subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.1610"
section_subject: "Oleate sodium."
cfr_reference: "21 CFR 522.1610"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.