--- kind: "section" citation: "21 C.F.R. § 522.1145" title: "21" number: "522.1145" heading: "Hyaluronate." url: "https://uscodex.org/cfr/21/522.1145" --- # §522.1145. Hyaluronate. - (a) - (1) **Specifications.** Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. - (2) **Sponsor.** See 054771 in [§ 510.600(c)](/cfr/21/510.600.md?p=c). - (3) **Conditions of use—** - (i) **Amount.** Small and medium-size joints (carpal, fetlock): 20 mg; larger joint (hock): 40 mg. Treatment may be repeated at weekly intervals for a total of three treatments. - (ii) **Indications for use.** Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. - (b) - (1) **Specifications.** Each milliliter of sterile aqueous solution contains 5 milligrams of hyaluronate sodium. - (2) **Sponsor.** See 054771 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter. - (3) **Conditions of use—** - (i) **Amount.** Small and medium-size joints (carpal, fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be repeated at weekly intervals for a total of four treatments. - (ii) **Indications for use.** Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. - (c) - (1) **Specifications.** Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. - (2) **Sponsor.** See No. 000010 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter. - (3) **Conditions of use—** - (i) **Amount.** Small and medium-size joints (carpal, fetlock): 20 mg. Treatment may be repeated after 1 or more weeks but not to exceed 2 injections per week for a total of 4 weeks. - (ii) **Indications for use.** For the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious synovitis associated with equine osteoarthritis. - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. - (d) - (1) **Specifications.** Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. - (2) **Sponsor.** See 000061 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter. - (3) **Conditions of use—** - (i) **Amount.** 50 milligrams in carpal and fetlock joints. - (ii) **Indications for use.** For treatment of equine carpal and fetlock joint dysfunction caused by traumatic and/or degenerative joint disease of mild to moderate severity. - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. - (e) - (1) **Specifications.** Each milliliter of solution contains: - (i) 10 milligrams (mg) hyaluronate sodium; or - (ii) 10 mg hyaluronate sodium with benzyl alcohol as a preservative. - (2) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter: - (i) **No.** 000010 for use of products described in [paragraph (e)(1)](#e-1) as in [paragraph (e)(3)](#e-3) of this section. - (ii) **No.** 017030 for use of product described in [paragraph (e)(1)(i)](#e-1-i) as in [paragraph (e)(3)](#e-3) of this section. - (3) **Conditions of use—** - (i) **Amount.** 20 mg of the product described in [paragraph (e)(1)(i)](#e-1-i) of this section by intra-articular injection into the carpus or fetlock; or 40 mg of the product described in paragraph [(e)(1)(i)](#e-1-i) or [(e)(1)(ii)](#e-1-ii) of this section by slow intravenous injection into the jugular vein. Treatment may be repeated at weekly intervals for a total of three treatments. - (ii) **Indications for use.** For treatment of carpal or fetlock joint dysfunction due to noninfectious synovitis associated with equine osteoarthritis. - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. - (f) - (1) **Specifications.** Each milliliter of sterile aqueous solution contains 11 milligrams of hyaluronate sodium. - (2) **Sponsor.** See 060865 in [§ 510.600(c)](/cfr/21/510.600.md?p=c). - (3) **Conditions of use—** - (i) **Amount.** Small and medium-size joints (carpal, fetlock): 22 mg; larger joint (hock): 44 mg. Treatment may be repeated at weekly intervals for a total of three treatments. - (ii) **Indications for use.** Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. - (iii) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ## Notes ### Amendments [49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 34279, June 16, 2015; 84 FR 39184, Aug. 9, 2019] ### Authority Authority: 21 U.S.C. 360b. ### Source Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted. ### Amendments [49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 34279, June 16, 2015; 84 FR 39184, Aug. 9, 2019]