21 CFR § 524.1448 - Mirtazapine transdermal ointment.
---
identifier: "/us/cfr/t21/s524.1448"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1448 - Mirtazapine transdermal ointment."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1448"
section_name: "Mirtazapine transdermal ointment."
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: "524"
part_name: "OPHTHALMIC AND TOPICAL 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 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---
# 524.1448 Mirtazapine transdermal ointment.
(a) *Specifications.* Each gram of ointment contains 20 milligrams (mg) mirtazapine.
(b) *Sponsor.* See No. 043264 in § 510.600(c) of this chapter.
(c) *Conditions of use*—(1) *Amount.* Administer topically by applying a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna of the cat's ear once daily for 14 days. Alternate the daily application of ointment between the left and right inner pinna of the ears.
(2) *Indications for use.* For body weight gain in cats with a history of weight loss.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[83 FR 64740, Dec. 18, 2018, as amended at 85 FR 45308, July 28, 2020; 88 FR 16549, Mar. 20, 2023]