subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "529"
part_subject: "CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "529.40"
section_subject: "Albuterol."
cfr_reference: "21 CFR 529.40"
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. A net weight of 6.7 grams of formulated albuterol sulfate is supplied in a pressurized aluminum canister within an actuator system equipped with a detachable nasal delivery bulb.
(b)Approvals. See No. 000010 in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.
(c)Conditions of use—(1) Amount. Each valve actuation (puff) of the device delivers 120 micrograms (mcg) of albuterol sulfate. One dose is three (3) puffs, totaling 360 mcg.
(2)Indications for use. For the immediate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction in horses.
(3)Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.