Section 201.161 - [Effective 12/18/2025] Medical gases(a) The requirements of sections 503(b)(4) and 502(f) of the Federal Food, Drug, and Cosmetic Act are deemed to have been met for a designated medical gas or a medically appropriate combination of designated medical gases if the labeling on its final use container bears the following:(1) In the case of oxygen: (i) A warning statement providing that uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful; that oxygen should not be used on patients who have stopped breathing unless used in conjunction with resuscitative equipment; and, in the case of oxygen that may be provided without a prescription for use in the event of depressurization or other environmental oxygen deficiency, or for oxygen deficiency or for use in emergency resuscitation when administered by properly trained personnel, a warning statement providing that oxygen may be used for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation, and that for all other medical applications a prescription is required.(ii) A clear and prominent warning containing the statements "No Smoking" and "No Vaping" and a graphic symbol conveying that smoking, vaping, and open flames near oxygen are dangerous.(2) In the case of a designated medical gas other than oxygen, and in the case of medically appropriate combinations of any designated medical gases:(i) A warning statement providing that the administration of the gas or gas combination (as applicable) may be hazardous or contraindicated; and that the gas or gas combination (as applicable) should be used only by or under the supervision of a licensed practitioner who is experienced in the use and administration of the gas or gas combination (as applicable) and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.(ii) The symbol "Rx only."(3) Appropriate directions and warnings concerning storage and handling.(b) A designated medical gas or medically appropriate combination of designated medical gases in a bulk or transport container must be identified with the name of the product contained therein and accompanied by documentation identifying the product as meeting applicable compendial standards.(c) For purposes of this section:(1) A designated medical gas means a drug that: (i) Is manufactured or stored in a liquefied, nonliquefied, or cryogenic state;(ii) Is administered as a gas; and(iii) Meets the definition in section 575(1) of the Federal Food, Drug, and Cosmetic Act.(2) A final use container means a container that is for direct use or access by a patient or healthcare provider to administer a designated medical gas or medically appropriate combination of designated medical gases. The term final use container does not include bulk or transport containers and does not include containers that are described in § 868.5655 of this chapter.(3) A bulk or transport container means a container used to transport or store designated medical gases or medically appropriate combinations of designated medical gases and that is not used directly to administer such gases to a patient.81 FR 81696, Nov. 18, 2016 81 FR 81696, 1/17/2017; 89 FR 51768, 12/18/2025