21 U.S. Code § 360ddd. Definitions
prev | next
In this part:
(1) The term “designated medical gas” means any of the following:
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.
(2) The term “medical gas” means a drug that—
is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and
(June 25, 1938, ch. 675, § 575, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1108; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(R), Dec. 13, 2016, 130 Stat. 1155.)
2016—Par. (1)(H). Pub. L. 114–255 inserted “for a new drug” after “any period of exclusivity” and “or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title,” after “section 355a of this title,”.
Changes to Regulations
“(a)Report.—Not later than 18 months after the date of the enactment of this Act [July 9, 2012], 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.
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].
“(c)Definitions.—In this section:
The term ‘Federal drug regulations’ means regulations in title 21 of the Code of Federal Regulations pertaining to drugs.
Rules of Construction
“Nothing in this subtitle [subtitle B (§§ 1111–1113) of title XI of Pub. L. 112–144, 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—
“(2) any gas listed in subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd(1)], as added by section 1111 of this Act, or any combination of any such gases, for an indication that—
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
“(3) any designated medical gas added pursuant to subparagraph (H) of section 575(1) of such Act [21 U.S.C. 360ddd(1)] for an indication that—