---

21 C.F.R. § 529.40   Albuterol.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

Browse Next

§ 529.40   Albuterol.

(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) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) 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) Limitations. Not for use in horses intended for food.

[67 FR 7072, Feb. 15, 2002]

Browse Next