US Codex
C.F.R.
Browse by date

View an earlier version

Latest
Current
Browse all versions by date
Notes

§522.1145. Hyaluronate.

21 C.F.R. § 522.1145

(a)
(1)
Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
(2)
Sponsor. See 054771 in § 510.600(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) 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) 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) 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) of this chapter:
(i)
No. 000010 for use of products described in paragraph (e)(1) as in paragraph (e)(3) of this section.
(ii)
No. 017030 for use of product described in paragraph (e)(1)(i) as in paragraph (e)(3) of this section.
(3)
Conditions of use—
(i)
Amount. 20 mg of the product described in paragraph (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) or (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).
(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, and revision history

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]