Regulation of medical gases

21 U.S.C. § 360ddd–1

• Title: 21 — Food and Drugs
• Chapter: 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
• Subchapter: V
• Part: G
• Current through: Pub. L. 119-99

Text

(a) Certification of designated medical gases
(1) Submission
Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information:
(A) A description of the medical gas.
(B) The name and address of the sponsor.
(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.
(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.
(2) Grant of certification
The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that—
(A) the medical gas subject to the certification is not a designated medical gas;
(B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; 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 for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b 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 or combination of designated medical gases deemed appropriate by the Secretary, unless any period of exclusivity for a new drug under clause (iii) or (iv) of section 355(c)(3)(E) of this title, clause (iii) or (iv) of section 355(j)(5)(F) of this title, or section 360cc of this title, or the extension of any such period under section 355a of this title, 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) and 352(f) of this title are deemed to have been met for a designated medical gas if the labeling on the final use container for such medical gas bears—
(I) the information required by section 353(b)(4) of this title;
(II) a warning statement concerning the use of the medical gas as determined by the Secretary 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 deemed under subparagraph (A)(i) to have in effect an approved application is eligible for any period of exclusivity for a new drug under section 355(c), 355(j), or 360cc of this title, or the extension of any such period under section 355a of this title, on the basis of such deemed approval.
(ii) Effect on certification
No period of exclusivity under section 355(c), 355(j), or section 360cc of this title, or the extension of any such period under section 355a of this title, with respect to an application for a drug product, 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) and section 360ddd(1)(H) of this title.
(4) Withdrawal, suspension, or revocation of approval
(A) Withdrawal, suspension of approval
Nothing in this part limits the Secretary's authority to withdraw or suspend approval of a drug product, including a designated medical gas deemed under this section to have in effect an approved application under section 355 of this title or section 360b of this title.
(B) Revocation of certification
The Secretary may revoke the grant of a certification under paragraph (2) if the Secretary determines that the request for certification contains any material omission or falsification.
(b) Prescription requirement
(1) In general
A designated medical gas shall be subject to the requirements of section 353(b)(1) of this title unless the Secretary exercises the authority provided in section 353(b)(3) of this title to remove such medical gas from the requirements of section 353(b)(1) of this title, the gas is approved for use without a prescription pursuant to an application under section 355 or 360b of this title, or the use in question is authorized pursuant to another provision of this chapter relating to use of medical products in emergencies.
(2) Oxygen
(A) No prescription required for certain uses
Notwithstanding paragraph (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), the requirements of section 353(b)(4) of this title shall be deemed to have been met if its labeling bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required.

History

(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.)

Editorial 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".