Title 21

SECTION 522.2478

522.2478 Trenbolone acetate and estradiol benzoate.

§ 522.2478 Trenbolone acetate and estradiol benzoate.

(a) Specifications. (1) Each implant consists of:

(i) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone acetate and 3.5 mg estradiol benzoate.

(ii) 4 pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.

(2) Each extended release implant consists of:

(i) 8 pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.

(ii) 6 pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(d) Conditions of use - (1) Steers fed in confinement for slaughter. (i) For an implant as described in paragraph (a)(1)(i) of this section:

(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.

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

(C) 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.

(ii) For an implant as described in paragraph (a)(1)(ii) of this section:

(A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.

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

(iii) For an implant as described in paragraph (a)(2)(i) of this section:

(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate in an extended release implant.

(B) Indications for use. For increased rate of weight gain and improved feed efficiency for up to 200 days.

(2) Heifers fed in confinement for slaughter. (i) For an implant as described in paragraph (a)(1)(i) of this section:

(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.

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

(C) Limitations. Implant subcutaneously in ear only. Not for use in dairy or beef replacement heifers. 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.

(ii) For an implant as described in paragraph (a)(1)(ii) of this section:

(A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.

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

(iii) For an implant as described in paragraph (a)(2)(i) of this section:

(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate in an extended release implant.

(B) Indications for use. For increased rate of weight gain and improved feed efficiency for up to 200 days.

(3) Pasture steers and heifers (slaughter, stocker, and feeder). (i) For an implant as described in paragraph (a)(2)(ii) of this section:

(A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate in an extended release implant.

(B) Indications for use. For increased rate of weight gain for up to 200 days.

(ii) [Reserved]

[67 FR 78972, Dec. 27, 2002, as amended at 69 FR 67818, Nov. 22, 2004; 79 FR 16197, Mar. 25, 2014; 79 FR 64116, Oct. 28, 2014]