Trenbolone acetate and estradiol.

21 C.F.R. § 522.2477
in effectEffective: 2024-07-01
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(a) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (1) No. 058198 for use in paragraphs (d)(1)(i)(B), (d)(1)(ii), (d)(2)(i)(B), (d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B), (d)(3)(i)(D), (d)(3)(ii), (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) of this section. (2) No. 000061 for use in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(ii), (d)(3)(i)(A), (d)(3)(i)(C), (d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section. (3) No. 054771 for use in paragraphs (d)(2)(i)(A), (C), (d)(2)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section. (b) Related tolerances. See §§ 556.240 and 556.739 of this chapter. (c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D), (d)(3)(i)(B), (d)(3)(i)(D), and (d)(4)(i)(B) 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 steers and heifers fed in confinement for slaughter—(i) Amounts and indications. (A) An implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency. (B) An implant containing 200 mg trenbolone acetate, 20 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of 10 pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An extended- and delayed-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (1 implant consisting of 10 coated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency during 70 to 200 days after implantation. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. 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 calves born to these cows. (2) Growing beef steers fed in confinement for slaughter—(i) Amounts and indications. (A) An implant containing 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency. (B) An implant containing 80 mg trenbolone acetate, 16 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An implant containing 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency. (D) An implant containing 120 mg trenbolone acetate, 24 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (E) An extended-release implant containing 200 mg trenbolone acetate and 40 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers fed in confinement for slaughter. 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 calves born to these cows. (3) Growing beef heifers fed in confinement for slaughter—(i) Amounts and indications. (A) An implant containing 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain. (B) An implant containing 80 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An implant containing 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency. (D) An implant containing 140 mg trenbolone acetate, 14 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (E) An extended-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef heifers fed in confinement for slaughter. 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 calves born to these cows. (4) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)—(i) Amounts and indications for use. (A) An implant containing 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain. (B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). 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 calves born to these cows.

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