§522.2343. Testosterone propionate and estradiol benzoate.
21 C.F.R. § 522.2343
No. 054771 for use as in paragraph (d)(1) of this section.
No. 058198 for use as in paragraph (d)(2) of this section.
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.”
Conditions of use—
Growing beef heifers fed in confinement for slaughter—
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.
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.
Growing beef heifers weighing 400 lbs or more—
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.
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.
Notes, amendments, and revision history
Amendments
[89 FR 42358, May 15, 2024]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[89 FR 42358, May 15, 2024]