21 U.S.C. § 360ddd-1
Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce 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:
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-
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:
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-
No designated medical gas deemed under subparagraph (A)(i) to have in effect an approved application is eligible for any period of exclusivity for a new drug 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.
No period of exclusivity under section 355(c), 355(j), or section 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) and section 360ddd(1)(H) of this title.
Nothing in this part limits the Secretary's authority to withdraw or suspend approval of a drug product, including a designated medical gas deemed under this section to have in effect an approved application under section 355 of this title or section 360b of this title.
The Secretary may revoke the grant of a certification under paragraph (2) if the Secretary determines that the request for certification contains any material omission or falsification.
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.
Notwithstanding paragraph (1), oxygen may be provided without a prescription for the following uses:
For oxygen provided pursuant to subparagraph (A), the requirements of section 353(b)(4) of this title shall be deemed to have been met if its labeling bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required.
21 U.S.C. § 360ddd-1
EDITORIAL NOTES
AMENDMENTS2016-Subsec. (a)(1). Pub. L. 114-255, §3101(a)(2)(S)(i), inserted "who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce" after "any person" in introductory provisions. Subsec. (a)(3)(A)(i)(VIII). Pub. L. 114-255, §3101(a)(2)(S)(ii)(I)(aa), inserted "for a new drug" after "any period of exclusivity".Subsec. (a)(3)(A)(ii). Pub. L. 114-255, §3101(a)(2)(S)(ii)(I)(bb), inserted "the" before "final use" in introductory provisions.Subsec. (a)(3)(B)(i). Pub. L. 114-255, §3101(a)(2)(S)(ii)(II)(aa), inserted "for a new drug" after "any period of exclusivity".Subsec. (a)(3)(B)(ii). Pub. L. 114-255, §3101(a)(2)(S)(ii)(II)(bb), inserted comma after "drug product".