subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.2478"
section_subject: "Trenbolone acetate and estradiol benzoate."
cfr_reference: "21 CFR 522.2478"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
(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.