21 CFR § 522.1940 - Progesterone and estradiol benzoate.

§ 522.1940 Progesterone 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 (d)(1)(i)(A), (d)(1)(ii) and (iii), (d)(2)(i)(A), (d)(2)(ii) and (iii), and (d)(3) of this section.

(2) No. 058198 for use as in paragraphs (d)(1) and (2) of this section.

(b) Related tolerances. See §§ 556.240 and 556.540 of this chapter.

(c) Special considerations. Labeling of implants described in paragraphs (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 in cattle. It is used for implantation as follows:

(1) Suckling beef calves at least 45 days old and up to 400 lb of body weight—(i) Amount.

(A) 100 milligrams (mg) progesterone and 10 mg estradiol benzoate (one implant consisting of 4 pellets, each pellet containing 25 mg progesterone and 2.5 mg estradiol benzoate) per implant dose.

(B) 100 mg progesterone and 10 mg estradiol benzoate (one implant consisting of 5 pellets, each of 4 pellets containing 25 mg progesterone and 2.5 mg estradiol benzoate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.

(ii) Indications for use. For increased rate of weight gain.

(iii) Limitations. For subcutaneous ear implantation, one dose per animal. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves because effectiveness and safety have not been established. Do not use in animals intended for subsequent breeding, or in dairy cows. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Growing beef steers weighing 400 lb or more—(i) Amount.

(A) 200 mg progesterone and 20 mg estradiol benzoate (one implant consisting of 8 pellets, each pellet containing 25 mg progesterone and 2.5 mg estradiol benzoate) per implant dose.

(B) 200 mg progesterone and 20 mg estradiol benzoate (one implant consisting of 9 pellets, each of 8 pellets containing 25 mg progesterone and 2.5 mg estradiol benzoate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.

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

(iii) Limitations. For subcutaneous ear implantation, one dose per animal. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves because effectiveness and safety have not been established. Do not use in animals intended for subsequent breeding, or in dairy cows. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(3) Steers fed in confinement for slaughter—(i) Amount. Reimplant 200 mg progesterone and 20 mg estradiol benzoate on approximately day 70 following an initial implant of 100 mg progesterone and 10 mg estradiol benzoate or 200 mg progesterone and 20 mg estradiol benzoate.

(ii) Indications for use. For additional improvement in rate of weight gain.

(iii) Limitations. For subcutaneous ear implantation. 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.

[69 FR 70055, Dec. 2, 2004, as amended at 77 FR 31723, May 30, 2012; 79 FR 16194, Mar. 25, 2014; 81 FR 48702, July 26, 2016; 87 FR 17946, Mar. 29, 2022; 88 FR 55566, Aug. 16, 2023]