21 C.F.R. § 522.2476

Current through September 30, 2024
Section 522.2476 - Trenbolone acetate
(a)Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section.
(2) No. 058198 for use as in paragraph (d) of this section.
(b)Related tolerances. See § 556.739 of this chapter.
(c)Special considerations. Labeling of implants described in paragraph (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the following: "Federal law restricts this drug to use by or on the order of a licensed veterinarian.".
(d)Conditions of use -
(1)Steers fed in confinement for slaughter -
(i)Amount. Use 126 days prior to slaughter; should be reimplanted once after 63 days.
(A) 140 milligrams (mg) trenbolone acetate (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.
(B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.
(ii)Indications for use. For 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. Use last 63 days prior to slaughter.
(A) 200 mg trenbolone acetate (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.
(B) 200 mg of trenbolone acetate (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 1 pellet containing 29 mg of 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.

21 C.F.R. §522.2476

66 FR 47961, Sept. 17, 2001, as amended at 69 FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25, 2009; 81 FR 48703, July 26, 2016; 88 FR 55566, Aug. 16, 2023
81 FR 48703, 7/26/2016; 88 FR 55566, 8/16/2023