21 U.S.C. § 360ddd: Definitions

Oxygen that meets the standards set forth in an official compendium. Nitrogen that meets the standards set forth in an official compendium. Nitrous oxide that meets the standards set forth in an official compendium. Carbon dioxide that meets the standards set forth in an official compendium. Helium that meets the standards set forth in an official compendium. Carbon monoxide that meets the standards set forth in an official compendium. Medical air that meets the standards set forth in an official compendium. Any other medical gas deemed appropriate by the Secretary, after taking into account any investigational new drug application or investigational new animal drug application for the same medical gas submitted in accordance with regulations applicable to such applications in title 21 of the Code of Federal Regulations, unless any period of exclusivity for a new drug under section 355(c)(3)(E)(ii) of this title or section 355(j)(5)(F)(ii) of this title , or the extension of any such period under section 355a of this title , or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title , applicable to such medical gas has not expired. is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and is administered as a gas. determine whether any changes to the Federal drug regulations are necessary for medical gases; and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report regarding any such changes. If the Secretary determines under subsection (a) that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the date of the enactment of this Act [ July 9, 2012 ]. The term ‘Federal drug regulations’ means regulations in title 21 of the Code of Federal Regulations pertaining to drugs. The term ‘medical gas’ has the meaning given to such term in section 575 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360ddd ], as added by section 1111 of this Act. The term ‘Secretary’ means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.” a drug that is approved prior to May 1, 2012 , pursuant to an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360b); is not included in, or is different from, those specified in subclauses (I) through (VII) of section 576(a)(3)(A)(i) of such Act [ 21 U.S.C. 360ddd–1(a)(3)(A)(i) ]; and is approved on or after May 1, 2012 , pursuant to an application submitted under section 505 or 512 [ 21 U.S.C. 355 , 360b]; or is not included in, or is different from, those originally added pursuant to subparagraph (H) of section 575(1) [ 21 U.S.C. 360ddd(1)(H) ] and section 576(a)(3)(A)(i)(VIII) [ 21 U.S.C. 360ddd–1(a)(3)(A)(i)(VIII) ]; and is approved on or after May 1, 2012 , pursuant to an application submitted under section 505 or 512 of such Act [ 21 U.S.C. 355 , 360b].”