§ 522.2343 - Testosterone propionate and estradiol benzoate.

§ 522.2343 Testosterone propionate and estradiol benzoate.

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

(1) No. 054771 for use as in paragraphs paragraph (d)(1)(i) and (d)(2) and (3) of this section.

(2) No. 058198 for use as in paragraph (d)(2) of this section.

(b) Related tolerances. See §§ 556.240 and 556.710 of this chapter.

(c) Special considerations. Labeling of the implants described in paragraph (d)(12)(ii) 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. For implantation in growing beef heifers weighing 400 lb or more as follows: —

(1) Amount. Growing beef heifers fed in confinement for slaughter —

(i)

20 milligrams (mg) estradiol benzoate and

Amounts and indications for use. An implant containing 200 mg testosterone propionate and 20 mg estradiol benzoate (one implant consisting of

8

eight pellets, each

pellet

containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate

and 25 mg testosterone propionate) per implant dose.(ii) 20 mg estradiol benzoate and 200 mg testosterone propionate

) for increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in 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.

(2) Growing beef heifers weighing 400 lbs or more —

(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of

9

eight pellets, each

of 8 pellets containing

containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate

and 25 mg testosterone propionate

, and

1

one pellet containing 29 mg tylosin tartrate)

per implant dose.

(2) Indications

for

use. For

increased rate of weight gain and improved feed efficiency.

(

3

ii)Limitations.

For subcutaneous ear implantation, one dose per animal

Implant pellets subcutaneously in ear only. Not

for use in dairy or beef replacement heifers

approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been

established. A withdrawal period has not been established for this product in preruminating calves.

evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves

to be processed for veal

born to these cows.

[69 89 FR 68252, Nov. 24, 2004, as amended at 77 FR 31723, May 30, 2012; 79 FR 16187, Mar. 25, 2014; 81 FR 48702, July 26, 2016. Redesignated and amended at 87 FR 10969, Feb. 28, 2022; 87 FR 17946, Mar. 29, 2022; 88 FR 55566, Aug. 16, 202342358, May 15, 2024]