... [Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR529.40] [Page 360] 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 ...

... 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 529.40 Albuterol. 529.50 Amikacin sulfate intrauterine solution. 529.400 Chlorhexidine tablets and suspension. 529.469 Competitive exclusion culture. 529.1003 Flurogestone acetate-impregnated vaginal sponge. 529.1030 Formalin. 529.1044 Gentamicin sulfate in certain other dosage forms. 529.1044a Gentamicin sulfate intrauterine solution. 529.1044b Gentamicin sulfate solution. 529.1115 Halothane. 529.1150 Hydrogen peroxide. 529.1186 Isoflurane. 529.1455 Methoxyflurane. 529.1660 Oxytetracycline. 529.1940 Progesterone intravaginal inserts. 529.2150 Sevoflurane. 529.2464 Ticarcillin powder. 529.2503 Tricaine methanesulfonate. ...

... ] (3) [Reserved] (4) Other essential uses. (i) (ii) [Reserved] (iii) Anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. (iv) Metered-dose cromolyn sodium human drugs administered by oral inhalation. (v) [Reserved] (vi) Metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. (vii) Metered-dose nedocromil sodium human drugs administered by oral inhalation. (viii) Metered-dose ipratropium bromide and albuterol sulfate, in combination, administered by oral inhalation for human use. (ix) Sterile aerosol talc administered intrapleurally by thoracoscopy for human use. (f) Any person may file a petition under part 10 of this chapter to request that FDA initiate rulemaking to amend paragraph (e) of this section to add an essential use. FDA may initiate notice-and-comment rulemaking to add an essential use on its own initiative or in response to a petition, if granted. (1) If the petition is to add use of a noninvestigational product ...