CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.1850]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1850 Polysulfated glycosaminoglycan.

(a) Specifications. (1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan.

(2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan.

(b) Sponsor. See No. 010797 in § 510.600(c) of this chapter.

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

(d) Conditions of use - (1) Horses - (i) Indications for use. For the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.

(ii) Amount - (A) Intra-articular use (carpal) : 250 mg once a week for 5 weeks.

(B) Intramuscular use (carpal and hock) : 500 mg every 4 days for 28 days.

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

(2) Dogs - (i) Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints.

(ii) Amount. 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections).

[72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009]