21 U.S. Code § 360ddd–1 - Regulation of medical gases
(a) Certification of designated medical gases
Beginning 180 days after July 9, 2012, any person may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information:
(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.
(2) Grant of certification
The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that—
(B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; or
(3) Effect of certification
(A) In general
(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:
(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.
(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 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 final use container for such medical gas bears—
(II) a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and
(B) Inapplicability of exclusivity provisions
(i) No exclusivity for a certified medical gas No designated medical gas deemed under subparagraph (A)(i) to have in effect an approved application is eligible for any period of exclusivity under section 355 (c), 355 (j), or 360cc of this title, or the extension of any such period under section 355a of this title, on the basis of such deemed approval.
(ii) Effect on certification No period of exclusivity under section 355 (c), 355 (j), orsection 360cc of this title, or the extension of any such period under section 355a of this title, with respect to an application for a drug product shall prohibit, limit, or otherwise affect the submission, grant, or effect of a certification under this section, except as provided in subsection (a)(3)(A)(i)(VIII) andsection 360ddd(1)(H) of this title.
(4) Withdrawal, suspension, or revocation of approval
(A) Withdrawal, suspension of approval
(b) Prescription requirement
(1) In general
A designated medical gas shall be subject to the requirements of section 353 (b)(1) of this title unless the Secretary exercises the authority provided in section 353 (b)(3) of this title to remove such medical gas from the requirements of section 353 (b)(1) of this title, the gas is approved for use without a prescription pursuant to an application under section 355 or 360b of this title, or the use in question is authorized pursuant to another provision of this chapter relating to use of medical products in emergencies.
(A) No prescription required for certain uses
Notwithstanding paragraph (1), oxygen may be provided without a prescription for the following uses: