REGULATION OF MEDICAL GASES.

SEC. 576. [21 U.S.C. 360ddd–1] REGULATION OF MEDICAL GASES. (a) Certification of Designated Medical Gases.— (1) Submission.—Beginning 180 days after the date of enactment of this section, 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 505 or 512, 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 505(c)(3)(E), clause (iii) or (iv) of section 505(j)(5)(F), or section 527, or the extension of any such period under section 505A, applicable to such indication for use for such gas or combination of gases has not expired. (ii) Labeling.—The requirements of sections 503(b)(4) and 502(f) 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 503(b)(4); (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 505(c), 505(j), or 527, or the extension of any such period under section 505A, on the basis of such deemed approval. (ii) Effect on certification.—No period of exclusivity under section 505(c), 505(j), or section 527, or the extension of any such period under section 505A, 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 575(1)(H). (4) Withdrawal, suspension, or revocation of approval.— (A) Withdrawal, suspension of approval.—Nothing in this subchapter 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 505 or section 512 of this Act. (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 503(b)(1) unless the Secretary exercises the authority provided in section 503(b)(3) to remove such medical gas from the requirements of section 503(b)(1), the gas is approved for use without a prescription pursuant to an application under section 505 or 512, or the use in question is authorized pursuant to another provision of this Act 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 503(b)(4) 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.