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: "522.2005"
section_subject: "Propofol."
cfr_reference: "21 CFR 522.2005"
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 emulsion contains 10 milligrams (mg) propofol.
(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1)No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section.
(2)No. 054771 for use as in paragraph (c) of this section.
(c)Conditions of use in dogs and cats—(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.
(2)Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
(ii)For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.