---
kind: "section"
citation: "21 U.S.C. § 360ddd–1"
title: "21"
title_heading: "Food and Drugs"
number: "360ddd–1"
heading: "Regulation of medical gases"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360ddd-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part G — Medical Gases"
---

# §360ddd–1. Regulation of medical gases

- (a) **Certification of designated medical gases—**
  - (1) **Submission—** Beginning 180 days after July 9, 2012, any [person](/usc/21/321.md?p=e) who seeks to initially introduce or deliver for introduction a [designated medical gas](/usc/21/360ddd.md?p=1) into [interstate commerce](/usc/21/321.md?p=b) may file with the [Secretary](/usc/21/321.md?p=d) a request for certification of a [medical gas](/usc/21/360ddd.md?p=2) as a [designated medical gas](/usc/21/360ddd.md?p=1). Any such request shall contain the following information:
    - (A) A description of the [medical gas](/usc/21/360ddd.md?p=2).
    - (B) The name and address of the [sponsor](/usc/21/360fff.md?p=8).
    - (C) The name and address of the facility or facilities where the [medical gas](/usc/21/360ddd.md?p=2) is or will be manufactured.
    - (D) Any other information deemed appropriate by the [Secretary](/usc/21/321.md?p=d) to determine whether the [medical gas](/usc/21/360ddd.md?p=2) is a [designated medical gas](/usc/21/360ddd.md?p=1).
  - (2) **Grant of certification—** The certification requested under [paragraph (1)](#a-1) is deemed to be granted unless, within 60 days of the filing of such request, the [Secretary](/usc/21/321.md?p=d) finds that—
    - (A) the [medical gas](/usc/21/360ddd.md?p=2) subject to the certification is not a [designated medical gas](/usc/21/360ddd.md?p=1);
    - (B) the request does not contain the information required under [paragraph (1)](#a-1) or otherwise lacks sufficient information to permit the [Secretary](/usc/21/321.md?p=d) to determine that the [medical gas](/usc/21/360ddd.md?p=2) is a [designated medical gas](/usc/21/360ddd.md?p=1); or
    - (C) denying the request is necessary to protect the public health.
  - (3) **Effect of certification—**
    - (A) **In general—**
      - (i) **Approved uses—** A [designated medical gas](/usc/21/360ddd.md?p=1) for which a certification is granted under [paragraph (2)](#a-2) is deemed, alone or in combination, as medically appropriate, with another [designated medical gas](/usc/21/360ddd.md?p=1) or gases for which a certification or certifications have been granted, to have in effect an approved application under section [355](/usc/21/355.md) or [360b](/usc/21/360b.md) of this title, subject to all applicable postapproval requirements, for the following indications for use:
        - (I) In the case of oxygen, the treatment or prevention of hypoxemia or hypoxia.
        - (II) In the case of nitrogen, use in hypoxic challenge testing.
        - (III) In the case of nitrous oxide, analgesia.
        - (IV) In the case of carbon dioxide, use in extracorporeal membrane oxygenation therapy or respiratory stimulation.
        - (V) In the case of helium, the treatment of upper airway obstruction or increased airway resistance.
        - (VI) In the case of medical air, to reduce the risk of hyperoxia.
        - (VII) In the case of carbon monoxide, use in lung diffusion testing.
        - (VIII) Any other indication for use for a [designated medical gas](/usc/21/360ddd.md?p=1) or combination of [designated medical gases](/usc/21/360ddd.md?p=1) deemed appropriate by the [Secretary](/usc/21/321.md?p=d), unless any period of exclusivity for a [new drug](/usc/21/321.md?p=p) under clause (iii) or (iv) of [section 355(c)(3)(E) of this title](/usc/21/355.md?p=c-3-E), clause (iii) or (iv) of [section 355(j)(5)(F) of this title](/usc/21/355.md?p=j-5-F), or [section 360cc of this title](/usc/21/360cc.md), or the extension of any such period under [section 355a of this title](/usc/21/355a.md), applicable to such indication for use for such gas or combination of gases has not expired.
