21 U.S.C. § 360ddd — Definitions

submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 239 words · no verdicts yet

in plain englishAI-generated · not legal advice

This section defines terms for the medical gas law, including ‘designated medical gas’ and ‘medical gas.’ Designated medical gases are oxygen, nitrogen, and similar gases meeting compendium standards. A ‘medical gas’ is a drug stored as liquid or gas, given to patients as gas.

In this part: (1) “Designated medical gas” means any of the following: (A) Oxygen that meets the standards in an official compendium. (B) Nitrogen that meets those standards. (C) Nitrous oxide that meets those standards. (D) Carbon dioxide that meets those standards. (E) Helium that meets those standards. (F) Carbon monoxide that meets those standards. (G) Medical air that meets those standards. (H) Any other medical gas the Secretary decides counts, after considering any pending investigational new drug or new animal drug application for that same gas — unless an exclusivity period for a new drug (under section 355(c)(3)(E)(ii) or 355(j)(5)(F)(ii), or an extension under section 355a) or for a new animal drug (under section 360b(c)(2)(F)) that applies to that gas hasn't expired yet. (2) “Medical gas” means a drug that (A) is manufactured or stored as a liquid, a non-liquid, or a cryogenic substance, and (B) is given to a patient as a gas.

the actual law source: uscode.house.gov ↗public domain

In this part:

(1)

The term “designated medical gas” means any of the following:

(A)

Oxygen that meets the standards set forth in an official compendium.

(B)

Nitrogen that meets the standards set forth in an official compendium.

(C)

Nitrous oxide that meets the standards set forth in an official compendium.

(D)

Carbon dioxide that meets the standards set forth in an official compendium.

(E)

Helium that meets the standards set forth in an official compendium.

(F)

Carbon monoxide that meets the standards set forth in an official compendium.

(G)

Medical air that meets the standards set forth in an official compendium.

(H)

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—

(A)

is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and

(B)

is administered as a gas.

Source credit: (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.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 112-144 · 126 Stat. 1108
2016Amended · Pub. L. 114-255 · 130 Stat. 1155

A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 1938-06-25.

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