New FDA labeling requirements for medical gas cylinders: What you need to know
The US Food and Drug Administration (FDA) has issued a Final Rule amending several sections of Title 21 of the US Code of Federal Regulations (CFR), setting the stage for notable changes across the medical gas industry.
Published on June 18, 2024, this rule revises requirements around current good manufacturing practice (CGMP), post-marketing safety reporting (pharmacovigilance), and, most notably, labeling for designated medical gases.
While the rule does not take effect until December 18, industry stakeholders, especially those handling medical oxygen and medical air, should begin preparing now. The changes reflect a growing emphasis on patient safety and clear hazard communication, particularly considering evolving use environments such as home healthcare settings.
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