§211.94. Drug product containers and closures. — Inbound Citations

(f) The product container and container components meet the requirements of § 211.94 of this chapter.

(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:

(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.”

(1) Each portable cryogenic medical gas container must be conspicuously marked with a 360° wraparound label identifying its contents. Such label must meet the requirements of § 213.94(e)(3) of this chapter and the following additional requirements.

(i) If the container holds a single gas, the name of the gas held in the container must be printed on the label in one of the following ways:

(A) Using lettering that appears in the color designated for the gas in paragraph (c) of this section and that is printed against a white background, or

(B) Using lettering that appears in white against a background that is painted in the color for the gas designated in paragraph (c) of this section.

(ii) The lettering for the name of the gas on the label must be at least 2 inches high.

(iii) The name of the gas must be printed continuously around the label and be capable of being read around the entire container.

(iv) The label must be on the sidewall of the container, as close to the top of the container as possible but below the top weld seam.

(v) A portable cryogenic medical gas container may only be colored in the color or colors designated in paragraph (c) of this section if the gas or gases held within the container correspond to that color or those colors.