      - (ii) **Labeling—** The requirements of sections [353(b)(4)](/usc/21/353.md?p=b-4) and [352(f)](/usc/21/352.md?p=f) of this title are deemed to have been met for a [designated medical gas](/usc/21/360ddd.md?p=1) if the [labeling](/usc/21/321.md?p=m) on the final use container for such [medical gas](/usc/21/360ddd.md?p=2) bears—
        - (I) the information required by [section 353(b)(4) of this title](/usc/21/353.md?p=b-4);
        - (II) a warning statement concerning the use of the [medical gas](/usc/21/360ddd.md?p=2) as determined by the [Secretary](/usc/21/321.md?p=d) by regulation; and
        - (III) appropriate directions and warnings concerning storage and handling.
    - (B) **Inapplicability of exclusivity provisions—**
      - (i) **No exclusivity for a certified medical gas—** No [designated medical gas](/usc/21/360ddd.md?p=1) deemed under [subparagraph (A)(i)](#a-3-A-i) to have in effect an approved application is eligible for any period of exclusivity for a [new drug](/usc/21/321.md?p=p) under section [355(c)](/usc/21/355.md?p=c), [355(j)](/usc/21/355.md?p=j), or [360cc](/usc/21/360cc.md) of this title, or the extension of any such period under [section 355a of this title](/usc/21/355a.md), on the basis of such deemed approval.
      - (ii) **Effect on certification—** No period of exclusivity under section [355(c)](/usc/21/355.md?p=c), [355(j)](/usc/21/355.md?p=j), or [section 360cc of this title](/usc/21/360cc.md), or the extension of any such period under [section 355a of this title](/usc/21/355a.md), with respect to an application for a [drug product](/usc/21/321.md?p=dd), 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)](#a-3-A-i-VIII) and [section 360ddd(1)(H) of this title](/usc/21/360ddd.md?p=1-H).
  - (4) **Withdrawal, suspension, or revocation of approval—**
    - (A) **Withdrawal, suspension of approval—** Nothing in this part limits the [Secretary](/usc/21/321.md?p=d)’s authority to withdraw or suspend approval of a [drug product](/usc/21/321.md?p=dd), including a [designated medical gas](/usc/21/360ddd.md?p=1) deemed under this section to have in effect an approved application under [section 355 of this title](/usc/21/355.md) or [section 360b of this title](/usc/21/360b.md).
    - (B) **Revocation of certification—** The [Secretary](/usc/21/321.md?p=d) may revoke the grant of a certification under [paragraph (2)](#a-2) if the [Secretary](/usc/21/321.md?p=d) determines that the request for certification contains any material omission or falsification.
- (b) **Prescription requirement—**
  - (1) **In general—** A [designated medical gas](/usc/21/360ddd.md?p=1) shall be subject to the requirements of [section 353(b)(1) of this title](/usc/21/353.md?p=b-1) unless the [Secretary](/usc/21/321.md?p=d) exercises the authority provided in [section 353(b)(3) of this title](/usc/21/353.md?p=b-3) to remove such [medical gas](/usc/21/360ddd.md?p=2) from the requirements of [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), the gas is approved for use without a prescription pursuant to an application under section [355](/usc/21/355.md) or [360b](/usc/21/360b.md) of this title, or the use in question is [authorized](/usc/21/360eee.md?p=2) pursuant to another provision of this chapter relating to use of medical [products](/usc/21/360eee.md?p=13) in emergencies.
  - (2) **Oxygen—**
    - (A) **No prescription required for certain uses—** Notwithstanding [paragraph (1)](#b-1), oxygen may be provided without a prescription for the following uses:
      - (i) For use in the event of depressurization or other environmental oxygen deficiency.
      - (ii) For oxygen deficiency or for use in emergency resuscitation, when administered by properly trained personnel.
    - (B) **Labeling—** For oxygen provided pursuant to [subparagraph (A)](#b-2-A), the requirements of [section 353(b)(4) of this title](/usc/21/353.md?p=b-4) shall be deemed to have been met if its [labeling](/usc/21/321.md?p=m) bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required.

## Source credit

(June 25, 1938, ch. 675, § 576, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1109; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(S), Dec. 13, 2016, 130 Stat. 1155.)

## Notes

### Editorial Notes

### Amendments

2016—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”.