[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR529.40]

[Page 325]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  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 Sec.  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]