PRIA, Government Policy, Made Personal

Summary

Starting 180 days after July 9, 2012, anyone who wants to first bring a “designated medical gas” into interstate commerce must ask the Secretary for a certification. The request must say what the gas is, who the sponsor is and where it is or will be made, and any other information the Secretary needs. The Secretary has 60 days to object. If the Secretary does not object in 60 days, the certification is treated as granted unless the gas is not a designated medical gas, the request is missing needed information, or denying it is needed to protect public health. A certified designated medical gas is treated as having an approved application for certain uses (for example: oxygen for treating or preventing low blood oxygen; nitrogen for hypoxic challenge testing; nitrous oxide for pain relief; carbon dioxide for ECMO or to stimulate breathing; helium for upper airway blockage or high airway resistance; medical air to lower risk of too much oxygen; carbon monoxide for lung diffusion testing), and for other uses the Secretary allows, unless a specific exclusivity period under sections 355(c)(3)(E)(iii) or (iv), 355(j)(5)(F)(iii) or (iv), or section 360cc, or its extension under section 355a, still applies. Labeling on the final container must include the info required by section 353(b)(4), a warning the Secretary sets, and storage/handling directions to meet sections 353(b)(4) and 352(f). The Secretary can withdraw approvals or revoke certifications for false or missing material facts. Designated medical gases are normally subject to prescription rules in section 353(b)(1), except when the Secretary removes that requirement, the gas is approved without a prescription under sections 355 or 360b, or emergency rules apply. Oxygen may be given without a prescription for depressurization or oxygen-deficient environments or for emergency resuscitation by trained staff; such emergency oxygen must be labeled that it is for emergency use only and that a prescription is required for other medical uses.

Title 21, §360ddd–1

Food and Drugs, Source: USLM XML via OLRC

(a)(1)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)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)(A)(i)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)The requirements of section 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)(i)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)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)(A)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)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)(1)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)(A)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)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.

Notes & Related Subsidiaries

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”.

§360ddd–1 Regulation of Medical Gases

Summary

Title 21, §360ddd–1

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata