In this part:
The term “designated medical gas” means any of the following:
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.
section 355(c)(3)(E)(ii) of this titlesection 355(j)(5)(F)(ii) of this titlesection 355a of this titlesection 360b(c)(2)(F) of this title 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 or , or the extension of any such period under , or any period of exclusivity for a new animal drug under , applicable to such medical gas has not expired.
The term “medical gas” means a drug that—
is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and
is administered as a gas.
June 25, 1938, ch. 675, § 575Pub. L. 112–144, title XI, § 1111126 Stat. 1108Pub. L. 114–255, div. A, title III, § 3101(a)(2)(R)130 Stat. 1155(, as added , , ; amended , , .)
Editorial Notes
Amendments
Pub. L. 114–255section 360b(c)(2)(F) of this titlesection 355a of this title2016—Par. (1)(H). inserted “for a new drug” after “any period of exclusivity” and “or any period of exclusivity for a new animal drug under ,” after “,”.
Statutory Notes and Related Subsidiaries
Changes to Regulations
Pub. L. 112–144, title XI, § 1112126 Stat. 1111
Report .—
Not later than 18 months after the date of the enactment of this Act [], the Secretary, after obtaining input from medical gas manufacturers and any other interested members of the public, shall—
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.
Regulations .—
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 [].
Definitions .—
In this section:
The term ‘Federal drug regulations’ means regulations in title 21 of the Code of Federal Regulations pertaining to drugs.
21 U.S.C. 360ddd The term ‘medical gas’ has the meaning given to such term in section 575 of the Federal Food, Drug, and Cosmetic Act [], 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.”
Rules of Construction
Pub. L. 112–144, title XI, § 1113126 Stat. 1112
Pub. L. 112–144“Nothing in this subtitle [subtitle B (§§ 1111–1113) of title XI of , enacting this section and sections 360ddd–1 and 360ddd–2 of this title and provisions set out as notes under this section] and the amendments made by this subtitle applies with respect to—“(1) “(2)“(A) “(B)
“(3)“(A) “(B)
, , , provided that:
21 U.S.C. 355 a drug that is approved prior to , pursuant to an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (, 360b);
21 U.S.C. 360ddd(1) any gas listed in subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and Cosmetic Act [], as added by section 1111 of this Act, or any combination of any such gases, for an indication that—
21 U.S.C. 360ddd–1(a)(3)(A)(i) 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 []; and
21 U.S.C. 355 is approved on or after , pursuant to an application submitted under section 505 or 512 [, 360b]; or
21 U.S.C. 360ddd(1) any designated medical gas added pursuant to subparagraph (H) of section 575(1) of such Act [] for an indication that—
21 U.S.C. 360ddd(1)(H)21 U.S.C. 360ddd–1(a)(3)(A)(i)(VIII) is not included in, or is different from, those originally added pursuant to subparagraph (H) of section 575(1) [] and section 576(a)(3)(A)(i)(VIII) []; and
21 U.S.C. 355 is approved on or after , pursuant to an application submitted under section 505 or 512 of such Act [, 360b].”