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: 21CFR522.1704]

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. 522.1704 Pentosan polysulfate sodium.

(a) Specifications. Each milliliter of solution contains 250 milligrams (mg) of pentosan polysulfate sodium.

(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Administer 3 mg per kilogram of body weight (1.4 mg per pound) by intramuscular injection once weekly for 4 weeks for a total of four doses.

(2) Indications for use. For the control of clinical signs associated with osteoarthritis in horses.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[88 FR 16548, Mar. 20, 2023, as amended at 88 FR 84701, Dec. 6, 2023]