21 CFR 522.2478 - Trenbolone acetate and estradiol benzoate.

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§ 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.

(c) Related tolerances. See §§ 556.240 and 556.739 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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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) [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]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558