(i)
Approved uses
A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b of this title, subject to all applicable postapproval requirements, for the following indications for use:
(I)
In the case of oxygen, the treatment or prevention of hypoxemia or hypoxia.
(II)
In the case of nitrogen, use in hypoxic challenge testing.
(III)
In the case of nitrous oxide, analgesia.
(IV)
In the case of carbon dioxide, use in extracorporeal membrane oxygenation therapy or respiratory stimulation.
(V)
In the case of helium, the treatment of upper airway obstruction or increased airway resistance.
(VI)
In the case of medical air, to reduce the risk of hyperoxia.
(VII)
In the case of carbon monoxide, use in lung diffusion testing.
(VIII)
Any other indication for use for a designated medical gas or combination of designated medical gases deemed appropriate by the Secretary, unless any period of exclusivity for a new drug under clause (iii) or (iv) of
section 355(c)(3)(E) of this title, clause (iii) or (iv) of
section 355(j)(5)(F) of this title, or
section 360cc of this title, or the extension of any such period under
section 355a of this title, applicable to such indication for use for such gas or combination of gases has not expired.
(ii)
Labeling
The requirements of sections 353(b)(4) and 352(f) of this title are deemed to have been met for a designated medical gas if the labeling on the final use container for such medical gas bears—
(I)
(II)
a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and
(III)
appropriate directions and warnings concerning storage and handling.