21 CFR § 522.1704 - Pentosan polysulfate sodium.

---
identifier: "/us/cfr/t21/s522.1704"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1704 - Pentosan polysulfate sodium."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1704"
section_name: "Pentosan polysulfate sodium."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 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]