21 C.F.R. § 522.2477 Trenbolone acetate and estradiol.
Title 21 - Food and Drugs
(a) [Reserved] (b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section. (1) No. 021641 for products and uses described in paragraph (d) of this section. (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of this section. (3) No. 000856 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii). (c) Related tolerances. See §§556.240 and 556.739 of this chapter. (d) Conditions of use—(1) Steers fed in confinement for slaughter—(i) Amount. (A) 120 milligrams (mg) trenbolone acetate and 24 mg estradiol (one implant consisting of 6 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose. (B) 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of 7 pellets, each of 6 pellets containing 20 mg trenbolone acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose. (C) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose. (D) 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of 4 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose. (E) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose. (F) 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of 5 pellets, each of 4 pellets containing 20 mg trenbolone acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose. (ii) Indications for use. For increased rate of weight gain and improved feed efficiency. (iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. 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. (2) Heifers fed in confinement for slaughter—(i) Amount. (A) 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose for use as in paragraph (d)(2)(ii)(A) of this section. (B) 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of 8 pellets, each of 7 pellets containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose for use as in paragraphs (d)(2)(ii)(A) of this section. (C) 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 4 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose for use as in paragraph (d)(2)(ii)(B) of this section. (D) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose for use as in paragraph (d)(2)(ii)(A) of this section. (E) 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 5 pellets, each of 4 pellets containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose for use as in paragraph (d)(2)(ii)(B) of this section. (ii) Indications for use. (A) For increased rate of weight gain and improved feed efficiency. (B) For increased rate of weight gain. (iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. 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. (3) Pasture cattle (slaughter, stocker, and feeder steers and heifers)—(i) Amount. (A) 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 2 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose. (B) 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 3 pellets, each of 2 pellets containing 20 mg trenbolone acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose. (ii) Indications for use. For increased rate of weight gain. (iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. 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. [60 FR 4376, Jan. 23, 1995, as amended at 61 FR 29480, June 11, 1996; 61 FR 41499, Aug. 9, 1996; 62 FR 28629, May 27, 1997; 64 FR 42597, Aug. 5, 1999; 64 FR 48294, Sept. 3, 1999; 65 FR 10706, Feb. 29, 2000; 65 FR 26748, May 9, 2000; 65 FR 45879, July 26, 2000; 65 FR 70663, Nov. 27, 2000; 66 FR 47961, Sept. 17, 2001; 67 FR 5724, Feb. 7, 2002; 67 FR 78358, Dec. 24, 2002; 68 FR 42250, July 17, 2003; 68 FR 48785, Aug. 15, 2003; 68 FR 55200, 55201, Sept. 23, 2003; 69 FR 500, Jan. 6, 2004; 69 FR 7116, Feb. 13, 2004; 69 FR 12271, Mar. 16, 2004; 69 FR 13735, Mar. 24, 2004; 69 FR 68253, Nov. 24, 2004; 70 FR 8290, Feb. 18, 2005]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.2477 Trenbolone acetate and estradiol.
