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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 522.1704: Pentosan polysulfate sodium.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
  4. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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