21 U.S.C. § 360ddd–1 — Regulation of medical gases

(a) Certification of designated medical gases (1) Starting 180 days after July 9, 2012, anyone who wants to be the first to bring a designated medical gas into interstate commerce may file a certification request with the Secretary. The request must include: (A) a description of the gas, (B) the sponsor's name and address, (C) the name and address of where it's made, and (D) any other information the Secretary decides is needed. (2) The certification is automatically granted unless, within 60 days, the Secretary finds: (A) the gas isn't actually a designated medical gas, (B) the request is missing required information or otherwise lacks enough detail, or (C) denying it is necessary to protect public health. (3)(A)(i) A certified designated medical gas — alone, or combined as medically appropriate with another certified gas — is treated as if it already has an approved application under section 355 or 360b, with all the usual post-approval requirements still applying, for these specific uses: (I) oxygen, for treating or preventing low blood or tissue oxygen; (II) nitrogen, for hypoxic challenge testing; (III) nitrous oxide, for pain relief; (IV) carbon dioxide, for use in ECMO therapy or breathing stimulation; (V) helium, for treating upper airway blockage or resistance; (VI) medical air, for reducing the risk of too much oxygen; (VII) carbon monoxide, for lung diffusion testing; and (VIII) any other use the Secretary approves, unless an unexpired exclusivity period covers that gas and use. (ii) The labeling requirements in sections 353(b)(4) and 352(f) count as met if the final container's label has: (I) the information required by section 353(b)(4), (II) a warning statement the Secretary sets by regulation, and (III) proper storage and handling directions. (B)(i) A certified medical gas treated as approved this way does not get to claim any new-drug exclusivity period based on that deemed approval. (ii) In turn, an exclusivity period on some other drug product cannot block, limit, or otherwise affect the submission, grant, or effect of a certification under this section — except as described in paragraph (3)(A)(i)(VIII) and section 360ddd(1)(H). (4)(A) None of this limits the Secretary's power to withdraw or suspend approval of a drug product, including a certified medical gas. (B) The Secretary may revoke a certification if the request contained a material omission or a false statement. (b) Prescription requirement (1) A designated medical gas normally needs a prescription under section 353(b)(1) — unless the Secretary removes that requirement using the authority in section 353(b)(3), the gas is approved for non-prescription use under an application under section 355 or 360b, or another provision allowing emergency use of medical products applies. (2)(A) Despite paragraph (1), oxygen can be given without a prescription: (i) during depressurization or another environmental oxygen shortage, or (ii) for oxygen deficiency or emergency resuscitation, when given by properly trained personnel. (B) For oxygen given this way, the labeling requirement in section 353(b)(4) is met if the label warns that the oxygen can be used for emergency purposes only, and that a prescription is required for all other medical uses.