Description
This guidance is intended to help small businesses better understand and comply with recently issued regulations on current good manufacturing practice (CGMP) and labeling for medical gases. On November 18, 2016 (81 FR 81685), FDA published a final rule “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” (ContainerClosure Rule or final rule). The final rule amends certain CGMP regulations regarding medical gases to increase the likelihood that the contents of medical gas containers are accurately identified on labeling and by container coloring and to reduce the likelihood of the wrong gas being connected to a supply system by requiring gas-specific outlet connections. The final rule also revises an existing labeling regulation (21 CFR 201.161) that exempts listed medical gases from certain otherwise-applicable labeling requirements under specified conditions (including meeting the applicable medical gas labeling and container closure requirements and including certain warning statement(s))
Scope & Applicability
Product Classes
5Designated medical gases as defined in section 575 of the FD&C Act; Specific reporting requirements for cylinder, dewar, or tank units
Includes oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air.; stability testing and expiration dating are not required for DMGs; Referred to as DMGs in distribution records; A drug manufactured or stored in a liquefied, nonliquefied, or cryogenic state
containers requiring 360 degree wraparound labels; Containers capable of being transported and intended to be attached to a medical gas supply system
Cylinders required to be colored on the shoulder portion
cylinders requiring color coding on the shoulder
Stakeholders
4Target audience for the compliance guide
Entities covered by the final rule including those who mix or fill gases
Personnel engaged in the manufacture or processing of medical gas.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
4Used to accurately identify the contents of medical gas containers
Permissible coloring for containers such as white
Specific colors assigned to different medical gases for identification
Labeling that allows the gas name to be seen from any vantage point
Identified Hazards
Hazards
1Risk of connecting incorrect gas to a supply system leading to injuries
Related CFR Sections (5)
- 21CFR201.161§ 201.161 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:Read full regulation →
- 21CFR211.94§ 211.94 Drug product containers and closures.
(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.Read full regulation →
- 21CFR211.125§ 211.125 Labeling issuance.
(a) Strict control shall be exercised over labeling issued for use in drug product labeling operations.Read full regulation →
- 21CFR201.328§ 201.328 Labeling of medical gas containers.
(a) Portable cryogenic medical gas containers. For the purposes of this section a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, orRead full regulation →
- 21CFR868.5655§ 868.5655 Portable liquid oxygen unit.
(a) Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen cRead full regulation →