(a) Specifications. Each milliliter (mL) of solution contains dinoprost tromethamine equivalent to 5 milligrams (mg) or 12.5 mg dinoprost.

(b) Sponsors. See sponsors in §510.600(c) of this chapter.

(1) No. 054771 for use of the 12.5 mg/mL product as in paragraph (d)(1) of this section.

(2) No. 054771 for use of the 5 mg/mL product as in paragraphs (d)(1), (2), and (3) of this section.

(3) No. 061133 for use of the 5 mg/mL product as in paragraphs (d)(2), (3), and (4) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Cattle. Administer product described in paragraph (b)(1) of this section as follows:

(i) Amount. 25 mg as a single intramuscular or subcutaneous injection.

(ii) Indications for use. As a luteolytic agent; effective only in those cattle having a corpus luteum, i.e., those which ovulated at least 5 days prior to treatment.

(A) For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.

(B) For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.

(C) For treatment of pyometra (chronic endometritis) in cattle.

(D) For abortion in beef cows, beef heifers and replacement dairy heifers.

(E) For use with gonadorelin injection as in §522.1077 of this chapter to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

(F) For use with progesterone intravaginal inserts as in §529.1940 of this chapter for synchronization of estrus in lactating dairy cows.

(G) For use with progesterone intravaginal inserts as in §529.1940 of this chapter for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.

(2) Horses—(i) Amount. 1 mg per 100 pounds of body weight as a single intramuscular injection.

(ii) Indications for use. For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.

(iii) Limitations. Do not use in horses intended for human consumption.

(3) Swine—(i) Amount. 10 mg as a single intramuscular injection.

(ii) Indications for use. For parturition induction in swine when injected within 3 days of normal predicted farrowing.

(4) Cattle. Administer product described in paragraph (b)(2) of this section as follows:

(i) Beef cattle and nonlactating dairy heifers—(A) Amount. 25 mg as an intramuscular injection either once or twice at a 10- to 12-day interval.

(B) Indications. For its luteolytic effect to control timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum.

(ii) Beef cattle and nonlactating dairy heifers—(A) Amount. 25 mg as a single intramuscular injection.

(B) Indications. For treatment of pyometra (chronic endometritis).

(iii) Nonlactating cattle—(A) Amount. 25 mg as a single intramuscular injection during the first 100 days of gestation.

(B) Indications. For its abortifacient effect in nonlactating cattle.

(iv) Lactating dairy cattle—(A) Amount. 25 mg as a single intramuscular injection.

(B) Indications. For treatment of unobserved (silent) estrus in lactating dairy cattle that have a corpus luteum.

(v) Dinoprost injection as provided by No. 054771 in §510.600(c) of this chapter may also be used concurrently with gonadorelin hydrochloride injection as in §522.1077 and with progesterone intravaginal inserts as in §529.1940 of this chapter.

[67 FR 41824, June 20, 2002, as amended at 79 FR 16187, Mar. 25, 2014; 79 FR 44278, July 31, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 61296, Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR 36789, June 8, 2016; 84 FR 8973, Mar. 13, 2019]