§360ddd–1 Regulation of medical gases

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 include a description of the gas, the sponsor’s name and address, the manufacturing site(s) address, and any other information the Secretary needs. The Secretary has 60 days to find problems. If within 60 days the Secretary does not say the gas is not designated, or that the request is missing required information, or that denial is needed to protect public health, the certification is treated as granted. A certified medical gas is treated as having an approved drug application for specific uses: oxygen for treating or preventing hypoxemia or hypoxia; nitrogen for hypoxic challenge testing; nitrous oxide for pain relief; carbon dioxide for ECMO or respiratory stimulation; helium for upper airway obstruction or high airway resistance; medical air to reduce hyperoxia risk; carbon monoxide for lung diffusion testing; and any other uses the Secretary allows unless a new-drug exclusivity period under clause (iii) or (iv) of section 355(c)(3)(E), clause (iii) or (iv) of section 355(j)(5)(F), or section 360cc, or its extension under section 355a, has not expired. The final container label must include the information required by section 353(b)(4), a warning the Secretary sets, and storage and handling directions to meet sections 353(b)(4) and 352(f). No exclusivity under sections 355(c), 355(j), or 360cc, or an extension under 355a, can be based on this treated approval. The Secretary may withdraw or suspend drug approvals and may revoke a certification for material omission or falsification. Designated medical gases are subject to the prescription rule in section 353(b)(1) unless the Secretary removes that requirement under section 353(b)(3), the gas is approved without a prescription under section 355 or 360b, or the use is allowed under other emergency rules. Oxygen may be supplied without a prescription for depressurization or other environmental oxygen deficiency and for emergency resuscitation by trained personnel; such oxygen must be labeled as for emergency use only and say a prescription is required for other medical uses to meet section 353(b)(4).