702, July 26, 2016. Redesignated and amended at 87 FR 10969, Feb. 28, 2022; 87 FR 17946, Mar. 29, 2022; 88 FR 55566, Aug. 16, 2023]

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