Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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 paragraph (d)(1) of this section.
(2) No. 058198 for use as in paragraph (d)(2) of this section.
(b) Related tolerances. See §§ 556.240 and 556.710 of this chapter.
(c) Special considerations. Labeling of the implants described in paragraph (d)(2) 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—(1) Growing beef heifers fed in confinement for slaughter—(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate) for increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
(2) Growing beef heifers weighing 400 lbs or more—(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.

Where this section sits in the code

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

(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 paragraph (d)(1) of this section.

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

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

(c) Special considerations. Labeling of the implants described in paragraph (d)(2) 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—(1) Growing beef heifers fed in confinement for slaughter—(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate) for increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.

(2) Growing beef heifers weighing 400 lbs or more—(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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