21 CFR § 522.1610 - Oleate sodium.

---
identifier: "/us/cfr/t21/s522.1610"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1610 - Oleate sodium."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1610"
section_name: "Oleate 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"
---


# 522.1610 Oleate sodium.

(a) *Specifications.* Each milliliter of solution contains 50 milligrams (mg) of sodium oleate.

(b) *Sponsor.* See No. 037990 in § 510.600(c) of this chapter.

(c) *Conditions of use in horses*—(1) *Amount.* Administer by parenteral injection depending on the area of response desired. An injection of 1 milliliter (mL) will produce a response of approximately 15 square centimeters. Do not inject more than 2 mL per injection site. Regardless of the number of injection sites, the total volume used should not exceed 10 mL.

(2) *Indications for use.* It is used in horses to stimulate infiltration of cellular blood components that subsequently differentiate into fibrous and/or fibrocartilagenous tissue.

(3) *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.

[41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 2014]