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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 21Chapter ISubchapter EPart 522 → §522.2477


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.2477   Trenbolone acetate and estradiol.

(a) [Reserved]

(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section.

(1) No. 058198 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of this section.

(2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(G), (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), (d)(3)(iii), (d)(4), and (d)(5) of this section.

(3) No. 054771 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) of this section.

(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.

(G) 200 milligram (mg) trenbolone acetate and 40 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose.

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

(iii) Limitations. Administer implant subcutaneously in the 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.

(F) 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.

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

(B) For increased rate of weight gain.

(iii) Limitations. Administer implant subcutaneously in the 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. Administer implant subcutaneously in the 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.

(4) Beef steers and heifers fed in confinement for slaughter—(i) Amount. Each extended- and delayed-release implant contains 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.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency during 70 to 200 days after implantation.

(iii) Limitations. Administer implant subcutaneously in the ear only. Do not use in lactating 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. Do not use in calves to be processed for veal. A withdrawal period has not been established for this product in pre-ruminating calves. Effectiveness and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (beef steers and heifers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated.

(5) Beef heifers fed in confinement for slaughter—(i) Amount. Each extended-release implant contains 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 6 coated and 4 uncoated pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol).

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

(iii) Limitations. Administer implant subcutaneously in the ear only. Do not use in lactating 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. Do not use in calves to be processed for veal. A withdrawal period has not been established for this product in pre-ruminating calves. Effectiveness and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (beef heifers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated.

[60 FR 4376, Jan. 23, 1995]

Editorial Note: For Federal Register citations affecting §522.2477, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

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