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

21 CFR 522.2005: Propofol.

(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), (c)(3), (d)(1), (d)(2)(i), and (d)(3) of this section.
(2) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), (c)(3), (d)(1), (d)(2)(ii), and (d)(3) of this section.
(3) Nos. 054771 and 068504 for use as in paragraphs (c)(1), (c)(2)(iii), and (c)(3) of this section.
(c) Conditions of use in dogs—(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; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
(ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
(iii) For induction and maintenance of general anesthesia; and for induction of general 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.
(d) Conditions of use in 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; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
(ii) For induction and maintenance of general anesthesia; and for induction of general 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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

(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), (c)(3), (d)(1), (d)(2)(i), and (d)(3) of this section.

(2) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), (c)(3), (d)(1), (d)(2)(ii), and (d)(3) of this section.

(3) Nos. 054771 and 068504 for use as in paragraphs (c)(1), (c)(2)(iii), and (c)(3) of this section.

(c) Conditions of use in dogs—(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; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.

(ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.

(iii) For induction and maintenance of general anesthesia; and for induction of general 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.

(d) Conditions of use in cats—(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.

(ii) For induction and maintenance of general anesthesia; and for induction of general 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.

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

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